WorldWideScience

Sample records for therapies product development

  1. Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

    Directory of Open Access Journals (Sweden)

    Janis eAncans

    2012-08-01

    Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

  2. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

    Science.gov (United States)

    Ancans, Janis

    2012-01-01

    Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

  3. [The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

    Science.gov (United States)

    Berger, A; Schüle, S; Flory, E

    2011-07-01

    Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

  4. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe

    Directory of Open Access Journals (Sweden)

    Andreas M. Farkas

    2017-05-01

    Full Text Available In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs. We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP, or gene therapy medicinal product (GTMP] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA and other Committees [Committee for Advanced Therapies (CAT and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%. ATMPs ODDs were primarily GTMPs (48.7% and SCTMPs (43.3%. TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP. Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three have received a marketing authorization (MAA and a 10-year market exclusivity. Strimvelis also completed their

  5. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.

    Science.gov (United States)

    Farkas, Andreas M; Mariz, Segundo; Stoyanova-Beninska, Violeta; Celis, Patrick; Vamvakas, Spiros; Larsson, Kristina; Sepodes, Bruno

    2017-01-01

    In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP), or gene therapy medicinal product (GTMP)] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA) and other Committees [Committee for Advanced Therapies (CAT) and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%). ATMPs ODDs were primarily GTMPs (48.7%) and SCTMPs (43.3%). TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD) ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP). Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three) have received a marketing authorization (MAA) and a 10-year market exclusivity. Strimvelis also completed their PIP

  6. Potency assay development for cellular therapy products: an ISCT review of the requirements and experiences in the industry.

    Science.gov (United States)

    Bravery, Christopher A; Carmen, Jessica; Fong, Timothy; Oprea, Wanda; Hoogendoorn, Karin H; Woda, Juliana; Burger, Scott R; Rowley, Jon A; Bonyhadi, Mark L; Van't Hof, Wouter

    2013-01-01

    The evaluation of potency plays a key role in defining the quality of cellular therapy products (CTPs). Potency can be defined as a quantitative measure of relevant biologic function based on the attributes that are linked to relevant biologic properties. To achieve an adequate assessment of CTP potency, appropriate in vitro or in vivo laboratory assays and properly controlled clinical data need to be created. The primary objective of a potency assay is to provide a mechanism by which the manufacturing process and the final product for batch release are scrutinized for quality, consistency and stability. A potency assay also provides the basis for comparability assessment after process changes, such as scale-up, site transfer and new starting materials (e.g., a new donor). Potency assays should be in place for early clinical development, and validated assays are required for pivotal clinical trials. Potency is based on the individual characteristics of each individual CTP, and the adequacy of potency assays will be evaluated on a case-by-case basis by regulatory agencies. We provide an overview of the expectations and challenges in development of potency assays specific for CTPs; several real-life experiences from the cellular therapy industry are presented as illustrations. The key observation and message is that aggressive early investment in a solid potency evaluation strategy can greatly enhance eventual CTP deployment because it can mitigate the risk of costly product failure in late-stage development. Copyright © 2013. Published by Elsevier Inc.

  7. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

    Science.gov (United States)

    Boráň, Tomáš; Menezes-Ferreira, Margarida; Reischl, Ilona; Celis, Patrick; Ferry, Nicolas; Gänsbacher, Bernd; Krafft, Hartmut; Lipucci di Paola, Michele; Sladowski, Dariusz; Salmikangas, Paula

    2017-09-01

    The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the European Union (EU) concerns the regulation on clinical trials (536/2014), which will come into force in 2018. With this new framework, a more harmonized and swift process for approval of clinical trials is anticipated, which is expected to support the entry of new innovations into the EU market. A survey on ATMPs in clinical trials during 2010-2015 in the EU was conducted in order to study the trends of ATMP development since the earlier survey published in 2012. According to the results, the number of clinical trials using ATMPs is slowly increasing in the EU. Yet, the focus is still in early development, and the projects are mainly carried out by small and medium-sized enterprises, academia, and hospitals. Oncology is the main area of clinical development. Yet, the balance between cell-based products and gene therapy medicinal products in this area may be changing in the future due to the new T-cell technologies. Many limitations and challenges are identified for ATMP development, requiring proportionate regulatory requirements. On the other hand, for such a novel field, the developers should be active in considering possible constraints and actively engage with authorities to look for solutions. This article provides up to-date information on forthcoming regulatory improvements and discusses the main challenges hampering the commercialization of ATMPs in the EU.

  8. Developing a dashboard for benchmarking the productivity of a medication therapy management program.

    Science.gov (United States)

    Umbreit, Audrey; Holm, Emily; Gander, Kelsey; Davis, Kelsie; Dittrich, Kristina; Jandl, Vanda; Odell, Laura; Sweeten, Perry

    To describe a method for internal benchmarking of medication therapy management (MTM) pharmacist activities. Multisite MTM pharmacist practices within an integrated health care system. MTM pharmacists are located within primary care clinics and provide medication management through collaborative practice. MTM pharmacist activity is grouped into 3 categories: direct patient care, nonvisit patient care, and professional activities. MTM pharmacist activities were tracked with the use of the computer-based application Pharmacist Ambulatory Resource Management System (PhARMS) over a 12-month period to measure growth during a time of expansion. A total of 81% of MTM pharmacist time was recorded. A total of 1655.1 hours (41%) was nonvisit patient care, 1185.2 hours (29%) was direct patient care, and 1190.4 hours (30%) was professional activities. The number of patient visits per month increased during the study period. There were 1496 direct patient care encounters documented. Of those, 1051 (70.2%) were face-to-face visits, 257 (17.2%) were by telephone, and 188 (12.6%) were chart reviews. Nonvisit patient care and professional activities also increased during the period. PhARMS reported MTM pharmacist activities and captured nonvisit patient care work not tracked elsewhere. Internal benchmarking data proved to be useful for justifying increases in MTM pharmacist personnel resources. Reviewing data helped to identify best practices from high-performing sites. Limitations include potential for self-reporting bias and lack of patient outcomes data. Implementing PhARMS facilitated internal benchmarking of patient care and nonpatient care activities in a regional MTM program. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  9. Development of local radiation therapy

    International Nuclear Information System (INIS)

    Lee, Seung Hoon; Lim, Sang Moo; Choi, Chang Woon; Chai, Jong Su; Kim, Eun Hee; Kim, Mi Sook; Yoo, Seong Yul; Cho, Chul Koo; Lee, Yong Sik; Lee, Hyun Moo

    1999-04-01

    The major limitations of radiation therapy for cancer are the low effectiveness of low LET and inevitable normal tissue damage. Boron Neutron Capture Therapy (BNCT) is a form of potent radiation therapy using Boron-10 having a high propensityof capturing theraml neutrons from nuclear reactor and reacting with a prompt nuclear reaction. Photodynamic therapy is a similiar treatment of modality to BNCT using tumor-seeking photosenistizer and LASER beam. If Boron-10 and photosensitizers are introduced selectively into tumor cells, it is theoretically possible to destroy the tumor and to spare the surrounding normal tissue. Therefore, BNCT and PDT will be new potent treatment modalities in the next century. In this project, we performed PDT in the patients with bladder cancers, oropharyngeal cancer, and skin cancers. Also we developed I-BPA, new porphyrin compounds, methods for estimation of radiobiological effect of neutron beam, and superficial animal brain tumor model. Furthermore, we prepared preclinical procedures for clinical application of BNCT, such as the macro- and microscopic dosimetry, obtaining thermal neutron flux from device used for fast neutron production in KCCH have been performed

  10. Development of local radiation therapy

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Seung Hoon; Lim, Sang Moo; Choi, Chang Woon; Chai, Jong Su; Kim, Eun Hee; Kim, Mi Sook; Yoo, Seong Yul; Cho, Chul Koo; Lee, Yong Sik; Lee, Hyun Moo

    1999-04-01

    The major limitations of radiation therapy for cancer are the low effectiveness of low LET and inevitable normal tissue damage. Boron Neutron Capture Therapy (BNCT) is a form of potent radiation therapy using Boron-10 having a high propensityof capturing theraml neutrons from nuclear reactor and reacting with a prompt nuclear reaction. Photodynamic therapy is a similiar treatment of modality to BNCT using tumor-seeking photosenistizer and LASER beam. If Boron-10 and photosensitizers are introduced selectively into tumor cells, it is theoretically possible to destroy the tumor and to spare the surrounding normal tissue. Therefore, BNCT and PDT will be new potent treatment modalities in the next century. In this project, we performed PDT in the patients with bladder cancers, oropharyngeal cancer, and skin cancers. Also we developed I-BPA, new porphyrin compounds, methods for estimation of radiobiological effect of neutron beam, and superficial animal brain tumor model. Furthermore, we prepared preclinical procedures for clinical application of BNCT, such as the macro- and microscopic dosimetry, obtaining thermal neutron flux from device used for fast neutron production in KCCH have been performed.

  11. Innovation in Product Development

    DEFF Research Database (Denmark)

    McAloone, Tim C.; Restrepo-Giraldo, John Dairo

    2005-01-01

    The course on Innovation in Product Development attempts to identify and understand the nature of innovation and product development and their important factors. The course takes both a theoretical and a practical approach and employs a mix of lectures, project work and group discussion. Format...... insight. Course content The following aspects of innovation in product development are considered: - Humans and products - Needs and products - Product life - Teams creating products - Products creating business - Product development models - Organising product development - Product development tools...... - The future of product development....

  12. A roadmap for cost-of-goods planning to guide economic production of cell therapy products.

    Science.gov (United States)

    Lipsitz, Yonatan Y; Milligan, William D; Fitzpatrick, Ian; Stalmeijer, Evelien; Farid, Suzanne S; Tan, Kah Yong; Smith, David; Perry, Robert; Carmen, Jessica; Chen, Allen; Mooney, Charles; Fink, John

    2017-12-01

    Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost-efficient therapeutic manufacturing. This roadmap guides the analysis of cost of goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. We present the specific COG considerations related to each of these elements as identified through a 2013 International Society for Cellular Therapy COG survey, highlighting the differences between autologous and allogeneic products. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long-term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  13. Developing Collaborative Product Development Capabilities

    DEFF Research Database (Denmark)

    Mahnke, Volker; Tran, Yen

    2012-01-01

    innovation strategies’. Our analyses suggest that developing such collaboration capabilities benefits from the search for complementary practices, the combination of learning styles, and the development of weak and strong ties. Results also underscore the crucial importance of co-evolution of multi......Collaborative product development capabilities support a company’s product innovation activities. In the context of the fast fashion sector, this paper examines the development of the product development capabilities (PDC) that align product development capabilities in a dual innovation context......, one, slow paced, where the firm is well established and the other, fast paced, which represents a new competitive arena in which the company competes. To understand the process associated with collaborative capability development, we studied three Scandinavian fashion companies pursuing ‘dual...

  14. Country report: Cuba. Local Production of 90Y And 188Re Radionuclides and Development of Radiopharmaceuticals for Therapy

    International Nuclear Information System (INIS)

    Xiques, Abmel; Hernández, Ignacio; Leyva, René; Pérez, Marylaine; Alonso, Luis Michel; Zamora, Minelys

    2010-01-01

    During the first period of this CRP we could test an efficient and reliable generator system based on ion-chromatography to obtain 90 Y from its parent radionuclide 90 Sr. This production scheme for 90 Y was outlined in the previous CRP related with the development of generator technologies. Quality parameters such as trace metals that can potentially interfere in the labeling of biomoléculas, 90 Y recovery, 90 Sr/ 90 Y ratio and radiation dose to bed matrix were evaluated. The results showed that high recovery and radionuclidic purity could be obtained for 90 Y during its repeated separation from the 90 Sr cow. No replacement or treatment of the cow were necessary and low waste generation and 90 Sr losses less that 0.1% after each run were also observed during the present study. A Fab’ fragment was enzimatically produced and purified from the monoclonal antibody h-R3 (Nimotuzumab®). The fragment and the parent antibody were successfully conjugated with DOTA and labeled with 90 Y. The radioinmunoconjugate thus obtained also exhibited a good 24 h in-vitro stability in an excess of DTPA. A 90 Y radiocoloid was prepared in a cromic phosphate particle for radiosynoviorthesis with promising results in animal models. Two alumina based 188 W/ 188 Re generators were prepared and their eluates were used in the labeling of hR3-DOTA conjugates. Quality control and in vivo evaluation in comparison with 99m Tc-hR3 showed very good results and similar pattern of distribution and pharmacokinetic and will be used in clinical trials for cancer patients. (author)

  15. Country report: Cuba. Local Production of {sup 90}Y And {sup 188}Re Radionuclides and Development of Radiopharmaceuticals for Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Xiques, Abmel; Hernández, Ignacio; Leyva, René; Pérez, Marylaine; Alonso, Luis Michel; Zamora, Minelys [Centro de Isotopos (CENTIS) (Cuba)

    2010-07-01

    During the first period of this CRP we could test an efficient and reliable generator system based on ion-chromatography to obtain {sup 90}Y from its parent radionuclide {sup 90}Sr. This production scheme for {sup 90}Y was outlined in the previous CRP related with the development of generator technologies. Quality parameters such as trace metals that can potentially interfere in the labeling of biomoléculas, {sup 90}Y recovery, {sup 90}Sr/{sup 90}Y ratio and radiation dose to bed matrix were evaluated. The results showed that high recovery and radionuclidic purity could be obtained for {sup 90}Y during its repeated separation from the {sup 90}Sr cow. No replacement or treatment of the cow were necessary and low waste generation and {sup 90}Sr losses less that 0.1% after each run were also observed during the present study. A Fab’ fragment was enzimatically produced and purified from the monoclonal antibody h-R3 (Nimotuzumab®). The fragment and the parent antibody were successfully conjugated with DOTA and labeled with {sup 90}Y. The radioinmunoconjugate thus obtained also exhibited a good 24 h in-vitro stability in an excess of DTPA. A {sup 90}Y radiocoloid was prepared in a cromic phosphate particle for radiosynoviorthesis with promising results in animal models. Two alumina based {sup 188}W/{sup 188}Re generators were prepared and their eluates were used in the labeling of hR3-DOTA conjugates. Quality control and in vivo evaluation in comparison with {sup 99m}Tc-hR3 showed very good results and similar pattern of distribution and pharmacokinetic and will be used in clinical trials for cancer patients. (author)

  16. Global product development

    DEFF Research Database (Denmark)

    Hansen, Zaza Nadja Lee; Ahmed-Kristensen, Saeema

    2011-01-01

    Globalisation has enabled companies to globalise their product development process. Today, everything from manufacturing to R&D can be globally distributed. This has led to a more complex and disintegrated product development process. This paper investigates the impacts companies have experienced...... operational solutions to counteract the negative impacts with varying degrees of success. This paper presents a unique look into global product development through an investigation of its impact on the organisation, the product development process, and the product. Furthermore, it shows the solutions...... as a result of this, and how they have been addressed. Data was collected through case studies of five Danish multinational corporations. The findings showed that the companies experienced several challenges when they globalised their product development process. They consequently implemented various...

  17. Accelerated product development

    NARCIS (Netherlands)

    Langerak, F.; Seth, J.N.; Malhotra, N.K.

    2011-01-01

    Accelerated product development is a competitive strategy that seeks to reduce the development cycle time of new products. However, there has been little theoretical advancement and empirical model testing in the identification of the conditions under which cycle time reduction is appropriate, the

  18. Global product development

    DEFF Research Database (Denmark)

    Taylor, Thomas Paul; Ahmed-Kristensen, Saeema

    2016-01-01

    Selecting key performance indicators in conventional product development is a challenging task for project management and is compound by global product development. Informed from the findings of two in depth case studies conducted with large Danish manufacturing companies, in this paper we develo...

  19. DESIGN VERSUS PRODUCT DEVELOPMENT?

    Directory of Open Access Journals (Sweden)

    Edu Grieco Mazzini Junior

    2015-03-01

    Full Text Available Design or product development? The questioning in relation to the employment of such terminology dates back to possible misconceptions regarding interpretation and approach them. Therefore, it can be stated that there are differences between these two terms? In this context, we highlight two views concerning the origin of the design. The first character creative and based on pre-industrial revolution, based on projective and methodologies directed towards the practice of designing products. And second, where design is understood as an industrial process: the development of new products includes, besides a creative procedure are developed, and symbolic formal solutions for products, but also a technical procedure based on the definition of the requirements concerning the product engineering. Is this the most widely accepted interpretation? theoretical studies were conducted from interpretations of the concept of the design proposed by the International Council of Societies of Industrial Design – ICSDI (2012, and for the characterization of the process of product development, we sought to develop an analogy between these two terminologies and can be proved that the use of one of terminology will not cause deviations of interpretation, since both deal with the life cycle of the product. The main results obtained until now the definition of design proposed by the ICSID where it is characterized as a creative activity focused on the complete life cycle of products is the more approaches of the concept of product development.

  20. Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

    Science.gov (United States)

    Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

    2015-01-01

    Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

  1. Transdisciplinary product development

    Directory of Open Access Journals (Sweden)

    Tomaž Savšek

    2015-12-01

    Full Text Available Research Question (RQ: How can transdisciplinary approach increase the product development process in future industry? Purpose: The aim of the research is to develop a model of an effective product development in the automotive industry based on the transdisciplinary approach. Method: We used a qualitative research approach in order to develop a theoretical framework of transdisciplinarity. The framework comprises the concurrent engineering and experts from different disciplines. The framework was represented by a mathematical model which based on stochastic dynamic programming. Results: We developed a theoretical frameworkand a practical case of transdisciplinary product development in the automotive industry. We presented a mathematical model and information environment which supports such a model. Organization: The findings of the research will provide higher productivity, lower operating costs, change in personnel structure, higher added value, lower sales costs, lower administration costs, reduction in growth of expenses, and lower costs of work equipment. Society: The research impact on higher customer’s satisfaction, increased flexibility of operations, better quality of information, improved control of sources, less waste materials and less pollution, improved planning process, more favourable consideration of employees , improved portfolio management, and better corporate presentation of company. Originality: Transdisciplinary framework combines methods of concurrent engineering and interdisciplinary approach in a process of product development. The development of such a framework is a complete novelty and represents an original approach to product development, which will be particularly suitable for the smart factories of the future. Transdisciplinary framework was transformed in to a mathematical model based on stochastic dynamic programming. Model is supported by the existing information warehouse and represents a potential for

  2. Regulatory Oversight of Cell and Gene Therapy Products in Canada.

    Science.gov (United States)

    Ridgway, Anthony; Agbanyo, Francisca; Wang, Jian; Rosu-Myles, Michael

    2015-01-01

    Health Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene therapy products (CGTPs) presents many challenges beyond those for protein biologics. Cells cannot be subjected to pathogen removal or inactivation procedures and must frequently be administered shortly after final formulation. Viral vector design and manufacturing control are critically important to overall product quality and linked to safety and efficacy in patients through concerns such as replication competence, vector integration, and vector shedding. In addition, for many CGTPs, the value of nonclinical studies is largely limited to providing proof of concept, and the first meaningful data relating to appropriate dosing, safety parameters, and validity of surrogate or true determinants of efficacy must come from carefully designed clinical trials in patients. Addressing these numerous challenges requires application of various risk mitigation strategies and meeting regulatory expectations specifically adapted to the product types. Regulatory cooperation and harmonisation at an international level are essential for progress in the development and commercialisation of these products. However, particularly in the area of cell therapy, new regulatory paradigms may be needed to harness the benefits of clinical progress in situations where the resources and motivation to pursue a typical drug product approval pathway may be lacking.

  3. European regulatory tools for advanced therapy medicinal products.

    Science.gov (United States)

    Flory, Egbert; Reinhardt, Jens

    2013-12-01

    Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

  4. A Framework For Product Development

    DEFF Research Database (Denmark)

    McAloone, Timothy Charles; Robotham, Antony John

    1999-01-01

    -aspect approach to product development; understanding the strategic conditions that affect product development; developing a coherent approach to product quality based on product-life thinking; addressing environmental needs in a proactive manner through innovation techniques; and understanding both...

  5. Development of Production Systems

    DEFF Research Database (Denmark)

    Christiansen, Thomas Bøhm

    1997-01-01

    This paper presents the initial considerations related to a Ph.D. study initiated at IPV, DTU in February 1997, concerning the research subject "Development of Production Systems". The content and aim of this paper is to 1) to introduce the study by......This paper presents the initial considerations related to a Ph.D. study initiated at IPV, DTU in February 1997, concerning the research subject "Development of Production Systems". The content and aim of this paper is to 1) to introduce the study by...

  6. Product development leadership

    DEFF Research Database (Denmark)

    Lindgren, Peter

    2006-01-01

    Peter Lindgren introducerer i sin artikel begrebet ”Product Development Leadership”, som sætter fokus på produktudviklingens strategiske og markedsmæssige rolle. Begrebet omfatter bl.a. virksomhedens evne til at generere eller indfange ideer og udvikle disse via eksisterende eller nye måder...

  7. Advanced therapy medicinal products: current and future perspectives.

    Science.gov (United States)

    Hanna, Eve; Rémuzat, Cécile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health benefits, but also to substantially impact the pharmaceuticals budget. The aim of this study was to characterise the ATMPs in development and discuss future implications in terms of market access. Clinical trials were searched in the following databases: EudraCT (EU Drug Regulating Authorities Clinical Trials), ClinicalTrials.gov, and ICTRP (International Clinical Trials Registry Platform of the World Health Organization). Trials were classified by category of ATMP as defined by European regulation EC No. 1394/2007, as well as by development phase and disease area. The database search identified 939 clinical trials investigating ATMPs (85% ongoing, 15% completed). The majority of trials were in the early stages (Phase I, I/II: 64.3%, Phase II, II/III: 27.9%, Phase 3: 6.9%). Per category of ATMP, we identified 53.6% of trials for somatic cell therapies, 22.8% for tissue-engineered products, 22.4% for gene therapies, and 1.2% for combined products (incorporating a medical device). Disease areas included cancer (24.8%), cardiovascular diseases (19.4%), musculoskeletal (10.5%), immune system and inflammation (11.5%), neurology (9.1%), and others. Of the trials, 47.2% enrolled fewer than 25 patients. Due to the complexity and specificity of ATMPs, new clinical trial methodologies are being considered (e.g., small sample size, non-randomised trials, single-arm trials, surrogate endpoints, integrated protocols, and adaptive designs). Evidence generation post-launch will become unavoidable to address payers' expectations. ATMPs represent a fast-growing field of interest. Although most of the products are in an early development phase, the combined trial phase and the potential to cure severe chronic conditions suggest that ATMPs may reach the market earlier than

  8. Leadership for product development

    DEFF Research Database (Denmark)

    Martensen, Anne; Dahlgaard, Jens Jørn

    1998-01-01

    by nonrecurring processes. Therefore, the general model requires an amplification and adjustment specific to this area. It will be discussed how the model can be suplemented with references to criterion parts and areas to address, especially relevant for a self-assessment of leadership in innovation. What should...... the criterion "leadership" comprise when the focus is on R and D? Eight new criterion parts will be discussed. It is believed, that the recommended approach will improve leadership for product development. Udgivelsesdato: JUL...

  9. THERAPY DEVELOPMENTS IN SOUTHERN AFRICA

    African Journals Online (AJOL)

    the potential benefits of structured treatment interruptions. Second, extensive .... suppression can facilitate restoration of CD4+ T-cell prolif- erative responses to recall ..... women after initiation of protease inhibitor therapy. In: 12th World.

  10. Consumer oriented new product development

    DEFF Research Database (Denmark)

    van Trijp, Hans C.M.; Grunert, Klaus G

    2014-01-01

    New product development is a necessary activity for a company’s competitiveness, profitability and growth. However, new product development is a risky activity as a large percentage of new product introductions fail to achieve their commercial targets. The present chapter reviews the existing evi...... evidence on new product success and failure factors. From that it introduces the perspective of consumer-oriented new product development as a way to balance new technological opportunity against identified consumer needs and desires....

  11. Gestalt Therapy: Development, Theory, and Techniques.

    Science.gov (United States)

    Witchel, Robert

    This paper presents a full review of the literature in the area of Gestalt Therapy and could be helpful in familiarizing people with this discipline. The roots contributing to the development of Gestalt therapy as presently practiced are explored briefly. Gestalt theory is presented in a developmental way, initially exploring the relationship…

  12. Cell Therapy and Tissue Engineering Products for Chondral Knee Injuries

    Directory of Open Access Journals (Sweden)

    Adriana Flórez Cabrera

    2017-07-01

    Full Text Available The articular cartilage is prone to suffer lesions of different etiology, being the articular cartilage lesions of the knee the most common. Although most conventional treatments reduce symptoms they lead to the production of fibrocartilage, which has different characteristics than the hyaline cartilage of the joint. There are few therapeutic approaches that promote the replacement of damaged tissue by functional hyaline cartilage. Among them are the so-called advanced therapies, which use cells and tissue engineering products to promote cartilage regeneration. Most of them are based on scaffolds made of different biomaterials, which seeded or not with endogenous or exogenous cells, can be used as cartilage artificial replacement to improve joint function. This paper reviews some therapeutic approaches focused on the regeneration of articular cartilage of the knee and the biomaterials used to develop scaffolds for cell therapy and tissue engineering of cartilage.

  13. Barriers towards integrated product development

    DEFF Research Database (Denmark)

    Sommer, Anita Friis; Dukovska-Popovska, Iskra; Steger-Jensen, Kenn

    2014-01-01

    The basis for product development in many large industrial companies is a traditional project management method positing non-overlapping phases, independent activities, and a dedicated project team. Research findings indicate that integrated product development methods increase performance compared...

  14. Market-based product development

    DEFF Research Database (Denmark)

    Bisp, Søren; Harmsen, Hanne

    1997-01-01

    A large body of research results on successful product development exists. The results are full of normative advice on how to conduct prod-uct development. At the same time studies have shown that product development practice has only to a very li extent been influenced by these research results...

  15. Micro Products - Product Development and Design

    DEFF Research Database (Denmark)

    Hansen, Hans Nørgaard

    2003-01-01

    Innovation within the field of micro and nano technology is to a great extent characterized by cross-disciplinary skills. The traditional disciplines like e.g. physics, biology, medicine and engineering are united in a common development process that can only take place in the presence of multi......-disciplinary competences. One example is sensors for chemical analysis of fluids, where chemistry, biology and flow mechanics all influence the design of the product and thereby the industrial fabrication of the product [1]. On the technological side the development has moved very fast, primarily driven by the need...... of the electronics industry to create still smaller chips with still larger capacity. Therefore the manufacturing technologies connected with micro/nano products in silicon are relatively highly developed compared to the technologies used for manufacturing micro products in metals, polymers and ceramics. For all...

  16. PRODUCTIVITY CHARACTERISTICS AND DEVELOPMENT ...

    African Journals Online (AJOL)

    ACSS

    2016-02-23

    Feb 23, 2016 ... The pulp and kernels of the fruit are the only by-products marketed by women and mainly girls who .... characteristics of trees and fruit involved, 30 adult hermaphrodite ..... Ethnobotanical research and traditional health care in.

  17. Mapping {sup 15}O Production Rate for Proton Therapy Verification

    Energy Technology Data Exchange (ETDEWEB)

    Grogg, Kira; Alpert, Nathaniel M.; Zhu, Xuping [Center for Advanced Radiological Sciences, Nuclear Medicine and Molecular Imaging, Radiology Department, Massachusetts General Hospital, Boston, Massachusetts (United States); Min, Chul Hee [Department of Radiological Science, College of Health Science, Yonsei University, Wonju, Kangwon (Korea, Republic of); Testa, Mauro; Winey, Brian [Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); Normandin, Marc D. [Center for Advanced Radiological Sciences, Nuclear Medicine and Molecular Imaging, Radiology Department, Massachusetts General Hospital, Boston, Massachusetts (United States); Shih, Helen A.; Paganetti, Harald; Bortfeld, Thomas [Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); El Fakhri, Georges, E-mail: elfakhri@pet.mgh.harvard.edu [Center for Advanced Radiological Sciences, Nuclear Medicine and Molecular Imaging, Radiology Department, Massachusetts General Hospital, Boston, Massachusetts (United States)

    2015-06-01

    Purpose: This work was a proof-of-principle study for the evaluation of oxygen-15 ({sup 15}O) production as an imaging target through the use of positron emission tomography (PET), to improve verification of proton treatment plans and to study the effects of perfusion. Methods and Materials: Dynamic PET measurements of irradiation-produced isotopes were made for a phantom and rabbit thigh muscles. The rabbit muscle was irradiated and imaged under both live and dead conditions. A differential equation was fitted to phantom and in vivo data, yielding estimates of {sup 15}O production and clearance rates, which were compared to live versus dead rates for the rabbit and to Monte Carlo predictions. Results: PET clearance rates agreed with decay constants of the dominant radionuclide species in 3 different phantom materials. In 2 oxygen-rich materials, the ratio of {sup 15}O production rates agreed with the expected ratio. In the dead rabbit thighs, the dynamic PET concentration histories were accurately described using {sup 15}O decay constant, whereas the live thigh activity decayed faster. Most importantly, the {sup 15}O production rates agreed within 2% (P>.5) between conditions. Conclusions: We developed a new method for quantitative measurement of {sup 15}O production and clearance rates in the period immediately following proton therapy. Measurements in the phantom and rabbits were well described in terms of {sup 15}O production and clearance rates, plus a correction for other isotopes. These proof-of-principle results support the feasibility of detailed verification of proton therapy treatment delivery. In addition, {sup 15}O clearance rates may be useful in monitoring permeability changes due to therapy.

  18. Consumer oriented new product development

    DEFF Research Database (Denmark)

    van Trijp, Hans C.M.; Grunert, Klaus G

    2014-01-01

    New product development is a necessary activity for a company’s competitiveness, profitability and growth. However, new product development is a risky activity as a large percentage of new product introductions fail to achieve their commercial targets. The present chapter reviews the existing...

  19. Platform-based production development

    DEFF Research Database (Denmark)

    Bossen, Jacob; Brunoe, Thomas Ditlev; Nielsen, Kjeld

    2015-01-01

    Platforms as a means for applying modular thinking in product development is relatively well studied, but platforms in the production system has until now not been given much attention. With the emerging concept of platform-based co-development the importance of production platforms is though...

  20. Horticulture Therapy Curriculum Development. Final Report.

    Science.gov (United States)

    Taylor, Sally; And Others

    This final report includes two major components: a narrative describing a project at Edmonds Community College, Washington, to develop a horticultural therapy curriculum and descriptions of six courses developed or revised during the project. The narrative reports the development of a supplementary interdisciplinary certification program to train…

  1. Developing Green Line Products

    DEFF Research Database (Denmark)

    Muñoz-Marin, Ana Maria; Lassen, Astrid Heidemann; Poulsen, Søren Bolvig

    2011-01-01

    This publication is based on the Master thesis “User-driven ecoinnovation process: Towards the implementation of the Green product line at JELD-WEN” written by Ana Maria Muñoz-Marin as her Graduation Project for the MSc. Global Innovation Management degree. The company-based experiment was carried...

  2. Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials.

    Science.gov (United States)

    Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. No failure risk rate per development phase is available for ATMPs. The discontinuation rate may prove helpful when assessing the

  3. Occupational therapy, professional development and ethics

    DEFF Research Database (Denmark)

    Dige, Morten

    2009-01-01

    The article's aim is to reflect on and contribute to developing occupational therapy as a profession. I propose an ethical interpretation of health and helping professions in general and occupational therapy in particular. According to this ethical interpretation, the essential function and mission...... principles and guidelines; it contributes to building up and preserving a shared professional identity; it puts emphasis on a client-centred perspective on professional work; and it provides a constructive framework for inter-professional co-operation....

  4. Production of 177Lu for targeted radionuclide therapy: Available options

    International Nuclear Information System (INIS)

    Dah, Ashutosh; Pillai, Maroor Raghavan Ambikalmajan; Knapp, Furn F. Jr.

    2015-01-01

    This review provides a comprehensive summary of the production of 177 Lu to meet expected future research and clinical demands. Availability of options represents the cornerstone for sustainable growth for the routine production of adequate activity levels of 177 Lu having the required quality for preparation of a variety of 177 Lu-labeled radiopharmaceuticals. The tremendous prospects associated with production of 177 Lu for use in targeted radionuclide therapy (TRT) dictate that a holistic consideration should evaluate all governing factors that determine its success. While both “direct” and “indirect” reactor production routes offer the possibility for sustainable 177 Lu availability, there are several issues and challenges that must be considered to realize the full potential of these production strategies. This article presents a mini review on the latest developments, current status, key challenges and possibilities for the near future. A broad understanding and discussion of the issues associated with 177 Lu production and processing approaches would not only ensure sustained growth and future expansion for the availability and use of 177 Lu-labeled radiopharmaceuticals, but also help future developments

  5. Environmental tools in product development

    DEFF Research Database (Denmark)

    Wenzel, Henrik; Hauschild, Michael Zwicky; Jørgensen, Jørgen

    1994-01-01

    A precondition for design of environmentally friendly products is that the design team has access to methods and tools supporting the introduction of environmental criteria in product development. A large Danish program, EDIP, is being carried out by the Institute for Product Development, Technical...... University of Denmark, in cooperation with 5 major Danish companies aiming at the development and testing of such tools. These tools are presented in this paper...

  6. Productivity tips for developers

    CERN Multimedia

    CERN. Geneva

    2018-01-01

    I like to read about productivity tools and techniques, but the problem is - most of them are completely overrated, the tips are not that useful or they are too difficult to implement. But, sometimes I can find some stuff that really makes me think "damn, how could I live without this before?!". Today, I would like to share some of them and hopefully hear about the tips and tricks that you use. Maybe we can find a way to share them somehow (github repo/forum)?

  7. Development of iPS (induced pluripotent stem cells) using natural product from extract of fish oocyte to provide stem cell for regenerative therapy

    Science.gov (United States)

    Meilany, Sofy; Firdausiyah, Qonitha S.; Naroeni, Aroem

    2017-02-01

    In this study, we developed a method to induce pluripotency of adult cells (fibroblast) into stem cells using a natural product, extract of fish oocyte, by comparing the extract concentration, 1 mg/ml and 2 mg/ml. The analyses were done by measuring the Nanog gene expression in cells using qPCR and detecting fibroblast marker anti H2-KK. The results revealed existence of a colony of stem cells in the cell that was induced with 2mg/ml concentration of oocytes. Nanoggene expression was analyzed by qPCR and the results showed expression of Nanog gene compared to the control. Analysis of result of fibroblast using Tali Cytometer and anti H2KK antibody showed loss of expression of Anti H2KK meaning there was transformation from fibroblast type cell to pluripotent cell type.

  8. Recent Developments in Hadron Therapy Accelerators

    CERN Document Server

    Klein, Hans-Udo

    2005-01-01

    In the last decade interest and investments in Hadron Therapy Systems have been steadily increasing resulting in a substantial number of projects currently under construction or entering detailed planning stage. Main routes are pure proton therapy systems and Carbon ion therapy systems which can also run on protons. While the basic accelerator concept for hadron therapy systems is well established there are many considerations on the type and layout of the particle delivery system including the accelerator, an energy selection system, either a fixed beam set up or a rotating gantry, the "nozzle" containing either a scattering or a scanning system, the patient positioner, and all associated control systems. The requirements for the accelerator include most stable beams to match the demand of modern fast scanning systems as well as fast switching between treatment rooms. Currently an ion/proton synchrotron, a pure proton synchrotron, a normalconducting proton cyclotron and a newly developed compact superconduct...

  9. Green development within Product families

    DEFF Research Database (Denmark)

    Lenau, Torben Anker; Willum, Ole; Frees, Niels

    2000-01-01

    occur, and uncover where the improvement potentials are in the product. The environmental knowledge obtained in this context will be valid for a number of years, and both the producer and other interested parties can use this information for setting priorities in their future planning. However, it can...... be very time consuming to perform an environmental Life Cycle Assessment (LCA), and it would be an advantage if a number of similar products - product families - could be handled in one and the same LCA as a whole. The project has presently developed a method for selecting and forming product families......From 1991 to 1996 the EDIP-methodology (Environmental Design of Industrial Products) was developed. One experience from the EDIP-project is that environmental assessment of products must give simple and operational conclusions, which can be acknowledged in the product development and by other...

  10. A framework for promoting scholarship productivity in occupational therapy curricula.

    Science.gov (United States)

    Scott, P J; Justiss, M J; Schmid, A A; Fisher, T F

    2013-01-01

    This paper describes a curricular model to support the production of quality research and development of occupational therapy professional students, prepared to become leaders in the production and utilization of evidence for practice. This model is designed for programs with faculty challenged by the dual mandate of program excellence and expectations for scholarly productivity needed for tenure and promotion: typically programs at research universities. The essence of the model is the paralleling of research and competencies for clinical practice where faculty and students participate as a community of scholars. It is based on the literature that addresses the tensions between achieving excellence in research and scholarly productivity, and excellence in teaching. The experience of one university with this model over a five-year period of time is shared with the student-faculty productivity outcomes. These outcomes include dissemination of 55 collaborative peer reviewed products and faculty has generated support for 25 paid graduate assistantships. The combination of student outcomes and faculty support for their research has strengthened the ability of the faculty to excel in meeting the University mandate of scholarship while providing a high quality professional educational program.

  11. Developing evaluation scales for horticultural therapy.

    Science.gov (United States)

    Im, Eun-Ae; Park, Sin-Ae; Son, Ki-Cheol

    2018-04-01

    This study developed evaluation scales for measuring the effects of horticultural therapy in practical settings. Qualitative and quantitative research, including three preliminary studies and a main study, were conducted. In the first study, a total of 779 horticultural therapists answered an open-end questionnaire based on 58 items about elements of occupational therapy and seven factors about singularity of horticultural therapy. In the second study, 20 horticultural therapists participated in in-depth interviews. In the third study, a Delphi method was conducted with 24 horticultural therapists to build a model of assessment indexes and ensure the validity. In the final study, the reserve scales were tested by 121 horticultural therapists in their practical settings for 1045 clients, to verify their reliability and validity. Preliminary questions in the effects area of horticultural therapy were developed in the first study, and validity for the components in the second study. In the third study, an expert Delphi survey was conducted as part of content validity verification of the preliminary tool of horticultural therapy for physical, cognitive, psychological-emotional, and social areas. In the final study, the evaluation tool, which verified the construct, convergence, discriminant, and predictive validity and reliability test, was used to finalise the evaluation tool. The effects of horticultural therapy were classified as four different aspects, namely, physical, cognitive, psycho-emotional, and social, based on previous studies on the effects of horticultural therapy. 98 questions in the four aspects were selected as reserve scales. The reliability of each scale was calculated as 0.982 in physical, 0.980 in cognitive, 0.965 in psycho-emotional, and 0.972 in social aspects based on the Cronbach's test of intra-item internal consistency and half reliability of Spearman-Brown. This study was the first to demonstrate validity and reliability by simultaneously

  12. Customer-driven Product Development

    DEFF Research Database (Denmark)

    Sommer, Anita Friis

    2011-01-01

    look for new ways to gain competitive advantage. In competitive markets there is a tendency of shorter product life cycles, and thus a competitive factor is to keep at pace with the market or even driving the market by developing new products. This research study seeks to investigate Customer......Demand chain management is a research area of increasing attention. It is the undertaking of reacting to customer requirements through a responsive chain going from customers through a focal company towards raw material distributors. With faster growing markets and increasing competition, companies......-driven Product Development (CDPD) from a demand chain management perspective. CDPD is the counterpart to typical research and development processes, which has no direct customer involvement. The proposition is that letting customers initiate and participate in the product development process...

  13. Integrating Product and Technology Development

    DEFF Research Database (Denmark)

    Meijer, Ellen Brilhuis; Pigosso, Daniela Cristina Antelmi; McAloone, Tim C.

    2016-01-01

    .g. managing dependencies) and opportunities (e.g. streamlining development). This paper presents five existing reference models for technology development (TD), which were identified via a systematic literature review, where their possible integration with product development (PD) reference models......Although dual innovation projects, defined in this article as the concurrent development of products and technologies, often occur in industry, these are only scarcely supported methodologically. Limited research has been done about dual innovation projects and their inherent challenges (e...... was investigated. Based on the specific characteristics desired for dual innovation projects, such as integrated product development and coverage of multiple development stages, a set of selection criteria was employed to select suitable PD and TD reference models. The integration and adaptation of the selected...

  14. Development of pharmaceuticals with radioactive rhenium for cancer therapy. Production of {sup 186}Re and {sup 188}Re, synthesis of labeled compounds and their biodistributions

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-03-01

    Production of the radioactive rhenium isotopes {sup 186}Re and {sup 188}Re, and synthesis of their labeled compounds have been studied together with the biodistributions of the compounds. This work was carried out by the Working Group on Radioactive Rhenium, consisting of researchers of JAERI and some universities, in the Subcommittee for Production and Radiolabeling under the Consultative Committee of Research on Radioisotopes. For {sup 186}Re, production methods by the {sup 185}Re(n,{gamma}){sup 186}Re reaction in a reactor and by the {sup 186}W(p,n){sup 186}Re reaction with an accelerator, which can produce nocarrier-added {sup 186}Re, have been established. For {sup 188}Re, a production method by the double neutron capture reaction of {sup 186}W, which produces a {sup 188}W/{sup 188}Re generator, has been established. For labeling of bisphosphonate, DMSA, DTPA, DADS, aminomethylenephosphonate and some monoclonal antibodies with the radioactive rhenium isotopes, the optimum conditions, including pH, the amounts of reagents and so on, have been determined for each compound. The biodistributions of each of the labeled compounds in mice have been also obtained. (author)

  15. Regulatory structures for gene therapy medicinal products in the European Union.

    Science.gov (United States)

    Klug, Bettina; Celis, Patrick; Carr, Melanie; Reinhardt, Jens

    2012-01-01

    Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. The majority of gene or cell therapy product development is carried out by academia, hospitals, and small- and medium-sized enterprises (SMEs). Thus, acknowledging the particular needs of these types of sponsors, the legislation also provides incentives for product development tailored to them. The European Medicines Agency (EMA) and, in particular, its Committee for Advanced Therapies (CAT) provide a variety of opportunities for early interaction with developers of ATMPs to enable them to have early regulatory and scientific input. An important tool to promote innovation and the development of new medicinal products by micro-, small-, and medium-sized enterprises is the EMA's SME initiative launched in December 2005 to offer financial and administrative assistance to smaller companies. The European legislation also foresees the involvement of stakeholders, such as patient organizations, in the development of new medicines. Considering that gene therapy medicinal products are developed in many cases for treatment of rare diseases often of monogenic origin, the involvement of patient organizations, which focus on rare diseases and genetic and congenital disorders, is fruitful. Two such organizations are represented in the CAT. Research networks play another important role in the development of gene therapy medicinal products. The European Commission is funding such networks through the EU Sixth Framework Program. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. Production of alpha emitters for therapy

    International Nuclear Information System (INIS)

    Vucina, J.; Orlic, M.; Lukic, D.

    2006-01-01

    The basis for the introduction of alpha emitters into nuclear medical practice are their radiobiological properties. High LET values and short ranges in biological tissues are advantageous in comparison with nowadays most often used beta emitters, primarily 90 Y and 131 I. Given are the most important criteria for the introduction of a given radionuclide in the routine use. Shown are the procedures for the production of the most important alpha emitters 211 At, 212 Bi and 213 Bi. (author)

  17. Development of radiolabelled compound using reactor producted RI - Evaluation of Ho-166 endovascular therapy to prevent restenosis after PTCA or stenting for occlusive coronary artery disease

    Energy Technology Data Exchange (ETDEWEB)

    Park, Chan Hee; Choi, Byung Il; Kim, Han Soo [Ajou University, Suwon (Korea)

    2000-04-01

    Occlusive coronary artery disease is managed successfully by percutaneous transfemoral coronary angioplasty (PTCA) or stenting with 95% success rate. However, restenosis after PTCA is not uncommon and the reported incidence of reocclusion is about 30 {approx} 40%. Therefore, the objective of the research was to develop endovascular brachytherapy using liquid form of Ho-166 in order to inhibit neointimal hyperplasia responsible for restenosis following PTCA or stenting. Our research was carried out in 3 stages: First stage - The effectiveness of radiation was confirmed by using animal model. Following over-sized balloon injury to rat carotid artery and porcine coronary artery, various external radiation doses were delivered. Second stage - For radiation dose distribution within the coronary artery and its surrounding tissues, Gafchromic film was used. In vitro dose distribution of Ho-166 utilizing water phantom and Gafchromic film was measured. Third stage - None uniform dose distribution from Ho-166 within the balloon caused by small air bubbles was eliminated by negative suction method. More accurate dose distribution was also possible using newly developed micrometer by our physicist. Limited number of human trial was performed without adverse effect. 40 refs. (Author)

  18. Innovating the Product Development Organisation

    DEFF Research Database (Denmark)

    Andreasen, Mogens Myrup; Hein, Lars

    1997-01-01

    The organisational innovation of the product development function is a doubtful affair since we can hardly describe why a specific organisation works. In this article two comprehensive innovation campaigns in Danish industry are described with reference to the nature, content and results...... of innovative processes and as the crux an attempt to explain principal elements in the changes of attitudes and behaviour in companies....

  19. Scientific Production about the Adherence to Antiretroviral Therapy

    Directory of Open Access Journals (Sweden)

    Regina Célia De Oliveira

    2017-09-01

    Full Text Available Objective: To identify the elite of authors about the subject adherence to antiretroviral therapy; to identify the journals turned to publishing articles about adherence to antiretroviral therapy; and to identify and analyze the most commonly used words in abstracts of articles about adherence to antiretroviral therapy. Method: A bibliometric study conducted through the Scopus base. We used articles published between 1996 and 2014, after application of the eligibility criteria, there were composed the sample with 24 articles. The data were analyzed descriptively. Were used the laws of bibliometric (Lotka, Bradford and Zipf and the conceptual cloud map of words, through the program Cmap tools. Results: Lotka's Law identified the 5 authors more productive (46% of the total published. Bradford is impaired in this study. Concerning Zipf, 3 zones were determined, 31.47% of the words with in the first zone, 26.46% in the second and 42.06% in the third. In the conceptual map, the words/factors that positively and negatively influence adherence were emphasized, among them the need for more research in the health services. Conclusion: There are few publications about the accession to antiretroviral therapy, and the scientific production is in the process of maturation. One can infer that the theme researched is not yet an obsolete topic. It should be noted that the Bibliometric was a relevant statistic tool to generate information about the publications about the antiretroviral therapy. Descriptors: Antiretroviral Therapy, Highly Active; Medication Adherence; Bibliometric; HIV; Acquired Immunodeficiency Syndrome

  20. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

    Science.gov (United States)

    Sato, Yoji

    2014-01-01

    In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.

