Pharmaceutical companies and healthcare providers: Going beyond the gift - An explorative review.

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Latten, Tom; Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk

2018-01-01

Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. The effects of bilateral interactions reported in the literature are similar to those reported in studies concerning unilateral

A CONTENT ANALYSIS OF THE MISSION STATEMENTS OF IRAN, TURKEY, INDIA AND UNITED STATES PHARMACEUTICAL COMPANIES

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Shahriar AZIZI

2014-06-01

Full Text Available Pharmaceutical companies play a critical role in healthcare economy. Articulating mission statement of a Pharmaceutical company results in guiding strategies and activities of the firm. In this survey, mission statements of Iranian, Turkish, Indian and American pharmaceutical companies are analyzed. By using content analysis, frequencies of nine elements of the mission statement according to Fred R. David including: customers, product/service, market, technology, survival/growth/profitability, philosophy, self-perception, public image and employee were investigated. 98 mission statements of pharmaceutical companies (32 iranain companies, 16 Turkish companies, 30 Indian companies, and 20 American companies were analyzed. Simple correspondence analysis was used to extract the perceptual map. Results indicate that two dimensions of perceptual map include: focus of mission (throughput or input/output, and focus of mission elements (market or support. Iranian companies placed on the quarter of throughput /support, American and Turkish companies placed on the quarter of throughput/market. Indian companies placed on the quarter of input and output/market.

Implementing Lean Manufacturing in Malaysian Small and Medium Startup Pharmaceutical Company

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Ibrahim, Wan Mohd Khairi bin Wan; Rahman, Mohamed Abdul; Abu Bakar, Mohd Rushdi bin

2017-03-01

Domestic pharmaceutical industry has been identified by the Malaysian government as an industry to be developed under its 11th economic development plan. Most homegrown pharmaceutical companies fall under the category of small and medium enterprises (SME) and therefore need to be highly efficient in their operations to compete with the multinationals. Though lean manufacturing is a well-known methodology to achieve an efficient operation, only a small percentage of the local SMEs implement it. The study aims to determine the real success factors in lean implementation through systematic review of relevant literature on lean manufacturing implementation in local companies, onsite observation of a selected SME company, Global Factor Sdn. Bhd. (GFSB), that successfully implemented lean manufacturing followed by actual implementation of lean project at IKOP Sdn. Bhd., a small startup pharmaceutical company. Lean tools like Gemba, value stream map (VSM) and spaghetti diagram were used to analyze and improve a process at IKOP Sdn. Bhd. The literature review showed that the implementation of lean manufacturing at Malaysian SMEs involved in pharmaceutical industry is at its infancy. Study at GFSB indicated that successful implementation of lean manufacturing stems from management support, employee’s commitment, government support and knowledge on lean among employees. Application of lean tools in IKOP Sdn. Bhd. to improve the process cycle efficiency of hand sanitizer, i-Hand 4.0, has shown that the GMP guidelines are not jeopardized. The Kaizen improvement project resulted in 46.3% reduction in lead time. It may be concluded that implementing lean manufacturing in any small local startup pharmaceutical company is beneficial in reducing operational costs and increasing the efficiency and effectiveness and does not conflict with the existing GMP guidelines.

Evaluation of productivity in Iranian pharmaceutical companies: A DEA-based Malmquist approach and panel data analysis.

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Varmaghani, Mehdi; Meshkini, Amir Hashemi; Farzadfar, Farshad; Yousefi, Mehdi; Yaghoubifard, Saeed; Varahrami, Vida; Darzi, Ehsan Rezaei; Anabi, Majid; Kebriaeezadeh, Abbas; Zekri, Hedieh-Sadat

2015-01-01

In this study, we aimed to assess comparative productivity of 21 pharmaceutical companies in Iran during 2000-2013. To evaluate the productivity trend of pharmaceutical companies in Iran, we used data envelopment analysis-based Malmquist index. "Total assets" and "capital stock" as inputs and "net sales" and "net profit" as outputs extracted from Tehran stock exchange, were selected to be included in the analysis. This method provides the possibility for analyzing the performance of each company in term of productivity changes over time. We also used an estimation generalized least square panel data model to identify the factors that might affect productivity of pharmaceutical companies in Iran using EViews 7 and Deep 2.1 software. The mean total productivity during all years of the study was 0.9829, which indicates the improvement in their overall productivity. The results, over the 13-year period, indicated that the range of productivity changes in pharmaceutical companies, that were included in this study, was between 0.884 and 1.098. Panel data model indicated that age of company could positively (t = 4.765978, P brand-generic scheme) and also the type of ownership did not have a significant effect on the productivity of pharmaceutical companies. In this study, pharmaceutical productivity trends were fluctuated that could be due to the sub-optimal attention of policy makers and managers of pharmaceutical companies toward long-term strategic planning, focusing on productivity improvement.

Legislative, educational, policy and other interventions targeting physicians' interaction with pharmaceutical companies: a systematic review.

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Alkhaled, Lina; Kahale, Lara; Nass, Hala; Brax, Hneine; Fadlallah, Racha; Badr, Kamal; Akl, Elie A

2014-07-01

Pharmaceutical company representatives likely influence the prescribing habits and professional behaviour of physicians. The objective of this study was to systematically review the effects of interventions targeting practising physicians' interactions with pharmaceutical companies. We included observational studies, non-randomised controlled trials (non-RCTs) and RCTs evaluating legislative, educational, policy or other interventions targeting the interactions between physicians and pharmaceutical companies. The search strategy included an electronic search of MEDLINE and EMBASE. Two reviewers performed duplicate and independent study selection, data abstraction and assessment of risk of bias. We assessed the risk of bias in each included study. We summarised the findings narratively because the nature of the data did not allow a meta-analysis to be conducted. We assessed the quality of evidence by outcome using the GRADE methodology. Of 11 189 identified citations, one RCT and three observational studies met the eligibility criteria. All four studies specifically targeted one type of interaction with pharmaceutical companies, that is, interactions with drug representatives. The RCT provided moderate quality evidence of no effect of a 'collaborative approach' between the pharmaceutical industry and a health authority. The three observational studies provided low quality evidence suggesting a positive effect of policies aiming to reduce interaction between physicians and pharmaceutical companies (by restricting free samples, promotional material, and meetings with pharmaceutical company representatives) on prescription behaviour. We identified too few studies to allow strong conclusions. Available evidence suggests a potential impact of policies aiming to reduce interaction between physicians and drug representatives on physicians' prescription behaviour. We found no evidence concerning interventions affecting other types of interaction with pharmaceutical

Renal studies in safety pharmacology and toxicology: A survey conducted in the top 15 pharmaceutical companies.

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Benjamin, Amanda; Gallacher, David J; Greiter-Wilke, Andrea; Guillon, Jean-Michel; Kasai, Cheiko; Ledieu, David; Levesque, Paul; Prelle, Katja; Ratcliffe, Sian; Sannajust, Frederick; Valentin, Jean-Pierre

2015-01-01

With the recent development of more sensitive biomarkers to assess kidney injury preclinically, a survey was designed i) to investigate what strategies are used to investigate renal toxicity in both ICH S7A compliant Safety Pharmacology (SP) studies after a single dose of a compound and within repeat-dose toxicity studies by large pharmaceutical companies today; ii) to understand whether renal SP studies have impact or utility in drug development and/or if it may be more appropriate to assess renal effects after multiple doses of compounds; iii) to ascertain how much mechanistic work is performed by the top 15 largest pharmaceutical companies (as determined by R&D revenue size); iv) to gain an insight into the impact of the validation of DIKI biomarkers and their introduction in the safety evaluation paradigm; and v) to understand the impact of renal/urinary safety study data on progression of projects. Two short anonymous surveys were submitted to SP leaders of the top 15 pharmaceutical companies, as defined by 2012 R&D portfolio size. Fourteen multiple choice questions were designed to explore the strategies used to investigate renal effects in both ICH S7A compliant SP studies and within toxicology studies. A 67% and 60% response rate was obtained in the first and second surveys, respectively. Nine out of ten respondent companies conduct renal excretory measurements (eg. urine analysis) in toxicology studies whereas only five out of ten conduct specific renal SP studies; and all of those 5 also conduct the renal excretory measurements in toxicology studies. These companies measure and/or calculate a variety of parameters as part of these studies, and also on a case by case basis include regulatory qualified and non-qualified DIKI biomarkers. Finally, only one company has used renal/urinary functional data alone to stop a project, whereas the majority of respondents combine renal data with other target organ assessments to form an integrated decision-making set

Pharmaceutical companies and healthcare providers: Going beyond the gift – An explorative review

Science.gov (United States)

Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk

2018-01-01

Introduction Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. Material and methods We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Results Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. Discussion and conclusion The effects of bilateral interactions reported in the literature are

Assessing stakeholder opinion on relations between cancer patient groups and pharmaceutical companies in Europe.

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Leto di Priolo, Susanna; Fehervary, Andras; Riggins, Phil; Redmond, Kathy

2012-01-01

The relationship between the pharmaceutical industry and cancer patient groups has been the subject of much scrutiny and skepticism, and some high-profile negative media coverage has focused attention on some of the problematic aspects of the relationship. Both the pharmaceutical industry and cancer patient groups have made an effort in recent years to improve the transparency and openness of their relations, specifically with regard to the financial support offered by pharmaceutical companies to patient groups. The objectives of this survey were to benchmark perceptions held by different stakeholder groups about current relationships between cancer patient groups and pharmaceutical companies in Europe, and to explore opinions about ways in which partnerships between patient groups and pharmaceutical companies could evolve to the benefit of cancer patients. The survey was conducted using a structured questionnaire that contained a combination of matrix, scaled, and open-ended questions. The questionnaire was developed based on a literature search and the findings from ten in-depth interviews conducted with policy makers and advocates working at an EU level. Telephone interviews were carried out using a structured questionnaire with a convenience sample of 161 policy makers, cancer healthcare group representatives, and cancer patient group leaders from France, Germany, Hungary, Italy, Latvia, the Netherlands, Poland, Portugal, Romania, Spain, Sweden, and the UK. The interviews took place in the relevant language of the country. The current relationship between the pharmaceutical industry and cancer patient groups in Europe is generally viewed as positive, but it is also viewed as being unequal, not transparent enough, and not sufficiently patient-centric. There is broad agreement that cancer patient groups can help companies identify unmet needs and contribute to the development of innovative medicines; however, there is some concern about cancer patients

Clinical trial allocation in multinational pharmaceutical companies – a qualitative study on influential factors

DEFF Research Database (Denmark)

Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik

2017-01-01

(1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting......Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were...... trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities...

ANALYSIS OF SCIENTIFIC RESEARCHES IN PHARMACEUTICAL PROMOTION GLOBALLY: TOWARDS INTERNATIONALLY DEVELOPING PRACTICALLY-ORIENTED GUIDELINES FOR PHARMACEUTICAL COMPANIES

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M. M. Bahlol

2016-01-01

Full Text Available Purpose. Pharmaceutical industry is transnational and globally important. Many pharmaceutical companies operate their business in multinational and international forms in different countries. Diverse researches from different countries indicated and confirmed marketing promotion importance in pharmaceutical field. Therefore, marketing promotion and its effects are a very important issue that should be globally investigated in real life and evidence context. We oriented our research according to these scientific and practical values.Methodology. We reviewed pharmaceutical marketing promotion researches from more than 25 different countries, e.g., USA, Canada, Italy, France, Russia, India, Egypt and Syria where we employed our knowledge of three widely spread languages, i.e., English, Russian and Arabic. Such language variation supports us with large and variable amount of scientific knowledge, deep understanding and ability of analysis. Some studies investigated average response to pharmaceutical marketing promotion and few studies took into consideration heterogeneity in their effects with respect to advertising medium or drug characteristics.Originality. We investigated empirical evidences of pharmaceutical marketing promotion that can be directed to either consumer or healthcare professionals.Findings. We extracted, gathered and associated information of pharmaceutical promotion globally which oriented us to several evidence and practical facts with regard to employing promotion tools in different definite situations pertinent to main directions; their welfare and health enhancing effects and adverse effects. Practical Implications- Consequently, we developed practically-oriented guidelines for companies concerning pharmaceutical promotion globally ate the end of this paper.

Advertising to the End Consumers by Pharmaceutical Companies: Blessing or Curse?

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Scott Goldberg

2013-10-01

Full Text Available The last several years have seen an increase inthe number of direct to consumer advertisements by pharmaceutical companies.Direct to Consumer advertisements (DTC means targeting the end consumerthrough advertisements on television, radio, in newspapers, magazines, and theInternet. The qualitative study presents data and supports  the need for a future quantitative study toask physicians and consumers their opinions on whether pharmaceutical companiesshould be allowed to advertise directly to the end consumer. This article reviewsthe literature on this controversial topic, supporting the need to explore thereserach questions in greater detail. A review of the literature suggests thereis financial motivation on the part of the pharmaceutical companies to increasetheir sales by advertsing directly to the end consumer as opposed to performingan educational service to the consumer.

The effect of capital structure on the profitability of pharmaceutical companies the case of iran.

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Mohammadzadeh, Mehdi; Rahimi, Farimah; Rahimi, Forough; Aarabi, Seyed Mohammad; Salamzadeh, Jamshid

2013-01-01

Funding combination is the most important issue for the companies while they know the amount of required capital. Companies should be careful regarding the appliance of financial providing methods compatible with the investment strategy of company and profitability. This study seeks to examine the relationship between the capital structure and the profitability of pharmaceutical companies in Iran. For this purpose, top 30 Iranian pharmaceutical companies defined as study samples and their financial data were gathered for the period of 2001-2010. In this study, the net margin profit and debts to asset ratio were used as indicators of profitability and capital structure, respectively and sales growth was used as a control variable. Results showed that there was significant negative relationship between the profitability and the capital structure which means that the pharmaceutical companies have established a Pecking Order Theory and the internal financing has led to more profitability.

MODERN METHODS OF PRICING IN THE STRATEGIC ACTIVITIES PLANNING OF PHARMACEUTICAL COMPANIES IN UKRAINE

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N. Slushaenko

2015-04-01

Full Text Available This article investigated the role of pricing for strategic activities of pharmaceutical companies. It has been modified Bass diffusion model for new products, and it has been conducted empirical testing of the model on the sample of the products of the Ukrainian pharmaceutical market. Among the analyzed pricing models for new product allocated to one that meets the needs of the pharmaceutical industry and is based on available statistics. Formed a clear selection algorithm pricing policy of the company to the new product.

Attitude and practice of dental surgeons towards pharmaceutical companies' marketing gifts.

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Tahir, Shaila; Rafique, Adeela; Ghafoor, Farkhanda; Saleem, Akif; Khan, Amanullah

2013-01-01

Interaction of pharmaceutical companies (PC) with healthcare services has been a reason for concern. In medicine, awareness of the ethical implications of these interactions have been emphasized upon, while this issue has not been highlighted in dentistry. This study undertook a cross-sectional rapid assessment procedure to gather views of dentists in various institutions towards unethical practices in health care and pharmaceutical industry. The purpose of this study was to assess the need for the formulation and implementation of guidelines for the interaction of dentists with the pharmaceutical and device industry in the best interest of patients. A group of 209 dentists of Lahore including faculty members, demonstrators, private practitioners and fresh graduates responded to a questionnaire to assess their attitudes and practices towards pharmaceutical companies' marketing gifts. The study was conducted during 2011 and provided interesting data that showed the pharmaceutical industry is approaching private practitioners more frequently than academicians and fresh graduates. Private practioners accepted the gifts but mostly recognized them as unethical (over 65%). Both groups considered sponsoring of on-campus lectures as acceptable (over 70%). Respondents are not fully aware of the ethical demands which are imperative for all health care industries, and there is a dire need of strict guidelines and code of ethics for the dentist's interaction with the pharmaceutical and device industry so that patient interest is protected.

What patients think about promotional activities of pharmaceutical companies in Turkey.

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Semin, Semih; Güldal, Dilek; Ozçakar, Nilgün; Mevsim, Vildan

2006-08-01

Drugs, as commercial products, are subject to diverse marketing methods including promotional activities. Although the legal/ethical aspects of promotional activities have been discussed in a limited manner, the patient has remained the neglected variable of this equation. The goal of our study, therefore, is to investigate the patients' opinion on the promotional activities of pharmaceutical companies. A descriptive study was conducted at 44 primary health care centers in Turkey and 584 volunteers who applied to these centers were included. A questionnaire consisting of 42 questions was developed with demographic information in the first section, and drug ads and promotions included in the second section. Chi-square test and logistic regression analysis were used for statistical analysis. The awareness and ethical evaluation of patients of the promotional activities. Nearly 83% of the participants were aware of the promotion issue. Eighty percent found it unethical, 82% suggested that promotional activities should be forbidden, restricted or regulated. 1/3 of the participants believed that physicians made their drug choices based on the gifts and ads of pharmaceutical companies. Half of them had low confidence in the prescriptions of physicians who accepted gifts from the pharmaceutical companies. 54.5% of patients also considered promotional activities as a factor which increased drug prices. In our study, a considerable number of patients were aware of promotions and the effects of promotion on prescriptions. The findings of our study may contribute to the development of effective regulations on this issue. Very strict measures controlling drug companies' promotion activities must be formulated. Further, these regulations must incorporate and take into consideration the patients' opinion. Today, the basic need for the proper use of drugs does not rest in pharmaceutical promotion, but in providing adequate health services and effective education for both people

Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.

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Geoffrey K Spurling

2010-10-01

Full Text Available BACKGROUND: Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing. METHODS AND FINDINGS: We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise. Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008, International Pharmaceutical Abstracts (1970 to February 2008, Embase (1997 to February 2008, Current Contents (2001 to 2008, and Central (The Cochrane Library Issue 3, 2007 using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies and other sources (138 studies. Articles were then excluded because they did not fulfil inclusion criteria (179 or quality appraisal criteria (18, leaving 58 included studies with 87 distinct

Clinical trial allocation in multinational pharmaceutical companies - a qualitative study on influential factors.

Science.gov (United States)

Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F

2017-06-01

Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

Is there an improvement on the Web sites of the national and international pharmaceutical companies in Turkey? A follow-up study.

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Yegenoglu, Selen; Aslan, Dilek; Sozen, Bilge

2012-04-01

In this follow-up study, we aimed to assess national and international pharmaceutical companies' Web sites using guidelines of The Association of Research-Based Pharmaceutical Companies (AIFD) and Pharmaceutical Manufacturers Association of Turkey (IEIS) to define whether there has been progress since 2004. We used two national guidelines in order to evaluate the Web sites of pharmaceutical companies in our study. The first guideline was from IEIS, and the second was from AIFD, which was issued recently. We collected our data between February 1 and April 30, 2011. Data analyses were performed using SPSS version 15.0. Chi squared test was done for comparing the two assessments in different years (2004 and 2011). In general, the progress that we were expecting was not satisfactory for both the international and national companies. The percentage of unmet criteria increased for "links" (from 48.0% to 52.0%) and for "mentioning the responsible person/firm for the Web site design" (from 40.6% to 59.4%) among national companies. We observed statistically significant progress only for the "information for the public" criterion (from 52.9% to 100%) among international companies. On the other hand, there was progress and a statistically significant difference in terms of not displaying any "drug ads" on the Web sites of national firms (from 55.9% to 87.5%), availability of "mail address" (from 88.2% to 100%), "telephone number" (from 88.2% to 100%), "indication of the target group" (from 23.5% to 52.1%), and "disclaimer stating the given information cannot replace a physician or pharmacist" (from 29.4% to 53.1%). Our major recommendation to pharmaceutical companies is to update their Web sites with evidence-based scientific information about themselves and their products using international and national standards. From the companies' perspective, this should be a priority responsibility based on the ethical aspect of individual and community health.

Author Self-disclosure Compared with Pharmaceutical Company Reporting of Physician Payments.

Science.gov (United States)

Alhamoud, Hani A; Dudum, Ramzi; Young, Heather A; Choi, Brian G

2016-01-01

Industry manufacturers are required by the Sunshine Act to disclose payments to physicians. These data recently became publicly available, but some manufacturers prereleased their data since 2009. We tested the hypotheses that there would be discrepancies between manufacturers' and physicians' disclosures. The financial disclosures by authors of all 39 American College of Cardiology and American Heart Association guidelines between 2009 and 2012 were matched to the public disclosures of 15 pharmaceutical companies during that same period. Duplicate authors across guidelines were assessed independently. Per the guidelines, payments disclosure was poor (κ = 0.238). There was a significant difference in error rates of disclosure among companies and authors (P = .019). Of disclosures by authors, companies failed to match them with an error rate of 71.6%. Of disclosures by companies, authors failed to match them with an error rate of 54.7%. Our analysis shows a concerning level of disagreement between guideline authors' and pharmaceutical companies' disclosures. Without ability for physicians to challenge reports, it is unclear whether these discrepancies reflect undisclosed relationships with industry or errors in reporting, and caution should be advised in interpretation of data from the Sunshine Act. Copyright © 2016 Elsevier Inc. All rights reserved.

CONSUMER PERCEPTION AND BRAND LOYALTY TOWARDS OVER THE COUNTER BRAND MEDICINES OF MAJOR PHARMACEUTICALS COMPANIES WITH SPECIAL REFERENCE TO RAJASTHAN

OpenAIRE

Abhishek Dadhich; Prof. (Dr.) Kavaldeep Dixit

2017-01-01

The study intends to explore the consumer perception towards over-the-counter (OTC) medicines and factors that influence consumer buying behavior for OTC brand medicines marketed by pharmaceutical companies. It also aims to study the impact of marketing mix factors on consumer perception and OTC brand loyalty. The research is descriptive in nature. It is based on primary data which is collected via structured questionnaire. The hundred respondents were participated in pilot study to understan...

The impact of total quality management on competitive advantage of pharmaceutical manufacturing companies in Jordan

OpenAIRE

Kamal A. M. Al-Qudah

2012-01-01

TQM is a general philosophy of management that attempts to enhance competitive advantage of organizations, This paper aims to investigate the impact of total quality management on competitive advantage of Pharmaceutical manufacturing companies in Jordan. The data are collected from mid- to senior-level managerial employees of Pharmaceutical manufacturing companies in Jordan. The data were analyzed using correlation and multiple regression analyses. The results indicate that, there is effec...

Validity of tools used for surveying physicians about their interactions with pharmaceutical company: a systematic review.

Science.gov (United States)

Lotfi, Tamara; Morsi, Rami Z; Zmeter, Nada; Godah, Mohammad W; Alkhaled, Lina; Kahale, Lara A; Nass, Hala; Brax, Hneine; Fadlallah, Racha; Akl, Elie A

2015-11-25

There is evidence that physicians' prescription behavior is negatively affected by the extent of their interactions with pharmaceutical companies. In order to develop and implement policies and interventions for better management of interactions, we need to understand physicians' perspectives on this issue. Surveys addressing physicians' interactions with pharmaceutical companies need to use validated tools to ensure the validity of their findings. To assess the validity of tools used in surveys of physicians about the extent and nature of their interactions with pharmaceutical companies, and about their knowledge, beliefs and attitudes towards such interactions; and to identify those tools that have been formally validated. We developed a search strategy with the assistance of a medical librarian. We electronically searched MEDLINE and EMBASE databases in September 2015. Teams of two reviewers conducted data selection and data abstraction. They identified eligible studies in one table and then abstracted the relevant data from the studies with validated tools in another table. Tables were piloted and standardized. We identified one validated questionnaire out of the 11 assessing the nature and extent of the interaction, and three validated questionnaires out of the 47 assessing knowledge, beliefs and attitudes of physicians toward the interaction. None of these validated questionnaires were used in more than one survey. The available supporting evidence of the issue of physicians' interaction with pharmaceutical company is of low quality. There is a need for research to develop and validate tools to survey physicians about their interactions with pharmaceutical companies.

Analysis the Efficiency and Productivity of Indonesian Pharmaceutical Public Companies Using Data Envelopment Analysis

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Dewi Hanggraeni

2014-08-01

Full Text Available As one of the biggest medicines market in the South East Asia, the pharmaceutical industry inIndonesia has a huge potential market. However, the majority supply of raw materials has been imported.Besides, regulations of the Health Ministry and the Trade Ministry have still hampered mostplayers in Indonesia pharmaceutical industry. Therefore, this study used Data Envelopment Analysis(DEA models to analyze efficiency and productivity change in the Indonesian pharmaceutical industrybetween 2006 and 2011, listed in the Indonesia Stock Exchange and also supported by applyingefficiency financial ratio. This study finds that the decision for the most relatively efficient companyis different using DEA compared to efficiency financial ratios, yet DEA has better measurement ofefficiency. It is proven by one of State-owned Enterprises has been evaluated underperformed by thefinancial ratio analysis, unexpectedly is efficient using the DEA approach. This study has also proposedand tested a hypothesis on the average efficiency to check if the domestic and foreign pharmaceuticalcompanies differ in their efficiency but the result implies that there is no significant statisticaldifference among them. This study indicates that firms having dominant contribution in selling overthe-counter medicines are more efficient than selling ethical medicines. Lastly, technological changecontribution has more influence to productivity change instead of pure technical efficiency change inIndonesia pharmaceutical companies.

Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies-Why and What?

OpenAIRE

Gummerus, Anu; Airaksinen, Marja; Bengtström, Mia; Juppo, Anne

2016-01-01

The purpose of this study was to investigate what kind of regulatory affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries. The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake regulatory affairs. The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related t...

Patient organizations' funding from pharmaceutical companies: is disclosure clear, complete and accessible to the public? An Italian survey.

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Cinzia Colombo

Full Text Available BACKGROUND: Many patients' and consumers' organizations accept drug industry funding to support their activities. As drug companies and patient groups move closer, disclosure become essential for transparency, and the internet could be a useful means of making sponsorship information accessible to the public. This survey aims to assess the transparency of a large group of Italian patient and consumer groups and a group of pharmaceutical companies, focusing on their websites. METHODOLOGY/PRINCIPAL FINDINGS: Patient and consumer groups were selected from those stated to be sponsored by a group of pharmaceutical companies on their websites. The websites were examined using two forms with principal (name of drug companies providing funds, amount of funding and secondary indicators of transparency (section where sponsors are disclosed, update of sponsorship. Principal indicators were applied independently by two reviewers to the patient and consumer groups' websites. Discordances were solved by discussion. One hundred fifty-seven Italian patient and consumer groups and 17 drug companies were considered. Thirteen drug companies (76% named at least one group funded, on their Italian websites. Of these, four (31% indicated the activities sponsored and two (15% the amount of funding. Of the 157 patient and consumer groups, 46 (29% named at least one pharmaceutical company as providing funds. Three (6% reported the amount of funding, 25 (54% the activities funded, none the proportion of income derived from drug companies. Among the groups naming pharmaceutical company sponsors, 15 (33% declared them in a dedicated section, five (11% on the home page, the others in the financial report or other sections. CONCLUSIONS/SIGNIFICANCE: Disclosure of funds is scarce on Italian patient and consumer groups' websites. The levels of transparency need to be improved. Disclosure of patient and consumer groups provided with funds is frequent on Italian pharmaceutical

The effect of educational gifts from pharmaceutical firms on medical students' recall of company names or products.

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Sandberg, W S; Carlos, R; Sandberg, E H; Roizen, M F

1997-10-01

To assess the influence of pharmaceutical advertising (in the form of books) directed at medical students and also to examine students' attitudes toward pharmaceutical representatives after interacting with them. Two groups of fourth-year medical students were surveyed: 166 residency applicants to the Department of Anesthesia and Critical Care between 1991 and 1993, who were questioned during their personal interviews with the department chair, and 39 fourth-year students from the University of Chicago Pritzker School of Medicine in 1994-95, who were surveyed by telephone. The students were asked if they had ever received a book from a pharmaceutical representative and, if so, to name the book. Then they were asked to name the book-giving company or a product associated with the company. Responses were compared using chi-square analysis. In all, 90% of the students had received one or more books and accurately recalled titles for 89% of them. However, only 25% of the named books were accurately associated with a pharmaceutical company or product. The Pritzker students, asked to recall interactions with pharmaceutical representatives, reported being skeptical of representatives who ignored them because they were students, but they rated as helpful and informative those who conversed with them or gave them gifts. Although gifts to medical students do not necessarily engender company or product recall, attention paid to medical students by pharmaceutical representatives engenders goodwill toward the representatives and their messages.

Ethics of pharmaceutical company relationships with the nursing profession: no free lunch...and no more pens?

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Crock, Elizabeth

2009-10-01

In recent years, nurses have increasingly become recipients of pharmaceutical company gifts, funding and sponsorship. There has been little discussion in the nursing literature, however, of the ethical and professional implications of nurses' acceptance of such sponsorship. This article examines ethical issues related to the issue of nurses' accepting benefits from pharmaceutical companies (and other commercial enterprises). It aims to encourage nurses to look critically at the implications of accepting such gifts/sponsorship, or to enter any form of relationship with commercial companies within the health sector, and to stimulate further discussion of this issue within the profession.

Russian Pharmaceutical Companies Export Potential in Emerging Regional Clusters

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Elena Vladimirovna Sapir

2016-12-01

Full Text Available This article analyzes a diverse range of the enterprise’s export potential growth factors in emerging pharmaceutical clusters of Central European Russia. Classification and comparative analysis were used to identify export potential attributes (production, finance, labor and marketing, which have allowed to reveal the strong connection of cluster and regional factor groups with the results of export performance. The purpose of the study is to provide exports-seeking pharmaceutical companies with a set of tools to enhance their export potential. The hypothesis that the cumulative impact of the specified attributes leads to the strengthening of pharmaceutical cluster export potential and promotes an effective integration of the region in the world economic space, is developed and tested. The methodology combines the geo-economy-based theory with the theory of clusters competitive advantages. The impacts of export potential growth factors are estimated by using an econometric model based on math statistics. Thus, five Russian regional pharmaceutical clusters (Belgorod, Kaluga, Moscow, Oryol, Yaroslavl are shown. Findings identify an objective causal link between enterprise export potential growth and competitiveness factors of cluster origin (network business chains, production functions interconnectedness and flexibility, production localization. An action plan for the purpose of the maximum use of competitive advantages of the cluster organization for export activities of the entities of the pharmaceutical industry is developed. Conclusions and recommendations of the study are intended to enterprises in pharmaceutical industry and regions’ public authorities, implementing cluster development strategies. It is thus essential to improve marketing and organizational innovations, reduction of commercial expenses under the cluster environment, development of drugs production and delivery chains from R&D to end-users in order to enjoy greater

Pharmaceutical companies and healthcare providers : Going beyond the gift. An explorative review

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Latten, Tom; Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk

2018-01-01

Introduction: Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to

Risk Analysis for Performance Improvement in a Romanian Pharmaceutical Company

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Dana Corina Deselnicu

2018-05-01

Full Text Available The paper presents risk management analysis carried out to investigate the operations of a Romanian company dealing with the distribution of pharmaceutical products. The main risks challenging the company were identified, described and classified, providing a scientific base for further analysis. Then, the identified inherent risks were evaluated using tools as the risk index method and the risk matrix in order to emphasize their tolerance level. According to the results of the evaluation, risk mitigation strategies and measures were advanced for the management of the analysed risks. Relevant conclusions were drawn from the experience.

Implementation of Supply Chain Management (SCM in pharmaceutical company, general principles and case study

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Zoran Nakov

2014-12-01

Full Text Available Supply Chain Management (SCM in pharmaceutical industry is defined as a “responsible SCM” and its implementation is according to the principles of: business ethics, rights of labor and principles of healthy and safe working environment. Pharmaceutical companies with implemented “responsible SCM” have to use management systems to facilitate continuous improvement in accordance with their working principles. The main purpose of this management system is to ensure the consistency, reliability and continuous improvement of all workflows within an organization.The analyzed case describes the project of European generic pharmaceutical company, which intends to implement best practice SCM operations for five European manufacturing sites and European logistics organizations (active ingredients supply, distribution centers, affiliate customers and third party manufacturers. The main objectives of the project were the creation of the future improved To-Be situation through implementation of new SCM models to the existing To-Day situation.

Corporate preparedness for pandemic influenza: a survey of pharmaceutical and biotechnology companies in Montgomery County, Maryland.

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Watkins, Rissah J; Barnett, Daniel J; Links, Jonathan M

2008-09-01

We conducted a survey of corporate preparedness for pandemic influenza among biotechnology and pharmaceutical companies in Montgomery County, Maryland, to determine the level of preparedness for this industry and geographic region. The survey, based on the HHS Business Pandemic Influenza Planning Checklist, established whether a company had a preparedness plan specific to pandemic influenza, the contents of its plan, or its reasons for a lack of a plan. A total of 50 companies participated in the survey. Of these, 40 did not have any type of preparedness plan, 3 were drafting plans, 6 had general preparedness plans that could be applied to an influenza pandemic, and only 1 company had a preparedness plan specifically designed to address pandemic influenza. Biotechnology and pharmaceutical companies in this geographic region are currently not well prepared for pandemic influenza. Public health officials should offer more help, possibly in the form of a model small business preparedness plan, and collaboration between companies should be encouraged to foster sharing of preparedness plans.

Interaction between pharmaceutical companies and physicians who prescribe antiretroviral drugs for treating AIDS

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Mario Cesar Scheffer

Full Text Available CONTEXT AND OBJECTIVE: Given that Brazil has a universal public policy for supplying medications to treat HIV and AIDS, the aim here was to describe the forms of relationship between physicians and the pharmaceutical companies that produce antiretrovirals (ARVs. DESIGN AND SETTING: Cross-sectional epidemiological study conducted in the state of São Paulo. METHODS : Secondary database linkage was used, with structured interviews conducted by telephone among a sample group of 300 physicians representing 2,361 professionals who care for patients with HIV and AIDS. RESULTS : Around two thirds (64% of the physicians prescribing ARVs for HIV and AIDS treatment in the state of São Paulo who were interviewed declared that they had some form of relationship with pharmaceutical companies, of which the most frequent were receipt of publications (54%, visits by sales promoters (51% and receipt of small-value objects (47%. CONCLUSIONS: Two forms of relationship between the pharmaceutical industry and physicians who deal with HIV and AIDS can be highlighted: facilitation of professionals' access to continuing education; and antiretroviral drug brand name promotion.

A study on the interactions of doctors with medical representatives of pharmaceutical companies in a Tertiary Care Teaching Hospital of South India.

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Gupta, Sandeep Kumar; Nayak, Roopa P; Sivaranjani, R

2016-01-01

The promotional activities by medical representatives (MRs) of the pharmaceutical companies can impact the prescribing pattern of doctors. Hence, the interaction between doctors and the pharmaceutical industry is coming under increasing scrutiny. The primary objective was to assess the attitude of the doctors toward the interaction with the MRs of the pharmaceutical company. The secondary objective was to assess the awareness of the doctors about regulations governing their interaction with the pharmaceutical company. This was a cross-sectional study. This study was carried out using a pretested questionnaire containing 10 questions between June and September 2014. The doctors working in the Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur (Tamil Nadu) during the study period was included. A total of 100 pretested questionnaires were distributed, and 81 doctors responded (response rate 81%). 37% doctors responded that they interacted with MR once a week whereas 25.9% told that they interact with MRs twice a month. About 69.1% doctors think that MR exaggerate the benefits of medicines and downplays the risks and contraindications of medicine(P = 0.000). 61.7% doctors think that MR has an impact on their prescribing (P = 0.000). 63% doctors stated that they had received promotional tools such as stationery items, drug sample, textbooks or journal reprints from MR in last 12 months (P = 0.0012). Unfortunately, 70.4% doctors have not read the guidelines about interacting with the pharmaceutical industry or its representative (P = 0.000). Rather than forbidding any connection between doctors and industry, it is better to establish ethical guidelines. The Medical Council of India code is a step in the right direction, but the majority of doctors in this study have not read the guidelines about interacting with the pharmaceutical industry or its representative.

A study on the interactions of doctors with medical representatives of pharmaceutical companies in a Tertiary Care Teaching Hospital of South India

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Sandeep Kumar Gupta

2016-01-01

Full Text Available Background: The promotional activities by medical representatives (MRs of the pharmaceutical companies can impact the prescribing pattern of doctors. Hence, the interaction between doctors and the pharmaceutical industry is coming under increasing scrutiny. Objective: The primary objective was to assess the attitude of the doctors toward the interaction with the MRs of the pharmaceutical company. The secondary objective was to assess the awareness of the doctors about regulations governing their interaction with the pharmaceutical company. Materials and Methods: This was a cross-sectional study. This study was carried out using a pretested questionnaire containing 10 questions between June and September 2014. The doctors working in the Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur (Tamil Nadu during the study period was included. Results: A total of 100 pretested questionnaires were distributed, and 81 doctors responded (response rate 81%. 37% doctors responded that they interacted with MR once a week whereas 25.9% told that they interact with MRs twice a month. About 69.1% doctors think that MR exaggerate the benefits of medicines and downplays the risks and contraindications of medicine(P = 0.000. 61.7% doctors think that MR has an impact on their prescribing (P = 0.000. 63% doctors stated that they had received promotional tools such as stationery items, drug sample, textbooks or journal reprints from MR in last 12 months (P = 0.0012. Unfortunately, 70.4% doctors have not read the guidelines about interacting with the pharmaceutical industry or its representative (P = 0.000. Conclusion: Rather than forbidding any connection between doctors and industry, it is better to establish ethical guidelines. The Medical Council of India code is a step in the right direction, but the majority of doctors in this study have not read the guidelines about interacting with the pharmaceutical industry or its representative.

R&D investments for neglected diseases can be sensitive to the economic goal of pharmaceutical companies.

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Dimitri, Nicola

2012-08-01

A fundamental problem with neglected diseases is how to induce pharmaceutical companies to invest resources for developing effective treatments. A recent debate focused on the role of economic incentives represented by monetary transfers to the firms. In this article I focus on the economic goals of pharmaceutical companies, as determinants for R&D effort. In particular, within a stylized framework, the work compares expected profit and expected productivity maximization, arguing that the former in general induces higher R&D investments than the latter. Therefore, as it is currently the case, when pharmaceutical firms focus on productivity, appropriate economic incentives might be needed for them to invest in R&D for neglected diseases. Copyright © 2012 Elsevier Ltd. All rights reserved.

Marketing orientation in pharmaceutical industry

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Prošić Danica

2006-01-01

Full Text Available Pharmaceutical companies are major stakeholders in the global health agenda Virtually all drugs used by patients in Europe reach markets through the promotion tactics of a small number of corporations with a tremendous impact on global health. The sector is both fast growing and highly profitable. Effective marketing strategies are a crucial ingredient in making sure pharmaceutical products and profits flow in a virtuous cycle. At first glance, the relationship between doctors and drug companies, as well as advertising practices for over-the-counter medication, appears tightly regulated. According to many consumer organizations, drug promotion in Europe today can be characterized as nice and friendly marketing. This refers to the creation of a false sense of trust that consumers associate with branded pharmaceutical products, as a result of pharmaceutical marketing efforts disguised as genuine corporate responsibility.

Challenges of access to medicine and the responsibility of pharmaceutical companies: a legal perspective.

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Ahmadiani, Saeed; Nikfar, Shekoufeh

2016-05-04

The right to health as a basic human right- and access to medicine as a part of it- have been a matter of attention for several decades. Also the responsibilities of different parties- particularly pharmaceutical companies- in realization of this right has been emphasized by World Health Organization. This is while many companies find no incentive for research and development of medicines related to rare diseases. Also some legal structures such as "patent agreements" clearly cause huge difficulties for access to medicine in many countries. High prices of brand medicine and no legal production of generics can increase the catastrophic costs- as well as morbidity-mortality of medication in lower income countries. Here we evidently review the current challenges in access to medicine and critically assess its legal roots. How societies/governors can make the pharmaceutical companies responsible is also discussed to have a look on possible future and actions that policy makers- in local or global level- can take.

Measuring the efficiency of large pharmaceutical companies: an industry analysis.

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Gascón, Fernando; Lozano, Jesús; Ponte, Borja; de la Fuente, David

2017-06-01

This paper evaluates the relative efficiency of a sample of 37 large pharmaceutical laboratories in the period 2008-2013 using a data envelopment analysis (DEA) approach. We describe in detail the procedure followed to select and construct relevant inputs and outputs that characterize the production and innovation activity of these pharmaceutical firms. Models are estimated with financial information from Datastream, including R&D investment, and the number of new drugs authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) considering the time effect. The relative performances of these firms-taking into consideration the strategic importance of R&D-suggest that the pharmaceutical industry is a highly competitive sector given that there are many laboratories at the efficient frontier and many inefficient laboratories close to this border. Additionally, we use data from S&P Capital IQ to analyze 2071 financial transactions announced by our sample of laboratories as an alternative way to gain access to new drugs, and we link these transactions with R&D investment and DEA efficiency. We find that efficient laboratories make on average more financial transactions, and the relative size of each transaction is larger. However, pharmaceutical companies that simultaneously are more efficient and invest more internally in R&D announce smaller transactions relative to total assets.

STOCHASTIC MODELING OF OPTIMIZED CREDIT STRATEGY OF A DISTRIBUTING COMPANY ON THE PHARMACEUTICAL MARKET

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M. Boychuk

2015-10-01

Full Text Available The activity of distribution companies is multifaceted. Ihey establish contacts with producers and consumers, determine the range of prices of medicines, do promotions, hold stocks of pharmaceuticals and take risks in their further selling.Their internal problems are complicated by the political crisis in the country, decreased purchasing power of national currency, and the rise in interest rates on loans. Therefore the usage of stochastic models of dynamic systems for the research into optimizing the management of pharmaceutical products distribution companies taking into account credit payments is of great current interest. A stochastic model of the optimal credit strategy of a pharmaceutical distributor in the market of pharmaceutical products has been constructed in the article considering credit payments and income limitations. From the mathematical point of view the obtained problem is the one of stochastic optimal control where the amount of monetary credit is the control and the amount of pharmaceutical product is the solution curve. The model allows to identify the optimal cash loan and the corresponding optimal quantity of pharmaceutical product that comply with the differential model of the existing quantity of pharmaceutical products in the form of Ito; the condition of the existing initial stock of pharmaceutical products; the limitation on the amount of credit and profit received from the product selling and maximize the average integral income. The research of the stochastic optimal control problem involves the construction of the left process of crediting with determination of the shift point of that control, the choice of the right crediting process and the formation of the optimal credit process. It was found that the optimal control of the credit amount and the shift point of that control are the determined values and don’t depend on the coefficient in the Wiener process and the optimal trajectory of the amount of

Pharmaceutical supply chain risks: a systematic review

Science.gov (United States)

2013-01-01

Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

Pharmaceutical supply chain risks: a systematic review.

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Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul

2013-12-19

Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.

Adverse-drug-event data provided by pharmaceutical companies.

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Cudny, Magdalena E; Graham, Angie S

2008-06-01

Pharmaceutical company drug information center (PCDIC) responses to queries about adverse drug events (ADEs) were studied to determine whether PCDICs search sources other than the prescribing information on the package insert (PI) and whether the PCDICs' approach differs according to whether an ADE is listed in the PI (labeled) or not (unlabeled). Companies were selected from a list of PCDICs in the Physicians' Desk Reference. One oral or injectable prescription drug from each company was selected. For each drug, a labeled ADE and an unlabeled ADE about which to query the PCDICs were randomly selected from the index of an annual publication on ADEs. The investigators telephoned the PCDICs with an open-ended inquiry about the incidence, timing, and management of the ADE as reported in the literature and the company's internal data; they clarified that the request did not concern a specific patient. Whether or not information was provided, the source searched was recorded (PI, literature, internal database), and the percentages of PCDICs that used each source for labeled and for unlabeled ADEs were analyzed. Results were obtained from 100 companies to questions about 100 drugs (200 ADEs). For ADEs overall, 80% used the PI, 50% the medical literature, and 38% internal data. For labeled versus unlabeled ADEs, respectively, the PI was used by 84% and 76%; literature, both 50%; and internal data, 35% and 41%. The PCDIC specialists referencing the PI did not always provide accurate or up-to-date information. Some specialists, when asked to query internal databases, said that was not an option. For both labeled and unlabeled ADEs, the PI was the primary source used by PCDICs to answer safety questions about their products, and internal data were the least-used source. Most resources used by PCDICs are readily available to practicing pharmacists.

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

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Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

Attitudes of medical students towards incentives offered by pharmaceutical companies- perspective from a developing nation- a cross sectional study

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2014-01-01

Background A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceutical companies and their incentives. Methods As part of a cross-sectional survey, a validated questionnaire previously used for assessing attitude of medical students towards pharmaceutical industry, was modified, pre-tested and distributed among consenting clinical year students at DUHS and AKU. Questions included acceptability of pharmaceutically sponsored gifts, events and tuition fee, and their impact on future prescription. Responses were graded as agree, disagree or neutral which were then scored according to the AMSA guidelines of ethical conduct. Results Out of a total of 353 targeted students 303 responded, corresponding to a response rate of 85.8%. Responses indicated that 42.7% students believed in no interaction with drug companies during medical school. However, 81% of students favored pharmaceutical sponsorship of student-body events/seminars at medical colleges. More than one-third of the students were comfortable receiving gifts from drug companies. Overall, the results of this study offer an interesting comparison between the students of a private medical school (AKU) and a public medical school (DUHS); AKU students exhibited a greater degree of mistrust towards drug information provided by pharmaceutical companies compared to DUHS students (p = 0.040). Furthermore, when asked if there was a need to incorporate guidelines in the undergraduate curriculum with regard to interaction with drug companies, 84.2% students at AKU agreed

Attitudes of medical students towards incentives offered by pharmaceutical companies -- perspective from a developing nation -- a cross-sectional study.

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Siddiqui, Usman Tariq; Shakoor, Amarah; Kiani, Sarah; Ali, Farwa; Sharif, Maryam; Kumar, Arun; Raza, Qasim; Khan, Naseer; Alamzaib, Sardar Mohammed; Farid-ul-Husnain, Syed

2014-05-05

A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceutical companies and their incentives. As part of a cross-sectional survey, a validated questionnaire previously used for assessing attitude of medical students towards pharmaceutical industry, was modified, pre-tested and distributed among consenting clinical year students at DUHS and AKU. Questions included acceptability of pharmaceutically sponsored gifts, events and tuition fee, and their impact on future prescription. Responses were graded as agree, disagree or neutral which were then scored according to the AMSA guidelines of ethical conduct. Out of a total of 353 targeted students 303 responded, corresponding to a response rate of 85.8%. Responses indicated that 42.7% students believed in no interaction with drug companies during medical school. However, 81% of students favored pharmaceutical sponsorship of student-body events/seminars at medical colleges. More than one-third of the students were comfortable receiving gifts from drug companies. Overall, the results of this study offer an interesting comparison between the students of a private medical school (AKU) and a public medical school (DUHS); AKU students exhibited a greater degree of mistrust towards drug information provided by pharmaceutical companies compared to DUHS students (p = 0.040). Furthermore, when asked if there was a need to incorporate guidelines in the undergraduate curriculum with regard to interaction with drug companies, 84.2% students at AKU agreed, compared to 54.9% at DUHS. Medical

How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

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Fleuranceau-Morel, P

2002-01-01

It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated

Developing good scientific publishing practices: one pharmaceutical company's perspective.

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Dowsett, Sherie A; Van Campen, Luann E; Bednar, Lisa A

2010-06-01

The scientific publishing practices of the pharmaceutical industry have been heavily criticized in recent years due to the inherent conflict of interest that arises when a pharmaceutical company publishes findings around its own drugs. Eli Lilly and Company ('Lilly') strives for transparency in its day-to-day activities, and, here, shares its principles, policies and practices on publishing "Lilly-sponsored" research. A conflict of interest does not necessarily equate to biased presentation of research findings, and operating a successful, for-profit business and maintaining a focus on improving the health of patients are not mutually exclusive goals. There is, however, potential for bias, and it is incumbent upon a for-profit to develop publication principles, policies and practices to address this. To this end, Lilly's Principles of Medical Research states that 'Lilly discloses publicly all medical research results that are important to patients, healthcare providers or payers--whether favorable or unfavorable to a Lilly product--in an accurate, objective, and balanced manner ...' The preparation of publications of Lilly-sponsored research involves close collaboration between external (i.e., academic or otherwise non-industry employees) and Lilly scientific researchers (including scientific writers), with both serving as authors. Lilly does not support 'ghost' or 'guest' authorship. Authorship is not just recognition of contribution but also public acknowledgement of responsibility for content, and all authors are expected to take an active role in developing the manuscript in line with the International Committee of Medical Journal Editors-based authorship requirements. This is agreed to by authors before the manuscript is started. Lilly provides external authors with access to the trial data for manuscript development. Lilly does not pay external authors for their involvement in manuscript development. Scientific writers at Lilly, often with advanced scientific

HRM Practices and its Impact on Employee Satisfaction: A Case of Pharmaceutical Companies in Bangladesh

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Solaiman Chowdhury

2016-01-01

compensation policy, performance appraisal, and industrial relations. The study suggests that the pharmaceutical companies should develop proper human resource policy and given emphasis on proper human resource practices to enhance the satisfaction of their employees and build them effective human resources.

The effects of advertising on sales in the pharmaceutical industry in ...

African Journals Online (AJOL)

Although advertising accounts for a major share of promotional expenditure of most companies in the pharmaceutical industry, most of them manifest considerable ignorance about how advertising works. This study aimed at determining the effect of advertising on the sales of pharmaceutical products bearing in mind the ...

R&D implementation in a department of laboratory medicine and pathology: a systematic review based on pharmaceutical companies.

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Feulefack, Joseph; Sergi, Consolato

2015-01-01

A systematic literature review on pharmaceutical companies may be a tool for guiding some procedures of R&D implementation in a department of Laboratory Medicine and Pathology. The use of pharmaceutical companies for this specific analysis arises from less variability of standards than healthcare facilities. In this qualitative and quantitative analysis, we focused on three useful areas of implementation, including R&D productivity, commercialization strategies, and expenditures determinants of pharmaceutical companies. Studies and reports of online databases from 1965 to 2014 were reviewed according to specific search terms. Initially, 218 articles and reports were found and examined, but only 91 were considered appropriate and used for further analysis.  We identified some suggested implementation strategies relevant for marketing to enhance companies' own R&D strategies; such as reliability of companies on "sourcing-in" R&D facilities and "think-tank" events. Regardless of the study and of the country, cash flow and profitability always positively influenced R&D expenditure, while sales and firm size did not. We consider that handling R&D determinants should require caution. It seems critical that implementation of R&D systems is directly related with productivity, if it reflects dual embodiment of efficiency and effectiveness. Scrutinizing the determinants of R&D expenditures emphasizes significant factors that are worth to highlight when planning an R&D investment strategy. Although there is no receipt fitting every situation, we think that health care plan makers may find relevant data in this systematic review in creating an initial implementation framework.

Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods.

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Jaberidoost, Mona; Olfat, Laya; Hosseini, Alireza; Kebriaeezadeh, Abbas; Abdollahi, Mohammad; Alaeddini, Mahdi; Dinarvand, Rassoul

2015-01-01

Pharmaceutical supply chain is a significant component of the health system in supplying medicines, particularly in countries where main drugs are provided by local pharmaceutical companies. No previous studies exist assessing risks and disruptions in pharmaceutical companies while assessing the pharmaceutical supply chain. Any risks affecting the pharmaceutical companies could disrupt supply medicines and health system efficiency. The goal of this study was the risk assessment in pharmaceutical industry in Iran considering process's priority, hazard and probability of risks. The study was carried out in 4 phases; risk identification through literature review, risk identification in Iranian pharmaceutical companies through interview with experts, risk analysis through a questionnaire and consultation with experts using group analytic hierarchy process (AHP) method and rating scale (RS) and risk evaluation of simple additive weighting (SAW) method. In total, 86 main risks were identified in the pharmaceutical supply chain with perspective of pharmaceutical companies classified in 11 classes. The majority of risks described in this study were related to the financial and economic category. Also financial management was found to be the most important factor for consideration. Although pharmaceutical industry and supply chain were affected by current political conditions in Iran during the study time, but half of total risks in the pharmaceutical supply chain were found to be internal risks which could be fixed by companies, internally. Likewise, political status and related risks forced companies to focus more on financial and supply management resulting in less attention to quality management.

[A comprehensive evaluation of intervention effects on workplace health promotion in a pharmaceutical company].

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Li, Shuang; Li, Tao; Li, Jian-guo; Chen, Li; Ren, Jun; Li, Chao-lin

2012-02-01

To evaluate the comprehensive workplace health promotion intervention effect in a pharmaceutical company. The evaluation was conducted by using questionnaires, access to information, on-site surveys, satisfaction surveys and interviews. After the intervention, the awareness rate of the staff on "Occupational Disease Prevention Law", occupational disease prevention measures, the definition of hypertension, HIV transmission and high blood pressure, coronary heart disease preventive measures, have been raised from 72.4%, 13.8%, 67.5%, 45.8%, 51.7% to 97.8%, 19.9%, 82.3%, 94.7%, 53.1% respectively. The lifestyle of the staff has been improved, the improvement rate of smoking, drinking, having breakfast 4 times a week and above are 98.5%, 70.2% and 30.6% separately. Out of the 47 evaluation indicators, 41 meet the requirements, 5 basically meet the requirements. After implementing workplace health promotion activities, the level of occupational safety and health management of the pharmaceutical company has been enhanced, the physical and mental health of the staff have been promoted. The WHP comprehensive interventions are feasible and effective.

Pharmaceutical compounds in drinking water

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Vikas Chander

2016-06-01

Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.

Pharmaceutical company perspectives on current safety risk communications in Japan.

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Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki

2014-01-01

In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.

Developments in the strategic planning of the major oil companies

International Nuclear Information System (INIS)

Jenkins, Gilbert

2000-01-01

This paper focuses on the changes in strategic planning of the major oil companies since the 1970s, and considers the reorganisations of the companies, and upstream and downstream planning. New directions for the major companies downstream operation in the retail and aviation sectors, and the influence of the BP/AMOCO/ARCO/BURMAH, EXXON/MOBIL and TOTAL/FINA/ELF mergers on the international oil industry are explored. Tables illustrating the earnings of the major oil companies for upstream and downstream operations, and chemicals in 1999, and for BP UK exploration and production, and refining and marketing profits (quarterly) for 1983-2000 are presented

Microcap pharmaceutical firms: linking drug pipelines to market value.

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Beach, Robert

2012-01-01

This article examines predictors of the future market value of microcap pharmaceutical companies. This is problematic since the large majority of these firms seldom report positive net income. Their value comes from the potential of a liquidity event such as occurs when a key drug is approved by the FDA. The typical scenario is one in which the company is either acquired by a larger pharmaceutical firm or enters into a joint venture with another pharmaceutical firm. Binary logistic regression is used to determine the impact of the firm's drug treatment pipeline and its investment in research and development on the firm's market cap. Using annual financial data from 2007 through 2010, this study finds that the status of the firm's drug treatment pipeline and its research and development expenses are significant predictors of the firm's future stock value relative to other microcap pharmaceutical firms.

ANALYSIS OF PHARMACEUTICAL COMPANIES’ ACTIVITIES THAT ARE DIRECTED TO PHYSICIANS IN EGYPT

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M. M. Bahlol

2016-01-01

Full Text Available Purpose. Pharmaceutical market is one of the largest world markets with its own conditions. In Middle East, Egypt is a major pharmaceutical emerging market and has geographical, historical and political effective leading role among Arab countries. This research aims to investigate pharmaceutical companies’ activities in Egypt directed to physicians.Methodology. Urveying through simple random probability sampling is the approach appropriate for broad and representative overview of situation in research. Therefore, a survey of 1068 physicians was conducted through interviews and establishing structured data collection questionnaire.Originality. This is the first empirical paper to investigate pharmaceutical companies’ activities directed to physicians in pharmaceutical market of Egypt. These activities include identifying pharmaceutical companies through visits of medical representatives, analysis of those visits, frequency of medical representatives’ visits, characteristics of information introduced by medical representatives to physicians, physicians’ trust in provided information, spending of pharmaceutical companies on physicians, promotional techniques applied by medical representatives. These findings are useful for managers in pharmaceutical industry. They can be also useful in other industries such as medical equipment.Findings. Pharmaceutical companies are employing medical representatives widely, as the most effective and widely-applied promotion tool in Egypt.Practical Implications. Coordinate marketing management vision with pharmaceutical market real context will lead to synergism effect in utilizing medical representatives’ activities.

The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s

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Kyu-Hwan SIHN

2015-12-01

market for vitamins and health tonics showed particularly explosive growth. As Korean industrial workers worked night and day to increase exports in the 1960s, they needed vitamins and health tonics for recovery from fatigue and to support vitality. The expansion of the general pharmaceuticals market was accompanied by increases in numbers of pharmaceutical companies. Competition intensified between pharmaceutical companies, leading some companies to search for new survival plans. The pharmaceutical industry underwent structural reform in 1960s, replacing imported medical substances with local products and inventing the new market of general pharmaceuticals. The market for vitamins and health tonics was increased, and a successful product could support a pharmaceutical company. On the contrary, a general pharmaceutical could affect the very existence of the company: if a company chased a popular product and the imitation bubble burst, then the company have lost its competitiveness in the world market.

[The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].

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Sihn, Kyu-Hwan

2015-12-01

vitamins and health tonics showed particularly explosive growth. As Korean industrial workers worked night and day to increase exports in the 1960s, they needed vitamins and health tonics for recovery from fatigue and to support vitality. The expansion of the general pharmaceuticals market was accompanied by increases in numbers of pharmaceutical companies. Competition intensified between pharmaceutical companies, leading some companies to search for new survival plans. The pharmaceutical industry underwent structural reform in 1960s, replacing imported medical substances with local products and inventing the new market of general pharmaceuticals. The market for vitamins and health tonics was increased, and a successful product could support a pharmaceutical company. On the contrary, a general pharmaceutical could affect the very existence of the company: if a company chased a popular product and the imitation bubble burst, then the company have lost its competitiveness in the world market.

Organisational change and the psychological contract at a pharmaceutical company

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Kelebogile D. Magano

2017-09-01

Full Text Available Orientation: Over a period of 6 years, a South African pharmaceutical company had been involved in several mergers and acquisitions. These changes had proved difficult for staff and staff attrition had risen. Research purpose: The objective of the study was to explore the perceptions of senior managers about the impact of change on the psychological contract. The sub-objectives were to determine what organisational factors contribute to changes in the psychological contract during periods of change, and the implications of the breach of the psychological contract for the company and its employees. Motivation for the study: As the company was set to embark on further mergers and acquisitions, the opinions of senior managers about how such changes should be addressed are important for the company. Research design, approach and method: A case study approach was used in this qualitative study. The population comprised 60 senior managers of whom 12 were purposefully selected for inclusion in the study. A semistructured interview schedule was used to capture the views of these managers and themes were extracted by means of content analysis. Main findings: Seven themes emerged which encapsulated the perceptions of senior managers about the impact of change on the psychological contract during periods of mergers and acquisitions – lack of communication, an absence of planning, lack of employee engagement, less than optimal human resources involvement, lack of preparation of the organisational culture and poor change management processes. These factors need to be addressed to strengthen the psychological contract of employees during periods of change. Practical/managerial implications: The study highlighted areas that leaders and managers of the company should consider when embarking on mergers and acquisitions if the psychological contract of employees is not to be negatively impacted. Contribution: While caution must be exercised in the

Pharmaceutical market access in emerging markets: concepts, components, and future.

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Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

2014-01-01

This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

The Pharmaceutical Industry Beamline of Pharmaceutical Consortium for Protein Structure Analysis

International Nuclear Information System (INIS)

Nishijima, Kazumi; Katsuya, Yoshio

2002-01-01

The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)

Improving the Practical Education of Chemical and Pharmaceutical Engineering Majors in Chinese Universities

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Zhao, Feng-qing; Yu, Yi-feng; Ren, Shao-feng; Liu, Shao-jie; Rong, Xin-yu

2014-01-01

Practical education in chemical engineering has drawn increasing attention in recent years. This paper discusses two approaches to teaching and learning about experiments among upper-level chemical and pharmaceutical engineering majors in China. On the basis of years of experience in teaching chemical and pharmaceutical engineering, we propose the…

Sale strategies of pharmaceutical companies in a "pharmerging" country: the problems will not improve if the gaps remain.

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Civaner, Murat

2012-08-01

This study aimed to examine the types of sales strategies used by pharmaceutical companies in a "pharmerging" market and to gain insight into the ways of avoiding the negative effects of these strategies. In-depth interviews were conducted with 22 physicians and company employees in the six largest cities of Turkey. The interviews were analyzed using content analysis. Various sales strategies, both legal and illegal, are universally applied. These methods target prescribers, patients, pharmacists, and society in general. Different types of companies, organizations, professionals, and science and ethical principles are used as means. Companies intervene immediately to prevent developments that may decrease sales, and exploit the educational and infrastructural needs. In contrast, physicians are overconfident about the effects of marketing and insufficiently educated on how to cope with the strategies and the drugs on the market, which make them vulnerable. Under these conditions, along with worldwide competition and economic volatility, policies that aim to set frameworks for pharmaceutical relationships have failed. Interventions are crucial, including instituting a national drug policy, minimizing the exposure to marketing, and addressing the educational and infrastructural needs of the prescribers. Without these interventions, gaps will continue to be exploited by companies for their own advantage, and the problems related to marketing will persist. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Evaluating the reliability and accuracy of the promotional brochures for the generic pharmaceutical companies in Iraq using World Health Organization guidelines.

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Mikhael, Ehab Mudher

2015-01-01

Pharmaceutical industries worldwide are heavily involved in aggressive drug promotions. Physician targeted promotion through medical representatives is one of the most common tactic for drug promotion by pharmaceutical drug companies. WHO states that medical representatives to work in an ethical way should make available to prescribers and dispensers complete and unbiased information for each product discussed; therefore this study aimed to evaluate the ethics in the medical brochures of generic pharmaceutical companies that are given through medical representatives to physicians in Iraq. An observational, cross-sectional study was conducted in Iraq - Baghdad from February to April 2014. Promotional drug brochures were collected mainly from pharmaceutical exhibition during attendance of medical conferences that were sponsored by generic pharmaceutical companies. Evaluation of each brochure was based primarily on WHO criteria for ethical medicinal drug promotion. The availability of emotional pictures in each brochure was also examined. Furthermore, references were checked to find their retrievability, source, and authenticity of presentations. Most medical brochures were for antibiotics, and drugs for cardiovascular diseases. All brochures mention drug name, with its active ingredient and indication, but there is a significant absence for drug interaction, while drug side effects and contraindications if present were written in a small font. Emotional picture presented in 70% of brochures. Reference citation was present in 72% of brochures, however only 75% of references in these brochures were correct. The information that is provided in medical brochures is biased and mainly persuasive since it is mainly focusing on the positive aspect of drug therapy.

Pharmaceutical new product development: the increasing role of in-licensing.

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Edwards, Nancy V

2008-12-01

Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

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Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

2017-09-18

Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

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Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history.

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Nagaich, Upendra; Sadhna, Divya

2015-01-01

There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall.

Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential.

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Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-12-01

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts. Considering the move toward early clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the influence of those gifts is becoming a matter of concern. This study examines the frequency and influence of student exposure to drug marketing in primary care settings, as well as student perceptions of physician-pharmaceutical company relationships. This was a two-phase study consisting of qualitative research followed by a cross-sectional survey. Clinical experience logbooks of 280 second-year students in one school were analysed, and the themes that emerged were used to develop a survey that was administered to 308 third-year students from two medical schools. Survey results showed a 91.2% exposure to any type of marketing, and 56.8% of students were exposed to all classes of marketing methods studied. Deliberate targeting of students by pharmaceutical representatives, in particular, was correlated with being less sensitive to the negative effects of and having positive opinions about interactions with pharmaceutical companies. The vast majority of students are exposed to drug marketing in primary care settings, and may become more vulnerable to that strategy. Considering that medical students are vulnerable and are targeted deliberately by pharmaceutical companies, interventions aimed at developing skills in the rational use of medicines and in strategies for coping with drug marketing should be devised.

Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

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Wang, Daniel Wei L; Ferraz, Octavio Luiz Motta

2012-01-01

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. © 2012 American Society of Law, Medicine & Ethics, Inc.

Nontraditional roles for certified pharmacy technicians in a pharmaceutical company.

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Fung, Stacey M; Gilmour, Christine; McCracken, David; Shane, Korban; Matsuura, Gary

2006-01-01

To describe nontraditional roles for Certified Pharmacy Technicians (CPhTs) within pharmaceutical industry. Drug information department within a large biotechnology/pharmaceutical organization. The Medical Communications department within Genentech uses a skills-mix staffing model in which employees with varying educational and training backgrounds work as a team on meeting the informational needs of consumers and health professionals who contact the company. One position within the department is that of Medical Communications Associate, responsible primarily for managing product inquiries. Medical Communications Associates have degrees in life sciences or an equivalent combination of education and experience, including a minimum of 2 years of related experience in the health care industry. Currently, four of the seven Medical Communications Associates in the department are CPhTs. Not applicable. Ability to recruit CPhTs for Medical Communications Associate positions, and job satisfaction of those hired into these positions. Critical basic skills needed for the Medical Communications Associate position include strong computer literacy, ability to multitask, and ability to work in an environment with frequent interruptions. Strong oral and written communications skills, customer service skills, ability to deal with stressful situations, product-specific knowledge, ability to work on a daily basis with Medical Communications Pharmacists, and knowledge of medical terminology are also important. The skills set of CPhTs matches these requirements, as evidenced by the experiences of the four staff members who have worked in the department for a total of 17 person-years. This nontraditional role for CPhTs can be rewarding and beneficial to all, affording an unique opportunity within the pharmaceutical industry. The skill set and experience of CPhTs can be used in the nontraditional pharmacy practice setting of drug information.

Trade Secrets in Life Science and Pharmaceutical Companies

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Nealey, Tara; Daignault, Ronald M.; Cai, Yu

2015-01-01

Trade secret protection arises under state common law and state statutes. In general, a trade secret is information that is not generally known to the public and is maintained as a secret, and it provides a competitive advantage or economic benefit to the trade secret holder. Trade secrets can be worth tens or hundreds of millions of dollars, and damage awards in trade secret litigation have been high; often, there is a lot at stake. Obtaining a trade secret through “improper means” is misappropriation. If the alleged trade secret, however, was developed independently, known publicly, or not maintained as a secret, then those defenses may successfully overcome a claim for trade secret misappropriation. With today’s interconnectedness in the biotechnology and pharmaceutical fields, more collaborations, joint ventures, and outsourcing arrangements among firms, and increased mobility of employees’ careers, life science companies need to not only understand how to protect their trade secrets, but also know how to defend against a claim for trade secret theft. PMID:25414378

Trade secrets in life science and pharmaceutical companies.

Science.gov (United States)

Nealey, Tara; Daignault, Ronald M; Cai, Yu

2014-11-20

Trade secret protection arises under state common law and state statutes. In general, a trade secret is information that is not generally known to the public and is maintained as a secret, and it provides a competitive advantage or economic benefit to the trade secret holder. Trade secrets can be worth tens or hundreds of millions of dollars, and damage awards in trade secret litigation have been high; often, there is a lot at stake. Obtaining a trade secret through "improper means" is misappropriation. If the alleged trade secret, however, was developed independently, known publicly, or not maintained as a secret, then those defenses may successfully overcome a claim for trade secret misappropriation. With today's interconnectedness in the biotechnology and pharmaceutical fields, more collaborations, joint ventures, and outsourcing arrangements among firms, and increased mobility of employees' careers, life science companies need to not only understand how to protect their trade secrets, but also know how to defend against a claim for trade secret theft. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

Corporate social responsibility practices of pharmaceutical companies in China: a scale development & empirical study

OpenAIRE

Qian Yiyun

2017-01-01

JEL Classification: M14 - Corporate Culture; Social Responsibility; I11 - Analysis of Health Care Markets Corporate Social Responsibility (CSR) has been a hot topic in literature ever since a couple of decades ago, and it roughly refers to the positive influence that a company’s operations have on its stakeholders. Amongst various industries, the pharmaceutical sector is one of the most debated in that these companies produce disease-curing and even life-saving products in a for-profit man...

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

Science.gov (United States)

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5�

An Instructional Design Model for Developing a Computer Curriculum To Increase Employee Productivity in a Pharmaceutical Company.

Science.gov (United States)

Stumpf, Mark R.

This report presents an instructional design model that was developed for use by the End-Users Computing department of a large pharmaceutical company in developing effective--but not lengthy--microcomputer training seminars to train office workers and executives in the proper use of computers and thus increase their productivity. The 14 steps of…

Financial aspects and the future of the pharmaceutical industry in the United States of america.

Science.gov (United States)

Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

2013-12-01

The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as "companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use". Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers' lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. THIS PAPER REPRESENTS A THOROUGH LITERATURE REVIEW OF THE MULTIFACETED SOURCES INCLUDING: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or - at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and

Risk Management in the Pharmaceutical Industry in Slovenian Companies

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Bucalo Nina

2017-05-01

Full Text Available The pharmaceutical industry is one of the most competitive businesses in the world. Supply chain in this industry has been directed towards the production of large batches to avoid lack of supplies, and the achievement of regulatory requirements, at the cost of high level of inventory, higher costs and inventory write-off due to expiration or other reasons. In recent years this industry is facing major changes and challenges such as intense globalization processes, increased competition and innovations in technologies, which has broadened and deepened risks in supply chain.

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

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Nguyen Diane

2013-01-01

Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

Impacts of international sanctions on Iranian pharmaceutical market.

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Cheraghali, Abdol Majid

2013-07-31

Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients.

The case for entrepreneurship in R&D in the pharmaceutical industry.

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Douglas, Frank L; Narayanan, V K; Mitchell, Lesa; Litan, Robert E

2010-09-01

A lack of entrepreneurial behaviour has often been highlighted as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Here, we present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at major pharmaceutical and biotechnology companies. Factors are highlighted that could be important in promoting entrepreneurial behaviour, which might serve as a catalyst for revitalizing R&D productivity.

Australian consumer responses to DTCA and other pharmaceutical company sponsored advertisements.

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Hall, Danika V; Jones, Sandra C

2008-10-01

This study aimed to elicit and compare the responses of Australian consumers towards New Zealand (NZ) direct-to-consumer-advertisements (DTCA) for prescription medicines and matched pharmaceutical company-sponsored advertisements from Australia. A survey questionnaire was mailed to a random sample of residents in a metropolitan area in NSW. Potential participants were randomised to receive one of four different advertisements: two for weight loss and two for Alzheimer's disease. A total of 413 responses were received and analysed. Participants reported that they were not likely to ask for a prescription from their doctor as a result of seeing any of the advertisements in the study. The Australian disease awareness advertisement that did not refer to a medicinal treatment was perceived as more valuable than the NZ DTCA or other Australian advertisement. Overall, participants found it easier to make sense of the more informational advertisements, and felt that there was insufficient information regarding the disease/condition and treatments in the more emotive and transformational advertisements. While there is concern over potential negative effects of pharmaceutical-sponsored disease awareness advertisements, this study found that Australian consumers perceived an informational advertisement with a list of disease symptoms to be valuable. These findings contribute to debate in New Zealand and Australia regarding DTCA and disease awareness advertising, and have the potential to inform guidelines relevant to the advertising of prescription medicine in each country.

Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

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Beran, Roy G

2004-01-01

Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal

Vulnerabilities to misinformation in online pharmaceutical marketing.

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De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-05-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.

Public administration and R&D localisation by pharmaceutical and biotech companies: a theoretical framework and the Italian case-study.

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Jommi, Claudio; Paruzzolo, Silvia

2007-04-01

This article has two objectives. It firstly provides a general framework for variables that influence R&D (Research and Development) localisation by pharmaceutical and biotech companies. The analysis of R&D localization includes both in-house R&D and contracted R&D. Following a systematic literature search, these variables were classified into four distinct categories: regulatory environment, institutional framework, national systems of innovation and local development and specialisation. The authors highlight that some of these factors directly depend on the action of public administrations (e.g., patent protection, price regulation, public investments in research, and incentives to private companies); others are indirectly influenced by public policies (e.g., GDP growth rate, infrastructures). This theoretical framework was used to analyse the Italian case-study. Pros and cons of the Italian context were investigated from the point of view of multinational pharmaceutical companies and the Italian Association of Biotech Companies. Interviews were chosen as the most appropriate data gathering technique given the exploratory nature of the study of the Italian context. The paper is divided into five parts. A brief introduction provides figures showing that Europe has been loosing positions compared with other Continents and the same has occurred in Italy compared with other EU countries. The second one illustrates the methodology. The third one is focused on variables affecting R&D localisation. In the fourth section the Italian case-study is discussed. Theoretical and empirical findings are summarised and discussed in the conclusions.

High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.

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Kurihara, Chieko; Kusuoka, Hideo; Ono, Shunsuke; Kakee, Naoko; Saito, Kazuyuki; Takehara, Kenji; Tsujide, Kiyokazu; Nabeoka, Yuzo; Sakuhiro, Takuya; Aoki, Hiroshi; Morishita, Noriko; Suzuki, Chieko; Kachi, Shigeo; Kondo, Emiko; Komori, Yukiko; Isobe, Tetsu; Kageyama, Shigeru; Watanabe, Hiroshi

2014-01-01

International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan. With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation. Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.

Strategic focus on 3R principles reveals major reductions in the use of animals in pharmaceutical toxicity testing.

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Elin Törnqvist

Full Text Available The principles of the 3Rs, Replacement, Reduction and Refinement, are being increasingly incorporated into legislations, guidelines and practice of animal experiments in order to safeguard animal welfare. In the present study we have studied the systematic application of 3R principles to toxicological research in the pharmaceutical industry, with particular focus on achieving reductions in animal numbers used in regulatory and investigatory in vivo studies. The work also details major factors influencing these reductions including the conception of ideas, cross-departmental working and acceptance into the work process. Data from 36 reduction projects were collected retrospectively from work between 2006 and 2010. Substantial reduction in animal use was achieved by different strategies, including improved study design, method development and project coordination. Major animal savings were shown in both regulatory and investigative safety studies. If a similar (i.e. 53% reduction had been achieved simultaneously within the twelve largest pharmaceutical companies, the equivalent reduction world-wide would be about 150,000 rats annually. The results point at the importance of a strong 3R culture, with scientific engagement, collaboration and a responsive management being vital components. A strong commitment in leadership for the 3R is recommended to be translated into cross-department and inter-profession involvement in projects for innovation, validation and implementation. Synergies between all the three Rs are observed and conclude that in silico-, in vitro- and in vivo-methods all hold the potential for applying the reduction R and should be consequently coordinated at a strategic level.

The pharmaceutical corporation and the 'good work' of managing women's bodies.

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Padamsee, Tasleem Juana

2011-04-01

Pharmaceutical companies are intricately intertwined with every aspect of contemporary medical reality, and they increasingly drive the social process of medicalization in order to establish and dominate markets for their drugs and devices. In addition to funding the majority of clinical research, organizing it to generate an evidence base that favors their innovations, and influencing the regulation of pharmaceutical drugs and devices, companies still spend substantial resources on direct attempts to shape the attitudes, dispositions, and prescribing behavior of physicians. This article sheds new light on our picture of the relationship between the pharmaceutical industry and physicians by examining a novel form of physician-directed communication produced by one prominent corporation. An interpretive, thematic analysis of ORGYN - the unique, full-length magazine published by the Organon Corporation between 1990 and 2003 - reveals two overarching messages it communicated to physicians during that period. First, it offered a compelling picture of the "good work" obstetricians and gynecologists do, which involves enabling women of reproductive age to control their fertility through contraception and infertility treatment, and providing symptom relief and preventive benefits to older women by increasing compliance with hormone therapy regimes. Second, it included pharmaceutical technology in every aspect of the doctor's work, portraying pharmaceutical corporations as the physician's "natural partner", and women patients as passive, disempowered objects of medical practice. Through these consistent messages, the print magazine ORGYN represented one important set of mechanisms by which a pharmaceutical corporation helped drive and sustain medicalization. The article ends with a consideration of the implications of ORGYN's messages for companies, doctors, women patients, and the study of medicalization. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Innovation in pharmaceutical and health biotechnology industries: challenges for a virtuous agenda].

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Vargas, Marco; Gadelha, Carlos Augusto Grabois; Costa, Laís Silveira; Maldonado, José

2012-12-01

Pharmaceutical and biotechnology industries comprise a major production subsystem of the health industrial complex in Brazil. It stands out for both its economic importance and its prominent role in developing new technologies in strategic areas. Strengthening the local production of generic drugs in the last decade has significantly increased the number of Brazilian companies in the local pharmaceutical market and has been an important turning point for this industry's growth. However, there remain major structural bottlenecks both in terms of production and continuous innovation. These bottlenecks reveal the high vulnerability of the Brazilian National Health System and point to the need of public policies that promote strengthening the production base and innovation in the pharmaceutical industry and that at the same time meet health-related social demands in health in Brazil.

Analysis of International Mergers and Acquisitions in the Pharmaceutical Industry

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Božo Matić

2011-07-01

Full Text Available There are numerous researches which analyze mergers and acquisitions, but most of them do not focus on a certain industry, but their sample considers companies from different industries. This paper focuses on mergers and acquisitions in the pharmaceutical industry. It is assumed that pharmaceutical companies with no experience in mergers and acquisitions achieve better results in relatively small and domestic mergers and acquisitions while pharmaceutical companies with greater experience in mergers and acquisitions are successful even in bigger and international mergers and acquisitions. Bigger mergers and acquisitions and international mergers and acquisitions are more risky for the companies so lack of experience in mergers and acquisitions additionally increases risks during the process of mergers and acquisitions. On average, such increase of the risk results in lower returns for stock owners of pharmaceutical companies.

Vulnerabilities to misinformation in online pharmaceutical marketing

Science.gov (United States)

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-01-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

Improving Overall Equipment Effectiveness Using CPM and MOST: A Case Study of an Indonesian Pharmaceutical Company

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Omega, Dousmaris; Andika, Aditya

2017-12-01

This paper discusses the results of a research conducted on the production process of an Indonesian pharmaceutical company. The company is experiencing low performance in the Overall Equipment Effectiveness (OEE) metric. The OEE of the company machines are below world class standard. The machine that has the lowest OEE is the filler machine. Through observation and analysis, it is found that the cleaning process of the filler machine consumes significant amount of time. The long duration of the cleaning process happens because there is no structured division of jobs between cleaning operators, differences in operators’ ability, and operators’ inability in utilizing available cleaning equipment. The company needs to improve the cleaning process. Therefore, Critical Path Method (CPM) analysis is conducted to find out what activities are critical in order to shorten and simplify the cleaning process in the division of tasks. Afterwards, The Maynard Operation and Sequence Technique (MOST) method is used to reduce ineffective movement and specify the cleaning process standard time. From CPM and MOST, it is obtained the shortest time of the cleaning process is 1 hour 28 minutes and the standard time is 1 hour 38.826 minutes.