  1. Development of cancer therapy facility of HANARO

    Energy Technology Data Exchange (ETDEWEB)

    Jun, Byung Jin; Hwang, S. Y.; Kim, M. J. and others

    2000-04-01

    Facilities of the research and clinical treatments of neutron capture therapy using HANARO are developed, and they are ready to install. They are BNCT irradiation facility and prompt gamma neutron activatiion analysis facility. Since every horizontal neutron facility of HANARO is long and narrow tangential beam tube, it is analysed that sufficient epithermal neutrons for the BNCT cannot be obtained but sufficient thermal neutrons can be obtained by a filter composed of silicon and bismuth single crystals. Since the thermal neutron penetaration increases significantly when the crystals are cooled, a filter cooled by liquid nitrogen is developed. So as to avoid interference with the reactor operation, a water shutter is developed. The irradiation room is designed for the temporary surgical operation as well. Handling tools to remove activated beam port plug and to install water shutter and filter are developed. The basic structure of the irradiation room is already installed and most of other parts are ready to install. Since no free beam port is available for the prompt gamma neutron activation analysis, a method obtaining almost pure thermal neutrons by the vertical diffraction of extra beam for the polarized neutron spectrometer is developed. This method is confirmed by analysis and experiments to give high enough neutron beam. Equipment and devices are provided to install this facility.

  2. Development of cancer therapy facility of HANARO

    International Nuclear Information System (INIS)

    Jun, Byung Jin; Hwang, S. Y.; Kim, M. J. and others

    2000-04-01

    Facilities of the research and clinical treatments of neutron capture therapy using HANARO are developed, and they are ready to install. They are BNCT irradiation facility and prompt gamma neutron activatiion analysis facility. Since every horizontal neutron facility of HANARO is long and narrow tangential beam tube, it is analysed that sufficient epithermal neutrons for the BNCT cannot be obtained but sufficient thermal neutrons can be obtained by a filter composed of silicon and bismuth single crystals. Since the thermal neutron penetaration increases significantly when the crystals are cooled, a filter cooled by liquid nitrogen is developed. So as to avoid interference with the reactor operation, a water shutter is developed. The irradiation room is designed for the temporary surgical operation as well. Handling tools to remove activated beam port plug and to install water shutter and filter are developed. The basic structure of the irradiation room is already installed and most of other parts are ready to install. Since no free beam port is available for the prompt gamma neutron activation analysis, a method obtaining almost pure thermal neutrons by the vertical diffraction of extra beam for the polarized neutron spectrometer is developed. This method is confirmed by analysis and experiments to give high enough neutron beam. Equipment and devices are provided to install this facility

  3. Feminist Identity Development: Implications for Feminist Therapy with Women.

    Science.gov (United States)

    McNamara, Kathleen; Rickard, Kathryn M.

    1989-01-01

    Discusses implications of the Downing and Roush (1985) feminist identity development model for feminist therapy with women. Describes potential pitfalls of feminist therapy and emergent issues at subsequent stages of client's identity development. Proposes research agenda for hypothesis testing of model when applied to therapy with women clients.…

  4. Gene therapy of cancer and development of therapeutic target gene

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Chang Min; Kwon, Hee Chung

    1998-04-01

    We applied HSV-tk/GCV strategy to orthotopic rat hepatoma model and showed anticancer effects of hepatoma. The increased expression of Lac Z gene after adenovirus-mediated gene delivery throughout hepatic artery was thought that is increased the possibility of gene therapy for curing hepatoma. With the construction of kGLP-laboratory, it is possible to produce a good quantity and quality of adenovirus in lage-scale production and purification of adenovirus vector. Also, the analysis of hepatoma related genes by PCR-LOH could be used for the diagnosis of patients and the development of therapeutic gene.

  5. Gene therapy of cancer and development of therapeutic target gene

    International Nuclear Information System (INIS)

    Kim, Chang Min; Kwon, Hee Chung

    1998-04-01

    We applied HSV-tk/GCV strategy to orthotopic rat hepatoma model and showed anticancer effects of hepatoma. The increased expression of Lac Z gene after adenovirus-mediated gene delivery throughout hepatic artery was thought that is increased the possibility of gene therapy for curing hepatoma. With the construction of kGLP-laboratory, it is possible to produce a good quantity and quality of adenovirus in lage-scale production and purification of adenovirus vector. Also, the analysis of hepatoma related genes by PCR-LOH could be used for the diagnosis of patients and the development of therapeutic gene

  6. Engaging in Productive Sector Development

    DEFF Research Database (Denmark)

    Whitfield, Lindsay; Buur, Lars

    Through a comparison of sector cases in Mozambique and Ghana, the paper analyzes why and how African states engage in developing productive sectors and with what success. It argues that successful state interventions depend on four factors: (1) sustained political support by the government...... in the four factors and thus different economic outcomes. Specifically, cocoa, export is a case of sustained political support, palm oil is a case of poorly implemented industrial policy, and horticulture export is a case of political neglect of an industry. In concluding, the paper emphasizes the political...

  7. Engaging in productive sector development

    DEFF Research Database (Denmark)

    Buur, Lars; Whitfield, Lindsay

    Through a comparison of sector cases in Mozambique and Ghana, the paper analyzes why and how African states engage in developing productive sectors and with what success. It argues that successful state interventions depend on four factors: (1) sustained political support by the government...... in the four factors and thus different economic outcomes. Specifically, cocoa, export is a case of sustained political support, palm oil is a case of poorly implemented industrial policy, and horticulture export is a case of political neglect of an industry. In concluding, the paper emphasizes the political...

  8. Next Generation Biopharmaceuticals: Product Development.

    Science.gov (United States)

    Mathaes, Roman; Mahler, Hanns-Christian

    2018-04-11

    Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (serum half-life and specificity) whilst further improving efficacy and safety and to open new and better avenues for treating patients, e.g., improving the potency of molecules, target binding, tissue penetration, tailored pharmacokinetics, and reduced adverse effects or immunogenicity.The next generation of biopharmaceuticals can pose specific chemistry, manufacturing, and control (CMC) challenges. In contrast to conventional proteins, next-generation biopharmaceuticals often require lyophilization of the final drug product to ensure storage stability over shelf-life time. In addition, next-generation biopharmaceuticals require analytical methods that cover different ways of possible degradation patterns and pathways, and product development is a long way from being straight forward. The element of "prior knowledge" does not exist equally for most novel formats compared to antibodies, and thus the assessment of critical quality attributes (CQAs) and the definition of CQA assessment criteria and specifications is difficult, especially in early-stage development.

  9. Effect of Physical Therapy Students' Clinical Experiences on Clinician Productivity.

    Science.gov (United States)

    Pivko, Susan E; Abbruzzese, Laurel D; Duttaroy, Pragati; Hansen, Ruth L; Ryans, Kathryn

    2016-01-01

    Physical therapy clinical education experiences (CEEs) are difficult to secure, particularly first-level CEEs. Our purpose was to determine 1) what impact student full-time CEEs have on PT clinician productivity and 2) whether there is a productivity difference between first vs final CEEs. Productivity logs, including possible factors impacting productivity, were distributed to clinician-student pairings on first and final CEEs. Two-week baseline data (without a student) were compared to weeks 1 and 6 (with a student) for 31 logs using a 2x4 repeated-measures ANOVA. In a subset of 17 logs for CEEs 8 weeks or longer, a 2x5 repeated-measures ANOVA was performed. There was a significant increase in the number of patients seen and CPT units billed by both levels of CEEs comparing weeks 1 and 6. In the subset of CEEs, 8 weeks or longer, there was a significant increase in the number of patients treated per hour at week 6 and a trend toward a change at week 8 when compared to baseline week A. The factors selected as impacting productivity were census (59%) and staffing (32%). Physical therapy clinician-student pairings showed an overall increase in productivity during both full-time first and final level CEEs.

  10. Toyota production system quality improvement initiative improves perioperative antibiotic therapy.

    Science.gov (United States)

    Burkitt, Kelly H; Mor, Maria K; Jain, Rajiv; Kruszewski, Matthew S; McCray, Ellesha E; Moreland, Michael E; Muder, Robert R; Obrosky, David Scott; Sevick, Mary Ann; Wilson, Mark A; Fine, Michael J

    2009-09-01

    To assess the role of a Toyota production system (TPS) quality improvement (QI) intervention on appropriateness of perioperative antibiotic therapy and in length of hospital stay (LOS) among surgical patients. Pre-post quasi-experimental study using local and national retrospective cohorts. We used TPS methods to implement a multifaceted intervention to reduce nosocomial methicillin-resistant Staphylococcus aureus infections on a Veterans Affairs surgical unit, which led to a QI intervention targeting appropriate perioperative antibiotic prophylaxis. Appropriate perioperative antibiotic therapy was defined as selection of the recommended antibiotic agents for a duration not exceeding 24 hours from the time of the operation. The local computerized medical record system was used to identify patients undergoing the 25 most common surgical procedures and to examine changes in appropriate antibiotic therapy and LOS over time. Overall, 2550 surgical admissions were identified from the local computerized medical records. The proportion of surgical admissions receiving appropriate perioperative antibiotics was significantly higher (P <.01) in 2004 after initiation of the TPS intervention (44.0%) compared with the previous 4 years (range, 23.4%-29.8%) primarily because of improvements in compliance with antibiotic therapy duration rather than appropriate antibiotic selection. There was no statistically significant decrease in LOS over time. The use of TPS methods resulted in a QI intervention that was associated with an increase in appropriate perioperative antibiotic therapy among surgical patients, without affecting LOS.

  11. New Product Development and Business Strategy of Research and Development

    International Nuclear Information System (INIS)

    Lee, Sun Cheol

    1998-05-01

    The contents of this book are new product development strategy of the top business, commercialization and new product development, development case analysis and framework of new product development, investigation strategy for idea of new product development, case analysis of research as development and goal of new product development, case analysis and planning and management for new product development, innovative item development and technical management against confusion, the map for determination procedure of development, strategy of market and goods and development strategy cases in leading company.

  12. Orff Music Therapy: History, Principles and Further Development

    Directory of Open Access Journals (Sweden)

    Melanie Voigt

    2013-12-01

    Full Text Available Orff Music Therapy, a developmental approach to music therapy, was developed by Gertrud Orff within the framework of social paediatrics in Munich, Germany. A short historical background of Orff Music Therapy is discussed. The history of the clinical setting in which it was developed is described as is Gertrud Orff’s professional background. The role of Orff-Schulwerk in Orff Music Therapy and the development of theoretical foundations are discussed. Current principles and practice of Orff Music Therapy, illustrated by a case example show how the profile of Orff Music Therapy has developed. On the basis of the case example, theory is related to practice. Finally, changes influencing Orff Music Therapy today, training and research are considered.

  13. The Challenges of New Product Development in a Developing Economy

    OpenAIRE

    M. O. Oduola; A. M. Yakubu

    2017-01-01

    New Product Development (NPD) involves creating a new product from concept to the market. The product could be entirely new or rebranding. It is a critical focus of any production firm. The increase in volume of new competitive products is an indicator of any fast growing production concern. However the challenges that could affect development of a new product in a developing economy include, but not limited to the following: Inadequate infrastructural facilities, lack of funding, low technol...

  14. Managing a Product Development Team

    Science.gov (United States)

    Lehtonen, Kenneth E.; Barrett, Larry

    2003-01-01

    Orbiting 380 miles above the earth, NASA s Hubble Space Telescope (HST) has returned a wealth of scientific data about our universe and galaxies beyond highlighted by spectacular images of the birth and death of stars, colliding galaxies, and other extra-worldly events. Despite its tremendous success for almost two decades, the HST ground support system experienced down-to-earth problems prior to the turn of the century, namely budgetary ones. To keep HST operating efficiently to 201 2 and beyond, the Vision 2000 project was conceived with the primary goal of substantially reducing the costs of operating and maintaining the spacecraft ground systems. Taking advantage of this atypical management opportunity, a set of Product Development Teams (PDTs) were established, whose charter was to re-engineer the ground system, and in doing so, reduce the remaining life-of-mission operating and maintenance costs, while providing improved reliability and increased capabilities.

  15. [Report from the Committee for Advanced Therapies (CAT). Pitfalls on the way from concept to medical treatment with advanced therapy medicinal products].

    Science.gov (United States)

    Reiss, M; Büttel, I C; Schneider, C K

    2011-07-01

    Advanced therapy medicinal products (ATMP) are highly innovative and complex medicines. They comprise gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products (TEP). With the European Regulation on ATMP that came into force in 2008, a consolidated regulatory framework was created, where the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) plays a central role. This article discusses pitfalls and challenges that the CAT has experienced in its discussions of various procedures. Often ATMPs are developed by small and medium-sized enterprises (SME) which also face nonscientific challenges. The CAT wishes to meet these challenges on a scientific and regulatory level during its 2010-2015 work program.

  16. Regulation of advanced therapy medicinal products in Europe and the role of academia.

    Science.gov (United States)

    Pearce, Kim F; Hildebrandt, Martin; Greinix, Hildegard; Scheding, Stefan; Koehl, Ulrike; Worel, Nina; Apperley, Jane; Edinger, Matthius; Hauser, Andrea; Mischak-Weissinger, Eva; Dickinson, Anne M; Lowdell, Mark W

    2014-03-01

    Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to ensure their free movement within the European Union while guaranteeing the highest level of health protection for patients. Academic good manufacturing practice (GMP) centers are major contributors in the development of ATMPs and this study assessed the impact of regulations on them. European academic and non-industrial facilities (n = 747) were contacted, and a representative sample of 50 replied to a detailed questionnaire. Experienced centres were further selected in every Member State (MS) for semi-structured interviews. Indicators of ATMP production and development success were statistically assessed, and opinions about directive implementation were documented. Facilities experienced in manufacturing cell therapy transplant products are the most successful in developing ATMPs. New centres lacking this background struggle to enter the field, and there remains a shortage of facilities in academia participating in translational research. This is compounded by heterogeneous implementation of the regulations across MS. GMP facilities successfully developing ATMPs are present in all MS. However, the implementation of regulations is heterogeneous between MS, with substantial differences in the definition of ATMPs and in the approved manufacturing environment. The cost of GMP compliance is underestimated by research funding bodies. This is detrimental to development of new ATMPs and commercialization of any that are successful in early clinical trials. Academic GMP practitioners should strengthen their political visibility and contribute to the development of functional and effective European Union legislation in this field. Copyright © 2014 International Society for Cellular Therapy. All rights reserved.

  17. Green product development : What does the country product space imply?

    NARCIS (Netherlands)

    Fraccascia, Luca; Giannoccaro, Ilaria; Albino, Vito

    This paper contributes to green product development by identifying the green products with the highest potential for growth in a country. To address our aim, we use the concept of product proximity and product space and, borrowing from the results of recent studies on complexity economics, we

  18. Product design and development engineering

    International Nuclear Information System (INIS)

    Lee, Kookhwan

    2008-01-01

    This book gives design of molded plastics, design of press product, design of die casting products, the application of communication terminal design, application and design of machine elements(screw, spring, bearing, gear, retaining ridge, drawing standards, KS and JIS material marks list), 3D CAD, concurrent engineering of product design, creative concept design.

  19. 76 FR 9028 - Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

    Science.gov (United States)

    2011-02-16

    ...] Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability AGENCY: Food and... Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene... for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance...

  20. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

    Science.gov (United States)

    Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

    2015-01-01

    In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

  1. From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU.

    Science.gov (United States)

    Pellegrini, Graziella; Lambiase, Alessandro; Macaluso, Claudio; Pocobelli, Augusto; Deng, Sophie; Cavallini, Gian Maria; Esteki, Roza; Rama, Paolo

    2016-06-01

    In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was established in different facilities and the clinical application in several hospitals. Advanced therapy medicinal products, including stem cells, are unique products with different challenges than other drugs: some uncertainties, in addition to benefit, cannot be avoided. This review will focus on all recent developments in the stem cell-based corneal therapy.

  2. Encountering Challenges with the EU Regulation on Advance Therapy Medical Products.

    Science.gov (United States)

    Mansnérus, Juli

    2015-12-01

    This article aims at analysing how well the Advanced Therapy Medical Product Regulation (EC) No. 1394/2007 (ATMP Regulation) meets the needs of small and medium-sized enterprises (SMES), academia and public tissue establishments developing advanced therapy medical products (ATMPS). Benefits and shortcomings of the ATMP Regulation are identified, and possible amendments are proposed to accelerate the translation of research into advanced therapies and to facilitate the commercialisation of ATMPS whilst ensuring safety. It was set up as a lex specialis to ensure the free movement of ATMPS within the EU in order to facilitate their access to the internal market and to foster the competitiveness of European pharmaceutical companies, while guaranteeing the highest level protection of public health. Since the adoption of the ATMP Regulation in late 2008, only 5 ATMPS have been granted marketing authorisations thus far. Hence, there is a need to analyse whether the ATMP Regulation meets its objectives.

  3. SU-E-P-07: Evaluation of Productivity Systems for Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Ramsey, C; Usynin, A [Thompson Cancer Survival Center, Knoxville, TN (United States)

    2014-06-01

    Purpose: Health systems throughout the United States are under increased financial pressure to reduce operating cost. As a result, productivity models developed by third-party consultants are being used to optimize staff to treatment volumes. The purpose of this study was to critically evaluate productivity systems for radiation oncology. Methods: Staffing efficiency was evaluated using multiple productivity models. The first model evaluated staffing levels using equal weighting of procedure codes and hours worked. A second productivity model was developed using hours worked by job class and relative value units for each procedure code. A third model was developed using the measured procedure times extracted from the electronic medical record, which tracks the wait and treatment times for each patient for each treatment fraction. A MatLab program was developed to query and analyze the daily treatment data. A model was then created to determine any theoretical gains in treatment productivity. Results: Productivity was evaluated for six radiation therapy departments operating nine linear accelerators delivering over 40,000 treatment fractions per year. Third party productivity models that do not take into consideration the unique nature of radiation therapy can be counterproductive. For example, other outpatient departments can compress their daily schedule to decrease the worked hours. This approach was tested using the treatment schedule evaluation tool developed as part of this study. It was determined that the maximum possible savings for treatment schedule compression was $32,000 per year per linac. All annual cost savings would be lost if only two patients per year choose to be treated elsewhere because of limited or restricted appointment times. Conclusion: The use of productivity models in radiation therapy can easily result in a loss of treatment revenue that is greater than any potential cost savings in reduced hours worked by staff.

  4. SU-E-P-07: Evaluation of Productivity Systems for Radiation Therapy

    International Nuclear Information System (INIS)

    Ramsey, C; Usynin, A

    2014-01-01

    Purpose: Health systems throughout the United States are under increased financial pressure to reduce operating cost. As a result, productivity models developed by third-party consultants are being used to optimize staff to treatment volumes. The purpose of this study was to critically evaluate productivity systems for radiation oncology. Methods: Staffing efficiency was evaluated using multiple productivity models. The first model evaluated staffing levels using equal weighting of procedure codes and hours worked. A second productivity model was developed using hours worked by job class and relative value units for each procedure code. A third model was developed using the measured procedure times extracted from the electronic medical record, which tracks the wait and treatment times for each patient for each treatment fraction. A MatLab program was developed to query and analyze the daily treatment data. A model was then created to determine any theoretical gains in treatment productivity. Results: Productivity was evaluated for six radiation therapy departments operating nine linear accelerators delivering over 40,000 treatment fractions per year. Third party productivity models that do not take into consideration the unique nature of radiation therapy can be counterproductive. For example, other outpatient departments can compress their daily schedule to decrease the worked hours. This approach was tested using the treatment schedule evaluation tool developed as part of this study. It was determined that the maximum possible savings for treatment schedule compression was $32,000 per year per linac. All annual cost savings would be lost if only two patients per year choose to be treated elsewhere because of limited or restricted appointment times. Conclusion: The use of productivity models in radiation therapy can easily result in a loss of treatment revenue that is greater than any potential cost savings in reduced hours worked by staff

  5. Decision making in global product development

    DEFF Research Database (Denmark)

    Søndergaard, Erik Stefan; Ahmed-Kristensen, Saeema

    2014-01-01

    Many engineering companies experience new challenges when globalising product development. Global product development (GPD) is a relatively nascent research area, and previous research reveals the need for decision support frameworks. This research investigates how decisions are made when compani...

  6. Advanced Therapy Medicinal Products in type I diabetes mellitus: technological and regulatory challenges

    Directory of Open Access Journals (Sweden)

    Camila Leal-Lopes

    2018-02-01

    Full Text Available Introduction: Type 1 Diabetes mellitus (T1DM is an autoimmune disorder which arises from the destruction of insulin-producing pancreatic β-cells. Currently, Brazil’s advanced therapy medicinal products (ATMP, developed for clinical research and therapeutic purposes, take place in the so-called Cellular Technology Centers (CTC, according to the Resolution nº. 9/2011 of the Collegiate Board of Directors (RDC, enacted by the National Health Surveillance Agency (Anvisa. Objective: This study was conducted with the main objective of describing and discussing the development of ATMP for T1DM treatment. Method: A qualitative research, narrative review and critical discussion of the literature were under taken. Results: ATMP promote new therapeutic approaches for Diabetes, holding great potential to restore the patients’ endogenous insulin secretion, improving their life quality, overcoming the chronic complications of Diabetes and reducing the socioeconomic burden. Nowadays, ATMP in T1DM comprise: a cell therapy; b gene therapy products; c tissue engineering and d ATMPassociated to biopharmaceutical products. Conclusions: Further research should contribute to stimulate public and private organizations to effectively act towards reducing the impact of Diabetes on individuals and the society as a whole. It is essential that Brazilian legislation closely follows the biotechnological developments, supporting the scientific progress and benefiting T1DM patients with modern and cutting-edge therapies.

  7. Product/Service-System Development

    DEFF Research Database (Denmark)

    Tan, Adrian; McAloone, Timothy Charles; Gall, Catherine

    2007-01-01

    Product/service-systems’ (PSS) are innovation strategies where instead of focusing on the value of selling physical products, one focuses on the value of the utility of products and services throughout the product’s life period. This approach enables companies to provide customers with offerings...... that continuously deliver value and create a strong competitive advantage. PSS attempts to transcend the old industrial credo that value is embedded in products and the consideration of ‘cost-quality-time’ relates to the physical artefact. While there is increasing interest in PSS, limited research has been done...

  8. Research into the Development of Voice Assessment in Music Therapy

    DEFF Research Database (Denmark)

    Storm, Sanne

    This study was a research into the development of a voice assessment profile (VOIAS). Already a preliminary literature search showed that no such profile within music therapy existed, and only very sparse research within music therapy focusing on and involving the human voice. The development...

  9. Evolving Product Information in Aligning Product Development Decisions across Disciplines

    NARCIS (Netherlands)

    Oude Luttikhuis, Ellen; de Lange, Jos; Lutters, Diederick; ten Klooster, Roland

    2015-01-01

    Today's product development is fragmented across various disciplines all with their own fields of expertise. Maintaining overview in consequences and implications of decisions is difficult, since many stakeholders are involved. To optimise the product development, many methods are developed based on

  10. The development of environmental productivity

    DEFF Research Database (Denmark)

    Henningsen, Geraldine; Henningsen, Arne; Schröder, Sascha T.

    the environmental productivity of individual generator units based on a panel data set for the period 1998 to 2011 that includes virtually all fuel-fired generator units in Denmark. We further decompose total productivity into technical efficiency, best practice ratio, and scale efficiency and use a global...... Malmquist index to calculate the yearly changes. By applying time series clustering, we can identify high, middle, and low performance groups of generator units in a dynamic setting. Our results indicate that the sectoral productivity only slightly increased over the fourteen years. Furthermore, we find...... that there is no overall high achiever group, but that the ranking, although time consistent, varies between the different productivity measures. However, we identify steam turbines and combustion engines for combined heat and power production as potential high performers, while combustion engines that only produce...

  11. Product development of pumpkin tablet

    Directory of Open Access Journals (Sweden)

    Kamgoed, T.

    2007-05-01

    Full Text Available The development of pumpkin tablet was studied and the drying conditions of pumpkin using a double drum dryer were optimized. The study factors were drying agents (maltodextrin D.E.13-16 andtapioca flour at different levels (3 and 5%, drying temperatures (130 and 140oC and drum dryer speeds (4 and 5 rpm. The results showed that the optimal conditions were using 3% maltodextrin D.E.13-16, dryingtemperature of 130oC and drum dryer speed of 4 rpm. The moisture, fat, bulk density, reducing sugars and granulometric retention of the obtained pumpkin powder were 3.39%, 1.42%, 1.004 g/ml, 12.63% and 0.67%, respectively and L*, a* and b* values were 73.85, -0.60 and 35.23, respectively. A study of suitable amount of icing sugar using different contents for tablet production (0, 10, 20, 30 and 40% was performedand showed that using 20% icing sugar was the most acceptable. The obtained pumpkin tablet was subjected to chemical, physical and microbiological analysis. The ash, moisture, protein, fat, fiber and carbohydratecontents were 1.87, 3.60, 3.34, 1.00, 2.26 and 87.99%, respectively. The reducing sugars and β-carotene contents were 5.44±0.61% and 3.79±0.57 mg/100g, respectively. The Aw, hardness and solubility were 0.56,3.25 kgf and 25.00 %, respectively. The L*, a* and b* values were 79.85, 0.28 and 23.64, respectively. The total microbial count and the yeast and mould count were <10 CFU/g. The shelf life of the pumpkin tabletwas at least 4 months at room temperature (35±2oC.

  12. Virtual Product Development on Venturi Pump

    Directory of Open Access Journals (Sweden)

    Sava Ianici

    2011-10-01

    Full Text Available Market globalization and increased customer demands are leading providers of low product series to the high cost of development and construction. To overcome noted challenges it is necessary to use process of virtual product development. In that way it is possible, even in early phases of product development, to assess the operational product behaviour. Even the specific customer demands are determined before the actual product design phase. The paper presents an up to date concept of virtual product development with application on assessment of operational behaviour of Venturi pumps.

  13. MEASURING PRODUCTIVITY OF SOFTWARE DEVELOPMENT TEAMS

    Directory of Open Access Journals (Sweden)

    Goparaju Purna Sudhakar

    2012-02-01

    Full Text Available This paper gives an exhaustive literature review of the techniques and models available tomeasure the productivity of software development teams. Definition of productivity, measuringindividual programmer’s productivity, and measuring software development team productivity arediscussed. Based on the literature review it was found that software productivity measurement canbe done using SLOC (Source Lines of Code, function points, use case points, object points, andfeature points. Secondary research findings indicate that the team size, response time, taskcomplexity, team climate and team cohesion have an impact on software development teamproductivity. List of factors affecting the software development team productivity are studied andreviewed.

  14. DEVELOPMENT AN APPATATUS IS FOR MAGNETIC THERAPY

    Directory of Open Access Journals (Sweden)

    М. M. Baran

    2012-12-01

    Full Text Available A new apparatus for magnetic therapy – magnetostimulator MS-2012 is described. A description of the functional scheme of the device is precented. Feature of the device is the usage of a microcontroller, which allows you to set the pulses of any frequency, shape (porosity, and allows independent channels control.

  15. CIRP Design 2012 Sustainable Product Development

    CERN Document Server

    2013-01-01

    During its life cycle, a product produces waste that is over 20 times its weight. As such it is critical to develop products that are sustainable. Currently product development processes lack high quality methods and tools that are empirically validated to support development of sustainable products. This book is a compilation of over forty cutting edge international research papers from the 22nd CIRP International Design Conference, written by eminent researchers from 15 countries, on engineering design process, methods and tools, broadly for supporting sustainable product development.   A variety of new insights into the product development process, as well as a host of methods and tools that are at the cutting edge of design research are discussed and explained covering a range of diverse topics. The areas covered include: ·Sustainable design and manufacturing, ·Design synthesis and creativity, ·Global product development and product life cycle management, ·Design for X (safety, reliability, manufactu...

  16. Production of fast neutron beams for therapy: The application of and need for nuclear data

    International Nuclear Information System (INIS)

    Chaudhri, M.A.

    1987-01-01

    A brief review of the historical development of the production of therapy neutron beams is presented, with special reference to the author's contribution, using the available nuclear data. Different nuclear reactions and target systems have been critically examined regarding their suitability for cyclotrons of different sizes. A few current problems in this field, especially relating to the nonavailability of appropriate nuclear data, where the nuclear physics and nuclear data communities can greatly contribute, are highlighted. Specific recommendations are made as to what sort of nuclear data need to be acquired/compiled that would be most useful in the neutron therapy programme. (author). 28 refs

  17. Product Configuration Systems - Implications for Product Innovation and Development

    DEFF Research Database (Denmark)

    Edwards, Kasper; Pedersen, Jørgen Lindgaard

    2004-01-01

    configurations. However, costs are but one parameter on which firms compete and firms must continually innovate new and develop existing products. This paper presents original empirical insights on implementation and use of product configuration systems in a number of Danish industrial firms. The paper discusses...... the organisational changes associated with PCS and how this affects product innovation and development. The paper begins by introducing product configuration systems, which are then placed in context to the firm as a process technology which coordinate different processes: product development, order acquisition......Product Configuration Systems (PCS) is a step in the direction of mass customization in the sense that PCS allows a firm to significantly lower the unit cost of configuration. Thus PCS is a valuable technology for lowering operating costs while retaining a high number of possible product...

  18. Structuring user-centred product development processes

    NARCIS (Netherlands)

    Hoolhorst, F.W.B.

    2012-01-01

    Within the last decades, product development industry has found itself facing a general increase in product use problems. These problems originate from a mismatch between the actual functionality that the product provides and the afforded product-user interaction versus the user’s expectations

  19. Linking quality goals and product development competences

    DEFF Research Database (Denmark)

    Olsen, Johanne Rønnow; Harmsen, Hanne; Friis, Alan

    2008-01-01

    Quality is a main determinant of consumer food choice. Product development is accordingly a key activity for companies, because it generates the products on the quality of which consumer choices are based. In this respect, product development managers have a focal role, as their personal quality......, including reversed laddering sessions with 18 product development managers. Discrepancies between managerial and consumer quality goals are uncovered. Furthermore, the results point to two general dilemmas faced by product development managers in relation to quality; an external stakeholder dilemma...... orientation influence the way product development is performed. The aim of this paper is to investigate managerial quality goals and how these may be linked to product development competences, which has not previously been studied. The study draws on an empirical, qualitative study in the Danish food industry...

  20. Addressing Pressing Needs in the Development of Advanced Therapies.

    Science.gov (United States)

    Morrow, David; Ussi, Anton; Migliaccio, Giovanni

    2017-01-01

    The commercial development of advanced therapy medicinal products (ATMPs) represents great opportunity for therapeutic innovation but is beset by many challenges for its developers. Although the ATMP field continues to progress at a rapid pace, evidenced by the increasing number of clinical trials conducted over the past few years, several factors continue to complicate the introduction of ATMPs as a curative treatment for multiple disease types, by blocking their translational pathway from research to the patient. While several recent publications (Trounson and McDonald, 2015; Abou-El-Enein et al., 2016a,b) as well as an Innovative Medicines Initiative consultation (IMI, 2016) this year have highlighted the major gaps in ATMP development, with manufacturing, regulatory, and reimbursement issues at the forefront, there remains to be formulated a coherent strategy to address these by bringing the relevant stakeholders to a single forum, whose task it would be to design and execute a delta plan to alleviate the most pressing bottlenecks. This article focuses on two of the most urgent areas in need of attention in ATMP development, namely manufacturing and reimbursement, and promotes the concept of innovation-dedicated research infrastructures to support a multi-sector approach for ensuring the successful development, entry, and ensuing survival of ATMPs in the healthcare market.

  1. Addressing Pressing Needs in the Development of Advanced Therapies

    Directory of Open Access Journals (Sweden)

    David Morrow

    2017-09-01

    Full Text Available The commercial development of advanced therapy medicinal products (ATMPs represents great opportunity for therapeutic innovation but is beset by many challenges for its developers. Although the ATMP field continues to progress at a rapid pace, evidenced by the increasing number of clinical trials conducted over the past few years, several factors continue to complicate the introduction of ATMPs as a curative treatment for multiple disease types, by blocking their translational pathway from research to the patient. While several recent publications (Trounson and McDonald, 2015; Abou-El-Enein et al., 2016a,b as well as an Innovative Medicines Initiative consultation (IMI, 2016 this year have highlighted the major gaps in ATMP development, with manufacturing, regulatory, and reimbursement issues at the forefront, there remains to be formulated a coherent strategy to address these by bringing the relevant stakeholders to a single forum, whose task it would be to design and execute a delta plan to alleviate the most pressing bottlenecks. This article focuses on two of the most urgent areas in need of attention in ATMP development, namely manufacturing and reimbursement, and promotes the concept of innovation-dedicated research infrastructures to support a multi-sector approach for ensuring the successful development, entry, and ensuing survival of ATMPs in the healthcare market.

  2. Genome Therapy of Myotonic Dystrophy Type 1 iPS Cells for Development of Autologous Stem Cell Therapy.

    Science.gov (United States)

    Gao, Yuanzheng; Guo, Xiuming; Santostefano, Katherine; Wang, Yanlin; Reid, Tammy; Zeng, Desmond; Terada, Naohiro; Ashizawa, Tetsuo; Xia, Guangbin

    2016-08-01

    Myotonic dystrophy type 1 (DM1) is caused by expanded Cytosine-Thymine-Guanine (CTG) repeats in the 3'-untranslated region (3' UTR) of the Dystrophia myotonica protein kinase (DMPK) gene, for which there is no effective therapy. The objective of this study is to develop genome therapy in human DM1 induced pluripotent stem (iPS) cells to eliminate mutant transcripts and reverse the phenotypes for developing autologous stem cell therapy. The general approach involves targeted insertion of polyA signals (PASs) upstream of DMPK CTG repeats, which will lead to premature termination of transcription and elimination of toxic mutant transcripts. Insertion of PASs was mediated by homologous recombination triggered by site-specific transcription activator-like effector nuclease (TALEN)-induced double-strand break. We found genome-treated DM1 iPS cells continue to maintain pluripotency. The insertion of PASs led to elimination of mutant transcripts and complete disappearance of nuclear RNA foci and reversal of aberrant splicing in linear-differentiated neural stem cells, cardiomyocytes, and teratoma tissues. In conclusion, genome therapy by insertion of PASs upstream of the expanded DMPK CTG repeats prevented the production of toxic mutant transcripts and reversal of phenotypes in DM1 iPS cells and their progeny. These genetically-treated iPS cells will have broad clinical application in developing autologous stem cell therapy for DM1.

  3. Extending product modeling methods for integrated product development

    DEFF Research Database (Denmark)

    Bonev, Martin; Wörösch, Michael; Hauksdóttir, Dagný

    2013-01-01

    Despite great efforts within the modeling domain, the majority of methods often address the uncommon design situation of an original product development. However, studies illustrate that development tasks are predominantly related to redesigning, improving, and extending already existing products...... and PVM methods, in a presented Product Requirement Development model some of the individual drawbacks of each method could be overcome. Based on the UML standard, the model enables the representation of complex hierarchical relationships in a generic product model. At the same time it uses matrix....... Updated design requirements have then to be made explicit and mapped against the existing product architecture. In this paper, existing methods are adapted and extended through linking updated requirements to suitable product models. By combining several established modeling techniques, such as the DSM...

  4. A short course in sustainable product development

    DEFF Research Database (Denmark)

    McAloone, Tim C.

    2005-01-01

    This short course in sustainable product development models, methods and mindsets is designed to fit into the Unical course on Engineering Design Methods. Three modules (called “seminars”) will guide you through . The demands for sustainable development . Professional methods for analysing and ch...... and changing products’ environmental profiles . A new approach to product service system development, where the physical product becomes an incidental aspect in the final offering to the customer...

  5. Business Cooperation and Regional Productive Development in ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Business Cooperation and Regional Productive Development in Chile, El ... program dedicated to strengthening independent policy research institutions, ... Call for proposals: Innovations for the economic inclusion of marginalized youth.

  6. Development of novel radiosensitizers for cancer therapy

    CERN Document Server

    Akamatsu, K

    2002-01-01

    The novel radiosensitizers for cancer therapy, which have some atoms with large X-ray absorption cross sections, were synthesized. The chemical and radiation (X-rays, W target, 100kVp) toxicities and the radiosensitivities to LS-180 human colon adenocarcinoma cells were also evaluated. 2,3,4,5,6-pentabromobenzylalcohol (PBBA) derivatives were not radiosensitive even around the maximum concentration. On the other hand, the hydrophilic sodium 2,4,6-triiodobenzoate (STIB) indicated meaningful radiosensitivity to the cells. Moreover, the membrane-specific radiosensitizers, cetyl fluorescein isthiocyanate (cetyl FITC), cetyl eosin isothiocyanate (cetyl br-FITC), cetyl erythrosin isothiocyanate (cetyl I-FITC), which aim for the membrane damage by X-ray photoabsorption on the target atoms, were localized in the plasma membrane. As the results of the colony formation assay, it was found that both cetyl FITC are similarly radiosensitive. In this report, we demonstrate the synthetic methods of the radiosensitizers, the...

  7. Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

    Science.gov (United States)

    Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

    2017-12-01

    Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

  8. Understanding users in product development

    DEFF Research Database (Denmark)

    Geert Jensen, Birgitte

    2012-01-01

    , the guideline contain a step by step process to develop easy‐to‐open packaging. The guideline is constructed in a way that allows the enterprise to pick and choose in respect to the enterprise´s needs and competences. The main focus in the development of the guidelines has been to produce a tool that function...... observations is a tool for user understanding and that the first step towards better packaging, goes through consensus in the organization regarding the need for more easy‐opening packaging....

  9. Concurrent Engineering in seafood product development

    DEFF Research Database (Denmark)

    Jonsdottir, Stella; Vesterager, Johan; Børresen, Torger

    1998-01-01

    benefit from the CE approach which can support product developers to provide concurrent specifications for raw materials, ingredients, packaging, and production methods. The approach involves the use of product models from which line extensions are more easily generated than by use of customary stepwise...... techniques. it is anticipated that other food industries also can benefit from the more simultaneous approach...

  10. Development of Production Control in Small Batch Production

    Directory of Open Access Journals (Sweden)

    Németh Péter

    2016-01-01

    Full Text Available Our aim with this paper is to develop a new performance measurement and control system for small batch production in the automotive industry. For this reason, we present our previous research results for warehouse performance measurement and adopt its methodology to production control. The proposed method is based on artificial intelligence (neural networks.

  11. Environmental improvement through product development

    DEFF Research Database (Denmark)

    McAloone, Tim C.; Bey, Niki

    Companies in Denmark and abroad are working increasingly to reduce human impacts on the environment and nature. At the same time there must still be a large focus on the creation of value for customers and consumers. This development gives rise to a huge potential for Danish companies, to create ...... Environmental Protection Agency’s company funding scheme. We hope you will be inspired!...

  12. Product Platform Development in Industrial Networks

    DEFF Research Database (Denmark)

    Karlsson, Christer; Skold, Martin

    2011-01-01

    The article examines the strategic issues involved in the deployment of product platform development in an industrial network. The move entails identifying the types and characteristics of generically different product platform strategies and clarifying strategic motives and differences. Number o...... of platforms and product brands serve as the key dimensions when distinguishing the different strategies. Each strategy has its own challenges and raises various issues to deal with.......The article examines the strategic issues involved in the deployment of product platform development in an industrial network. The move entails identifying the types and characteristics of generically different product platform strategies and clarifying strategic motives and differences. Number...

  13. An Emerging Theoretical Model of Music Therapy Student Development.

    Science.gov (United States)

    Dvorak, Abbey L; Hernandez-Ruiz, Eugenia; Jang, Sekyung; Kim, Borin; Joseph, Megan; Wells, Kori E

    2017-07-01

    Music therapy students negotiate a complex relationship with music and its use in clinical work throughout their education and training. This distinct, pervasive, and evolving relationship suggests a developmental process unique to music therapy. The purpose of this grounded theory study was to create a theoretical model of music therapy students' developmental process, beginning with a study within one large Midwestern university. Participants (N = 15) were music therapy students who completed one 60-minute intensive interview, followed by a 20-minute member check meeting. Recorded interviews were transcribed, analyzed, and coded using open and axial coding. The theoretical model that emerged was a six-step sequential developmental progression that included the following themes: (a) Personal Connection, (b) Turning Point, (c) Adjusting Relationship with Music, (d) Growth and Development, (e) Evolution, and (f) Empowerment. The first three steps are linear; development continues in a cyclical process among the last three steps. As the cycle continues, music therapy students continue to grow and develop their skills, leading to increased empowerment, and more specifically, increased self-efficacy and competence. Further exploration of the model is needed to inform educators' and other key stakeholders' understanding of student needs and concerns as they progress through music therapy degree programs. © the American Music Therapy Association 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  14. Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

    Science.gov (United States)

    Davies, Benjamin M; Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

    2014-01-01

    There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

  15. Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

    Directory of Open Access Journals (Sweden)

    Benjamin M Davies

    2014-09-01

    Full Text Available There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

  16. Proton linac for hospital-based fast neutron therapy and radioisotope production

    International Nuclear Information System (INIS)

    Lennox, A.J.; Hendrickson, F.R.; Swenson, D.A.; Winje, R.A.; Young, D.E.

    1989-09-01

    Recent developments in linac technology have led to the design of a hospital-based proton linac for fast neutron therapy. The 180 microamp average current allows beam to be diverted for radioisotope production during treatments while maintaining an acceptable dose rate. During dedicated operation, dose rates greater than 280 neutron rads per minute are achievable at depth, DMAX = 1.6 cm with source to axis distance, SAD = 190 cm. Maximum machine energy is 70 MeV and several intermediate energies are available for optimizing production of isotopes for Positron Emission Tomography and other medical applications. The linac can be used to produce a horizontal or a gantry can be added to the downstream end of the linac for conventional patient positioning. The 70 MeV protons can also be used for proton therapy for ocular melanomas. 17 refs., 1 fig., 1 tab

  17. New product development with dynamic decision support

    CSIR Research Space (South Africa)

    Venter, JP

    2007-08-01

    Full Text Available The development of new and improved management methods for new product development is important. Existing methods suffer from a number of shortcomings, especially the ability to deal with a mixture of quantitative and qualitative data. The objective...

  18. New product development with dynamic decision support

    CSIR Research Space (South Africa)

    Venter, Jacobus P

    2009-06-01

    Full Text Available The development of new and improved management methods for new product development is important. Existing methods suffer from a number of shortcomings, especially their inability to deal with a mixture of quantitative and qualitative data...

  19. Development of bioactive materials for glioblastoma therapy

    Directory of Open Access Journals (Sweden)

    Jun Yang

    2016-09-01

    Full Text Available Glioblastoma is the most common and deadly human brain cancers. Unique barriers hinder the drug delivering pathway due to the individual position of glioblastoma, including blood-brain barrier and blood-brain tumor barrier. Numerous bioactive materials have been exploited and applied as the transvascular delivery carriers of therapeutic drugs. They promote site-specific accumulation and long term release of the encapsulated drugs at the tumor sites and reduce side effects with systemic delivery. And the delivery systems exhibit a certain extent of anti-glioblastoma effect and extend the median survival time. However, few of them step into the clinical trials. In this review, we will investigate the recent studies of bioactive materials for glioblastoma chemotherapy, including the inorganic materials, lipids and polymers. These bioactive materials construct diverse delivery vehicles to trigger tumor sites in brain intravenously. Herein, we exploit their functionality in drug delivery and discuss the deficiency for the featured tumors, to provide guidance for establishing optimized therapeutic drug formulation for anti-glioblastoma therapy and pave the way for clinical application.

  20. Key performance indicators: Global product development

    DEFF Research Database (Denmark)

    Taylor, Thomas Paul; Ahmed-Kristensen, Saeema

    2014-01-01

    The decision to globalise parts of product development is a consequence of an increasingly competitive world market. The variety of risks and opportunities as a result of the decision make it difficult for management to evaluate if global product development has been successful. This paper invest...

  1. Market Dynamics and Productivity in Developing Countries ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    25 nov. 2009 ... Market Dynamics and Productivity in Developing Countries : Economic Reforms in the Middle East and North Africa. Book cover Market Dynamics and Productivity in Developing Countries: Economic Reforms in the Middle East. Directeur(s):. Khalid Sekkat. Maison(s) d'édition: Springer, CDRI. 25 novembre ...

  2. Short lecture series in sustainable product development

    DEFF Research Database (Denmark)

    McAloone, Tim C.

    2005-01-01

    Three lectures in sustainable product development models, methods and mindsets should give insight into the way of thinking about the environment when developing products. The first two lectures will guide you through: . Environmental problems in industry & life-cycle thinking . Professional...... methods for analysing and changing products’ environmental profiles . Sustainability as a driver for innovation...

  3. Re-Examining Group Development in Adventure Therapy Groups.

    Science.gov (United States)

    DeGraaf, Don; Ashby, Jeff

    1998-01-01

    Small-group development is an important aspect of adventure therapy. Supplementing knowledge of sequential stages of group development with knowledge concerning within-stage nonsequential development yields a richer understanding of groups. Integrating elements of the individual counseling relationship (working alliance, transference, and real…

  4. Challenging the sustainability of micro products development

    DEFF Research Database (Denmark)

    De Grave, Arnaud; Olsen, Stig Irving

    2006-01-01

    Environmental aspects are one of the biggest concerns regarding the future of manufacturing and product development sustainability. Furthermore, micro products and micro technologies are often seen as the next big thing in terms of possible mass market trend and boom. Many questions are raised...... and the intermediate parts which can be in-process created. Possible future trends for micro products development scheme involving environmental concerns are given....

  5. Coordiantion by using Product Specifications in Product Development

    DEFF Research Database (Denmark)

    Terkelsen, Søren Bendix

    1997-01-01

    This paper is based on a case study. It treats the coordination by generating product specifications in product development. This paper contains three very important aspects, which cause a need for coordination, and call attention to the coordination mechanisms. The three aspects are task...... uncertainty, task complexity, and dependencies between activities. If one want to select coordination mechanisms, which improve the performance in product development, it is very important to have a knowledge about these three aspects. In the following the aspects are identified in the literature...

  6. Managing Virtual Product Development team: A Review

    Directory of Open Access Journals (Sweden)

    Amir Mohammad Colabi

    2014-05-01

    Full Text Available Although there are many potential benefits associated with the use of virtual product development teams, exploiting these benefits requires an appropriate management. Managing virtual product development team is a critical issue as many of these teams fail to accomplish their goals. Review of previous literature shows that body of knowledge in managing virtual product development teams is fragmented and inconsistent. The main objective of this paper is to categorize the previous research on the subject of virtual product development team management in order to integrate the research into a thematic model and to enable recommendations for future research. So, this study reviews and summarizes empirical research in the field, also conceptual and qualitative papers, experiences, reports and explorative case studies. Results show that there are three fields of research in this area, including: Virtual production and Virtual team in Product Development, Managing virtual team in R&D[1] and product development, Managing global virtual product development teams. In order to organize previous studies in this area, a thematic map is proposed which shows the structure and sequence of research. Finally, a comprehensive discussion on the future directions in this field is proposed.

  7. Service-oriented product development strategies

    DEFF Research Database (Denmark)

    Tan, Adrian Ronald

    Manufacturing companies have traditionally focused their efforts on designing, developing and producing physical products for the market. Today, global competition, outsourcing and legislation commend that companies take greater responsibility of their products. This is driving some manufacturers...... to shift their business strategies from selling products (e.g. photocopying machines) to the provision of services (e.g. document services). Instead of the product itself, the activity and knowledge associated with the use of the product is perceived to be of more value to customers. In the research...... community, service-oriented approaches that embrace this change of business focus from individual products to total integrated customer solutions are termed Product/Service-Systems (PSS). The research in this thesis addresses the systematic design and development of PSS solutions in manufacturing firms...

  8. Developing product families based on architectures

    DEFF Research Database (Denmark)

    Harlou, Ulf

    2006-01-01

    family master plan (PFMP). The PFMP aims at modelling product families and especially variety of product families. The results of this thesis build on research literature and experiences from the industrial partners. Extensive verifications of the theory contributions, models and tools have been carried......The subject of this PhD thesis is development of product families based on architectures. Companies are introducing more and more product variants to fulfil the market demands. These new variants add complexity to many of the processes and systems in the companies. Reuse of standard designs (i.......e. design entities) and re-use of the way new products are developed can simplify the processes and systems. Case studies show that reuse can lead to reduction of cost and time-to-market of new products. One of the means for managing reuse of standard designs within product families are architectures...

  9. Design and development of novel bandages for compression therapy.

    Science.gov (United States)

    Rajendran, Subbiyan; Anand, Subhash

    2003-03-01

    During the past few years there have been increasing concerns relating to the performance of bandages, especially their pressure distribution properties for the treatment of venous leg ulcers. This is because compression therapy is a complex system and requires two or multi-layer bandages, and the performance properties of each layer differs from other layers. The widely accepted sustained graduated compression mainly depends on the uniform pressure distribution of different layers of bandages, in which textile fibres and bandage structures play a major role. This article examines how the fibres, fibre blends and structures influence the absorption and pressure distribution properties of bandages. It is hoped that the research findings will help medical professionals, especially nurses, to gain an insight into the development of bandages. A total of 12 padding bandages have been produced using various fibres and fibre blends. A new technique that would facilitate good resilience and cushioning properties, higher and more uniform pressure distribution and enhanced water absorption and retention was adopted during the production. It has been found that the properties of developed padding bandages, which include uniform pressure distribution around the leg, are superior to existing commercial bandages and possess a number of additional properties required to meet the criteria stipulated for an ideal padding bandage. Results have indicated that none of the mostly used commercial padding bandages provide the required uniform pressure distribution around the limb.

  10. New product development: A batik multifunctional chair

    Science.gov (United States)

    Indrawati, Sri; Sukmaningsih, Nias

    2017-11-01

    The biggest challenge facing by Batik industry in ASEAN Economic Community (AEC) era is the greater number of fashion competitors both domestically and internationally. Based on that condition, the development of new product variants by considering product performance and price is needed. This research was conducted to develop batik products with a new target market. Products that being developed is batik multifunctional chair using integrated value engineering and analytic hierarchy process methods. This research has been done in several stages, ie. Information stage, creative stage, value analysis and product prototyping. The results of this research shows that the batik multifunctional chair product criteria are aesthetic (29%), multifunctional (34%) and ergonomic (37%). There are three new product design alternatives that successfully being developed. Based on value analysis, the product design alternatives that have the highest value is alternative design 2, the value is 2,37. The production cost for this design is Rp. 500.000,-. Alternative design 2 specification are using Mahoni wood, Batik parang rusak pattern with natural coloring process, can be used as table and fit with customer's body anthropometry. Then a batik multifunctional chair prototype is developed based on the best alternative design.

  11. Product development projects dynamics and emergent complexity

    CERN Document Server

    Schlick, Christopher

    2016-01-01

    This book primarily explores two topics: the representation of simultaneous, cooperative work processes in product development projects with the help of statistical models, and the assessment of their emergent complexity using a metric from theoretical physics (Effective Measure Complexity, EMC). It is intended to promote more effective management of development projects by shifting the focus from the structural complexity of the product being developed to the dynamic complexity of the development processes involved. The book is divided into four main parts, the first of which provides an introduction to vector autoregression models, periodic vector autoregression models and linear dynamical systems for modeling cooperative work in product development projects. The second part presents theoretical approaches for assessing complexity in the product development environment, while the third highlights and explains closed-form solutions for the complexity metric EMC for vector autoregression models and linear dyn...

  12. Problems of radiation therapy in developing countries

    Energy Technology Data Exchange (ETDEWEB)

    Lyimo, R; Neumeister, K

    1988-01-01

    Poverty as well as lack of proper cancer programmes has prevented the early detection of cancer in developing countries. Radiotherapy is applied mostly in advanced cases only. To change the situation comprehensive programmes must be introduced with particular attention to the importance of cancer control. The establishment of cancer societies as well as the introduction of centres for training of radiological personnel will really improve the situation. A realistic method for the optimization of radiotherapy in developing countries should be the use of radiomodification such as hypoxyradiotherapy.

  13. Integrated product development: Competencies meet and products arise

    DEFF Research Database (Denmark)

    Jensen, Birger Boutrup; Stacey, Julia

    2000-01-01

    and process competencies throughout the whole development process. Of course, this is easier said than done but integrating various competencies into the product development prepares the ground for a better balance and consequently more products. Databases, for instance are a good example of a tool that can...... the development process and diminish the risk of inventing sliced bread once again. Furthermore the databases may be used as a foundation for a more effective and frictionless communication across departments. The project has its starting point in case studies of three Danish food companies. A research group...

  14. Product development capability and marketing strategy for new durable products

    OpenAIRE

    Banerjee, Sumitro; Soberman, David A.

    2013-01-01

    Our objective is to understand how a firm’s product development capability (PDC) affects the launch strategy for a durable product that is sequentially improved over time in a market where consumers have heterogeneous valuations for quality. We show that the launch strategy of firms is affected by the degree to which consumers think ahead. However, only the strategy of firms with high PDC is affected by the observability of quality. When consumers are myopic and quality is observable, both hi...

  15. New Product Development Based on Demand

    OpenAIRE

    Davis-Krook, Shelby

    2015-01-01

    The purpose of this thesis was to determine how to develop a new product based on demand within a target market for an international company. Specifically looking at developing a new product line in an already developed brand, Alpha Performance. The research I have conducted in the following topics may help Alpha Performance if they choose to use my findings to create a one of a kind woman’s clothing line based on the demands of the Finnish market: target market research, product demand rese...

  16. Developing a Decision Model of Sustainable Product Design and Development from Product Servicizing in Taiwan

    Science.gov (United States)

    Huang, Yu-Chen; Tu, Jui-Che; Hung, So-Jeng

    2016-01-01

    In response to the global trend of low carbon and the concept of sustainable development, enterprises need to develop R&D for the manufacturing of energy-saving and sustainable products and low carbon products. Therefore, the purpose of this study was to construct a decision model for sustainable product design and development from product…

  17. Integrating ergonomics into the product development process

    DEFF Research Database (Denmark)

    Broberg, Ole

    1997-01-01

    and production engineers regarding information sources in problem solving, communication pattern, perception of ergonomics, motivation and requests to support tools and methods. These differences and the social and organizational contexts of the development process must be taken into account when considering......A cross-sectional case study was performed in a large company producing electro-mechanical products for industrial application. The purpose was to elucidate conditions and strategies for integrating ergonomics into the product development process thereby preventing ergonomic problems at the time...... of manufacture of new products. In reality the product development process is not a rational problem solving process and does not proceed in a sequential manner as decribed in engineering models. Instead it is a complex organizational process involving uncertainties, iterative elements and negotiation between...

  18. Development and production of Zenith fissile elements

    Energy Technology Data Exchange (ETDEWEB)

    George, D; Wheatley, C C.H.; Lloyd, H

    1959-06-15

    The development of a new glass-bonded alumina-uranium oxide composition forming the fissile component of the Zenith fuel elements is described, together with the production of the initial charge containing 15 Kg. of U{sub 235]; the composition is capable of retaining fission product gases at high temperatures. The description includes criticality considerations, details of manufacture, and production statistics of the 11,000 discs produced.

  19. Towards Integrated Product and Package Development

    OpenAIRE

    Bramklev, Caroline

    2007-01-01

    The global company operates from a number of locations worldwide, resulting in implications for the transport, handling and storage of product and parts transported within the company as well as between the company divisions and suppliers and/or consumers. In these companies, the package becomes a frequently used object to complement product features and achieve an effective and efficient means of logistics. In this context, it is interesting to integrate package development in the product...

  20. Development and efficacy of music therapy techniques within palliative care.

    Science.gov (United States)

    Clements-Cortés, Amy

    2016-05-01

    Music therapy is increasingly becoming an intervention used in palliative care settings around the globe. While the specialty of palliative care music therapy is relatively young having emerged in the late 1980s, there is a strong and growing body of evidence demonstrating its efficacy in assisting a variety of issues common at end-of-life. There are multiple music therapy techniques that are implemented with clients in palliative care and they can be categorized in four broad areas: receptive, creative, recreative and combined. These techniques will be presented with respect to their development by clinicians as supported by the descriptive and research literature. Information is also provided on the use of music therapy in facilitating the grieving and bereavement process. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. Art Therapy. Prevention Against the Development of Depression

    DEFF Research Database (Denmark)

    Skov, Vibeke

    2013-01-01

    as a mixed-methods design, with the quantitative part imbedded in the qualitative part. Seven participants were chosen to participate in an art therapy group during a 6-month intervention with a total of 13 meetings. The inclusion criteria were identification of mild to moderate depression based on the test......The aim in this research study was to focus on art therapy as a method to explore the inner life as prevention against the development of depression and to address the possibility for art therapy to be used as an early intervention tool related to depression. A Jungian epistemology was used...... as a frame for the overall understanding of well-being together with a holistic approach, including the biological, psychological, social and spiritual domains in life. Art therapy processes in the clinical part of the study aimed to include all these levels as the activation of these are considered...

  2. Evolutionary product development in working class housing

    NARCIS (Netherlands)

    Eger, Arthur O.; Lee, L.; van Lombaerde, P.

    2009-01-01

    The well‐known economical product life cycle describes the typical pattern of a product’s turnover over time. Although it has become a central concept in product development and marketing, it has severe practical limitations. Probably one of the most important limitations is that it is a purely

  3. Exploring purchasing involvement in product development

    NARCIS (Netherlands)

    Wynstra, J.Y.F.; Weggeman, M.C.D.P.; Weele, van A.J.

    2003-01-01

    With increasing outsourcing and the growing importance of product innovation as a means for creating competitive advantage, the integration of purchasing and product development processes has become a key issue for many firms. Although, consequently, the integration of purchasing and suppliers in

  4. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].

    Science.gov (United States)

    Jost, Nils; Schüssler-Lenz, Martina; Ziegele, Bettina; Reinhardt, Jens

    2015-11-01

    The aim of scientific advice is to support pharmaceutical developers in regulatory and scientific questions, thus facilitating the development of safe and efficacious new medicinal products. Recent years have shown that the development of advanced therapy medicinal products (ATMPs) in particular needs a high degree of regulatory support. On one hand, this is related to the complexity and heterogeneity of this group of medicinal products and on the other hand due to the fact that mainly academic research institutions and small- and medium-sized enterprises (SMEs) are developing ATMPs. These often have limited regulatory experience and resources. In 2009 the Paul-Ehrlich-Institut (PEI) initiated the Innovation Office as a contact point for applicants developing ATMPs. The mandate of the Innovation Office is to provide support on regulatory questions and to coordinate national scientific advice meetings concerning ATMPs for every phase in drug development and especially with view to the preparation of clinical trial applications. On the European level, the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicinal Agency (EMA) offers scientific advice. This article describes the concepts of national and EMA scientific advice concerning ATMPs and summarizes the experience of the last six years.

  5. Test Marketing in New Product Development

    Science.gov (United States)

    Klompmaker, Jay E.; And Others

    1976-01-01

    Discusses the role of test marketing in new product development, based on interviews with marketing executives. Attempts to clarify when a test market should be done, what its aims should be, and how it should be used. (JG)

  6. The Reality of Virtual Reality Product Development

    Science.gov (United States)

    Dever, Clark

    Virtual Reality and Augmented Reality are emerging areas of research and product development in enterprise companies. This talk will discuss industry standard tools and current areas of application in the commercial market. Attendees will gain insights into how to research, design, and (most importantly) ship, world class products. The presentation will recount the lessons learned to date developing a Virtual Reality tool to solve physics problems resulting from trying to perform aircraft maintenance on ships at sea.

  7. Co-ordinating Product Developing Activities

    DEFF Research Database (Denmark)

    Terkelsen, Søren Bendix

    1996-01-01

    The paper contains a presentation of research methods to be used in case studies in product development and a presentation on how to deal with Design Co-ordination according to litterature......The paper contains a presentation of research methods to be used in case studies in product development and a presentation on how to deal with Design Co-ordination according to litterature...

  8. Development of medical application methods using radiation. Radionuclide therapy

    International Nuclear Information System (INIS)

    Choi, Chang Woon; Lim, S. M.; Kim, E.H.; Woo, K. S.; Chung, W. S.; Lim, S. J.; Choi, T. H.; Hong, S. W.; Chung, H. Y.; No, W. C.; Oh, B. H.; Hong, H. J.

    1999-04-01

    In this project, we studied following subjects: 1. development of monoclonal antibodies and radiopharmaceuticals 2. clinical applications of radionuclide therapy 3. radioimmunoguided surgery 4. prevention of restenosis with intracoronary radiation. The results can be applied for the following objectives: 1) radionuclide therapy will be applied in clinical practice to treat the cancer patients or other diseases in multi-center trial. 2) The newly developed monoclonal antibodies and biomolecules can be used in biology, chemistry or other basic life science research. 3) The new methods for the analysis of therapeutic effects, such as dosimetry, and quantitative analysis methods of radioactivity, can be applied in basic research, such as radiation oncology and radiation biology

  9. Development of medical application methods using radiation. Radionuclide therapy

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Chang Woon; Lim, S. M.; Kim, E.H.; Woo, K. S.; Chung, W. S.; Lim, S. J.; Choi, T. H.; Hong, S. W.; Chung, H. Y.; No, W. C. [Korea Atomic Energy Research Institute. Korea Cancer Center Hospital, Seoul, (Korea, Republic of); Oh, B. H. [Seoul National University. Hospital, Seoul (Korea, Republic of); Hong, H. J. [Antibody Engineering Research Unit, Taejon (Korea, Republic of)

    1999-04-01

    In this project, we studied following subjects: 1. development of monoclonal antibodies and radiopharmaceuticals 2. clinical applications of radionuclide therapy 3. radioimmunoguided surgery 4. prevention of restenosis with intracoronary radiation. The results can be applied for the following objectives: (1) radionuclide therapy will be applied in clinical practice to treat the cancer patients or other diseases in multi-center trial. (2) The newly developed monoclonal antibodies and biomolecules can be used in biology, chemistry or other basic life science research. (3) The new methods for the analysis of therapeutic effects, such as dosimetry, and quantitative analysis methods of radioactivity, can be applied in basic research, such as radiation oncology and radiation biology.

  10. Expert Opinion on Three Phage Therapy Related Topics: Bacterial Phage Resistance, Phage Training and Prophages in Bacterial Production Strains

    Directory of Open Access Journals (Sweden)

    Christine Rohde

    2018-04-01

    Full Text Available Phage therapy is increasingly put forward as a “new” potential tool in the fight against antibiotic resistant infections. During the “Centennial Celebration of Bacteriophage Research” conference in Tbilisi, Georgia on 26–29 June 2017, an international group of phage researchers committed to elaborate an expert opinion on three contentious phage therapy related issues that are hampering clinical progress in the field of phage therapy. This paper explores and discusses bacterial phage resistance, phage training and the presence of prophages in bacterial production strains while reviewing relevant research findings and experiences. Our purpose is to inform phage therapy stakeholders such as policy makers, officials of the competent authorities for medicines, phage researchers and phage producers, and members of the pharmaceutical industry. This brief also points out potential avenues for future phage therapy research and development as it specifically addresses those overarching questions that currently call for attention whenever phages go into purification processes for application.

  11. Enviromental Development Plan: special nuclear materials production

    International Nuclear Information System (INIS)

    1980-07-01

    This Environmental Development Plan includes the process steps and facilities necessary for the production of plutonium and tritium for Government needs and the production of some other radioactive materials that will be used for heat and radiation sources by domestic and international customers. The production reactors and the spent fuel processing plants and their effluents are discussed, but the defense wastes from them are treated in a separate EDP. The scope does not include transportation, decontamination and decommissioning, safeguards and security, or use of the SNM products

  12. Lessons Learned In Developing The VACIS Products

    International Nuclear Information System (INIS)

    Orphan, Victor J.

    2011-01-01

    SAIC's development of VACIS provides useful 'lessons learned' in bridging the gap from an idea to a security or contraband detection product. From a gamma densitometer idea for solving a specific Customs Service (CS) requirement (detection of drugs in near-empty tanker trucks) in mid-1990's, SAIC developed a broad line of vehicle and cargo inspections systems (over 500 systems deployed to date) based on a gamma-ray radiographic imaging technique. This paper analyzes the reasons for the successful development of VACIS and attempts to identify ''lessons learned'' useful for future security and contraband detection product developments.

  13. Production of {sup 177}Lu for targeted radionuclide therapy: Available options

    Energy Technology Data Exchange (ETDEWEB)

    Dah, Ashutosh [Isotope Production and Applications Division, Bhabha Atomic Research Centre (BARC), Mumbai (India); Pillai, Maroor Raghavan Ambikalmajan [Molecular Group of Companies. Kerala (India); Knapp, Furn F. Jr. [Medical Isotopes Program, Isotope Dept. Group, Oak Ridge National Laboratory (ORNL), Oak Ridge (United States)

    2015-06-15

    This review provides a comprehensive summary of the production of {sup 177}Lu to meet expected future research and clinical demands. Availability of options represents the cornerstone for sustainable growth for the routine production of adequate activity levels of {sup 177}Lu having the required quality for preparation of a variety of {sup 177}Lu-labeled radiopharmaceuticals. The tremendous prospects associated with production of {sup 177}Lu for use in targeted radionuclide therapy (TRT) dictate that a holistic consideration should evaluate all governing factors that determine its success. While both “direct” and “indirect” reactor production routes offer the possibility for sustainable {sup 177}Lu availability, there are several issues and challenges that must be considered to realize the full potential of these production strategies. This article presents a mini review on the latest developments, current status, key challenges and possibilities for the near future. A broad understanding and discussion of the issues associated with {sup 177}Lu production and processing approaches would not only ensure sustained growth and future expansion for the availability and use of {sup 177}Lu-labeled radiopharmaceuticals, but also help future developments.

  14. Impact of product development efforts on product introduction and product customization abilities

    DEFF Research Database (Denmark)

    Chaudhuri, Atanu; Dawar, Saloni

    2014-01-01

    This paper investigates the impact of efforts in new product development-manufacturing integration (NPDMI) on new product introduction (NPI) and product customization (PC) abilities and the moderating effects of product design complexity and importance of new product development order winners...... (NPIOW) on the above relationships. The results from the data on 136 Indian manufacturing plants show that NPDMI, product design complexity and NPIOW all have significant positive impact on NPI and PC abilities. Importance of NPIOW has a positive moderating effect on the relationship between NPDMI and PC...... ability change but product design complexity demonstrate no such effect on the above relationships....

  15. New product development processes for ICT-for-development projects

    CSIR Research Space (South Africa)

    McAlister, BN

    2012-08-01

    Full Text Available in developing regions of the world is increasing rapidly. A number of methods and practices have been used by organizations to develop and deliver such ICT solutions, but a need exists to formalize product development processes for use in the ICT...

  16. Improving Marketing's Contribution to New Product Development

    NARCIS (Netherlands)

    Drechsler, Wenzel; Natter, Martin; Leeflang, Peter S. H.

    In many firms, the marketing department plays a minor role in new product development (NPD). However, recent research demonstrates that marketing capabilities more strongly influence firm performance than other areas such as research and development. This finding underscores the importance of

  17. Spirit in Motion: Developing a Spiritual Practice in Drama Therapy.

    Science.gov (United States)

    Cyr, Douglas Philip

    This document describes the theoretical and experiential process of utilizing a variety of action-oriented approaches for the development of a spiritual practice within the field of drama therapy. It explores the nature of the self from a variety of psychological perspectives, and introduces the concept of an ontologically- and…

  18. Using market information in product development

    DEFF Research Database (Denmark)

    Søndergaard, Helle Alsted; Harmsen, Hanne

    2007-01-01

    development are also fulfilled since the development teams recognize the value of the information and actively use it in their product development decision making. However, the means-end approach cannot (in its present form) reveal experienced quality since the approach includes no trying of the product...... of abstraction in consumers' minds. At the same time they are reminded that this information should feed into the process of making decisions in product development....... on the understanding of consumers' vertical and horizontal decision structure) combined with considerations on effective internal use of the information. Design/methodology/approach - The suggested model is applied in case studies in an action research project, and experiences with the application are discussed...

  19. Hospital-based proton linear accelerator for particle therapy and radioisotope production

    Science.gov (United States)

    Lennox, Arlene J.

    1991-05-01

    Taking advantage of recent advances in linear accelerator technology, it is possible for a hospital to use a 70 MeV proton linac for fast neutron therapy, boron neutron capture therapy, proton therapy for ocular melanomas, and production of radiopharmaceuticals. The linac can also inject protons into a synchrotron for proton therapy of deep-seated tumors. With 180 μA average current, a single linac can support all these applications. This paper presents a conceptual design for a medical proton linac, switchyard, treatment rooms, and isotope production rooms. Special requirements for each application are outlined and a layout for sharing beam among the applications is suggested.

  20. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation.

    Science.gov (United States)

    de Wilde, Sofieke; Veltrop-Duits, Louise; Hoozemans-Strik, Merel; Ras, Thirza; Blom-Veenman, Janine; Guchelaar, Henk-Jan; Zandvliet, Maarten; Meij, Pauline

    2016-06-01

    Since the implementation of the European Union (EU) regulation for advanced therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing authorization approval in the EU. Recognizing the major developments in the ATMP field, starting mostly in academic institutions, we investigated which hurdles were experienced in the whole pathway of ATMP development towards clinical care. Quality interviews were executed with different stakeholders in The Netherlands involved in the ATMP development field, e.g. academic research groups, national authorities and patient organizations. Based on the hurdles mentioned in the interviews, questionnaires were subsequently sent to the academic principal investigators (PIs) and ATMP good manufacturing practice (GMP) facility managers to quantify these hurdles. Besides the familiar regulatory routes of marketing authorization (MA) and hospital exemption (HE), a part of the academic PIs perceived that ATMPs should become available by the Tissues and Cells Directive or did not anticipate on the next development steps towards implementation of their ATMP towards regular clinical care. The main hurdles identified were: inadequate financial support, rapidly evolving field, study-related problems, lacking regulatory knowledge, lack of collaborations and responsibility issues. Creating an academic environment stimulating and planning ATMP development and licensing as well as investing in expanding the relevant regulatory knowledge in academic institutions seems a prerequisite to develop ATMPs from bench to patient. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  1. Mindfulness-based cognitive therapy for depression: trends and developments.

    Science.gov (United States)

    MacKenzie, Meagan B; Kocovski, Nancy L

    2016-01-01

    Mindfulness-based cognitive therapy (MBCT) was developed as a psychological intervention for individuals at risk of depressive relapse. Possible mechanisms of change for this intervention are in line with its theoretical underpinnings, and include increases in mindfulness and/or decreases in negative repetitive thoughts. This review provides an overview of current trends in MBCT research, including efficacy and questions regarding the specific effects of MBCT in light of recent comparisons with structurally equivalent control conditions, mechanisms of change, and moderators of treatment outcome. In addition, future directions are discussed, such as challenges with training an adequate number of therapists and disseminating this therapy.

  2. PLM system support for modular product development

    DEFF Research Database (Denmark)

    Bruun, Hans Peter Lomholt; Mortensen, Niels Henrik; Harlou, Ulf

    2015-01-01

    A modular design strategy both enables, but also demands, parallelism in design activities and collaboration between a diversity of disciplines in companies, which often involves supporting computer-based tools for enhancing interaction, design management, and communication. Product data management...... (PDM) and product lifecycle management (PLM) systems offer support by automating and managing some of the operational complexity of modular design activities. PLM system tools are used for handling a variety of product definitions, to manage workflow of development activities, and to measure relational...... properties such as cost and performance. Companies often use a PLM tool for management of CAD files, documents, and drawings, but they do not take advantage of the full potential of the PLM system to support the development activities of modular product designs. The key result of this paper...

  3. Knowledge Management in Product Development Projects

    International Nuclear Information System (INIS)

    Sheik Muhamad, S.

    2016-01-01

    Full text: Product data management system (PDM) solutions control vast quantities of information generated by engineers during the product development process. They provide vaulting capabilities to control access to shared data,workflow to distribute it, and configured product structures to relate it to product components. Nuclear Malaysia has the desire to have a proper CAD management system and this is achieved with the use of PDM system to manage all their designs throughout the product lifecycle, i.e., for drawing distribution and design change. The type of documents that Nuclear Malaysia manages are CAD files (as generated by CATIA, AUTOCAD), engineering files, reports, project files, documents (WORD, PDF), spreadsheet (EXCEL), bills of material, manufacturing processes and drawings. Besides managing drawings, we also want to control and manage engineering changes (ECO & ECR) in electronic format. (author

  4. [Instinct therapy--raw food with meat with exclusion of milk products. Report No. 16].

    Science.gov (United States)

    Jallut, O

    1989-06-13

    Instinct therapy is a diet consisting exclusively of food in its natural form, which has not been subjected to cooking, preserving or seasoning. Dairy products are forbidden. Indications are numerous and rather imprecise including especially cancer. Burger developed Instinct therapy in 1964 as a diet according to his own philosophy. 1980 he left Switzerland because the practice of "metasexuality" had caused him problems with the law. He founded a school of Instinct therapy in 1982 in France and published his book "La guerre du cru" (The Raw Food Fight) in 1985. In Switzerland, Besuchet took on the teaching of Burger in 1978 and was very active in giving lectures. He died in June 1985 of mediastinal cancer. According to Burger, man originally ate raw food and his instinct has not evolved since those pre-historic times, but has been "artificially modified" by cooked food and the consumption of non-human milk. If man could re-develop his natural instinct and eat only fresh food, which is not prepared in any way, he could solve his health problems and restore defenses against diseases such that these could become beneficial. Cooked food, milk and cereals are thought to be the cause of cancer but instinctive eating would help to avoid or to cure cancer. No preclinical or clinical trials have been carried out. The theories of Burger and Besuchet are based on unverifiable personal experiences.

  5. Sharia Bank Product Development through Mudhrabah Investment

    OpenAIRE

    Trimulato Trimulato

    2016-01-01

    Sharia banking now has a strong legal framework with the presence of law number 21 of 2008 on sharia banking in Indonesia. This regulation enforces sharia banking to develop products to achieve the targeted market share of 5%. In third-party fund products, more innovation is needed to attract people to entrust their funds in sharia banks. The visible data of mudharabah fund raising deposit products in March 2013 amounted to Rp100.746.000.000 and Rp115.728.000.000 in mudharabah deposits was vi...

  6. Research and development for ethylbenzene production

    Energy Technology Data Exchange (ETDEWEB)

    Xue, Mingwei; Sun, Hongmin; Shen, Zhenhao; Zhang, Bin; Yang, Weimin [SINOPEC Shanghai Research Institute of Petrochemical Technology (China); Huan, Mingyao

    2013-11-01

    Ethylbenzene (EB) is important raw material for the production of styrene. Now, EB is mainly produced by the alkylation of benzene with ethylene catalyzed by zeolite in vapour phase or liquid phase. Shanghai Research Institute of Petrochemical Technology (SRIPT) began to research the catalysts for the production of ethylbenezene in 1993. With near 20 years work, three series of catalysts for the alkylation of benzene with pure ethylene, dilute ethylene and ethanol are in commerical in China. This paper mainly introduced the research and development of SRIPT for the EB production. (orig.)

  7. Development Considerations for Nanocrystal Drug Products.

    Science.gov (United States)

    Chen, Mei-Ling; John, Mathew; Lee, Sau L; Tyner, Katherine M

    2017-05-01

    Nanocrystal technology has emerged as a valuable tool for facilitating the delivery of poorly water-soluble active pharmaceutical ingredients (APIs) and enhancing API bioavailability. To date, the US Food and Drug Administration (FDA) has received over 80 applications for drug products containing nanocrystals. These products can be delivered by different routes of administration and are used in a variety of therapeutic areas. To aid in identifying key developmental considerations for these products, a retrospective analysis was performed on the submissions received by the FDA to date. Over 60% of the submissions were for the oral route of administration. Based on the Biopharmaceutics Classification System (BCS), most nanocrystal drugs submitted to the FDA are class II compounds that possess low aqueous solubility and high intestinal permeability. Impact of food on drug bioavailability was reduced for most nanocrystal formulations as compared with their micronized counterparts. For all routes of administration, dose proportionality was observed for some, but not all, nanocrystal products. Particular emphasis in the development of nanocrystal products was placed on the in-process tests and controls at critical manufacturing steps (such as milling process), mitigation and control of process-related impurities, and the stability of APIs or polymorphic form (s) during manufacturing and upon storage. This emphasis resulted in identifying challenges to the development of these products including accurate determination of particle size (distribution) of drug substance and/or nanocrystal colloidal dispersion, identification of polymorphic form (s), and establishment of drug substance/product specifications.

  8. Development of RI Target Production Technology

    International Nuclear Information System (INIS)

    Jeong, Do Young; Ko, Kwang Hoon; Kim, Cheol Jung; Kim, Taek Soo; Rho, Si Pyo; Park, Hyun Min; Lim, Gwon; Cha, Yong Ho; Han, Jae Min

    2010-04-01

    This project was accomplished with an aim of productive technical development on the 'enriched target' which is used essentially in radioisotope production. The research was advanced systematically with target production pilot system configuration and core technical development. We composed Yb-176 productive pilot system which equip the chemical purification technique of medical treatment level and proved its capability. Possibilities to separate Zn-67 by the method of using the polarizing light in principle and to separate Zn-70 by the method of using the double optical pumping in theory were also proved. RI target production technologies are recognized excessively with monopolistic techniques of part atomic energy advanced nations such as Russia and US and they are come, but we prepared the opportunity will be able to complete a full cycle of like (RI material production -> RI target production -> RI application) with this project accomplishment. When considering only the direct demand of stable isotope which is used in various industrial, we forecast with the fact that RI target markets will become larger with the approximately 5 billion dollars in 2020 and this technology will contribute in the domestic rising industry creation with high value added

  9. Innovation in Product Development: Notes for course 41629

    DEFF Research Database (Denmark)

    McAloone, Timothy Charles; Tan, Adrian

    2003-01-01

    The course on Innovatino in Product Development attempts to identify and understand the nature of innovation and product development and their important factors. The course takes both a theoretical and a practical approach and employs a mix of lectures, project work and group discussion. Format...... insight. Course content The following aspects of innovation in product development are considered: - Humans and products - Needs and products - Product life - Teams creating products - Products creating business - Product development models - Organising product development - Product development tools...... - The future of product development...

  10. Smart consumer products with a pathfinder product development strategy

    Science.gov (United States)

    Robertson, Alec

    1994-09-01

    It is generally acknowledged that technologies diffuse through industry and that the rate of diffusion varies both within different industries and according to the circumstances. Innovation is a process involving risk, especially during the adoption and adaptation of a powerful new technology. Central to a consumer products success using new technology is the quality of their designs and the nature of their forms. Form is of prime importance in influencing the purchasing decisions of consumers and it is also influential in determining the relationships between people in its use environment. The acceptance of a new product into the world is often unduly ad hoc. Many failures are created for each success and there are few guidelines to assist the formulation of a strategy for creating an appropriate form. It is suggested below that success of consumer products incorporating 'smart structures' may be determined not only by the function of products and systems, but also by the form they take. The definition of a desirable product form depends entirely on the point of view taken: technological, commercial, ecological, cultural, and social. However any design using new will incorporate the old and the new. The probability of acceptance of a new product is enhanced by maintaining a fine balance between imaginative and creative form and that with which people are familiar and prefer: a new design may be rejected if it is too novel and unfamiliar, or too traditional. The acceptance of a new product and its subsequent development depends on the success designers and engineers have when dealing with the initial forms, particularly using new technology such as 'smart structures'.

  11. Strategies for fuel cell product development. Developing fuel cell products in the technology supply chain

    International Nuclear Information System (INIS)

    Hellman, H.L.

    2004-01-01

    Due to the high cost of research and development and the broad spectrum of knowledge and competences required to develop fuel cell products, many product-developing firms outsource fuel cell technology, either partly or completely. This article addresses the inter-firm process of fuel cell product development from an Industrial Design Engineering perspective. The fuel cell product development can currently be characterised by a high degree of economic and technical uncertainty. Regarding the technology uncertainty: product-developing firms are more often then not unfamiliar with fuel cell technology technology. Yet there is a high interface complexity between the technology supplied and the product in which it is to be incorporated. In this paper the information exchange in three current fuel cell product development projects is analysed to determine the information required by a product designer to develop a fuel cell product. Technology transfer literature suggests that transfer effectiveness is greatest when the type of technology (technology uncertainty) and the type of relationship between the technology supplier and the recipient are carefully matched. In this line of thinking this paper proposes that the information required by a designer, determined by the design strategy and product/system volume, should be met by an appropriate level of communication interactivity with a technology specialist. (author)

  12. Natural products as potential cancer therapy enhancers: A preclinical update

    Directory of Open Access Journals (Sweden)

    Abed Agbarya

    2014-09-01

    Full Text Available Cancer is a multifactorial disease that arises as a consequence of alterations in many physiological processes. Recently, hallmarks of cancer were suggested that include sustaining proliferative signaling, evading growth suppressors, resisting cell death, enabling replicative immortality, inducing angiogenesis, and activating invasion and metastasis, along with two emerging hallmarks including reprogramming energy metabolism and escaping immune destruction. Treating multifactorial diseases, such as cancer with agents targeting a single target, might provide partial treatment and, in many cases, disappointing cure rates. Epidemiological studies have consistently shown that the regular consumption of fruits and vegetables is strongly associated with a reduced risk of developing chronic diseases, such as cardiovascular diseases and cancer. Since ancient times, plants, herbs, and other natural products have been used as healing agents. Moreover, the majority of the medicinal substances available today have their origin in natural compounds. Traditionally, pharmaceuticals are used to cure diseases, and nutrition and herbs are used to prevent disease and to provide an optimal balance of macro- and micro-nutrients needed for good health. We explored the combination of natural products, dietary nutrition, and cancer chemotherapeutics for improving the efficacy of cancer chemotherapeutics and negating side effects.

  13. Development of a quarterly referral productivity report.

    Science.gov (United States)

    Wu, Cai; Sandoval, Alex; Hicks, Katrina N; Edwards, Tim J; Green, Lyle D

    2007-10-11

    The Office of Physician Relations at The University of Texas M. D. Anderson Cancer Center (MDACC) has developed a dynamic referral productivity reporting tool for its Multidisciplinary Care Centers (MCC). The tool leverages information within the institution's Enterprise Information Warehouse (EIW) using business intelligent software Hyperion Intelligent Explorer Suite 8.3. the referral productivity reports are intended to provide each MCC with detailed referral and registration data outlining how, and from where, patients arrive here for treatment. The reports supports operational and strategic initiatives aimed at improving referral processes and market related program development.

  14. Performance Measurement in Global Product Development

    DEFF Research Database (Denmark)

    Taylor, Thomas Paul; Ahmed-Kristensen, Saeema

    2013-01-01

    there is a requirement for the process to be monitored and measured relative to the business strategy of an organisation. It was found that performance measurement is a process that helps achieve sustainable business success, encouraging a learning culture within organisations. To this day, much of the research into how...... performance is measured has focussed on the process of product development. However, exploration of performance measurement related to global product development is relatively unexplored and a need for further research is evident. This paper contributes towards understanding how performance is measured...

  15. Customer/User Workshops in Product development

    DEFF Research Database (Denmark)

    Brandt, Eva; Binder, Thomas

    1997-01-01

    In a recent product development project, we have taken part in establishing and organising a series of workshops with a group of customers/users of a future product line through out the development project. The workshops is a kind of informal meetingplace for engineering, marketing, customers...... and discuss experiences with this kind of collaborative fora. We have tried to demonstrate that having an on-going dialogue with users/customers also during detailed design in not only a means to keep 'the voive of the customer alive'. We have found that the workshops have an important impact on securing...

  16. Developing Technology Products - A Physicist's Perspective

    Science.gov (United States)

    Burka, Michael

    2014-03-01

    There are many physicists working in the industrial sector. We rarely have the word physicist in our job title; we are far more commonly called engineers or scientists. But, we are physicists, and we succeed because our training in physics has given us the habits of mind and the technical skills that one needs to solve complex technical challenges. This talk will explore the transition from physics research to technology product development using examples from my own career, first as a postdoctoral fellow and research scientist on the LIGO project, and then developing products in the spectroscopy, telecommunications, and medical device industries. Approaches to identifying and pursuing opportunities in industry will be discussed.

  17. Success rates for product development strategies in new drug development.

    Science.gov (United States)

    Dahlin, E; Nelson, G M; Haynes, M; Sargeant, F

    2016-04-01

    While research has examined the likelihood that drugs progress across phases of clinical trials, no research to date has examined the types of product development strategies that are the most likely to be successful in clinical trials. This research seeks to identify the strategies that are most likely to reach the market-those generated using a novel product development strategy or strategies that combine a company's expertise with both drugs and indications, which we call combined experience strategies. We evaluate the success of product development strategies in the drug development process for a sample of 2562 clinical trials completed by 406 US pharmaceutical companies. To identify product development strategies, we coded each clinical trial according to whether it consisted of an indication or a drug that was new to the firm. Accordingly, a clinical trial that consists of both an indication and a drug that were both new to the firm represents a novel product development strategy; indication experience is a product development strategy that consists of an indication that a firm had tested previously in a clinical trial, but with a drug that was new to the firm; drug experience is a product development strategy that consists of a drug that the firm had prior experience testing in clinical trials, but with an indication that was new to the firm; combined experience consists of both a drug and an indication that the firm had experience testing in clinical trials. Success rates for product development strategies across clinical phases were calculated for the clinical trials in our sample. Combined experience strategies had the highest success rate. More than three and a half percent (0·036) of the trials that combined experience with drugs and indications eventually reached the market. The next most successful strategy is drug experience (0·025) with novel strategies trailing closely (0·024). Indication experience strategies are the least successful (0·008

  18. Targeting arachidonic acid pathway by natural products for cancer prevention and therapy.

    Science.gov (United States)

    Yarla, Nagendra Sastry; Bishayee, Anupam; Sethi, Gautam; Reddanna, Pallu; Kalle, Arunasree M; Dhananjaya, Bhadrapura Lakkappa; Dowluru, Kaladhar S V G K; Chintala, Ramakrishna; Duddukuri, Govinda Rao

    2016-10-01

    Arachidonic acid (AA) pathway, a metabolic process, plays a key role in carcinogenesis. Hence, AA pathway metabolic enzymes phospholipase A 2 s (PLA 2 s), cyclooxygenases (COXs) and lipoxygenases (LOXs) and their metabolic products, such as prostaglandins and leukotrienes, have been considered novel preventive and therapeutic targets in cancer. Bioactive natural products are a good source for development of novel cancer preventive and therapeutic drugs, which have been widely used in clinical practice due to their safety profiles. AA pathway inhibitory natural products have been developed as chemopreventive and therapeutic agents against several cancers. Curcumin, resveratrol, apigenin, anthocyans, berberine, ellagic acid, eugenol, fisetin, ursolic acid, [6]-gingerol, guggulsteone, lycopene and genistein are well known cancer chemopreventive agents which act by targeting multiple pathways, including COX-2. Nordihydroguaiaretic acid and baicalein can be chemopreventive molecules against various cancers by inhibiting LOXs. Several PLA 2 s inhibitory natural products have been identified with chemopreventive and therapeutic potentials against various cancers. In this review, we critically discuss the possible utility of natural products as preventive and therapeutic agents against various oncologic diseases, including prostate, pancreatic, lung, skin, gastric, oral, blood, head and neck, colorectal, liver, cervical and breast cancers, by targeting AA pathway. Further, the current status of clinical studies evaluating AA pathway inhibitory natural products in cancer is reviewed. In addition, various emerging issues, including bioavailability, toxicity and explorability of combination therapy, for the development of AA pathway inhibitory natural products as chemopreventive and therapeutic agents against human malignancy are also discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Development of dosimetry tools for proton therapy research

    International Nuclear Information System (INIS)

    Kim, Jong-Won; Kim, Dogyun

    2010-01-01

    Dosimetry tools for proton therapy research have been developed to measure the properties of a therapeutic proton beam. A CCD camera-scintillation screen system, which can verify the 2D dose distribution of a scanning beam and can be used for proton radiography, was developed. Also developed were a large area parallel-plate ionization chamber and a multi-layer Faraday cup to monitor the beam current and to measure the beam energy, respectively. To investigate the feasibility of locating the distal dose falloff in real time during patient treatment, a prompt gamma measuring system composed of multi-layer shielding structures was then devised. The system worked well for a pristine proton beam. However, correlation between the distal dose falloff and the prompt gamma distribution was blurred by neutron background for a therapy beam formed by scattering method. We have also worked on the design of a Compton camera to image the 2D distribution of prompt gamma rays.

  20. Recent developments in drying of food products

    Science.gov (United States)

    Valarmathi, T. N.; Sekar, S.; Purushothaman, M.; Sekar, S. D.; Rama Sharath Reddy, Maddela; Reddy, Kancham Reddy Naveen Kumar

    2017-05-01

    Drying is a dehydration process to preserve agricultural products for long period usage. The most common and cheapest method is open sun drying in which the products are simply laid on ground, road, mats, roof, etc. But the open sun drying has some disadvantages like dependent on good weather, contamination by dust, birds and animals consume a considerable quantity, slow drying rate and damages due to strong winds and rain. To overcome these difficulties solar dryers are developed with closed environment for drying agricultural products effectively. To obtain good quality food with reduced energy consumption, selection of appropriate drying process and proper input parameters is essential. In recent years several researchers across the world have developed new drying systems for improving the product quality, increasing the drying rate, decreasing the energy consumption, etc. Some of the new systems are fluidized bed, vibrated fluidized bed, desiccant, microwave, vacuum, freeze, infrared, intermittent, electro hydrodynamic and hybrid dryers. In this review the most recent progress in the field of drying of agricultural food products such as new methods, new products and modeling and optimization techniques has been presented. Challenges and future directions are also highlighted. The review will be useful for new researchers entering into this ever needed and ever growing field of engineering.

  1. Natural products as starting points for future anti-malarial therapies: going back to our roots?

    Directory of Open Access Journals (Sweden)

    Wells Timothy NC

    2011-03-01

    Full Text Available Abstract Background The discovery and development of new anti-malarials are at a crossroads. Fixed dose artemisinin combination therapy is now being used to treat a hundred million children each year, with a cost as low as 30 cents per child, with cure rates of over 95%. However, as with all anti-infective strategies, this triumph brings with it the seeds of its own downfall, the emergence of resistance. It takes ten years to develop a new medicine. New classes of medicines to combat malaria, as a result of infection by Plasmodium falciparum and Plasmodium vivax are urgently needed. Results Natural product scaffolds have been the basis of the majority of current anti-malarial medicines. Molecules such as quinine, lapachol and artemisinin were originally isolated from herbal medicinal products. After improvement with medicinal chemistry and formulation technologies, and combination with other active ingredients, they now make up the current armamentarium of medicines. In recent years advances in screening technologies have allowed testing of millions of compounds from pharmaceutical diversity for anti-malarial activity in cellular assays. These initiatives have resulted in thousands of new sub-micromolar active compounds – starting points for new drug discovery programmes. Against this backdrop, the paucity of potent natural products identified has been disappointing. Now is a good time to reflect on the current approach to screening herbal medicinal products and suggest revisions. Nearly sixty years ago, the Chinese doctor Chen Guofu, suggested natural products should be approached by dao-xing-ni-shi or ‘acting in the reversed order’, starting with observational clinical studies. Natural products based on herbal remedies are in use in the community, and have the potential unique advantage that clinical observational data exist, or can be generated. The first step should be the confirmation and definition of the clinical activity of herbal

  2. The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.

    Science.gov (United States)

    Rafiq, Qasim A; Ortega, Ilida; Jenkins, Stuart I; Wilson, Samantha L; Patel, Asha K; Barnes, Amanda L; Adams, Christopher F; Delcassian, Derfogail; Smith, David

    2015-11-01

    Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.