MANAGING INDUSTRIAL PHARMACEUTICAL RESEARCH-AND-DEVELOPMENT - A COMPARATIVE-STUDY OF MANAGEMENT CONTROL AND INNOVATIVE EFFECTIVENESS IN EUROPEAN AND ANGLO-AMERICAN COMPANIES

NARCIS (Netherlands)

OMTA, SWF; BOUTER, LM; VANENGELEN, JML

1994-01-01

Drug regulation and pricing have put strong pressure on the cost-benefit ratio of the innovative pharmaceutical industry. Therefore a study has been conducted in fourteen large and medium sized companies to determine some important organisational and managerial factors influencing success in

Need of the regulation for profit percentage investment by pharmaceutical companies in new drug discovery research from the various local traditional medicinal and plant systems.

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Bhattarai, M D

2012-01-01

In the modern medical systems the active pharmacological ingredients, effective against any disease is identified, purified and studied for its various effects and side-effects whereas it is not so in the traditional systems. Therefore, it is not surprising that safety concerns have often been raised about the traditional medical products. The major issue now, is to make appropriate situation with basic supports to bring all the available experts and resources together for the identification, purification, and study of efficacy and safety of the active molecules of the popular traditional medicines. Government and public sectors in the countries with such rich traditional medicinal and plant systems have related experts, but they also have much hurdle regarding recruitment and retention of expert human resources, getting fund, purchase and maintenance of equipment, bureaucratic formalities and others. The pharmaceutical companies have basic laboratories with related infrastructure and human resources as well as interest about bringing the drug molecules. To bridge the gap, there is a need of the regulation which will make the pharmaceutical companies to invest certain percentage of their profit in the field of research to identify new drug molecules and to study their effects. It is just not an issue of discovering the active molecule but also of creating the concept and culture of research, purity and quality of drugs, safety of people, and future direction of the human society.

Pharmaceutical Distribution Market Channels in Poland

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Agnieszka Woś

2009-09-01

Full Text Available Distribution on the pharmaceutical market in Poland is interesting and the most difficult sphere to manage. Numerous varied and specialized companies operating on the market cause that the processes of choosing middlemen in distribution channels are very complex. The hereby article presents the role and location of the companies operating within distribution channels on the pharmaceutical market. It draws attention to the development of non-pharmacy and non-wholesale sales channels.

Mergers and innovation in the pharmaceutical industry.

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Comanor, William S; Scherer, F M

2013-01-01

Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.

Aspects of research and development contract terms in the bio/pharmaceutical sector.

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Banerjee, Tannista

2012-01-01

The cost of new drug development is increasing every year. Pharmaceutical companies use R&D joint ventures, mergers, and outsource different stages of pharmaceutical R&D activities for a faster and cost minimizing method of innovation. Pharmaceutical companies outsource R&D activities to independent small biotech or pharmaceutical companies that specialize in different stages of pharmaceutical R&D. This chapter examines the determinants of the payment structure of research contracts between large bio/pharmaceutical companies and specialized research firms. Determinants of R&D contracts are analyzed using detailed R&D contract data between bio/pharmaceutical companies and independent research firms for 10 years. A multinomial logit model is used in order to understand the determinants of three different types of contracts; royalty contracts, fixed payment contracts, and the mixed contracts. Under uncertainty, the likelihood of a royalty contract rises for the early stages of the research and with the patent stock of the research firm. It is more likely to observe both royalty and fixed payment if the pharmaceutical client has past contracts with the same research firm. The results also suggest that if Food and Drug Administration (FDA) is more stringent in any disease area in reviewing the new drug application, then the likelihood of signing pure royalty contract decreases. Understanding the nature of R&D contracts and the effects of FDA's behavior on the pharmaceutical R&D contract is important because these contracts not only affect the cost of new drug invention but also the quality and the rate of invention. VALUE: Results are useful for both the pharmaceutical companies and the economic/business researchers.

[E-commerce of pharmaceuticals].

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Shani, Segev

2003-05-01

The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

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Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

2017-01-01

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight's evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.

Internet pharmaceutical sales: attributes, concerns, and future forecast.

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Bruckel, Katy; Capozzoli, Ernest A

2003-01-01

Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters.

Impact of Corporate Reputation on Brand Differentiation: An Empirical Study from Iranian Pharmaceutical Companies.

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Vahabzadeh, Afshin; Vatanpour, Hossein; Dinarvand, Rasoul; Rajabzadeh, Ali; Salamzadeh, Jamshid; Mohammadzadeh, Mehdi

2017-01-01

The influence of company reputation or what is often referred to as corporate reputation on branding strategy and producing intangible asset for different industries has been researched in western countries, but there is a gap for the generalizability of findings to countries out of the United State and Europe. To establish the western researcher's external validity of theories in other countries and to obtain a better understanding of the influences of branding and company reputation on pharmaceutical business markets, the researchers applied this study for Iran, a country in the Middle East. The obtained results using SEM (by P.L.S. 2.0 software) showed a good relationship between value creation and brand differentiation (β =0.360 and t-value = 3.167), between corporate communication and brand differentiation (β = 0.022 and t-value = 3.668), and between strategic resources and brand differentiation (β = 0.289 and t-value = 2.247). This study is a pioneering attempt in Iran to measure the impact of corporate reputation on brand differentiation strategy.

Impact of Corporate Reputation on Brand Differentiation: An Empirical Study from Iranian Pharmaceutical Companies

Science.gov (United States)

vahabzadeh, Afshin; vatanpour, Hossein; dinarvand, Rasoul; rajabzadeh, Ali; salamzadeh, Jamshid; mohammadzadeh, Mehdi

2017-01-01

The influence of company reputation or what is often referred to as corporate reputation on branding strategy and producing intangible asset for different industries has been researched in western countries, but there is a gap for the generalizability of findings to countries out of the United State and Europe. To establish the western researcher’s external validity of theories in other countries and to obtain a better understanding of the influences of branding and company reputation on pharmaceutical business markets, the researchers applied this study for Iran, a country in the Middle East. The obtained results using SEM (by P.L.S. 2.0 software) showed a good relationship between value creation and brand differentiation (β =0.360 and t-value = 3.167), between corporate communication and brand differentiation (β = 0.022 and t-value = 3.668), and between strategic resources and brand differentiation (β = 0.289 and t-value = 2.247). This study is a pioneering attempt in Iran to measure the impact of corporate reputation on brand differentiation strategy. PMID:29552075

Drug repurposing from the perspective of pharmaceutical companies.

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Cha, Y; Erez, T; Reynolds, I J; Kumar, D; Ross, J; Koytiger, G; Kusko, R; Zeskind, B; Risso, S; Kagan, E; Papapetropoulos, S; Grossman, I; Laifenfeld, D

2018-01-01

Drug repurposing holds the potential to bring medications with known safety profiles to new patient populations. Numerous examples exist for the identification of new indications for existing molecules, most stemming from serendipitous findings or focused recent efforts specifically limited to the mode of action of a specific drug. In recent years, the need for new approaches to drug research and development, combined with the advent of big data repositories and associated analytical methods, has generated interest in developing systematic approaches to drug repurposing. A variety of innovative computational methods to enable systematic repurposing screens, experimental as well as through in silico approaches, have emerged. An efficient drug repurposing pipeline requires the combination of access to molecular data, appropriate analytical expertise to enable robust insights, expertise and experimental set-up for validation and clinical development know-how. In this review, we describe some of the main approaches to systematic repurposing and discuss the various players in this field and the need for strategic collaborations to increase the likelihood of success in bringing existing molecules to new indications, as well as the current advantages, considerations and challenges in repurposing as a drug development strategy pursued by pharmaceutical companies. This article is part of a themed section on Inventing New Therapies Without Reinventing the Wheel: The Power of Drug Repurposing. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v175.2/issuetoc. © 2017 The British Pharmacological Society.

What do Libyan doctors perceive as the benefits, ethical issues and influences of their interactions with pharmaceutical company representatives?

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Alssageer, Mustafa Ali; Kowalski, Stefan Robert

2013-01-01

Evidence suggests that 80-90% of doctors in most countries across the world are frequently visited by pharmaceutical company representatives (PCRs). The objective of study to examine perceptions of Libyan doctors between August and October 2010, regarding the benefits, ethical issues and influences of their interactions with (PCRs). An anonymous questionnaire was circulated to 1,000 Libyan doctors in selected public and private practice settings in Tripoli, Benghazi and Sebha. The major benefits of PCR visits reported in the 608 evaluable responses were; receiving new information about products (94.4%). The majority of doctors (75%) were not against the provision of gifts but were more comfortable if it was "cheap" (51%) and had educational value (51%). Doctors who received more printed materials, simple gifts or drug samples were less likely to disapprove of accepting gifts (p5]. Effective marketing can positively influence an individual's attitude towards a product and because there is an association between attitude, intention and behaviour [6], persuasive communication can generate a positive attitude and increase the potential for influence [7]. PCRs can accomplish behaviour change because they directly communicate with prescribers. During a visit they attempt to raise awareness of their products, provide product information and encourage a favourable attitude towards their company and product [8]. They employ verbal persuasion techniques and also provide other incentives such as gifts, free drug samples and sponsored educational events [2]. The provision of promotional gifts can be seen as a friendship building technique to reinforce the communication nexus between PCRs and doctors but it can also potentially erode professional barriers [9]. Contact between a PCR and a medical practitioner is therefore viewed by drug companies as a vital part of their marketing strategy and frequent visits, together with written promotional materials, gifts and other

The Effects of Technology Entrepreneurship on Customers and Society: A Case Study of a Spanish Pharmaceutical Distribution Company.

Science.gov (United States)

Muñoz, Rosa M; Sánchez de Pablo, Jesús D; Peña, Isidro; Salinero, Yolanda

2016-01-01

The main purpose of this paper is to provide an understanding, within the field of corporate entrepreneurship, of the various factors that enable technology entrepreneurship in established firms and its principal effects on customers and society. The paper reports on a case study regarding technology entrepreneurship in a Spanish company whose activity is pharmaceutical distribution. This company has been able to overcome the consequences of the worldwide crisis and start an innovative process which includes the installation of new information technology (IT) and an investment of 6 million Euros. It is, in this respect, a model to imitate and the objective of this paper is therefore to discover the managers' entrepreneurial orientation (EO) characteristics which have made this possible, along with the organizational and social effects resulting from the process. We verify that EO is present in this company and that the development of new IT has important effects on customers and the population.

The Effects of Technology Entrepreneurship on Customers and Society: A Case Study of a Spanish Pharmaceutical Distribution Company

Science.gov (United States)

Muñoz, Rosa M.; Sánchez de Pablo, Jesús D.; Peña, Isidro; Salinero, Yolanda

2016-01-01

The main purpose of this paper is to provide an understanding, within the field of corporate entrepreneurship, of the various factors that enable technology entrepreneurship in established firms and its principal effects on customers and society. The paper reports on a case study regarding technology entrepreneurship in a Spanish company whose activity is pharmaceutical distribution. This company has been able to overcome the consequences of the worldwide crisis and start an innovative process which includes the installation of new information technology (IT) and an investment of 6 million Euros. It is, in this respect, a model to imitate and the objective of this paper is therefore to discover the managers’ entrepreneurial orientation (EO) characteristics which have made this possible, along with the organizational and social effects resulting from the process. We verify that EO is present in this company and that the development of new IT has important effects on customers and the population. PMID:27445938

Differential pricing of new pharmaceuticals in lower income European countries.

Science.gov (United States)

Kaló, Zoltán; Annemans, Lieven; Garrison, Louis P

2013-12-01

Pharmaceutical companies adjust the pricing strategy of innovative medicines to the imperatives of their major markets. The ability of payers to influence the ex-factory price of new drugs depends on country population size and income per capita, among other factors. Differential pricing based on Ramsey principles is a 'second-best' solution to correct the imperfections of the global market for innovative pharmaceuticals, and it is also consistent with standard norms of equity. This analysis summarizes the boundaries of differential pharmaceutical pricing for policymakers, payers and other stakeholders in lower-income countries, with special focus on Central-Eastern Europe, and describes the feasibility and implications of potential solutions to ensure lower pharmaceutical prices as compared to higher-income countries. European stakeholders, especially in Central-Eastern Europe and at the EU level, should understand the implications of increased transparency of pricing and should develop solutions to prevent the limited accessibility of new medicines in lower-income countries.

[The influence of the relationship between physicians and pharmaceutical companies on the patient from the point of view of policy-makers in Israel].

Science.gov (United States)

Nissanholtz-Gannot, Rachel; Shani, Segev; Shvarts, Shifra

2010-11-01

The relationship between doctors and pharmaceutical companies is an integral part of the health system in Israel and the whole world. The mutual need for such a relationship requires us, as a society, to examine its influence on the individual and the system as a whole. This research examines the relationship from the points of view of the relevant parties within the health system and outside the health system (decision-makers). The authors used in-depth interviews and qualitative research methods in order to examine and understand the various positions of decision-makers. The position of the decision-makers, regarding all the aspects of this relationship, expresses their wishes and depends on their point of view. The impact of the relationship between the doctors and the pharmaceutical companies was examined with regard to the prescription behavior of the doctor. All the government representatives, all the physicians' representatives and those of the health funds, believe that the physicians' prescription behavior is impacted by the relationship. There are those who perceive this to be a negative trend and some doctors believe it to be a positive trend. With regard to possible harm to the patient, the parties believe that the relationship does not harm the patient, whereas most of the government representatives identify harm to the patients, both on the economic and health levels. The authors believe that the "influence" which exists or could exist on the part of the pharmaceutical companies is the main stumbling block in this relationship, which is expressed in the decision-makers' perspective.

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa

Directory of Open Access Journals (Sweden)

Hennig, Michael

2017-01-01

Full Text Available In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA when performing outsourced clinical studies.This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s.Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.

Pharmaceutical representatives' beliefs and practices about their professional practice: a study in Sudan.

Science.gov (United States)

Idris, K M; Mustafa, A F; Yousif, M A

2012-08-01

Pharmaceutical representatives are an important promotional tool for pharmaceutical companies. This cross-sectional, exploratory study aimed to determine pharmaceutical representatives' beliefs and practices about their professional practice in Sudan. A random sample of 160 pharmaceutical representatives were interviewed using a pretested questionnaire. The majority were male (84.4%) and had received training in professional sales skills (86.3%) and about the products being promoted (82.5%). Only 65.6% agreed that they provided full and balanced information about products. Not providing balanced information was attributed by 23.1% to doctors' lack of time. However, 28.1% confessed they sometimes felt like hiding unfavourable information, 21.9% were sometimes or always inclined to give untrue information to make sales and 66.9% considered free gifts as ethically acceptable. More attention is needed to dissemination of ethical codes of conduct and training about the ethics of drug promotion for pharmaceutical representatives in Sudan.

Bioremediation Kinetics of Pharmaceutical Industrial Effluent

OpenAIRE

M. Šabić; M. Vuković Domanovac; Z. Findrik Blažević; E. Meštrović

2015-01-01

In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmente...

Russian Pharmaceutical Companies Export Potential in Emerging Regional Clusters

OpenAIRE

Elena Vladimirovna Sapir; Igor Andreyevich Karachyov; Mingzhu Zhang

2016-01-01

This article analyzes a diverse range of the enterprise’s export potential growth factors in emerging pharmaceutical clusters of Central European Russia. Classification and comparative analysis were used to identify export potential attributes (production, finance, labor and marketing), which have allowed to reveal the strong connection of cluster and regional factor groups with the results of export performance. The purpose of the study is to provide exports-seeking pharmaceutical c...

A survey of pharmaceutical company representative interactions with doctors in Libya

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Mustafa A. Alssageer

2012-09-01

Full Text Available Objectives: To examine the frequency of pharmaceutical company representative (PCR interactions with doctors in Libya and review possible associations between these interactions and the personal and practice setting characteristics of doctors. Method: An anonymous survey questionnaire was circulated to 1,000 Libyan doctors in selected public and private practice settings in Tripoli, Benghazi and Sebha. Results: A questionnaire return rate of 61% (608 returned questionnaires was achieved. Most respondents (94% reported that they had been visited by PCRs at least ‘once’ in the last year. Fifty per cent of respondents met with PCRs at least once a month, and 20% at least once a week. The following characteristics were significantly associated with meeting with a representative more than once a week: age, gender (male > female, years of practice, being a specialist (other than an anaesthesiologist or working in private practice. Ninety-one per cent of doctors reported that they had received at least one kind of relationship gift during the last year. Printed materials (79%, simple gifts (73% and drug samples (69% were the most common relationship products given to respondents. Reimbursements or sponsored items were reported by 33% of respondents. Physician specialists were more likely to receive drug samples or sponsored items than residents, general practitioners, anaesthesiologists or surgeons (P<0.01. Participants working in private practice alone or in both sectors were more likely to receive printed materials, simple gifts or free samples from PCRs than doctors working in the public sector (P<0.05. Conclusion: Libyan doctors are frequently visited by PCRs. Doctors, working in private practice or specialist practice, are especially targeted by promotional activities. An agreed code of conduct for pharmaceutical promotion in Libya between doctors and PCRs should be created.

Information sources and utilization patterns of pharmaceutical ...

African Journals Online (AJOL)

The study investigated the adequacy of pharmaceutical scientists' information environment in feeding their occupational activities. Data was collected through observation and through questionnaire administration to all the twenty-seven scientists in two large pharmaceutical companies in Lagos, Nigeria. Findings revealed ...

Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

Science.gov (United States)

Batt, Sharon

2016-07-01

A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. © 2016 The Hastings Center.

Effect of Promotional Strategies of Pharmaceutical Companies on Doctors' Prescription Pattern in South East Nigeria

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Linus Onah

2010-02-01

Full Text Available AIM: Drug promotions use multifaceted approaches incorporating hospital and office detailing by marketing representatives. Very few studies exist on their influence on doctors’ prescription pattern in Nigeria. We examined the scope and effects of marketing strategies on the prescription habits of doctors in Enugu, South East Nigeria. METHOD: This was a cross-sectional study; 210 self-administered structured questionnaires were distributed among doctors in six major hospitals in Enugu. Ethical approval was obtained from the University of Nigeria Teaching Hospital Ethics Committee, Enugu. RESULTS: There was 88% response rate, with more males than females (M:F= 2.2: 1. Most were residents-in-training/ house officers (69% while consultants were 7.1% of the group. Stickers, drug presentations/ launches and personal souvenirs were most commonly employed marketing strategies. Most doctors (60% attending a drug presentation felt influenced. While 87.5% appreciated the benefits of marketing strategies, about 70% would consider patients’ socioeconomic status before prescribing. Continuing medical education and stiff competition were reasons adduced for the marketing strategies. CONCLUSION: Pharmaceutical companies in Nigeria adopt varied strategies to influence doctors’ prescriptions. Often this aim is achieved. The practice is accepted by most who nevertheless will consider other factors when deciding on what to prescribe. [TAF Prev Med Bull 2010; 9(1.000: 1-6

Perceptions and Attitudes of Egyptian Health Professionals and Policy-Makers towards Pharmaceutical Sales Representatives and Other Promotional Activities.

Science.gov (United States)

Kamal, Susan; Holmberg, Christine; Russell, Jean; Bochenek, Tomasz; Tobiasz-Adamczyk, Beata; Fischer, Christiane; Tinnemann, Peter

2015-01-01

Pharmaceutical promotion activities in low and middle-income countries are often neither regulated nor monitored. While Egypt has the highest population and per capita use of medicines in the Arab world, we know very little about pharmaceutical companies promotional activities in the country. To explore and analyze the perceptions of physicians towards promotional and marketing activities of pharmaceutical companies among physicians and pharmacists in Egypt. Perspectives of different healthcare system stakeholders were explored through semi-structured, in-depth interviews conducted in 2014 in Cairo, Egypt. Interviewees were chosen via purposive sampling and snowball technique. Each interview was recorded and transcribed. Then qualitative, thematic analysis was conducted with the help of NVIVO software. The majority of physicians and pharmacists acknowledged exposure to pharmaceutical promotion. It was commonly believed that interaction with the pharmaceutical industry is necessary and both associated risks and benefits were acknowledged. The interviewed physicians considered themselves competent enough to minimize risks and maximize benefits to their prescribing habits. Views diverged on the extent and magnitude of the risks and benefits of pharmaceutical promotion, especially in regard to the influence on patients' health. Pharmaceutical promotion in Egypt is intensely directed at prescribers and dispensers. Physicians, pharmacists and policymakers expressed little skepticism to the influence of promotion towards their individual prescribing. Raising awareness of the pitfalls of pharmaceutical promotion is necessary, especially among the less experienced physicians.

Macro-economic factors influencing the architectural business model shift in the pharmaceutical industry.

Science.gov (United States)

Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves; Richy, Florent-Frederic

2016-10-01

Technological innovations, new regulations, increasing costs of drug productions and new demands are only few key drivers of a projected alternation in the pharmaceutical industry. The purpose of this review is to understand the macro economic factors responsible for the business model revolution to possess a competitive advantage over market players. Areas covered: Existing literature on macro-economic factors changing the pharmaceutical landscape has been reviewed to present a clear image of the current market environment. Expert commentary: Literature shows that pharmaceutical companies are facing an architectural alteration, however the evidence on the rationale driving the transformation is outstanding. Merger & Acquisitions (M&A) deals and collaborations are headlining the papers. Q1 2016 did show a major slowdown in M&A deals by volume since 2013 (with deal cancellations of Pfizer and Allergan, or the downfall of Valeant), but pharmaceutical analysts remain confident that this shortfall was a consequence of the equity market volatility. It seems likely that the shift to an M&A model will become apparent during the remainder of 2016, with deal announcements of Abbott Laboratories, AbbVie and Sanofi worth USD 45billion showing the appetite of big pharma companies to shift from the fully vertical integrated business model to more horizontal business models.

A lesson from Japan: research and development efficiency is a key element of pharmaceutical industry consolidation process.

Science.gov (United States)

Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

2014-02-01

Scholarly attention to pharmaceutical companies' ability to sustain research and development (R&D) productivity has increased as they increasingly handle business challenges. Furthermore, the deterioration of R&D productivity has long been considered a major cause of mergers and acquisitions (M&As). This study attempts to investigate quantitatively the possible causes of the deterioration and the relationship between the deterioration and M&As by examining the Japanese pharmaceutical industry. Japan from 1980 to 1997 is an ideal case because of the availability of official data, but more importantly the significant changes in its business environment at the time. Using the Malmquist Index and data envelopment analysis, we measured the deterioration of R&D productivity from 1980 to 1997 based on a sample of 15 Japanese companies. Two lessons can be learned from Japan's case. First, to sustain R&D productivity over the long term, companies should use licensing activities and focus on the dominant therapeutic franchises. Second, if a company fails significantly to catch up with the benchmark, it is likely to pursue an M&A or seek an alternative way to improve R&D productivity. These findings appear similar to the current situation of the global pharmaceutical industry, although Japan pursued more licensing activities than M&A to improve R&D productivity.

Considering the Future of Pharmaceutical Promotions in Social Media

Science.gov (United States)

Carpentier, Francesca Renee Dillman

2016-01-01

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. PMID:27239874

18 CFR 260.1 - FERC Form No. 2, Annual report for Major natural gas companies.

Science.gov (United States)

2010-04-01

... report for Major natural gas companies. 260.1 Section 260.1 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY APPROVED FORMS, NATURAL GAS ACT STATEMENTS AND REPORTS (SCHEDULES) § 260.1 FERC Form No. 2, Annual report for Major natural gas companies. (a...

Micro factors bringing the pharmaceutical industry to a seismic shaking a qualitative research.

Science.gov (United States)

Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves

2017-06-01

Due to changing macro and micro factors, expiring patents and falling net income, pharmaceutical companies need to rethink their vertical business model. The trend shows cross-sectorial partnerships and consolidation to remain and compete on the market. Areas covered: Quantitative research interviewing a target group of 25 key executives from small, mid and large global pharmaceutical companies rounded with qualitative literature research completing the analysis. Expert commentary: Uncertainty in the industry due to changing external factors i.e. pricing pressures, regulations or an economic slowdown, slowing down innovations and new drug outcomes. Pharmaceutical companies understand the existing hurdles, and are critically optimistic implementing new business models. Also, various stakeholders are included in the value chain due to their growing importance. During the next years, the industry will be restructured from volume towards value, and only pharmaceutical companies' clairaudient and reciprocate to the changes with an out-off the box thinking will be able to resist on the market. Small biotech companies should focus on research, and big pharmaceutical companies entering at development focusing on the process until the distribution. This execution business recommendation would enable the best know-how at the right point, mitigating the risk and enhancing the patient outcomes.

Creating knowledge structures in the pharmaceutical industry: the increasing significance of virtual organisation.

Science.gov (United States)

Salazar, A; Howells, J

2000-01-01

This paper explores the specific trend and challenges facing the pharmaceutical industry regarding the exploitation of Internet e-commerce technology and virtual organisation to develop and maintain competitive advantage. There are two important facets of the current trend. One is the rapid development of a complex network of alliances between the established pharmaceutical companies and the specialised biotechnology company start-ups. The other is the rapid growth of internet e-commerce companies dedicated to developing specialised technological platforms for acquiring and selling genetic and biochemical knowledge. The underlying challenge is how big pharmaceutical companies can emulate some of the innovation processes of smaller biotechnology company start-ups, and how they can appropriate and applied new technological knowledge on the development of new drugs. Pharmaceutical companies in order to retain competitive advantage need to continuously monitor all aspects of knowledge management with regard to the R&D and manufacturing process (as well as customer management and marketing). Technological change and organisational restructuring should be aimed at boosting the capacity of large firms to innovate rapidly.

Application of the Lean Methodology in a company from the pharmaceutical and food industry

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Juliana Keiko Sagawa

2016-06-01

Full Text Available The main goal of Lean Manufacturing is the reduction of waste and consequently the improvement of manufacturing efficiency and quality. This paper presents a case study in a company from the pharmaceutical, health and food industry. The value stream was mapped, aiming to identify waste and the possible ways of reducing it, according to the lean principles. Among the proposed solutions is the implementation of Kanban cards and the implementation of a panel for stock control and production leveling (heijunka. A 70% reduction of the total lead time was estimated as a potential result (from 71 to 19 days. The proposed improvements sought to provide a balance given the trade-off between more flexible production with smaller batches, and the lower total set up time of larger batches.

Pharmacoligaclly Active: Clinical Trials and the Pharmaceuticals ...

African Journals Online (AJOL)

Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...

Polish physicians' cooperation with the pharmaceutical industry and its potential impact on public health.

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Marta Makowska

Full Text Available This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health.It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland.The majority of respondents (96.8% said that they had talked with pharmaceutical sales representatives (PSRs in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3% said they trusted the information provided by PSRs. Over one third of respondents (36.4% claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law.The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical

Polish physicians' cooperation with the pharmaceutical industry and its potential impact on public health.

Science.gov (United States)

Makowska, Marta

2017-01-01

This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical guidelines

Polish physicians’ cooperation with the pharmaceutical industry and its potential impact on public health

Science.gov (United States)

2017-01-01

Objective This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. Methods It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians’ website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. Results The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. Conclusions The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency

Conceptualizing Pharmaceutical Plants

DEFF Research Database (Denmark)

Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel

2006-01-01

In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....

INNOVATIVE AND INDUSTRIAL-PERFORMANCE IN PHARMACEUTICAL RESEARCH-AND-DEVELOPMENT, A MANAGEMENT CONTROL PERSPECTIVE

NARCIS (Netherlands)

OMTA, SWF; BOUTER, LM; VANENGELEN, JML

In this paper management control is related to innovative and industrial performance in 14 non-biotech pharmaceutical companies. The study consisted of questionnaires, sent to the heads of the different research departments of European research laboratories of leading pharmaceutical companies,

Proceed to the innovation in the pharmaceutical industry. The case of Spain

Directory of Open Access Journals (Sweden)

Aída Salazar García

2015-01-01

Full Text Available This article explores sectors identified innovation in Spanish pharmaceutical companies. It also considers domestic firms and foreign subsidiaries in the country. The analysis covers the period 2009 to 2011 for a population N=200 affiliates at that time Farmaindustria and Plan Profarma. The work involved a search of useful information on the websites of pharmaceutical companies based in Spain statically describes the innovative profile of the Spanish pharmaceutical through descriptive statistical analysis. Thus a foundation for documenting the results in a database in order to get a picture with determination on the behavior of Spanish pharmaceutical sector and possible trends is created.The high content of literary contribution on the pharmaceutical sector is expressed in a globalized national and international level, rejecting data and information that could provide signals threat or opportunity regarding short period time, and which in turn are comparable to other years since the Spanish pharmaceutical industry is constituted by companies of foreign origin (50.5% and domestic capital (49.5%. Of the latter SMEs are the protagonists of small innovations established in Madrid and Barcelona mainly.

How pharmaceutical industry employees manage competing commitments in the face of public criticism.

Science.gov (United States)

Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

2013-10-01

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the "medical affairs" departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance.

Are results from pharmaceutical-company-sponsored studies available to the public?

Science.gov (United States)

Dal-Ré, Rafael; Pedromingo, Alejandro; García-Losa, Manuel; Lahuerta, Juan; Ortega, Rafael

2010-11-01

Only 53% and 63% of studies and clinical trials results presented at congresses are published. Company-sponsored trial results are being posted on publicly accessible Web sites. We analyzed the public availability (publication or posting on a Web site) rate, time to publication, and factors predicting public availability of results of studies sponsored by a pharmaceutical company. This was a retrospective cohort study analyzing all studies conducted by GlaxoSmithKline in Spain between 2001 and 2006. Initiation and completion were defined as first participant/first visit and last participant/last visit (or their equivalents). Papers published up to 31 March 2009 were considered. Logistic regression models were used to identify factors predicting public availability of results. The cohort comprised 143 studies (94 clinical trials; of these, 87 were included in international products clinical development plans). Public availability rate was 80% (114/143) for all studies and 78% (73/94) for clinical trials; publication rates were 68% and 61%, respectively. The median time to publication for all studies and trials was 27.3 and 28.4 months, respectively. Study associated to a cancelled project was the only significant factor associated with lower publication rate for all studies [odds ratio (OR) 0.069; 95% confidence interval (CI) 0.02-024; p public availability rate (OR 0.052; 95% CI 0.007-0.382; p = 0.004) for trial results. Therapy area, sample size, positive trial results, duration of experimental phase, and being a clinical trial did not predict publication or public availability. Eighty percent of studies included in this analysis are publicly available. Web site posting increases public availability rate of clinical trial results from 61% to 78%. Cancellation of projects is the single factor negatively influencing publication and public availability rates.

ECONOMIC CONSEQUENCES OF PEAK OIL FOR THE MAJOR MULTINATIONAL OIL AND GAS COMPANIES

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Antonio García-Amate

2018-03-01

Full Text Available The main goal of this work is to analyze the financial statements of the five major multinational oil and gas companies, for the 2011-2015 period, in the framework of the peak oil phenomenon. Peak oil can affect key financial indicators (e.g., earnings volatility, leverage that are used by managers, investors, and stockholders and which may potentially lead to changes in the decision making by management. Our results show that the decline in oil production affects the decisions about investment in new oil wells, leverage, dividends paid, shares purchased and net income involving the five major companies. In addition, we study the evolution of oil prices, and its influence in several items of the financial statements. Even though oil prices were at high levels during 2011-2014, however, the net income of the five companies actually declined due to the impact of peak oil. Finally, data for the last year studied (2015 indicate a general deterioration in return ratios and other accounting variables. Although the new investments should have been profitable, they have been influenced by peak oil, compromising the economic position of the companies. The advice to these companies would be to relax their investments, especially during a period of falling oil prices. Company managers need to recognize the prolonged duration of peak oil and price trends to promote profitability recovery decisions.

[Dangerous liaisons--physicians and pharmaceutical sales representatives].

Science.gov (United States)

Granja, Mónica

2005-01-01

Interactions between physicians and detailers (even when legitimate ones) raise scientific and ethical questions. In Portugal little thinking and discussion has been done on the subject and the blames for bribery have monopolized the media. This work intended to review what has been said in medical literature about these interactions. How do physicians see themselves when interacting with pharmaceutical companies and their representatives? Do these companies in fact change their prescriptive behaviour, and, if so, how do they change it? How can physicians interact with detailers and still keep their best practice? A Medline research, from 1966 till 2002, was performed using the key-words as follows. A database similar to Medline but concerning medical journals published in Portugal, Index das Revistas Médicas Portuguesas, was also researched from 1992 to 2002. Pharmaceutical companies are profit bound and they allot promoting activities, and detailing in particular, huge amounts of money. Most physicians hold firmly to the belief that they are able to resist and not be influenced by drug companies promotion activities. Nevertheless, all previous works on literature tell us the opposite. Market research also indicates that detailers effectively promote drug sales. Various works also suggest that the information detailers provide to physicians may be largely incorrect, even comparing it to the written information provided by the pharmaceutical companies they work for. The frequency at which portuguese physicians (especially family physicians) contact with pharmaceutical sales representatives is higher than the frequency reported in countries where the available studies come from (namely, Canada and the United States of America). This may put portuguese physicians at a higher risk, making it imperative that work and wide debate are initiated among the class.

Interactions between physicians and pharmaceutical sales representatives in Saudi Arabia.

Science.gov (United States)

Alosaimi, Fahad Dakheel; Alkaabba, Abdulaziz; Qadi, Mahdi; Albahlal, Abdullah; Alabdulkarim, Yasir; Alabduljabbar, Mohammad; Alqahtani, Faisal

2013-01-01

Interaction between physicians and pharmaceutical sales representative (PR) is a major component of the promotional activities by pharmaceutical companies. The lack of studies examining the magnitude of this interaction in Saudi Arabia is evident. The objective of this study is to estimate the magnitude and associated characteristics of physician-PR interaction. A cross-sectional study was conducted among physicians working in the different regions of Saudi Arabia between March and July of 2012. A cross-sectional study was undertaken between March and July of 2012 in the different regions of Saudi Arabia. A self-administrated questionnaire was developed and handed to all participants, both in paper and electronic formats. A total of 663 participants completed the questionnaire. The participation rate was 66.3% (663/1000). The majority of the participants (72.9%) reported interaction with PRs. This was lower among residents/interns compared to higher ranking employees (55.6% vs 83.6%, P strategy to reduce negative impact.

Direct‐to‐consumer advertising of pharmaceuticals: developed countries experiences and Turkey

OpenAIRE

Semin, Semih; Aras, Şahbal; Guldal, Dilek

2006-01-01

While several major problems concerning drugs occur in the world, the attempts to direct‐to‐consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives’ work efficiency; drug reimbursement restrictions; and t...

Grid computing in large pharmaceutical molecular modeling.

Science.gov (United States)

Claus, Brian L; Johnson, Stephen R

2008-07-01

Most major pharmaceutical companies have employed grid computing to expand their compute resources with the intention of minimizing additional financial expenditure. Historically, one of the issues restricting widespread utilization of the grid resources in molecular modeling is the limited set of suitable applications amenable to coarse-grained parallelization. Recent advances in grid infrastructure technology coupled with advances in application research and redesign will enable fine-grained parallel problems, such as quantum mechanics and molecular dynamics, which were previously inaccessible to the grid environment. This will enable new science as well as increase resource flexibility to load balance and schedule existing workloads.

Recognizing misleading pharmaceutical marketing online.

Science.gov (United States)

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2014-01-01

In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.

Postgraduate Courses in Pharmaceutical Medicine in Italy

Directory of Open Access Journals (Sweden)

Domenico Criscuolo

2017-06-01

Full Text Available Italy has a significant tradition of excellence in the area of clinical trials (CTRs: important achievements in the clinical development of rifampicin and adriamycin, the two most famous drugs discovered in the research laboratories of two Italian pharmaceutical companies, paved the way to the establishment of a culture of clinical development, mainly in the areas of antimicrobials and oncology. Despite the fact that now the Italian market of pharmaceuticals is largely dominated by multinational companies with headquarters outside Italy, the contribution of Italian studies to the clinical development of new drugs is still significant. Indeed, it largely exceeds the percentage of Italian inhabitants versus the ones living in the remaining EU countries, as Italy has about 12% of EU population, but has a 17% share of the EU CTRs. Education in Pharmaceutical Medicine is now a must for all professionals interested to work either in pharma companies or in contract research organizations: several Italian universities are offering high quality courses, and in the last 10 years, more than 1,200 professionals received a postgraduate education in pharmaceutical medicine. This result places Italy on top of countries concerned about the professional education of people involved in drug development and will represent an asset for a larger involvement of Italian clinical sites in the global process of clinical research.

[Research in the pharmaceutical industry cannot be objective].

Science.gov (United States)

Becker-Brüser, Wolfgang

2010-01-01

In the face of tight public budgets more and more studies are being funded by the pharmaceutical industry. At the same time responsibility for conducting company-funded trials is increasingly being shifted to contract research organisations. Pharmaceutical manufacturers sponsor trials that primarily pursue company interests. The dominance of company-funded research does not only have a bearing on the choice of study priorities, though. Company sponsorship also has an influence on the results of trials. Company-funded trials are four times more likely to find evidence in favour of the trial drug than studies funded by other sponsors. There are several contributory factors, from study design (design bias) to data manipulation. And non-publication (publication bias) can distort knowledge. As a result, it is largely impossible to reliably assess the benefit and harm of medical drugs on the basis of published trials. This will have repercussions for the reliability of meta-analyses, guidelines and patient information leaflets. One consequence may be treatment errors.

Does brand differentiate pharmaceuticals?

Science.gov (United States)

Bednarik, Josef

2005-12-01

Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

[AIDS and social justice: pharmaceutical industry and economics].

Science.gov (United States)

López Guzmán, José

2008-01-01

This article takes a broad look at the complicated framework of relationships between the third world and pharmaceutical companies. In the first part of the work reference is made to the poverty of these countries, their lack of education in terms of health, the scarcity of basic hygiene, and their greatly limited access to medicines, especially those for treating AIDS. The article then proceeds to the issue of the pharmaceutical companies' degree of responsibility for the reduced availability of medicines in certain areas of the world. One of the factors that most limits access to medicines is their price, and many sectors of society propose taking action on the patents of drugs (rescinding or limiting them) in order to lower their price. However, the problem of patent exemption is more complicated than it seems at first glance, and comes with its own risks. If, for lack of funds or the uncertainty concerning a return on the capital invested, pharmaceutical companies discontinue research and development of new drugs, AIDS therapy would worsen. It is imperative and urgent to develop new drugs against the AIDS because of its resistance to the drugs currently available. The article concludes with the pharmaceutical industry's effort to look for possible forms of collaboration with developing countries.

[An analysis of the pharmaceuticals market in Vietnam].