  3. Sharia Bank Product Development through Mudhrabah Investment

    Directory of Open Access Journals (Sweden)

    Trimulato Trimulato

    2016-12-01

    Full Text Available Sharia banking now has a strong legal framework with the presence of law number 21 of 2008 on sharia banking in Indonesia. This regulation enforces sharia banking to develop products to achieve the targeted market share of 5%. In third-party fund products, more innovation is needed to attract people to entrust their funds in sharia banks. The visible data of mudharabah fund raising deposit products in March 2013 amounted to Rp100.746.000.000 and Rp115.728.000.000 in mudharabah deposits was visible on April 2014, which is an increase of less than 2% each month. This research uses a qualitative descriptive methodology, and is focused on fund raising products in shari'ah banking, particularly in the form of mudharabah investments for a definitive result. The results show that sharia banking requires innovative fund raising for third-party products, such as mudharabah investment products. These investments provide certainty of results despite using mudharabah and are based on the certainty that projector financing has been agreed by the sharia with the creditor banks. This investment product can be offered to both individuals and groups/collectives. Keywords: sharia banking, investment, mudharabah

  4. Mechatronics design principles for biotechnology product development.

    Science.gov (United States)

    Mandenius, Carl-Fredrik; Björkman, Mats

    2010-05-01

    Traditionally, biotechnology design has focused on the manufacture of chemicals and biologics. Still, a majority of biotechnology products that appear on the market today is the result of mechanical-electric (mechatronic) construction. For these, the biological components play decisive roles in the design solution; the biological entities are either integral parts of the design, or are transformed by the mechatronic system. This article explains how the development and production engineering design principles used for typical mechanical products can be adapted to the demands of biotechnology products, and how electronics, mechanics and biology can be integrated more successfully. We discuss three emerging areas of biotechnology in which mechatronic design principles can apply: stem cell manufacture, artificial organs, and bioreactors. Copyright 2010 Elsevier Ltd. All rights reserved.

  5. Reference model for apparel product development

    Directory of Open Access Journals (Sweden)

    Isabel Cristina Moretti

    2017-03-01

    Full Text Available The purpose of this paper was to develop a reference model for the implementation of the process of product development (PDP for apparel. The tool was developed through an interactive process of comparison between theoretical. Managers in companies and professionals working in this market can utilize the reference model as a source for the organization and improvement of the PDP for apparel and the universities as a reference source for systematized teaching of this process. This model represents the first comprehensive attempt to develop an instrument at a detailed level (macro phases, phases, activities, inputs and outputs at each stage and at the gates to systematize the PDP process for fashion products and to consider its particularities.

  6. Sustainable development perspectives of poultry production

    DEFF Research Database (Denmark)

    Vaarst, Mette; Steenfeldt, Sanna; Horsted, Klaus

    2015-01-01

    or more of the four aspects, e.g., pollution and antibiotic use, biodiversity (environmental aspects), conditions for farm workers and animal welfare (social aspects), governance of the food chain (institutional aspects), and the development of poultry from a valuable food to a cheap staple food...... throughout major parts of the world (economic aspects). There are numerous potential pathways for sustainable development of poultry production. Poultry are living, sentient animals that can be well integrated into many different types of urban and rural farming systems, where they benefit from...... and contribute to such systems and to the livelihood of households around the globe, with special emphasis on women. Furthermore, local production provides potential for production with minimum transport and, concomitantly, minimum usage of fossil fuels. Among the terrestrial animals, poultry has the best...

  7. Consumer evaluations of products from developing countries

    NARCIS (Netherlands)

    Verlegh, P.W.J.

    2002-01-01

    Consumers use country of origin as a signal or proxy for product quality. Consumers have little confidence in the ability of less developed countries to produce high quality goods. On the other hand emotionally attachment to a country or associations of "exoticness" or "authenticity" can lead to a

  8. Consumer-driven food product development

    NARCIS (Netherlands)

    Linnemann, A.R.; Benner, M.; Verkerk, R.; Boekel, van M.A.J.S.

    2006-01-01

    Food product development needs to be based on consumers' needs and wishes to be successful. Factors that have become relevant in this respect are presented and their impact discussed, like mass-individualization, globalization and an altered interpretation of the food quality concept by consumers.

  9. Indicators for establishing SME product development networks

    NARCIS (Netherlands)

    Post, G.J.J.; Hop, L.; Aken, van J.E.

    2001-01-01

    The results of research into SME product development networks are presented. The paper provides insight to the process of establishing such networks and the use of indicators in the design and monitoring of this process. It is based on five extensive case studies and in addition on several in-depth

  10. Integrated Micro Product and Technology Development

    DEFF Research Database (Denmark)

    Hansen, Hans Nørgaard

    2003-01-01

    The paper addresses the issues of integrated micro product and technology development. The implications of the decisions in the design phase on the subsequent manufacturing processes are considered vital. A coherent process chain is a necessary prerequisite for the realisation of the industrial...... potential of micro technology....

  11. Development of hydrogen production technology using FBR

    International Nuclear Information System (INIS)

    Ono, Kiyoshi; Otaki, Akira; Chikazawa, Yoshitaka; Nakagiri, Toshio; Sato, Hiroyuki; Sekine, Takashi; Ooka, Makoto

    2004-06-01

    This report describes the features of technology, the schedule and the organization for the research and development regarding the hydrogen production technology using FBR thermal energy. Now, the hydrogen production system is proposed as one of new business models for FBR deployment. This system is the production of hydrogen either thermal energy at approximately from 500degC to 550degC or electricity produced by a sodium cooled FBR. Hydrogen is expected to be one of the future clean secondary energies without carbon-dioxide emission. Meanwhile the global energy demand will increase, especially in Asian countries, and the energy supply by fossil fuels is not the best choice considering the green house effect and the stability of energy supply. The development of the hydrogen technology using FBR that satisfies 'sustainable energy development' and 'utilization of energies free from environmental pollution' will be one of the promising options. Based on the above mentioned recognition, we propose the direction of the development, the issues to be solved, the time schedule, the budget, and the organization for R and D of three hydrogen production technologies, the thermochemical hybrid process, the low temperature steam reforming process, and the high temperature steam electrolysis process in JNC. (author)

  12. Increasing Sales by Developing Production Consortiums.

    Science.gov (United States)

    Smith, Christopher A.; Russo, Robert

    Intended to help rehabilitation facility administrators increase organizational income from manufacturing and/or contracted service sources, this document provides a decision-making model for the development of a production consortium. The document consists of five chapters and two appendices. Chapter 1 defines the consortium concept, explains…

  13. User-centeredness and Product Development

    DEFF Research Database (Denmark)

    Binder, Thomas; Brandt, Eva; Buur, Jacob

    1998-01-01

    TLA life cycle of approximately five years; Is it a new specialist domain that has to find its place among all the other specialities involved in product development; Or is it really so that we should continue co claim that what we are involved in has a calling for everyone engaged in bringing...

  14. Implementing Life Cycle Assessment in Product development

    DEFF Research Database (Denmark)

    Bhander, Gurbakhash Singh

    2003-01-01

    The overall aim of the paper is to provide an understanding of the environmental issues involved in the early stages of product development and the capacity of life cycle assessment techniques to address these issues. The paper aims to outline the problems for the designer in evaluating the envir......The overall aim of the paper is to provide an understanding of the environmental issues involved in the early stages of product development and the capacity of life cycle assessment techniques to address these issues. The paper aims to outline the problems for the designer in evaluating......, and of the opportunities for introducing environmental criteria in the design process through meeting the information requirements of the designer on the different life cycle stages, producing an in-depth understanding of the attitudes of practitioners among product developers to the subject area, and an understanding...... of possible future directions for product development. An Environmentally Conscious Design method is introduced and trade-offs are presented between design degrees of freedom and environmental solutions. Life cycle design frameworks and strategies are addressed. The paper collects experiences and ideas around...

  15. The develop of technology production in Spain

    International Nuclear Information System (INIS)

    Fernandez Labastida, J. M.

    2007-01-01

    Spanish Science and Technology system has been very effective in scientific production but not in technology transfer to economic activities. A cultural change is needed to improve the knowledge transfer mechanisms. Some specific actions are proposed in order to develop useful instruments to achieve a better technology transfer system. (Author)

  16. Challenges and future in vaccines, drug development, and immunomodulatory therapy.

    Science.gov (United States)

    Kling, Heather M; Nau, Gerard J; Ross, Ted M; Evans, Thomas G; Chakraborty, Krishnendu; Empey, Kerry M; Flynn, JoAnne L

    2014-08-01

    Pulmonary diseases and infections are among the top contributors to human morbidity and mortality worldwide, and despite the successful history of vaccines and antimicrobial therapeutics, infectious disease still presents a significant threat to human health. Effective vaccines are frequently unavailable in developing countries, and successful vaccines have yet to be developed for major global maladies, such as tuberculosis. Furthermore, antibiotic resistance poses a growing threat to human health. The "Challenges and Future in Vaccines, Drug Development, and Immunomodulatory Therapy" session of the 2013 Pittsburgh International Lung Conference highlighted several recent and current studies related to treatment and prevention of antibiotic-resistant bacterial infections, highly pathogenic influenza, respiratory syncytial virus, and tuberculosis. Research presented here focused on novel antimicrobial therapies, new vaccines that are either in development or currently in clinical trials, and the potential for immunomodulatory therapies. These studies are making important contributions to the areas of microbiology, virology, and immunology related to pulmonary diseases and infections and are paving the way for improvements in the efficacy of vaccines and antimicrobials.

  17. DNA repair mechanisms in cancer development and therapy.

    Science.gov (United States)

    Torgovnick, Alessandro; Schumacher, Björn

    2015-01-01

    DNA damage has been long recognized as causal factor for cancer development. When erroneous DNA repair leads to mutations or chromosomal aberrations affecting oncogenes and tumor suppressor genes, cells undergo malignant transformation resulting in cancerous growth. Genetic defects can predispose to cancer: mutations in distinct DNA repair systems elevate the susceptibility to various cancer types. However, DNA damage not only comprises a root cause for cancer development but also continues to provide an important avenue for chemo- and radiotherapy. Since the beginning of cancer therapy, genotoxic agents that trigger DNA damage checkpoints have been applied to halt the growth and trigger the apoptotic demise of cancer cells. We provide an overview about the involvement of DNA repair systems in cancer prevention and the classes of genotoxins that are commonly used for the treatment of cancer. A better understanding of the roles and interactions of the highly complex DNA repair machineries will lead to important improvements in cancer therapy.

  18. DNA Repair Mechanisms in Cancer Development and Therapy

    Directory of Open Access Journals (Sweden)

    Alessandro eTorgovnick

    2015-04-01

    Full Text Available DNA damage has been long recognized as causal factor for cancer development. When erroneous DNA repair leads to mutations or chromosomal aberrations affecting oncogenes and tumor suppressor genes, cells undergo malignant transformation resulting in cancerous growth. Genetic defects can predispose to cancer: Mutations in distinct DNA repair systems elevate the susceptibility to various cancer types. However, DNA damage not only comprises a root cause for cancer development but also continues to provide an important avenue for chemo- and radiotherapy. Since the beginning of cancer therapy, genotoxic agents have been applied that trigger DNA damage checkpoints that halt the growth and trigger the apoptotic demise of cancer cells. We provide an overview about the involvement of DNA repair systems in cancer prevention and the classes of genotoxins that are commonly used for the treatment of cancer. A better understanding of the roles and interactions of the highly complex DNA repair machineries will lead to important improvements in cancer therapy.

  19. Three-Dimensional Printing of Medicinal Products and the Challenge of Personalized Therapy.

    Science.gov (United States)

    Zema, Lucia; Melocchi, Alice; Maroni, Alessandra; Gazzaniga, Andrea

    2017-07-01

    By 3-dimensional (3D) printing, solid objects of any shape are fabricated through layer-by-layer addition of materials based on a digital model. At present, such a technique is broadly exploited in many industrial fields because of major advantages in terms of reduced times and costs of development and production. In the biomedical and pharmaceutical domains, the interest in 3D printing is growing in step with the needs of personalized medicine. Printed scaffolds and prostheses have partly replaced medical devices produced by more established techniques, and more recently, 3D printing has been proposed for the manufacturing of drug products. Notably, the availability of patient-tailored pharmaceuticals would be of utmost importance for children, elderly subjects, poor and high metabolizers, and individuals undergoing multiple drug treatments. 3D printing encompasses a range of differing techniques, each involving advantages and open issues. Particularly, solidification of powder, extrusion, and stereolithography have been applied to the manufacturing of drug products. The main challenge to their exploitation for personalized pharmacologic therapy is likely to be related to the regulatory issues involved and to implementation of production models that may allow to efficiently turn the therapeutic needs of individual patients into small batches of appropriate drug products meeting preset quality requirements. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  20. Mindfulness-based cognitive therapy for depression: trends and developments

    OpenAIRE

    MacKenzie, Meagan B; Kocovski, Nancy L

    2016-01-01

    Meagan B MacKenzie,1 Nancy L Kocovski21Department of Psychology, Ryerson University, Toronto, ON, Canada; 2Department of Psychology, Wilfrid Laurier University, Waterloo, ON, CanadaAbstract: Mindfulness-based cognitive therapy (MBCT) was developed as a psychological intervention for individuals at risk of depressive relapse. Possible mechanisms of change for this intervention are in line with its theoretical underpinnings, and include increases in mindfulness and/or decreases in nega...

  1. Development of Viral Vectors for Gene Therapy for Chronic Pain

    Directory of Open Access Journals (Sweden)

    Yu Huang

    2011-01-01

    Full Text Available Chronic pain is a major health concern that affects millions of people. There are no adequate long-term therapies for chronic pain sufferers, leading to significant cost for both society and the individual. The most commonly used therapy for chronic pain is the application of opioid analgesics and nonsteroidal anti-inflammatory drugs, but these drugs can lead to addiction and may cause side effects. Further studies of the mechanisms of chronic pain have opened the way for development of new treatment strategies, one of which is gene therapy. The key to gene therapy is selecting safe and highly efficient gene delivery systems that can deliver therapeutic genes to overexpress or suppress relevant targets in specific cell types. Here we review several promising viral vectors that could be applied in gene transfer for the treatment of chronic pain and further discuss the possible mechanisms of genes of interest that could be delivered with viral vectors for the treatment of chronic pain.

  2. Challenges of managing the development of breakthrough products in Japan

    NARCIS (Netherlands)

    Song, X.M.; Parry, M.E.

    1999-01-01

    We propose a contingency model and hypothesize that increases in product innovativeness weaken the influence of product synergies and development proficiencies on product performance. We incorporate these hypotheses in a path model linking measures of product synergy, development proficiency,

  3. Developing a Support Tool for Global Product Development Decisions

    DEFF Research Database (Denmark)

    Søndergaard, Erik Stefan; Ahmed-Kristensen, Saeema

    2016-01-01

    This paper investigates how global product development decisions are made through a multiple-case study in three Danish engineering. The paper identifies which information and methods are applied for making decisions and how decision-making can be supported based on previous experience. The paper...... presents results from 51 decisions made in the three companies, and based on the results of the studies a framework for a decision-support tool is outlined and discussed. The paper rounds off with an identification of future research opportunities in the area of global product development and decision-making....

  4. Metric integration architecture for product development

    Science.gov (United States)

    Sieger, David B.

    1997-06-01

    Present-day product development endeavors utilize the concurrent engineering philosophy as a logical means for incorporating a variety of viewpoints into the design of products. Since this approach provides no explicit procedural provisions, it is necessary to establish at least a mental coupling with a known design process model. The central feature of all such models is the management and transformation of information. While these models assist in structuring the design process, characterizing the basic flow of operations that are involved, they provide no guidance facilities. The significance of this feature, and the role it plays in the time required to develop products, is increasing in importance due to the inherent process dynamics, system/component complexities, and competitive forces. The methodology presented in this paper involves the use of a hierarchical system structure, discrete event system specification (DEVS), and multidimensional state variable based metrics. This approach is unique in its capability to quantify designer's actions throughout product development, provide recommendations about subsequent activity selection, and coordinate distributed activities of designers and/or design teams across all design stages. Conceptual design tool implementation results are used to demonstrate the utility of this technique in improving the incremental decision making process.

  5. Carborane derivative development for boron neutron capture therapy. Final report

    International Nuclear Information System (INIS)

    Barnum, Beverly A.; Yan Hao; Moore, Roger; Hawthorne, M. Frederick; Baum, Kurt

    1999-01-01

    Boron Neutron Capture Therapy [BNCT] is a binary method of cancer therapy based on the capture of neutrons by a boron-10 atom [ 10 B]. Cytotoxic 7 Li nuclei and α-particles are emitted, with a range in tissue of 9 and 5 microm, respectively, about one cell diameter. The major obstacle to clinically viable BNCT is the selective localization of 5-30 ppm 10 B in tumor cells required for effective therapy. A promising approach to BNCT is based on hydrophilic boron-rich oligomeric phosphate diesters, or ''trailers'' that have been shown to concentrate selectively in tumor tissue. Examples of these compounds were prepared previously at high cost using an automated DNA synthesizer. Direct synthesis methods are needed for the production of gram-scale quantities for further biological evaluation. The work accomplished as a result of the collaboration between Fluorochem, Inc. and UCLA demonstrates that short oligomers containing at least five carborane units with four phosphodiester linkages can be prepared in substantial quantities. This work was accomplished by the application of standard phosphoramidite coupling chemistry

  6. Cancer incidence and novel therapies developed in Japan

    Directory of Open Access Journals (Sweden)

    Masaru Iwasaki

    2012-01-01

    Full Text Available According to the ministry of Health, Labour and welfare of Japan, Cancer has been the leading cause of death in Japan since 1981. [1] As per the data in 2010, in Japan, one in every three deaths was due to cancer. [2] The Japanese Government has introduced so far, three terms of 10 years strategies for Cancer control since 1984 till date. The budget allocated for cancer control in 2009 was 52.5 billion yen in Japan. [3] Lung is the leading site for cancer in both males and females in Japan. In males, following the lung, stomach, liver, colon and pancreas are other leading sites while in the females, stomach, colon, pancreas and breast are the other leading sites.[1] In 2006, the cancer incidence was 694,000 and the male cancer incidence was 1.4 times as large as that of females. The peak age for cancer deaths in males is their fifties while in the females it is the sixties among Japanese. In addition to the conventional treatments such as surgery, radiotherapy and chemotherapy, some of other therapies in practice in Japan are the Hyperthermia [4] that uses high temperatures to kill or damage the cancer cells, the Ion Beam therapy using proton beams [5] to damage the DNA of the cells as cancer cells have high rate of cell divisions and lesser ability to repair DNA damage, the molecular targeted therapies that interfere with a specific molecular target involved in tumour growth and progression [6] and most importantly the autologous cell based Immunotherapies. Modern Cancer Immunotherapy started in the 1970s in Japan. The immunopotentiators using compounds from Bacteria, Beta Glucans from fungi were the first forms of modern Immunotherapy. Then was the era of direct injection of cytokines such as Interleukins, Interferons etc. The adverse effects associated with the injection of cytokines led to development of cell based Immunotherapies in the 1980s. [7] Immuno-cell therapies involve isolation of immune cells which are then processed and re

  7. Progress and challenges in the development of a cell-based therapy for hemophilia A.

    Science.gov (United States)

    Fomin, M E; Togarrati, P P; Muench, M O

    2014-12-01

    Hemophilia A results from an insufficiency of factor VIII (FVIII). Although replacement therapy with plasma-derived or recombinant FVIII is a life-saving therapy for hemophilia A patients, such therapy is a life-long treatment rather than a cure for the disease. In this review, we discuss the possibilities, progress, and challenges that remain in the development of a cell-based cure for hemophilia A. The success of cell therapy depends on the type and availability of donor cells, the age of the host and method of transplantation, and the levels of engraftment and production of FVIII by the graft. Early therapy, possibly even prenatal transplantation, may yield the highest levels of engraftment by avoiding immunological rejection of the graft. Potential cell sources of FVIII include a specialized subset of endothelial cells known as liver sinusoidal endothelial cells (LSECs) present in the adult and fetal liver, or patient-specific endothelial cells derived from induced pluripotent stem cells that have undergone gene editing to produce FVIII. Achieving sufficient engraftment of transplanted LSECs is one of the obstacles to successful cell therapy for hemophilia A. We discuss recent results from transplants performed in animals that show production of functional and clinically relevant levels of FVIII obtained from donor LSECs. Hence, the possibility of treating hemophilia A can be envisioned through persistent production of FVIII from transplanted donor cells derived from a number of potential cell sources or through creation of donor endothelial cells from patient-specific induced pluripotent stem cells. © 2014 International Society on Thrombosis and Haemostasis.

  8. Progress and challenges in the development of a cell-based therapy for hemophilia A

    Science.gov (United States)

    Fomin, Marina E.; Togarrati, Padma Priya; Muench, Marcus O.

    2015-01-01

    Hemophilia A results from an insufficiency of factor VIII (FVIII). Although replacement therapy with plasma-derived or recombinant FVIII is a life-saving therapy for hemophilia A patients, such therapy is a life-long treatment rather than a cure for the disease. In this review we discuss the possibilities, progress and challenges that remain in the development of a cell-based cure for hemophilia A. The success of cell therapy depends on the type and availability of donor cells, the age of the host and method of transplantation, and the levels of engraftment and production of FVIII by the graft. Early therapy, possibly even prenatal transplantation, may yield the highest levels of engraftment by avoiding immunological rejection of the graft. Potential cell sources of FVIII include a specialized subset of endothelial cells known as liver sinusoidal endothelial cells (LSECs) present in the adult and fetal liver, or patient-specific endothelial cells derived from induced pluripotent stem cells (iPSCs) that have undergone gene editing to produce FVIII. Achieving sufficient engraftment of transplanted LSECs is one of the obstacles to successful cell therapy for hemophilia A. We discuss recent results from transplants performed in animals that show production of functional and clinically relevant levels of FVIII obtained from donor LSECs. Hence, the possibility of treating hemophilia A can be envisioned through persistent production of FVIII from transplanted donor cells derived from a number of potential cell sources or through creation of donor endothelial cells from patient-specific iPSCs. PMID:25297648

  9. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

    Science.gov (United States)

    de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

    2018-03-21

    A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Sustainability Assessment Model in Product Development

    Science.gov (United States)

    Turan, Faiz Mohd; Johan, Kartina; Nor, Nik Hisyamudin Muhd; Omar, Badrul

    2017-08-01

    Faster and more efficient development of innovative and sustainable products has become the focus for manufacturing companies in order to remain competitive in today’s technologically driven world. Design concept evaluation which is the end of conceptual design is one of the most critical decision points. It relates to the final success of product development, because poor criteria assessment in design concept evaluation can rarely compensated at the later stages. Furthermore, consumers, investors, shareholders and even competitors are basing their decisions on what to buy or invest in, from whom, and also on what company report, and sustainability is one of a critical component. In this research, a new methodology of sustainability assessment in product development for Malaysian industry has been developed using integration of green project management, new scale of “Weighting criteria” and Rough-Grey Analysis. This method will help design engineers to improve the effectiveness and objectivity of the sustainable design concept evaluation, enable them to make better-informed decisions before finalising their choice and consequently create value to the company or industry. The new framework is expected to provide an alternative to existing methods.

  11. Production cost structure in US outpatient physical therapy health care.

    Science.gov (United States)

    Lubiani, Gregory G; Okunade, Albert A

    2013-02-01

    This paper investigates the technology cost structure in US physical therapy care. We exploit formal economic theories and a rich national data of providers to tease out implications for operational cost efficiencies. The 2008-2009 dataset comprising over 19 000 bi-weekly, site-specific physical therapy center observations across 28 US states and Occupational Employment Statistics data (Bureau of Labor Statistics) includes measures of output, three labor types (clinical, support, and administrative), and facilities (capital). We discuss findings from the iterative seemingly unrelated regression estimation system model. The generalized translog cost estimates indicate a well-behaved underlying technology structure. We also find the following: (i) factor demands are downwardly sloped; (ii) pair-wise factor relationships largely reflect substitutions; (iii) factor demand for physical therapists is more inelastic compared with that for administrative staff; and (iv) diminishing scale economies exist at the 25%, 50%, and 75% output (patient visits) levels. Our findings advance the timely economic understanding of operations in an increasingly important segment of the medical care sector that has, up-to-now (because of data paucity), been missing from healthcare efficiency analysis. Our work further provides baseline estimates for comparing operational efficiencies in physical therapy care after implementations of the 2010 US healthcare reforms. Copyright © 2012 John Wiley & Sons, Ltd.

  12. Development of Processed Products from Guapple

    Directory of Open Access Journals (Sweden)

    Teresita Acevedo

    1995-12-01

    Full Text Available The study aimed to develop processed products from guapple. Characterization of the guapple fruit was intially conducted before proceeding to formulation studies.The following characteristics of the guapple fruit were observed: color of outer skin - yellow green with Munsell notation of 10 Y7/6, color of inner flesh - off white with Munsell notation of 7.5Y 8/2; texture, 20.4-37.1 mm; average weight per piece, from 219 to 420 gms; ph, 3.7; titrable acidity (citric acid, 0.34%, and soluble solids, 2.6° Brix.The identified processed products from guapple were puree, pickles, and preserves. Standardized processes and formulations for each of these products were developed in semi-pilot scale. Removal of the skin for the guapple preserves and pickles was facilitated using 5% brine-l % CaCI2.Suitable packaging materials were also identified. Flexible films were used for guapple puree while glass jars and flexible films were found to be satisfactory both for guapple pickles and preserves.Physico-chemical, microbiological, and sensory evaluation were done after two months of storage. Based on these tests, the pasteurization process of 180° F for 20 minutes for puree and 10 minutes for preserves and pickles, was found to make the products commercially sterile.

  13. Developing symbiotic consortia for lignocellulosic biofuel production

    Energy Technology Data Exchange (ETDEWEB)

    Zuroff, Trevor R.; Curtis, Wayne R. [Pennsylvania State Univ., University Park, PA (United States). Dept. of Chemical Engineering

    2012-02-15

    The search for petroleum alternatives has motivated intense research into biological breakdown of lignocellulose to produce liquid fuels such as ethanol. Degradation of lignocellulose for biofuel production is a difficult process which is limited by, among other factors, the recalcitrance of lignocellulose and biological toxicity of the products. Consolidated bioprocessing has been suggested as an efficient and economical method of producing low value products from lignocellulose; however, it is not clear whether this would be accomplished more efficiently with a single organism or community of organisms. This review highlights examples of mixtures of microbes in the context of conceptual models for developing symbiotic consortia for biofuel production from lignocellulose. Engineering a symbiosis within consortia is a putative means of improving both process efficiency and stability relative to monoculture. Because microbes often interact and exist attached to surfaces, quorum sensing and biofilm formation are also discussed in terms of consortia development and stability. An engineered, symbiotic culture of multiple organisms may be a means of assembling a novel combination of metabolic capabilities that can efficiently produce biofuel from lignocellulose. (orig.)

  14. Decision Making Processes for Global Product Development - a Case Study

    DEFF Research Database (Denmark)

    Søndergaard, Erik Stefan; Ahmed-Kristensen, Saeema

    2015-01-01

    Global Product Development (GPD), outsourcing and offshoring of product development is a widespread phenomenon on today’s global economy, and consequently most engineering manufacturing companies will have to make decisions regarding how to organise their product development activities globally...

  15. PROGame: A process framework for serious game development for motor rehabilitation therapy.

    Science.gov (United States)

    Amengual Alcover, Esperança; Jaume-I-Capó, Antoni; Moyà-Alcover, Biel

    2018-01-01

    Serious game development for rehabilitation therapy is becoming increasingly popular because of the motivational advantages that these types of applications provide. Consequently, the need for a common process framework for this category of software development has become increasingly evident. The goal is to guarantee that products are developed and validated by following a coherent and systematic method that leads to high-quality serious games. This paper introduces a new process framework for the development of serious games for motor rehabilitation therapy. We introduce the new model and demonstrate its application for the development of a serious game for the improvement of the balance and postural control of adults with cerebral palsy. The development of this application has been facilitated by two technological transfer contracts and is being exploited by two different organizations. According to clinical measurements, patients using the application improved from high fall risk to moderate fall risk. We believe that our development strategy can be useful not only for motor rehabilitation therapy, but also for the development of serious games in many other rehabilitation areas.

  16. Collaborative product development and situated knowledge contexts

    DEFF Research Database (Denmark)

    Andersen, Poul Houman; Munksgaard, Kristin B.

    2009-01-01

    Purpose - The purpose of this paper is to develop a framework for understanding how problem formulation, information search and division of work in new product development (NPD) activities is shaped by mind sets vested in organizations with diverging positions in the value chain and correspondingly...... situated knowledge contexts. The authors aim to focus on how this influences the marketability of new product ideas. Design/methodology/approach - The empirical data are derived from exploratory observation studies of NPD meetings and interviews of involved managers and specialists in three business dyads....... The cases involve ingredient and meat suppliers, retail chains and marketing agencies located in Denmark. Findings - The authors show that the scope and organization of NPD activities indeed are shaped by the combinations of situated knowledge contexts involved. An important intervening variable however...

  17. Drivers of Changes in Product Development Rules

    DEFF Research Database (Denmark)

    Christiansen, John K.; Varnes, Claus J.

    2015-01-01

    regimes. However, the analysis here indicates that there are different drivers, both internal and external, that cause companies to adopt new rules or modify their existing ones, such as changes in organizational structures, organizational conflicts, and changes in ownership or strategy. In addition......Purpose: - The purpose of this research is to investigate the drivers that induce companies to change their rules for managing product development. Most companies use a form of rule-based management approach, but surprisingly little is known about what makes companies change these rules...... 10 years based on three rounds of interviews with 40 managers. Findings: - Previous research has assumed that the dynamics of product development rules are based on internal learning processes, and that increasingly competent management will stimulate the implementation of newer and more complex rule...

  18. Top Management Involvement in New Product Development

    DEFF Research Database (Denmark)

    Felekoglu, Burcu; Maier, Anja; Moultrie, James

    2010-01-01

    a broader conceptual space than this participation. This paper reviews the literature on top management involvement in new product development (NPD) and discusses relevance of different theoretical perspectives from other disciplines such as management, organisational behaviour and communication to analyse......Involvement of top managers in new product development (NPD) is a critical factor affecting NPD performance and frequently considered to be the participation of top management to certain activities in NPD or their NPD related behaviours. However, “Top management involvement in NPD” occupies...... antecedents, realisation and consequences of top management involvement in NPD. It is argued that top management has different involvement at different NPD levels: organisation level and project level. Resulting from this literature review, a tentative framework for top management involvement in NPD...

  19. Model of the Product Development Lifecycle.

    Energy Technology Data Exchange (ETDEWEB)

    He, Sunny L. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Roe, Natalie H. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Wood, Evan [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Nachtigal, Noel M. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Helms, Jovana [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-10-01

    While the increased use of Commercial Off-The-Shelf information technology equipment has presented opportunities for improved cost effectiveness and flexibility, the corresponding loss of control over the product's development creates unique vulnerabilities and security concerns. Of particular interest is the possibility of a supply chain attack. A comprehensive model for the lifecycle of hardware and software products is proposed based on a survey of existing literature from academic, government, and industry sources. Seven major lifecycle stages are identified and defined: (1) Requirements, (2) Design, (3) Manufacturing for hardware and Development for software, (4) Testing, (5) Distribution, (6) Use and Maintenance, and (7) Disposal. The model is then applied to examine the risk of attacks at various stages of the lifecycle.

  20. Decisions on new product development under uncertainties

    Science.gov (United States)

    Huang, Yeu-Shiang; Liu, Li-Chen; Ho, Jyh-Wen

    2015-04-01

    In an intensively competitive market, developing a new product has become a valuable strategy for companies to establish their market positions and enhance their competitive advantages. Therefore, it is essential to effectively manage the process of new product development (NPD). However, since various problems may arise in NPD projects, managers should set up some milestones and subsequently construct evaluative mechanisms to assess their feasibility. This paper employed the approach of Bayesian decision analysis to deal with the two crucial uncertainties for NPD, which are the future market share and the responses of competitors. The proposed decision process can provide a systematic analytical procedure to determine whether an NPD project should be continued or not under the consideration of whether effective usage is being made of the organisational resources. Accordingly, the proposed decision model can assist the managers in effectively addressing the NPD issue under the competitive market.

  1. Mindfulness-based cognitive therapy for depression: trends and developments

    Directory of Open Access Journals (Sweden)

    MacKenzie MB

    2016-05-01

    Full Text Available Meagan B MacKenzie,1 Nancy L Kocovski21Department of Psychology, Ryerson University, Toronto, ON, Canada; 2Department of Psychology, Wilfrid Laurier University, Waterloo, ON, CanadaAbstract: Mindfulness-based cognitive therapy (MBCT was developed as a psychological intervention for individuals at risk of depressive relapse. Possible mechanisms of change for this intervention are in line with its theoretical underpinnings, and include increases in mindfulness and/or decreases in negative repetitive thoughts. This review provides an overview of current trends in MBCT research, including efficacy and questions regarding the specific effects of MBCT in light of recent comparisons with structurally equivalent control conditions, mechanisms of change, and moderators of treatment outcome. In addition, future directions are discussed, such as challenges with training an adequate number of therapists and disseminating this therapy.Keywords: MBCT, efficacy, mechanisms of change, dissemination, moderators

  2. Medical Countermeasure Product Development - Alternatives Paper

    Science.gov (United States)

    2014-04-01

    Maritime Research Laboratory of the Defence Science and Technology Organisation (DSTO) in 1995 as a Research Scientist. In January 1997 he was promoted... biosecurity role to supply to the Government and the World Health Organisation (WHO). In the future there may be circumstances where there is no... standards to solve national priority CBR or infectious disease threats. The PPP may enable Government to: • access and grow product development

  3. Transferring World Class Production to Developing Countries

    DEFF Research Database (Denmark)

    Bruun, Peter; Mefford, Robert Neil

    1998-01-01

    Strategic reasons for firms to transfer world-class production methods and technology to developing countries are discussed and the importance of the management aspects of technology transfer are emphasized. A five stage model of the technology transfer process which bases the choice of the produ....... The barriers and challenges of implementation are considered, and a socio-technical systems approach is proposed as a way to addapt to local conditions....

  4. Learning within a product development working practice

    OpenAIRE

    Bang Mathiasen, John

    2012-01-01

    The subject matter chosen for this PhD, learning within a Product Development (PD) working practice, might give rise to wonder given that I have a theoretical education within supply chain management, achieved practical experience as senior supply chain manager and finally, conducted a great many lectures dealing with supply chain management. Offhand, it may seem an odd choice, but my practical experience, briefly illustrated in the below, triggered the decision to study learni...

  5. Development of fission Mo production technology

    International Nuclear Information System (INIS)

    Kim, B. K.; Park, K. B.; Jun, B. J.; Park, J. H.; Choung, W. M.; Lee, K. I.; Woo, M. S.; Whang, D. S.; Kim, Y. K.; Yoo, J. H.; Sohn, D. S.; Lee, Y. W.; Na, S. H.; Koo, Y. H.; Hwang, D. H.; Joo, P. K.

    1997-08-01

    The feasibility study is accomplished in this project for the development of fission moly production. The KAERI process proposed for development in KAERI is discussed together with those of the American Cintichem and Russian IPPE, each of which would be plausible for introduction whenever the indigenous development is not much feasible. For the conceptual design of the KAERI irradiation target, analysis method is set up and some preliminary analysis is performed accordingly for the candidate design. To establish chemical process concepts for the afore-mentioned three processes, characteristics, operation conditions, and the management of the generated wastes are investigated. Basic requirements of hotcell facilities for chemical processing and a possible way of utilizing the existing hotcells are discussed in parallel with the counter-measures for the construction of new hotcell facilities. Various conditions of target irradiation for fission moly production in Hanaro are analyzed. Plan for introduction of the relevant technology introduction and for procurement of highly enriched uranium are considered. On the basis of assuming some conditions, the economic feasibility study for fission moly production is also overviewed. (author). 22 refs., 28 tabs., 24 figs

  6. LEAN PRACTICES FOR PRODUCT DEVELOPMENT PROCESS

    Directory of Open Access Journals (Sweden)

    Guilherme Luz Tortorella

    2015-06-01

    Full Text Available Lean product development (LPD is an approach that comprises lean principles and management practices that aim to reduce waste and improve operational effectiveness throughout the entire value stream in continuous improvement endless journey. Due to that, the ability to innovate, change and learn continuously is a key element in order to minimize product development problems. Several LPD techniques are presented in the literature as possible enablers for lean implementation. However, little has been known about the impact of these enablers on the problems related to product development processes. Thus, this paper aims to examine the relationship between five LPD practices’ constructs and the occurrence frequency of eleven LPD problems’ constructs in companies that are implementing lean. Moreover, the identification of relevant relationships between LPD practices’ and problems’ constructs may contribute to specify the contexts in which problems are expected to occur. The study sample comprises sixty four companies already undergoing lean implementation both in shop floor and offices area. The results indicate that the same practices’ constructs, which are deemed as influential for minimizing LPD problems, present different relationship intensities among them.

  7. Environmental Priorities In Strategic Product Development

    DEFF Research Database (Denmark)

    Simon, M; Poole, S.; Sweatman, A.

    2000-01-01

    -design framework consisting of analyse, report, prioritize and improve steps, at both strategic and operational levels. Tests the framework by application in an Electrolux subsidiary producing vacuum cleaners, tabulates LCA results for one product and its constituents and components. Concludes that prioritizing......Reports progress of the Design for Environmental Decision Support (DEEDS) project, gives the project's aim as the development of appropriate tools and methods for eco-design for use in the electrical/electronics sector. Bases development of the tools and methods on the results of a survey of 19...

  8. GELCASTING: From laboratory development toward industrial production

    Energy Technology Data Exchange (ETDEWEB)

    Omatete, O.O.; Janney, M.A.; Nunn, S.D.

    1995-07-01

    Gelcasting, a ceramic forming process, was developed to overcome some of the limitations of other complex-shape forming techniques such as injection molding and slip casting. In gelcasting, a concentrated slurry of ceramic powder in a solution of organic monomers is poured into a mold and then polymerized in-situ to form a green body in the shape of the mold cavity. Thus, it is a combination of polymer chemistry with slip processing and represents minimal departure from standard ceramic processing. The simplicity of the process has attracted industrial partners and by collaboration between them and the developers, the process is being advanced from the laboratory toward industrial production.

  9. Accelerator based production of auger-electron-emitting isotopes for radionuclide therapy

    International Nuclear Information System (INIS)

    Thisgaard, H.

    2008-08-01

    In this research project the focus has been on the identification and production of new, unconventional Auger-electron-emitting isotopes for targeted radionuclide therapy of cancer. Based on 1st principles dosimetry calculations on the subcellular level, the Auger-emitter 119Sb has been identified as a potent candidate for therapy. The corresponding imaging analogue 117Sb has been shown from planar scintigraphy and single-photon emission computed tomography (SPECT) to be suitable for SPECT-based dosimetry of a future Sb-labeled radiopharmaceutical. The production method of these radioisotopes has been developed using a low-energy cyclotron via the nuclear reactions 119Sn(p,n)119Sb and 117Sn(p,n)117Sb including measurements of the excitation function for the former reaction. Moreover, a new high-yield radiochemical separation method has been developed to allow the subsequent separation of the produced 119Sb from the enriched 119Sn target material with high radionuclidic- and chemical purity. A method that also allows efficient recovery of the 119Sn for recycling. To demonstrate the ability of producing therapeutic quantities of 119Sb and other radioisotopes for therapy with a low-energy cyclotron, two new 'High Power' cyclotron targets were developed in this study. The target development was primarily based on theoretical thermal modeling calculations using finite-element-analysis software. With these targets, I have shown that it will be possible to produce several tens of GBq of therapeutics isotopes (e.g. 119Sb or 64Cu) using the PETtrace cyclotron commonly found at the larger PET-centers in the hospitals. Finally, research in a new method to measure the radiotoxicity of Auger-emitters invitro using cellular microinjection has been carried out. The purpose of this method is to be able to experimentally evaluate and compare the potency of the new and unconventional Auger-emitters (e.g. 119Sb). However, due to experimental complications, the development of this

  10. Accelerator based production of auger-electron-emitting isotopes for radionuclide therapy

    Energy Technology Data Exchange (ETDEWEB)

    Thisgaard, H.

    2008-08-15

    In this research project the focus has been on the identification and production of new, unconventional Auger-electron-emitting isotopes for targeted radionuclide therapy of cancer. Based on 1st principles dosimetry calculations on the subcellular level, the Auger-emitter 119Sb has been identified as a potent candidate for therapy. The corresponding imaging analogue 117Sb has been shown from planar scintigraphy and single-photon emission computed tomography (SPECT) to be suitable for SPECT-based dosimetry of a future Sb-labeled radiopharmaceutical. The production method of these radioisotopes has been developed using a low-energy cyclotron via the nuclear reactions 119Sn(p,n)119Sb and 117Sn(p,n)117Sb including measurements of the excitation function for the former reaction. Moreover, a new high-yield radiochemical separation method has been developed to allow the subsequent separation of the produced 119Sb from the enriched 119Sn target material with high radionuclidic- and chemical purity. A method that also allows efficient recovery of the 119Sn for recycling. To demonstrate the ability of producing therapeutic quantities of 119Sb and other radioisotopes for therapy with a low-energy cyclotron, two new 'High Power' cyclotron targets were developed in this study. The target development was primarily based on theoretical thermal modeling calculations using finite-element-analysis software. With these targets, I have shown that it will be possible to produce several tens of GBq of therapeutics isotopes (e.g. 119Sb or 64Cu) using the PETtrace cyclotron commonly found at the larger PET-centers in the hospitals. Finally, research in a new method to measure the radiotoxicity of Auger-emitters invitro using cellular microinjection has been carried out. The purpose of this method is to be able to experimentally evaluate and compare the potency of the new and unconventional Auger-emitters (e.g. 119Sb). However, due to experimental complications, the development

  11. South Africa's nuclear hydrogen production development programme

    International Nuclear Information System (INIS)

    Van Ravenswaay, J.P.; Van Niekerk, F.; Kriek, R.J.; Blom, E.; Krieg, H.M.; Van Niekerk, W.M.K.; Van der Merwe, F.; Vosloo, H.C.M.

    2010-01-01

    In May 2007 the South African Cabinet approved a National Hydrogen and Fuel Cell Technologies R and D and Innovation Strategy. The strategy will focus on research, development and innovation for: i) wealth creation through high value-added manufacturing and developing platinum group metals catalysis; ii) building on the existing knowledge in high temperature gas-cooled reactors (HTGR) and coal gasification Fischer-Tropsch technology, to develop local cost-competitive hydrogen production solutions; iii) to promote equity and inclusion in the economic benefits from South Africa's natural resource base. As part of the roll-out strategy, the South African Department of Science and Technology (DST) created three Competence Centres (CC), including a Hydrogen Infrastructure Competence Centre hosted by the North-West University (NWU) and the Council for Scientific and Industrial Research (CSIR). The Hydrogen Infrastructure CC is tasked with developing hydrogen production, storage, distribution as well as codes and standards programmes within the framework of the DST strategic objectives to ensure strategic national innovation over the next fifteen years. One of the focus areas of the Hydrogen Infrastructure CC will be on large scale CO 2 free hydrogen production through thermochemical water-splitting using nuclear heat from a suitable heat source such as a HTGR and the subsequent use of the hydrogen in applications such as the coal-to-liquid process and the steel industry. This paper will report on the status of the programme for thermochemical water-splitting as well as the associated projects for component and technology development envisaged in the Hydrogen Infrastructure CC. The paper will further elaborate on current and future collaboration opportunities as well as expected outputs and deliverables. (authors)

  12. Testing Software Development Project Productivity Model

    Science.gov (United States)

    Lipkin, Ilya

    Software development is an increasingly influential factor in today's business environment, and a major issue affecting software development is how an organization estimates projects. If the organization underestimates cost, schedule, and quality requirements, the end results will not meet customer needs. On the other hand, if the organization overestimates these criteria, resources that could have been used more profitably will be wasted. There is no accurate model or measure available that can guide an organization in a quest for software development, with existing estimation models often underestimating software development efforts as much as 500 to 600 percent. To address this issue, existing models usually are calibrated using local data with a small sample size, with resulting estimates not offering improved cost analysis. This study presents a conceptual model for accurately estimating software development, based on an extensive literature review and theoretical analysis based on Sociotechnical Systems (STS) theory. The conceptual model serves as a solution to bridge organizational and technological factors and is validated using an empirical dataset provided by the DoD. Practical implications of this study allow for practitioners to concentrate on specific constructs of interest that provide the best value for the least amount of time. This study outlines key contributing constructs that are unique for Software Size E-SLOC, Man-hours Spent, and Quality of the Product, those constructs having the largest contribution to project productivity. This study discusses customer characteristics and provides a framework for a simplified project analysis for source selection evaluation and audit task reviews for the customers and suppliers. Theoretical contributions of this study provide an initial theory-based hypothesized project productivity model that can be used as a generic overall model across several application domains such as IT, Command and Control

  13. Novel approaches are needed to develop tomorrow's antibacterial therapies.

    Science.gov (United States)

    Spellberg, Brad; Bartlett, John; Wunderink, Rich; Gilbert, David N

    2015-01-15

    Society faces a crisis of rising antibiotic resistance even as the pipeline of new antibiotics has been drying up. Antibiotics are a public trust; every individual's use of antibiotics affects their efficacy for everyone else. As such, responses to the antibiotic crisis must take a societal perspective. The market failure of antibiotics is due to a combination of scientific challenges to discovering and developing new antibiotics, unfavorable economics, and a hostile regulatory environment. Scientific solutions include changing the way we screen for new antibiotics. More transformationally, developing new treatments that seek to disarm pathogens without killing them, or that modulate the host inflammatory response to infection, will reduce selective pressure and hence minimize resistance emergence. Economic transformation will require new business models to support antibiotic development. Finally, regulatory reform is needed so that clinical development programs are feasible, rigorous, and clinically relevant. Pulmonary and critical care specialists can have tremendous impact on the continued availability of effective antibiotics. Encouraging use of molecular diagnostic tests to allow pathogen-targeted, narrow-spectrum antibiotic therapy, using short rather than unnecessarily long course therapy, reducing inappropriate antibiotic use for probable viral infections, and reducing infection rates will help preserve the antibiotics we have for future generations.

  14. Association of subcutaneous testosterone pellet therapy with developing secondary polycythemia

    Science.gov (United States)

    Rotker, Katherine Lang; Alavian, Michael; Nelson, Bethany; Baird, Grayson L; Miner, Martin M; Sigman, Mark; Hwang, Kathleen

    2018-01-01

    A variety of methods for testosterone replacement therapy (TRT) exist, and the major potential risks of TRT have been well established. The risk of developing polycythemia secondary to exogenous testosterone (T) has been reported to range from 0.4% to 40%. Implantable T pellets have been used since 1972, and secondary polycythemia has been reported to be as low as 0.4% with this administration modality. However, our experience has suggested a higher rate. We conducted an institutional review board-approved, single-institution, retrospective chart review (2009–2013) to determine the rate of secondary polycythemia in 228 men treated with subcutaneously implanted testosterone pellets. Kaplan–Meyer failure curves were used to estimate time until the development of polycythemia (hematocrit >50%). The mean number of pellets administered was 12 (range: 6–16). The mean follow-up was 566 days. The median time to development of polycythemia whereby 50% of patients developed polycythemia was 50 months. The estimated rate of polycythemia at 6 months was 10.4%, 12 months was 17.3%, and 24 months was 30.2%. We concluded that the incidence of secondary polycythemia while on T pellet therapy may be higher than previously established. PMID:29205178

  15. Challenges and Future in Vaccines, Drug Development, and Immunomodulatory Therapy

    Science.gov (United States)

    Nau, Gerard J.; Ross, Ted M.; Evans, Thomas G.; Chakraborty, Krishnendu; Empey, Kerry M.; Flynn, JoAnne L.

    2014-01-01

    Pulmonary diseases and infections are among the top contributors to human morbidity and mortality worldwide, and despite the successful history of vaccines and antimicrobial therapeutics, infectious disease still presents a significant threat to human health. Effective vaccines are frequently unavailable in developing countries, and successful vaccines have yet to be developed for major global maladies, such as tuberculosis. Furthermore, antibiotic resistance poses a growing threat to human health. The “Challenges and Future in Vaccines, Drug Development, and Immunomodulatory Therapy” session of the 2013 Pittsburgh International Lung Conference highlighted several recent and current studies related to treatment and prevention of antibiotic-resistant bacterial infections, highly pathogenic influenza, respiratory syncytial virus, and tuberculosis. Research presented here focused on novel antimicrobial therapies, new vaccines that are either in development or currently in clinical trials, and the potential for immunomodulatory therapies. These studies are making important contributions to the areas of microbiology, virology, and immunology related to pulmonary diseases and infections and are paving the way for improvements in the efficacy of vaccines and antimicrobials. PMID:25148426

  16. Affordability for sustainable energy development products

    International Nuclear Information System (INIS)

    Riley, Paul H.

    2014-01-01

    Highlights: • Clean cookstoves that also generate electricity improve affordability. • Excel spreadsheet model to assist stakeholders to choose optimum technology. • Presents views for each stakeholder villager, village and country. • By adding certain capital costs, affordability and sustainability are improved. • Affordability is highly dependent on carbon credits and social understandings. - Abstract: Clean burning products, for example cooking stoves, can reduce household air pollution (HAP), which prematurely kills 3.5 million people each year. By careful selection of components into a product package with micro-finance used for the capital payment, barriers to large-scale uptake of products that remove HAP are reduced. Such products reduce smoke from cooking and the lighting from electricity produced, eliminates smoke from kerosene lamps. A bottom-up financial model, that is cognisant of end user social needs, has been developed to compare different products for use in rural areas of developing countries. The model is freely available for use by researchers and has the ability to assist in the analysis of changing assumptions. Business views of an individual villager, the village itself and a country view are presented. The model shows that affordability (defined as the effect on household expenses as a result of a product purchase) and recognition of end-user social needs are as important as product cost. The effects of large-scale deployment (greater that 10 million per year) are described together with level of subsidy required by the poorest people. With the assumptions given, the model shows that pico-hydro is the most cost effective, but not generally available, one thermo-acoustic technology option does not require subsidy, but it is only at technology readiness level 2 (NASA definition) therefore costs are predicted and very large investment in manufacturing capability is needed to meet the cost target. Thermo-electric is currently the only

  17. Development of radioisotope production in the Philippines

    Energy Technology Data Exchange (ETDEWEB)

    Cabalfin, E G [Philippine Nuclear Research Institute, Quezon (Philippines)

    1998-10-01

    The Philippine Nuclear Research Institute (PNRI) started its activities on radioisotope production more than three decades ago, when the Philippine Research Reactor (PRR-1) started operating at its full rated power of 1 MW. Since then, several radionuclides in different chemical forms, were routinely produced and supplied for use in nuclear medicine, industry, agriculture, research and training, until the conversion of the PRR-1 to a 3 MW TRIGA type reactor. After the criticality test of the upgraded reactor, a leak was discovered in the pool liner. With the repair of the reactor still ongoing, routine radioisotope production activities have been reduced to dispensing of imported bulk {sup 131}I. In the Philippines, radioisotopes are widely used in nuclear medicine, with {sup 131}I and {sup 99m}Tc as the major radionuclides of interest. Thus the present radioisotope production program of PNRI is directed to meet this demand. With the technical assistance of the International Atomic Energy Agency (IAEA), PNRI is setting up a new {sup 131}I production facility. The in-cell equipment have been installed and tested using both inactive and active target, obtained from BATAN, Indonesia. In order to meet the need of producing {sup 99}Mo-{sup 99m}Tc generators, based on low specific activity reactor-produced {sup 99}Mo, research and development work on the preparation of {sup 99m}Tc gel generators is ongoing. (author)

  18. Renal denervation therapy for hypertension: pathways for moving development forward.

    Science.gov (United States)

    White, William B; Galis, Zorina S; Henegar, Jeffrey; Kandzari, David E; Victor, Ronald; Sica, Domenic; Townsend, Raymond R; Turner, J Rick; Virmani, Renu; Mauri, Laura

    2015-05-01

    This scientific statement provides a summary of presentations and discussions at a cardiovascular Think Tank co-sponsored by the American Society of Hypertension (ASH), the United States Food and Drug Administration (FDA), and the National Heart, Lung, and Blood Institute (NHLBI) held in North Bethesda, Maryland, on June 26, 2014. Studies of device therapies for the treatment of hypertension are requested by regulators to evaluate their safety and efficacy during their development programs. Think Tank participants thought that important considerations in undertaking such studies were: (1) Preclinical assessment: how likely it is that both efficacy and safety data indicating benefit in humans will be obtained, and/or whether a plausible mechanism of action for efficacy can be identified; (2) Early human trial(s): the ability to determine that the device has an acceptable benefit-to-risk balance for its use in the intended patient population and without the influence of drug therapy during a short-term follow-up period; and (3) Pivotal Phase III trial(s): the ability to prove the effectiveness of the device in a broad population in which the trial can be made as non-confounded as possible while still allowing for the determination for benefits when added to antihypertensive therapies. Copyright © 2015 American Society of Hypertension. All rights reserved.

  19. Developing Home-Based Virtual Reality Therapy Interventions.

    Science.gov (United States)

    Lin, Janice; Kelleher, Caitlin L; Engsberg, Jack R

    2013-02-01

    Stroke is one of the leading causes of serious long-term disability. However, home exercise programs given at rehabilitation often lack in motivational aspects. The purposes of this pilot study were (1) create individualized virtual reality (VR) games and (2) determine the effectiveness of VR games for improving movement in upper extremities in a 6-week home therapy intervention for persons with stroke. Participants were two individuals with upper extremity hemiparesis following a stroke. VR games were created using the Looking Glass programming language and modified based on personal interests, goals, and abilities. Participants were asked to play 1 hour each day for 6 weeks. Assessments measured upper extremity movement (range of motion and Action Research Arm Test [ARAT]) and performance in functional skills (Canadian Occupational Performance Measure [COPM] and Motor Activity Log [MAL]). Three VR games were created by a supervised occupational therapist student. The participants played approximately four to six times a week and performed over 100 repetitions of movements each day. Participants showed improvement in upper extremity movement and participation in functional tasks based on results from the COPM, ARAT, and MAL. Further development in the programming environment is needed to be plausible in a rehabilitation setting. Suggestions include graded-level support and continuation of creating a natural programming language, which will increase the ability to use the program in a rehabilitation setting. However, the VR games were shown to be effective as a home therapy intervention for persons with stroke. VR has the potential to advance therapy services by creating a more motivating home-based therapy service.

  20. Country report: Serbia. Development, Preparing and Quality Assurance of Radiopharmaceuticals Based on 188Re and 90Y for Radionuclide Therapy: The Possibilities for their Production in Laboratory for Radioisotopes, Ins «Vinča»

    International Nuclear Information System (INIS)

    Djokić, Divna

    2010-01-01

    The main object of the research planed for this project was to optimize the procedures for the 90 Y and 188 Re labelling of different compounds as well as their in vitro and in vivo evaluation. The work has been involved setting up the facilities, standardization of preparing protocols, and improving existing quality assurance/quality control (QA/QC) procedures in order to supply reliable products to the national nuclear medicine community

  1. Country report: Serbia. Development, Preparing and Quality Assurance of Radiopharmaceuticals Based on {sup 188}Re and {sup 90}Y for Radionuclide Therapy: The Possibilities for their Production in Laboratory for Radioisotopes, Ins «Vinča»

    Energy Technology Data Exchange (ETDEWEB)

    Djokić, Divna [Vinča Institute of Nuclear Sciences, Laboratory for Radioisotopes, Belgrade (Serbia)

    2010-07-01

    The main object of the research planed for this project was to optimize the procedures for the {sup 90}Y and {sup 188}Re labelling of different compounds as well as their in vitro and in vivo evaluation. The work has been involved setting up the facilities, standardization of preparing protocols, and improving existing quality assurance/quality control (QA/QC) procedures in order to supply reliable products to the national nuclear medicine community.

  2. Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

    Science.gov (United States)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-05-01

    On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.

  3. Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market – Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014

    Science.gov (United States)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A.; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-01-01

    On September 11, 2014, a workshop entitled ‘Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market’ was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT. PMID:26195933

  4. Atopic dermatitis in children: prospects of using innovation products as an external therapy

    Directory of Open Access Journals (Sweden)

    M. M. Tlish

    2016-01-01

    Full Text Available Goal of the research: to determine the efficacy of a new line of Atopic cosmetic products for skin care in children suffering from atopic dermatitis. Materials and methods: The study involved three groups of 15 children aged 3-12 suffering from atopic dermatitis in each group. Subjects from Group 1 were treated with Atopic Soothing Cream, from Group 2 with Atopic Soothing Stick Cream and from Group 3 with Atopic Everyday Care Cream. Different inclusion and exclusion criteria were developed for each group, and the algorithm for the product application and efficacy criteria were determined. According to recommendations, Atopic Soothing Cream and Atopic Soothing Stick Cream were applied to clean and dry skin in the morning and in the evening for the study period of 14 days. The patients’ skin condition was assessed prior to the study and on Day 14 of the therapy; the assessment covered parameters necessary for calculating the SCORAD Index. Atopic Everyday Care Cream was applied to clean and dry skin in the morning and in the evening for 28 days. The patients’ skin condition was assessed prior to the study and on Days 14 and 28 of the therapy including the SCORAD Index and assessments of the skin hydration level of the epidermal corneous layer and transepidermal waster loss (TEWL using the DermaLabCombo CORTEX device. According to the study results, the line of Atopic cosmetic products fully complies with the properties specified by the manufacturer, reliably improves the skin condition in children suffering from atopic dermatitis, has no irritant or sensitizing effect, and can be recommended for the complex treatment and rehabilitation of patients suffering from the pathology.

  5. Development of radioisotope production in JAERI

    International Nuclear Information System (INIS)

    Yamabayashi, H.; Kato, H.; Umezawa, H.

    1992-01-01

    Since 1962, we have been developing methods and technology for producing a wide variety of processed radioisotopes and sealed radiation sources by using the JAERI's reactors, JRR-2, JRR-3, JRR-4 and JMTR, and providing the products to domestic users. At present, 29 nuclides and 31 products are on our list of processed radioisotopes. Some of those isotopes such as P-32, S-35, Cr-51 and short-lived nuclides are being produced regularly for distribution, but most of the rest are produced upon request. The radiation sources of Co-60 needles and Ir-192 pellets for industrial use and Gd-153 pellet, 7 kinds of Ir-192 and Au-198 grain for medical applications are produced and distributed routinely. (author)

  6. Management Control in New Product Development

    DEFF Research Database (Denmark)

    Jørgensen, Brian; Messner, Martin

    2009-01-01

    organizations to better manage tensions between efficiency and flexibility, which is arguably a key issue in many organizations today. Our paper contributes to this stream of research by detailing how enabling control functions in the particular setting of new product development. To this end, we draw upon......Several studies in management control have drawn upon the concepts of coercive and enabling forms of bureaucracy (Adler and Borys 1996) to discuss how the features of a control system may affect employees' attitudes toward control. This question is relevant because enabling forms of control allow...... and flexibility. In addition, our paper sets out to explore how strategic change can influence the operation of enabling control. Focusing on the introduction of a new product strategy in our case organization, we describe employees' repair efforts in adapting the control system to their own needs. We find...

  7. Hypoglycemia evaluation and reporting in diabetes: Importance for the development of new therapies.

    Science.gov (United States)

    Klonoff, David C; Alexander Fleming, G; Muchmore, Douglas B; Frier, Brian M

    2017-07-01

    Hypoglycemia complicating diabetes therapy is well recognized to be an ever-present threat to patients, their families, providers, payers, and regulators. Despite this being widely acknowledged, the regulatory stance on hypoglycemia as an endpoint in clinical trials to support new product registration has not evolved in any meaningful way since the publication of a position paper by an American Diabetes Association (ADA) Workgroup in 2005. As the impact of hypoglycemia on persons affected by diabetes is of major importance when assessing new treatments, the historical position of regulatory agencies on hypoglycemia is reviewed with respect to product approvals. The purpose of this article is to present proposals for facilitating development of therapies that reduce hypoglycemia risk through (1) development of composite measures of benefit for regulatory endpoints and (2) facilitation of the fulfillment of an unmet clinical need for reducing hypoglycemia. In view of greater comprehension of the effects of hypoglycemia, coupled with improved methodology to assess its frequency, the authors recommend: (1) a numerical cut point of <54 mg/dl (<3.0 mmol/L) as a clinically relevant level with which to define meaningful hypoglycemia for trials of diabetes therapies; (2) utilization in clinical trials of mature glucose monitoring technologies for purposes of regulatory evaluation and clinical decision-making; and (3) development of primary efficacy endpoint composites that include hypoglycemia rates and glycemic control. Copyright © 2017 John Wiley & Sons, Ltd.

  8. Biomarkers in the clinical development of asthma therapies.

    Science.gov (United States)

    Staton, Tracy L; Choy, David F; Arron, Joseph R

    2016-01-01

    Here we review how biomarkers have been used in the design, execution and interpretation of recent clinical studies of therapeutic candidates targeting cytokine-mediated inflammatory pathways in asthma. This review focuses on type 2 inflammation, as there are multiple therapeutics and/or clinical studies that can be compared within that specific pathway. Comparative analyses of data from these clinical studies illustrate the utility of biomarkers to quantify pharmacodynamic effects, clarify mechanism of action and stratify patients, which may facilitate the interpretation of outcomes in the development of molecularly targeted therapies. These case examples provide a basis for biomarker considerations in the design of future studies in the asthma setting.

  9. LIVESTOCK PRODUCTION FOR A SUSTAINABLE DEVELOPMENT

    Directory of Open Access Journals (Sweden)

    Giuseppe Maiorano

    2014-02-01

    Full Text Available The development of society is based on the existence of food resources. The past half-century has seen marked growth in food production, allowing for a dramatic decrease in the proportion of the world’s people that are hungry, despite a doubling of the total population. Recently, the FAO predicted a higher increase of the consumption of foods of animal origin by 2050. So far, the increased demand for food has been supplied by agriculture due to an improvement of techniques, an increase of cultivated land areas and an increase of water and energy consumption. The environmental assessment of human activities is presently a hot topic. It is not only important from an ecological perspective, but also from the view of efficient utilization of limited natural resources. The livestock sector that increasingly competes for scarce resources (land, water, and energy has a severe impact on air, water and soil quality because of its emissions. The environmental impact of food of animal origin is currently quantified by so-called CO2eq-footprints. Therefore, in the future, it will be necessary to achieve a sustainable supply of food, especially of animal origin, because land and other production factors are not unlimited resources. This lecture deals with related problems linked to the production of foods of animal origin and some possible sustainable solutions for the increasing demand of these products, by means of a detailed analysis of the carbon footprint by the livestock, as well as the land requirement, biodiversity, energy and water footprint in livestock production.

  10. Development of fission Mo-99 production technology

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jin Ho; Choung, W. M.; Lee, K. I. and others

    2001-05-01

    This R and D project is planed to supply domestic demands of Mo-99 through fission route, and consequently this project will be expected to rise up utilization of HANARO and KAERI's capability for marketing extension into domestic and oversea radiopharmaceutical market. HEU and LEU target types are decided and designed for fission Mo-99 production in domestic. Experimental study of target fabrication technology was performed and developed processing equipments. And conceptual design of target loading/unloading in/from HANARO device are performed. Tracer test of Mo-99 separation and purification process was performed, test results reach to Mo-99 recovery yield above 80% and decontamination factor above 1600. Combined Mo-99 separation and purification process was decided for hot test scheduled from next year, and performance test was performed. Conceptual design for modification of existing hot cell for fission Mo-99 production facility was performed and will be used for detail design. Assumption for the comparison of LEU and HEU target in fission Mo-99 production process were suggested and compared of merits and demerits in view of fabrication technology and economy feasibility.

  11. Development of fission Mo-99 production technology

    International Nuclear Information System (INIS)

    Park, Jin Ho; Choung, W. M.; Lee, K. I. and others

    2001-05-01

    This R and D project is planed to supply domestic demands of Mo-99 through fission route, and consequently this project will be expected to rise up utilization of HANARO and KAERI's capability for marketing extension into domestic and oversea radiopharmaceutical market. HEU and LEU target types are decided and designed for fission Mo-99 production in domestic. Experimental study of target fabrication technology was performed and developed processing equipments. And conceptual design of target loading/unloading in/from HANARO device are performed. Tracer test of Mo-99 separation and purification process was performed, test results reach to Mo-99 recovery yield above 80% and decontamination factor above 1600. Combined Mo-99 separation and purification process was decided for hot test scheduled from next year, and performance test was performed. Conceptual design for modification of existing hot cell for fission Mo-99 production facility was performed and will be used for detail design. Assumption for the comparison of LEU and HEU target in fission Mo-99 production process were suggested and compared of merits and demerits in view of fabrication technology and economy feasibility

  12. Material interaction and art product in art therapy assessment in adult mental health

    NARCIS (Netherlands)

    Pénzes, I.J.N.J.; Hooren, S. van; Dokter, D.; Smeijsters, H.; Hutschemaekers, G.J.M.

    2016-01-01

    Background: Art materials have a central role in art therapy. The way a client interacts with art materials - material interaction - is an important source of information in art therapy assessment in adult mental health. The aim of this study was to develop the categories of material interaction and

  13. Development of synthetic gasoline production process

    Energy Technology Data Exchange (ETDEWEB)

    Imai, T; Fujita, H; Yamada, K; Suzuki, T; Tsuchida, Y

    1986-01-01

    As oil deposits are limited, it is very important to develop techniques for manufacturing petroleum alternatives as substitute energy sources to brighten the outlook for the future. The Research Association for Petroleum Alternatives Development (RAPAD) in Japan is engaged in the research and development of production techniques for light hydrocarbon oils such as gasoline, kerosene, and light oil from synthesis gas (CO, H/sub 2/) obtained from the raw materials of natural gas, coal, etc. Regarding the MTG process of synthesizing gasoline via methanol from synthesis gas and the STG process of directly synthesizing gasoline from synthesis gas, Cosmo Oil Co., Ltd. and Mitsubishi Heavy Industries, Ltd., members of RAPAD, have sought jointly to develop catalysts and processes. As a result of this co-operation, the authors have recently succeeded in developing a new catalyst with a long life span capable of providing a high yield and high selectivity. Additionally, the authors are currently on the verge of putting into effect a unique two-step STG process of synthesizing high octane gasoline via dimethyl ether, referred to as the AMSTG process.

  14. Conceptualization about conservation, production and development

    International Nuclear Information System (INIS)

    Angel, Augusto

    1994-01-01

    The article tries the conceptualization, production and development, of the environmental sciences or environmentalism and ecology; they are made a series of reflections that it haven't just been defined still these sciences with clarity like a epistemological field in front of the other sciences, or in combination or in integration with them that doesn't have, unfortunately, for the way like it has been come developing the science western, many possibilities of theoretical approach, in fact for the sciences compartment. The author comments that this compartment was obligatory inside the development process begun by Europe and that it ends fundamentally in the capitalist development. That the positivism and the empiricism like expression forms have been indispensable to dominate the nature and to exploit it; so that there we needed specialized sciences that had the capacity the resources that it needed the development. The environmentalism and, before the environmentalism, the ecology is putting us in a quite complicated noise, and it is that more and more they are putting us before the pressure that in fact the natural resources are integrated to complex systems, and it is that the science is not organized to manage systems

  15. Consequences of new product development speed : a meta-analysis

    NARCIS (Netherlands)

    Cankurtaran, P.; Langerak, F.; Griffin, A.

    2013-01-01

    Five meta-analyses previously have been published on the topic of new product development involving the concept of new product development speed. Three of these studies have investigated antecedents to new product development success, of which just one was new product development speed. The other

  16. Development of high productivity pipeline girth welding

    International Nuclear Information System (INIS)

    Yapp, David; Liratzis, Theocharis

    2010-01-01

    The trend for increased oil and gas consumption implies a growth of long-distance pipeline installations. Welding is a critical factor in the installation of pipelines, both onshore and offshore, and the rate at which the pipeline can be laid is generally determined by the speed of welding. This has resulted in substantial developments in pipeline welding techniques. Arc welding is still the dominant process used in practice, and forge welding processes have had limited successful application to date, in spite of large investments in process development. Power beam processes have also been investigated in detail and the latest laser systems now show promise for practical application. In recent years the use of high strength steels has substantially reduced the cost of pipeline installation, with X70 and X80 being commonly used. This use of high strength pipeline produced by thermomechanical processing has also been researched. They must all meet three requirments, high productivity, satisfactory weld properties, and weld quality

  17. Development of a Medical Cyclotron Production Facility

    Science.gov (United States)

    Allen, Danny R.

    2003-08-01

    Development of a Cyclotron manufacturing facility begins with a business plan. Geographics, the size and activity of the medical community, the growth potential of the modality being served, and other business connections are all considered. This business used the customer base established by NuTech, Inc., an independent centralized nuclear pharmacy founded by Danny Allen. With two pharmacies in operation in Tyler and College Station and a customer base of 47 hospitals and clinics the existing delivery system and pharmacist staff is used for the cyclotron facility. We then added cyclotron products to contracts with these customers to guarantee a supply. We partnered with a company in the process of developing PET imaging centers. We then built an independent imaging center attached to the cyclotron facility to allow for the use of short-lived isotopes.

  18. Development of a Medical Cyclotron Production Facility

    International Nuclear Information System (INIS)

    Allen, Danny R.

    2003-01-01

    Development of a Cyclotron manufacturing facility begins with a business plan. Geographics, the size and activity of the medical community, the growth potential of the modality being served, and other business connections are all considered. This business used the customer base established by NuTech, Inc., an independent centralized nuclear pharmacy founded by Danny Allen. With two pharmacies in operation in Tyler and College Station and a customer base of 47 hospitals and clinics the existing delivery system and pharmacist staff is used for the cyclotron facility. We then added cyclotron products to contracts with these customers to guarantee a supply. We partnered with a company in the process of developing PET imaging centers. We then built an independent imaging center attached to the cyclotron facility to allow for the use of short-lived isotopes

  19. Strategic Alignment and New Product Development

    DEFF Research Database (Denmark)

    Acur, Nuran; Kandemir, Destan; Boer, Harry

    2012-01-01

    Strategic alignment is widely accepted as a prerequisite for a firm’s success, but insight into the role of alignment in, and its impact on, the new product evelopment (NPD) process and its performance is less well developed. Most publications on this topic either focus on one form of alignment...... of NPD performance indicators. Strategic planning and innovativeness appear to affect technological, market, and NPD-marketing alignment positively. Environmental munificence is negatively associated with NPD-marketing alignment, but has no effect on the two other forms of alignment. Technological change...... has a positive effect on technological alignment, a negative effect on NPD-marketing alignment, but no effect on market alignment. These findings suggest that internal capabilities are more likely to be associated with the development of strategic alignment than environmental factors are. Furthermore...

  20. Knowledge sharing in international product development teams

    DEFF Research Database (Denmark)

    Sonne, Anne-Mette; Harmsen, Hanne

    Many companies are facing an increasing need to compete on a global scale. But as companies move into multiple markets, the process of developing new products becomes increasingly complex. Coping successfully with the increased internationalization forces companies to excel at collaboration...... company are far from trivial and the problems associated with transfer will increase with geographical and cultural difference (Bresman et al., 1999). Especially tacit knowledge is difficult to transport across national boarders (Kogut & Zander, 1992) and not much research exists on how companies overcome...... development process is by using teams. Teams are considered one of the best tools for exchanging especially tacit knowledge, since this kind of knowledge is transferred best through personal interaction and face-to-face meetings (Madhavan & Grover, 1998; Nonaka, 1994). In accordance with this, more and more...

  1. Bilateral Ischemic Optic Neuropathy Developed under Interferon Therapy

    Directory of Open Access Journals (Sweden)

    Fatih Selcukbiricik

    2012-01-01

    Full Text Available Introduction. Interferon is a glycoprotein produced by assigned cells of immune system. It has been used in many different diseases. Although flu-like syndrome, myalgia, rash, hypotension, thrombocytopenia and peripheral neuropathy due to interferon use are encountered frequently, ocular side effects are rare, generally mild and transient. Case Report. 47-year-old female patient, presented with a mass lesion in right renal pelvis. Right radical nephrectomy was applied and the histopathological examination was consistent with papillary renal cell carcinoma. Interferon alpha treatment was started subcutaneously at the dose of 5 MIU/3 times in a week. Four weeks after the interferon therapy, suddenly bilateral visual loss developed. We discussed the diagnosis, followup, and treatment of the patient who developed irreversible ischemic optic neuropathy and had no previous known primary systemic disease to cause this condition. Conclusion. We suggest that patients should be screened for risk factors causing optic ischemic neuropathy, before interferon therapy. Although there was no adequate information in the literature for the followup, patients should be monitorized before, 1 month after, and 2 months after the treatment. And if there is no complication, we suggest that they should be followed up at 3-month intervals.

  2. Protein engineering for biofuel production: Recent development

    Directory of Open Access Journals (Sweden)

    Nisha Singh

    2016-09-01

    Full Text Available The unstable and unsure handiness of crude oil sources moreover the rising price of fuels have shifted international efforts to utilize renewable resources for the assembly of greener energy and a replacement which might additionally meet the high energy demand of the globe. Biofuels represent a sustainable, renewable, and also the solely predictable energy supply to fossil fuels. During the green production of Biofuels, several in vivo processes place confidence in the conversion of biomass to sugars by engineered enzymes, and the subsequent conversion of sugars to chemicals via designed proteins in microbial production hosts. Enzymes are indispensable within the effort to provide fuels in an ecologically friendly manner. They have the potential to catalyze reactions with high specificity and potency while not using dangerous chemicals. Nature provides an in depth assortment of enzymes, however usually these should be altered to perform desired functions in needed conditions. Presently available enzymes like cellulose are subject to tight induction and regulation systems and additionally suffer inhibition from numerous end products. Therefore, more impregnable and economical catalyst preparations ought to be developed for the enzymatic method to be more economical. Approaches like protein engineering, reconstitution of protein mixtures and bio prospecting for superior enzymes are gaining importance. Advances in enzyme engineering allow the planning and/or directed evolution of enzymes specifically tailored for such industrial applications. Recent years have seen the production of improved enzymes to help with the conversion of biomass into fuels. The assembly of the many of those fuels is feasible due to advances in protein engineering. This review discusses the distinctive challenges that protein engineering faces in the method of changing lignocellulose to biofuels and the way they're addressed by recent advances in this field.

  3. Production of 103mRh for cancer therapy

    International Nuclear Information System (INIS)

    Skarnemark, G.; Oedegaard-Jensen, A.; Bernhardt, P.

    2009-01-01

    Radioactive nuclides that emit charged particles with short range are of great interest for internal radiotherapy of small tumors or even single cancer cells. Such therapy uses radio-labelled molecules that find cancer cells and attach to them. When the radionuclide decays it destroys the cancer cell but does not affect the surrounding healthy tissue. Internal radiotherapy may be a complement to surgery, chemotherapy or external irradiation. For larger tumors it is possible to use β-emitters like 90 Y but for small tumors the required short range limits the choice of radio-nuclides to emitters of alpha-particles or low energy electrons, e.g., Auger electrons. A promising α-emitter is 211 At that has undergone laboratory and clinical tests. An example of the other decay mode is the low energy electron emitter 103m Rh. A study performed by BERNHARDT et al. showed that this nuclide has very favorable properties: low electron energy, suitable half-life (56 min) and a low photon/electron ratio (p/e = 0.04). It has also the advantage that it can be produced via a generator containing either 103 Ru or 103 Pd. (author)

  4. Food production - Present and future development

    International Nuclear Information System (INIS)

    Lamm, C.G.

    1974-01-01

    This year the joint FAO/IAEA Division of Atomic Energy in Food and Agriculture celebrates its 10th anniversary. The aim of these two United Nations organizations is to ensure that the technical services of both FAO and IAEA are fully co-ordinated and their programmes are designed to assist developing Member States to apply isotopes and radiation techniques to the solution of food and agricultural problems. More precisely, the medium-term objectives of the Joint Division are to exploit the potential of nuclear techniques in research and development for increasing and stabilizing agricultural production, improving food quality, protecting agricultural products from spoilage and losses and minimizing pollution of food and the agricultural environment. This account of what radioisotopes can do for man in the agricultural field is therefore to a great extent a review of the activities of the Joint Division and a prediction of its future fields of emphasis, especially in the light of the present long-range and world-wide food crisis. (author)

  5. A Framework for successful new product development

    Directory of Open Access Journals (Sweden)

    Nadia Bhuiyan

    2011-12-01

    Full Text Available Purpose: The purpose of this paper is to propose a framework of critical success factors, metrics, and tools and techniques for implementing metrics for each stage of the new product development (NPD process.Design/methodology/approach: To achieve this objective, a literature review was undertaken to investigate decades of studies on NPD success and how it can be achieved. These studies were scanned for common factors for firms that enjoyed success of new products on the market.Findings: The paper summarizes NPD success factors, suggests metrics that should be used to measure these factors, and proposes tools and techniques to make use of these metrics. This was done for each stage of the NPD process, and brought together in a framework that the authors propose should be followed for complex NPD projects.Research limitations/implications: Several different research directions could provide additional useful information both to firms finding critical success factors (CSF and measuring product development success as well as to academics performing research in this area. The main research opportunity exists in implementing or testing the proposed framework.Practical implications: The framework can be followed by managers of complex NPD projects to ensure success.Originality/value: While many studies have been conducted on critical success factors for NPD, these studies tend to be fragmented and focus on one or a few phases of the NPD process. To the authors’ knowledge, this is the first time a framework that synthesizes these studies into a single framework.

  6. The 1st symposium of Research Center for Charged Particle Therapy on fundamental development of the charged particle therapy

    International Nuclear Information System (INIS)

    Soga, Fuminori

    2002-06-01

    This issue is the collection of the paper presented at the 1st Symposium of Research Center for Charged Particle Therapy on fundamental development of the charged particle therapy. The 31 of the presented papers are indexed individually. (J.P.N.)

  7. Development of Technology for Image-Guided Proton Therapy

    Science.gov (United States)

    2012-10-01

    develop data analysis software  Install and test tablet PCs Year 2 ending 9/30/2009  Design PET scanner  Design mechanical gantry...of the PET instrument  Measure positron-emitting isotope production  Use dual-energy CT and MRI to determine the composition of materials Year...forms on tablet PCs Phase 5 Scope of Work Year 1 ending 9/30/2009  Identify a vendor consortium to develop a solution for CBCT on or near

  8. Development of inverse-planning system for neutron capture therapy

    International Nuclear Information System (INIS)

    Kumada, Hiroaki; Yamamoto, Kazuyoshi; Maruo, Takeshi

    2006-01-01

    To lead proper irradiation condition effectively, Japan Atomic Energy Agency (JAEA) is developing an inverse-planning system for neutron capture therapy (NCT-IPS) based on the JAEA computational dosimetry system (JCDS) for BNCT. The leading methodology of an optimum condition in the NCT-IPS has been applied spatial channel theory with adjoint flux solution of Botzman transport. By analyzing the results obtained from the adjoint flux calculations according to the theory, optimum incident point of the beam against the patient can be found, and neutron spectrum of the beam which can generate ideal distribution of neutron flux around tumor region can be determined. The conceptual design of the NCT-IPS was investigated, and prototype of NCT-IPS with JCDS is being developed. (author)

  9. Hormones and tumour therapy: current clinical status and future developments in endocrine therapy of breast cancer

    International Nuclear Information System (INIS)

    Szepesi, T.; Schratter-Sehn, A.U.

    1982-01-01

    Postoperative adjuvant hormone therapy and hormone therapy in disseminated breast cancer will be discussed systematically. The classical ablative and additive endocrine therapeutic measures - with the exception of ovarectomy and gestagen therapy - are increasinlgy being replaced by antagonists. Individual chapters discuss recent experience with combined hormone-radiotherapy or hormone-chemotherapy. In addition, a successful therapy scheme for the treatment of disseminated breast cancer will be presented. (Author)

  10. Potential development of bioethanol production in Vojvodina

    Energy Technology Data Exchange (ETDEWEB)

    Dodic, Sinisa N.; Popov, Stevan D.; Dodic, Jelena M.; Rankovic, Jovana A.; Zavargo, Zoltan Z. [Department of Biotechnology and Pharmaceutical Engineering, Faculty of Technology, University of Novi Sad, Bul. cara Lazara 1, Novi Sad 21000, Vojvodina (RS)

    2009-12-15

    The Autonomous Province of Vojvodina is an Autonomous Province in Serbia, containing about 27% of its total population according to the 2002 Census. Contribution of renewable energy sources in total energy consumption of Vojvodina contemporary amounts to less than 1%, apropos 280 GWh/year. By combining of methods of introduction of new and renewable sources, systematic application of methods for increasing of energetic efficacy, as well as of introduction of the new technologies, percentage of contribution of the non-conventional energy sources in Vojvodina could be increased to as much as 20%. This paper presents the potential of development of bioethanol production in Vojvodina. Production of bioethanol on small farms can be successfully applied for processing of only 30 kg of corn per day, with obtaining of crude ethanol in the so-called 'brandy ladle' and use of lygnocellulosic agricultural wastes as an energy source. In a case of construction of a larger number of such plants, the only possible solution is seen in the principle of construction of the so-called 'satellite plants', which will on small farm produce crude ethanol, with obtaining and consumption of stillage for animal feeding, and consumption of agricultural wastes as energetic fuels. If stillage is to be used as feed in wet feeding, it is estimated that, because of restrictions established by the magnitude of animal farm, the upper limit of capacity of such enterprises that process is at some 10-15 tons of corn per day, and production of 3000-3500 hL of absolute ethanol per day. In such a case, for animal feeding necessary is to have herd with 1300-1700 of milking cows or 5000-25,000 heads of sheep and/or pigs. Technological model of separate grain processing ad bioethanol production from dextrose hydrolysates of starch is interesting for countries possessing plants for bioethanol production from molasses and plants for cereals processing into starch and dextrose hydrolysates

  11. Human resource development for uranium production cycle

    International Nuclear Information System (INIS)

    Ganguly, C.

    2014-01-01

    Nuclear fission energy is a viable option for meeting the ever increasing demand for electricity and high quality process heat in a safe, secured and sustainable manner with minimum carbon foot print and degradation of the environment. The growth of nuclear power has shifted from North America and Europe to Asia, mostly in China and India. Bangladesh, Vietnam, Indonesia, Malaysia and the United Arab Emirates are also in the process of launching nuclear power program. Natural uranium is the basic raw material for U-235 and Pu-239, the fuels for all operating and upcoming nuclear power reactors. The present generation of nuclear power reactors are mostly light water cooled and moderated reactor (LWR) and to a limited extent pressurized heavy water reactor (PHWR). The LWRs and PHWRs use low enriched uranium (LEU with around 5% U-235) and natural uranium as fuel in the form of high density UO_2 pellets. The uranium production cycle starts with uranium exploration and is followed by mining and milling to produce uranium ore concentrate, commonly known as yellow cake, and ends with mine and mill reclamation and remediation. Natural uranium and its daughter products, radium and radon, are radioactive and health hazardous to varying degrees. Hence, radiological safety is of paramount importance to uranium production cycle and there is a need to review and share best practices in this area. Human Resource Development (HRD) is yet another challenge as most of the experts in this area have retired and have not been replaced by younger generation because of the continuing lull in the uranium market. Besides, uranium geology, exploration, mining and milling do not form a part of the undergraduate or post graduate curriculum in most countries. Hence, the Technical Co-operation activities of the IAEA are required to be augmented and more country specific and regional training and workshop should be conducted at different universities with the involvement of international experts

  12. Technological progress and challenges towards cGMP manufacturing of human pluripotent stem cells based therapeutic products for allogeneic and autologous cell therapies.

    Science.gov (United States)

    Abbasalizadeh, Saeed; Baharvand, Hossein

    2013-12-01

    Recent technological advances in the generation, characterization, and bioprocessing of human pluripotent stem cells (hPSCs) have created new hope for their use as a source for production of cell-based therapeutic products. To date, a few clinical trials that have used therapeutic cells derived from hESCs have been approved by the Food and Drug Administration (FDA), but numerous new hPSC-based cell therapy products are under various stages of development in cell therapy-specialized companies and their future market is estimated to be very promising. However, the multitude of critical challenges regarding different aspects of hPSC-based therapeutic product manufacturing and their therapies have made progress for the introduction of new products and clinical applications very slow. These challenges include scientific, technological, clinical, policy, and financial aspects. The technological aspects of manufacturing hPSC-based therapeutic products for allogeneic and autologous cell therapies according to good manufacturing practice (cGMP) quality requirements is one of the most important challenging and emerging topics in the development of new hPSCs for clinical use. In this review, we describe main critical challenges and highlight a series of technological advances in all aspects of hPSC-based therapeutic product manufacturing including clinical grade cell line development, large-scale banking, upstream processing, downstream processing, and quality assessment of final cell therapeutic products that have brought hPSCs closer to clinical application and commercial cGMP manufacturing. © 2013.

  13. Biotechnology and genetic engineering in the new drug development. Part II. Monoclonal antibodies, modern vaccines and gene therapy.

    Science.gov (United States)

    Stryjewska, Agnieszka; Kiepura, Katarzyna; Librowski, Tadeusz; Lochyński, Stanisław

    2013-01-01

    Monoclonal antibodies, modern vaccines and gene therapy have become a major field in modern biotechnology, especially in the area of human health and fascinating developments achieved in the past decades are impressive examples of an interdisciplinary interplay between medicine, biology and engineering. Among the classical products from cells one can find viral vaccines, monoclonal antibodies, and interferons, as well as recombinant therapeutic proteins. Gene therapy opens up challenging new areas. In this review, a definitions of these processes are given and fields of application and products, as well as the future prospects, are discussed.

  14. Integrated durability process in product development

    International Nuclear Information System (INIS)

    Pompetzki, M.; Saadetian, H.

    2002-01-01

    This presentation describes the integrated durability process in product development. Each of the major components of the integrated process are described along with a number of examples of how integrated durability assessment has been used in the ground vehicle industry. The durability process starts with the acquisition of loading information, either physically through loads measurement or virtually through multibody dynamics. The loading information is then processed and characterized for further analysis. Durability assessment was historically test based and completed through field or laboratory evaluation. Today, it is common that both the test and CAE environments are used together in durability assessment. Test based durability assessment is used for final design sign-off but is also critically important for correlating CAE models, in order to investigate design alternatives. There is also a major initiative today to integrate the individual components into a process, by linking applications and providing a framework to communicate information as well as manage all the data involved in the entire process. Although a single process is presented, the details of the process can vary significantly for different products and applications. Recent applications that highlight different parts of the durability process are given. As well as an example of how integration of software tools between different disciplines (MBD, FE and fatigue) not only simplifies the process, but also significantly improves it. (author)

  15. Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs.

    Science.gov (United States)

    Abou-El-Enein, Mohamed; Römhild, Andy; Kaiser, Daniel; Beier, Carola; Bauer, Gerhard; Volk, Hans-Dieter; Reinke, Petra

    2013-03-01

    Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. The "Clean-Room Technology Assessment Technique" (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions. Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  16. [Play therapy--psychotherapy with play as the medium: II. New developments].

    Science.gov (United States)

    von Gontard, Alexander; Lehmkuhl, Gerd

    2003-02-01

    A wide array of new forms and combinations of play therapy have been developed. The aim of the second part of this paper is to present an overview of these newer approaches, including: focussed therapies for specific disorders; behavioural approaches like the Cognitive-Behavioral Play Therapy and the Parent-Child Interaction Therapy; various combinations with family therapy; and therapies especially for preschool children like Filial Therapy, Developmental Play Therapy and Thera-play. Following a phase of experiments and combinations, the empirical evaluation of many play-therapy forms is needed. Especially questions of the differential indication of specific play-therapies and their effectiveness in the therapeutical practice need to be studied.

  17. Intensity Modulated Radiation Therapy. Development of the technique

    International Nuclear Information System (INIS)

    Rafailovici, L.; Alva, R.; Chiozza, J.; Donato, H.; Falomo, S.; Cardiello, C.; Furia, O.; Martinez, A.; Filomia, M.L.; Sansogne, R.; Arbiser, S.; Dosoretz, B.

    2008-01-01

    Full text: Introduction: Intensity Modulated Radiation Therapy (IMRT) is a result of advances in computer sciences that allowed the development of new technology related to planning and radiation therapy. IMRT was developed to homogenize the dose in the target volumes and decrease the dose in the surrounding healthy tissue. Using a software with high calculation capacity a simultaneous irradiation with different doses in a given volume is achieved. IMRT is based on internal planning. Material and methods: 628 patients were treated with IMRT in prostate lesions, head and neck, breast, thorax, abdomen and brain since August 2008. The software for IMRT is the XIO CMS and the accelerator used is a Varian Clinac 6 / 100. IMRT requires a first simulation, where immobilization systems are selected (mats, thermoplastic masks, among others) and the demarcation of the target structures, healthy tissue and dose prescription by a tattoo. Images of CT / MRI are merged when necessary. Once the system made the treatment optimization, this one is regulated by modulators. These are produced by numerical control machines from digital files produced by software. In a second modulation the planned irradiation is checked and tattoo is carried out according with this. We have a strict process of quality assurance to assess the viability of the plan before its implementation. We use the Map Check it possible to compare the dose on the central axis and the distribution in the whole plane regarding to that generated by the planning system. From 03/2008 the virtual simulation process was implemented integrating the described stages. Results and Conclusions: IMRT is a complex technique. The meticulous planning, implementation of process and quality control allows the use of this technique in a reliable and secure way. With IMRT we achieved a high level of dose conformation, less irradiation of healthy tissue, lower rates of complications and the dose escalation for some tumors. (authors) [es

  18. Hiring, Developing, and Organizing Individual Employees for New Product Development versus Product-related Service Innovation

    DEFF Research Database (Denmark)

    Knudsen, Mette Præst; Schleimer, Stephanie

    should be hired. For the latter case, these employees’ individual careers must be developed internally once hired. The paper therefore carries important implication for the innovation management literature and related human resource practices at different organizational levels.......This study examines how manufacturing firms should organize their human resources by maximizing the value of individual employees for different forms of innovations. In particular, it examines the hiring, developing, and structural organization of human resources for optimizing different innovation...... the value of human resource hiring and developing practices for new product development success; organizations will find it more beneficial to invest predominantly in employees with the highest possible educational level, whilst for product-related service innovations; employees with more general skills...

  19. Antibody production in response to staphylococcal MS-1 phage cocktail in patients undergoing phage therapy

    Directory of Open Access Journals (Sweden)

    Maciej Żaczek

    2016-10-01

    Full Text Available In this study, we investigated the humoral immune response (through the release of IgG, IgA, and IgM antiphage antibodies to a staphylococcal phage cocktail in patients undergoing experimental phage therapy at the Phage Therapy Unit, Medical Center of the Ludwik Hirszfeld Institute of Immunology and Experimental Therapy in Wrocław, Poland. We also evaluated whether occurring antiphage antibodies had neutralizing properties towards applied phages (K rate. Among 20 examined patients receiving the MS-1 phage cocktail orally and/or locally, the majority did not show a noticeably higher level of antiphage antibodies in their sera during phage administration. Even in those individual cases with an increased immune response, mostly by induction of IgG and IgM, the presence of antiphage antibodies did not translate into unsatisfactory clinical results of phage therapy. On the other hand, a negative outcome of the treatment occurred in some patients who showed relatively weak production of antiphage antibodies before and during treatment. This may imply that possible induction of antiphage antibodies is not an obstacle to the implementation of phage therapy and support our assumption that the outcome of the phage treatment does not primarily depend on the appearance of antiphage antibodies in sera of patients during therapy. These conclusions are in line with our previous findings. The confirmation of this thesis is of great interest as regards the efficacy of phage therapy in humans.