Science.gov (United States)

Simonet, D

2001-01-01

This article sheds a light on the Vietnamese pharmaceutical market. The progress that has been made in the recent years following the opening of the Vietnamese regime to the western world, although not easy, brought a certain number of opportunities for domestic firms and foreign investors. The pharmaceutical Vietnamese industry started to emerge at the beginning of the 1990s. Although, the consumption of drugs is low, it does reach the sum of $ 5.5 per capita. As the majority of these products are imported, foreign companies tend to dominate the market both in volume and in diversity. The state has always played an important role with the implementation of a strict price control strategy and most national drug companies remain state-owned. The production and consumption of drugs were also largely influenced by state policies as the latter also control hospitals. In the second half of the eighties, the progressive liberalisation of the country allowed private drug pharmacies to appear and advertisement campaigns became legal. Because the lack of specific products like antibiotics was clear, the government increased the flow of imports, including private imports by citizens. Sources of imports have become more diverse, although France remains an important source of supply. Fournier, Lipha and Pierre Fabre are among the French drug manufacturers located in Vietnam. Other foreign companies include from India, South Korea, Thailand and Germany. Joint ventures were also created with French and Japanese companies. The import of medical materials is subjected to authorisations from the Ministry of Health and the Ministry of Foreign Trade as it is necessary to obtain a licence to do so. Licences are issued on the basis of the production of drugs that do not currently exist on the local market. But Vietnam also exports pharmaceutical products to Laos, Cambodia, and Cuba. Local resources constitute an important source of new products and have stirred a strong interest among

Exposure of Medical Students to Pharmaceutical Marketing in Primary Care Settings: Frequent and Influential

Science.gov (United States)

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-01-01

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts.…

Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research.

Science.gov (United States)

Orzan, G; Zara, I A; Purcarea, V L

2012-12-15

Recent years have seen an "explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer's thoughts and tailor specific marketing messages.

Key differences and similarities in ways of managing and supporting radical pharmaceutical front end innovation

DEFF Research Database (Denmark)

Aagaard, Annabeth

2015-01-01

of the Danish and US based pharmaceutical company, H. Lundbeck A/S, and a comparative study including five European and American pharmaceutical companies. The findings from the study reveal a number of similarities and differences in innovation management and FEI support of radical projects and among...... pharmaceutical companies, which represent a growing market. The value added and the contribution of this paper to the existing FEI literature is therefore in the specificity of the empirical setting in which the issue is investigated. Read More: http://www.worldscientific.com/doi/abs/10.1142/S1363919615500115...

制药企业实施新版GMP存在的问题与应对措施%Pharmaceutical Companies to Implement New GMP Issues and Countermeasures Exist

Institute of Scientific and Technical Information of China (English)

曾毅均

2016-01-01

After the implementation of new GMP,pharmaceutical companies in the implementation there are different problems. After binding the author’s work experience,and with reference to the relevant literature on the implementation of the new GMP pharmaceutical companies the problems were summarized discussed,and based on their experience in quality management proposed the corresponding countermeasures.%新版GMP实施后，制药企业在执行时都存在着不同问题。结合作者的工作经验，并参考相关文献后，对制药企业执行新版GMP存在的问题进行了归纳探讨，并根据自身的质量管理经验提出了相应的应对措施。

FACTORS AFFECTING EMPLOYEE JOB SATISFACTION OF PHARMACEUTICAL SECTOR

OpenAIRE

Mosammod Mahamuda Parvin; M M Nurul Kabir

2011-01-01

The Pharmaceutical sector plays a vital role in underpinning the economic development of a country. This study attempts to evaluate job satisfaction of employees in different pharmaceutical companies. It focuses on the relative importance of job satisfaction factors and their impacts on the overall job satisfaction of employees. It also investigates the impacts of pharmaceutical type, work experience, age, and sex differences on the attitudes toward job Satisfaction. The result shows that sal...

Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research

Science.gov (United States)

Orzan, G; Zara, IA; Purcarea, VL

2012-01-01

Recent years have seen an “explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer’s thoughts and tailor specific marketing messages. PMID:23346245

Legal considerations for social media marketing by pharmaceutical industry.

Science.gov (United States)

Yang, Y Tony; Chen, Brian

2014-01-01

Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

[Early achievements of the Danish pharmaceutical industry-6 Pharmacia].

Science.gov (United States)

Grevsen, Jørgen V; Kruse, Edith; Kruse, Poul R

2014-01-01

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The

Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.

Science.gov (United States)

Cohen-Kohler, Jillian Clare; Esmail, Laura C

2007-09-01

This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.

New Product Development in the Pharmaceutical Industry: Evidence from a generic market.

Science.gov (United States)

Yousefi, Nazila; Mehralian, Gholamhossein; Rasekh, Hamid Reza; Yousefi, Mina

2017-01-01

In today's competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem the same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively.

APPROACHES TO IMPLEMENTATION OF AN INTEGRATED MANAGEMENT SYSTEM IN THE PHARMACEUTICAL INDUSTRY. GALENICAL PHARMACEUTICAL PRODUCTION

Directory of Open Access Journals (Sweden)

Ershova Elena Vladimirovna

2015-10-01

Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.

Pharmaceutical technology management--profitable business avenue.

Science.gov (United States)

Puthli, Shivanand P

2010-01-01

Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

PARTICULARITIES OF MODERN PHARMACEUTICAL PROMOTION

Directory of Open Access Journals (Sweden)

Юрий Владимирович Тарасов

2014-02-01

Full Text Available Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1

The emerging role of MD Pharmacology postgraduate in pharmaceutical industry

OpenAIRE

Pratishtha Banga Chaudhari

2016-01-01

Patient-benefit is a shared goal of the pharmaceutical company and the treating doctor. At the same time, the pharmaceutical company- in order to recur its R and D costs has to balance patient centricity with making profits. Consequently, the commercial benefits from prescription of a product and education about optimal use of product both become the responsibilities of same organization. This often leads to allegations of bias by the regulators. We are in an era where regulatory bodies close...

Pharmaceutical strategy and innovation: an academics perspective.

Science.gov (United States)

Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

2007-06-01

The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences.

Evaluating the impact of Brexit on the pharmaceutical industry.

Science.gov (United States)

Kazzazi, Fawz; Pollard, Cleo; Tern, Paul; Ayuso-Garcia, Alejandro; Gillespie, Jack; Thomsen, Inesa

2017-01-01

The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry.

'Get with the Program!': pharmaceutical marketing, symptom checklists and self-diagnosis.

Science.gov (United States)

Ebeling, Mary

2011-09-01

During more than a decade of direct-to-consumer advertising (DTC) of pharmaceuticals in the United States, several highly controversial and contested disease states have been promoted to affect diagnostic and prescribing outcomes that are favorable to a company's branded drug. Influencing medical diagnosis is essential to the branding of a disease, which helps to protect pharmaceutical intellectual property and assures higher profits for drug companies. Enormous marketing as well as medical resources are deployed to ensure that new diagnoses of disease states are recognized. While much work has been done investigating the marketing processes necessary to shape and define diagnoses for many of these new disease states, such as Premenstrual Dysphoric Disorder (PMDD), the promotion of self-diagnosis within pharmaceutical marketing campaigns garner little sociological attention. This article reviews and analyzes branded disease awareness campaigns sponsored by pharmaceutical companies that employ self-diagnostic "tools". By using the example of one specific disease state, PMDD, I illustrate how the marketing of self-diagnosis transforms the patient into a consumer in order to achieve the aims of a drug company. This example is contextualized within the larger theoretical framework on the sociology of diagnosis. Consideration is given to how the marketing of self-diagnosis goes beyond Jutel's (2009) description of diagnosis as being the "classification tool of medicine" and becomes a marketing tool to construct a well-educated consumer who will demand medical diagnoses inline with a drug company's objectives. Copyright © 2011 Elsevier Ltd. All rights reserved.

Gore offers to help drug companies pursue research.

Science.gov (United States)

1996-03-08

A meeting convened between Vice President Al Gore and executives of leading pharmaceutical companies to determine means of accelerating efforts to develop vaccines, therapeutics, and microbicides for people with HIV. Gore explained that the administration will work with pharmaceutical companies to determine the long-term effectiveness of drugs approved by the Food and Drug Administration (FDA), work with international groups to increase investment in vaccine development, help develop new microbicides for women with HIV, and identify promising areas of AIDS research. According to advocates, the Clinton Administration has made great strides in improving and accelerating the FDA's drug approval process. The next goal of the pharmaceutical research agenda should be to include consumer advocates in the decision-making process.

Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda.

Science.gov (United States)

Paumgartten, Francisco José Roma

2016-12-22

In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.

E-detailing: information technology applied to pharmaceutical detailing.

Science.gov (United States)

Montoya, Isaac D

2008-11-01

E-detailing can be best described as the use of information technology in the field of pharmaceutical detailing. It is becoming highly popular among pharmaceutical companies because it maximizes the time of the sales force, cuts down the cost of detailing and increases physician prescribing. Thus, the application of information technology is proving to be beneficial to both physicians and pharmaceutical companies. When e-detailing was introduced in 1996, it was limited to the US; however, numerous other countries soon adopted this novel approach to detailing and now it is popular in many developed nations. The objective of this paper is to demonstrate the rapid growth of e-detailing in the field of pharmaceutical marketing. A review of e-detailing literature was conducted in addition to personal conversations with physicians. E-detailing has the potential to reduce marketing costs, increase accessibility to physicians and offer many of the advantages of face-to-face detailing. E-detailing is gaining acceptance among physicians because they can access the information of a pharmaceutical product at their own time and convenience. However, the drug safety aspect of e-detailing has not been examined and e-detailing remains a supplement to traditional detailing and is not yet a replacement to it.

[Attractiveness of France for international clinical research: 8th survey conducted by Leem (French association for pharmaceutical companies)].

Science.gov (United States)

Galaup, Ariane; Barthélémy, Philippe; Pouletty-Lefebvre, Brigitte; Béhier, Jehan-Michel; Zetlaoui, Jean; Borel, Thomas

2018-04-18

The Leem (French association of pharmaceutical companies) has conducted the eighth survey on attractiveness of France for clinical research. It serves to measure France's global competitiveness for international clinical trials and assess its strengths and areas of excellence. It also highlights the potential for progress and emerging trends at a time when the regulatory environment in France and Europe is undergoing change. This survey has been updated every two years since 2002 using the same methodology. It assesses the current status of research undertaken in France by the pharmaceutical industry between January 1st 2014 and December 31st 2015. Thirty companies (62% of the French market) have participated in this 8th survey which involved 3474 centers (versus 2860 in 2014) and 16,622 patients (versus 14,634 in 2014) enrolled in France across 586 clinical trials (versus 613 in 2014). This survey shows a reduction in the number of phase I and phase II trials. It also confirms that the studies conducted in France are primarily concerned with oncology (45%). Despite improvements across hospital contracts times (due to the adoption of the sole agreement) and performance indicators in trials (such as the number of patients enrolled by center), trial setup times in France are still overly lengthy (with stable times by French authorities). Ensuring that clinical research remains a priority issue for country is crucial for patients because of rapid access to innovation but also for the vitality of the French economy. Constructive dialogue with stakeholders on the subject of clinical research is essential to enhance the attractiveness of France and to improve the continuum between research, innovation and care. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Report raises questions about drug companies advertising budgets.

Science.gov (United States)

1999-08-06

A report by AIDS Action cites that data, indicates the pharmaceutical industry is spending more resources on marketing and advertising than on research and development (R&D). The pharmaceutical industry blames the high cost of AIDS drugs on R&D information compiled from annual reports and industry publications show excessive marketing as the source. A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA) disputes the information in the AIDS Action report as misleading. According to PhRMA, research spending has been steadily increasing, and at a greater rate than any other industry. In addition, PhRMA noted that pharmaceutical companies have already dedicated money to fund initiatives in developing countries. Solutions proposed by AIDS Action include lowering drug prices or transferring funds from marketing to research, and reestablishing the "reasonable pricing clause" between National Institutes of Health and those companies seeking tax breaks for R&D.

Public Innovation Policy in the Pharmaceutical Industry: the Cases of the EU and USA

Directory of Open Access Journals (Sweden)

Z. A. Mamedyarov

2017-01-01

Full Text Available Purpose: the main purpose of this article was to study the modern tools of the public innovation policy in the global pharmaceutical industry (US and EU cases, which is one of the most knowledge-intensive sectors of the global economy. During the study, it was necessary to achieve the following objectives: to identify main components of the innovation policy in the sector, to consider the role of intellectual property protection, measures of innovation support, regulatory control and other factors, and, also, to identify comparative characteristics of innovation processes within the US and the EU pharmaceutical sector. Methods: this article is based on a qualitative comparative study of the US and EU innovation policy in the pharmaceutical industry. Industryoriented innovation support measures (i.e. levels of private and public financing have been quantitatively analyzed, including the evaluation of the levels of R&D productivity; also, a comparative study of the pharma patent statistics in the leading countries have been performed. This article highlights the problems of intellectual property protection, which remains an important source of financial stability for major pharma companies being the basis for new innovation agenda. Low R&D productivity and high costs of new innovative drugs together emphasize the significance of the analysis of current innovation processes within the pharmaceutical industry, and could open the way for building more effective managerial and business processes. Results: the global pharmaceutical industry today is under thorough control of government regulators and civil society organizations seeking to improve mechanisms of the drugs distribution, in order to make drugs more accessible, safe and clean. This high regulation level impedes innovation within existing pharma business models, and leads to high costs of the newest drugs. The study revealed that successful pharmaceutical innovation today requires

Reverse logistics in a pharmaceutical company: a case study

NARCIS (Netherlands)

R.H. Teunter (Ruud); K. Inderfurth (Karl); S. Minner; R. Kleber

2003-01-01

textabstractSchering spends considerable effort to undertake product recovery activities in pharmaceutical production. The two main recovery activities are by-product recycling and solvent reuse. The main driver for engaging in these activities is economical. Recovery leads to annual savings of

Idea management in support of pharmaceutical front end innovation

DEFF Research Database (Denmark)

Aagaard, Annabeth

2012-01-01

The pharmaceutical industry faces continuing pressures from rising R&D costs and depreciating value of patents, as patent lives is eroded by testing procedures and pressures from public authorities to cut health care costs. These challenges have increased the focus on shortening development times......, which again put pressure on the efficiency of front end innovation (FEI). In the attempt to overcome these various challenges pharmaceutical companies are looking for new models to support FEI. This paper explores in what way idea management can be applied as a tool in facilitation of front end...... innovation in practice. First I show through a literature study, how idea management and front end innovation are related and may support each other. Hereafter I apply an exploratory case study of front end innovation in eight medium to large pharmaceutical companies in examination of how idea management...

[The aspects of pricing policy in Azerbaijan pharmaceutical sector].

Science.gov (United States)

Dzhalilova, K I; Alieva, K Ia

2012-01-01

The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceutical companies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers.

Strategic imperatives for globalization of industries in developing countries: an Indian pharmaceutical industry example.

Science.gov (United States)

Srivastava, Rajesh; Chandra, Ashish; Kumar, Girish

2004-01-01

The annual global pharmaceutical sales have grown over 466 billion dollars, almost 50% of which comes from North America. Among developing countries, India, with 16% of the world population, accounts for only a small percentage of the global pharmaceutical industry. Until recently, India has had virtually no pharmaceutical industry worth the name producing drugs from basic raw materials and it used to rely mostly on the imports from countries like the USA and England for all its requirements of drugs. On the other hand, India has seen a plethora of multinational pharmaceutical companies come and do business in India. This paper develops a matrix which provides a broad guidance to the mid- to large-size Indian pharmaceutical domestic companies, which should embark on the path to global expansion to establish their might as well.

Pharmaceutical company spending on research and development and promotion in Canada, 2013-2016: a cohort analysis.

Science.gov (United States)

Lexchin, Joel

2018-01-01

Competing claims are made about the amount of money that pharmaceutical companies spend on research and development (R&D) versus promotion. This study investigates this question in the Canadian context. Two methods for determining industry-wide figures for spending on promotion were employed. First, total industry spending on detailing and journal advertising for 2013-2016 was abstracted from reports from QuintilesIMS. Second, the mean total promotion spending for the years 2002-2005 was used to estimate total spending for 2013-2016. Total industry spending on R&D came from the Patented Medicine Prices Review Board (PMPRB). R&D to promotion spending using each method of determining the amount spent on promotion was compared for 2013-2016 inclusive. Data on the 50 top promoted drugs, the amounts spent, the companies marketing these products and their overall sales were abstracted from the QuintilesIMS reports. Spending on R&D and promotion as a percent of sales was compared for these companies. Industry wide, the ratio of R&D to promotion spending went from 1.43 to 2.18 when promotion was defined as the amount spent on detailing and journal advertising for the 50 most promoted drugs. Calculating total promotion spending from the mean of the 2002-2005 figures the ratio was 0.88 to 1.32 for the 50 most promoted drugs. For individual companies marketing one or more of the 50 most promoted drugs, mean R&D spending ranged from 3.7% of sales to 4.1% compared to mean promotion spending that went from 1.7 to 1.9%. The ratio of spending on R&D to promotion varied from 2.11 to 2.32. Eight to 10 companies per year spent more on promotion than on R&D. Depending on the method used to determine promotion spending, industry-wide the ratio of R&D spending to promotion ranges from 1.45 to 2.18 (sales representatives and journal advertising only) or from 0.88 to 1.32 (total promotion spending estimated based 2003-2005 data.) For the individual companies promoting one or more of the

Regulating the relationship between physicians and pharmaceutical companies: a qualitative and descriptive analysis of the impact of Israeli legislation.

Science.gov (United States)

Nissanholtz-Gannot, Rachel; Yankellevich, Ariel

2017-09-26

The Israeli National Health Insurance Law was amended in 2010 to require the disclosure of payments above 2500 NIS from pharmaceutical companies (PCs) to medical personnel and organizations. We examined if the law had an impact on the relationship between physicians in the Israeli health system and the pharmaceutical industry. We conducted 42 in-depth semi-structured interviews with representatives of relevant stakeholders regarding the effects and extent of the law and the interviewees' attitudes about regulating the relationship between physicians and PCs. In addition, we analyzed reports on payments from PCs to various components of the health system. The majority of interviewees agreed that transparency is important to the relationship between PCs and physicians and none of them opposed the disclosure of payments. Most interviewees reported to have witnessed a change in the regulatory climate of the relationship between PCs and physicians, prompted mostly by self-regulatory measures of the pharmaceutical industry. The most significant change in this relationship appeared to be the enactment of contractual relations between PCs and physicians. There was a pervasive feeling that self-regulation is more effective than state regulation. The impact of the law on the behavior of individual physicians was claimed to be limited at best. Suggested causes were lack of awareness of the law, particularly among physicians; ambiguous definition of "payments" and loopholes in the law that attract other forms of remuneration to physicians and lack of enforcement of the law. According to reports published by the Ministry of Health, Pharma Israel, and the Israeli Medical association, although there had been some disclosure of payments by both donors and beneficiaries, there were inconsistencies between the total payments disclosed by PCs and those disclosed by their beneficiaries. There is a broad agreement that transparency is important to the PCs-physicians relationship. In

RFID in the pharmaceutical industry: addressing counterfeits with technology.

Science.gov (United States)

Taylor, Douglas

2014-11-01

The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.

The role of entrepreneurial activities in academic pharmaceutical science research.

Science.gov (United States)

Stinchcomb, Audra L

2010-06-01

Academic pharmaceutical science research is expanding further and further from the University setting to encompass the for-profit private company setting. This parallels the National Institutes of Health momentum to include multiple funding opportunities for University and private company collaboration. It has been recognized that the nonprofit and for-profit combination research model can accelerate the commercialization of pharmaceutical products, and therefore more efficiently improve human health. Entrepreneurial activities require unique considerations in the University environment, but can be modeled after the commercialization expansion of the academic healthcare enterprise. Challenges and barriers exist to starting a company as an entrepreneurial faculty member, but the rewards to one's personal and professional lives are incomparable. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association

Collaborating to Compete: A Search into Capabilities and Strategic Alliances in the Pharmaceutical Industry

Directory of Open Access Journals (Sweden)

Marisa Ohba

2007-06-01

Full Text Available Athough there is a profusion of studies related to strategic alliances and technological capacities which evaluate the issues individually, there is a scarcity of studies with empirical evidence relative to the implications of strategic alliances at the technological capacity configuration. Drawing on a scrutiny of specialised databases (Galé, Dialog, and Business & Industry covering the 1993-2003 period, this article examines the entry and exit composition of innovative capabilities of 25 pharmaceutical companies’ capabilities involved in such alliances. They are organised in three groups: (i large pharmaceutical companies (‘big-pharma’; (ii large bio-pharmaceutical companies (‘bio-pharma’; and (iii small and research-intensive companies. In terms of strategic alliance implications, a change was observed on the technological capacities’ configuration. The evidence suggests that the criteria for partner choice and technological capacity depend on the objectives and needs of each different group of company. Such type of evidence is important to provide researchers, corporate managers, and policy-makers with a concrete notion of the extent to which such division of innovative labour occurs and the actual changes going on the structure and organisation of innovative activities in the pharmaceutical industry.

Ethical pharmaceutical promotion and communications worldwide: codes and regulations

Science.gov (United States)

2014-01-01

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

Science.gov (United States)

Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

2014-03-29

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

Major multinational food and beverage companies and informal sector contributions to global food consumption: implications for nutrition policy

Directory of Open Access Journals (Sweden)

Yach Derek

2011-08-01

Full Text Available Abstract Background In recent years, 10 major multinational food and beverage companies have worked together within the International Food and Beverage Alliance (IFBA to increase their commitments to public health. Current IFBA commitments include initiatives to improve the nutrition quality of products and how these products are advertised to children. The impact and magnitude of IFBA member contributions to the total market share of packaged foods and beverages consumed remain incompletely understood, however. Methods In order to evaluate this impact, we examined packaged food and soft drink company shares provided by Euromonitor, an international independent market analysis company. Packaged foods include baby food, bakery, canned/preserved food, chilled/processed food, confectionery, dairy, dried processed food, frozen processed food, ice cream, meal replacement, noodles, oils and fats, pasta, ready meals, sauces, dressings and condiments, snack bars, soup, spreads, and sweet and savoury snacks. Soft drinks include carbonates, packaged fruit/vegetable juice, bottled water, functional drinks, concentrates, ready-to-drink tea, ready-to-drink coffee and Asian specialty drinks. We calculated the market shares for IFBA companies, globally and within nine countries--the US, China, India, Egypt, South Africa, Brazil, Mexico, Turkey and the UK. Results Worldwide, the top ten packaged food companies account for 15.2% of sales, with each individual company contributing less than 3.3%. The top ten soft drink companies account for 52.3% of sales worldwide; Coca-Cola and PepsiCo lead with 25.9% and 11.5% of sales, respectively. Conclusions Although the top ten soft drink companies account for half of global sales, the top ten packaged food companies account for only a small proportion of market share with most individual companies contributing less than 3.3% each. Major multinational companies need to be joined by the myriad of small- and medium

Major multinational food and beverage companies and informal sector contributions to global food consumption: implications for nutrition policy

Science.gov (United States)

2011-01-01

Background In recent years, 10 major multinational food and beverage companies have worked together within the International Food and Beverage Alliance (IFBA) to increase their commitments to public health. Current IFBA commitments include initiatives to improve the nutrition quality of products and how these products are advertised to children. The impact and magnitude of IFBA member contributions to the total market share of packaged foods and beverages consumed remain incompletely understood, however. Methods In order to evaluate this impact, we examined packaged food and soft drink company shares provided by Euromonitor, an international independent market analysis company. Packaged foods include baby food, bakery, canned/preserved food, chilled/processed food, confectionery, dairy, dried processed food, frozen processed food, ice cream, meal replacement, noodles, oils and fats, pasta, ready meals, sauces, dressings and condiments, snack bars, soup, spreads, and sweet and savoury snacks. Soft drinks include carbonates, packaged fruit/vegetable juice, bottled water, functional drinks, concentrates, ready-to-drink tea, ready-to-drink coffee and Asian specialty drinks. We calculated the market shares for IFBA companies, globally and within nine countries--the US, China, India, Egypt, South Africa, Brazil, Mexico, Turkey and the UK. Results Worldwide, the top ten packaged food companies account for 15.2% of sales, with each individual company contributing less than 3.3%. The top ten soft drink companies account for 52.3% of sales worldwide; Coca-Cola and PepsiCo lead with 25.9% and 11.5% of sales, respectively. Conclusions Although the top ten soft drink companies account for half of global sales, the top ten packaged food companies account for only a small proportion of market share with most individual companies contributing less than 3.3% each. Major multinational companies need to be joined by the myriad of small- and medium-sized enterprises in developing and

Major multinational food and beverage companies and informal sector contributions to global food consumption: implications for nutrition policy.

Science.gov (United States)

Alexander, Eleanore; Yach, Derek; Mensah, George A

2011-08-01

In recent years, 10 major multinational food and beverage companies have worked together within the International Food and Beverage Alliance (IFBA) to increase their commitments to public health. Current IFBA commitments include initiatives to improve the nutrition quality of products and how these products are advertised to children. The impact and magnitude of IFBA member contributions to the total market share of packaged foods and beverages consumed remain incompletely understood, however. In order to evaluate this impact, we examined packaged food and soft drink company shares provided by Euromonitor, an international independent market analysis company. Packaged foods include baby food, bakery, canned/preserved food, chilled/processed food, confectionery, dairy, dried processed food, frozen processed food, ice cream, meal replacement, noodles, oils and fats, pasta, ready meals, sauces, dressings and condiments, snack bars, soup, spreads, and sweet and savoury snacks. Soft drinks include carbonates, packaged fruit/vegetable juice, bottled water, functional drinks, concentrates, ready-to-drink tea, ready-to-drink coffee and Asian specialty drinks. We calculated the market shares for IFBA companies, globally and within nine countries--the US, China, India, Egypt, South Africa, Brazil, Mexico, Turkey and the UK. Worldwide, the top ten packaged food companies account for 15.2% of sales, with each individual company contributing less than 3.3%. The top ten soft drink companies account for 52.3% of sales worldwide; Coca-Cola and PepsiCo lead with 25.9% and 11.5% of sales, respectively. Although the top ten soft drink companies account for half of global sales, the top ten packaged food companies account for only a small proportion of market share with most individual companies contributing less than 3.3% each. Major multinational companies need to be joined by the myriad of small- and medium-sized enterprises in developing and implementing programs to improve the

A new e-beam application in the pharmaceutical industry

International Nuclear Information System (INIS)

Sadat, Theo; Malcolm, Fiona

2005-01-01

The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a 'miniature' low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned

Strategic analysis of the performance of companies trading pharmaceutical products in the Republic of Serbia: As a integrated system of indicators

Directory of Open Access Journals (Sweden)

Čavlin Miroslav S.

2015-01-01

Full Text Available Modern approach to strategic analysis is based on the usage of appropriate systems of indicators, economic and financial, that especially stand out, recommending certain models that are discussed in this paper. In addition to the limitations of the availability of data for a specific analysis which is the subject of this paper, attention is focused on the presentation of the method of 'Force Five' pESTLE. This method has been applied for external analysis of the strategic plan as well as a comparative method of analysis of the financial performance of the related activities of the company, as a core internal resource analysis and management of the companies in the business of trading pharmaceutical products in the Republic of Serbia. In the presented analysis we have indicated the possibility of using an integrative internal and external analysis that produced the financial and non-financial information in order to understand the strategic position of the company. Such an integral concept analysis (strategic and operational creates a unique information and objective basis for the relevant assessment of growth and development and competitive capacity of enterprises.

Transformational and Transactional Leadership Impact on Organizational Performance in Pharmaceutical Industry in Yemen

Directory of Open Access Journals (Sweden)

مراد محمد النشمي

2017-12-01

Full Text Available This study aimed at revealing the impact on transformational and transactional leadership in organizational performance of Pharmaceutical Industry in Yemen. The researchers have used descriptive analytical methods to answer the study questions and test the hypotheses. Questionnaire has been used for collecting quantitative data from the study sample which is a number of 227 middle and executive management in pharmaceutical companies. The study findings show that there is significant effect of all the dimensions of transformational and transactional leadership on organizational performance. Based on the regression analysis applied in the study, results indicated that transformational leadership is of the highest influencing variables on organizational performance. The study concluded that pharmaceutical companies adoption of modern leadership styles leads to distinguished performance. Keywords: Transformational leadership, Transactional leadership, Organizational performance, Pharmaceutical Industry.

Characteristics of physicians targeted by the pharmaceutical industry to participate in e-detailing.

Science.gov (United States)

Alkhateeb, Fadi M; Khanfar, Nile M; Doucette, William R; Loudon, David

2009-01-01

Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceutical companies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing.

Customer relationship management in the contract pharmaceutical industry: an exploratory study for measuring success.

Science.gov (United States)

Kros, John F; Nadler, Scott; Molis, Justin

2007-01-01

Managing customer relationships is a very important issue in business-to-business markets. This research investigates the growing number of available resources defining Customer Relationship Management (CRM) efforts, and how they are being applied within the Contract Pharmaceutical Manufacturing industry. Exploratory study results using face-to-face and telephone questionnaires based on four criteria for rating a company's CRM efforts are presented. Data was collected from large Contract Pharmaceutical Manufacturing companies in the US market. The results and conclusions are discussed relating how the Contract Pharmaceutical Manufacturing industry is implementing CRM including some potential steps to take when considering a CRM initiative.

Pharmaceutical regulation in Europe and its impact on corporate R&D.

Science.gov (United States)

Eger, Stephan; Mahlich, Jörg C

2014-12-01

Many European countries regulate the markets for prescription drugs in order to cope with rising health expenditures. On the other hand, regulation distorts incentives to invest in pharmaceutical R&D. This study aims at empirically assessing the impact of regulation on pharmaceutical R&D expenditures. We analyze a sample of 20 leading pharmaceutical companies between 2000 and 2008. The share of sales in Europe serves as a proxy for the degree of pharmaceutical regulation. We control for other firm specific determinants of R&D such as cash flow, company size, leverage ratio, growth rate, and Tobin's q. Our results suggest a nonlinear relationship between European sales ratio and R&D intensity. Beyond a threshold of 33% of sales generated in Europe, a higher presence in Europe is associated with lower R&D investments. The results can be interpreted as further evidence of the deteriorating effect of regulation on firm's incentives to invest in R&D.

FORMATION AND FURTHER DEVELOPMENT OF MODERN PROMOTION OF PHARMACEUTICAL PRODUCTS

Directory of Open Access Journals (Sweden)

Юрий Владимирович Тарасов

2014-02-01

Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2

[The pharmaceutical market in Mexico: size, value, and concentration].

Science.gov (United States)

Torres Guerra, Sandra; Gutiérrez, Juan Pablo

2009-07-01

To describe the pharmaceutical drug market in Mexico in terms of its size, structure, business' market power, and consumer negotiating power. A descriptive study based on data from the 2004 Economics Census and the reports of IMS Health, Inc. (Norwalk, Connecticut, United States of America). Sales amounts and volumes of Mexico's pharmaceutical companies from 2002-2005 were obtained and the Herfindahl-Hirschman Index (HHI) and its inverse were calculated as indicators of the market's degree of concentration; also, price elasticity was determined by a product index. The total value of the products manufactured by the pharmaceutical sector was 115 billion in 2006 Mexican pesos, of which 99% pertained to companies categorized as large. This amount constituted 1.2% of the national gross domestic product that year (20.0% of the health sector's portion, estimated to be 6.0%) and 3.9% of the total value of manufactured goods. The HHI of Mexico's pharmaceutical market during the study period was about 0.04, albeit with a steady decline, and its inverse decreased from 23 to 26. The price elasticity of pharmaceutical products was minimal (0.007, 0.003, and -0.002). This study constitutes a preliminary description of Mexico's pharmaceutical market, one of the country's most dynamic economic sectors. It confirmed that the market is a rigid oligopoly, and thus supports enactment of firmer regulatory tools to reduce the power of the manufacturers in favor of that of the consumers.

Value of pharmaceuticals: ensuring the future of research and development.

Science.gov (United States)

Serajuddin, Hamida K; Serajuddin, Abu T M

2006-01-01

To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after

Measuring brand loyalty in the pharmaceutical industry of South Africa / Hilde du Plooy

OpenAIRE

Du Plooy, Hilde

2012-01-01

Brands are recognised as one of the most valuable assets that a company can possess and therefore brands are key role-players in the business strategies of organisations. The rivalry amongst competitors in the pharmaceutical industry is fierce and companies should design their strategies in such a way in order to achieve competitive advantage. Brand loyalty is regarded as a powerful tool in the development of pharmaceutical brands. The main aim of this study was to measure b...

"Does organizational culture influence the ethical behavior in the pharmaceutical industry?".

Science.gov (United States)

Nagashekhara, Molugulu; Agil, Syed Omar Syed

2011-12-01

Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer's V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India.

Design of Continuous Crystallizers for Production of Active Pharmaceutical Ingredients

DEFF Research Database (Denmark)

Capellades Mendez, Gerard; Christensen, Troels V.

The production of Active Pharmaceutical Ingredients (APIs) is conducted primarily in batch processes. This manufacturing approach is reinforced by a patent-driven business model and the need to minimize the process development times for newly patented drugs. However, the regulatory and business...... environments are now changing. The increasing costs of drug development, combined with the strict regulations and the competition from generic manufacturers, have pushed pharmaceutical companies to seek cheaper and more sustainable production methods. Transition from batch to Continuous Pharmaceutical...

Long-Term Collaboration Network Based on ClinicalTrials.gov Database in the Pharmaceutical Industry

Directory of Open Access Journals (Sweden)

Heyoung Yang

2018-01-01

Full Text Available Increasing costs, risks, and productivity problems in the pharmaceutical industry are important recent issues in the biomedical field. Open innovation is proposed as a solution to these issues. However, little statistical analysis related to collaboration in the pharmaceutical industry has been conducted so far. Meanwhile, not many cases have analyzed the clinical trials database, even though it is the information source with the widest coverage for the pharmaceutical industry. The purpose of this study is to test the clinical trials information as a probe for observing the status of the collaboration network and open innovation in the pharmaceutical industry. This study applied the social network analysis method to clinical trials data from 1980 to 2016 in ClinicalTrials.gov. Data were divided into four time periods—1980s, 1990s, 2000s, and 2010s—and the collaboration network was constructed for each time period. The characteristic of each network was investigated. The types of agencies participating in the clinical trials were classified as a university, national institute, company, or other, and the major players in the collaboration networks were identified. This study showed some phenomena related to the pharmaceutical industry that could provide clues to policymakers about open innovation. If follow-up studies were conducted, the utilization of the clinical trial database could be further expanded, which is expected to help open innovation in the pharmaceutical industry.

Appeals court reverses verdict favoring drug companies.

Science.gov (United States)

1995-06-02

An appeals court reversed a verdict favoring drug companies after the widow of a hemophiliac, whose death was linked to HIV-tainted blood products, sued four pharmaceutical companies to pay damages. The four companies, Alpha Therapeutic Corp., Miles Laboratories Inc., Armour Pharmaceutical Co., and Baxter Travenol Laboratories Inc., provided Factor VIII, a clotting concentrate, to [name removed] [name removed], the plaintiff's husband, from 1972 until his death in 1987. [Name removed]'s wife sued the companies, alleging that the defendants negligently solicited blood plasma from paid donors who had a high risk of having HIV, failed to determine whether any lots of Factor VIII contained plasma from an at-risk donor, failed to warn consumers of possible risks, and failed to heat-treat HIV and other viruses in Factor VIII, despite industry-wide knowledge of the risk of infection. The three-judge panel said the trial judge's decision to avoid ruling on the antigenic stimulation theory, based on insufficient evidence, was improper. In addition, the appeals court said a retrial is necessary because of improper remarks made by Alpha's attorney.

Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

Science.gov (United States)

Twine, Richard

2013-12-01

In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

Patent holdings of US biotherapeutic companies in major markets.

Science.gov (United States)

Sebastian, Teena E; Yerram, Chandra Bindu; Saberwal, Gayatri

2009-05-01

In previous studies we examined the (United States, US) patent holdings of 109 largely North American biotech companies developing therapeutics that, in particular, have an interest in discovery stage science. There appears little correlation between the number of patents and the number of products of individual companies. Here we quantified and compared the 103 US-headquartered companies' patent holdings in Australia, Canada, Europe, Japan and the US. The companies demonstrate variable and surprising patterns of patent holdings across these countries or regions. For most companies, patent holdings are not in proportion to the importance of the country as a biotech or pharma market. These results have implications for the patenting strategies of small biotech companies involved in drug discovery.

Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea.

Science.gov (United States)

Lee, Munjae

2015-08-01

The purpose of this study is to analyze the influence of the corporate governance of pharmaceutical companies on research and development (R&D) investment. The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general, and internal transactions were extracted from TS-2000 of the Korea Listed Company Association. Sample firms were those that belong to the medical substance and drug manufacturing industries. Ultimately, 786 firm-year data of 81 firms were included in the sample (unbalanced panel data). The shareholding ratio of major shareholders and foreigners turned out to have a statistically significant influence on R&D investment (p ratio of institutional investors and the ratio of outside directors. The higher the shareholding ratio of the major shareholders, the greater the R&D investment. There will be a need to establish (or switch to) a holding company structure. Holding companies can directly manage R&D in fields with high initial risks, and they can diversify these risks. The larger the number of foreign investors, the greater the R&D investment, indicating that foreigners directly or indirectly impose pressure on a manager to make R&D investments that bring long-term benefits.

Liquidity Analysis Using Cash Flow Ratios as Compared to Traditional Ratios in the Pharmaceutical Sector in Jordan

OpenAIRE

Sulayman H. Atieh

2014-01-01

The purpose of this study is to examine the liquidity position of the Jordanian pharmaceutical sector using the traditional ratios as compared to the more recently developed cash flow ratios. The research involved the comparison between traditional ratios and cash flow ratios of the big seven companies of the pharmaceutical industry in Jordan over six years period (2007¨C2012). The companies were all from the same sector, and the data was obtained from the annual reports of these companies. T...

An export-marketing model for pharmaceutical firms (the case of iran).

Science.gov (United States)

Mohammadzadeh, Mehdi; Aryanpour, Narges

2013-01-01

Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires.

An Export-Marketing Model for Pharmaceutical Firms (The Case of Iran)

Science.gov (United States)

Mohammadzadeh, Mehdi; Aryanpour, Narges

2013-01-01

Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires. PMID:24250597

LEARNING ORGANISATION CHALLENGE FOR ROMANIAN PHARMACEUTICAL SMEs

Directory of Open Access Journals (Sweden)

Otilia-Maria BORDEIANU

2014-04-01

Full Text Available The concept of the learning organization has gone through many changes both theoretically and also as practical implementation. Learning organizations do not appear automatically, they require a strong commitment for developing the skills needed in the workplace, and this commitment should start from the top of the organization. The learning process should be managed at different levels within the organization. Learning, therefore, is made up of several different components and requires a special management. Successful companies are the result of carefully cultivated attitudes, commitments and management processes. This paper investigates the learning organization dimensions analysed in case of pharmaceutical SMEs from Romania. The results obtained in this study allow us to draw relevant conclusions, constituting a practical starting point for businesses. The paper highlights the fact that SMEs pharmaceutical companies have taken important steps toward learning organization model, but reaching different levels from one key dimension to another.

Direct‐to‐consumer advertising of pharmaceuticals: developed countries experiences and Turkey

Science.gov (United States)

Semin, Semih; Aras, Şahbal; Guldal, Dilek

2006-01-01

Abstract While several major problems concerning drugs occur in the world, the attempts to direct‐to‐consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives’ work efficiency; drug reimbursement restrictions; and the escalating role of the Internet in the consumer market. Some of the main disadvantages of the DTCA are: increasing drug expenditures, unnecessary drug consumption and adverse effect risks. Even though the influence of pharmaceuticals on health services and the economy hold the same importance in the developed and developing countries, its negative consequences have increased by encompassing developing countries in its grip. Therefore, in this review, using Turkey as an example, the situation of direct‐to‐consumer advertisements in developing countries is analysed in relation with developed countries. PMID:17324191

Direct-to-consumer advertising of pharmaceuticals: developed countries experiences and Turkey.

Science.gov (United States)

Semin, Semih; Aras, Sahbal; Guldal, Dilek

2007-03-01

While several major problems concerning drugs occur in the world, the attempts to direct-to-consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives' work efficiency; drug reimbursement restrictions; and the escalating role of the Internet in the consumer market. Some of the main disadvantages of the DTCA are: increasing drug expenditures, unnecessary drug consumption and adverse effect risks. Even though the influence of pharmaceuticals on health services and the economy hold the same importance in the developed and developing countries, its negative consequences have increased by encompassing developing countries in its grip. Therefore, in this review, using Turkey as an example, the situation of direct-to-consumer advertisements in developing countries is analysed in relation with developed countries.

Conducting pharmaceutical R&D in India - Critical components of entry strategies.

Science.gov (United States)

Gulati, Rajiv

2008-11-01

In the face of challenges associated with expiring patents, the rising cost of R&D and pressure on pricing, most major pharmaceutical companies are seeking ways to enhance productivity, reduce costs and augment the late-stage new-product pipeline. Exploiting the R&D capabilities in India is one option that can be helpful in achieving these goals. However, considering the challenges involved, important considerations must be incorporated to ensure that an appropriate R&D strategy is meticulously implemented. In creating suitable strategies, it is important to understand the historical perspective that provides insight into the relative strengths of companies in India across the R&D value chain. In addition, the ability of a company to take risks and commit to a long-term investment will largely determine the model that is selected. To implement a given model, an understanding of cultural differences and infrastructural challenges that must be overcome is extremely important. The ultimate factor that determines success or failure, however, lies within the organization. Preparing an organization by establishing appropriate structures and processes is imperative.

A cheat sheet to navigate the complex maze of pharmaceutical exclusivities in Europe.

Science.gov (United States)

Tomas, Marta Cavero; Peng, Bo

2017-07-01

As the two leading markets for pharmaceutical and biotech companies, the USA and Europe offer incentives to stimulate drug innovation, including patent and regulatory exclusivities. These exclusivities extend periods during which companies can market their products free of generic or other competition and recoup their investment. Pharmaceutical and biotech companies should carefully assess the different types of exclusivities available when developing regulatory submissions, patent filing strategies. The authors have previously summarized the USA exclusivities in an earlier publication. This article focuses on European exclusivities. Due to space limitations, it focuses on small molecule drugs. Analogously to the format previously used, we have provided a cheat sheet of European exclusivities for small molecule drugs in Figure 1 .

Pharmaceutical advertising as a consumer empowerment device.

Science.gov (United States)

Rubin, P H

2001-01-01

Pharmaceutical companies have greatly increased their level of "direct-to-consumer" (DTC) advertising in recent years. For 1998, estimates are that over $1.1 billion was spent on this form of advertising, increased from $850 million in 1997 and $600 million in 1996. In 1998, 84 separate drugs were advertised to consumers. The impetus was a decision in August of 1997 by the Food and Drug Administration to reduce the restrictions on DTC advertising on television. As a result, such ads have become very common on TV, and 32 products were advertised on TV in 1998. Pharmaceutical companies advertise because they think that advertising will make money for them. But how will this make money? It will make money by providing consumers with the information they need to make proper decisions about medication. That is, DTC advertising is profitable exactly because it empowers consumers and enables them to purchase useful drugs. The goals of advertising companies and consumers are both for consumers to have information about the most beneficial drug for particular conditions, and so advertising is beneficial both to manufacturers and to consumers. This article describes emerging trends in DTC within the context of the life sciences sector.

Information flow in the pharmaceutical supply chain.

Science.gov (United States)

Yousefi, Nazila; Alibabaei, Ahmad

2015-01-01

Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.

The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

Science.gov (United States)

Stanley, A G; Jackson, D; Barnett, D B

2005-04-01

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

"But doctors do it...": nurses' views of gifts and information from the pharmaceutical industry.

Science.gov (United States)

Jutel, Annemarie; Menkes, David B

2009-06-01

Most nurses, like their physician counterparts, lack education regarding pharmaceutical marketing strategies, and little is known of their beliefs and practices regarding this industry. Nurses are increasingly targeted by pharmaceutical companies as they become more involved in prescription and as policies restrict pharmaceutical companies' contact with physicians. To assess nurses' beliefs and reported practices concerning pharmaceutical marketing and sponsorship strategies. We conducted parallel Web- and paper-based surveys of a sample of senior registered nurses employed by government-funded health boards in 2 regions of New Zealand to explore their contact with the pharmaceutical industry as well as their beliefs and practices regarding information, gifts, and sponsorship provided by pharmaceutical companies. Returns were tested using Fisher's exact test to determine consistency in response between regions. Results for key outcome variables, including attitude toward the value of industry-derived information, were analyzed by region and in aggregate. Most nurses had contact with pharmaceutical sales representatives (69/106), accepted gifts from representatives (79/105), and believed information from the pharmaceutical industry probably improved their practice (71/106). Half believed that they would be able to detect misleading information if it were present, and 35% believed that accepting gifts and sponsorship was ethically acceptable. We found positive associations between the belief that information from the industry improved practice and reported acceptance of conference funding (OR 3.63; 95% CI 1.41 to 11.55), free food (OR 3.24; 95% CI 2.03 to 7.55), or gifts (OR 3.52; 95% CI 1.38 to 8.95). Nurses generally acknowledge the presence of pharmaceutical marketing in the hospital and the ethical challenges it presents; nonetheless, they also generally accept marketing gifts and may underestimate both the ethical challenges and their own susceptibility to

Pharmaceutical penetration of new drug and pharmaceutical market structure in Taiwan: hospital-level prescription of thiazolidinediones for diabetes.

Science.gov (United States)

Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune

2010-06-01

This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.

Do cost-sharing and entry deregulation curb pharmaceutical innovation?

Science.gov (United States)

Grossmann, Volker

2013-09-01

This paper examines the role of both cost-sharing schemes in health insurance systems and the regulation of entry into the pharmaceutical sector for pharmaceutical R&D expenditure and drug prices. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to higher R&D spending of pharmaceutical companies. The relationship between R&D spending per firm and the number of firms may be hump-shaped. In this case, the number of rivals which maximizes R&D expenditure per firm is decreasing in the coinsurance rate and increasing in labor productivity. Copyright © 2013 Elsevier B.V. All rights reserved.

Effluent treatment plant for pharmaceutical unit at Bahipheru - case study

International Nuclear Information System (INIS)

Hayat, A.

1997-01-01

This project has been awarded to environ (Pvt) Ltd., on turnkey basis, and is an integrated waste treatment facility for pharmaceuticals companies, manufacturing paracetamole, aspirin and various pharmaceuticals intermediates, from phenol as basic raw material. A highly toxic waste water, containing high concentrations of phenolics and sulfate ions is generated at this plant and has to be treatment before final disposal into an irrigation channel. (author)

Boycott threat forces French company to abandon RU486.

Science.gov (United States)

Dorozynski, A

1997-04-19

Threatened boycotts by American anti-abortion groups have forced the French pharmaceutical company Roussel-Uclaf, a subsidiary of the German company Hoechst, to stop production and distribution of mifepristone (RU-486), which the protesters call "the abortion pill." All patent rights have been transferred, without charge, to Dr. Edouard Sarkiz, one of the pill's developers. Hoechst, which had acquired Marion Pharmaceuticals to form a new group, Hoechst-Marion-Roussel, had increased its share of the US pharmaceutical market from 1% to 4% in doing so and could not tolerate a boycott. RU-486, which was discovered by Professor Etienne Baulieu, was introduced in France in 1987 as an alternative to surgical abortion. Although Hoechst, then a majority stockholder of Roussel-Uclaf, had asked the French firm to interrupt production of the pill in 1988, the French minister of health and social affairs at that time, Claude Evin, ordered production to be continued. Approximately 25% of French women seeking abortion use RU-486; it is also used in Britain, Sweden, and China (women in China must pay for the drug, while surgical abortion is free). All American firms have refused to buy the drug from Roussel-Uclaf. An offer to the World Health Organization was ignored. The American Population Council obtained the right to use RU-486 in 1993. Dr. Sarkiz has formed Exelgyn, a small nonprofit company, to produce and distribute RU-486; research into other uses for the drug will also be conducted. There has been limited research into its use as an emergency contraceptive and as a treatment for endometriosis, uterine fibroma, and breast cancer. According to Professor Baulieu, the drug could be used in treating wounds and burns because of its antiglucocorticoid and immunosuppressive properties; preliminary research by the professor indicates the drug could also possibly be used as a reversible male contraceptive because of its action on the membranes of spermatozoa. The drug's use in

LIFE CYCLE OF THE PHARMACEUTICAL PRODUCT AND PRIMARY STRATEGIC GOALS

Directory of Open Access Journals (Sweden)

Cristina\tCIOT

2015-12-01

Full Text Available In addition to innovation, production at high standards, market and marketing policy, pharmaceutical companies need strategies that could cope with apparent contradictions, convergences and divergences, centralisation and involution, at the global and local level, focus and liberty, domestic production and external supply, ownership and alliances, networks and hierarchies, science or market orientation, all these being part of the essence of a profitable and expanding pharmaceutical company. Specialists appreciate that the 20 century will remain in the collective memory for its technological achievements, including a better understanding of the atomic structure, „information explosion” encouraged by the progress of the computer technology, the news from space exploration. If one wants to evaluate its importance in terms of impact on people’s lives, the 20 century could be called THE DRUG AREA. Many experts agree that, at the end of this century, pharmaceutical products would have a higher importance for our lives due to the special progress in neurobiology, immunology, molecular biology, cellular differentiation, cell membrane and genetic studies. In the pharmaceutical industry, important funds are directed towards research and development, while few understand and appreciate the contribution brought by the pharmaceutical marketing system and by the professionals in this field. These ones make the drug accessible at the right time and place, in the required quantity, at a reasonable price and with all the information required.

Nurse practitioners' perceptions and participation in pharmaceutical marketing.

Science.gov (United States)

Crigger, Nancy; Barnes, Kristen; Junko, Autumn; Rahal, Sarah; Sheek, Casey

2009-03-01

This paper reports on a study conducted to describe family nurse practitioners' perceptions towards and participation in pharmaceutical marketing and to explore the relationships among related variables. The pharmaceutical industry's intense global marketing strategies have resulted in widespread concern in healthcare professionals and professional groups, sectors of the public in many countries, and in the World Health Organization. Research on healthcare providers' participation in pharmaceutical marketing indicates that these relationships are conflicts of interests and compromise healthcare providers' prescribing practices and trust. Nursing, as a discipline, appears to be slow to address the impact of pharmaceutical marketing on nursing practice. Questionnaires about perceptions and participation in pharmaceutical marketing were completed by a random sample of 84 licensed family nurse practitioners in the United States of America in 2007. Family nurse practitioners viewed pharmaceutical company marketing uncritically as educational and beneficial. They also perceived other providers but not themselves as influenced by pharmaceutical marketing. The findings supported those found in previous research with nurses and physicians. Lack of education, participation in marketing and psychological and social responses may impede family nurse practitioners' ability to respond critically and appropriately to marketing strategies and the conflict of interest it creates.

General public knowledge, perceptions and practice towards pharmaceutical drug advertisements in the Western region of KSA.

Science.gov (United States)

Al-Haddad, Mahmoud S; Hamam, Fayez; Al-Shakhshir, Sami M

2014-04-01

This study aims to examine general public knowledge and behavior toward pharmaceutical advertisements in the Western part of KSA. A cross sectional convenience sampling technique was used in this study. A total of 1445 valid questionnaires were received and analyzed using SPSS version 16 at alpha value of 0.05. Majority of respondents were aware of different types of drugs to be advertised and drug advertisements should seek approval from the health authorities. Television and Internet showed the highest effect on consumers. Almost half of the participants preferred an advertised drug over non-advertised one. Most of the respondents indicated that the quality of frequently advertised drugs is not better than those prescribed by the doctors. Majority of participants had positive beliefs toward advertised drugs concerning their role in education and spreading of awareness among the public. Pharmaceutical advertisements harm the doctor-patient relationship as evidenced by one-third of the investigated sample. Moreover, majority of the participants mentioned that they would consult another doctor or even change the current doctor if he/she refused to prescribe an advertised medication. Results of this study could be used to develop awareness programs for the general public and try to enforce the regulations and policies to protect the general public and patients from the business oriented pharmaceutical companies and drug suppliers.

The return of the pharmaceutical industry to the market of contraception.

Science.gov (United States)

Johansson, E D

2000-01-01

In the 1980s and 1990s, the litigious climate in the US had a catastrophic effect on sales of many major contraceptives. Although oral contraceptives escaped controversy, the intrauterine device (IUD) and Norplant(R) were two targets of damaging litigation. The IUD was withdrawn from the market in 1985. Since 1994 when the attacks began against Norplant, its US sales have dramatically declined, even though no fault has been found in the method or its development. In general, pharmaceutical companies were extremely hesitant to develop new contraceptives during this period. The bleak outlook, however, began to shift in the late 1990s, as fertility rates began to decrease worldwide and contraceptive users increased. By 2025, 2500 million women will comprise the customer base for contraception. Global pharmaceutical companies are now participating in expanding markets overseas and have launched and continue to develop a range of new long-term reversible, and highly effective, contraceptive products outside the traditional oral contraceptive field. Two new contraceptives on the way to the US market are: Mirena, a levonorgestrel-releasing intrauterine system manufactured by Schering-Leiras; and Implanon, a single implant system manufactured by Organon of the Netherlands. Other birth control methods soon to be launched include: emergency contraceptives, the contraceptive patch, monthly contraceptive injections, mifepristone for medical abortion, and modified oral contraceptives.

Dual market structures and the likelihood of repeated ties - evidence from pharmaceutical biotechnology

NARCIS (Netherlands)

Roijakkers, A.H.W.M.; Hagedoorn, J.; Kranenburg, van H.

2005-01-01

This paper analyses the role of repeated ties in the high-tech pharmaceutical biotechnology industry, a sector that is characterized by a strong dual market structure. Our most important finding is that previous ties in pairs of large pharmaceutical companies and small biotechnology firms have a

Open Data for Research and Strategic Monitoring in the Pharmaceutical and Biotech Industry

Directory of Open Access Journals (Sweden)

Baldissera Giovani

2017-04-01

Full Text Available Open data is considered the new oil. As oil can be used to produce fertilisers, pesticides, lubricants, plastics and many other derivatives, so data is considered the commodity to use and re-use to create value. The number of initiatives supporting free access to data has increased in the last years and open data is becoming the norm in the public sector; the approach empowers stakeholders and nurtures the economy. Even if at early stage, private companies also are adapting to the open data market. A survey was conducted to which thirteen companies of different size (from micro enterprises to world-leading pharmas in the pharmaceutical and biotech sector and representing four business models archetypes of companies exploiting open data (aggregators, developers, enrichers and enablers participated. The information collected provides a snapshot of the use of open data by the pharmaceutical and biotech industry in 2015–2016. The companies interviewed use open data to complement proprietary data for research purposes, to implement licensing-in/licensing-out strategies, to map partnerships and connections among players or to identify key expertise and hire staff. Pharmaceutical and biotech companies have made of the protection of knowledge a dogma at the foundation of their business models, but using and contributing to the open data movement may change their approach to intellectual property and innovation.

[In-depth assessment of work-related stress in a major company undergoing restructuring].

Science.gov (United States)

Magrini, Andrea; Pelagalli, Maria Felicia; Pietroiusti, Antonio; Livigni, Lucilla; Guidi, Stefano; Moscatelli, Maurizia; Mascioli, Marco; D'Orsi, Fulvio; Zolla, Antonella; Bagnara, Sebastiano

2015-07-08

An in-depth assessment of work-related stress was conducted in a major national telecommunications company undergoing major changes. The assessment was made on three homogeneous groups of workers and covered a large representative sample of the corresponding populations. To identify the main sources of stress for the three populations of workers, stimulate a discussion on the possible corrective actions, and assess the impact of the on-going organizational changes on workers' health. The assessment started with an analysis of the objective stress indicators listed in the INAIL (National Insurance Institute for Occupational Diseases and Accidents) Checklist. This was followed by a combination of qualitative and quantitative investigations on work context and tasks and on the subjective perceptions of workers, which were carried out by using: semi-structured interviews with management, field observations of work tasks, focus groups and questionnaires (GHQ-12, HSE Indicator Tool, ad-hoc questionnaire). The assessment allowed identification of the critical areas to be addressed with specific interventions: relationship with the company, work performance, work organization, and equipment. the investigation allowed to identification of specific practical actions (improvement of technological tools; professional development through training courses) as well as strategic actions ( re-establish relationship of trust with the company) so as to mitigate the workers' level of stress. Analysis of the results also showed that the three targeted populations differed in the degree of acceptance and understanding of the organizational changes.

Pharmaceutical market in Serbia

Directory of Open Access Journals (Sweden)

Veselin Tima Dickov

2012-02-01

Full Text Available Marketing concept formed around the focus on the consumers, their needs, wants and demands, evolves in the case of pharmaceutical into a care of the complex interest of constituents generating demand on this market and #8211; pres scribers whose role is to select therapies, pharmacists who dispense drugs within a specialized distribution channel to the final consumer -patient, alongside the payers and #8211; the state and or insurance companies refund a part of or total costs of the pharmaceutical product. A special challenge that the subject raises is the existence of controversy generated from two sources. Marketing controversy stems from criticism leveled at the effectiveness and efficiency of marketing activities and the debatable ethical code of conduct. [J Intercult Ethnopharmacol 2012; 1(1.000: 44-51

ECONOMIC AND FINANCIAL IMPLICATIONS OF THE PHARMACEUTICAL INDUSTRY IN ROMANIA

Directory of Open Access Journals (Sweden)

Georgiana Daniela Minculete Piko

2014-09-01

Full Text Available In the wake of the financial crisis, most industries witnessed an economic downturn also boosted by the austerity measures imposed by the state. The pharmaceutical sector is one of the few sectors that followed an upward trend. Although the economic and financial crisis has long taken hold of the entire world, the domino theory did not apply to this industry; instead, the “butterfly effect” became evident. The phrase refers to the fact that the wings of a butterfly create small changes that may finally alter the route of certain elements. In the pharmaceutical industry, minor changes in research and development finally led to spectacular innovations. At present, there are no such big investments in research and development in Romania as there are in Europe; yet, due to mergers and acquisitions between Romanian and foreign companies, the pharmaceutical sector in Romania significantly contributes to the creation of added value in terms of economic development. The added value of the pharmaceutical industry in our country has increased significantly in recent years. The purpose of this article is to highlight the financial and economic significance of the pharmaceutical industry in Romania. This industry is one with an average degree of concentration; thus, the average liquidity and solvency indicators in this sector were calculated with a view to emphasizing its financial independence. The findings of this research indicate a high level of financial independence in this industry, as pharmaceutical companies are able to meet payment deadlines. This study highlights the importance of such an industry in times of economic crisis, the financial stability of the pharmaceutical sector reinforcing the need for massive investment in research and development.

Incentives for Starting Small Companies Focused on Rare and Neglected Diseases.

Science.gov (United States)

Ekins, Sean; Wood, Jill

2016-04-01

Starting biotech or pharmaceutical companies is traditionally thought to be based around a scientist, their technology platform or a clinical candidate spun out from another company. Between us we have taken a different approach and formed two small early stage companies after initially leveraging the perspective of a parent with a child with a life-threatening rare disease. Phoenix Nest ( http://www.phoenixnestbiotech.com/ ) was co-founded to work on treatments for Sanfilippo syndrome a devastating neurodegenerative lysosomal storage disorder. In the space of just over 3 years we have built up collaborations with leading scientists in academia and industry and been awarded multiple NIH small business grants. The second company, Collaborations Pharmaceuticals Inc. ( http://www.collaborationspharma.com/ ) was founded to address some of the other 7000 or so rare diseases as well as neglected infectious diseases. The Rare Pediatric Disease Priority Review Voucher is likely the most important incentive for companies working on rare diseases with very small populations. This may also be partially responsible for the recent acquisitions of rare disease companies with late stage candidates. Lessons learned in the process of starting our companies are that rare disease parents or patients can readily partner with a scientist and fund research through NIH grants rather than venture capital or angel investors initially. This process may be slow so patience and perseverance is key. We would encourage other pharmaceutical scientists to meet rare disease parents, patients or advocates and work with them to further the science on their diseases and create a source of future drugs.

Complexity of major UK companies between 2006 and 2010: Hierarchical structure method approach

Science.gov (United States)

Ulusoy, Tolga; Keskin, Mustafa; Shirvani, Ayoub; Deviren, Bayram; Kantar, Ersin; Çaǧrı Dönmez, Cem

2012-11-01

This study reports on topology of the top 40 UK companies that have been analysed for predictive verification of markets for the period 2006-2010, applying the concept of minimal spanning tree and hierarchical tree (HT) analysis. Construction of the minimal spanning tree (MST) and the hierarchical tree (HT) is confined to a brief description of the methodology and a definition of the correlation function between a pair of companies based on the London Stock Exchange (LSE) index in order to quantify synchronization between the companies. A derivation of hierarchical organization and the construction of minimal-spanning and hierarchical trees for the 2006-2008 and 2008-2010 periods have been used and the results validate the predictive verification of applied semantics. The trees are known as useful tools to perceive and detect the global structure, taxonomy and hierarchy in financial data. From these trees, two different clusters of companies in 2006 were detected. They also show three clusters in 2008 and two between 2008 and 2010, according to their proximity. The clusters match each other as regards their common production activities or their strong interrelationship. The key companies are generally given by major economic activities as expected. This work gives a comparative approach between MST and HT methods from statistical physics and information theory with analysis of financial markets that may give new valuable and useful information of the financial market dynamics.

Supramolecular Pharmaceutical Sciences: A Novel Concept Combining Pharmaceutical Sciences and Supramolecular Chemistry with a Focus on Cyclodextrin-Based Supermolecules.

Science.gov (United States)

Higashi, Taishi; Iohara, Daisuke; Motoyama, Keiichi; Arima, Hidetoshi

2018-01-01

Supramolecular chemistry is an extremely useful and important domain for understanding pharmaceutical sciences because various physiological reactions and drug activities are based on supramolecular chemistry. However, it is not a major domain in the pharmaceutical field. In this review, we propose a new concept in pharmaceutical sciences termed "supramolecular pharmaceutical sciences," which combines pharmaceutical sciences and supramolecular chemistry. This concept could be useful for developing new ideas, methods, hypotheses, strategies, materials, and mechanisms in pharmaceutical sciences. Herein, we focus on cyclodextrin (CyD)-based supermolecules, because CyDs have been used not only as pharmaceutical excipients or active pharmaceutical ingredients but also as components of supermolecules.

THE STUDY FOR REGIONAL RETAIL PHARMACEUTICAL MARKET

Directory of Open Access Journals (Sweden)

O. V. Sokolova

2015-01-01

Full Text Available Pharmacy organizations are an element of regional pharmaceutical market infrastructure formation. They have different character and activity type, organizational and legal forms, types of properties. The revelation of the features of retail pharmaceutical market of Yaroslavl oblast was the purpose of the study. The analysis of the data of regional department of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation  n Yaroslavl oblast in the beginning of 2014 showed that there are 137 acting commercial entities, which have licenses for pharmaceutical activity. The region has 487  pharmacy organizations which implement pharmaceutical activity of state (14.6%, municipal (7.4%, and private (78.0% forms of ownership. Some companies function in Yaroslavl (43.9% and Rybinsk (22.4% municipal district. The analysis of organization and legal forms revealed that 48.9% of pharmacy organizations are registered as ltd, 14.6% are state, and 14.2% are private entrepreneurs, public limited companies amount to 10.9%, the rest pharmacy organizations are included into municipal unitary enterprises and private limited companies – 7.39% and 4.1% correspondingly. The structure of retail market is represented by single pharmacy organizations (51.1% as well as organizations joined into pharmacy chains from two and more PO (48.9%. The share of commercial entities which include one PO amounted to 14.4% of all PO. Share of pharmacy chains (42.3% which include from 2 to 9 PO are 46.8% of all PO. Pharmacy chains, which have more than 9 retails spots amount to 6.6% of the total number of commercial entities. 38.8% of PO function within them. Pharmacy chains prevalence (42.3%, joined into 9 PO; pharmacy chains, which have more than 9 PO, and include state sector PO (14.6% are the features of the regional market.

Environmental management practices in the Lebanese pharmaceutical industries: implementation strategies and challenges.

Science.gov (United States)

Massoud, May A; Makarem, N; Ramadan, W; Nakkash, R

2015-03-01

This research attempts to provide an understanding of the Lebanese pharmaceutical industries' environmental management strategies, priorities, and perceptions as well as drivers, barriers, and incentives regarding the implementation of the voluntary ISO 14001 Environmental Management System. Accordingly, a semistructured in-depth interview was conducted with the pharmaceutical industries. The findings revealed a significant lack of knowledge about the standard among the industries. The main perceived drivers for adopting the ISO 14001 are improving the companies' image and overcoming international trade. The main perceived barriers for acquiring the standard are the lack of government support and the fact that ISO 14001 is not being legally required or enforced by the government. Moreover, results revealed that adopting the ISO 14001 standard is not perceived as a priority for the Lebanese pharmaceutical industries. Although the cost of certification was not considered as a barrier for the implementation of ISO 14001, the majority of the pharmaceutical industries are neither interested nor willing to adopt the Standard if they are not exposed to any regulatory pressure or external demand. They are more concerned with quality and safety issues with the most adopted international standard among the industries being the ISO 9001 quality management system. This study highlights the aspect that financial barriers are not always the hurdles for implementing environmental management strategies in developing countries and underscores the need for regulatory frameworks and enforcement.

R&D INTENSITY AND IPO UNDERPRICING: CASE STUDY ON PHARMACEUTICAL AND BIOTECH INDUSTRIES IN THE US

Directory of Open Access Journals (Sweden)

Tommy C. Efrata

2016-02-01

Full Text Available Asymmetric information between the issuer to potential investors believed by some academics in finance as one of the main causes of the phenomenon of underpricing at the time of the initial public offering (IPO. On science and technology-based company main problem lies in how to conduct assessments on the future value of a product that is still in the development stage. The issue became more prominent on pharmaceutical companies and biotechnology, due to the characteristics of this industry is the high expense, complex process, and the lengthy process of research and development (R & D of a product. This study describes the characteristics above is associated with the phenomenon of underpricing when companies conduct IPO. The samples are 82 pharmaceutical companies and biotechnology conduct IPO in the United States stock market in 1998-2005. The results of this study revealed a negative correlation between the intensity of R & D and IPO underpricing phenomenon in this industry. These studies have identified R & D as the main source of information asymmetry that led to the phenomenon of underpricing for pharmaceutical companies and biotechnology.

[The pharmaceutical industry in the industrial chemical group: the National Union of Chemical-Pharmaceutical Laboratories (1919-1936)].

Science.gov (United States)

Nozal, Raúl Rodríquez

2011-01-01

The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'.

Microbiological quality of pharmaceutical products in Bangladesh: current research perspective

OpenAIRE

Rashed Noor; Nagma Zerin; Kamal Kanta Das

2015-01-01

Pharmaceutical industrialization in Bangladesh, both by multinational and local companies, has increased significantly in the last two decades. Most of the pharmaceutical products are found to be therapeutically competent to meet the demands of general population satisfactorily. However, complaints regarding the compromised quality of the products stored in markets are also reported very often. In order to ensure the overall drug user safety, the present review discussed the pr...

Equipment and Analytical Companies Meeting Continuous Challenges May 20-21 2014 Continuous Manufacturing Symposium.

Science.gov (United States)

Page, Trevor; Dubina, Henry; Fillipi, Gabriele; Guidat, Roland; Patnaik, Saroj; Poechlauer, Peter; Shering, Phil; Guinn, Martin; Mcdonnell, Peter; Johnston, Craig

2015-03-01

papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.

Science.gov (United States)

Page, Trevor; Dubina, Henry; Fillipi, Gabriele; Guidat, Roland; Patnaik, Saroj; Poechlauer, Peter; Shering, Phil; Guinn, Martin; Mcdonnell, Peter; Johnston, Craig

2015-03-01

papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Authentication of gold nanoparticle encoded pharmaceutical tablets using polarimetric signatures.

Science.gov (United States)

Carnicer, Artur; Arteaga, Oriol; Suñé-Negre, Josep M; Javidi, Bahram

2016-10-01

The counterfeiting of pharmaceutical products represents concerns for both industry and the safety of the general public. Falsification produces losses to companies and poses health risks for patients. In order to detect fake pharmaceutical tablets, we propose producing film-coated tablets with gold nanoparticle encoding. These coated tablets contain unique polarimetric signatures. We present experiments to show that ellipsometric optical techniques, in combination with machine learning algorithms, can be used to distinguish genuine and fake samples. To the best of our knowledge, this is the first report using gold nanoparticles encoded with optical polarimetric classifiers to prevent the counterfeiting of pharmaceutical products.

Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints

OpenAIRE

Kesselheim, Aaron S.; Mello, Michelle M.; Studdert, David M.

2011-01-01

Editors' Summary Background Before a pharmaceutical company can market a new prescription drug in the US, the drug has to go through a long approval process. After extensive studies in the laboratory and in animals, the pharmaceutical company must test the drug's safety and efficacy in a series of clinical trials in which groups of patients with specific diseases are given the drug according to strict protocols. The results of these trials are reviewed by Federal Drug Administration (FDA, the...

Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market.

Science.gov (United States)

Shabaninejad, Hosein; Mehralian, Gholamhossein; Rashidian, Arash; Baratimarnani, Ahmad; Rasekh, Hamid Reza

2014-04-03

Pharmaceutical industry is knowledge-intensive and highly globalized, in both developed and developing countries. On the other hand, if companies want to survive, they should be able to compete well in both domestic and international markets. The main purpose of this paper is therefore to develop and prioritize key factors affecting companies' competitiveness in pharmaceutical industry. Based on an extensive literature review, a valid and reliable questionnaire was designed, which was later filled up by participants from the industry. To prioritize the key factors, we used the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS). The results revealed that human capital and macro-level policies were two key factors placed at the highest rank in respect of their effects on the competitiveness considering the industry-level in pharmaceutical area. This study provides fundamental evidence for policymakers and managers in pharma context to enable them formulating better polices to be proactively competitive and responsive to the markets' needs.

Preclinical Pharmacokinetic/Pharmacodynamic Modeling and Simulation in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape

OpenAIRE

Schuck, Edgar; Bohnert, Tonika; Chakravarty, Arijit; Damian-Iordache, Valeriu; Gibson, Christopher; Hsu, Cheng-Pang; Heimbach, Tycho; Krishnatry, Anu Shilpa; Liederer, Bianca M; Lin, Jing; Maurer, Tristan; Mettetal, Jerome T; Mudra, Daniel R; Nijsen, Marjoleen JMA; Raybon, Joseph

2015-01-01

The application of modeling and simulation techniques is increasingly common in preclinical stages of the drug discovery and development process. A survey focusing on preclinical pharmacokinetic/pharmacodynamics (PK/PD) analysis was conducted across pharmaceutical companies that are members of the International Consortium for Quality and Innovation in Pharmaceutical Development. Based on survey responses, ~68% of companies use preclinical PK/PD analysis in all therapeutic areas indicating its...

Quality management benchmarking: FDA compliance in pharmaceutical industry.

Science.gov (United States)

Jochem, Roland; Landgraf, Katja

2010-01-01

By analyzing and comparing industry and business best practice, processes can be optimized and become more successful mainly because efficiency and competitiveness increase. This paper aims to focus on some examples. Case studies are used to show knowledge exchange in the pharmaceutical industry. Best practice solutions were identified in two companies using a benchmarking method and five-stage model. Despite large administrations, there is much potential regarding business process organization. This project makes it possible for participants to fully understand their business processes. The benchmarking method gives an opportunity to critically analyze value chains (a string of companies or players working together to satisfy market demands for a special product). Knowledge exchange is interesting for companies that like to be global players. Benchmarking supports information exchange and improves competitive ability between different enterprises. Findings suggest that the five-stage model improves efficiency and effectiveness. Furthermore, the model increases the chances for reaching targets. The method gives security to partners that did not have benchmarking experience. The study identifies new quality management procedures. Process management and especially benchmarking is shown to support pharmaceutical industry improvements.

How might the Trans-Pacific Partnership impact on the pharmaceutical sector in Vietnam?

Science.gov (United States)

Binh, Nguyen Hoa; Anh, Pham Ngoc Kieu; Phuong, Nguyen Minh

2016-07-01

Ratification of the Trans-Pacific Partnership (TPP) will attract a large number of foreign drug companies in the coming years to Vietnam. It is anticipated to bring investment to Vietnam's pharmaceutical industries, lead to increased infrastructure and enable the use of more sophisticated technologies for the discovery, development and manufacture of drugs. However, with respect to pharmaceutical companies, which are producing generic drugs primarily, the availability of biologic will be reduced. Thus, the consequence is, an increase in drug cost resulting in difficulties for patients wishing to procure these drugs. This will be particularly detrimental for developing countries, such as Vietnam and Malaysia.

Generic Pharmaceutical Association (GPhA) - 2015 Annual Meeting (February 9-11, 2015 - Miami Beach, Florida, USA).

Science.gov (United States)

Bowman, M

2015-02-01

The Generic Pharmaceutical Association (GPhA) chairman Craig Wheeler (Momenta Pharmaceuticals), welcomed attendees to the 2015 Annual Meeting by reflecting on the contributions of the generic industry over the past year and some of the challenges that lie ahead. In 2014, 86% of prescriptions dispensed in the U.S. were generic, contributing to the USD 1.4 trillion savings generated by the industry since its inception; however, there are still many challenges to face, including consolidation of customers, lag in Abbreviated New Drug Application (ANDA) approval timelines, restrictive Risk Evaluation and Mitigation Strategy (REMS) programs and labeling legislations. The continued drive into the branded business by many GPhA member companies has resulted in the association planning a structural division for companies involved in biologic and biosimilar products. During the 3-day meeting, attendees listened to expert panels discuss major business, regulatory and market trends developing in the generic industry, with insights from the U.S. Food and Drug Administration (FDA) and market analysts. The meeting also provided attendees with numerous opportunities to socialize and network with key decision makers in the industry. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Conceptual Configuration of Pharmaceutical Plants in 3D

DEFF Research Database (Denmark)

Ladeby, Klaes Rohde; Larsen, Bent Dalgaard; Gjøl, Mikkel

2007-01-01

In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. Configuration and 3D models can help validate the decisions made in the conceptual design process. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....

Models for open innovation in the pharmaceutical industry.

Science.gov (United States)

Schuhmacher, Alexander; Germann, Paul-Georg; Trill, Henning; Gassmann, Oliver

2013-12-01

The nature of the pharmaceutical industry is such that the main driver for its growth is innovation. In view of the vast challenges that the industry has been facing for several years and, in particular, how to manage stagnating research and development (R&D) productivity, pharmaceutical companies have opened their R&D organizations to external innovation. Here, we identify and characterize four new types of open innovator, which we call 'knowledge creator', 'knowledge integrator', 'knowledge translator' and 'knowledge leverager', and which describe current open R&D models. Copyright © 2013 Elsevier Ltd. All rights reserved.

Qualitative insights into promotion of pharmaceutical products in Bangladesh: how ethical are the practices?

Science.gov (United States)

Mohiuddin, Mahrukh; Rashid, Sabina Faiz; Shuvro, Mofijul Islam; Nahar, Nahitun; Ahmed, Syed Masud

2015-12-01

The pharmaceutical market in Bangladesh is highly concentrated (top ten control around 70 % of the market). Due to high competition aggressive marketing strategies are adopted for greater market share, which sometimes cross limit. There is lack of data on this aspect in Bangladesh. This exploratory study aimed to fill this gap by investigating current promotional practices of the pharmaceutical companies including the role of their medical representatives (MR). This qualitative study was conducted as part of a larger study to explore the status of governance in health sector in 2009. Data were collected from Dhaka, Chittagong and Bogra districts through in-depth interview (healthcare providers and MRs), observation (physician-MR interaction), and round table discussion (chief executives and top management of the pharmaceutical companies). Findings reveal a highly structured system geared to generate prescriptions and ensure market share instituted by the pharmaceuticals. A comprehensive training curriculum for the MRs prepares the newly recruited science graduates for generating enough prescriptions by catering to the identified needs and demands of the physicians expressed or otherwise, and thus grab higher market-share for the companies they represent. Approaches such as inducements, persuasion, emotional blackmail, serving family members, etc. are used. The type, quantity and quality of inducements offered to the physicians depend upon his/her capacity to produce prescriptions. The popular physicians are cultivated meticulously by the MRs to establish brand loyalty and fulfill individual and company targets. The physicians, willingly or unwillingly, become part of the system with few exceptions. Neither the regulatory authority nor the professional or consumer rights bodies has any role to control or ractify the process. The aggressive marketing of the pharmaceutical companies compel their MRs, programmed to maximize market share, to adopt unethical means if

Factors That Attract Foreign Pharmaceutical Companies Setting Up R&D Center In Malaysia

OpenAIRE

Hee, Kenneth Kang Koon

2003-01-01

The development of the biotechnology and pharmaceutical industry is far reaching and their broad applications and great impacts have attracted global interest to enter these industries. Pharmaceutical R&D is a costly and risky business, but in recent years the financial rewards from R&D have more than offset its cost and risk. In order to ensure the continuous growth of Malaysia’s economy, the Malaysia government is actively developing these industries to be their star industry in 21st centur...

Pharmaceutical cocrystals, salts and polymorphs: Advanced characterization techniques.

Science.gov (United States)

Pindelska, Edyta; Sokal, Agnieszka; Kolodziejski, Waclaw

2017-08-01

The main goal of a novel drug development is to obtain it with optimal physiochemical, pharmaceutical and biological properties. Pharmaceutical companies and scientists modify active pharmaceutical ingredients (APIs), which often are cocrystals, salts or carefully selected polymorphs, to improve the properties of a parent drug. To find the best form of a drug, various advanced characterization methods should be used. In this review, we have described such analytical methods, dedicated to solid drug forms. Thus, diffraction, spectroscopic, thermal and also pharmaceutical characterization methods are discussed. They all are necessary to study a solid API in its intrinsic complexity from bulk down to the molecular level, gain information on its structure, properties, purity and possible transformations, and make the characterization efficient, comprehensive and complete. Furthermore, these methods can be used to monitor and investigate physical processes, involved in the drug development, in situ and in real time. The main aim of this paper is to gather information on the current advancements in the analytical methods and highlight their pharmaceutical relevance. Copyright © 2017 Elsevier B.V. All rights reserved.

Restoring a reputation: invoking the UNESCO Universal Declaration on Bioethics and Human Rights to bear on pharmaceutical pricing.