  20. Antibody Production in Response to Staphylococcal MS-1 Phage Cocktail in Patients Undergoing Phage Therapy.

    Science.gov (United States)

    Żaczek, Maciej; Łusiak-Szelachowska, Marzanna; Jończyk-Matysiak, Ewa; Weber-Dąbrowska, Beata; Międzybrodzki, Ryszard; Owczarek, Barbara; Kopciuch, Agnieszka; Fortuna, Wojciech; Rogóż, Paweł; Górski, Andrzej

    2016-01-01

    In this study, we investigated the humoral immune response (through the release of IgG, IgA, and IgM antiphage antibodies) to a staphylococcal phage cocktail in patients undergoing experimental phage therapy at the Phage Therapy Unit, Medical Center of the Ludwik Hirszfeld Institute of Immunology and Experimental Therapy in Wrocław, Poland. We also evaluated whether occurring antiphage antibodies had neutralizing properties toward applied phages (K rate). Among 20 examined patients receiving the MS-1 phage cocktail orally and/or locally, the majority did not show a noticeably higher level of antiphage antibodies in their sera during phage administration. Even in those individual cases with an increased immune response, mostly by induction of IgG and IgM, the presence of antiphage antibodies did not translate into unsatisfactory clinical results of phage therapy. On the other hand, a negative outcome of the treatment occurred in some patients who showed relatively weak production of antiphage antibodies before and during treatment. This may imply that possible induction of antiphage antibodies is not an obstacle to the implementation of phage therapy and support our assumption that the outcome of the phage treatment does not primarily depend on the appearance of antiphage antibodies in sera of patients during therapy. These conclusions are in line with our previous findings. The confirmation of this thesis is of great interest as regards the efficacy of phage therapy in humans.

  1. Development and Commercialization of an Ideal Mechanical Wound Therapy System

    Science.gov (United States)

    2015-12-01

    work is a mature, TRL 8 design frozen prototype that has successfully overcome sealing issues which plague all COTS NPWT dressings and is the first...required 2-3x more frequently with COTS dressings . While great advance was made, especially given the small budget of this pilot project, work remains... work , would negate the successes of the prior work and investment. Stated Task Accomplished? Due Date Completion Date Task 1. Product Development

  2. Antitumor potential induction and free radicals production in melanoma cells by Boron Neutron Capture Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Faiao-Flores, F. [Biochemical and Biophysical Laboratory, Butantan Institute, 1500 Vital Brasil Avenue, Sao Paulo (Brazil)] [Faculty of Medicine, University of Sao Paulo, 455 Doutor Arnaldo Avenue, Sao Paulo (Brazil); Coelho, P.R.P.; Muniz, R.O.R.; Souza, G.S. [Institute for Nuclear and Energy Research, 2242 Lineu Prestes Avenue, Sao Paulo (Brazil); Arruda-Neto, J. [Physics Institute, University of Sao Paulo, 187 Matao Street, Sao Paulo (Brazil)] [FESP, Sao Paulo Engineering School, 5520 Nove de Julho Avenue, Sao Paulo (Brazil); Maria, Durvanei A., E-mail: durvaneiaugusto@yahoo.com.br [Biochemical and Biophysical Laboratory, Butantan Institute, 1500 Vital Brasil Avenue, Sao Paulo (Brazil)

    2011-12-15

    Antiproliferative and oxidative damage effects occurring in Boron Neutron Capture Therapy (BNCT) in normal fibroblasts and melanoma cell lines were analyzed. Melanoma cells and normal fibroblasts were treated with different concentrations of Boronophenylalanine and irradiated with thermal neutron flux. The cellular viability and the oxidative stress were determined. BNCT induced free radicals production and proliferative potential inhibition in melanoma cells. Therefore, this therapeutic technique could be considered efficient to inhibit growth of melanoma with minimal effects on normal tissues. - Highlights: Black-Right-Pointing-Pointer Boron Neutron Capture Therapy (BNCT) induces melanoma cell death. Black-Right-Pointing-Pointer BNCT stimulates free radicals production and proliferative inhibition in melanoma cells. Black-Right-Pointing-Pointer It produces tumor membrane degeneration and destruction with apoptotic bodies formation. Black-Right-Pointing-Pointer This therapy damages tumor cells selectively, with minimum effects on normal adjacent tissue.

  3. Development and optimization of a diode laser for photodynamic therapy.

    Science.gov (United States)

    Lim, Hyun Soo

    2011-01-01

    This study demonstrated the development of a laser system for cancer treatment with photodynamic therapy (PDT) based on a 635 nm laser diode. In order to optimize efficacy in PDT, the ideal laser system should deliver a homogeneous nondivergent light energy with a variable spot size and specific wavelength at a stable output power. We developed a digital laser beam controller using the constant current method to protect the laser diode resonator from the current spikes and other fluctuations, and electrical faults. To improve the PDT effects, the laser system should deliver stable laser energy in continuous wave (CW), burst mode and super burst mode, with variable irradiation times depending on the tumor type and condition. The experimental results showed the diode laser system described herein was eminently suitable for PDT. The laser beam was homogeneous without diverging and the output power increased stably and in a linear manner from 10 mW to 1500 mW according to the increasing input current. Variation between the set and delivered output was less than 7%. The diode laser system developed by the author for use in PDT was compact, user-friendly, and delivered a stable and easily adjustable output power at a specific wavelength and user-set emission modes.

  4. Customer empowerment in new product development

    NARCIS (Netherlands)

    C. Fuchs (Christoph); M. Schreier (Martin)

    2012-01-01

    textabstractCompanies have traditionally taken responsibility for deciding what products and product innovations are offered to customers. However, a growing number of companies are turning this relationship on its head by asking customers not only for help in creating new products, but also in

  5. The Importance of Production Frequency in Therapy for Childhood Apraxia of Speech

    Science.gov (United States)

    Edeal, Denice Michelle; Gildersleeve-Neumann, Christina Elke

    2011-01-01

    Purpose: This study explores the importance of production frequency during speech therapy to determine whether more practice of speech targets leads to increased performance within a treatment session, as well as to motor learning, in the form of generalization to untrained words. Method: Two children with childhood apraxia of speech were treated…

  6. Direct anti-atherosclerotic therapy; development of natural anti-atherosclerotic drugs preventing cellular cholesterol retention.

    Science.gov (United States)

    Orekhov, Alexander N

    2013-01-01

    The results of numerous clinical trials with statins and other drugs have demonstrated the principal possibility of the prevention and regression of atherosclerosis by pharmacotherapy. This review describes the use of cultured human arterial cells for the mass screening of anti-atherosclerotic substances, the investigation of the mechanisms responsible for their atherosclerosis-related effects, and the optimization of anti-atherosclerotic and anti-atherogenic drug and dietary therapies. Natural products can be considered promising drugs for anti-atherosclerotic therapy. Our basic studies have shown that cellular lipidosis is the principal event in the genesis of atherosclerotic lesions. Using cellular models and natural products, we have developed an approach to prevent lipid accumulation in arterial cells. Based on our knowledge of atherosclerosis, we developed drugs that possess direct anti-atherosclerotic activity. Two-year treatment with allicor (garlic powder) has a direct anti-atherosclerotic effect on carotid atherosclerosis in asymptomatic men. Inflaminat (calendula, elder, and violet), which possesses anti-cytokine activity, has been shown to cause the regression of carotid atherosclerosis following the treatment of asymptomatic men for one year. The phytoestrogen-rich drug karinat (garlic powder, extract of grape seeds, green tea leaves, hop cones, β-carotene, α-tocopherol, and ascorbic acid) prevents the development of carotid atherosclerosis in postmenopausal women. Thus, our basic findings were successfully translated into clinical practice. Because of this translation, a novel approach to antiatherosclerotic therapy was developed. Our clinical trial confirmed the efficacy of both the novel approach and the novel drugs.

  7. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  8. Conditions and strategies for integrating ergonomics into product development

    DEFF Research Database (Denmark)

    Broberg, Ole

    1996-01-01

    Ergonomics considerations at the stage of product development in industry is a major strategy for prevention of work-related injuries and illnesses among employees at the time of manufacture of new products. This study elucidates some important conditions and possibilities for integrating...... such considerations during the product development process. Special attention is paid to the role of design and production engineers. Based on different understandings of the product development process four approaches to integration of ergonomics are outlined....

  9. Environmentally-friendly product development: methods and tools

    National Research Council Canada - National Science Library

    Abele, Eberhard; Anderl, R; Birkhofer, Herbert

    2005-01-01

    ... to assess a product's environmental effects. Fig. 1. Vision of Environment as a key target for product development vvi Preface Product related environmental issues are getting more and more political and public awareness. Development of environmentally friendly products has become an action item for both, politics and industry (UNFCCC 1997). Energy...

  10. Development of a men's Preference for Testosterone Replacement Therapy (P-TRT instrument

    Directory of Open Access Journals (Sweden)

    Szeinbach SL

    2012-08-01

    Full Text Available Sheryl L Szeinbach,1 Enrique Seoane-Vazquez,2 Kent H Summers31Ohio State University, College of Pharmacy, Columbus, OH, USA; 2International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, 3Endo Health Solutions, Chadds Ford, PA, USABackground: This study used a standard research approach to create a final conceptual model and the Preference for the Testosterone Replacement Therapy (P-TRT instrument.Methods: A discussion guide was developed from a literature review and expert opinion to direct one-on-one interviews with participants who used testosterone replacement therapy and consented to participate in the study. Data from telephone interviews were transcribed for theme analysis using NVivo 9 qualitative analysis software, analyzed descriptively from a saturation grid, and used to evaluate men's P-TRT. Data from cognitive debriefing for five participants were used to evaluate the final conceptual model and validate the initial P-TRT instrument.Results: Item saturation and theme exhaustion was achieved by 58 male participants of mean age 55.0 ± 10.0 (22–69 years who had used testosterone replacement therapy for a mean of 175.0 ± 299.2 days. The conceptual model was developed from items and themes obtained from the participant interviews and saturation grid. Items comprising eight dimensions were used for instrument development, ie, ease of use, effect on libido, product characteristics, physiological impact, psychological impact, side effects, treatment experience, and preference. Results from the testosterone replacement therapy preference evaluation provide a detailed insight into why most men preferred a topical gel product over an injection or patch.Conclusion: Items and themes relating to use of testosterone replacement therapy were in concordance with the final conceptual model and 29-item P-TRT instrument. The standard research approach used in this study produced the

  11. The importance of clinical mistletoe cancer therapy and korean mistletoe pharmacopuncture preparation development and application possibility for oriental medicine

    Directory of Open Access Journals (Sweden)

    Ok-Byung Choi

    2009-03-01

    Full Text Available Objectives : Mistletoe extracts have been in use for around 85 years, predominantly in the area of cancer therapy. Today mistletoe preparations are among the most prescribed drugs in cancer medicine, thus constituting a standard biological therapy in the area of oncology. The purpose of this study is to analyze the practical implications of mistletoe cancer therapy, their clinical status, their preparation techniques and companies. Contents : Mistletoe therapy for cancer has been developed within the context of anthroposophical medicine. One major effect of mistletoe extract is that it stimulates the immune system and cancer defences. In Germany, a total of eight different mistletoe preparations are available, five developed by Anthroposophic Medicine and three evolved from research in phytotherapy. Therapy always consists of an introductory phase in order to test the patient′s tolerance, find the right dosage and choose the most suitable preparation. This paper covers the background of mistletoe medical plant materials, mistletoe therapy for cancer, the anthroposophical medicine and clinical research, the practical regulation of treatment, preparation of mistletoe drugs. Result & suggestion : Mistletoe extracts are a complementary teratment of cancer, widely used in intergrative cancer care. The study of the integration of korean mistletoe extracts to oriental cancer medicine, its development and feasibility in Korea are urgently needed. The products, substances, compositions of european mistletoe drugs are very similar to those of oriental medicine theory. Applying the mistletoe cancer therapy and its preparation techniques to oriental medicine, the herbal acupuncture preparation should be modernized and korean mistletoe products are to be developed. To this end, government and herbal acupuncture society need to interact each other for the development of oriental mistletoe cancer medicine.

  12. EVALUATION OF PRODUCT DEVELOPMENT PROCESS USING EMVS

    Directory of Open Access Journals (Sweden)

    Iara Tonissi Moroni Cutovoi

    2014-12-01

    Full Text Available This paper evaluates a PDP model application in an auto parts company, leader in its segment. From the application of lean thinking in the supply chain and the EMVS performance analysis methodology for PDP, a check list is created to avoid waste in project management. In this paper, we show that EMVS can be positively impacted through active management of knowledge within a project. This paper suggests that the value-enabling portion of a project manager's role requires aligning knowledge across these three key domains regarding PDP Gates (Phases at company manufacturers of auto parts, Lean Thinking and Value Stream, and methodology for managing projects through performance-term rates and costs. The results show that the methodology has positive aspects, but its implementation takes time and has repercussions throughout the supply chain. Further this research try to explain the types of wastes and view of new products' development is enhanced and associates a manufacturing strategy focus on EMVS performance analysis and lean thinking, PDP and value stream mapping  showing the important of contribution this tools at reduction of waste.

  13. Invasive Fetal Therapy: Global Status and Local Development

    Directory of Open Access Journals (Sweden)

    Ming Chen

    2004-12-01

    Full Text Available There are few congenital anomalies that can be treated in utero, despite the rapid development of fetal medicine. The number of available antenatal treatments is growing with the advance of supplementary tools, especially ultrasound and endoscopy. Disorders involving accumulation of excessive fluid in the amniotic cavity (polyhydramnios, chest (hydrothorax, abdomen (ascites and urinary system (obstructive uropathy are regularly treated using aspiration or shunt drainage under ultrasound monitoring. Electrolyte solutions or concentrated blood component supplements are used to treat oligohydramnios (amnioinfusion and amniopatch and fetal anemia (fetal transfusion. Placental tumor (chorioangioma and fetal tumors (cystic hygroma and sacrococcygeal teratoma are also successfully treated by antenatal injection of medications. Fetoscopic procedures, especially obstetric endoscopy, are now used regularly in North America, Europe, Australasia and Japan after the validity was established in the treatment of twin-twin transfusion syndrome when compared with traditional amnioreduction. However, most procedures involving surgical fetoscopy or open fetal surgery remain experimental. Their validity and efficacy are not confirmed in a number of fetal diseases for which they were claimed to be effective. A brief review of the global status and history of invasive fetal therapy is given, and its status in Taiwan is also described. Future development in this field relies on greater understanding of the basic physiology and pathology of the diseases involved, as well as on the progress of sophisticated instrumentation.

  14. Foundation-industry relationships--a new business model joint-venture philanthropy in therapy development.

    Science.gov (United States)

    Bartek, Ronald J

    2014-01-01

    The business model for medical therapy development has changed drastically. Large companies that once conducted their own Research and Development (R&D) and funded all the preclinical studies, all phases of clinical development and marketing of the products are increasingly turning to others for more and more of the earlier work in hopes of being able to in-license a de-risked program well downstream, take it through the final phases of clinical development and into the marketplace. This new paradigm has required patient-advocacy foundations, especially in the rare-disease space, to become far more effective in building relationships with all the players along the therapy-development pathway -- academic scientists, government agencies, other foundations with overlapping interests, biotechs, small biopharmaceutical entities and even the larger industry companies. From the perspective of the patient-advocacy community, these increasingly essential public-private partnerships have taken on the nature of what could be called joint-venture philanthropy and involve a broad spectrum of collaborations and financial relationships between foundations and industry partners that are not without concerns about potential conflicts of interest.

  15. Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients.

    Science.gov (United States)

    Papadaki, Magdalini

    2017-01-01

    For the nascent field of advanced therapies, collaboration will be a game-changer, turning scientific progress that was once unimaginable into transformative medical practice. Despite promise for lifelong management and even cure of disease, skepticism remains about the feasibility of their delivery to patients, fueling investment risks. With the potential for long-term effectiveness in need of frequent reassessment, current approaches to predict real-life drug performance bear little relevance, necessitating novel and iterative schemes to monitoring the benefit-risk profiles throughout the life span of advanced therapies. This work explains that reinventing an adoption route for Advanced Therapy Medicinal Products is as much about the scientific and clinical components, as it is about the organizational structures, requiring an unprecedented level of interactions between stakeholders not traditionally connected; from developers and regulators, to payers, patients, and funders. By reflecting on the successes and lessons learned from the growing space of global precompetitive consortia and public-private partnerships, as well as a number of emerging accelerated development pathways, this work aims to inform the foundations for a future roadmap that can smooth the path to approval, reimbursement, and access, while delivering value to all stakeholders. Echoing the growing demands to bring these transformative products to patients, it provides critical insights to enhance our capacity in three fundamental domains: deploying the operational flexibilities offered by the growing space of collaborations, utilizing emerging flexible and accelerated pathways to tackle challenges in quantifying long-term effectiveness, and building the necessary digital and clinical infrastructure for knowledge development.

  16. Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients

    Directory of Open Access Journals (Sweden)

    Magdalini Papadaki

    2017-05-01

    Full Text Available For the nascent field of advanced therapies, collaboration will be a game-changer, turning scientific progress that was once unimaginable into transformative medical practice. Despite promise for lifelong management and even cure of disease, skepticism remains about the feasibility of their delivery to patients, fueling investment risks. With the potential for long-term effectiveness in need of frequent reassessment, current approaches to predict real-life drug performance bear little relevance, necessitating novel and iterative schemes to monitoring the benefit–risk profiles throughout the life span of advanced therapies. This work explains that reinventing an adoption route for Advanced Therapy Medicinal Products is as much about the scientific and clinical components, as it is about the organizational structures, requiring an unprecedented level of interactions between stakeholders not traditionally connected; from developers and regulators, to payers, patients, and funders. By reflecting on the successes and lessons learned from the growing space of global precompetitive consortia and public–private partnerships, as well as a number of emerging accelerated development pathways, this work aims to inform the foundations for a future roadmap that can smooth the path to approval, reimbursement, and access, while delivering value to all stakeholders. Echoing the growing demands to bring these transformative products to patients, it provides critical insights to enhance our capacity in three fundamental domains: deploying the operational flexibilities offered by the growing space of collaborations, utilizing emerging flexible and accelerated pathways to tackle challenges in quantifying long-term effectiveness, and building the necessary digital and clinical infrastructure for knowledge development.

  17. Developing Communication with the Autistic Child Through Music Therapy.

    Science.gov (United States)

    Boxill, Edith Hillman

    The author's use of music therapy is illustrated in her account of therapy sessions with two autistic children. Music is seen to be particularly useful with the autistic child because it can make use of the child's rhythmic stereotypical actions to increase the child's self awareness. Techniques such as reflection (mimicking, through song and…

  18. Modelling architectures in multi-product oriented technology development

    DEFF Research Database (Denmark)

    Guðlaugsson, Tómas Vignir

    are not completely defined. Yet, decisions need to be made during technology development on the capabilities to be provided through the development to fulfil future application requirements,provide a foundation for future products, and development of a production system capable of producing future products...

  19. Managing R&D and New Product Development

    NARCIS (Netherlands)

    von Zedtwitz, Maximilian; Friesike, Sascha; Gassmann, Oliver; Dodgson, Mark; Gann, David M.; Phillips, Nelson

    2014-01-01

    This article examines the importance of R&D and new product development and explores their management. It describes three central aspects of managing R&D and new product development in firms: the product development funnel, R&D portfolio management, and R&D organization. Concepts such as the ‘fuzzy

  20. The gender gap in peer-reviewed publications by physical therapy faculty members: a productivity puzzle.

    Science.gov (United States)

    Kaufman, Regina R; Chevan, Julia

    2011-01-01

    Studies of peer-reviewed article publication by faculty in higher education show men publish more than women. Part of the difference in publishing appears to be attributable directly to gender. Gender differences in publishing productivity have not been explored in physical therapy. The purpose of this study was to explore effects of gender on peer-reviewed publication productivity in physical therapy. This was a cross-sectional study using survey methods. A survey was administered to a random sample of 881 physical therapy faculty members; 459 responses were used for analysis. Men were more likely than women to be married, have children, hold a PhD degree, be tenured or on a tenure track, and hold the position of department chair. There was a significant difference in peer-reviewed publication rates between male and female respondents. Negative binomial regression models revealed that female gender was a negative predictor of peer-reviewed publication, accounting for between 0.51 and 0.58 fewer articles per year for women than for men over the course of a career. Reasons for the gender differences are not clear. Factors such as grant funding, laboratory resources, nature of collaborative relationships, values for different elements of the teaching/research/service triad, and ability to negotiate the academic culture were not captured by our model. The gender gap in peer-reviewed publishing productivity may have implications for individuals and the profession of physical therapy and should be subject to further exploration.

  1. Corporate Production Transfers to Developing Countries

    DEFF Research Database (Denmark)

    Bruun, Peter; Wulff, Henrik

    1997-01-01

    Production transfer is defined by the set of activities attached to send off, receipt and running-in a production system in a new environment. The activities concern handling of physical elements as well as non-material, knowledge based issues like documentation, education/training and management...

  2. Recent progress in development of radioisotope production

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Byung Mok [HANARO Center, Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    1998-10-01

    The Korea multipurpose research reactor, HANARO(Hi-flux Advanced Neutron Application Reactor) is designed and constructed to obtain high density neutron flux (max. 5x10{sup 14} n/cm{sup 2}{center_dot}sec) with relatively low thermal output (30 MW) in order to utilize for various studies such as fuel and material test, radioisotope production, neutron activation analysis, neutron beam experiment, neutron transmutation doping, etc. HANARO has 32 vertical channels (3 in-core, 4 out-core, 25 reflector) and 7 horizontal channels. KAERI has constructed 4 concrete hot cells for production of Co-60, Ir-192, etc. and 6 lead hot cells for production of medical RIs(I-131, Mo-99, etc.). Other 11 lead hot cells will be completed by Feb. 1998 for production of Sm-153, Dy-165, Ho-166, etc. Clean room facilities were installed for production of radiopharmaceuticals. (author)

  3. Development of fission Mo-99 production technology

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jin Ho; Choung, W. M.; Lee, K. I. and others

    2000-05-01

    Fission Mo-99 is the only parent nuclide of Tc-99m, an extremely useful tool for mdeical diagnosis, with an estimated usage of greater than 80% of nuclear medicine applicatons. HEU and LEU targets to optimize in HANARO irradiation condition suggested and designed for domestic production of fission Mo-99. The optimum process conditions are established in each unit process to meet quality requirements of fission Mo-99 products, and the results of performance test in combined process show Mo separation and purification yield of the above 97%. The concept of Tc generator production process is established, and the result of performance test show Tc production yield of 98.4% in Tc generator procuction process. The drafts is prepared for cooperation of technical cooperation and business investment with foreign country. Evaluation on economic feasibility is accompanied for fission Mo-99 and Tc-99m generator production.

  4. Development of fission Mo-99 production technology

    International Nuclear Information System (INIS)

    Park, Jin Ho; Choung, W. M.; Lee, K. I. and others

    2000-05-01

    Fission Mo-99 is the only parent nuclide of Tc-99m, an extremely useful tool for mdeical diagnosis, with an estimated usage of greater than 80% of nuclear medicine applicatons. HEU and LEU targets to optimize in HANARO irradiation condition suggested and designed for domestic production of fission Mo-99. The optimum process conditions are established in each unit process to meet quality requirements of fission Mo-99 products, and the results of performance test in combined process show Mo separation and purification yield of the above 97%. The concept of Tc generator production process is established, and the result of performance test show Tc production yield of 98.4% in Tc generator procuction process. The drafts is prepared for cooperation of technical cooperation and business investment with foreign country. Evaluation on economic feasibility is accompanied for fission Mo-99 and Tc-99m generator production

  5. Developing and Implementing a Quality Assurance Strategy for Electroconvulsive Therapy.

    Science.gov (United States)

    Hollingsworth, Jessa; Baliko, Beverly; McKinney, Selina; Rosenquist, Peter

    2018-04-17

    The literature provides scant guidance in effective quality assurance strategies concerning the use of electroconvulsive therapy (ECT) for the treatment of psychiatric conditions. Numerous guidelines are published that provide guidance in the delivery of care; however, little has been done to determine how a program or facility might ensure compliance to best practice for safety, tolerability, and efficacy in performing ECT. The objective of this project was to create a quality assurance strategy specific to ECT. Determining standards for quality care and clarifying facility policy were key outcomes in establishing an effective quality assurance strategy. An audit tool was developed utilizing quality criteria derived from a systematic review of ECT practice guidelines, peer review, and facility policy. All ECT procedures occurring over a 2-month period of May to June 2017 were retrospectively audited and compared against target compliance rates set for the facility's ECT program. Facility policy was adapted to reflect quality standards, and audit findings were used to inform possible practice change initiatives, were used to create benchmarks for continuous quality monitoring, and were integrated into regular hospital quality meetings. Clarification on standards of care and the use of clinical auditing in ECT was an effective starting point in the development of a quality assurance strategy. Audit findings were successfully integrated into the hospital's overall quality program, and recognition of practice compliance informed areas for future quality development and policy revision in this small community-based hospital in the southeastern United States. This project sets the foundation for a quality assurance strategy that can be used to help monitor procedural safety and guide future improvement efforts in delivering ECT. Although it is just the first step in creating meaningful quality improvement, setting clear standards and identifying areas of greatest

  6. What and how about customer-driven product development

    DEFF Research Database (Denmark)

    Sommer, Anita Friis; Steger-Jensen, Kenn

    2012-01-01

    Collaborative product development is of increasing interest as customer demands increases while product life cycles decrease. This study investigates how suppliers handle active customers including managing customer requests for new products and customer-driven product development. A large...... structured literature review of the top 20 supply chain management journals is conducted to explore existing literature. Research states the importance of active integration in product development, but does not provide answers to how suppliers can manage this in practice. A 2x2 matrix is developed describing...... the differing views on customers in existing research including customer actions on both new and existing products....

  7. D-T neutron generator development for cancer therapy. 1980 annual progress report

    International Nuclear Information System (INIS)

    Bacon, F.M.; Walko, R.J.; Bickes, R.W. Jr.; Cowgill, D.F.; Riedel, A.A.; O'Hagan, J.B.

    1980-05-01

    This report summarizes the work completed during the first year of a two-year grant by NCI/HEW to investigate the feasibility of developing a D-T neutron generator for use in cancer therapy. Experiments have continued on the Target Test Facility (TTF) developed during a previous grant to investigate high-temperature metal hydrides for use as target materials. The high voltage reliability of the TTF has been improved so that 200 kV, 200 mA operation is now routine. In recent target tests, the D-D neutron production rate was measured to be > 1 x 10 11 /s, a rate that corresponds to a D-T neutron production rate of > 1 x 10 13 /s - the desired rate for use in cancer therapy. Deuterium concentration depth profiles in the target, measured during intense ion beam bombardment, show that deuterium is depleted near the surface of the target due to impurities implanted by the ion beam. Recent modifications of the duopigatron ion source to reduce secondary electron damage to the electrodes also improved the ion source efficiency by about 40%. An ultra high vacuum version of the TTF is now being constructed to determine if improved vacuum conditions will reduce ion source impurities to a sufficiently low level that the deuterium near the surface of the target is not depleted. Testing will begin in June 1980

  8. Development of a booklet on insulin therapy for children with diabetes mellitus type 1.

    Science.gov (United States)

    Moura, Denizielle de Jesus Moreira; Moura, Nádya Dos Santos; Menezes, Luciana Catunda Gomes de; Barros, Ariane Alves; Guedes, Maria Vilani Cavalcante

    2017-01-01

    to describe the process of developing of an educational booklet on insulin therapy for children with diabetes mellitus type 1. methodological approach, in which the following steps were carried out: selecting of the content and type of technology to be developed (for this step, an integrative review, an analysis of the comments of blogs about Diabetes Mellitus type 1 and interviews with the children were performed), creation of images, formatting and layout composition. the work resulted in the production of the final version of the educational booklet, which was titled Aplicando a insulina: a aventura de Beto [Applying insulin: Beto's adventure]. The process of developing of the booklet was based on the active participation of the children and guided by the theoretical framework of Piagetian Constructivism. the resource is a facilitator for the improvement of the knowledge and practices of self care of children with Diabetes Mellitus type 1.

  9. The Current of Continuing Professional Development for Product Designers

    OpenAIRE

    山内, 勉; Yamauchi, Tsutomu

    2010-01-01

    Product Designers are required some skills and knowledge in the product development. Based on my professional career, I presumed three skills, they are, Technical skills, Conceptual skills and Human skills. In this study, I interviewed some Product Designers to make sure what skills are needed in the product development process. It emerged that Product Designers are expected to improve their Conceptual and Human skills besides Technical skills for playing a part at the upper and lower stage o...

  10. Proposal for product development model focused on ce certification methodology

    Directory of Open Access Journals (Sweden)

    Nathalia Marcia Goulart Pinheiro

    2015-09-01

    Full Text Available This paper presents a critical analysis comparing 21 product development models in order to identify whether these structures meet the demands Product Certification of the European Community (CE. Furthermore, it presents a product development model, comprising the steps in the models analyzed, including improvements in activities for referred product certification. The proposed improvements are justified by the growing quest for the internationalization of products and processes within companies.

  11. New developments of 11C post-accelerated beams for hadron therapy and imaging

    Science.gov (United States)

    Augusto, R. S.; Mendonca, T. M.; Wenander, F.; Penescu, L.; Orecchia, R.; Parodi, K.; Ferrari, A.; Stora, T.

    2016-06-01

    Hadron therapy was first proposed in 1946 and is by now widespread throughout the world, as witnessed with the design and construction of the CNAO, HIT, PROSCAN and MedAustron treatment centres, among others. The clinical interest in hadron therapy lies in the fact that it delivers precision treatment of tumours, exploiting the characteristic shape (the Bragg peak) of the energy deposition in the tissues for charged hadrons. In particular, carbon ion therapy is found to be biologically more effective, with respect to protons, on certain types of tumours. Following an approach tested at NIRS in Japan [1], carbon ion therapy treatments based on 12C could be combined or fully replaced with 11C PET radioactive ions post-accelerated to the same energy. This approach allows providing a beam for treatment and, at the same time, to collect information on the 3D distributions of the implanted ions by PET imaging. The production of 11C ion beams can be performed using two methods. A first one is based on the production using compact PET cyclotrons with 10-20 MeV protons via 14N(p,α)11C reactions following an approach developed at the Lawrence Berkeley National Laboratory [2]. A second route exploits spallation reactions 19F(p,X)11C and 23Na(p,X)11C on a molten fluoride salt target using the ISOL (isotope separation on-line) technique [3]. This approach can be seriously envisaged at CERN-ISOLDE following recent progresses made on 11C+ production [4] and proven post-acceleration of pure 10C3/6+ beams in the REX-ISOLDE linac [5]. Part of the required components is operational in radioactive ion beam facilities or commercial medical PET cyclotrons. The driver could be a 70 MeV, 1.2 mA proton commercial cyclotron, which would lead to 8.1 × 10711C6+ per spill. This intensity is appropriate using 11C ions alone for both imaging and treatment. Here we report on the ongoing feasibility studies of such approach, using the Monte Carlo particle transport code FLUKA [6,7] to simulate

  12. New developments of {sup 11}C post-accelerated beams for hadron therapy and imaging

    Energy Technology Data Exchange (ETDEWEB)

    Augusto, R.S., E-mail: r.s.augusto@cern.ch [European Organization for Nuclear Research – CERN, 1211 Geneva 23 (Switzerland); Ludwig Maximilians – University of Munich, Munich (Germany); Mendonca, T.M.; Wenander, F. [European Organization for Nuclear Research – CERN, 1211 Geneva 23 (Switzerland); Penescu, L. [MedAustron GmbH, Wiener Neustadt (Austria); Orecchia, R. [CNAO – Centro Nazionale di Adroterapia Oncologica per il trattamento dei tumori, Pavia (Italy); Parodi, K. [Ludwig Maximilians – University of Munich, Munich (Germany); Ferrari, A.; Stora, T. [European Organization for Nuclear Research – CERN, 1211 Geneva 23 (Switzerland)

    2016-06-01

    Hadron therapy was first proposed in 1946 and is by now widespread throughout the world, as witnessed with the design and construction of the CNAO, HIT, PROSCAN and MedAustron treatment centres, among others. The clinical interest in hadron therapy lies in the fact that it delivers precision treatment of tumours, exploiting the characteristic shape (the Bragg peak) of the energy deposition in the tissues for charged hadrons. In particular, carbon ion therapy is found to be biologically more effective, with respect to protons, on certain types of tumours. Following an approach tested at NIRS in Japan [1], carbon ion therapy treatments based on {sup 12}C could be combined or fully replaced with {sup 11}C PET radioactive ions post-accelerated to the same energy. This approach allows providing a beam for treatment and, at the same time, to collect information on the 3D distributions of the implanted ions by PET imaging. The production of {sup 11}C ion beams can be performed using two methods. A first one is based on the production using compact PET cyclotrons with 10–20 MeV protons via {sup 14}N(p,α){sup 11}C reactions following an approach developed at the Lawrence Berkeley National Laboratory [2]. A second route exploits spallation reactions {sup 19}F(p,X){sup 11}C and {sup 23}Na(p,X){sup 11}C on a molten fluoride salt target using the ISOL (isotope separation on-line) technique [3]. This approach can be seriously envisaged at CERN-ISOLDE following recent progresses made on {sup 11}C{sup +} production [4] and proven post-acceleration of pure {sup 10}C{sup 3/6+} beams in the REX-ISOLDE linac [5]. Part of the required components is operational in radioactive ion beam facilities or commercial medical PET cyclotrons. The driver could be a 70 MeV, 1.2 mA proton commercial cyclotron, which would lead to 8.1 × 10{sup 711}C{sup 6+} per spill. This intensity is appropriate using {sup 11}C ions alone for both imaging and treatment. Here we report on the ongoing feasibility

  13. Bioethanol production from crops - recent developments

    International Nuclear Information System (INIS)

    Dalton, Colin

    1992-01-01

    The author notes much higher rates of ethanol production in Brazil and the United States of America than in the European Economic Community. While bioethanol from arable crops makes environmental sense there is, at present, a sizeable difference between the value of fuel ethanol (Pound 100-130/t) and the cost of producing it (Pound 236-Pound 450/t). This gap could be remedied using excise duty. Farmers would like to change crop production but await a political initiative. The technology for bioethanol production still needs some fine tuning, with ETBE (an ether produced from reacting isobutylene with ethanol) being preferred to other methods. (UK)

  14. Development of Smart Phthalocyanine-based Photosensitizers for Photodynamic Therapy

    Science.gov (United States)

    Chow, Yun Sang

    Phthalocyanines are versatile functional dyes that have shown great potential in cancer theranostics, especially in photodynamic therapy (PDT). This research work aims to develop "smart" phthalocyanine-based photosensitizers for targeted PDT. This thesis describes the synthesis, spectroscopic characterization, photophysical properties, and in vitro photodynamic activities of several series of carefully designed phthalocyanine-based photosensitizers. Chapter 1 presents an overview of PDT, including its historical development, photophysical mechanisms, and biological mechanisms. Various classes of photosensitizers are introduced with emphasis putting on phthalocyanines, which exhibit ideal characteristics of photosensitizers for PDT. In recent years, several approaches have been used to develop photosensitizers with higher tumor selectivity and minimal skin photosensitivity after PDT. Activatable photosensitizers can provide a "turn on" mechanism to offer an additional control of the specificity of treatment. Photosensitizers can also work cooperatively with the tumor-targeting groups or anticancer drugs so as to achieve targeted or dual therapy, which can enhance the efficacy of PDT. The novel approaches mentioned above have been widely used and combined to form multi-functional photosensitizing agents. These novel concepts and development of PDT are discussed and illustrated with relevant examples at the end of this chapter. To minimize the prolonged skin photosensitivity, photosensitizers that can only be activated by tumor-associated stimuli have been developed. Due to the abnormal metabolism in tumor tissues, their surface usually exhibits a lower pH compared to that of the normal tissues. Also, the pH difference between the intracellular and the physiological environment provides a pH-activation mechanism. Chapter 2 presents the synthesis and spectroscopic characterization of a pH-responsive zinc(II) phthalocyanine tetramer, in which the phthalocyanine units

  15. Developing products and services for a deregulated market while regulated

    International Nuclear Information System (INIS)

    Haites, E.F.

    1997-01-01

    Products and services developed for a deregulated electric power industry were discussed. The wide-ranging discussion covered products created by unbundling existing services, new products and services related to energy use, products created by expansion into communications services, and the pricing of products and services. In addition to products and services, the discussion also covered strategies for a deregulated market and the challenges of raising equity capital in a regulated environment

  16. Challenges associated with knowledge sharing in international product development teams

    DEFF Research Database (Denmark)

    Sonne, Anne-Mette; Harmsen, Hanne

    on product development teams, knowledge sharing, and international product development management to form a conceptual framework of factors that influence knowledge sharing in international teams. Four in-depth case studies are used to explore and expand the understanding of the challenges associated...... with international product development teams. Results indicate that international product development might not be as international as would be expected and that even if many of the characteristics and problems associated with international product development in the literature are found, there are also a number...

  17. Education and Manpower development for Cleaner Production

    DEFF Research Database (Denmark)

    Jørgensen, Michael Søgaard

    1996-01-01

    An overview of the needs for education and training for dissemination and implementation of cleaner production. Expericne from training in companies and training of officials from public authorities and from integration into engineering, business and management and social science curricula...

  18. Market Dynamics and Productivity in Developing Countries

    International Development Research Centre (IDRC) Digital Library (Canada)

    Mining and Quarrying and manufacturing industrial production quantity index ..... Notably, the survival rate of the manufacture of wearing apparel, except footwear ...... Thus, weaknesses in design makes Tunisia's public credit registry a less ...

  19. Production and separation of terbium-149 and terbium-152 for targeted cancer therapy

    International Nuclear Information System (INIS)

    Sarkar, S.; Leigh, J.

    1997-01-01

    This work reports the production and separation of useful quantities of 149 , 152 Tb from natural neodymium ( nat Nd) and 141 Pr for in vitro studies by bombarding the targets with 12 C projectiles. The physical, chemical and nuclear properties of radionuclides determine their efficacy in therapy and diagnosis. Tb-149 is an alpha-emitter with a half-life of 4.1h and 152 Tb is a positron emitter with a half-life of 17.5 h. Both of the isotopes have suitable gamma emission with good branching ratio suggesting their application to diagnosis apart from therapy. Alpha-emitters are effective in controlling cancer because of their short range and high Relative Biological Effectiveness. Long-lived positron emitters are effective in studying physiological function in positron emission tomography other than therapy. The aim of this work is to optimise the production and carrier free separation of terbium. Because of the presence of other stable isotopes in nat Nd, a number of other lanthanides are produced by secondary reactions during the production of terbium. In order to remove the secondary products, α-hydroxyisobutyric acid of pH 5 was used as eluent. satisfactory separation of terbium was achieved and demonstrate that useful quantities of 144,152 Tb can be produced by Tandem accelerator from 141 Pr and nat Nd targets

  20. Candida albicans biofilm development in vitro for photodynamic therapy study

    International Nuclear Information System (INIS)

    Suzuki, Luis Claudio

    2009-01-01

    Photodynamic therapy (PDT) is a phototherapy based on the use of a photo sensitizer (PS) in the presence of low intensity light with resonant wavelength of absorption of the PS and biological systems that can raise awareness, generating reactive oxygen species. Studies show that PDT has a lethal effect on Candida albicans. The biofilm formed by C. albicans is the cause of infections associated with medical devices such as catheters, with a proven resistance to antifungal agents, and the removal of the catheter colonized almost always is necessary. However, few studies in literature report the behavior and response of biofilm organized by C. albicans against PDT. The aims of this study were to develop a methodology for in vitro biofilm formation of C. albicans, evaluate the sensitivity of the biofilm of C. albicans to antimicrobial photodynamic therapy using PS as the methylene blue (MB) and hypocrellin B: La +3 (HBL a+3 ) and analyze the biofilm by Optical Coherence Tomography (OCT). For biofilm formation, discs were made from elastomeric silicone catheters. The PS were dissolved in solution of PBS, and the MB had two different concentrations tested in the biofilm: 100μM and 1mM; HBLa +3 only one of 10μM. The irradiation of both dyes with the microorganism was done by two different LEDs, one with red emission at λ = 630nm ± 20nm and the other one blue emission at λ = 460nm ± 30nm. We performed a curve of survival fraction versus time of irradiation of each sample with biofilm and suspension of the microorganism in the yeast form to verify the susceptibility of the front PDT. The yeast showed 100% reduction using both PS, but at different times of irradiation (30s to HBLa +3 and 6 min for the MB at 100μM). When the therapy was applied in biofilm, the MB 100μM did not show any significant reduction, while at concentration of 1mM was reduced by 100% after 6 min of irradiation. The HBLa +3 biofilm group showed a lower reduction in the concentration of 10μM in

  1. Liposomal Drug Product Development and Quality: Current US Experience and Perspective.

    Science.gov (United States)

    Kapoor, Mamta; Lee, Sau L; Tyner, Katherine M

    2017-05-01

    Research in the area of liposomes has grown substantially in the past few decades. Liposomes are lipid bilayer structures that can incorporate drug substances to modify the drug's pharmacokinetic profile thereby improving drug delivery. The agency has received over 400 liposomal drug product submissions (excluding combination therapies), and there are currently eight approved liposomal drug products on the US market. In order to identify the pain points in development and manufacturing of liposomal drug products, a retrospective analysis was performed from a quality perspective on submissions for new and generic liposomal drug products. General analysis on liposomal drug product submissions was also performed. Results indicated that 96% of the submissions were Investigational New Drug (IND) applications, 3% were New Drug Applications (NDAs), and the remaining 1% was Abbreviated New Drug Applications (ANDAs). Doxorubicin hydrochloride was the most commonly used drug substance incorporated into the liposomes (31%). The majority of the liposomal products were administered via intravenous route (84%) with cancer (various types) being the most common indication (63%). From a quality perspective, major challenges during the development of liposomal drug products included identification and (appropriate) characterization of critical quality attributes of liposomal drug products and suitable control strategies during product development. By focusing on these areas, a faster and more efficient development of liposomal drug products may be achieved. Additionally, in this way, the drug review process for such products can be streamlined.

  2. Development of venetoclax for therapy of lymphoid malignancies

    Directory of Open Access Journals (Sweden)

    Zhu H

    2017-03-01

    Full Text Available Huayuan Zhu,1,2 Alexandru Almasan1 1Department of Cancer Biology, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; 2Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, People’s Republic of China Abstract: B-cell lymphoma-2 (BCL-2 family dysfunction and impairment of apoptosis are common in most B-cell lymphoid malignancies. Venetoclax (Venclexta™, formerly ABT-199, GDC-0199 is a highly selective BCL-2 inhibitor, which mimics its BCL-2 homology 3-domain to induce apoptosis. It was approved for treatment of previously treated chronic lymphocytic leukemia (CLL patients with 17p deletion early in 2016. It has also been in clinical trials for other B-cell lymphoid malignancies. Unlike the other recently approved targeted agents idelalisib and ibrutinib, so far there has been no relapse reported in some patients. Also, unlike the other targeted agents, it is effective against tumor cells that reside in the blood marrow. Despite its promising outcome in CLL, preclinical data have already uncovered mechanistic insights underlying venetoclax resistance, such as upregulation of MCL-1 or BCL-xL expression and protective signaling from the microenvironment. In this review, we describe the role of the BCL-2 family in the pathogenesis of B-cell lymphoid malignancies, the development of venetoclax, and its current clinical outcome in CLL and other B-cell malignancies. We also discuss the resistance mechanisms that develop following venetoclax therapy, potential strategies to overcome them, and how this knowledge can be translated into clinical applications. Keywords: BCL-2, BCL-xL, chronic lymphocytic leukemia, MCL-1, venetoclax

  3. THE DEVELOPMENT OF NEUROSCAFFOLD FOR THE GLIOBLASTOMA THERAPY

    Directory of Open Access Journals (Sweden)

    Yu. S. Maklygina

    2017-01-01

    Full Text Available Current paper presents the results of the system development for intracranial implantation aimed on therapy and prevention of brain gliomas relapse. The main property of the system, in prospective,  will be to direct the growth of glioma cells localized in the region  adjacent to the site of the removed tumor along the fi bers towards  the proximal part of the fiber-optic scaffold (neuroport. Such  approach will allow carrying out cells diagnostics by the  photoluminescence signal and provide subsequent destruction of  malignant cells by photodynamic action. Besides, this system could  be used for monitoring the processes occurring in the probed area in order to control the possible relapses. The localization of cells along  the fi ber structures covered with gelatin compound, which is the  source of amino acids during cultivation, was shown during the glioma cells growth dynamics study. Moreover, four different designs of intracranial scaffold models, serving as ports for diagnostic and therapeutic laser radiation delivery, were developed and  successfully tested in the framework of the research. The results  obtained on the rats brain with induced tumors (glioma C6 after  neuroport implantation demonstrate sufficiently intense fluorescence in the tumor bed after intravenous injection of the  nonmetallic sulfonated phthalocyanine based photosensitizer, and a  pronounced photodynamic effect leading to total destruction of the  tumor. In this way, the results of this study open the prospects of creating the neuroport with an internal fi ber structure that focuses the glioma cells growth.