Science.gov (United States)

Hurst, Daniel J

2017-03-01

In public health, the issue of pharmaceutical pricing is a perennial problem. Recent high-profile examples, such as the September 2015 debacle involving Martin Shkreli and Turing Pharmaceuticals, are indicative of larger, systemic difficulties that plague the pharmaceutical industry in regards to drug pricing and the impact it yields on their reputation in the eyes of the public. For public health ethics, the issue of pharmaceutical pricing is rather crucial. Simply, individuals within a population require pharmaceuticals for disease prevention and management. In order to be effective, these pharmaceuticals must be accessibly priced. This analysis will explore the notion of corporate social responsibility in regards to pharmaceutical pricing with an aim of restoring a positive reputation upon the pharmaceutical industry in the public eye. The analysis will utilize the 2005 United Nations Educational, Scientific, and Cultural Organization's Universal Declaration on Bioethics and Human Rights (UDBHR) to establish implications regarding the societal responsibilities of pharmaceutical companies in a global context. To accomplish this, Article 14 of the UDBHR-social responsibility and health-will be articulated in order to advocate a viewpoint of socially responsible capitalism in which pharmaceutical companies continue as profit-making ventures, yet establish moral concern for the welfare of all their stakeholders, including the healthcare consumer.

Pharmaceutical policy and the pharmacy profession

DEFF Research Database (Denmark)

Traulsen, Janine Marie; Almarsdóttir, Anna Birna

2005-01-01

In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and indu......In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy...... and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy...... in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental...

The simple economics of risk-sharing agreements between the NHS and the pharmaceutical industry.

Science.gov (United States)

Barros, Pedro Pita

2011-04-01

The introduction of new (and expensive) pharmaceutical products is one of the major challenges for health systems. The search for new institutional arrangements is natural. The use of the so-called risk-sharing agreements is one example. Recent discussions have somewhat neglected the economic fundamentals underlying risk-sharing agreements. We argue here that risk-sharing agreements, although attractive due to the principle of paying by results, also entail risks. Too many patients may be put under treatment. Prices are likely to be adjusted upward, in anticipation of future risk-sharing agreements between the pharmaceutical company and the third-party payer. An available instrument is a verification cost per patient treated, which allows obtaining the first-best allocation of patients to the new treatment, under the agreement. Overall, the welfare effects of risk-sharing agreements are ambiguous, and caution is urged regarding their use. Copyright © 2010 John Wiley & Sons, Ltd.

The epiphany of data warehousing technologies in the pharmaceutical industry.

Science.gov (United States)

Barrett, J S; Koprowski, S P

2002-03-01

The highly competitive pharmaceutical industry has seen many external changes to its landscape as companies consume each other increasing their pipelines while removing redundant functions and processes. Internally, companies have sought to streamline the discovery and development phases in an attempt to improve candidate selection and reduce the time to regulatory filing. In conjunction with efforts to screen and develop more compounds faster and more efficiently, database management systems (DBMS) have been developed for numerous groups supporting various R&D efforts. An outgrowth of DBMS evolution has been the birth of data warehousing. Often confused with DBMS, data warehousing provides a conduit for data residing across platforms, networks, and in different data structures. Through the use of metadata, the warehouse establishes connectivity of varied data stores (operational detail data, ODD) and permits identification of data ownership, location and transaction history. This evolution has closely mirrored and in some ways been driven by the electronic submission (formerly CANDA). The integration of the electronic submissions and document management with R&D data warehousing initiatives should provide a platform by which companies can address compliance with 21 CFR Part 11. Now more than ever "corporate memory" is being extended to the data itself. The when, why and how of successes and failures are constantly being probed by R&D management teams. The volume of information being generated by today's pharmaceutical companies requires mining of historical data on a routine basis. Data warehousing represents a core technology to assist in this endeavor. New initiatives in this field address the necessity of data portals through which warehouse data can be web-enabled and exploited by diverse data customers both internal and external to the company. The epiphany of data warehousing technologies within the pharmaceutical industry has begun and promises to change

New Product Introduction in the Pharmaceutical Industry

DEFF Research Database (Denmark)

Hansen, Klaus Reinholdt Nyhuus

Due to the limited time of the monopoly provided by patent protection that is used for recouping the R&D investment, pharmaceutical companies focus on keeping time-to-market for new products as short as possible. This process is however getting more uncertain, as the outcome of clinical trials...... is unknown and negotiations with authorities have become harder, making market introduction more difficult. This dissertation treats the new product introduction process in the pharmaceutical industry from an operations perspective. The overarching aim of this dissertation is to improve the planning...... uncertainty and several important industry characteristics. The model is used to gain several insights on the use of risk packaging and on keeping time-to-market short. As capacity in secondary pharmaceutical production is critical for product availability, a capacity planning model for a new drug delivery...

Radiation protection in the pharmaceutical-chemical industry

International Nuclear Information System (INIS)

Griesser, R.

1992-01-01

Some aspects of the use of ionizing radiation in research in the pharmaceutical and chemical industries will be discussed, the emphasis being placed on the handling of open radioactive materials in research laboratories. The compliance with official regulations and the preparation of company internal radiation protection regulations are described. 1 tab., 9 refs

The impact of TRIPS on innovation and exports: a case study of the pharmaceutical industry in India.

Science.gov (United States)

Malhotra, Prabodh

2008-01-01

Currently, there is a debate on what impact the implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) in India would have on its pharmaceutical industry and health care. The debate hinges primarily on two major questions. First, will the new patent regime provide an impetus for innovation in the pharmaceutical industry? Second, how far will India's pharmaceutical exports of copied versions of patented drugs to developing countries be restricted under the new regime? The first question seeks to find out if TRIPS will increase India's innovative capabilities to fill the current vacuum to develop drugs for tropical diseases. The large multinational companies (MNCs) that dominate the global pharmaceutical industry have no interest in commercial ventures that have little potential for great returns on investment. The second question attempts to find a solution to the lack of access to medicine in most developing countries. Indian manufacturers' supply of reverse-engineered drugs, which cost only a fraction of the prices charged by MNCs, may be coming to an end under the new regime. Against this backdrop, this article attempts to analyse the impact of strengthening intellectual property rights in India.

Drug companies' evidence to justify advertising.

Science.gov (United States)

Wade, V A; Mansfield, P R; McDonald, P J

1989-11-25

Ten international pharmaceutical companies were asked by letter to supply their best evidence in support of marketing claims for seventeen products. Fifteen replies were received. Seven replies cited a total of 67 references: 31 contained relevant original data and only 13 were controlled trials, all of which had serious methodological flaws. There were four reports of changes in advertising claims and one company ceased marketing nikethamide in the third world. Standards of evidence used to justify advertising claims are inadequate.

Prospective of Transformation of Current Models of the Global Pharmaceutical Market

Directory of Open Access Journals (Sweden)

Yuriy Solodkovskyy

2012-02-01

Full Text Available This article thoroughly analyzes the current state of the global pharmaceutical market, defines the key factors for its development and outlines the promising areas of transformation of existing business models of top companies. The forecasted data relating to the market development until 2015 have been investigated. The global, market, technological and organizational factors of transformation of modern model of the global pharmaceutical market have been identified.

Direct-to-consumer communication on prescription only medicines via the internet in the Netherlands, a pilot study. Opinion of the pharmaceutical industry, patient associations and support groups.

Science.gov (United States)

Fabius, A Mariette; Cheung, Ka-Chun; Rijcken, Cristianne J F; Vinkers, Christiaan H; Talsma, Herre

2004-06-01

Investigation of the current application of direct-to-consumer (DTC) communication on prescription only medicines via the Intemet in the Netherlands. Questionnaires were sent by e-mail to 43 Dutch innovative pharmaceutical industries and 130 Patient Association and Support Groups (PASGs). In this pilot study, the response of the pharmaceutical industry was rather low but the impression is that they were willing to invest in DTC communication. The majority of the websites of PASGs did not link to websites of pharmaceutical companies. The PASGs had no opinion whether patients can make a good distinction between DTC advertising and information on websites of the pharmaceutical industry nor about the quality. PASGs did not think unambiguously about the impact on the patient-doctor relationship. The impact of DTC communication on prescription only medicines via the internet is not yet clear in the Netherlands.

An analysis of the relationship between staff qualification and export readiness of pharmaceutical companies: the case of iran.

Science.gov (United States)

Mohammadzadeh, Mehdi

2012-01-01

Export and the readiness to export constitute the first step of international marketing, which are affected by both internal and external factors of firms. One of the most important internal factors is the presence of skilled personnel. The purpose of this study was to define the relationship between staff qualification and encouragment with the readiness level of Iranian pharmacuetical firms for engagement in export marketing. The research was based on a single case study on a basket of seven leading domestic firms. For the bias reduction, questionnaires as well as interviews with managers were used. The performance of the studied factor was lower than the desired level for export readiness and there was much scope for improvement in staff qualifications to achieve such readiness. The results of this research enable small and medium-sized pharmaceutical companies to evaluate their staff qualification levels needed for export readiness and to detect their shortcomings in order to improve them.

Sponsorship of National Health Organizations by Two Major Soda Companies.

Science.gov (United States)

Aaron, Daniel G; Siegel, Michael B

2017-01-01

Obesity is a pervasive public health problem in the U.S. Reducing soda consumption is important for stemming the obesity epidemic. However, several articles and one book suggest that soda companies are using their resources to impede public health interventions that might reduce soda consumption. Although corporate sponsorship by tobacco and alcohol companies has been studied extensively, there has been no systematic attempt to catalog sponsorship activities of soda companies. This study investigates the nature, extent, and implications of soda company sponsorship of U.S. health and medical organizations, as well as corporate lobbying expenditures on soda- or nutrition-related public health legislation from 2011 to 2015. Records of corporate philanthropy and lobbying expenditures on public health legislation by soda companies in the U.S. during 2011-2015 were found through Internet and database searches. From 2011 to 2015, the Coca-Cola Company and PepsiCo were found to sponsor a total of 95 national health organizations, including many medical and public health institutions whose specific missions include fighting the obesity epidemic. During the study period, these two soda companies lobbied against 29 public health bills intended to reduce soda consumption or improve nutrition. There is surprisingly pervasive sponsorship of national health and medical organizations by the nation's two largest soda companies. These companies lobbied against public health intervention in 97% of cases, calling into question a sincere commitment to improving the public's health. By accepting funding from these companies, health organizations are inadvertently participating in their marketing plans. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Who has used internal company documents for biomedical and public health research and where did they find them?

Science.gov (United States)

Wieland, L Susan; Rutkow, Lainie; Vedula, S Swaroop; Kaufmann, Christopher N; Rosman, Lori M; Twose, Claire; Mahendraratnam, Nirosha; Dickersin, Kay

2014-01-01

To describe the sources of internal company documents used in public health and healthcare research. We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%). Articles using documents from pharmaceutical companies (20/361; 6%) were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%). The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%). Most articles (346/361; 96%) used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles), the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceutical company documents, but the search retrieved an impractical number of citations for review. Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data) exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been less used for research, indicating a need for funding for

Doctors and pharmaceutical industry.

Science.gov (United States)

Beran, Roy G

2009-09-01

The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.

Influence of pharmaceutical marketing on prescription practices of physicians.

Science.gov (United States)

Narendran, Roshni; Narendranathan, M

2013-01-01

In India same drug molecules are sold under different brand names by different pharmaceuticals. To persuade the physicians to prescribe their brands pharmaceuticals engage in marketing techniques like giving samples, gifts, sponsoring travel etc. Many countries are striving to reduce the impact of incentives on prescription behaviour. This study explores the influence of pharmaceutical marketing on the prescription practices of doctors in India. There were 103 study subjects - 50 doctors and 53 sales personnel. Data collection was done by a self administered questionnaire. Data were collected on 36 variables which were supposed to influence prescription. The effectiveness of the promotional strategies on prescription behaviour was marked in a seven point Likert scale ranging from "not at all effective" (score=1) to "extremely effective" (score=7). Open ended questions were used to collect qualitative data. Good rapport with the doctor, launch meetings, reputation of the company, quality of the drug and brand names significantly influenced prescription behaviour, while direct mailers, advertisements in journals and giving letter pads and other brand reminders were less effective. Commonly used method of giving samples was not among the twenty most effective methods influencing prescription. Product quality and good company are still factors that influence prescription. Pharmaceutical marketing influences the choice of brands by a physician. The more expensive strategies involved in public relations are more effective. Sending mails and journal advertisements are less effective strategies. How expensive marketing strategies affect cost of the medicines has to be explored further.

Reducing systems biology to practice in pharmaceutical company research; selected case studies.

Science.gov (United States)

Benson, N; Cucurull-Sanchez, L; Demin, O; Smirnov, S; van der Graaf, P

2012-01-01

Reviews of the productivity of the pharmaceutical industry have concluded that the current business model is unsustainable. Various remedies for this have been proposed, however, arguably these do not directly address the fundamental issue; namely, that it is the knowledge required to enable good decisions in the process of delivering a drug that is largely absent; in turn, this leads to a disconnect between our intuition of what the right drug target is and the reality of pharmacological intervention in a system such as a human disease state. As this system is highly complex, modelling will be required to elucidate emergent properties together with the data necessary to construct such models. Currently, however, both the models and data available are limited. The ultimate solution to the problem of pharmaceutical productivity may be the virtual human, however, it is likely to be many years, if at all, before this goal is realised. The current challenge is, therefore, whether systems modelling can contribute to improving productivity in the pharmaceutical industry in the interim and help to guide the optimal route to the virtual human. In this context, this chapter discusses the emergence of systems pharmacology in drug discovery from the interface of pharmacokinetic-pharmacodynamic modelling and systems biology. Examples of applications to the identification of optimal drug targets in given pathways, selecting drug modalities and defining biomarkers are discussed, together with future directions.

A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey.

Science.gov (United States)

Van Campen, Luann E; Allen, Albert J; Watson, Susan B; Therasse, Donald G

2015-04-03

Background : Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods : Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results : Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions : Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service

Effective executive management in the pharmaceutical industry.

Science.gov (United States)

Tran, Hoang; Kleiner, Brian H

2005-01-01

Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they

Transparency in the pharmaceutical industry - A cost accounting approach to the prices of drugs

NARCIS (Netherlands)

Broekhof, Martijn

2002-01-01

The WTO TRIPS agreement grants pharmaceutical companies patent rights on new innovative drugs. Patents give these companies the opportunity to charge higher prices for their drugs in order to recover their R&D expenses. For developing countries this is one of the reasons why people in developing

Use and practice of achiral and chiral supercritical fluid chromatography in pharmaceutical analysis and purification.

Science.gov (United States)

Lemasson, Elise; Bertin, Sophie; West, Caroline

2016-01-01

The interest of pharmaceutical companies for complementary high-performance chromatographic tools to assess a product's purity or enhance this purity is on the rise. The high-throughput capability and economic benefits of supercritical fluid chromatography, but also the "green" aspect of CO2 as the principal solvent, render supercritical fluid chromatography very attractive for a wide range of pharmaceutical applications. The recent reintroduction of new robust instruments dedicated to supercritical fluid chromatography and the progress in stationary phase technology have also greatly benefited supercritical fluid chromatography. Additionally, it was shown several times that supercritical fluid chromatography could be orthogonal to reversed-phase high-performance liquid chromatography and could efficiently compete with it. Supercritical fluid chromatography is an adequate tool for small molecules of pharmaceutical interest: synthetic intermediates, active pharmaceutical ingredients, impurities, or degradation products. In this review, we first discuss about general chromatographic conditions for supercritical fluid chromatography analysis to better suit compounds of pharmaceutical interest. We also discuss about the use of achiral and chiral supercritical fluid chromatography for analytical purposes and the recent applications in these areas. The use of preparative supercritical fluid chromatography by pharmaceutical companies is also covered. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

An approach for management of mobile devices in pharmaceutical company

OpenAIRE

Prešeren, Tadej

2008-01-01

The areas of the mobile device management is developing very fast. Hence, the thesis “An approach for management of mobile devices in pharmaceutical company” introduces all key directives that should be considered when implementing mobile device management. A survey of standards and recommendations on the mobile device security has been elaborated. Relevant guidelines for security policy definition are presented with the risk analysis for mobile device usage. Furthermore, the model for mana...

Pattern of Duplicate Presentations at National Hematology-Oncology Meetings: Influence of the Pharmaceutical Industry.

Science.gov (United States)

Ramchandren, Radhakrishnan; Schiffer, Charles A

2016-03-01

The major large US hematology-oncology meetings sponsored by the American Society of Hematology (ASH) and American Society of Clinical Oncology (ASCO) have specific guidelines in place discouraging submission of scientific information presented previously at other meetings. Nonetheless, duplicate submissions are frequent. The incidence and motivations for duplicate hematologic presentations and the influence of the pharmaceutical industry on this process have not been thoroughly analyzed. Therefore, were viewed four consecutive ASH and ASCO meetings to assess the frequency of duplicate abstract presentations. All abstracts presented at ASCO2010 in the area of malignant hematology were compared with abstracts from ASCO and ASH 2009 and ASH 2010, and funding sources were reviewed. More than half (54%) of all abstracts submitted to ASCO 2010 acknowledged pharmaceutical company support. Almost one third (31%) of ASCO 2010 abstracts were resubmitted in the 2-year time period, and it was notable that a high fraction (75%) of these duplicate abstracts had pharmaceutical industry sponsorship, compared with 42% of the abstracts that were submitted only once. Despite current guidelines prohibiting duplicate abstract presentation, a substantial proportion (31%) of abstracts at large international hematology-oncology meetings are duplicative, with potential negative consequences. In addition, a disproportionate percentage of the duplicate abstracts rely on pharmaceutical industry support (75%), suggesting that marketing strategies may be a motivation for some of these repetitive submissions.

Farmácia Popular Program: pharmaceutical market analysis of antihypertensive acting on the renin-angiotensin system medicines

Directory of Open Access Journals (Sweden)

Rondineli Mendes da Silva

Full Text Available Abstract This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP, a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health included private retail pharmacy sales volume (pharmaceutical units and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.

[Written pharmaceutical advertising--still unreliable?].

Science.gov (United States)

Gladsø, Kristin Haugen; Garberg, Hedda Rosland; Spigset, Olav; Slørdal, Lars

2014-09-02

Marketing by the pharmaceutical industry affects doctors' prescribing habits. All pharmaceutical advertising received by nine doctors in two GP offices over a period of three months was collected. The advertising material was sorted by compound. For each compound, the advert with the highest number of references was selected. The cited references were obtained, and the claims in the adverts were assessed in terms of their consistency with the source data based on the provisions in the Norwegian regulations on pharmaceuticals. The references were also assessed with regard to the incidence of conflicts of interest among authors. The doctors received a total of 270 shipments of advertising for 46 different compounds. Altogether 95% of the 173 references cited in the 46 selected adverts could be obtained. The adverts contained a total of 156 claims. Of these, 56% were assessed as correct when compared to the source data and as having clinical relevance. Altogether 75% of the journal articles reported relevant conflicts of interest for the authors. About half the claims in the adverts were found to be correct and clinically relevant. These results concur with those from a methodologically identical study based on advertising material collected in 2004. The cited literature was of varying quality and often funded by the pharmaceutical companies. The findings indicate that the target group should be sceptical of this type of marketing.

Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

Science.gov (United States)

Calis, S; Oner, F; Kas, S; Hincal, A A

2001-06-01

Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

[Advertising and Zeitgeist. The advertising of Schwabe Pharmaceuticals].

Science.gov (United States)

Hofmann, Cornelia; Riha, Ortrun

2015-01-01

This contribution explores the advertisements for homeopathic products in magazines in the first half of the twentieth century, focusing on the period between 1933 and 1945 and based on the example of the pharmaceutical company Dr Willmar Schwabe. In the first half of the twentieth century, Schwabe Pharmaceuticals was market leader for homeopathic and other complementary medical products (phytotherapy, biochemicals). The example chosen as well as the time frame complement the existing research. We searched three German publications (the homeopathy journal Leipziger Populäre Zeitschrift für Homöopathie, the medical weekly Münchner Medizinische Wochenschrift and the pharma magazine Pharmazeutische Zeitung) and collected target-group-specific results for laypersons, physicians and pharmacists. Analysis of the images and texts in the selected advertisements often reflected the historical background and the respective health policies (wartime requirements, times of need, "Neue Deutsche Heilkunde"). The history of this traditional company was seen as an important point in advertising, as were the recognisability of the brand through the company logo, the emphasis on the high quality of their products and the reference to the company's own research activities. We furthermore found the kind of argumentation that is typical of natural medicine (naturalness, the power of the sun, prominent representatives). Schwabe met the expectations of its clients, who were interested in complementary medicine, whilst pursuing an approach to homeopathy that was compatible with natural science, and it presented itself as a modern, scientifically oriented enterprise. The company did not lose credibility as a result, but increased its clientele by expanding to include the whole naturopathic market.

Faces of pricing and profit planning at the doorstep of the EU: government pricing policy in the innovative pharmaceutical sector in Turkey

OpenAIRE

De Kervenoael, Ronan J.; Nilsson, Ulf

2006-01-01

The majority of research on the pharmaceutical sector has focused on an overall micro economic, medical oriented welfare issues, whereas the marketing management role of the innovative drug manufacturer has to a large extent been disregarded. Using the case of Turkey, through a series of in-depth interviews with highly innovative companies, other marketing management possibilities to develop pricing strategies and plan for profit are explored based on broader definitions of value and transpar...

Radiopharmaceuticals using radioactive compounds in pharmaceutics and medicine

International Nuclear Information System (INIS)

Theobald, A.

1989-01-01

This review of the latest techniques and developments indicates the importance of radiopharmaceutical techniques in the development of drug compounds. It presents practical demonstrations, offers practical exercises, as well as the underlying theoretical considerations: it will supplement existing (mostly American) texts in this subject, since most industrial pharmaceutical companies have a keen interest in the area and most pharmaceutical courses include the subject at degree level. The authors emphasize the pharmaceutical applications throughout. They review targeting aspects, including cell and protein labelling: and discuss radiotracers in testing dosage forms and formulation studies. Safety and legislation are considered, with reviews of the handling techniques, radiation monitoring, radiochromatography and the use of computer techniques. The latter part of the work discusses standards for radiopharmaceuticals, sterility and pyrogen testing, as well as both radiochromatographic and electrophoretic methods and their importance to quality control. (author)

An insight into the emerging role of regional medical advisor in the pharmaceutical industry

Directory of Open Access Journals (Sweden)

Sandeep Kumar Gupta

2013-01-01

Full Text Available The position of regional medical advisor (RMA is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry′s increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP guidelines.

[Animal welfare and corporate welfare in pharmaceutical R&D - the future of third-party assessment].

Science.gov (United States)

Suzuki, Makoto

For research and development (R&D) of new drugs, animal experimentation is indispensable, and research institutes, pharmaceutical companies, or contract research organizations routinely conduct preclinical studies of efficacy, safety, or metabolism using laboratory animals. However, animal experimentation entails some organizational risks. One is the suspension of R&D of a new drug, because in the course of clinical studies it becomes apparent that the drug has limited efficacy, unexpected side effects, and/or unexpected metabolites. Another risk is damage to the company image by development of an unfavorable reputation. Society has accepted animal experimentation as a necessary evil, but if such experimentation is not conducted with adequate concern for animal welfare, social sanctions will against that institute, company or organization will result. Once this happens, it is difficult to recover a good public image. Therefore, pharmaceutical companies must conduct animal experiments so as to obtain highly useful data without sacrificing public favor. One way to maintain a good reputation is through third-party accreditation, which verifies that the institute, company or organization and its researchers value animal welfare appropriately.

Case histories in pharmaceutical risk management.

Science.gov (United States)

McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

2009-12-01

The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).

Homochiral drugs: a demanding tendency of the pharmaceutical industry.

Science.gov (United States)

Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

2009-01-01

The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

Who has used internal company documents for biomedical and public health research and where did they find them?

Directory of Open Access Journals (Sweden)

L Susan Wieland

Full Text Available OBJECTIVE: To describe the sources of internal company documents used in public health and healthcare research. METHODS: We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. RESULTS: Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%. Articles using documents from pharmaceutical companies (20/361; 6% were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%. The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%. Most articles (346/361; 96% used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles, the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceutical company documents, but the search retrieved an impractical number of citations for review. CONCLUSIONS: Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been

Characterizing the interaction between physicians, pharmacists and pharmaceutical representatives in a middle-income country: A qualitative study.

Directory of Open Access Journals (Sweden)

Rima Hajjar

Full Text Available Studies around the world have shown that interactions between pharmaceutical companies, pharmacists and physicians have a great influence on prescribing and drug dispensing practices. In middle-income countries, the nature and extent of these interactions have not been well researched. Our objectives were to qualitatively explore the nature of the interactions between pharmaceutical companies, physicians and pharmacists, their impact on drug prescription and dispensing practices in Lebanon.We used grounded theory approach as well as the known sponsor, purposive, and snowballing sampling strategies to identify interviewees from the three respective groups: physicians, pharmacists, and pharmaceutical representatives. We conducted semi-structured and analyzed transcripts thematically. This study encompassed 6 pharmaceutical representatives, 13 physicians and 13 pharmacists. The following themes emerged: purpose and driver for the interactions, nature of the interactions, incentives, impact on prescription practices, ethical considerations, and suggestions for managing the interactions. The main purposes for the interaction were educational, promotional, and monitoring prescription practices and dispensing, while the main drivers for these interactions were market potential and neighborhood socio-economic status. Physicians, pharmacists and pharmaceutical representatives who engage in these interactions benefit from a variety of incentives, some of which were characterized as unethical. It appears that pharmaceutical companies give prominence to selected physicians within their communities. Although members of the three interviewed groups refer to some of the interactions as being problematic, they described a culture of acceptance of gift giving. We developed a framework that depicts the prevailing politico-cultural environment, the interactions between the three professional groups, and their impact on drug prescription. Underreporting is the main

Characterizing the interaction between physicians, pharmacists and pharmaceutical representatives in a middle-income country: A qualitative study.

Science.gov (United States)

Hajjar, Rima; Bassatne, Aya; Cheaito, Mohamad Ali; Naser El Dine, Rabie; Traboulsy, Sarah; Haddadin, Fadi; Honein-AbouHaidar, Gladys; Akl, Elie A

2017-01-01

Studies around the world have shown that interactions between pharmaceutical companies, pharmacists and physicians have a great influence on prescribing and drug dispensing practices. In middle-income countries, the nature and extent of these interactions have not been well researched. Our objectives were to qualitatively explore the nature of the interactions between pharmaceutical companies, physicians and pharmacists, their impact on drug prescription and dispensing practices in Lebanon. We used grounded theory approach as well as the known sponsor, purposive, and snowballing sampling strategies to identify interviewees from the three respective groups: physicians, pharmacists, and pharmaceutical representatives. We conducted semi-structured and analyzed transcripts thematically. This study encompassed 6 pharmaceutical representatives, 13 physicians and 13 pharmacists. The following themes emerged: purpose and driver for the interactions, nature of the interactions, incentives, impact on prescription practices, ethical considerations, and suggestions for managing the interactions. The main purposes for the interaction were educational, promotional, and monitoring prescription practices and dispensing, while the main drivers for these interactions were market potential and neighborhood socio-economic status. Physicians, pharmacists and pharmaceutical representatives who engage in these interactions benefit from a variety of incentives, some of which were characterized as unethical. It appears that pharmaceutical companies give prominence to selected physicians within their communities. Although members of the three interviewed groups refer to some of the interactions as being problematic, they described a culture of acceptance of gift giving. We developed a framework that depicts the prevailing politico-cultural environment, the interactions between the three professional groups, and their impact on drug prescription. Underreporting is the main limitation of this

Corporate social responsibility in countries with mature and emerging pharmaceutical sectors

Science.gov (United States)

Volodina, Anna; Sax, Sylvia; Anderson, Stuart

2009-01-01

In recent decades the concept of Corporate Social Responsibility (CSR) has been adopted by many business sectors, including the pharmaceutical industry. However, in this and other sectors its application remains variable, particularly between mature and developing economies. Its stakeholders include pharmacy and medical students, their attitude to the involvement of companies in socially responsible activities will be important determinants of public response to the industry. Objective: To investigate the knowledge, attitudes and practices of senior medical and pharmacy students towards the CSR concept in the pharmaceutical sector in mature (Germany) and developing (Russia) markets. Methods: A questionnaire survey was carried out among senior pharmacy and medical students during the summer semester 2008 in two Russian and one German university. In each country 120 questionnaires were distributed. The response rate was 95% in Russia and 93% in Germany. Results: Although the relevance of CSR was widely acknowledged by the students, very few were aware of CSR practices currently performed by companies. The reputation of the pharmaceutical industry was generally poor: less than 15% of respondents gave credence to the information provided in advertisements and fully supported pricing strategies as well as policies towards the developing countries. When choosing an employer more than 90% of respondents consider the policies affecting an employee directly as pivotal. However, for a high proportion of students (59% in Russia and 64% in Germany) socially irresponsible behavior by companies has a significant negative impact. Conclusions: This paper identifies practices which students believe should be a part of the CSR programmes for the pharmaceutical industry, and also some that should be abandoned. It recommends that corporate communication on CSR should be expanded. Key differences are seen in perceptions of students in Germany and Russia towards the extent of

Corporate social responsibility in countries with mature and emerging pharmaceutical sectors

Directory of Open Access Journals (Sweden)

Sax S

2009-12-01

Full Text Available In recent decades the concept of Corporate Social Responsibility (CSR has been adopted by many business sectors, including the pharmaceutical industry. However, in this and other sectors its application remains variable, particularly between mature and developing economies. Its stakeholders include pharmacy and medical students, their attitude to the involvement of companies in socially responsible activities will be important determinants of public response to the industry.Objective: To investigate the knowledge, attitudes and practices of senior medical and pharmacy students towards the CSR concept in the pharmaceutical sector in mature (Germany and developing (Russia markets. Methods: A questionnaire survey was carried out among senior pharmacy and medical students during the summer semester 2008 in two Russian and one German university. In each country 120 questionnaires were distributed. The response rate was 95% in Russia and 93% in Germany. Results: Although the relevance of CSR was widely acknowledged by the students, very few were aware of CSR practices currently performed by companies. The reputation of the pharmaceutical industry was generally poor: less than 15% of respondents gave credence to the information provided in advertisements and fully supported pricing strategies as well as policies towards the developing countries. When choosing an employer more than 90% of respondents consider the policies affecting an employee directly as pivotal. However, for a high proportion of students (59% in Russia and 64% in Germany socially irresponsible behavior by companies has a significant negative impact. Conclusions: This paper identifies practices which students believe should be a part of the CSR programmes for the pharmaceutical industry, and also some that should be abandoned. It recommends that corporate communication on CSR should be expanded. Key differences are seen in perceptions of students in Germany and Russia towards the

Corporate social responsibility in countries with mature and emerging pharmaceutical sectors.

Science.gov (United States)

Volodina, Anna; Sax, Sylvia; Anderson, Stuart

2009-10-01

In recent decades the concept of Corporate Social Responsibility (CSR) has been adopted by many business sectors, including the pharmaceutical industry. However, in this and other sectors its application remains variable, particularly between mature and developing economies. Its stakeholders include pharmacy and medical students, their attitude to the involvement of companies in socially responsible activities will be important determinants of public response to the industry. To investigate the knowledge, attitudes and practices of senior medical and pharmacy students towards the CSR concept in the pharmaceutical sector in mature (Germany) and developing (Russia) markets. A questionnaire survey was carried out among senior pharmacy and medical students during the summer semester 2008 in two Russian and one German university. In each country 120 questionnaires were distributed. The response rate was 95% in Russia and 93% in Germany. Although the relevance of CSR was widely acknowledged by the students, very few were aware of CSR practices currently performed by companies. THE REPUTATION OF THE PHARMACEUTICAL INDUSTRY WAS GENERALLY POOR: less than 15% of respondents gave credence to the information provided in advertisements and fully supported pricing strategies as well as policies towards the developing countries. When choosing an employer more than 90% of respondents consider the policies affecting an employee directly as pivotal. However, for a high proportion of students (59% in Russia and 64% in Germany) socially irresponsible behavior by companies has a significant negative impact. This paper identifies practices which students believe should be a part of the CSR programmes for the pharmaceutical industry, and also some that should be abandoned. It recommends that corporate communication on CSR should be expanded. Key differences are seen in perceptions of students in Germany and Russia towards the extent of irresponsible actions and the variation between them.

After compulsory licensing: coming issues in Canadian pharmaceutical policy and politics.

Science.gov (United States)

Lexchin, J

1997-04-01

Bills C-22 and C-91 eliminated compulsory licensing for pharmaceutical products in Canada. However, in the wake of these bills there are pressing issues of pharmaceutical policy that need to be decided. The value of additional spending in pharmaceutical R and D has yet to be evaluated. There needs to be a public debate about how far government policy should go in encouraging pharmaceutical R and D as opposed to investing resources in other areas. There has been a continuing escalation in the cost of the average prescription, due to the introduction of newer, but not necessarily more effective, medications. So far government has not been willing to commit resources to promote cost-effective prescribing. Pharmaceutical companies are now lobbying for more rapid approval of products and an extension to the normal patent period to make up for the time that drugs spend in the regulatory process. The process that the government uses to resolve these issues will be just as important as the ultimate decisions.

Medicines Information and the Regulation of the Promotion of Pharmaceuticals.

Science.gov (United States)

Leonardo Alves, Teresa; Lexchin, Joel; Mintzes, Barbara

2018-05-02

Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutical companies with the aim of enhancing product sales. We look in greater detail at promotion techniques aimed at prescribers, such as sales representatives, pharmaceutical advertisements in medical journals and use of key opinion leaders, along with the quality of information provided and the effects thereof. We also discuss promotion to the public, through direct-to-consumer advertising, and its effects. Finally, we consider initiatives to regulate promotion that come from industry, government and nongovernmental organizations.

Pharmaceutical portfolio management: global disease burden and corporate performance metrics.

Science.gov (United States)

Daems, Rutger; Maes, Edith; Mehra, Maneesha; Carroll, Benjamin; Thomas, Adrian

2014-09-01

Biopharmaceutical companies face multiple external pressures. Shareholders demand a profitable company while governments, nongovernmental third parties, and the public at large expect a commitment to improving health in developed and, in particular, emerging economies. Current industry commercial models are inadequate for assessing opportunities in emerging economies where disease and market data are highly limited. The purpose of this article was to define a conceptual framework and build an analytic decision-making tool to assess and enhance a company's global portfolio while balancing its business needs with broader social expectations. Through a case-study methodology, we explore the relationship between business and social parameters associated with pharmaceutical innovation in three distinct disease areas. The global burden of disease-based theoretical framework using disability-adjusted life-years provides an overview of the burden associated with particular diseases. The social return on investment is expressed as disability-adjusted life-years averted as a result of the particular pharmaceutical innovation. Simultaneously, the business return on investment captures the research and development costs and projects revenues in terms of a profitability index. The proposed framework can assist companies as they strive to meet the medical needs of populations around the world for decades to come. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Drugs for cardiovascular disease in India: perspectives of pharmaceutical executives and government officials on access and development-a qualitative analysis.

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Newman, Charles; Ajay, Vamadevan S; Srinivas, Ravi; Bhalla, Sandeep; Prabhakaran, Dorairaj; Banerjee, Amitava

2016-01-01

India shoulders the greatest global burden of cardiovascular diseases (CVDs), which are the leading cause of mortality worldwide. Drugs are the bedrock of treatment and prevention of CVD. India's pharmaceutical industry is the third largest, by volume, globally, but access to CVD drugs in India is poor. There is a lack of qualitative data from government and pharmaceutical sectors regarding CVD drug development and access in India. By purposive sampling, we recruited either Indian government officials, or pharmaceutical company executives. We conducted a stakeholder analysis via semi-structured, face-to-face interviews in India. Topic guides allow for the exploration of key issues across multiple interviews, along with affording the interviewer the flexibility to examine matters arising from the discussions themselves. After transcription, interviews underwent inductive thematic analysis. Ten participants were interviewed (Government Officials: n = 5, and Pharmaceutical Executives: n = 5). Two themes emerged: i) 'Policy-derived Factors'; ii) 'Patient- derived Factors' with three findings. First, both government and pharmaceutical participants felt that the focus of Indian pharma is shifting to more complex, high-quality generics and to new drug development, but production of generic drugs rather than new molecular entities will remain a major activity. Second, current trial regulations in India may restrict India's potential role in the future development of CVD drugs. Third, it is likely that the Indian government will tighten its intellectual property regime in future, with potentially far-reaching implications on CVD drug development and access. Our stakeholder analysis provides some support for present patent regulations, whilst suggesting areas for further research in order to inform future policy decisions regarding CVD drug development and availability. Whilst interviewees suggested government policy plays an important role in shaping the industry, a

Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry.

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Song, Chie Hoon; Han, Jeung-Whan

2016-01-01

Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies. It further discusses how the mix of competition policies and strategic instruments can be used to maintain declining revenue streams from the blockbuster business model of the pharmaceutical industry. The review provides a comprehensive overview of the research on various strategies, offers both theoretical and practical guidelines for strategy transformation that companies can use to prolong the market exclusivity, and identifies knowledge gaps that needed to be addressed in order to improve efficiency in policy design.

[Early achievements of the Danish pharmaceutical industry-7].

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Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2014-01-01

A/S GEA Farmaceutisk Fabrik was established as a family business in 1927 by the pharmacist Knud L. Gad Andresen who until then had been employed in the pharmaceutical industry. Gad Andresen wanted to run a company focusing on the development of generics, and he wanted this development to take place in a close cooperation with Danish physicians. This has indeed been achieved with success. In 1995 GEA was purchase'd by the American pharmaceutical company Bristol-Myers Squibb who in a press release characterized GEA as Denmark's second largest manufacturer of generics. Immediately after this takeover GEA's R&D department ceased the research in innovative products and from now on exclusively focused on the development of generics. Three years later GEA was sold to the German generic company Hexal who later on resold GEA to the Swiss generic company Sandoz. GEA changed ownership another couple of times until the last owner went bankrupt in 2011. GEA is yet again a model example of an early Danish pharmaceutical company which was established as an individual company, and which had a long commercial success with the production and marketing of generics. GEA's earliest products, the organotherapeutics, were not innovations. The innovative products were developed already in the 1890s in Denmark by Alfred Benzon, and later on copies followed a.o. from Medicinalco and from foreign companies before GEA marketed their generics. Therefore GEA had to promote their preparations as especially qualified medicinal products and to intimate that the products of the competitors were less "active'". At the end of the 1920s the Ministry of Health became aware of the fact that there might be health problems related to the none-existing control of both the or- ganotherapeutic preparations and actually also the other medicinal products of the pharmaceutical industry. Therefore the Ministry had requested the National Board of Health for a statement regarding this problem. The National Board

Integrating systems Approaches into Pharmaceutical Sciences

DEFF Research Database (Denmark)

Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.

2008-01-01

During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...