  4. FiR 1 reactor in service for boron neutron capture therapy (BNCT) and isotope production

    International Nuclear Information System (INIS)

    Auterinen, I.; Salmenhaara, S.E.J. . Author

    2004-01-01

    The FiR 1 reactor, a 250 kW Triga reactor, has been in operation since 1962. The main purpose for the existence of the reactor is now the Boron Neutron Capture Therapy (BNCT), but FiR 1 has also an important national role in providing local enterprises and research institutions in the fields of industrial measurements, pharmaceuticals, electronics etc. with isotope production and activation analysis services. In the 1990's a BNCT treatment facility was built at the FiR 1 reactor located at Technical Research Centre of Finland. A special new neutron moderator material Fluental TM (Al+AlF3+Li) developed at VTT ensures the superior quality of the neutron beam. Also the treatment environment is of world top quality after a major renovation of the whole reactor building in 1997. Recently the lithiated polyethylene neutron shielding of the beam aperture was modified to ease the positioning of the patient close to the beam aperture. Increasing the reactor power to 500 kW would allow positioning of the patient further away from the beam aperture. Possibilities to accomplish a safety analysis for this is currently under considerations. Over thirty patients have been treated at FiR 1 since May 1999, when the license for patient treatment was granted to the responsible BNCT treatment organization, Boneca Corporation. Currently three clinical trial protocols for tumours in the brain as well as in the head and neck region are recruiting patients. (author)

  5. Modelling and using product architectures in mechatronic product development

    DEFF Research Database (Denmark)

    Bruun, Hans Peter Lomholt; Mortensen, Niels Henrik

    , experiences by using the architecture representation in a mechatronic development project, and the scope of using the architecture model as a skeleton for a data structure in a PLM system. The fundamental idea for planning and modeling holistic architectures is that an improved understanding of the whole...

  6. DEVELOPMENT OF WOOD-BASED PRODUCTS WORLDWIDE

    Directory of Open Access Journals (Sweden)

    Marius C. BARBU

    2015-12-01

    Full Text Available The tendency in recent decades for manufacturing plants of semi-finished products such as composite panels, has been to invest in order to achieve high production capacities (>2,000 m³/day for panels and >3,000 t/day for paper with one line. The trend of concentrating the primary processing capacities and manufacturing wood-based panels will continue for the next few years not only in Europe but in North and South America as well. The ten largest panel manufacturers had a combined manufacturing capacity that exceeded a third of the worldwide production capacity. The financial crisis that started in 2008 has caused the closure of a large number of factories especially in North America and Central Europe. Small- and medium-sized producers will only survive if they will continue to specialize in the manufacture of panel types and sizes (niche products that are “unprofitable” for mega-groups. The installed production capacity worldwide of all wood-based composite panels combined (includes PY, PB, MDF, OSB rose by more than 2.5 times between 1980 and 2005 (225 mil.m³, and continues to increase despite the crises reaching approx. 300 mil.m³ in 2013. The forecast for the coming years varies greatly from continent to continent. In North America and Central Europe, both a consolidation of the available production capacities and the closure of less efficient older lines are expected. The lowest point of the effect of the financial crisis on the building industry seems to have been overcome. The furniture production companies will continue to move from one continent and region to another.

  7. PDC Journeys to Product Analysis Development and Additive Manufacturing?

    International Nuclear Information System (INIS)

    Shalina Sheik Muhamad

    2015-01-01

    The technology for product development and manufacturing has gone through many advancements. It is widely recognised that it would provide competitive advantage for engineering organization in term of product development cycle, productivity, sustainability and efficiency. We begin by describing the general characteristic of design process that will need to be integrated in product life cycle management. In Nuclear Malaysia, especially in engineering design activities the majority have been using 3D modelling. This paper discusses on the current product design practiced in Nuclear Malaysia, new product development process and new manufacturing technique which is additive manufacturing. (author)

  8. Development of an Advanced Injectable Therapy for Ischemic Vascular Disease

    Science.gov (United States)

    2017-10-01

    14. ABSTRACT Cardiovascular diseases are the most common causes of death for Americans and it is estimated that 20% of the population over 65 years of...therapies due to overall poor health or diffuse vascular disease. A promising approach to this problem is to induce the growth of new vessels using...angiogenic therapy with growth factors to restore flow to the ischemic tissues. Unfortunately, many clinical trials using growth factors for treating

  9. Product Innovation Development in the Companies of Creative Industries

    Directory of Open Access Journals (Sweden)

    Rolandas Strazdas

    2011-10-01

    Full Text Available Many authors distinguish product innovation as a key factor for long-term competitiveness. Dominant narrow perception of a product is leading towards incorrect product development process and the consequent result is a bad product. Narrow perception of a product is one of the main paralysing factors affecting the creator in the process of product development, which leads towards a low level of product innovation. As a result, a company is losing its uniqueness, originality, and is not of  interest neither for consumers nor the product developers themselves. This article deals with the product perception problems in the companies of creative industries. The main limiting factors for the perception of a product are analysed in the article as well as possibilities to expand the perception of a product. Five main product development methods: conservative, delegative, holistic, limited open, fully open are described in the article. The choice of the product development methods is especially important for the creative industries companies whose product development process is very intensive. 

  10. Company competencies as a network: The role of product development

    DEFF Research Database (Denmark)

    Harmsen, Hanne; Grunert, Klaus G.; Bove, Karsten

    2000-01-01

    investigate these matters in a survey with top managers in 513 Danish production companies. Ten areas important for achieving company objectives are identified. These are product development, market intelligence, production management, strategy and vision, sales, market responsiveness, promotion, internal co......-operation, image, and finally supply management. Product development is rated a fairly important competence as it ranks four with sales, market responsiveness, and production management as numbers one to three. Yet a distressing negative impact on overall company success is found for product development......Product development managers and academics like to assure themselves and each other that new product development is one of the most critical areas of company competence and contributes positively to company success But does top management agree? Because if they do not, the consequences will heavily...

  11. Sustainable Product Development Through a Life-Cycle Approach to Product and Service Creation (Keynote speech)

    DEFF Research Database (Denmark)

    McAloone, Timothy Charles

    . These two schools of environmental re-search practice are mirrored in the way in which industry approaches environmental problems. Since the definition in 1987 of Sustainable Development [2] efforts have been made to relate the goals and ideals of sustainabil-ity to the domain of product development, thus...... adding new dimensions, such as social and moral values, to the original agenda of environmental improvement. The redefinition of the role of the product developer, from environmentally conscious product de-veloper to sustainably aware product developer has led to new insights into the way in which...... products are developed and used ¿ and to where environmental effects occur in the lifetime of a product. The role of the product developer is thus more complex in relation to sustainability, as the focus for improvement of a product may not (and very often does not) lie in the physical artefactual...

  12. Human Resource Development for Uranium Production Cycle

    International Nuclear Information System (INIS)

    Ganguly, C.

    2014-01-01

    Concluding Remarks & Suggestions: • HRD will be one of the major challenges in the expanding nuclear power program in countries like China and India. • China and India get uranium raw material from domestic mines and international market. In addition, China has overseas uranium property. India is also exploring the possibility of overseas Joint Venture and uranium properties. For uranium production cycle there is a need for trained geologist, mining engineers, chemical and mechanical engineers. • There is a need for introducing specialization course on “uranium production cycle” at post graduate levels in government and private universities. Overseas Utilities and private firms in India engaged in nuclear power and fuel cycle activities may like to sponsor MTech students with assurance of employment after the successful completion of the course. • The IAEA may consider to extend Technical Assistance to universities in HRD in nuclear power and fuel cycle in general and uranium production cycle in particular - IAEA workshops, with participation of international experts, on uranium geology, mining, milling and safety and best practices in uranium production cycle will be of great help. • The IAEA – UPSAT could play an important role in HRD in uranium production cycle

  13. Increase in interleukin-8 production from circulating neutrophils upon antibiotic therapy in cystic fibrosis patients.

    Science.gov (United States)

    Montemurro, Pasqualina; Mariggiò, Maria A; Barbuti, Giovanna; Cassano, Amalia; Vincenti, Alessandra; Serio, Gabriella; Guerra, Lorenzo; Diana, Anna; Santostasi, Teresa; Polizzi, Angela; Fumarulo, Ruggiero; Casavola, Valeria; Manca, Antonio; Conese, Massimo

    2012-12-01

    It is not known whether antibiotic therapy for lung disease in cystic fibrosis (CF) has an influence on circulating polymorphonuclear neutrophil (PMN) function and apoptosis. Blood PMNs were obtained from 14 CF patients before and after antibiotic treatment for an acute exacerbation, and from 10 healthy controls. PMNs were evaluated for production of reactive oxygen species (ROS) by spectrophotometry, of cytokines in the conditioned medium by ELISA, and apoptotic response by cytofluorimetry. ROS and interleukin (IL)-8 were produced at higher levels by CF PMNs pre-therapy than control PMNs under basal conditions. IL-8 levels further increased after therapy. Early apoptotic response was higher in CF PMNs pre-therapy than in control PMNs, and this pattern did not change after antibiotic treatment. Circulating PMNs are primed in CF acute patients. Further studies are needed to consider PMN-produced IL-8 as a biomarker to evaluate response to antibiotic therapy in CF patients. Copyright © 2012 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  14. Developing new markets for oil sands products

    International Nuclear Information System (INIS)

    Crandall, G.

    2004-01-01

    This paper presents a review by Purvin and Gertz of western Canadian crude oil supply. This energy consulting firm provides advise to the energy sector. It suggests that oil sands production will surpass declining conventional production. Oil sands supply includes bitumen, synthetic crude oil (SCO), and diluent. It is forecasted that oil sands will increase from 42 per cent of western supply in 2002 to 78 per cent in 2015. The potential of Alberta's oil sands was discussed along with a recent study of refined products and petrochemicals from bitumen. Upgrading, refining and petrochemical case studies were presented. The author examined if a Canadian oil sands upgrading project with high capital costs can be competitive with competing projects in the United States and internationally. In addition to supply and demand issues, the presentation examined infrastructure capability and market potential in the United States. The economic potential and risks of preferred business cases compared to upgrading to SCO were also evaluated. 15 figs

  15. An Empirical Study of Capability Development within Product Innovation Projects

    Directory of Open Access Journals (Sweden)

    Alireza Javanmardi Kashan

    2015-04-01

    Full Text Available The objective of this paper is to develop insights into firms’ strategic capability development processes within product innovation projects. In particular, the research aims at investigating the interactions among product innovation, knowledge processes, and capability development within firms. Building on qualitative data from the auto-industry, our analysis reveals that across four product innovation projects, the case company developed architectural knowledge and capability. Findings reveal that, along with changes at each level of product architecture, “design knowledge” and “design capability” have been developed at the same level of product architecture, leading to capability development at that level. Furthermore, findings suggest that such capability transformation resulting from knowledge and capability creation over the course of case projects leads to modularization of product architecture. Overall, the research contributes to identifying and emphasizing the role of micro processes in capability development and renewal, which in turn enhances our understanding of strategic capability development processes.

  16. Consequences of new product development speed : a meta-analysis

    NARCIS (Netherlands)

    Cankurtaran, P.; Langerak, F.; Griffin, A.

    2011-01-01

    Despite the widespread contention that development speed is a prerequisite for successful new product development, there exists insufficient, often conflicting empirical evidence regarding how speed relates to the different dimensions of new product success. Given that new product success is a

  17. The Challenge of Providing Renal Replacement Therapy in Developing Countries: The Latin American Perspective.

    Science.gov (United States)

    Obrador, Gregorio T; Rubilar, Ximena; Agazzi, Evandro; Estefan, Janette

    2016-03-01

    The costs of health care place developing countries under enormous economic pressure. Latin America is a region characterized by wide ethnic and per capita gross domestic product variations among different countries. Chronic kidney failure prevalence and incidence, as well as provision of renal replacement therapy (RRT), have increased in all Latin American countries over the last 20 years. From an ethical point of view, life-sustaining therapies such as RRT should be available to all patients with chronic kidney disease who might benefit. However, even among Latin American countries with similar per capita incomes and health care expenditures, only some have been able to achieve universal access to RRT. This indicates that it is not just a problem of wealth or distribution of scarce health care resources, but one of social justice. Strategies to increase the availability of RRT and renal palliative-supportive care, as well as implementation of interventions to prevent chronic kidney disease development and progression, are needed in Latin America and other developing countries. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  18. Development of a Music Therapy Service in an Australian Public Rehabilitation Hospital

    OpenAIRE

    Jeanette Tamplin

    2006-01-01

    It is often challenging to find information about the details and development of clinical music therapy programs in other parts of the world. This article addresses a gap in the literature by describing the evolution of a neurological rehabilitation program over the past two years in Melbourne, Australia. After providing some local details on the development of rehabilitation music therapy in this part of the world, a brief rationale is offered for the place of music therapy in clinical rehab...

  19. Parallel Development of Products and New Business Models

    OpenAIRE

    Lund, Morten; Hansen, Poul H. Kyvsgård

    2014-01-01

    The perception of product development and the practical execution of product development in professional organizations have undergone dramatic changes in recent years. Many of these chances relate to introduction of broader and more cross-disciplinary views that involves new organizational functions and new concepts. These chances can be captured in various generations of practice. This paper will discuss the recent development of 3rd generation product development process models and the emer...

  20. Formalizing the concept phase of product development

    NARCIS (Netherlands)

    Schuts, M.; Hooman, J.

    2015-01-01

    We discuss the use of formal techniques to improve the concept phase of product realisation. As an industrial application, a new concept of interventional X-ray systems has been formalized, using model checking techniques and the simulation of formal models. cop. Springer International Publishing

  1. THE NECESSITY OF DEVELOPING BLUEBERRY PRODUCTION

    Directory of Open Access Journals (Sweden)

    Florentina BADIU

    2013-12-01

    Full Text Available This article presents the advantages of cultivating blueberries, both economically and from an alimentary and therapeutic point of view. By calculating profit per hectare for the most productive varieties of blueberry, it was shown that this culture is particularly profitable for young farmers. In fact, blueberries have significant therapeutic value, being used in food and pharmaceutical industry.

  2. Developments and constraints in fermentative hydrogen production

    NARCIS (Netherlands)

    Bartacek, J.; Zabranska, J.; Lens, P.N.L.

    2007-01-01

    Fermentative hydrogen production is a novel aspect of anaerobic digestion. The main advantage of hydrogen is that it is a clean and renewable energy source/carrier with high specific heat of combustion and no contribution to the Greenhouse effect, and can be used in many industrial applications.

  3. Production of Ac-225 for cancer therapy by photon-induced transmutation of Ra-226.

    Science.gov (United States)

    Melville, G; Meriarty, H; Metcalfe, P; Knittel, T; Allen, B J

    2007-09-01

    The increasing application of Ac-225 for cancer therapy indicates the potential need for its increased production and availability. The production of Ac-225 has been achieved using bremsstrahlung photons from an 18 MV medical linear accelerator (linac) to bombard a Ra-226 target. A linac dose of 2800 Gy produced about 64 microCi of Ra-225, which decays to Ac-225. This result, while consistent with the theoretical calculations, is far too low to be of practical use. A more powerful linac is required that runs at a higher current, longer pulse length and higher frequency for practical production. This process could also lead to the reduction of the nuclear waste product Ra-226.

  4. Current advanced therapy cell-based medicinal products for type-1-diabetes treatment.

    Science.gov (United States)

    Cañibano-Hernández, Alberto; Del Burgo, Laura Sáenz; Espona-Noguera, Albert; Ciriza, Jesús; Pedraz, Jose Luis

    2018-03-27

    In the XXI century diabetes mellitus has become one of the main threats to human health with higher incidence in regions such as Europe and North America. Type 1 diabetes mellitus (T1DM) occurs as a consequence of the immune-mediated destruction of insulin producing β-cells located in the endocrine part of the pancreas, the islets of Langerhans. The administration of exogenous insulin through daily injections is the most prominent treatment for T1DM but its administration is frequently associated to failure in glucose metabolism control, finally leading to hyperglycemia episodes. Other approaches have been developed in the past decades, such as whole pancreas and islet allotransplantation, but they are restricted to patients who exhibit frequent episodes of hypoglycemia or renal failure because the lack of donors and islet survival. Moreover, patients transplanted with either whole pancreas or islets require of immune suppression to avoid the rejection of the transplant. Currently, advanced therapy medicinal products (ATMP), such as implantable devices, have been developed in order to reduce immune rejection response while increasing cell survival. To overcome these issues, ATMPs must promote vascularization, guaranteeing the nutritional contribution, while providing O 2 until vasculature can surround the device. Moreover, it should help in the immune-protection to avoid acute and chronic rejection. The transplanted cells or islets should be embedded within biomaterials with tunable properties like injectability, stiffness and porosity mimicking natural ECM structural characteristics. And finally, an infinitive cell source that solves the donor scarcity should be found such as insulin producing cells derived from mesenchymal stem cells (MSCs), embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). Several companies have registered their ATMPs and future studies envision new prototypes. In this review, we will discuss the mechanisms and etiology of

  5. The Role of the EMTC for development and recognition of the music therapy profession

    DEFF Research Database (Denmark)

    Ridder, Hanne Mette Ochsner; Lerner, Adrienne; Suvini, Ferdinando

    2015-01-01

    , and therefore the training of students, continuing education and research. This leads to a further demand for recognition of music therapy as a profession and for regulation, registration and governmental recognition. Looking back over the past 60 years, we are able to define some common paths of development......The rapid development of music therapy in Europe is reflected in the increasing number of trained professionals, music therapy positions and research publications. A development of the discipline implies increased requirements regarding the skills and competences of music therapy clinicians...... in relation to the music therapy profession throughout the European countries. With this as a starting point, as well as our own engagement in the European Music Therapy Confederation (EMTC) for more than a decade, we will explore the innate complexity of the profession and formulate our views for the future...

  6. PLM SOLUTION DESIGN FOR NEW PRODUCT DEVELOPMENT.-CASE STUDY

    OpenAIRE

    Varsha Arun Chitale*, Prof. R.B. Patil, Prof. Amol R. Patil

    2016-01-01

    In competition business environment, companies recognize the importance of collaboration throughout the entire product lifecycle. The main focus of the paper is on the collaboration in New Product Development (NPD) processes and how Product Lifecycle Management (PLM) strategy are likely to paradigm support advanced collaboration strategies, such as Mass Customization and Customer Co-Creation. The relation between these strategies and product lifecycle phases related to New Product Developmen...

  7. Psychoactive natural products: overview of recent developments

    Directory of Open Access Journals (Sweden)

    István Ujváry

    2014-03-01

    Full Text Available Natural psychoactive substances have fascinated the curious mind of shamans, artists, scholars and laymen since antiquity. During the twentieth century, the chemical composition of the most important psychoactive drugs, that is opium, cannabis, coca and "magic mushrooms", has been fully elucidated. The mode of action of the principal ingredients has also been deciphered at the molecular level. In the past two decades, the use of herbal drugs, such as kava, kratom and Salvia divinorum, began to spread beyond their traditional geographical and cultural boundaries. The aim of the present paper is to briefly summarize recent findings on the psychopharmacology of the most prominent psychoactive natural products. Current knowledge on a few lesser-known drugs, including bufotenine, glaucine, kava, betel, pituri, lettuce opium and kanna is also reviewed. In addition, selected cases of alleged natural (or semi-natural products are also mentioned.

  8. Development of Souvenir Production Transaction Processing System

    Science.gov (United States)

    Rumambi, H.; Kaparang, R.; Lintong, J.

    2018-01-01

    This research aims to design a souvenir production transaction processing system for the craftsmen in North Sulawesi. The craftsmen make very simple recordings about souvenir production transactions and use documents that are not in accordance with the generally accepted accounting practices. This research uses qualitative method. The data is collected through interviews, observations, documents and literatures studies. The research stages are conducted in preliminary studies, data collection, data analyzed and system design. The design of system is built from chart of account, accounting cycle and documents as input and get processed in accounting recording. The outputs are financial statements. The system design provides benefits for the craftsmen in assessing the financial performance and getting financing from bank.

  9. The discovery and development of HIV therapy: the new challenges

    Directory of Open Access Journals (Sweden)

    Carlo Federico Perno

    2011-01-01

    Full Text Available The therapy of HIV infection has been dramatically improved over the years, and allowed the achievement of unexpected results. The availability of many drugs, and the knowledge of HIV related pathogenesis, helped in selecting highly effective antiviral therapies, yet today a major challenge stands, that is the selection of the best regimen(s in clinical practice. In this frame, evidence-based medicine remains a cornerstone of modern medicine, but its structure needs to be adapted to the new challenges, made by an excess of information (not always fully reliable, by highly sophisticated statistical systems that may overlook the clinical practice despite their ability to define the statistical significance, and the limited number of independent controlled studies. The revision of the criteria of evidence-based medicine, and their adaptation to the new tools available, may allow a better contribution to the definition of the best therapy for each single patient.

  10. Productivity Research and Development Planning Workshop.

    Science.gov (United States)

    1986-03-01

    mission. These ideas must come from everyone in all echelons of the Comand. The MAC quality of worklife efforts consist of quality circles, labor-manage...that would not have been captured by the measure as initially formulated by the PIG. The balance of the plan and recommenda- tions made by the PMWG...people are doing things. We have the suggestion program, the quality of worklife program, and the Tech Mod program. All of these programs are productivity

  11. Development of the production of special steels for nuclear industries

    International Nuclear Information System (INIS)

    Vieillard-Baron, B.

    1977-01-01

    The development of electro-nuclear industries has a powerful impact on the production of special steels, although the quantity of material applied to the non-conventional parts of nuclear power plants is quite small as compared to the total production requirements in this industrial field. Evolution bears on the product research, development and testing methods, on the technical and marketing services - in particular the establishment of quality control teams and assurance manuals - and the implementation of high performance production equipments. Manufacturing must however take place under normal work load and productivity conditions of production tools, and thus ensure a satisfactory profitability on investments entailed [fr

  12. MODERNIZATION OF NATIONAL ECONOMY THROUGH DEVELOPMENT OF REGIONAL PRODUCTION INFRASTRUCTURE

    Directory of Open Access Journals (Sweden)

    T. G. Guilyadov

    2011-01-01

    Full Text Available Any region’s economy comprises production and non-production spheres which are interconnected and equivalent. Key part of any regional production sphere is its production infrastructure whose value is double: it defines the level of regional economic development on one hand, andinterrelation with the whole national economy on the other hand. The greatest and most important regional production infrastructure elements are transportation infrastructure, information/communication infrastructure and communal infrastructure. Analysis and solution of issues related to development of the basic regional production infrastructure elements as suggested in the article will be very useful for modernization of the national economy.

  13. Investigating product development strategy in beverage industry using factor analysis

    Directory of Open Access Journals (Sweden)

    Naser Azad

    2013-03-01

    Full Text Available Selecting a product development strategy that is associated with the company's current service or product innovation, based on customers’ needs and changing environment, plays an important role in increasing demand, increasing market share, increasing sales and profits. Therefore, it is important to extract effective variables associated with product development to improve performance measurement of firms. This paper investigates important factors influencing product development strategies using factor analysis. The proposed model of this paper investigates 36 factors and, using factor analysis, we extract six most influential factors including information sharing, intelligence information, exposure strategy, differentiation, research and development strategy and market survey. The first strategy, partnership, includes five sub-factor including product development partnership, partnership with foreign firms, customers’ perception from competitors’ products, Customer involvement in product development, inter-agency coordination, customer-oriented approach to innovation and transmission of product development change where inter-agency coordination has been considered the most important factor. Internal strengths are the most influential factors impacting the second strategy, intelligence information. The third factor, introducing strategy, introducing strategy, includes four sub criteria and consumer buying behavior is the most influencing factor. Differentiation is the next important factor with five components where knowledge and expertise in product innovation is the most important one. Research and development strategy with four sub-criteria where reducing product development cycle plays the most influential factor and finally, market survey strategy is the last important factor with three factors and finding new market plays the most important role.

  14. Current pathogenic Escherichia coli foodborne outbreak cases and therapy development.

    Science.gov (United States)

    Yang, Shih-Chun; Lin, Chih-Hung; Aljuffali, Ibrahim A; Fang, Jia-You

    2017-08-01

    Food contamination by pathogenic microorganisms has been a serious public health problem and a cause of huge economic losses worldwide. Foodborne pathogenic Escherichia coli (E. coli) contamination, such as that with E. coli O157 and O104, is very common, even in developed countries. Bacterial contamination may occur during any of the steps in the farm-to-table continuum from environmental, animal, or human sources and cause foodborne illness. To understand the causes of the foodborne outbreaks by E. coli and food-contamination prevention measures, we collected and investigated the past 10 years' worldwide reports of foodborne E. coli contamination cases. In the first half of this review article, we introduce the infection and symptoms of five major foodborne diarrheagenic E. coli pathotypes: enteropathogenic E. coli (EPEC), Shiga toxin-producing E. coli/enterohemorrhagic E. coli (STEC/EHEC), Shigella/enteroinvasive E. coli (EIEC), enteroaggregative E. coli (EAEC), and enterotoxigenic E. coli (ETEC). In the second half of this review article, we introduce the foodborne outbreak cases caused by E. coli in natural foods and food products. Finally, we discuss current developments that can be applied to control and prevent bacterial food contamination.

  15. Popular product development: strategy, innovation and decision making

    Directory of Open Access Journals (Sweden)

    Maria Cecília Sobral

    2007-09-01

    Full Text Available This work studies the decision process involved in the development of a popular product in Brazil for a multinational company. The method was case study. The product was launched in the market at the end of 2003, being the first popular product of the company in the world. Some interesting points of this study: a The importance of the new market (the bottom of income pyramid to the company; b The development of a product specifically addressed to the needs of this market with a totally customized solution; c The decision of a new product platform development.

  16. Challenges in Introducing New Products: A Case Study on the New Product Development Process

    Science.gov (United States)

    Rankin, Robert; Mintu-Wimsatt, Alma

    2017-01-01

    The case is based on an actual product introduction, and is designed to provide instruction on the new product development process. With the cost to launch new products estimated at least US $15 million and new product failure rates ranging from 40% to 80%, it is imperative that students learn how to determine the financial and market feasibility…

  17. [Example of product development by industry and research solidarity].

    Science.gov (United States)

    Seki, Masayoshi

    2014-01-01

    When the industrial firms develop the product, the research result from research institutions is used or to reflect the ideas from users on the developed product would be significant in order to improve the product. To state the software product which developed jointly as an example to describe the adopted development technique and its result, and to consider the modality of the industry solidarity seen from the company side and joint development. The software development methods have the merit and demerit and necessary to choose the optimal development technique by the system which develops. We have been jointly developed the dose distribution browsing software. As the software development method, we adopted the prototype model. In order to display the dose distribution information, it is necessary to load four objects which are CT-Image, Structure Set, RT-Plan, and RT-Dose, are displayed in a composite manner. The prototype model which is the development technique was adopted by this joint development was optimal especially to develop the dose distribution browsing software. In a prototype model, since the detail design was created based on the program source code after the program was finally completed, there was merit on the period shortening of document written and consist in design and implementation. This software eventually opened to the public as an open source. Based on this developed prototype software, the release version of the dose distribution browsing software was developed. Developing this type of novelty software, it normally takes two to three years, but since the joint development was adopted, it shortens the development period to one year. Shortening the development period was able to hold down to the minimum development cost for a company and thus, this will be reflected to the product price. The specialists make requests on the product from user's point of view are important, but increase in specialists as professionals for product

  18. Product development for catering - how to integrate issues on nutrition, quality and environment in the products

    DEFF Research Database (Denmark)

    Jørgensen, Michael Søgaard

    1996-01-01

    Overview of the experience with integration of issues on nutrition, quality and environment from a development and technology assessment project about product development for the catering sector......Overview of the experience with integration of issues on nutrition, quality and environment from a development and technology assessment project about product development for the catering sector...

  19. Company competencies as a network: The role of product development

    DEFF Research Database (Denmark)

    Harmsen, Hanne; Grunert, Klaus G.; Bove, Karsten

    2000-01-01

    Product development managers and academics like to assure themselves and each other that new product development is one of the most critical areas of company competence and contributes positively to company success But does top management agree? Because if they do not, the consequences will heavily...... influence the resource allocation to product development and career possibilities of NPD's. This study examines how top managers view the importance of product development relative to other central competence areas. While asking managers about their perception is one way of evaluating the importance, its...... contribution to company success is another important measure. In this study the impact of product development, relative to other important competence areas is measured to further assess how critical product development actually is for overall company success. Hanne Harmsen, Klaus G. Grunert and Karsten Bove...

  20. Integrated product development and experience of communication in education

    NARCIS (Netherlands)

    H. Ihle; Ir. Dick van Schenk Brill; Ir. Peter van Kollenburg; Ir. H.E.V. Veenstra

    2000-01-01

    The Technical Departments at the Fontys University of Professional Education in Eindhoven, The Netherlands, offer a course which is devel-oped around the principles of Concurrent Engi-neering. Integrated Product Development (IPD) project teams are multi-disciplinary groups which develop products in

  1. Treatment facilities, human resource development, and future prospect of particle beam therapy

    International Nuclear Information System (INIS)

    Tamaki, Tomoaki; Nakano, Takashi

    2015-01-01

    The number of particle beam therapy facilities is increasing globally. Among the countries practicing particle beam therapy, Japan is one of the leading countries in the field with four operating carbon-ion therapy facilities and ten operating proton therapy facilities. With the increasing number of particle beam therapy facilities, the human resource development is becoming extremely important, and there has been many such efforts including the Gunma University Program for Cultivating Global Leaders in Heavy Ion Therapeutics and Engineering, which aimed to educate and train the radiation oncologists, medical physicists, accelerator engineers, and radiation biologists to become global leaders in the field of particle beam therapy. In the future, the benefit and effectiveness of particle beam therapy should be discussed and elucidated objectively in a framework of comprehensive cancer care. (author)

  2. Consumer orientation of product developers and their product perception compared to that of consumers

    NARCIS (Netherlands)

    Sijtsema, S.J.; Backus, G.B.C.; Linnemann, A.R.; Jongen, W.M.F.

    2004-01-01

    This research concludes that although product developers (58, response rate 35%) and consumers (344, response rate 57%) perceive health and its relation to product characteristics in the same way, the perception of product developers is more extreme. Furthermore, factor analysis reveals four

  3. Systematic Product Development of Control and Diagnosis Functionalities

    Science.gov (United States)

    Stetter, R.; Simundsson, A.

    2017-01-01

    In the scientific field of systematic product development a wide range of helpful methods, guidelines and tools were generated and published in recent years. Until now little special attention was given to design guidelines aiming at supporting product development engineers to design products that allow and support control or diagnosis functions. The general trend to ubiquitous computing and the first development steps towards cognitive systems as well as a general trend toward higher product safety, reliability and reduced total cost of ownership (TCO) in many engineering fields lead to a higher importance of control and diagnosis. In this paper a first attempt is made to formulate general valid guidelines how products can be developed in order to allow and to achieve effective and efficient control and diagnosis. The guidelines are elucidated on the example of an automated guided vehicle. One main concern of this paper is the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of systematic product development have attracted significant attention during the last decades. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The paper starts with a background describing Systematic Product Development. The second section deals with the product development of the sample product. The third part clarifies the notions monitoring, control and diagnosis. The following parts summarize some insights and formulate first hypotheses concerning control and diagnosis in Systematic Product Development.

  4. Electroconvulsive Therapy. Consensus Development Conference Statement, Vol. 5, No. 11.

    Science.gov (United States)

    National Institutes of Health (DHHS), Bethesda, MD.

    Electroconvulsive therapy (ECT), a treatment for severe mental illness in which a brief application of electric stimulus is used to produce a generalized seizure, has been in use for over 45 years. Controversies still exist today concerning the use of ECT. In 1985, the National Institutes of Health and the National Institute of Mental Health held…

  5. The early career researcher's toolkit:translating tissue engineering, regenerative medicine and cell therapy products

    OpenAIRE

    Rafiq, Qasim A.; Ortega, Ilida; Jenkins, Stuart I.; Wilson, Samantha L.; Patel, Asha K.; Barnes, Amanda L.; Adams, Christopher F.; Delcassian, Derfogail; Smith, David

    2015-01-01

    Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in...

  6. Two different approaches in skin cancer therapy: using a photosensitizer/a natural product

    Science.gov (United States)

    Abraham, Annie; Gayathri, Devi D.; Cibin, T. R.; Ramaiah, D.

    2010-02-01

    This paper deals with two potential modes for the treatment of skin cancer-one a novel approach using a squaraine dye and the other using a natural product- the flavonoid fraction of Saraca asoka. Squaraine dye is a photosensitizing agent, which is preferentially taken up and retained by the tumor cells and when irradiated with high power visible light results in the selective destruction of the tumor cells by photodynamic therapy. The uniqueness of this mode of treatment lies in the selective destruction of tumor cells without affecting the neighbouring normal cells, which is much advantageous over radiation therapy now frequently used. The chemopreventive and therapeutic effects of the plant component are explored as well. The experimental models were Swiss albino mice in which skin tumor was induced by DMBA. Marked reduction in tumor volume and burden in the treated groups were observed. The reversal of biochemical enzyme markers like rhodanese, myeloperoxidase, β-D glucuronidase, lactate dehydrogenase, hexokinase and sialic acid to near normal levels were observed in the PDT and flavonoid fraction treated groups. The live photographs of the experimental animals and histopathological data further support the obtained results. The study assumes importance as it combines a traditional treatment mode and a novel aspect in cancer therapy using the same experimental models. Also this is the first report on PDT using a squaraine dye for skin cancer therapy in vivo.

  7. Product carbon footprint developments and gaps

    DEFF Research Database (Denmark)

    Kronborg Jensen, Jesper

    2012-01-01

    Purpose - Over the last decade, multiple initiatives have been undertaken to learn how to capture the carbon footprint of a supply chain at a product level. The purpose of this paper is to focus on the process of standardization to secure consistency of product carbon footprinting (PCF) and to ou....../value - Papers that outline the standardization process for PCF have been examined, but this paper adds value by categorizing the field, outlining the latest standards, and by being the first paper to compare standards for PCF on selected criteria and identify gaps....... when conducting a PCF, and a paradox exists concerning methods for securing future standardization of PCF. Research limitations/implications - Standards for evaluating emission of greenhouse gases (GHGs) in supply chains are evaluated without consideration of other environmental impacts. In addition......, the research only compares international standards, thereby excluding national initiatives. Practical implications - Standardization efforts can be expected to shape the future practice of measuring emission of GHGs in companies and supply chains which provides a framework for reducing impacts. Originality...

  8. Critical elements in the development of cell therapy potency assays for ischemic conditions.

    Science.gov (United States)

    Porat, Yael; Abraham, Eytan; Karnieli, Ohad; Nahum, Sagi; Woda, Juliana; Zylberberg, Claudia

    2015-07-01

    A successful potency assay for a cell therapy product (CTP) used in the treatment of ischemic conditions should quantitatively measure relevant biological properties that predict therapeutic activity. This is especially challenging because of numerous degrees of complexity stemming from factors that include a multifactorial complex mechanism of action, cell source, inherent cell characteristics, culture method, administration mode and the in vivo conditions to which the cells are exposed. The expected biological function of a CTP encompasses complex interactions that range from a biochemical, metabolic or immunological activity to structural replacement of damaged tissue or organ. Therefore, the requirements for full characterization of the active substance with respect to biological function could be taxing. Moreover, the specific mechanism of action is often difficult to pinpoint to a specific molecular entity; rather, it is more dependent on the functionality of the cellular components acting in a in a multifactorial fashion. In the case of ischemic conditions, the cell therapy mechanism of action can vary from angiogenesis, vasculogenesis and arteriogenesis that may activate different pathways and clinical outcomes. The CTP cellular attributes with relation to the suggested mechanism of action can be used for the development of quantitative and reproducible analytical potency assays. CTPs selected and released on the basis of such potency assays should have the highest probability of providing meaningful clinical benefit for patients. This White Paper will discuss and give examples for key elements in the development of a potency assay for treatment of ischemic disorders treated by the use of CTPs. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  9. What Happens to Integrated Product Development Models with Product/Service-System Approaches?

    DEFF Research Database (Denmark)

    Tan, Adrian; McAloone, Timothy Charles; Andreasen, Mogens Myrup

    2006-01-01

    Integrated Product Development (IPD) has traditionally focused on the development activities relating to physical technological artefacts. With the advent of business approaches for manufacturing firms based on providing customers the utility of integrated products and services – a term dubbed...... ‘product/service-systems (PSS)’ – companies need to extend their activities to include new dimensions of development. Within the paradigm of mass production and consumption, traditional product-oriented business strategies regarded physical technological artefacts (products) as the mediators of customer...... value. Value was based on the exchange of products between a providing company and a receiving customer. The more products the company could sell, the more revenue it generated. At the point of sale the ownership and responsibility of the product was transferred from company to customer. A customer...

  10. Crisis Situations in Engineering Product Development

    DEFF Research Database (Denmark)

    Muenzberg, Christopher; Hammer, Jens; Brem, Alexander

    2016-01-01

    approaches reduce the problem identification time and increase the efficiency of crisis management. The goal of this research is to identify methods which are able to support the crisis management process successfully. Therefore, a literature-based analysis of developing methods, especially TRIZ is conducted......Crisis situations are special situations during the development process. They are characterized by time and handling pressure. Therefore, it is necessary to identify and apply a methodical problem solving approach to overcome these situations. Due to their prescriptive character, problem solving...

  11. Strength development of concrete : balancing production requirements and ecological impact

    NARCIS (Netherlands)

    Onghena, S.; Grunewald, S.; Schutter, G; Jaime C., Galvez; Aguado de Cea, Antonio; Fernandez-Ordonez, David; Sakai, Koji; Reye s, Encarnación; Casati, Maria J .; Enfedaque, Alejandro; Alberti, Marcos G.; de la Fuente, Albert

    2016-01-01

    The effective production of concrete structures requires adequate control of
    strength development in order to realise the scheduled production cycles. Demoulding of elements can take place only when sufficient strength is gained and the production cycle has to be maintained with seasonal changes

  12. Towards the production of EPA: a developing country perspective

    CSIR Research Space (South Africa)

    Maharajh, Dheepak M

    2015-03-01

    Full Text Available are focussed towards increased production of high purity EPA. This provides a window of opportunity for a supply of competing products that are rich in algal EPA. Recently the CSIR developed a technology for the production of EPA by an indigenous algal isolate...

  13. Development of the radioisotope production facility for the HANARO

    International Nuclear Information System (INIS)

    Lee, Ji Bok; Wu, J. S.; Baik, S. T.

    1998-06-01

    Hot cell and related facilities were developed in the RI production building of the HANARO. 1. development of concrete H/C and related components 2. development of lead H/C and related components 3. development of the hydraulic transfer system 4. development of radiation monitoring system 5. development of purification system for Co-60 storage pool 6. development of the fire fighting system for H/C 7. development of the experimental equipment. (author). 15 figs

  14. SPECIFIC FEATURES OF DEVELOPMENT OF ORGANIC PRODUCTS MARKET IN UKRAINE

    Directory of Open Access Journals (Sweden)

    T. Kharchenko

    2013-08-01

    Full Text Available The article is dedicated to the development of new and improvement of existing theoretical and methodological basis of forming and developing the market of organic products, its correspondence to the present-day situation, determination of problems and ways of their solving, introduction in practical activity of Ukrainian enterprises. The main objective of the article is to determine the specific features of forming and developing organic products market in Ukraine, and the perspective directions of its development based on analysis and practice of functioning of such markets in the world. The environmentally sound products market in the world is being analyzed, some information on the countries with the most commodity turnover of organic products, structure of international market of organic products, volumes of sales of organic products in the European countries is provided. As a result of studying the modern trends of economic development the authors reach a conclusion on problems of standard introduction, investigate the European norms and requirements for organic products. The conducted research allows distinguishing the basic features of Ukrainian market of organic products: it quickly grows, which makes it especially appealing for the participants of market relations, however entry into this market requires considerable capital investments and is characterized by high risk; criteria for qualifying products as environmentally sound products are unstructured and unclear. The potential for growth of organic products market in Ukraine is examined.

  15. Product Development in Higher Education Marketing

    Science.gov (United States)

    Durkin, Mark; Howcroft, Barry; Fairless, Craig

    2016-01-01

    Purpose: During the last 20 years or so the changing environment in which universities operate has meant that commensurately more emphasis has been placed on marketing principles. In light of this emphasis, it is perhaps a little surprising that relatively little attention has been directed towards the processes by which universities develop their…

  16. Workforce Development, Higher Education and Productive Systems

    Science.gov (United States)

    Hordern, Jim

    2014-01-01

    Workforce development partnerships between higher education institutions and employers involve distinctive social and technical dynamics that differ from dominant higher education practices in the UK. The New Labour government encouraged such partnerships in England, including through the use of funding that aimed to stimulate reform to…

  17. Environmental improvement through product development - in Japanese

    DEFF Research Database (Denmark)

    McAloone, Tim C.; Bey, Niki

    Companies in Denmark and abroad are working increasingly to reduce human impacts on the environment and nature. At the same time there must still be a large focus on the creation of value for customers and consumers. This development gives rise to a huge potential for Danish companies, to create ...... Environmental Protection Agency’s company funding scheme. We hope you will be inspired!...

  18. Designer-made meat and dairy products: Consumer-led product development

    DEFF Research Database (Denmark)

    Grunert, Klaus G.; Valli, Carlotta

    2001-01-01

    targeting these segments were derived and tested with consumers from these segments. Results show considerable potential for the development of food products which are differentiated in a consumer-based way. The paper closes with a step-model for consumer-led product development adapted to the current state...... of branding and differentiation in the product category.......Consumers differ in the kind of qualities they expect from food products, and they also differ in the way they infer quality from the product information available. Nevertheless, much product innovation in the food sector is still not geared towards specific consumer segments. This is especially...

  19. Designer made meat and dairy products: Consumer-led product development

    DEFF Research Database (Denmark)

    Grunert, Klaus G.; Valli, Carlotta

    targeting these segments were derived and tested with consumers from these segments. Results show considerable potential for the development of food products which are differentiated in a consumer-based way. The paper closes with a step-model for consumer-led product development adapted to the current state...... of branding and differentiation in the product category.......Consumers differ in the kind of qualities they expect from food products, and they also differ in the way they infer quality from the product information available. Nevertheless, much product innovation in the food sector is still not geared towards specific consumer segments. This is especially...

  20. Developing engineering processes through integrated modelling of product and process

    DEFF Research Database (Denmark)

    Nielsen, Jeppe Bjerrum; Hvam, Lars

    2012-01-01

    This article aims at developing an operational tool for integrated modelling of product assortments and engineering processes in companies making customer specific products. Integrating a product model in the design of engineering processes will provide a deeper understanding of the engineering...... activities as well as insight into how product features affect the engineering processes. The article suggests possible ways of integrating models of products with models of engineering processes. The models have been tested and further developed in an action research study carried out in collaboration...... with a major international engineering company....

  1. Influence of metals on cytokines production in connection with successful implantation therapy in dentistry.

    Science.gov (United States)

    Podzimek, Stepan; Tomka, Milan; Nemeth, Tibor; Himmlova, Lucie; Matucha, Petr; Prochazkova, Jarmila

    2010-01-01

    In most of patients in need of implantation treatment in the oral cavity, implants heal well, nevertheless, there are some individuals, in whom titanium implants fail for reasons, which remain unclear. The aim of our study was to determine if there is a difference between metal influenced IL-1β, IL-4, IL-6, TNF-α and IFN-γ cytokines production in patients with successfully healed implants compared to those, whose implant therapy was unsuccessful. The two study groups included 12 patients with failed dental titanium implants and 9 patients with successfully healed implants. In the subjects, cytokine production was established after lymphocyte cultivation with mercury, nickel and titanium antigens. IL-1β levels were significantly increased in all patients after stimulation with titanium and in patients with accepted implants compared to patients with failed implants after the stimulation with mercury and titanium. Titanium caused significantly increased IL-6 production in all patients. TNF-α and IFN-γ levels were also significantly increased after the stimulation with titanium. Significantly increased TNF-α levels were found in patients with accepted implants as compared to patients with failed implants. Increased production of IL-1β a IL-6 cytokines in reaction to titanium and increased production of TNF-α and IFN-γ cytokines in reaction to mercury, which is very often present in the form of amalgam in the oral cavity of persons in need of implant therapy, can play an important role in immune reactions during implant healing process. In patients with failed titanium implants, decreased production of these cytokines may participate in implant failure.

  2. Strategy Development through Interview Technique from Narrative Therapy

    DEFF Research Database (Denmark)

    Kryger, Anders

    2017-01-01

    Purpose: The purpose of this paper is to demonstrate the successful strategy formulation process of a new purchasing department at an international engineering group. Design/methodology/approach: The strategy formulation was co-created by the department manager and employees at a storytelling...... workshop, facilitated with interview technique from narrative therapy, and later authorized by the business area director. The organizational intervention preceded the scholarly inquiry. Findings: Employees’ retrospective storytelling about working at the company enabled them to formulate a joint mission...... statement using words and expressions from their own stories. Prospective storytelling enabled them to formulate a joint medium- and long-term vision and a corresponding action plan. This paper proposes interview technique from narrative therapy as a new practice-oriented strategic management tool and calls...

  3. Development of anti-counterfeit consumer product authentication system

    Directory of Open Access Journals (Sweden)

    Olena V. Narimanova

    2015-06-01

    Full Text Available Aim of the research is to develop an anti-counterfeit consumer product authentication system. The main requirements for this system are formulated, the choice of method of consumer product authentication is substantiated. The scheme of anti-counterfeit consumer product authentication system is developed basing on previously proposed method of checking the QR-code integrity and authenticity. The proposed within the system consumer product authentication technology is simple, economical for implementation, does not require the external changes of product packaging, does not affect existing production process. The technology can be recommended for the use to private businesses and government institutions that are interested in the security of their products from counterfeiting, as well as tracking and removing from circulation the counterfeit consumer products.

  4. The value of information updating in new product development

    CERN Document Server

    Artmann, Christian

    2009-01-01

    This work shows how managing uncertainty in new product development can be improved by conducting an information update during the development process. The book details the comprehensive model needed to perform that information update.