Pfizer and the Challenges of the Global Pharmaceutical Industry 2013 (B)

DEFF Research Database (Denmark)

Kratochvil, Renate; Nell, Phillip Christopher

2017-01-01

This is part of a case series. The overall case focuses on the overall pharmaceutical market, such as industry structure and trends, as well as the strategic position of innovative (R&D intensive) pharmaceutical companies. Case A starts with a description of Pfizer struggling to hold its position...... as an industry leader and questions whether this is indicative for the current developments of the entire industry, putting big pharmaceutical companies’ power and influence under pressure. Such trends are, for example, slower sales growth, expiring patents, increasing competition from generics, shorter product...... pharmaceutical companies’ (and in particular Pfizer's) strategic moves (such as mega M&As) to conquer recent trends. The reader is then referred back to Pfizer's situation, its recent strategic initiatives, and competitor’s behaviour. Both cases feature comprehensive information and a large number of tables...

Pfizer and the Challenges of the Global Pharmaceutical Industry 2013 (A)

DEFF Research Database (Denmark)

Kratochvil, Renate; Nell, Phillip Christopher

2018-01-01

This is part of a case series. The overall case focuses on the overall pharmaceutical market, such as industry structure and trends, as well as the strategic position of innovative (R&D intensive) pharmaceutical companies. Case A starts with a description of Pfizer struggling to hold its position...... as an industry leader and questions whether this is indicative for the current developments of the entire industry, putting big pharmaceutical companies’ power and influence under pressure. Such trends are, for example, slower sales growth, expiring patents, increasing competition from generics, shorter product...... pharmaceutical companies’ (and in particular Pfizer's) strategic moves (such as mega M&As) to conquer recent trends. The reader is then referred back to Pfizer's situation, its recent strategic initiatives, and competitor’s behaviour. Both cases feature comprehensive information and a large number of tables...

Assessing the Factors Associated With Iran's Intra-Industry Trade in Pharmaceuticals.

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Yusefzadeh, Hassan; Hadian, Mohammad; Abolghasem Gorji, Hassan; Ghaderi, Hossein

2015-03-30

Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran's intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. This study assessed the factors associated with Iran's intra-industry trade in pharmaceuticals with the rest of the world during the 2001-2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran's pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran's IIT in pharmaceuticals. The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran's intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn't have the expected signs. In addition, we found that Iran's IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. In order to get more prepared for integration into the global economy, the development of Iran's IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade.

Occurrence and reduction of pharmaceuticals in the water phase at Swedish wastewater treatment plants

DEFF Research Database (Denmark)

Falås, Per; Andersen, Henrik Rasmus; Ledin, Anna

2012-01-01

During the last decade, several screening programs for pharmaceuticals at Swedish wastewater treatment plants (WWTPs) have been conducted by research institutes, county councils, and wastewater treatment companies. In this study, influent and effluent concentrations compiled from these screening...... programs were used to assess the occurrence and reduction of non-antibiotic pharmaceuticals for human usage. The study is limited to full-scale WWTPs with biological treatment. Based on the data compiled, a total of 70 non-antibiotic pharmaceuticals have been detected, at concentrations ranging from a few...... WWTPs were identified. Further comparison based on the biological treatment showed lower reduction degrees for several pharmaceuticals in trickling filter plants compared to activated sludge plants with nitrogen removal....

A CADD-alog of strategies in pharma

Science.gov (United States)

Warr, Wendy A.

2017-03-01

A special issue on computer-aided drug design (CADD) strategies in pharma discusses how CADD groups in different environments work. Perspectives were collected from authors in 11 organizations: four big pharmaceutical companies, one major biotechnology company, one smaller biotech, one private pharmaceutical company, two contract research organizations (CROs), one university, and one that spans the breadth of big pharmaceutical companies and one smaller biotech.

Globalization of the pharmaceutical industry and the growing dependency of developing countries: the case of Turkey.

Science.gov (United States)

Semin, Semih; Güldal, Dilek

2008-01-01

In developing countries, the effect of globalization on the pharmaceutical sector has resulted in a decrease in exportation and domestic production, accompanied by an increase in importation of pharmaceuticals and a rise in prices and expenditures. As an example of a developing country, Turkey has been facing the long-standing and increasing pressure of global regulations placed on its pharmaceutical sector. This has led to an increasing dependency on multinational companies and a gradual deterioration of an already weakened domestic pharmaceutical sector. This case study of Turkey offers points to consider in the world of increasing globalization, as it offers lessons on ways of examining the effects of globalization on the pharmaceutical industry of developing countries.

Health technology assessment of medicines in Greece: pharmaceutical industry executives' views.

Science.gov (United States)

Armataki, Eleni; Karampli, Eleftheria; Kyriopoulos, John; Pavi, Elpida

2014-04-01

The aim of this study was to investigate originator pharmaceutical companies' practices in relation to health technology assessment (HTA) and the views and perceptions of their executives on the importance of HTA in pricing and reimbursement of medicines in Greece. A qualitative study was performed, using individual semi-structured interviews based on an interview schedule with open-ended questions. The target population was market access departments' executives of originator pharmaceutical companies. Our target sample consisted of sixteen executives, of whom ten agreed to participate. Saturation point was reached after eight interviews. Data were audio recorded, transcribed verbatim, and analyzed using content analysis. Participants considered HTA as a very important complementary tool for decision making in health policy, particularly in the field of pharmaceuticals and medical devices. They believed that, in Greece, HTA could be institutionalized for the reimbursement mechanism of medicines under certain conditions relating to current health policy-making attitudes and conditions pertaining in the country. They considered that there are many constraints which must be overcome as well as opportunities to be exploited. Decisions in pharmaceutical policy should be scientifically substantiated and HTA should be institutionalized primarily for reimbursement decisions. Development of guidelines for conducting pharmaco-economic evaluation, change in health policy goals, recording of cost and epidemiological data, and broader participation of all stakeholders in HTA decision-making processes are suggested as prerequisites for a successful implementation of HTA in Greece.

Trade in Health Service: Unfair Competition of Pharmaceutical Products in Nepal

Directory of Open Access Journals (Sweden)

Madhusudan Subedi

2010-02-01

Full Text Available About 35 percent of the total demand for medicines in Nepal is covered by Nepali Pharmaceutical companies, and such companies are moving ahead for producing different kinds of medicines. The Government of Nepal, Department of Drug Administration (DDA has formulated different regulations and guidelines to ensure ethical practices in the medical sector of Nepal. Ethical Promotion of Medicine-2007 was developed and released to encourage the improvement of health care through the rational use of medicine and discourage unethical practices. It is distressing that the guidelines have not been implemented properly due to the conflict of interests among concerned stakeholders. The cost of medicine has been very expensive and poor people have always suffered. Key Words: Bonus; Ethical Guideline; Unethical Practices; Pharmaceutical Regulation; Conflict of Interest DOI: 10.3126/dsaj.v3i0.2783 Dhaulagiri Journal of Sociology and Anthropology Vol.3 2009 123-142

Acquiring Pharmaceutical Industry Assets in the UK: 1 + 1 = 1?

Science.gov (United States)

Kanavos, Panos; Angelis, Aris

2014-01-01

The recent AstraZeneca takeover bid from Pfizer puts pharmaceutical R&D once again on the public agenda. Three pertinent questions are (a) what can be expected from this acquisition, (b) what are the implications for the UK economy and science base, and (c) whether such a deal should go ahead. Although the key driver behind this acquisition would be an improvement in company performance and shareholder value, past evidence suggests that mergers and acquisitions (M&A) of large pharmaceutical companies imply a neutral net effect on productivity, if not a decline, with employment decreasing and R&D spend following a similar trend. Similarities between the two companies include dropping sales; however, relative to its size, AstraZeneca has a more promising R&D pipeline, especially in therapeutic areas where Pfizer's strength is currently limited (e.g. oncology). Ensuring a portfolio diversification would make Pfizer's takeover proposal a knight's one, but history points towards a knave-like behavior.

Pharmaceutical virtue.

Science.gov (United States)

Martin, Emily

2006-06-01

In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

Assessing the value and market attractiveness of the accessible tourism industry in Europe: a focus on major travel and leisure companies

Directory of Open Access Journals (Sweden)

James Bowtell

2015-10-01

Full Text Available Purpose – The purpose of this paper is to examine the accessible tourism market potential, alongside the implications of operating in the accessible tourism market and an assessment of major travel and leisure company involvement. The research focused on providing a market value forecast using historic data from 2005 and extrapolating this to 2025. An examination of the reasons for and against major travel and leisure company involvement in the accessible tourism market was accompanied by an analysis of managerial perceptions. Design/methodology/approach – The exploration of travel patterns of disabled tourists, in particular spend per head per holiday, was used to measure the value of the demand side of accessible tourism. Semi-structured interviews were carried out with employees of major travel and leisure companies in managerial positions. Findings – The study indicates that the accessible tourism market is a distinct sector, possessing the capacity for extensive future growth, and thus presents major travel providers with a potentially substantial and lucrative market, generating potential revenues of �88.6 billion by 2025. Research limitations/implications – Due to a lack of existing data an assumption had to be made on the evolution of travel spend per head per holiday. However, the formula used, using GDP/Capita growth, is a recognised way of forecasting this kind of data in the travel and leisure industry. Originality/value – This is the first paper to provide an examination of the reasons for and against major travel and leisure company involvement in the accessible tourism market, as well providing a forecast of the market value up to 2025.

Code of ethics for the national pharmaceutical system: Codifying and compilation.

Science.gov (United States)

Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin

2013-05-01

Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended.

Penicillin dust exposure and penicillin resistance among pharmaceutical workers in Tehran, Iran.

Science.gov (United States)

Farshad, Ali Asghar; Enferadi, Mojtaba; Bakand, Shahnaz; Jamshidi Orak, Rouhangiz; Mirkazemi, Roksana

2016-07-01

Antimicrobial resistance (AMR) adversely impacts the prevention and treatment of a wide range of infections and is considered as a serious threat to global public health. Occupational-related AMR is a neglected area of research. To assess exposure to penicillin dust, penicillin active materials, and to report the frequency of penicillin resistance among pharmaceutical workers in Tehran, Iran. A quasi-experimental study was conducted among workers on a penicillin production line in a pharmaceutical company (n = 60) and workers in a food producing company (n = 60). Data were collected via survey, air sampling, and throat swab. The mean overall concentrations of penicillin dust and penicillin active material were 6.6 and 4.3 mg/m 3 , respectively, in the pharmaceutical industry. Streptococcus pneumoniae (S. pneumoniae) was detected in 45% (27) individuals in the exposed group, 92.6% of which showed penicillin resistance. Resistance was significantly higher among workers in penicillin production line (p = 0.014). High level of AMR among workers in penicillin production line is a health risk for the workers as well as society as a whole through the spread of drug resistant micro-organisms.

Risk Communication and the Pharmaceutical Industry: what is the reality?

Science.gov (United States)

Edwards, Brian; Chakraborty, Sweta

2012-11-01

Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards 'Dear Healthcare Professional Communications', there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a company's risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are

Tria Pharmaceuticals in the Baltics

DEFF Research Database (Denmark)

Kratochvil, Renate; Nell, Phillip C.

2016-01-01

Linda, a management consultant, had to solve a tricky problem regarding difficulties with the 'Baltic region subsidiary' of a global pharmaceutical company. She was hired by their Regional Headquarters (RHQ) for Central and Eastern Europe to disentangle this multifaceted challenge (eg sales down...... on the topic were the cultural misunderstandings between the employees of the various countries, or the company’s outdated products. Linda was challenged to, first, get a clear and comprehensive picture of the situation, and, second, propose a well-conceived solution to the RHQ. This case is written as a two...

Cloud computing in pharmaceutical R&D: business risks and mitigations.

Science.gov (United States)

Geiger, Karl

2010-05-01

Cloud computing provides information processing power and business services, delivering these services over the Internet from centrally hosted locations. Major technology corporations aim to supply these services to every sector of the economy. Deploying business processes 'in the cloud' requires special attention to the regulatory and business risks assumed when running on both hardware and software that are outside the direct control of a company. The identification of risks at the correct service level allows a good mitigation strategy to be selected. The pharmaceutical industry can take advantage of existing risk management strategies that have already been tested in the finance and electronic commerce sectors. In this review, the business risks associated with the use of cloud computing are discussed, and mitigations achieved through knowledge from securing services for electronic commerce and from good IT practice are highlighted.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

Science.gov (United States)

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Innovation strategies for generic drug companies: moving into supergenerics.

Science.gov (United States)

Ross, Malcolm S F

2010-04-01

Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

Particularities of the logistic operations in the pharmaceutical domain

Directory of Open Access Journals (Sweden)

Ana BUTNARU

2010-12-01

Full Text Available The management of logistic operations has a very important role in the case of pharmaceutical products. The purpose of this article is to analyse the particularity of the logistic operations management in the pharmaceutical domain. This is seen in the fact that there is the obligativity of using the exclusive distribution system, because the carriers do not have selling right to the final users. In the pharmaceutical domain, the logistic channels may be represented by a system of vertical marketing, made from producers, en-gross sellers and en-detail sellers that action in the frame of an unified system in which a member of the channel may detain property right over the other members the vertical marketing system may be corporative or contractual. In Romania the medicine producers adopted both marketing systems. Organising and distributing medicine from the specialised unities (pharmaceutical deposit, close circuit pharmacy or comunitary pharmacy are settled through laws thjat are specific to the pharmaceutical domain. In these conditions the mission of the company is to give medicine with a balance between price – quality – asureness – eficacity, for giving accesibility to different treatments. The role of the state is significant, reason for an interdisciplinary approaching that may drive to ideas, oppinions that may be aplied.

Tropical Journal of Pharmaceutical Research, June 2002; 1 (1): 63-22

African Journals Online (AJOL)

Clinical Phamacy

middlemen and drug wholesalers. Other sources were the “open markets” and pharmaceutical company representatives, (Table 1). Fifty-six. (81%) of the respondents agreed that they checked on the source of their drugs before procurement. The factors that determined where respondents made their purchases included ...

Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

Science.gov (United States)

Banerjee, Tannista; Nayak, Arnab

2017-01-01

This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

Directory of Open Access Journals (Sweden)

Lončar Irma M.

2013-01-01

Full Text Available In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5% quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM on drug packaging was not of great importance, since most of them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc.. on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company

Assessing the Factors Associated With Iran’s Intra-Industry Trade in Pharmaceuticals

Science.gov (United States)

Yusefzadeh, Hassan; Hadian, Mohammad; Gorji, Hassan Abolghasem; Ghaderi, Hossein

2015-01-01

Background: Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran’s intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. Methods: This study assessed the factors associated with Iran’s intra-industry trade in pharmaceuticals with the rest of the world during the 2001–2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran’s IIT in pharmaceuticals. Results: The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran’s intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn’t have the expected signs. In addition, we found that Iran’s IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. Conclusions: In order to get more prepared for integration into the global economy, the development of Iran’s IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade. PMID:26156931

Create a translational medicine knowledge repository--research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons?

Science.gov (United States)

Littman, Bruce H; Marincola, Francesco M

2011-05-10

Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development.

Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

Science.gov (United States)

Dresser, Rebecca

2006-01-01

Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.

Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry

OpenAIRE

Song, Chie Hoon; Han, Jeung-Whan

2016-01-01

Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explo...

New strategies for innovation in global health: a pharmaceutical industry perspective.

Science.gov (United States)

Witty, Andrew

2011-01-01

Diseases that disproportionately affect developing countries play a large role in stalling economic and social development. Pharmaceutical companies are driving crucial research into new vaccines and medicines; however, although there is an imperative for industry to research new therapies for diseases of the poor, the financial returns are often seen as limited. This is beginning to change. The pharmaceutical industry and the public sector are thinking differently than before about how to improve access to medicines and advance research and development for neglected diseases. The public and private sectors must work together to develop a wide range of innovative tools, partnerships, and approaches.

Information flow in the pharmaceutical supply chain

OpenAIRE

Yousefi, Nazila; Alibabaei, Ahmad

2015-01-01

Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, man...

The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures

Science.gov (United States)

Lee, Munjae; Choi, Mankyu

2015-01-01

Objectives This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association (KLCA), and data related to stock price is extracted from KISVALUE-Ⅲ of NICE Information Service Co., Ltd. Stata 12.0 was used as the statistical package for panel analysis. Results The current ratio had a positive influence on R&D investment, the debt ratio had a negative influence on R&D investment, and return on investment and net sales growth rate did not have a significant influence on R&D investment. Conclusion It was found in this study that the higher liquidity ratio, the greater the R&D investment. The stability of pharmaceutical companies has a negative influence on R&D investment. This finding is consistent with the prediction that if a company faces a financial risk, it will be passive in R&D investment due to its financial difficulties. PMID:26730355

The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures.

Science.gov (United States)

Lee, Munjae; Choi, Mankyu

2015-10-01

This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association (KLCA), and data related to stock price is extracted from KISVALUE-Ⅲ of NICE Information Service Co., Ltd. Stata 12.0 was used as the statistical package for panel analysis. The current ratio had a positive influence on R&D investment, the debt ratio had a negative influence on R&D investment, and return on investment and net sales growth rate did not have a significant influence on R&D investment. It was found in this study that the higher liquidity ratio, the greater the R&D investment. The stability of pharmaceutical companies has a negative influence on R&D investment. This finding is consistent with the prediction that if a company faces a financial risk, it will be passive in R&D investment due to its financial difficulties.

Is Industry-University Interaction Promoting Innovation in the Brazilian Pharmaceutical Industry?

Science.gov (United States)

Paranhos, Julia; Hasenclever, Lia

2011-01-01

This paper analyses industry-university interaction and its characteristics in the Brazilian pharmaceutical system of innovation, taking account of the relevance of company strategies, the approach of the universities and the actions of government. By analysing primary and secondary data the authors show that, for as long as corporate investment…

An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

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Chatterjee S

2012-12-01

Full Text Available Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA to pharmaceutical manufacturers for promotional violations.Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL, and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market.Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6% followed by unsubstantiated efficacy claims (18.6%. Warning letters were primarily directed to manufacturers of cardiovascular (14.6%, anti-microbial (14.6%, and CNS (12.5% drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%. Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health.

[Fourcroy and pharmaceutical journals].

Science.gov (United States)

Bonnemain, Bruno

2011-04-01

Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

Financial Aspects and the Future of the Pharmaceutical Industry in the United States of America

OpenAIRE

Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

2013-01-01

Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one ...

A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran.

Science.gov (United States)

Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Ebadifard Azar, Farbod; Nabilo, Bahram; Abolghasem Gorji, Hassan; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

2015-04-23

Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world's greatest businesses. The aim of this study was to analyze Iran's comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran's trade in this field. To identify Iran's comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran's intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran's Customs Administration, Iran's pharmaceutical Statistics, World Bank and International Trade Center. The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world's total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran's pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran's intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade.

Could the Pharmaceutical Industry Benefit from Full-Scale Adoption of Radio-Frequency Identification (RFID) Technology with New Regulations?

Science.gov (United States)

Coustasse, Alberto; Kimble, Craig A; Stanton, Robert B; Naylor, Mariah

2016-01-01

Healthcare regulators are directing attention to the pharmaceutical supply chain with the passage of the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA). Adoption of Radio-Frequency Identification (RFID) technology has the ability to improve compliance, reduce costs, and improve safety in the supply chain but its implementation has been limited; primarily because of hardware and tag costs. The purpose of this research study was to analyze the benefits to the pharmaceutical industry and healthcare system of the adoption of RFID technology as a result of newly implemented supply chain regulations. The methodology was a review following the steps of a systematic review with a total of 96 sources used. With the DSCSA, pharmaceutical companies must track and trace prescription drugs across the supply chain, and RFID can resolve many track-and-trace issues with manufacturer control of data. The practical implication of this study is that pharmaceutical companies must continue to have the potential to increase revenues, decrease associated costs, and increase compliance with new FDA regulations with RFID. Still, challenges related to regulatory statute wording, implementation of two-dimensional barcode technology, and the variety of interfaces within the pharmaceutical supply chain have delayed adoption and its full implementation.

Mechanisms determining prices of products on the pharmaceutical market

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Klaudia LUCIUS

2015-07-01

Full Text Available The pharmaceutical market is characterized by the existence of state regulations restricting his freedom to market and is one of the fastest growing sectors of the economy all over the world. Factors that have a real impact on determining the price of drugs can be grouped into three categories: medical factors, economic factors, political and environmental factors. In the group of medical factors can be distinguished patent protection, the cost of producing the drug and the value of the drug. To economic factors, taking into account the aspect of market competitiveness of companies, include: the size of the producer, nature of the company - whether it is a research unit of the pharmaceutical company, return on investment – effectiveness of use of expenditure with the aim of achieving a profit (return on investment, ROI, profitability entity. The remaining group of factors (environmental, and political relate mainly to national regulations. They are connected with among others the registration system of marketing authorization, whether a reimbursement system that determines whether and how drugs are financed from public funds. Membership in the European Union forces on all Member States to make reimbursement decisions by the so-called Transparency Directive. It is connected with the obligation to justify decisions, and calling upon objective reasons. Medical Technology Assessment Agency formulating recommendations take into account factors i.e. a therapeutic, benefits for the patients, cost-effectiveness, impact on the budget.

Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.

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Henschke, Cornelia; Sundmacher, Leonie; Busse, Reinhard

2013-03-01

In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The role of pharmaceutical marketing and other factors in prescribing decisions: the Yemeni experience.

Science.gov (United States)

Al-Areefi, Mahmoud Abdullah; Hassali, Mohamed Azmi; Mohamed Ibrahim, Mohamed Izham B

2013-01-01

Prescribing decisions are a complex phenomenon and influenced by many pharmacological and non-pharmacological factors. Little is known about the actual prescribing behaviors of physicians or the factors behind their prescribing decisions. The objective of this study was to explore the factors that influence physicians' prescribing decisions and the role of the marketing activities by pharmaceutical companies in this decision-making process. A semi-structured interview with the critical incident technique method was used to encourage physicians to describe the particular situations of prescribing for specific newly marketed drugs. All interviews were transcribed verbatim and thematic content analysis with systematic and comprehensive coding was employed to identify categories of physicians' reasons for either prescribing or not of the study drugs. Factors that influence prescribing of the study drugs (223 critical incidents) were categorized in six major themes. Drug characteristics, the most frequently mentioned by physicians as reasons of prescribe, were implicated in 70 (31.4%) incidents, followed by pharmaceutical company mentioned in 53 (23.8%) incidents, indications, 31 (13.9%) incidents, and patient contexts, 26 (11.7%) incidents. Environmental factors as information and evidence were implicated in 22 (9.9%) incidents, and physician factor, 21 (9.4%) incidents. Prescribing is a complex process and physicians integrate different factors. Although physicians make a considerable on patient contexts and treatment outcomes, they still rely on their personal experiences when making prescribing in addition to firms' source of information and firms' marketing activities. Copyright © 2013 Elsevier Inc. All rights reserved.

Analysis on Time-Lag Effect of Research and Development Investment in the Pharmaceutical Industry in Korea.

Science.gov (United States)

Lee, Munjae; Choi, Mankyu

2015-08-01

The aim of this study is to analyze the influence of the research and development (R&D) investment of pharmaceutical companies on enterprise value. The period of the empirical analysis is from 2000 to 2012, considering the period after the influence of the financial crisis. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association, and data related to stock price were extracted from KISVALUE-III of National Information and Credit Evaluation Information Service Co., Ltd. STATA 12.0 was used as the statistical package for panel analysis. In the pharmaceutical firms, the influence of the R&D intensity with regard to Tobin's q was found to be positive. However, only the R&D expenditure intensities of previous years 2 and 5 (t-2 and t-5, respectively) were statistically significant (p company, such as generic, incrementally modified drugs, and biosimilar products.

Organizing Global IS Management to Meet Competitive Challenges: Experiences from the Pharmaceutical Industry

OpenAIRE

Bettina Schwarzer

1995-01-01

Despite the widely acknowledged importance information technology plays in multinational corporations, many companies lack an understanding of when and how to (re)organize global IS management. The issues of timing and organization of global IS management, however, seem to be of utmost importance in a company’s attempt to implement a new, global business strategy. Based on three case studies from the pharmaceutical industry, this paper analyzes the sequence in which business strategy, organ...

[Pharmaceutical marketers: professional and informative aspects].

Science.gov (United States)

Hevia, A; López-Valpuesta, F J; Vázquez, J A; Castellanos, A

1993-10-01

This study tries to know the opinion of pharmaceutical detailers about their profession, as well as their pharmacological knowledge. 75 questionnaires were distributed to an equal number of detailers. The questionnaires were composed of two parts. In the first one, several questions about their profession were posed. In the second one, the questions were about Pharmacology. The main results were that most of them have got only lower degrees; however, they all have carried out training courses in their companies. With regard to pharmacological questions, percentage of success was 61%.

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

Science.gov (United States)

Erices, Rainer; Frewer, Andreas; Gumz, Antje

2018-01-01

After the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear. A keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied. At least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal

Responsiveness to physicians' requests for information concerning drug interactions: a comparison of brand and generic companies.

Science.gov (United States)

Thomas, M; Lexchin, J

1990-01-01

Research-based pharmaceutical companies maintain that there are important differences between themselves and their generic competitors. Prominent among them is an alleged greater ability to provide accurate and rapid responses to requests from physicians for information about drug products. This study evaluates pharmaceutical company behavior with regard to these issues. Two drug-drug interactions were identified, along with all of the companies in Canada marketing any of the four drugs involved. Each company received a letter describing symptoms suggestive of an interaction in a patient taking its particular product and the relevant second drug. The companies were asked if they were aware of any evidence of an interaction involving the two drugs. They were also asked to provide references regarding the interaction. Responses were received from all companies contacted except one. There were no significant differences (in the hypothesized direction) between the generic and brand companies with regard to either the accuracy or promptness of the response, or the usefulness of the references cited. On the contrary, generic firms were markedly quicker to respond than were brand manufacturers. The latter were slightly more likely to acknowledge evidence of an adverse drug interaction, and to provide useful references to relevant published research.

Private versus social incentives for pharmaceutical innovation

OpenAIRE

González, Paula

2016-01-01

We provide a theoretical framework to contribute to the current debate regarding the tendency of pharmaceutical companies to direct their R&D toward marketing products that are follow-on drugs of already existing drugs, rather than toward the development of breakthrough drugs. We construct a model with a population of patients who can be treated with drugs that are horizontally and vertically differentiated. In addition to a pioneering drug, a new drug can be marketed as the result of an inno...

Private versus Social Incentives for Pharmaceutical Innovation

OpenAIRE

González, Paula; Macho-Stadler, Ines; Pérez-Castrillo, David

2015-01-01

We provide a theoretical framework to contribute to the current debate regarding the tendency of pharmaceutical companies to direct their R&D toward marketing products that are “follow-on” drugs of already existing drugs, rather than toward the development of breakthrough drugs. We construct a model with a population of patients who can be treated with drugs that are horizontally and vertically differentiated. In addition to a pioneering drug, a new drug can be marketed as the result of an in...

Create a translational medicine knowledge repository - Research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons?

Directory of Open Access Journals (Sweden)

Marincola Francesco M

2011-05-01

Full Text Available Abstract Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development.

Analysis and control of issues that delay pharmaceutical projects

Directory of Open Access Journals (Sweden)

Nallam Sai Nandeswara Rao

2015-10-01

Full Text Available Every project will have certain objectives and service levels to be achieved. The success of a project depends on several dimensions like time, cost/budget, quality, etc. and managing a project involves completing the project within time, within budget and with quality to satisfy the users. Because of the significance of health, pharmaceutical companies realized the importance of project management methods and techniques to make available the life saving drugs in time to the needy patients and hospitals. In literature, there is meager information about pharmaceutical project management oriented towards analysis of issues and factors that contribute to the failure or success of projects. This study attempts to analyse different issues that contribute to time delays in pharmaceutical product-based projects, group them under a finite set of prominent factors and identify remedial measures to control those delays. The feedback of project people of some big pharmaceutical firms of Indian sub-continent was collected for this purpose. Exploratory factor analysis (EFA has been used to reduce the reasons for time delays to a limited number of prominent factors and the EFA model has been further examined by confirmatory factor analysis (CFA for its validation. Remedial measures under each factor of time delays have been gathered and a framework designed to mitigate the time delays in pharmaceutical projects. The derived factors that delay the pharmaceutical projects include resource, monitoring & control, scheduling and planning problems. Important remedial measures like blended resource approach, estimation and forecast of shortage of labour and skills, regular quality training, etc. have been recommended.

Metabolic engineering: the ultimate paradigm for continuous pharmaceutical manufacturing.

Science.gov (United States)

Yadav, Vikramaditya G; Stephanopoulos, Gregory

2014-07-01

Research and development (R&D) expenditures by pharmaceutical companies doubled over the past decade, yet candidate attrition rates and development times rose markedly during this period. Understandably, companies have begun downsizing their pipelines and diverting investments away from R&D in favor of manufacturing. It is estimated that transitioning to continuous manufacturing could enable companies to compete for a share in emerging markets. Accordingly, the model for continuous manufacturing that has emerged commences with the conversion of late-stage intermediates into the active pharmaceutical ingredient (API) in a series of continuous flow reactors, followed by continuous solid processing to form finished tablets. The use of flow reactions for API synthesis will certainly generate purer products at higher yields in shorter times compared to equivalent batch reactions. However, transitioning from batch to flow configuration simply alleviates transport limitations within the reaction milieu. As the catalogue of reactions used in flow syntheses is a subset of batch-based chemistries, molecules such as natural products will continue to evade drug prospectors. Also, it is uncertain whether flow synthesis can deliver improvements in the atom and energy economies of API production at the scales that would achieve the levels of revenue growth targeted by companies. Instead, it is argued that implementing metabolic engineering for the production of oxidized scaffolds as gateway molecules for flow-based addition of electrophiles is a more effective and scalable strategy for accessing natural product chemical space. This new paradigm for manufacturing, with metabolic engineering as its engine, would also permit rapid optimization of production variables and allow facile scale-up from gram to ton scale to meet material requirements for clinical trials, thus recasting manufacturing as a tool for discovery. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran

Science.gov (United States)

Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Azar, Farbod Ebadifard; Nabilo, Bahram; Gorji, Hassan Abolghasem; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

2015-01-01

Background: Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world’s greatest businesses. The aim of this study was to analyze Iran’s comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran’s trade in this field. Methods: To identify Iran’s comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran’s intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran’s Customs Administration, Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Results: The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world’s total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran’s pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran’s intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. Conclusions: The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade. PMID:26153184

Does pharmaceutical advertising affect journal publication about dietary supplements?

Directory of Open Access Journals (Sweden)

Hood Kaylene L

2008-04-01

Full Text Available Abstract Background Advertising affects consumer and prescriber behaviors. The relationship between pharmaceutical advertising and journals' publication of articles regarding dietary supplements (DS is unknown. Methods We reviewed one year of the issues of 11 major medical journals for advertising and content about DS. Advertising was categorized as pharmaceutical versus other. Articles about DS were included if they discussed vitamins, minerals, herbs or similar products. Articles were classified as major (e.g., clinical trials, cohort studies, editorials and reviews or other (e.g., case reports, letters, news, and others. Articles' conclusions regarding safety and effectiveness were coded as negative (unsafe or ineffective or other (safe, effective, unstated, unclear or mixed. Results Journals' total pages per issue ranged from 56 to 217 while advertising pages ranged from 4 to 88; pharmaceutical advertisements (pharmads accounted for 1.5% to 76% of ad pages. Journals with the most pharmads published significantly fewer major articles about DS per issue than journals with the fewest pharmads (P Conclusion These data are consistent with the hypothesis that increased pharmaceutical advertising is associated with publishing fewer articles about DS and publishing more articles with conclusions that DS are unsafe. Additional research is needed to test alternative hypotheses for these findings in a larger sample of more diverse journals.

Bioremediation Kinetics of Pharmaceutical Industrial Effluent

Directory of Open Access Journals (Sweden)

M. Šabić

2015-05-01

Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental

Multiscale mechanistic modeling in pharmaceutical research and development.

Science.gov (United States)

Kuepfer, Lars; Lippert, Jörg; Eissing, Thomas

2012-01-01

Discontinuation of drug development projects due to lack of efficacy or adverse events is one of the main cost drivers in pharmaceutical research and development (R&D). Investments have to be written-off and contribute to the total costs of a successful drug candidate receiving marketing authorization and allowing return on invest. A vital risk for pharmaceutical innovator companies is late stage clinical failure since costs for individual clinical trials may exceed the one billion Euro threshold. To guide investment decisions and to safeguard maximum medical benefit and safety for patients recruited in clinical trials, it is therefore essential to understand the clinical consequences of all information and data generated. The complexity of the physiological and pathophysiological processes and the sheer amount of information available overcharge the mental capacity of any human being and prevent a prediction of the success in clinical development. A rigorous integration of knowledge, assumption, and experimental data into computational models promises a significant improvement of the rationalization of decision making in pharmaceutical industry. We here give an overview of the current status of modeling and simulation in pharmaceutical R&D and outline the perspectives of more recent developments in mechanistic modeling. Specific modeling approaches for different biological scales ranging from intracellular processes to whole organism physiology are introduced and an example for integrative multiscale modeling of therapeutic efficiency in clinical oncology trials is showcased.

Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.

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Hecker, Sandra J; Preston, Christopher; Foote, MaryAnn

2003-01-01

Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed.

The ethics of pharmaceutical research funding: a social organization approach.

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Gray, Garry C

2013-01-01

This paper advances a social organization approach to examining unethical behavior. While unethical behaviors may stem in part from failures in individual morality or psychological blind spots, they are both generated and performed through social interactions among individuals and groups. To illustrate the value of a social organization approach, a case study of a medical school professor's first experience with pharmaceutical-company-sponsored research is provided in order to examine how funding arrangements can constrain research integrity. The case illustrates three significant ways that institutional corruption can occur in the research process. First, conflicts of norms between pharmaceutical companies, universities, and affiliated teaching hospitals can result in compromises and self-censorship. Second, normal behavior is shaped through routine interactions. Unethical behaviors can be (or can become) normal behaviors when they are produced and reproduced through a network of social interactions. Third, funding arrangements can create networks of dependency that structurally distort the independence of the academic researcher in favor of the funder's interests. More broadly, the case study demonstrates how the social organization approach deepens our understanding of the practice of ethics. © 2013 American Society of Law, Medicine & Ethics, Inc.

Global health: the ethical responsibility of the pharmaceutical industry.

Science.gov (United States)

Lassen, Lars Christian; Thomsen, Mads Krogsgaard

2007-02-01

Health as a global issue concerns all and clearly manifests global inequality. All stakeholders of the healthcare systems and disease treatment--including the pharmaceutical industry--have an ethical obligation to contribute to promoting global health. At Novo Nordisk we primarily focus on providing our contribution to global health through defeating diabetes. At the same time we stand by being a private company required to deliver a financial profit, which is why we must create positive results on the financial, the environmental and the social bottom lines. In this article we attempt to provide a brief overview of some of the initiatives that we think business companies can take--and therefore are also obliged to in promoting global health. Further, we have pointed out a number of dilemmas within research and development as well as business ethics that all companies face when they convert the ethical principles to daily practice globally.

Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

Science.gov (United States)

Lexchin, J; Holbrook, A

1994-07-01

To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). Analytic study. All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion.

Musculoskeletal symptoms in pharmaceutical sales representatives.

Science.gov (United States)

Sang, Katherine; Gyi, Diane; Haslam, Cheryl

2010-03-01

Musculoskeletal disorders (MSDs) are a leading cause of work-related ill health. Existing literature indicates that pharmaceutical sales representatives (PSRs) report a high prevalence of MSDs, possibly exacerbated by the nature of work (prolonged driving and manual handling). In addition, they experience difficulty in accessing occupational health services. To assess the prevalence of musculoskeletal symptoms and associated risk factors among PSRs in order to assist their occupational health management through raising risk awareness. A self-completed questionnaire distributed to 205 PSRs within a UK pharmaceutical company was used to assess the prevalence of musculoskeletal symptoms, psychosocial factors, work tasks undertaken and company car use. To assist understanding of work tasks and organizational factors, semi-structured interviews were undertaken with a sample of 12 key personnel. The questionnaire response rate was 68%. PSRs reported high mileage and 100% reported working from the car in a typical day. Forty-seven per cent reported both manual handling for > or = 4 h/day and 'often' or 'sometimes' working from the car. Fifty-seven per cent reported low back symptoms in the last 12 months. Interview data revealed issues relating to car choice, storage in the boot and working from the car, which should be considered when developing priorities for preventive management of MSDs. Musculoskeletal symptoms appear to be a problem for PSRs, with risk factors reported as prolonged driving, sitting in the car, working from the car and manual handling. Interventions to facilitate their occupational health management should focus on raising awareness of the risks of prolonged driving and working from the car.

Hospitals plan to start their own generic drug company

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Robbins RA

2018-01-01

Full Text Available The New York Times reports that groups representing more than 450 hospitals plan to form their own generic drug company (1. Intermountain Healthcare is leading the collaboration with several other large hospital groups, Ascension, SSM Health and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form a not-for-profit drug company. The new firm is looking to create generic versions of about 20 existing drugs that the group says cost too much now or are in short supply. The article did not name the drugs targeted but expects the first of its pharmaceutical products to become available in 2019. Members of the consortium will contribute funds to finance the new drug company.

The Applied Aspects of Transposition and Integration of Development Resources in the System of Strategic Management of the Pharmaceutical Industry Enterprises

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Mykhailiuk Myroslava О.

2018-02-01

Full Text Available The article is aimed at researching the transposition and integration of development resources in the system of strategic management of pharmaceutical enterprises. It has been determined that in the current of market functioning, resources are transformed into development resources. The proposed scheme of transposition and integration of development resources in the system of strategic management of enterprises provides a combination of resource opportunities of company with market conditions and reflects synergistic interaction between two classical theories of strategic management: the M. Porter’s sectoral competition theory and the resource theory. The basic priorities of development of the pharmaceutical industry in the contemporary market environment are defined and trends of activity of pharmaceutical companies are indicated. Enterprises are distributed according to the criterion of introduction of development resources strategy, measures on increase of efficiency of their activity are suggested.

Global Market Entry Strategy and Point-A Perspective of Chinese Pharmaceutical Enterprise

Institute of Scientific and Technical Information of China (English)

TonyZhang

2003-01-01

After joining WTO, China will not only open its door wider to foreign investment and operations in Chinese market, but also play an increasing role in global market. However, unlike many other Chinese industries that are already major suppliers or producers of consumer products at global market, majority of pharmaceutical enterprises in China remain domestic operations. Today there are still major obstacles for Chinese pharmaceutical enterprises to overcome in entering key markets such as US and Europe.

Private versus social incentives for pharmaceutical innovation.

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González, Paula; Macho-Stadler, Inés; Pérez-Castrillo, David

2016-12-01

We provide a theoretical framework to contribute to the current debate regarding the tendency of pharmaceutical companies to direct their R&D toward marketing products that are "follow-on" drugs of already existing drugs, rather than toward the development of breakthrough drugs. We construct a model with a population of patients who can be treated with drugs that are horizontally and vertically differentiated. In addition to a pioneering drug, a new drug can be marketed as the result of an innovative process. We analyze physician prescription choices and the optimal pricing decision of an innovative firm. We also characterize the incentives of the innovative firm to conduct R&D activities, disentangling the quest for breakthrough drugs from the firm effort to develop follow-on drugs. Our results offer theoretical support for the conventional wisdom that pharmaceutical firms devote too many resources to conducting R&D activities that lead to incremental innovations. Copyright © 2016 Elsevier B.V. All rights reserved.

A practical discussion of risk management for manufacturing of pharmaceutical products.

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Mollah, A Hamid; Baseman, Harold S; Long, Mike; Rathore, Anurag S

2014-01-01

Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing. Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

Science.gov (United States)

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

Business Ethics and CSR in Pharmaceutical Industry in the Czech Republic and Hungary?

Directory of Open Access Journals (Sweden)

Markéta Lőrinczy

2015-01-01

Full Text Available How do business ethics and CSR form part of pharmaceutical business in the Czech Republic and Hungary? The question was analyzed through empirical studies where surveys were the main tool. The research investigated business ethics, CSR, ethical code, ethical involvement of employees as factors that might be important to achieve ethical behaviour in the pharmaceutical industry. Results showed that, with 69.4% response rate, that Czech and Hungarian original companies are more towards ethical behaviour and the employees know more about the organization they work for. The data were compared with parametric statistical analysis based on Mann-Whitney U calculator.

Concept for the generation of the model designated for the simulation of interaction between enterprises comprising one major construction company

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Dubovkina Alla Viktorovna

2014-12-01

Full Text Available The author offers an original concept designated for the generation of the model designated to simulate interaction between the enterprises comprising one major construction company within the framework of the production and logistics chain, comprising production facilities, transport enterprises, construction and assembly companies. The author has identified the factors that may produce an adverse effect on construction operations or cause untimely commissioning of a construction facility. The author employed methods of mathematics to describe the operations performed by each constituent enterprise. A graphic model describing each operation was compiled through the integration of mathematical functions. The model binds specific operations, performed by constituent companies, to deadlines, drives attention to interaction bottlenecks, and makes adjustments to assure reliable attainment of the main goal, that is, the timely commissioning of a construction facility.

Effect of educational interventions and medical school policies on medical students' attitudes toward pharmaceutical marketing practices: a multi-institutional study.

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Kao, Audiey C; Braddock, Clarence; Clay, Maria; Elliott, Donna; Epstein, Scott K; Filstead, William; Hotze, Tim; May, Win; Reenan, Jennifer

2011-11-01

To determine the effect of educational interventions on medical students' attitudes toward pharmaceutical industry marketing practices and whether restrictive medical school policies governing medicine-industry interactions are associated with student support for banning such interactions. Prospective cohort study involving the graduating classes of 2009 (intervention, n=474) and 2010 (control, n=459) at four U.S. medical schools. Intervention students experienced a former pharmaceutical representative's presentation, faculty debate, and a Web-based course. Both groups completed baseline and follow-up attitude surveys about pharmaceutical marketing. A total of 482 students (51.6%) completed both surveys. In regression analyses, intervention students were more likely than control students to think that physicians are strongly or moderately influenced by pharmaceutical marketing (OR, 2.29; 95% CI, 1.46-3.59) and believed they would be more likely to prescribe a company's drug if they accepted that company's gifts and food (OR, 1.68; 95% CI, 1.12-2.52). Intervention students were more likely to support banning interactions between pharmaceutical representatives and students (OR, 4.82; 95% CI, 3.02-7.68) and with physicians (OR, 6.88; 95% CI, 4.04-11.70). Students from schools with more restrictive policies were more likely to support banning interactions between pharmaceutical representatives and students (OR, 1.99; 95% CI, 1.26-3.16) and with physicians (OR, 3.44; 95% CI, 2.05-5.79). Education about pharmaceutical marketing practices and more restrictive policies governing medicine-industry interactions seem to increase medical students' skepticism about the appropriateness of such marketing practices and disapproval of pharmaceutical representatives in the learning environment.

Jednání obchodních zástupců farmaceutických společností očima farmaceutických asistentů.

OpenAIRE

Hutarová, Edita

2017-01-01

Ethical behavior is an inseparable part of business life and can have a major impact on corporate culture in business companies and their communication with clients. The aim of this work was to find out how the behavior of sales representatives of pharmaceutical companies in pharmaceutical pharmacies is perceived, to describe the ethical aspects in this field, and then to propose recommendations for adjusting internal rules, values or ethical code in a selected pharmaceutical company. This ta...

Feasibility of commercial space manufacturing, production of pharmaceuticals. Volume 2: Technical analysis

Science.gov (United States)

1978-01-01

A technical analysis on the feasibility of commercial manufacturing of pharmaceuticals in space is presented. The method of obtaining pharmaceutical company involvement, laboratory results of the separation of serum proteins by the continuous flow electrophoresis process, the selection and study of candidate products, and their production requirements is described. The candidate products are antihemophilic factor, beta cells, erythropoietin, epidermal growth factor, alpha-1-antitrypsin and interferon. Production mass balances for antihemophelic factor, beta cells, and erythropoietin were compared for space versus ground operation. A conceptual description of a multiproduct processing system for space operation is discussed. Production requirements for epidermal growth factor of alpha-1-antitrypsin and interferon are presented.

Are drug companies living up to their human rights responsibilities? The Merck perspective.

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Geralyn S Ritter

2010-09-01

Full Text Available BACKGROUND TO THE DEBATE: The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

Are drug companies living up to their human rights responsibilities? Moving toward assessment.

Science.gov (United States)

Gruskin, Sofia; Raad, Zyde

2010-09-28

The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

Are drug companies living up to their human rights responsibilities? The Merck perspective.

Science.gov (United States)

Ritter, Geralyn S

2010-09-28

The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

Diagnosis of poor safety culture as a major shortcoming in OHSAS 18001-certified companies.

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Ghahramani, Abolfazl

2017-04-07

The evaluation of safety performance in occupational health and safety assessment series (OHSAS) 18001-certified companies provides useful information about the quality of the management system. A certified organization should employ an adequate level of safety management and a positive safety culture to achieve a satisfactory safety performance. The present study conducted in six manufacturing companies: three OHSAS 18001-certified, and three non-certified to assess occupational health and safety (OHS) as well as OHSAS 18001 practices. The certified companies had a better OHS practices compared with the non-certified companies. The certified companies slightly differed in OHS and OHSAS 18001 practices and one of the certified companies had the highest activity rates for both practices. The results indicated that the implemented management systems have not developed and been maintained appropriately in the certified companies. The in-depth analysis of the collected evidence revealed shortcomings in safety culture improvement in the certified companies. This study highlights the importance of safety culture to continuously improve the quality of OHSAS 18001 and to properly perform OHS/OHSAS 18001 practices in the certified companies.

Considering the Future of Pharmaceutical Promotions in Social Media Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Science.gov (United States)

Carpentier, Francesca Renee Dillman

2016-02-09

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim's article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim's rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA's attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. © 2016 by Kerman University of Medical Sciences.

How to revive breakthrough innovation in the pharmaceutical industry.

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Munos, Bernard H; Chin, William W

2011-06-29

Over the past 20 years, pharmaceutical companies have implemented conservative management practices to improve the predictability of therapeutics discovery and success rates of drug candidates. This approach has often yielded compounds that are only marginally better than existing therapies, yet require larger, longer, and more complex trials. To fund them, companies have shifted resources away from drug discovery to late clinical development; this has hurt innovation and amplified the crisis brought by the expiration of patents on many best-selling drugs. Here, we argue that more breakthrough therapeutics will reach patients only if the industry ceases to pursue "safe" incremental innovation, re-engages in high-risk discovery research, and adopts collaborative innovation models that allow sharing of knowledge and costs among collaborators.

The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures

OpenAIRE

Lee, Munjae; Choi, Mankyu

2015-01-01

Objectives This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association (KLCA), and data related to stock price is extracted from ...

Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

Science.gov (United States)

Henry, David; Doran, Evan; Kerridge, Ian; Hill, Suzanne; McNeill, Paul M; Day, Richard

2005-11-28

It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

Curing the disobedient patient: medication adherence programs as pharmaceutical marketing tools.

Science.gov (United States)

Lamkin, Matt; Elliott, Carl

2014-01-01

Pharmaceutical companies have long focused their marketing strategies on getting doctors to write more prescriptions. But they lose billions in potential sales when patients do not take their prescribed drugs. Getting patients to "adhere" to drug therapies that have unpleasant side effects and questionable efficacy requires more than mere ad campaigns urging patients to talk to their doctors. It requires changing patients' beliefs and attitudes about their medications through repeated contact from people patients trust. Since patients do not trust drug companies, these companies are delivering their marketing messages through nurses, pharmacists, and even other patients--leveraging patients' trust in these intermediaries to persuade them to consume more brand name drugs. Armed with the premise that better adherence improves patients' health, drug companies justify manipulating patients by reframing reasonable decisions to decline therapy as pathological, and promote brand loyalty in the guise of offering medical care. © 2014 American Society of Law, Medicine & Ethics, Inc.

[Opinion of primary care physicians from Ourense on various features of the pharmaceutical prescription].

Science.gov (United States)

Díaz Grávalos, G J; Palmeiro Fernández, G; Núnñez Masid, E; Casado Górriz, I

2001-01-01

To learn the opinion of the primary care Physicians of Ourense (Spain) with respect to certain aspects of their prescription of medicines, such as their awareness of the price of drugs, the induced prescribing perceived, their relationship with the pharmaceutical industry and their opinions concerning possible measures for reducing the expenditure on medicines. In this transversal descriptive study, all of the primary care physicians in the province of Ourense (243) were surveyed by means of a previously-approved questionnaire sent to them by post. The questionnaire included demographic characteristics of the physicians, the influence of cost when prescribing medicines, their estimate of the price of 15 drugs routinely prescribed and their opinion on different aspects relating to induced prescription, the pharmaceutical industry and different strategies in order to curtail the expenditure on medicines. In order to analyze the results, the chi 2 and Student's t tests and an analysis of the variance were used, together with the Spearman correlation coefficient with alpha = 0.05. The level of participation of the physicians surveyed was 42.8% (104). The average daily duration of visits by pharmaceutical company representatives was 13.6 minutes, with new specialities being the topic of greatest interest. Close to 27% admitted to having participated in clinical testing sponsored by the industry. 23% considered the price to be a priority when prescribing. Induced prescription accounted for 39.7% of the total. The majority of physicians chose co-payment as the means for reducing expenditure on medicines. In the estimate of prices, the overall percentage of error was 45.7%, underestimating the more expensive medicines and overestimating the less expensive. There is a significant lack of awareness of the price of drugs among the primary care physicians. Most of the physicians do not feel that the price of a drug should be a priority when prescribing medicines. There is a

The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

Science.gov (United States)

Arpinelli, Fabio; Bamfi, Francesco

2006-10-31

The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs.

[Innovation guidelines and strategies for pharmaceutical engineering of Chinese medicine and their industrial translation].

Science.gov (United States)

Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

2013-01-01

This paper briefly analyzes the bottlenecks and major technical requirements for pharmaceutical industry of Chinese medicine, providing current status of pharmaceutical engineering of Chinese medicine. The innovation directions and strategies of the pharmaceutical engineering for manufacturing Chinese medicine are proposed along with the framework of their core technology. As a consequence, the development of the third-generation pharmaceutical technology for Chinese medicine, featured as "precision, digital and intelligent", is recommended. The prospects of the pharmaceutical technology are also forecasted.

The Influence of Emerging Markets on the Pharmaceutical Industry.

Science.gov (United States)

Tannoury, Maya; Attieh, Zouhair

2017-01-01

Emerging markets represent an exceptional opportunity for the pharmaceutical industry. Although a precise definition is not yet available, economists define emerging markets as developing prosperous countries in which investment is expected to result in higher income despite high risks. Qualifying a market as emerging is not merely based on the economic status of the country, but also on several criteria that render the definition applicable to each country. Jim O'Neil, retired chairman of asset management at Goldman Sachs, identified leading economies of emerging markets: Brazil, Russia, India, and China (BRIC) and later Brazil, Russia, India, China, and South Africa (BRICS) and then Mexico, Indonesia, South Korea, and Turkey (MIST), which followed years later as the second tier of nations. Sales of the pharmaceutical markets in BRICS and MIST countries doubled in 5 years, reaching a market share of approximately 20%. The shift toward these new markets has been attributed to the large populations, growing prosperity, and increasing life expectancy in BRICS and MIST countries. In addition, companies are experiencing flattened growth of developed markets, expiration of patents leading to the up-selling of less expensive generic drugs, and tight regulations enforced in mature markets. Particular attention must therefore be given to these emerging markets. The strategies adopted by pharmaceutical companies that want to expand in these markets must be tailored to the pace of development of each country. These countries need drugs against infectious diseases and communicable diseases such as sexually transmitted diseases. They are readily exploitable territories for the innovative products of pharmaceuticals. Nevertheless, with the increase in wealth and longevity, a change of lifestyle is occurring. These changes accompany a shift in disease patterns. A disproportionally fast rise in the incidence of noncommunicable diseases such as cardiovascular illnesses, diabetes

Presentation of a Novel Model for Evaluation of Commercialization of Research and Development: Case Study of the Pharmaceutical Biotechnology Industry.

Science.gov (United States)

Emami, Hassan; Radfar, Reza

2017-01-01

The current situation in Iran suggests an appropriate basis for developing biotechnology industries, because the patents for the majority of hi-tech medicines registered in developed countries are ending. Biosimilar and technology-oriented companies which do not have patents will have the opportunity to enter the biosimilar market and move toward innovative initiatives. The present research proposed a model by which one can evaluate commercialization of achievements obtained from research with a focus on the pharmaceutical biotechnology industry. This is a descriptive-analytic study where mixed methodology is followed by a heuristic approach. The statistical population was pharmaceutical biotechnology experts at universities and research centers in Iran. Structural equations were employed in this research. The results indicate that there are three effective layers within commercialization in the proposed model. These are a general layer (factors associated with management, human capital, legal infrastructure, communication infrastructure, a technical and executive infrastructures, and financial factors), industrial layer (internal industrial factors and pharmaceutical industry factors), and a third layer that included national and international aspects. These layers comprise 6 domains, 21 indices, 41 dimensions, and 126 components. Compilation of these layers (general layer, industrial layer, and national and international aspects) can serve commercialization of research and development as an effective evaluation package.

A survey of the effects of brand value on customer satisfaction in pharmaceutical and biological industries

OpenAIRE

Alipour, A.; Feizi, S.J.; Heidari, M.

2016-01-01

. The purpose of this study was to describe how companies in pharmaceutical and biological sectors can ensure their position in different markets by relying on sustainable, competitive advantages, resulting from the use of a well-defined marketing model with particular emphasis on brand improvement. As competition becomes more intense among companies and phenomena such as global marketing grow in importance, domestic industries in each country become obliged to improve their competitive advan...

Considering the Future of Pharmaceutical Promotions in Social Media; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

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Francesca Renee Dillman Carpentier

2016-04-01

Full Text Available This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media.

LEAN AND SIX SIGMA CONCEPTS APPLICATION IN PHARMACEUTICAL INDUSTRY

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Katarina Pavlović

2012-03-01

Full Text Available LEAN thinking and Six Sigma have been utilized by manufacturing industries to decrease cost and improve quality and productivity by reducing variation and production defects [1]. Because of the dramatic successes in manufacturing, there is rising interest among companies in the pharmaceutical industry, which chooses to implement LEAN in order to accomplish such goals as decreased wait time to release product to the market, reduce production waste, and improve communication with end users and raize quality level both in the production and in testing laboratories. In this article, basics of LEAN and Six Sigma are presented and suggestion was given for application of their concepts in pharmaceutical industry together with harmonization with legal regulation represented by requirements Good Manufacturing Practice (cGMP, in order to work "smarter", more cost-effectively and avoid was ting time and other resources.

LEAN AND SIX SIGMA CONCEPTS - APPLICATION IN PHARMACEUTICAL INDUSTRY

Directory of Open Access Journals (Sweden)

Katarina Pavlović

2011-06-01

Full Text Available LEAN thinking and Six Sigma have been utilized by manufacturing industries to decrease cost and improve quality and productivity by reducing variation and production defects. Because of the dramatic successes in manufacturing, there is rising interest among companies in the pharmaceutical industry, which choose to implement LEAN in order to accomplish such goals as decreased wait time to release product to the market, reduce production waste, improve communication with end users and raise quality level both in the production and in testing laboratories. In this article, basics of LEAN and Six Sigma are presented and suggestion was given for application of their concepts in pharmaceutical industry together with harmonization with legal regulation represented by requirements Good Manufacturing Practice (cGMP, in order to work "smarter", more cost- effectively and avoid wasting time and other resources.

Pharmaceutical Sponsorship Bias Influences Thrombolytic Literature in Acute Ischemic Stroke

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Ryan P Radecki

2011-05-01

Full Text Available Background: The efficacy of thrombolytic therapy for acute ischemic stroke remains controversial in Emergency Medicine and has not been fully endorsed by either the American College of Emergency Physicians or the American Academy of emergency medicine. A growing recognition exists of the influence of pharmaceutical sponsorship on the reported findings of published clinical trials. Sponsorship bias has been suggested as a potential criticism of the literature and guidelines favoring thrombolytic therapy. Objective: The objective of this study is to review the most influential literature regarding thrombolytic therapy for acute ischemic stroke and document the presence or absence of pharmaceutical sponsorship. Methods: A publication-citation analysis was performed to identify the most frequently cited articles pertaining to thrombolytic therapy for acute ischemic stroke. Identified articles were reviewed for disclosures of pharmaceutical funding. Results: Of the 20 most-cited articles pertaining to thrombolytic therapy for acute stroke, 17 (85% disclosed pharmaceutical sponsorship. These disclosures range from general sponsorship to direct employment of authors by pharmaceutical companies. Conclusion: An overwhelming predominance of the most influential literature regarding thrombolytic therapy for acute ischemic stroke is susceptible to sponsorship bias. This potential bias may provide a basis for physician concern regarding the efficacy and safety of thrombolytic therapy. Further, large, independent, placebo-controlled studies may be required to guide therapy and professional guidelines definitively for acute ischemic stroke. [West J Emerg Med. 2011;12(4:435–441.

What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study.

Science.gov (United States)

Parsons, Suzanne; Starling, Bella; Mullan-Jensen, Christine; Tham, Su-Gwan; Warner, Kay; Wever, Kim

2016-01-07

To explore European-based pharmaceutical industry professionals' beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Pharmaceutical companies in the UK, Poland and Spain. 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Pharmaceutical care education in Kuwait: pharmacy students' perspectives.

Science.gov (United States)

Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B

2014-07-01

Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients' quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. To investigate pharmacy students' attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists' physical separation from patient care areas (82.6%). Pharmacy students' attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and advocate implementation of pharmaceutical care while also

Implementation of the ICRP-60 Recommendations by Swiss Pharmaceutical Companies

International Nuclear Information System (INIS)

Sturm, R. P.; Traub, K.; Berlepsch, P.; Reischmann, F. J.; Zoubek, N.

2004-01-01

Switzerland was among the first countries that adapted its national law to the recommendations of the ICRP-publication No. 60. Already in 1991, the Federal Parliament enacted a new Radiological Protection Act. In 1994, the Federal Government adopted the new Radiation Protection Ordinance. Federal Ministries followed with technical ordinances and guidelines, e.g., for radioactive waste in 1996, for handling open sources in 1997, for X-rays in 1998 and for the training and dosimetry of radiation workers in 1999. In 1996, the Council of the European Union (Switzerland is not a member of the EU) decreed the Directive for the Protection of the Health of Workers and the General Public against the Dangers Arising from Ionising Radiation. Based on this directive, Germany adopted a new Radiation Protection Ordinance in 2001 and a new X-Ray-Ordinance in 2002. To transform the ordinances into radiation protection in the workplace further technical ordinances and guidelines are under development. Almost ten years ago, users of ionising radiation in Switzerland had to deal with the problems of implementing the new radiation protection legislation into their local rules that Germany and other EU companies are facing now. Therefore it may be interesting and helpful for authorities and companies in the EU to learn from the experience of their Swiss colleagues. (Author) 4 refs

Globalisation and Its Impact on Competitiveness: the Case of the British and German Pharmaceutical Industry

OpenAIRE

Christel Lane; Jocelyn Probert

2003-01-01

This paper assesses the degree of financial and economic globalisation of British and German pharmaceutical companies during 1990 and 2001 and explores the changing balance between globalisation and national embeddedness. It tries to explain both the much lower degree of globalisation of German as compared to British companies in 1990, as well as their catching up at the beginning of the 21st century. The paper suggests that the lesser degree of globalisation of German firms during most of th...

Hazardous Waste Cleanup: Bristol-Myers Squibb Company Worldwide Medicines in Brunswick, New Jersey

Science.gov (United States)

The Bristol-Myers Squibb Company (BMS) is located at 1 Squibb Drive in New Brunswick, New Jersey. The site has been an active pharmaceutical manufacturing and research and development facility since it began operation by E.R. Squibb and Sons, Inc. in 1907.

Analyzing the role of social networks in mapping knowledge flows: A case of a pharmaceutical company in India

Directory of Open Access Journals (Sweden)

V. Murale

2014-03-01

Full Text Available Knowledge Management literature lays emphasis on the fact that a major chunk of knowledge dissemination occurs through the various forms of social networks that exist within the organizations. A social network is a simple structure comprising of set of actors or nodes that may have relationships ties with one another. The social network analysis (SNA will help in mapping and measuring formal and informal relationships to understand what facilitates or impedes the knowledge flows that bind interacting units. This paper aims at studying the knowledge flows that happen through the social networks. It first, provides a conceptual framework and review of literature on the recent research and application of knowledge mapping and SNA, followed by a discussion on application of SNA for mapping knowledge flows in a pharmaceutical firm. In the last part, Knowledge maps are presented to illustrate the actual knowledge flow in firm.

Growth strategy for an emerging biopharmaceutcal company

OpenAIRE

Winsborrow, Beatrice Gay

2006-01-01

Inimex Pharmaceuticals, Inc. is a privately held biopharmaceutical company dedicated to the discovery, development and commercialization of new human medicines based on the selective modulation of the innate immune response. Since Inimex’s background is in human drug development, no formal animal health activities have been a part of Inimex operations. This initial analysis shows that Inimex has opportunity in the animal health market. Inimex is in a good place to evaluate a potential re...

Characterization of the evolution of the pharmaceutical regulatory environment.

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Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

2013-01-01

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

Investigation of major international and Turkish companies via hierarchical methods and bootstrap approach

Science.gov (United States)

Kantar, E.; Deviren, B.; Keskin, M.

2011-11-01

We present a study, within the scope of econophysics, of the hierarchical structure of 98 among the largest international companies including 18 among the largest Turkish companies, namely Banks, Automobile, Software-hardware, Telecommunication Services, Energy and the Oil-Gas sectors, viewed as a network of interacting companies. We analyze the daily time series data of the Boerse-Frankfurt and Istanbul Stock Exchange. We examine the topological properties among the companies over the period 2006-2010 by using the concept of hierarchical structure methods (the minimal spanning tree (MST) and the hierarchical tree (HT)). The period is divided into three subperiods, namely 2006-2007, 2008 which was the year of global economic crisis, and 2009-2010, in order to test various time-windows and observe temporal evolution. We carry out bootstrap analyses to associate the value of statistical reliability to the links of the MSTs and HTs. We also use average linkage clustering analysis (ALCA) in order to better observe the cluster structure. From these studies, we find that the interactions among the Banks/Energy sectors and the other sectors were reduced after the global economic crisis; hence the effects of the Banks and Energy sectors on the correlations of all companies were decreased. Telecommunication Services were also greatly affected by the crisis. We also observed that the Automobile and Banks sectors, including Turkish companies as well as some companies from the USA, Japan and Germany were strongly correlated with each other in all periods.

Analysis of thermal energy storage for a pharmaceutical company

Energy Technology Data Exchange (ETDEWEB)

Henze, Gregor P. [Colorado Univ., Boulder, CO (US). Dept. of Civil, Environmental and Architectural Engineering (CEAE); Biffar, Bernd; Wienecke, Marcus [Boehringer Ingelheim Pharma GmbH und Co. KG, Biberach (Germany); Becker, Martin P. [Biberach Univ. of Applied Sciences (Germany). Dept. of Architectural and Energy Engineering

2009-07-01

A pharmaceutical facility located in Southern Germany is experiencing a trend of growing cooling loads to be met by the chilled water plant composed of ten chillers of greatly varying cost effectiveness. With a capacity shortfall inevitable, the question arises whether to install an additional chiller or improve the utilization of the existing chillers, in particular those with low operating costs per unit cooling, through the addition of a chilled water thermal energy storage (TES) system. To provide decision support in this matter, an optimization environment was developed and validated that adopts mixed integer programming as the approach to optimizing the chiller dispatch for any load condition, while an overarching dynamic programming based optimization approach optimizes the charge/discharge strategy of the TES system. In this fashion, the chilled water plant optimization is decoupled but embedded in the TES control optimization. The approach was selected to allow for arbitrary constraints and optimization horizons, while ensuring a global optimum to the problem. The results show that a relatively small TES tank provides significant economic and operational benefits. Yet, in order to facilitate long-term supply security, a larger TES tank capacity was decided on and the TES system was constructed in 2008. (orig.)

Integrating systems approaches into pharmaceutical sciences.

NARCIS (Netherlands)

Westerhoff, H.V.; Mosekilde, E.; Noe, C.; Clemensen, A.M.

2008-01-01

During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose

Financial Times Global Pharmaceutical & Biotechnology Conference 2009.

Science.gov (United States)

Scattereggia, Jennifer

2010-01-01

The Financial Times Global Pharmaceutical & Biotechnology conference, held in London, included topics covering the current and future challenges confronting the pharma and biotech industry, and presented possible solutions to those challenges. This conference report highlights selected presentations on the industry challenges for big pharma companies, diversification as a solution to industry problems, overcoming challenges with collaborations and M&As, and the role of emerging markets in the pharma industry. Other subjects discussed included the expected impact of personalized medicine on the industry, the entry of big pharma into the generics market and the problems that are confronting the small pharma and biotech industry.

Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians' attitudes and prescribing habits: a systematic review.

Science.gov (United States)

Fickweiler, Freek; Fickweiler, Ward; Urbach, Ewout

2017-09-27

The objective of this review is to explore interactions between physicians and the pharmaceutical industry including sales representatives and their impact on physicians' attitude and prescribing habits. PubMed, Embase, Cochrane Library and Google scholar electronic databases were searched from 1992 to August 2016 using free-text words and medical subject headings relevant to the topic. Studies included cross-sectional studies, cohort studies, randomised trials and survey designs. Studies with narrative reviews, case reports, opinion polls and letters to the editor were excluded from data synthesis. Two reviewers independently extracted the data. Data on study design, study year, country, participant characteristics, setting and number of participants were collected. Pharmaceutical industry and pharmaceutical sales representative (PSR) interactions influence physicians' attitudes and their prescribing behaviour and increase the number of formulary addition requests for the company's drug. Physician-pharmaceutical industry and its sales representative's interactions and acceptance of gifts from the company's PSRs have been found to affect physicians' prescribing behaviour and are likely to contribute to irrational prescribing of the company's drug. Therefore, intervention in the form of policy implementation and education about the implications of these interactions is needed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Knowledge, attitudes, and practices toward malaria risk and prevention among frequent business travelers of a major oil and gas company.

Science.gov (United States)

Berg, Johannes; Breederveld, Daan; Roukens, Anna H; Hennink, Yvonne; Schouten, Marjolijn; Wendt, Judy K; Visser, Leo G

2011-01-01

Despite significant morbidity and mortality among business travelers due to malaria, very little has been published on knowledge, attitudes, and practices (KAP) toward malaria risk. The aim of this study was to assess KAP among frequent international business travelers (FBT) and to identify recommendations for improving malaria prevention that could be applied to the wider FBT community in occupational health. A retrospective web-based survey was conducted in 2005 among self-registered FBT of an oil and gas company based in the Netherlands. The survey was completed by 328 of the 608 self-registered FBT (54%). Fifty-four percent of respondents had visited a high-risk area for malaria. Most respondents (96%) were experienced travelers; the majority (71%) sought health advice before their trip and made use of a company health resource. Fever was recognized as a malaria symptom by all FBT; travel to high-risk malaria areas was correctly identified by 96%, and 99% of these travelers adhered to use of adequate personal protective measures. The proportion of travelers carrying appropriate anti-malaria drug regimen was positively associated with receiving company advice among FBT traveling to high-risk destinations (RR = 2.10, 95% CI: 1.21-3.67), but not for those traveling to low- or no-risk destinations. Only 8% (14) of those going to a high-risk area were not carrying malaria prophylaxis. One in five of FBT traveling to no-risk areas were unnecessarily carrying malaria prophylaxis. The majority of KAP results were excellent. We postulate that a company culture with a strong focus on health, safety, security, and environment can positively contribute to high KAP scores. Notwithstanding the excellent findings, this study also provides a cautionary tale for company health functions against overprescribing of malaria prophylaxis. It demonstrates the need for constant review and audit of adherence to quality criteria. © 2011 International Society of Travel Medicine.

Distribution of bacterial contamination in non-sterile pharmaceutical materials and assessment of its risk to the health of the final consumers quantitatively

Directory of Open Access Journals (Sweden)

Mostafa Essam Eissa

2016-09-01

Full Text Available Bacterial contamination control in pharmaceutical products is a critical aspect in the field of drug manufacturing industry due to the encountered risk to the patients' health and possibly their life. The application of commercial bacterial identification system is crucial to identify the type of contamination and its source to anticipate the impact of bioburden on the products and setting corrective and preventive actions. During the period of one year, random samples from raw materials and final products were tested according to United States Pharmacopeia, and those that showed suspect results for specified microorganisms and/or out-of-specification limits or showed out-of-trend results were subjected to further identification by using miniaturized biochemical identification system after performing Gram stain. From the total bacterial isolates of the investigated products, more than 60% were primarily belonging to Micrococcaceae 16.98% (empty hard gelatin capsules, Enterobacteriaceae 18.86% (vaginal cream applicator, plastic caps for bottles, Sorbitol solution, finished hard gelatin capsule product, topical cream and oral suspension and Bacillaceae 24.53% (Talc powder, liquid oral preparation and finished hard gelatin capsule product. Gram Positive and Negative samples were 56.60% and 41.51% respectively from the total investigated sample products and materials. Finished pharmaceutical products constituted 53.33% and 68.18% from Gram-positive and Gram-negative microorganisms respectively. An approach to quantitative risk assessment for pharmaceutical products was conducted on selected medicinal items and showed that Enterobacteriaceae followed by Burkholderiaceae contributed by more than 80% to the major hazard that could be delivered to patients through drugs. The applied risk can be used as a milestone for setting goals by pharmaceutical companies to improve the safety of medicinal products microbiologically and to identify the major sources

Launching of New Pharmaceutical Product and Promotional Challenges

OpenAIRE

Manish Gunjan; Jegathambigai Rameshwar Naidu; Ishab Kumar; Yogesh Kumar

2016-01-01

ABSTRACT Purpose: The purpose of the study was to find out the basic challenges and major aspects in launching of new pharmaceutical products, and the usual way to overcome with the concerned challenges. The second most important purpose was to find out the role of innovative and creative way in promotion of new pharmaceutical product and its impact on their market value. Methodology: I went through questionnaire based survey on 10 medical representatives and 10 doctors respectively to find o...

Major multinational food and beverage companies and informal sector contributions to global food consumption: implications for nutrition policy

OpenAIRE

Yach Derek; Alexander Eleanore; Mensah George A

2011-01-01

Abstract Background In recent years, 10 major multinational food and beverage companies have worked together within the International Food and Beverage Alliance (IFBA) to increase their commitments to public health. Current IFBA commitments include initiatives to improve the nutrition quality of products and how these products are advertised to children. The impact and magnitude of IFBA member contributions to the total market share of packaged foods and beverages consumed remain incompletely...

An Export-Marketing Model for Pharmaceutical Firms (The Case of Iran)

OpenAIRE

Mohammadzadeh, Mehdi; Aryanpour, Narges

2013-01-01

Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalizati...

The devil is in the details: the pharmaceutical industry's use of gifts to physicians as marketing strategy.

Science.gov (United States)

McFadden, David W; Calvario, Elizabeth; Graves, Cynthia

2007-06-01

Marketing costs exceed 30% of revenues for the pharmaceutical industry, with over 90% of the effort aimed at physicians. Although there are currently unprecedented numbers of regulatory activities focusing on relationships between the pharmaceutical industry and the medical profession, such legislation is often unrecognized or flouted. The potential influence, although minimized by both parties, must not be ignored. Physicians and drug companies will need to re-evaluate their responsibilities to their patients and their shareholders, and both groups should assume proactive and guidance roles in the transformation.

Medical Representatives' Intention to Use Information Technology in Pharmaceutical Marketing.

Science.gov (United States)

Kwak, Eun-Seon; Chang, Hyejung

2016-10-01

Electronic detailing (e-detailing), the use of electronic devices to facilitate sales presentations to physicians, has been adopted and expanded in the pharmaceutical industry. To maximize the potential outcome of e-detailing, it is important to understand medical representatives (MRs)' behavior and attitude to e-detailing. This study investigates how information technology devices such as laptop computers and tablet PCs are utilized in pharmaceutical marketing, and it analyzes the factors influencing MRs' intention to use devices. This study has adopted and modified the theory of Roger's diffusion of innovation model and the technology acceptance model. To test the model empirically, a questionnaire survey was conducted with 221 MRs who were working in three multinational or eleven domestic pharmaceutical companies in Korea. Overall, 28% and 35% of MRs experienced using laptop computers and tablet PCs in pharmaceutical marketing, respectively. However, the rates were different across different groups of MRs, categorized by age, education level, position, and career. The results showed that MRs' intention to use information technology devices was significantly influenced by perceived usefulness in general. Perceived ease of use, organizational and individual innovativeness, and several MR characteristics were also found to have significant impacts. This study provides timely information about e-detailing devices to marketing managers and policy makers in the pharmaceutical industry for successful marketing strategy development by understanding the needs of MRs' intention to use information technology. Further in-depth study should be conducted to understand obstacles and limitations and to improve the strategies for better marketing tools.

Eli Lilly and Company's bioethics framework for human biomedical research.

Science.gov (United States)

Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

2015-11-01

Current ethics and good clinical practice guidelines address various aspects of pharmaceutical research and development, but do not comprehensively address the bioethical responsibilities of sponsors. To fill this void, in 2010 Eli Lilly and Company developed and implemented a Bioethics Framework for Human Biomedical Research to guide ethical decisions. (See our companion article that describes how the framework was developed and implemented and provides a critique of its usefulness and limitations.) This paper presents the actual framework that serves as a company resource for employee education and bioethics deliberations. The framework consists of four basic ethical principles and 13 essential elements for ethical human biomedical research and resides within the context of our company's mission, vision and values. For each component of the framework, we provide a high-level overview followed by a detailed description with cross-references to relevant well regarded guidance documents. The principles and guidance described should be familiar to those acquainted with research ethics. Therefore the novelty of the framework lies not in the foundational concepts presented as much as the attempt to specify and compile a sponsor's bioethical responsibilities to multiple stakeholders into one resource. When such a framework is employed, it can serve as a bioethical foundation to inform decisions and actions throughout clinical planning, trial design, study implementation and closeout, as well as to inform company positions on bioethical issues. The framework is, therefore, a useful tool for translating ethical aspirations into action - to help ensure pharmaceutical human biomedical research is conducted in a manner that aligns with consensus ethics principles, as well as a sponsor's core values.

Comprehensive taxonomy and worldwide trends in pharmaceutical policies in relation to country income status.

Science.gov (United States)

Maniadakis, N; Kourlaba, G; Shen, J; Holtorf, A

2017-05-25

Rapidly evolving socioeconomic and technological trends make it challenging to improve access, effectiveness and efficiency in the use of pharmaceuticals. This paper identifies and systematically classifies the prevailing pharmaceutical policies worldwide in relation to a country's income status. A literature search was undertaken to identify and taxonomize prevailing policies worldwide. Countries that apply those policies and those that do not were then grouped by income status. Pharmaceutical policies are linked to a country's socioeconomics. Developed countries have universal coverage and control pharmaceuticals with external and internal price referencing systems, and indirect price-cost controls; they carry out health technology assessments and demand utilization controls. Price-volume and risk-sharing agreements are also evolving. Developing countries are underperforming in terms of coverage and they rely mostly on restrictive state controls to regulate prices and expenditure. There are significant disparities worldwide in the access to pharmaceuticals, their use, and the reimbursement of costs. The challenge in high-income countries is to maintain access to care whilst dealing with trends in technology and aging. Essential drugs should be available to all; however, many low- and middle-income countries still provide most of their population with only poor access to medicines. As economies grow, there should be greater investment in pharmaceutical care, looking to the policies of high-income countries to increase efficiency. Pharmaceutical companies could also develop special access schemes with low prices to facilitate coverage in low-income countries.

Pharmaceutical care education in Kuwait: pharmacy students’ perspectives

Directory of Open Access Journals (Sweden)

Katoue MG

2014-09-01

Full Text Available Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods: A descriptive, cross-sectional survey of pharmacy students (n=126 was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results: The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%, lack of pharmacist time (83.3%, organizational obstacles (82.6%, and pharmacists’ physical separation from patient care areas (82.6%. Conclusion: Pharmacy students’ attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University

Basic pharmaceutical technology

OpenAIRE

Angelovska, Bistra; Drakalska, Elena

2017-01-01

The lecture deals with basics of pharmaceutical technology as applied discipline of pharmaceutical science, whose main subject of study is formulation and manufacture of drugs. In a broad sense, pharmaceutical technology is science of formulation, preparation, stabilization and determination of the quality of medicines prepared in the pharmacy or in pharmaceutical industry

Negative environmental impacts of antibiotic-contaminated effluents from pharmaceutical industries.

Science.gov (United States)

Bielen, Ana; Šimatović, Ana; Kosić-Vukšić, Josipa; Senta, Ivan; Ahel, Marijan; Babić, Sanja; Jurina, Tamara; González Plaza, Juan José; Milaković, Milena; Udiković-Kolić, Nikolina

2017-12-01

Effluents from pharmaceutical industries are recognized as significant contributors to aquatic pollution with antibiotics. Although such pollution has been mostly reported in Asia, knowledge on industrial discharges in other regions of the world, including Europe, and on the effects associated with such exposures is still limited. Thus, we performed chemical, microbiological and ecotoxicological analyses of effluents from two Croatian pharmaceutical industries during four seasons. In treated effluents of the company synthesizing macrolide antibiotic azithromycin (AZI), the total concentration of AZI and two macrolide by-products from its synthesis was 1-3 orders of magnitude higher in winter and springtime (up to 10.5 mg/L) than during the other two seasons (up to 638 μg/L). Accordingly, the highest total concentrations (up to 30 μg/L) in the recipient river were measured in winter and spring. Effluents from second company formulating veterinary antibiotics contained fluoroquinolones, trimethoprim, sulfonamides and tetracyclines ranging from low μg/L to approx. 200 μg/L. Low concentrations of these antibiotics, from below the limit of quantification to approx. few μg/L, have also been measured in the recipient stream. High frequency of culturable bacteria resistant to AZI (up to 83%) or sulfamethazine (up to 90%) and oxytetracycline (up to 50%) were also found in studied effluents. Finally, we demonstrated that toxicity to algae and water fleas often exceeded the permitted values. Most highly contaminated effluents induced multiple abnormalities in zebrafish embryos. In conclusion, using a wide array of analyses we have demonstrated that discharges from pharmaceutical industries can pose a significant ecological and public health concern due to their toxicity to aquatic organisms and risks for promoting development and spread of antibiotic resistance. Copyright © 2017 Elsevier Ltd. All rights reserved.