  5. Risk management of new product development process

    OpenAIRE

    Aleixo, Gonçalo Granja

    2009-01-01

    Dissertation submitted to Faculdade de Ciências e Tecnologia of Universidade Nova de Lisboa for the achievement of Integrated Master´s degree in Industrial Management Engineering Winners in today´s global changing environment, are those who continuously pursuit innovations in order to guarantee their sustainability. If in the presence of a certain environment many enterprises makes enormous mistakes, in an uncertain environment as the development of innovations, these mistakes will be mult...

  6. Matching food service products to consumer demands through product development alliances and modularisation

    DEFF Research Database (Denmark)

    Olsen, Johanne Rønnow

    2009-01-01

    of product development managers (with the main themes food trends, meal solutions and product development alliances), as well as data from sensory studies of interactions between meal components. Apart from the quality cycle mentioned above, the research has generated the tools listed below to be applied......, more specifically, meal solutions. The results of this research contribute to the knowledge base on product development in the food industry, mainly regarding quality, product development alliances and modularisation,and fill several gaps in the literature. Future research should focus on further...... in the composition of meal solutions and, therefore cannot control all processing steps and interactions with other meal components. In this project, it is proposed that cooperation between food producers on product development (product development alliances) in relation to meal solutions can improve the quality...

  7. Product Development and Commercialization of Diagnostic or Life Science Products for Scientists and Researchers.

    Science.gov (United States)

    Alonso, Meghan M

    2017-01-01

    Commercializing a diagnostic or life science product often encompasses different goals than that of research and grant funding. There are several necessary steps, and a strategy needs to be well defined in order to be successful. Product development requires input from and between various groups within a company and, for academia, outside entities. The product development stakeholder groups/entities are research, marketing, development, regulatory, manufacturing, clinical, safety/efficacy, and quality. After initial research and development, much of the work in product development can be outsourced or jointly created using public-private partnerships. This chapter serves as an overview of the product development process and provides a guide to best define a product strategy.

  8. Development of glass ceramics for the incorporation of fission products

    International Nuclear Information System (INIS)

    De, A.K.; Luckscheiter, B.; Lutze, W.; Malow, G.; Schiewer, E.

    1976-01-01

    Spontaneous devitrification of fission-product-containing borosilicate glasses can be avoided by controlled crystallization after melting. Glass ceramics have been developed from a vitrified simulated waste and further improvement of product properties was achieved. In particular perovskite, h-celsian, diopside and eucryptite glass ceramics were prepared. These contained leach resistant host phases which exhibited considerable enrichment of long-lived fission products. All products showed increased impact resistance, but the thermal expansion was only slightly improved

  9. Food production in developing countries - the role of plant biotechnology

    OpenAIRE

    D. I. Ferreira

    1995-01-01

    The world is facing major problems with regard to food production. Agricultural land suffers from various conditions which make it less efficient for crop production while the rapid population growth, especially in developing countries, raises concern for sustainable food production. The Green Revolution has failed to secure sustainable food production and it is hoped that biotechnology will facilitate the transition to more sustainable agriculture. Excellent progress has been made with b...

  10. Genetic Algorithms for Development of New Financial Products

    Directory of Open Access Journals (Sweden)

    Eder Oliveira Abensur

    2007-06-01

    Full Text Available New Product Development (NPD is recognized as a fundamental activity that has a relevant impact on the performance of companies. Despite the relevance of the financial market there is a lack of work on new financial product development. The aim of this research is to propose the use of Genetic Algorithms (GA as an alternative procedure for evaluating the most favorable combination of variables for the product launch. The paper focuses on: (i determining the essential variables of the financial product studied (investment fund; (ii determining how to evaluate the success of a new investment fund launch and (iii how GA can be applied to the financial product development problem. The proposed framework was tested using 4 years of real data from the Brazilian financial market and the results suggest that this is an innovative development methodology and useful for designing complex financial products with many attributes.

  11. Development and use of dynamic product-line architectures

    NARCIS (Netherlands)

    Andersson, J; Bosch, J

    Software product families are used to shorten time-to-market, improve quality and lower cost, by means of effective reuse. The paper presents the results of case study conducted at four Swedish companies that are involved in either the development of or development with a software product family.

  12. Shouldn’t customers control customized product development

    NARCIS (Netherlands)

    Smets, L.P.M.; Langerak, F.; Rijsdijk, S.A.

    2013-01-01

    Nowadays, customized product development (CPD) is increasingly prevalent in business-to-business settings, which has motivated manufacturers into development approaches wherein the customer plays an active role. When the customer is merely viewed as a passive receiver of the customized product, the

  13. Managing supplier involvement in new product development: a portfolio approach

    NARCIS (Netherlands)

    Wynstra, Finn; ten Pierick, E.

    2000-01-01

    Supplier involvement in new product development projects has become an increasingly popular method for improving project effectiveness (product costs and quality) and project efficiency (development costs and time). One of the key issues in managing this involvement is determining which type of

  14. Cybersecurity and the Medical Device Product Development Lifecycle.

    Science.gov (United States)

    Jones, Richard W; Katzis, Konstantinos

    2017-01-01

    Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

  15. Field studies into the dynamics of product development tasks

    NARCIS (Netherlands)

    Oorschot, van K.E.; Bertrand, J.W.M.; Rutte, C.G.

    2005-01-01

    Purpose – This paper aims to describe three exploratory field studies investigating which characteristics add to later time to market and/or low product functionality of newly developed products. The studies are conducted at the level of developments tasks, or work packages. The first and second

  16. Development of a Quantitative Tool to Assess the Content of Physical Therapy for Infants

    NARCIS (Netherlands)

    Blauw-Hospers, Cornill H.; Dirks, Tineke; Hulshof, Lily J.; Hadders-Algra, Mijna

    2010-01-01

    Purpose: The study aim was to describe and quantify physical therapy interventions for infants at high risk for developmental disorders. Methods: An observation protocol was developed based on knowledge about infant physical therapy and analysis of directly observable physiotherapeutic (PT) actions.

  17. Developing an Integrative Play Therapy Group Model for Middle School Male Students to Address Bullying Behaviors

    Science.gov (United States)

    Jordan, Jakarla

    2016-01-01

    This research examines the systematic process of developing an integrative play therapy group model for middle school male students, ages 11-15 who participate in bullying behaviors. Play therapy approaches and evidence-based practices are documented as effective measures for addressing bullying behaviors with children and adolescents. This group…

  18. Music Therapy Assessment and Development of Parental Competences in Families Where Children Have Experienced Emotional Neglect

    DEFF Research Database (Denmark)

    Jacobsen, Stine Lindahl

    2012-01-01

    In trying to aid difficulties within social services of assessing families at risk, the thesis sat out to strengthen, further develop, and test a music therapy assessment tool, Assessment of Parenting Competencies (APC). The study also aimed to examine the effect of music therapy on parenting...

  19. Recent development and gene therapy for glycogen storage disease type Ia.

    Science.gov (United States)

    Chou, Janice Y; Kim, Goo-Young; Cho, Jun-Ho

    2017-09-01

    Glycogen storage disease type Ia (GSD-Ia) is an autosomal recessive metabolic disorder caused by a deficiency in glucose-6-phosphatase-α (G6Pase-α or G6PC) that is expressed primarily in the liver, kidney, and intestine. G6Pase-α catalyzes the hydrolysis of glucose-6-phosphate (G6P) to glucose and phosphate in the terminal step of gluconeogenesis and glycogenolysis, and is a key enzyme for endogenous glucose production. The active site of G6Pase-α is inside the endoplasmic reticulum (ER) lumen. For catalysis, the substrate G6P must be translocated from the cytoplasm into the ER lumen by a G6P transporter (G6PT). The functional coupling of G6Pase-α and G6PT maintains interprandial glucose homeostasis. Dietary therapies for GSD-Ia are available, but cannot prevent the long-term complication of hepatocellular adenoma that may undergo malignant transformation to hepatocellular carcinoma. Animal models of GSD-Ia are now available and are being exploited to both delineate the disease more precisely and develop new treatment approaches, including gene therapy.

  20. Development of novel arginase inhibitors for therapy of endothelial dysfunction

    Directory of Open Access Journals (Sweden)

    Jochen eSteppan

    2013-09-01

    Full Text Available Endothelial dysfunction and resulting vascular pathology have been identified as an early hallmark of multiple diseases, including diabetes mellitus. One of the major contributors to endothelial dysfunction is a decrease in nitric oxide (NO bioavailability, impaired NO signaling and an increase in the amount of reactive oxygen species (ROS. In the endothelium NO is produced by eNOS (endothelial nitric oxide synthase, for which L-arginine is a substrate. Arginase, an enzyme critical in the urea cycle also metabolizes L-arginine, thereby directly competing with eNOS for their common substrate and constraining its bioavailability for eNOS, thereby compromising NO production. Arginase expression and activity is upregulated in many cardiovascular diseases including ischemia reperfusion injury, hypertension, atherosclerosis, and diabetes mellitus. More importantly, since the 1990s, specific arginase inhibitors such as N-hydroxy-guanidinium or N-hydroxy-nor-L-arginine, and boronic acid derivatives, such as, 2(S-amino-6-boronohexanoic acid, and S-(2-boronoethyl-L-cysteine (BEC, that can bridge the binuclear manganese cluster of arginase have been developed. These highly potent and specific inhibitors can now be used to probe arginase function and thereby modulate the redox milieu of the cell by changing the balance between NO and ROS. Inspired by this success, drug discovery programs have recently led to the identification of α-α-disubstituted amino acid based arginase inhibitors (such as (R-2-amino-6-borono-2-(2-(piperidin-1-ylethylhexanoic acid, that are currently under early investigation as therapeutics. Finally, some investigators concentrate on identification of plant derived compounds with arginase inhibitory capability, such as piceatannol-3'-O-β-D-glucopyranoside (PG. All of these synthesized or naturally derived small molecules may represent novel therapeutics for vascular disease particularly that associated with diabetes.

  1. Action Research in User-Centered Product Development

    DEFF Research Database (Denmark)

    Brandt, Eva

    2004-01-01

    Technological development and increased international competition have imposed a significant burden on the product development function of many companies. The growing complexity of products demands a larger product development team with people having various competencies. Simultaneously...... the importance of good quality, usability and customisation of products is growing, and many companies want to involve customers and users directly in the development work. Both the complexity and quality demand new ways of working that support collaboration between people with various competencies, interests...... and responsibilities both inside and outside the company. This paper reports experiences from using action research to introduce new user-centred work practices in two commercial product development projects. The interventions varied. In the first project it was found rewarding to engage customers and users...

  2. Development techniques of total product maintenance

    International Nuclear Information System (INIS)

    Kim, S. D.; Oh, Y. W.; Soong, W. S.; Oh, W. H.

    2000-06-01

    Facilities should be maintained in solid operational condition and the time required for correcting the malfunctions should be minimized since the operational pause due to malfunctions would be one of the most influencing factors on the accomplishments of research goals. It is well-known that we are able to obtain about a 30% reduction of the disbursement through the scheduled pre-repairing processes and to minimize the duration of the malfunctions provided that the relevant factors were administered under systematic coordination. Hence, the development of the facility integrity management system is necessary in order to minimize the duration of the operational pause due to malfunctions with the least disbursement and to minimize the repair time, and also to maximize the efficiency of the budget execution, manpower organization and maintenance management

  3. Product development of Indian cargo scanner

    International Nuclear Information System (INIS)

    2017-01-01

    A cargo scanner is required for nonintrusive screening of suspected cargo containers in trade, using high energy X-ray, to detect any mis-declarations, contraband goods concealment or hidden ammunition or explosives. The cargo scanners help authorities to process large number of suspected cargo with a high level of confidence with other additional benefit of faster clearance, minimised intrusive inspection and generating secured digital record of the process. BARC is in process of developing Indian Cargo Scanner with indigenous X-ray source. Proof of concept and conformance of the results to the international standards has been demonstrated in laboratory. Full scale equipment named as Portal scanner shall be demonstrated at Gamma field Trombay in year 2017. Subsequently the technology transfer may be done to a suitable Indian vendor

  4. Development techniques of total product maintenance

    Energy Technology Data Exchange (ETDEWEB)

    Kim, S. D.; Oh, Y. W.; Soong, W. S.; Oh, W. H

    2000-06-01

    Facilities should be maintained in solid operational condition and the time required for correcting the malfunctions should be minimized since the operational pause due to malfunctions would be one of the most influencing factors on the accomplishments of research goals. It is well-known that we are able to obtain about a 30% reduction of the disbursement through the scheduled pre-repairing processes and to minimize the duration of the malfunctions provided that the relevant factors were administered under systematic coordination. Hence, the development of the facility integrity management system is necessary in order to minimize the duration of the operational pause due to malfunctions with the least disbursement and to minimize the repair time, and also to maximize the efficiency of the budget execution, manpower organization and maintenance management.

  5. Using Compilers to Enhance Cryptographic Product Development

    Science.gov (United States)

    Bangerter, E.; Barbosa, M.; Bernstein, D.; Damgård, I.; Page, D.; Pagter, J. I.; Sadeghi, A.-R.; Sovio, S.

    Developing high-quality software is hard in the general case, and it is significantly more challenging in the case of cryptographic software. A high degree of new skill and understanding must be learnt and applied without error to avoid vulnerability and inefficiency. This is often beyond the financial, manpower or intellectual resources avail-able. In this paper we present the motivation for the European funded CACE (Computer Aided Cryptography Engineering) project The main objective of CACE is to provide engineers (with limited or no expertise in cryptography) with a toolbox that allows them to generate robust and efficient implementations of cryptographic primitives. We also present some preliminary results already obtained in the early stages of this project, and discuss the relevance of the project as perceived by stakeholders in the mobile device arena.

  6. Access to advanced therapy medicinal products in the EU: where do we stand?

    Science.gov (United States)

    Mahalatchimy, A

    2011-05-01

    The European Union has a public health strategy and will generally ensure in all its policies and activities a "high level of human health protection". The new Regulation (EC) n 1394/2007 on advanced therapy medicinal products (ATMP), stems from this global policy and aims to harmonise access to the ATMP market. A real will for the harmonisation is clearly expressed in legal texts and enforced in the implementable procedures and requirements. However, several barriers remain. On the one hand, the scope of the ATMP Regulation is limited. On the other hand, Member States benefit from a wide margin of action.

  7. THE RENEWABLE ENERGY PRODUCTION-ECONOMIC DEVELOPMENT NEXUS

    Directory of Open Access Journals (Sweden)

    Gorkemli Kazar

    2014-04-01

    Full Text Available As renewable energy requirements increases, its relation with development is controversial. In this study, by taking human development index for development level, the relationship between renewable electricity net generation values and development has been searched with panel analysis. Study covers two different time periods: 1980-2010 with 5 year data to analyze long term effects and 2005-2010 yearly data for short term effects. Unlike previous studies, energy generation has been taken into consideration for it is thought to be more related with economic development. It is found that in the long run economic development will be leading to renewable energy production, while in the short run there exists a bidirectional causal relationship between renewable energy production and economic development. In addition, the causal relationship between economic development and renewable energy production varies both in the long run and in the short run due to human development level of the countries.

  8. Parallel Development of Products and New Business Models

    DEFF Research Database (Denmark)

    Lund, Morten; Hansen, Poul H. Kyvsgård

    2014-01-01

    The perception of product development and the practical execution of product development in professional organizations have undergone dramatic changes in recent years. Many of these chances relate to introduction of broader and more cross-disciplinary views that involves new organizational functi...... and innovation management the 4th generation models are increasingly including the concept business models and business model innovation....... functions and new concepts. These chances can be captured in various generations of practice. This paper will discuss the recent development of 3rd generation product development process models and the emergence of a 4th generation. While the 3rd generation models included the concept of innovation...

  9. The development of 60Co γ knife therapy sources

    International Nuclear Information System (INIS)

    Wu Rihua; Li Xingyi; Wu Guihua; Xia Bing; Zhang Jirong; Chen Tieguang

    2001-01-01

    60 Co γ gamma knife source is a kernel unit of γ knife therapy equipment. It has small active core, high specific activity, narrow half dark area, best focus form, long use period. The research of 60 Co γ knife sources are presented. Specifications of γ knife sources, technical parameters, safety performance, structure feature, procedure and quality control during research are discussed. 60 Co γ source consists of high specific activity cobalt pellets and double stainless steel sealed by argon arc welding. Its safety performance, surface contamination and leakage testing meet the requirements of GB 4075 and GB 4076

  10. Building a roadmap for developing combination therapies for Alzheimer's disease.

    Science.gov (United States)

    Perry, Daniel; Sperling, Reisa; Katz, Russell; Berry, Donald; Dilts, David; Hanna, Debra; Salloway, Stephen; Trojanowski, John Q; Bountra, Chas; Krams, Michael; Luthman, Johan; Potkin, Steven; Gribkoff, Val; Temple, Robert; Wang, Yaning; Carrillo, Maria C; Stephenson, Diane; Snyder, Heather; Liu, Enchi; Ware, Tony; McKew, John; Fields, F Owen; Bain, Lisa J; Bens, Cynthia

    2015-03-01

    Combination therapy has proven to be an effective strategy for treating many of the world's most intractable diseases. A growing number of investigators in academia, industry, regulatory agencies, foundations and advocacy organizations are interested in pursuing a combination approach to treating Alzheimer's disease. A meeting co-hosted by the Accelerate Cure/Treatments for Alzheimer's Disease Coalition, the Critical Path Institute and the Alzheimer's Association addressed challenges in designing clinical trials to test multiple treatments in combination and outlined a roadmap for making such trials a reality.

  11. Between Product Development and Mass Production: Tensions as Triggers for Concept-Level Learning

    Science.gov (United States)

    Jalonen, Meri; Ristimäki, Päivi; Toiviainen, Hanna; Pulkkis, Anneli; Lohtander, Mika

    2016-01-01

    Purpose: This paper aims to analyze learning in organizational transformations by focusing on concept-level tensions faced in two young companies, which were searching for a reorientation of activity with a production network between innovative product development and efficient mass production. Design/methodology/approach: An intervention-based…

  12. Developing engineering design core competences through analysis of industrial products

    DEFF Research Database (Denmark)

    Hansen, Claus Thorp; Lenau, Torben Anker

    2011-01-01

    Most product development work carried out in industrial practice is characterised by being incremental, i.e. the industrial company has had a product in production and on the market for some time, and now time has come to design a new and upgraded variant. This type of redesign project requires...... that the engineering designers have core design competences to carry through an analysis of the existing product encompassing both a user-oriented side and a technical side, as well as to synthesise solution proposals for the new and upgraded product. The authors of this paper see an educational challenge in staging...... a course module, in which students develop knowledge, understanding and skills, which will prepare them for being able to participate in and contribute to redesign projects in industrial practice. In the course module Product Analysis and Redesign that has run for 8 years we have developed and refined...

  13. Developing and promoting OKP production system: a JIT production planning approach

    Science.gov (United States)

    Samavati, Mehran

    2011-10-01

    The role of production in competitive system of market on one hand and the changing conditions of market on the other hand has caused the need for more developed planning in such environments. The general purpose of the present research is to realize One-of- a- Kind- Product model (OKP) that is developed in two stages. In OKP model presented in 1994 only one sample of each product is produced and only one production method is considered for each product. In order to make OKP model more real and to use it in promoting more production methods, the following developments were made in this research: 1-First Development: Considering various methods for producing each product. 2-Second Development: Producing more than one sample of each product, while considering various production methods for each product. These models promoted OKP model of 1994. They can be used in more diversified production methods in order to promote them. In present model, while describing the main OKP model new models are provided as well. The significance of OKP has been described in Introduction

  14. Self-care under the perspective of Occupational Therapy: analysis of scientific production

    Directory of Open Access Journals (Sweden)

    Regina Célia Titotto Castanharo

    2014-04-01

    Full Text Available This is an exploratory descriptive study aiming to explain how self-care has been addressed by Occupational Therapy (OT. Data collection was carried out by consulting LILACS, SciELO databases and national journals of Occupational Therapy. From 1994 to 2012, twelve articles published by occupational therapists were selected considering the following keywords on abstracts or full texts: occupational therapy, self-care, daily activities or daily life activities. The results were submitted to integrative review and thematic analysis. The categories evidenced were self-care and activities of daily life; autonomy and independence for self-care; and intervention of OT favoring self-care by the individual. The results showed different dimensions of self-care when associated with the individual and private autonomy as well as with professional interdisciplinary practices of OT. The intervention in this area is directed to human performance in the cycles of life, faced with situations of vulnerability, such as disease and social exclusion. Adaptations, modifications, assistive technology resources and/or functional rehabilitation are used to promote the independence of individuals, favoring autonomy and recovery routines. We observed similarities between the conceptions of self-care found in the scientific production of OT and in the Orem’s concepts (1971-2001. In general, health professionals can achieve benefits to the systematization of knowledge that underlie their practice when they articulate them with the knowledge systematized by other areas.

  15. The Effects of Development Team Skill on Software Product Quality

    Science.gov (United States)

    Beaver, Justin M.; Schiavone, Guy A.

    2006-01-01

    This paper provides an analysis of the effect of the skill/experience of the software development team on the quality of the final software product. A method for the assessment of software development team skill and experience is proposed, and was derived from a workforce management tool currently in use by the National Aeronautics and Space Administration. Using data from 26 smallscale software development projects, the team skill measures are correlated to 5 software product quality metrics from the ISO/IEC 9126 Software Engineering Product Quality standard. in the analysis of the results, development team skill is found to be a significant factor in the adequacy of the design and implementation. In addition, the results imply that inexperienced software developers are tasked with responsibilities ill-suited to their skill level, and thus have a significant adverse effect on the quality of the software product. Keywords: software quality, development skill, software metrics

  16. Development of cell-cycle checkpoint therapy for solid tumors.

    Science.gov (United States)

    Tamura, Kenji

    2015-12-01

    Cellular proliferation is tightly controlled by several cell-cycle checkpoint proteins. In cancer, the genes encoding these proteins are often disrupted and cause unrestrained cancer growth. The proteins are over-expressed in many malignancies; thus, they are potential targets for anti-cancer therapies. These proteins include cyclin-dependent kinase, checkpoint kinase, WEE1 kinase, aurora kinase and polo-like kinase. Cyclin-dependent kinase inhibitors are the most advanced cell-cycle checkpoint therapeutics available. For instance, palbociclib (PD0332991) is a first-in-class, oral, highly selective inhibitor of CDK4/6 and, in combination with letrozole (Phase II; PALOMA-1) or with fulvestrant (Phase III; PALOMA-3), it has significantly prolonged progression-free survival, in patients with metastatic estrogen receptor-positive, HER2-negative breast cancer, in comparison with that observed in patients using letrozole, or fulvestrant alone, respectively. In this review, we provide an overview of the current compounds available for cell-cycle checkpoint protein-directed therapy for solid tumors. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  17. Unifying the field: developing an integrative paradigm for behavior therapy.

    Science.gov (United States)

    Eifert, G H; Forsyth, J P; Schauss, S L

    1993-06-01

    The limitations of early conditioning models and treatments have led many behavior therapists to abandon conditioning principles and replace them with loosely defined cognitive theories and treatments. Systematic theory extensions to human behavior, using new concepts and processes derived from and built upon the basic principles, could have prevented the divisive debates over whether psychological dysfunctions are the results of conditioning or cognition and whether they should be treated with conditioning or cognitive techniques. Behavior therapy could also benefit from recent advances in experimental cognitive psychology that provide objective behavioral methods of studying dysfunctional processes. We suggest a unifying paradigm for explaining abnormal behavior that links and integrates different fields of study and processes that are frequently believed to be incompatible or antithetical such as biological vulnerability variables, learned behavioral repertoires, and that also links historical and current antecedents of the problem. An integrative paradigmatic behavioral approach may serve a unifying function in behavior therapy (a) by promoting an understanding of the dysfunctional processes involved in different disorders and (b) by helping clinicians conduct functional analyses that lead to theory-based, individualized, and effective treatments.

  18. [Collage therapy and an analysis of production process in collage work].

    Science.gov (United States)

    Sato, S

    1998-10-01

    An application of collage as an art form has been made in clinical psychology, and has been established as collage therapy. This paper attempted to answer the following questions: What kind of behavior people show during production of collage work; how the production behavior differs from person to person; what causes the behavior differences. The framework of creative problem solving and behavior analysis technique with VTR were used, and behavior characteristics of mentally retarded subjects (N = 20) were compared with non-retarded adults (N = 20). Results revealed three behavior patterns: Whole linear type ([SEAF]n), partially repeated linear type ([SE]n and [AF]m), and circuit type ([SEA]n and [AF]m) from the analysis of transition probability of four fundamental action elements (search [S], extraction [E], arrangement [A] and fixation [F]) of collage work production. The difference in the production process of each subject may be attributed to the difference in proportions of the three behavior patterns. The proportion difference in turn appeared to reflect that on the global-local dimension in the work production plan.

  19. Dynamic simulation for effective workforce management in new product development

    OpenAIRE

    M. Mutingi

    2012-01-01

    Effective planning and management of workforce for new product development (NPD) projects is a great challenge to many organisations, especially in the presence of engineering changes during the product development process. The management objective in effective workforce management is to recruit, develop and deploy the right people at the right place at the right time so as to fulfill organizational objectives. In this paper, we propose a dynamic simulation model to address the workforce mana...

  20. Project and Innovation Management in New Product Development Processes

    DEFF Research Database (Denmark)

    Henriksen, Leif; Gayretli, Ahmet

    2010-01-01

    Although the process of innovation is one of the most important drivers behind the growth and prosperity of today’s global economy, it is one of the least understood. This paper aims to address specific problems in carrying out new product development processes. There are crucial issues related...... to product design processes like inefficient project management, increasing product complexity, conflict management, shortfall of existing methods and tools, and high failures in new product introduction. A new approach has been proposed for a system based platform, which consist of a product platform...

  1. Cognitive Development in Infantile-Onset Pompe Disease Under Very Early Enzyme Replacement Therapy.

    Science.gov (United States)

    Lai, Chih-Jou; Hsu, Ting-Rong; Yang, Chia-Feng; Chen, Shyi-Jou; Chuang, Ya-Chin; Niu, Dau-Ming

    2016-12-01

    Most patients with infantile-onset Pompe disease die in early infancy before beginning enzyme replacement therapy, which has made it difficult to evaluate the impact of Pompe disease on cognitive development. Patients with infantile-onset Pompe disease can survive with enzyme replacement therapy, and physicians can evaluate cognitive development in these patients. We established an effective newborn screening program with quick clinical diagnostic criteria. Cognitive and motor development were evaluated using the Bayley Scales of Infant and Toddler Development-Third Edition at 6, 12, and 24 months of age. The patients who were treated very early demonstrate normal cognitive development with no significant change in cognition during this period (P = .18 > .05). The cognitive development was positively correlated with motor development (r = 0.533, P = .011). The results indicated that very early enzyme replacement therapy could protect cognitive development in patients with infantile-onset Pompe disease up to 24 months of age. © The Author(s) 2016.

  2. Development of system technology for radiation cancer therapy with the dexterous auto lesions tracking

    International Nuclear Information System (INIS)

    Kim, Seungho; Jeong, Kyungmin; Jung, Seungho; Lee, Namho

    2013-01-01

    The project objectives are to establish the fundamental core technologies for precise auto lesions tracking radiation cancer therapy and developing related system technology as well. Radiation cancer therapy apparatus should be domestically produced to reduce medical expenses, hence advanced technologies are suggested and developed to make cost down medical expenses and save expenditure for importing 10 million dollars/set from overseas. To achieve these targets, we have carried out reviewing of domestic and foreign technology trend. Based on review of state-of-the-art technology, radiation sensory system is studied. 3m high precise image processing technique and intelligent therapy planning software are developed. Also precedent study on the redundant robot for dexterous motion control system has been performed for developing of radiation cancel therapy robot system

  3. Impact of nanotechnology on the delivery of natural products for cancer prevention and therapy.

    Science.gov (United States)

    Siddiqui, Imtiaz A; Sanna, Vanna

    2016-06-01

    Chemoprevention of human cancer by dietary products is a practical approach of cancer control, especially when chemoprevention is involved during the early stages of the carcinogenesis process. Research over the last few decades has clearly demonstrated the efficacy of dietary products for chemoprevention in cell culture and preclinical animal model systems. However, these in vitro and in vivo effects have not been able to be translated to bedside for clinical use. Among many reasons, inefficient systemic delivery and bioavailability of promising chemopreventive agents are considered to significantly contribute to such a disconnection. Since its advent in the field of cancer, nanotechnology has provided researchers with expertise to explore new avenues for diagnosis, prevention, and therapy of the disease. In a similar trait, we introduced a novel concept in which nanotechnology was utilized for enhancing the outcome of chemoprevention (Cancer Res. 2009; 69:1712-1716). This idea, which we termed as 'nanochemoprevention', was exploited by several laboratories and has now become an advancing field in chemoprevention research. This review summarizes some of these applications of nanotechnology in medicine, particularly focused on controlled and sustained release of bioactive compounds with emphasis on current and future utilization of nanochemoprevention for prevention and therapy of cancer. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  4. The lean product design and development journey a practical view

    CERN Document Server

    Pessôa, Marcus Vinicius Pereira

    2017-01-01

    This book presents a series of high performance product design (PD) and development best practices that can create or improve product development organization. In contrast to other books that focus only on Toyota or other individual companies applying lean IPD, this book explains the lean philosophy more broadly and includes discussions of systems engineering, design for X (DFX), agile development, integrated product development, and project management. The “Lean Journey” proposed here takes a value-centric approach, where the lean principles are applied to PD to allow the tools and methods selected to emerge from observation of the individual characteristics of each enterprise. This means that understanding lean product development (LPD) is not about knowing which tools are available but knowing how to apply the philosophy. The book comes with an accompanying manual with problems and solutions available on Springer Extras.

  5. New development in CAR-T cell therapy.

    Science.gov (United States)

    Wang, Zhenguang; Wu, Zhiqiang; Liu, Yang; Han, Weidong

    2017-02-21

    Chimeric antigen receptor (CAR)-engineered T cells (CAR-T cells) have yielded unprecedented efficacy in B cell malignancies, most remarkably in anti-CD19 CAR-T cells for B cell acute lymphoblastic leukemia (B-ALL) with up to a 90% complete remission rate. However, tumor antigen escape has emerged as a main challenge for the long-term disease control of this promising immunotherapy in B cell malignancies. In addition, this success has encountered significant hurdles in translation to solid tumors, and the safety of the on-target/off-tumor recognition of normal tissues is one of the main reasons. In this mini-review, we characterize some of the mechanisms for antigen loss relapse and new strategies to address this issue. In addition, we discuss some novel CAR designs that are being considered to enhance the safety of CAR-T cell therapy in solid tumors.

  6. New development in CAR-T cell therapy

    Directory of Open Access Journals (Sweden)

    Zhenguang Wang

    2017-02-01

    Full Text Available Abstract Chimeric antigen receptor (CAR-engineered T cells (CAR-T cells have yielded unprecedented efficacy in B cell malignancies, most remarkably in anti-CD19 CAR-T cells for B cell acute lymphoblastic leukemia (B-ALL with up to a 90% complete remission rate. However, tumor antigen escape has emerged as a main challenge for the long-term disease control of this promising immunotherapy in B cell malignancies. In addition, this success has encountered significant hurdles in translation to solid tumors, and the safety of the on-target/off-tumor recognition of normal tissues is one of the main reasons. In this mini-review, we characterize some of the mechanisms for antigen loss relapse and new strategies to address this issue. In addition, we discuss some novel CAR designs that are being considered to enhance the safety of CAR-T cell therapy in solid tumors.

  7. The intractability of non-word production difficulties in jargon aphasia: Insights from therapy

    Directory of Open Access Journals (Sweden)

    Arpita Bose

    2015-04-01

    Full Text Available Severe word production difficulties remain one of the most challenging clinical symptoms to treat in individuals with jargon aphasia (JA. Although research has found a beneficial effect of phonological therapy in JA (e.g., FF in Bose 2013; GF in Robson et al., 1998, a lack of improvement in naming performance following this approach has also been reported (e.g., P9 in Leonard et al., 2008. Clinically, it is important to determine why some individuals with JA improve following phonological therapy when others do not. This research investigates the effect of phonological therapy on naming performance in JA and explores possible reasons for improvement or lack thereof (e.g., input/ output processing skills, ability to use and maintain cues. Methods Participant: AM, an 86 year old, English-speaking male, was 16 years post-stroke and presented with persistent, severe neologistic jargon, characterized by very high proportions of non-words and perseverations. Part 1: Effects of phonological cuing (initial phoneme vs. semantic cuing (semantically-related item on naming performance were tested on items from the Philadelphia Naming Test (Roach et al., 1996 to determine the most suitable course of therapy. Part 2: Using a single-subject multiple baseline design, Phonological Component Analysis (Leonard et al., 2008 was administered for three sets of words. In addition to analysis of therapy performance, naming accuracy was compared across three lists in three instances of a word being treated (i.e., 1st attempt without any phonological cues, 2nd attempt immediately after the phonological cues, and 3rd attempt after review of the phonological cues. Results and Discussion Part 1: Results showed a significant increase in naming accuracy following phonological cuing [χ2 (1 = 5.782, p = .01], whereas semantic cuing did not [χ2 (1 =.386, ns], thus motivating the implementation of a phonological therapy. Part 2: There was a significant difference in accuracy

  8. International product development - Challenges in knowledge sharing

    DEFF Research Database (Denmark)

    Sonne, Anne-Mette

    2008-01-01

    Knowledge and internationalization are two important concepts in the corporate world today. Knowledge is companies' most important resource, and internationalization is a factor which affects all areas of management - particularly product development. The development of successful products...... for the international market rests on a company's ability to cooperate and to share knowledge. In order to develop products for the international market, companies must be capable of expanding knowledge sharing across geographical and professional divides. This is the focus of a new MAPP PhD dissertation....

  9. New Product Development (NPD) Process - An Example of Industrial Sector

    Science.gov (United States)

    Kazimierska, Marianna; Grębosz-Krawczyk, Magdalena

    2017-12-01

    This aim of this article is to present the process of new product introduction on example of industrial sector in context of new product development (NPD) concept. In the article, the concept of new product development is discussed and the different stages of the process of new electric motor development are analysed taking into account its objectives, implemented procedures, functions and responsibilities division. In the article, information from secondary sources and the results of empirical research - conducted in an international manufacturing company - are used. The research results show the significance of project leader and regular cooperation with final client in the NPD process.

  10. Natural product derived insecticides: discovery and development of spinetoram.

    Science.gov (United States)

    Galm, Ute; Sparks, Thomas C

    2016-03-01

    This review highlights the importance of natural product research and industrial microbiology for product development in the agricultural industry, based on examples from Dow AgroSciences. It provides an overview of the discovery and development of spinetoram, a semisynthetic insecticide derived by a combination of a genetic block in a specific O-methylation of the rhamnose moiety of spinosad coupled with neural network-based QSAR and synthetic chemistry. It also emphasizes the key role that new technologies and multidisciplinary approaches play in the development of current spinetoram production strains.

  11. A Product Development Decision Model for Cockpit Weather Information Systems

    Science.gov (United States)

    Sireli, Yesim; Kauffmann, Paul; Gupta, Surabhi; Kachroo, Pushkin

    2003-01-01

    There is a significant market demand for advanced cockpit weather information products. However, it is unclear how to identify the most promising technological options that provide the desired mix of consumer requirements by employing feasible technical systems at a price that achieves market success. This study develops a unique product development decision model that employs Quality Function Deployment (QFD) and Kano's model of consumer choice. This model is specifically designed for exploration and resolution of this and similar information technology related product development problems.

  12. A Product Development Decision Model for Cockpit Weather Information System

    Science.gov (United States)

    Sireli, Yesim; Kauffmann, Paul; Gupta, Surabhi; Kachroo, Pushkin; Johnson, Edward J., Jr. (Technical Monitor)

    2003-01-01

    There is a significant market demand for advanced cockpit weather information products. However, it is unclear how to identify the most promising technological options that provide the desired mix of consumer requirements by employing feasible technical systems at a price that achieves market success. This study develops a unique product development decision model that employs Quality Function Deployment (QFD) and Kano's model of consumer choice. This model is specifically designed for exploration and resolution of this and similar information technology related product development problems.

  13. Development of Personalized Cancer Therapy for Men with Advanced Prostate Cancer

    Science.gov (United States)

    2017-10-01

    AWARD NUMBERS: W81XWH-14-1-0554 TITLE: Development of Personalized Cancer Therapy for Men with Advanced Prostate Cancer PRINCIPAL INVESTIGATOR...Dr. Nora M. Navone CONTRACTING ORGANIZATION: The University of Texas MD Anderson Cancer Center 1515 Holcombe Blvd. Houston, TX 77030-4009...COVERED 09/22/2016-09/21/2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER N/A Development of Personalized Cancer Therapy for Men with Advanced

  14. Development of a Novel Targeted RNAi Delivery Technology inTherapies for Metabolic Diseases

    Science.gov (United States)

    2017-10-01

    report Impact on other disciplines: Nothing to report Impact on technology transfer: Nothing to report Impact on society : Nothing to report 5. CHANGES...AWARD NUMBER: W81XWH-15-1-0569 TITLE: Development of a Novel Targeted RNAi Delivery Technology in Therapies for Metabolic Diseases PRINCIPAL...COVERED 30Sep2016 - 29Sep2017 4. TITLE AND SUBTITLE Development of a Novel Targeted RNAi Delivery Technology in Therapies for Metabolic Diseases 5a

  15. BOBATH THERAPY IN CORRECTION OF PSYCHOMOTOR DEVELOPMENT OF CHILDREN WITH ORGANIC INJURIES CNS

    OpenAIRE

    Bukhovets, B. O.; Romanchuk, A. P.

    2014-01-01

    The article represents therapy of Bobath such as one of the most effective author method which use in correction psychomotor development of children with disorders of musculoskeletal system. Bobath method is not new in the correction of movement disorders since last century and still supplementing and improving. In this work highlight topic of the effective use Bobath therapy in correction of psychomotor development in children age 3 – 6 years with organic involvement CNS. the experiment w...

  16. Anticoagulation therapy a risk factor for the development of chronic subdural hematoma

    DEFF Research Database (Denmark)

    Aspegren, Oskar P.; Åstrand, Ramona; Lundgren, Maria I.

    2013-01-01

    Chronic subdural hematoma (CSDH) is a common disease among the elderly and with increasing incidence we have chosen to focus on associations between development and recurrence of CSDH and anticoagulation and/or antiplatelet agent therapy.......Chronic subdural hematoma (CSDH) is a common disease among the elderly and with increasing incidence we have chosen to focus on associations between development and recurrence of CSDH and anticoagulation and/or antiplatelet agent therapy....

  17. Phage Therapy Approaches to Reducing Pathogen Persistence and Transmission in Animal Production Environments: Opportunities and Challenges.

    Science.gov (United States)

    Colavecchio, Anna; Goodridge, Lawrence D

    2017-06-01

    The era of genomics has allowed for characterization of phages for use as antimicrobials to treat animal infections with a level of precision never before realized. As more research in phage therapy has been conducted, several advantages of phage therapy have been realized, including the ubiquitous nature, specificity, prevalence in the biosphere, and low inherent toxicity of phages, which makes them a safe and sustainable technology for control of animal diseases. These unique qualities of phages have led to several opportunities with respect to emerging trends in infectious disease treatment. However, the opportunities are tempered by several challenges to the successful implementation of phage therapy, such as the fact that an individual phage can only infect one or a few bacterial strains, meaning that large numbers of different phages will likely be needed to treat infections caused by multiple species of bacteria. In addition, phages are only effective if enough of them can reach the site of bacterial colonization, but clearance by the immune system upon introduction to the animal is a reality that must be overcome. Finally, bacterial resistance to the phages may develop, resulting in treatment failure. Even a successful phage infection and lysis of its host has consequences, because large amounts of endotoxin are released upon lysis of Gram-negative bacteria, which can lead to local and systemic complications. Overcoming these challenges will require careful design and development of phage cocktails, including comprehensive characterization of phage host range and assessment of immunological risks associated with phage treatment.

  18. Psychologists experience of cognitive behaviour therapy in a developing country: a qualitative study from Pakistan

    Directory of Open Access Journals (Sweden)

    Ayub Muhammad

    2010-01-01

    Full Text Available Abstract Background Psychological therapies especially Cognitive Behaviour Therapy (CBT are used widely in the West to help patients with psychiatric problems. Cognitive Behaviour Therapy has an established evidence base for the treatment of different emotional disorders. In spite of these developments in the developed world, patients in most developing countries hardly benefit from non pharmacological interventions. Although a significant number of psychologists are trained in Pakistan each year, psychological interventions play only a minor role in treatment plans in Pakistan. We conducted interviews with psychologists in Pakistan, to explore their experiences and their views on "providing CBT in Pakistan". These interviews were conducted as part of a project whose focus was to try to develop culturally-sensitive CBT in Pakistan. Methods In depth semi structured interviews were conducted with 5 psychologists working in psychiatry departments in Lahore, Pakistan. Results All the psychologists reported that psychotherapies, including CBT, need adjustments for use in Pakistan, although they were not able to elicit on these in details. Four major themes were discovered, hurdles in therapy, therapy related issues, involvement of the family and modification in therapy. The biggest hurdles in therapy were described to be service and resource issues. Conclusions For CBT to be acceptable, accessible and effective in Non Western cultures numerous adjustments need to be made, taking into consideration; factors related to service structure and delivery, patient's knowledge and beliefs about health and the therapy itself. Interviews with the psychologists in these countries can give us insights which can guide development of therapy and manuals to support its delivery.

  19. Idea work between object worlds - political process in product development?

    DEFF Research Database (Denmark)

    Gish, Liv; Clausen, Christian

    product ideas come from a variety of sources, but how do they actually emerge, develop, gain momentum and stabilise (van de Ven 1986) in an organisational setting including a diversity of knowledge domains and perspectives? This paper illustrates how an STS approach including notions of translation......Concerns for companies’ ability to innovate are increasingly focused on so called ‘front-end innovation’ being identified as a space where ideas for new products are created, exchanged and developed. The work with product ideas is claimed as being crucial to the innovation process in companies. New...... of actor networks (Callon 1986), object worlds (Bucciarelli 2005) and political process theory (Dawson et al 2000) can inform the staging of innovative work with product ideas. The paper reports on an in-depth case study of the development of a new product, the so called “A” labelled Alpha Pro circulation...

  20. APPLICABILITY OF ACTIVITY BASED COSTING IN NEW PRODUCT DEVELOPMENT PROCESSES

    Directory of Open Access Journals (Sweden)

    Ewa Wanda MARUSZEWSKA

    2015-01-01

    Full Text Available The purpose of the article is to emphasis that activity based costing is a proper tool for engineers to enhance their deci-sion-making process while developing new product. The theoretical analysis shows that variety of factors shall be en-compassed into new product decision-making process and therefore engineers and management should pay great attention to proper cost allocation. The paper suggests the usage of Activity Based Costing methodology for new product development decision-making process. Author states that application ABC in the process of rational decision-making referring to new product development enables managers and engineers to prioritize possible solutions, and reallocate resources used in production process in order to meet wider organizational goals. It would also contribute in coopera-tion of managers and engineers for the sake of organizational goal.

  1. Product development in the European and overseas food industry

    OpenAIRE

    Balogh, Sandor

    2007-01-01

    In the present study various product development trends in the food industry are reviewed with the main focus on convenience, organic and functional foods. Also highlighted are differences between the U.S. and Europe in terms of consumer habits and food supply trends. Through exploring the reasons behind differences in the extent of product innovation, the author illustrates the different role convenience products have in the US and European markets. Also revealed is the relationship linking ...

  2. Mobility, productivity, gender and career development of Argentinean life scientists

    OpenAIRE

    Koen Jonkers

    2011-01-01

    In this study we use survival or event history analysis to explore the effect of international mobility, gender and productivity on career development of researchers in CONICET life science research institutes in Buenos Aires. We find support for our hypothesis that various productivity measures can explain the likelihood of promotion. Given the same level of productivity, female researchers tend to take longer to being promoted. Unconditionally international work experience has a positive ef...

  3. Market Driving to Develop Rabbit Meat Products in Indonesia

    OpenAIRE

    Atien Priyanti; Yono Cahyo Rahadjo

    2012-01-01

    Rabbit meat is a nutritional food containing high protein and low cholesterol, fat and sodium. Current research in rabbit production is aimed for developing production strategies to increase the nutritional and economic values of rabbit meat products as functional food. Nowadays, producing rabbit is a popular farming activity in many parts of Indonesia as a small and medium scale operation for food security and cash income. Rabbit farming is to produce meat, skin and hides, fur, organic ferti...

  4. Microbeam radiation therapy. Physical and biological aspects of a new cancer therapy and development of a treatment planning system

    Energy Technology Data Exchange (ETDEWEB)

    Bartzsch, Stefan

    2014-11-05

    Microbeam Radiation Therapy (MRT) is a novel treatment strategy against cancer. Highly brilliant synchrotron radiation is collimated to parallel, a few micrometre wide, planar beams and used to irradiate malignant tissues with high doses. The applied peak doses are considerably higher than in conventional radiotherapy, but valley doses between the beams remain underneath the established tissue tolerance. Previous research has shown that these beam geometries spare normal tissue, while being effective in tumour ablation. In this work physical and biological aspects of the therapy were investigated. A therapy planning system was developed for the first clinical treatments at the European Synchrotron Radiation Facility in Grenoble (France) and a dosimetry method based on radiochromic films was created to validate planned doses with measurements on a micrometre scale. Finally, experiments were carried out on a cellular level in order to correlate the physically planned doses with the biological damage caused in the tissue. The differences between Monte Carlo dose and dosimetry are less than 10% in the valley and 5% in the peak regions. Developed alternative faster dose calculation methods deviate from the computational intensive MC simulations by less than 15% and are able to determine the dose within a few minutes. The experiments in cell biology revealed an significant influence of intercellular signalling on the survival of cells close to radiation boundaries. These observations may not only be important for MRT but also for conventional radiotherapy.

  5. Development of Hybrid Product Breakdown Structure for NASA Ground Systems

    Science.gov (United States)

    Monaghan, Mark W.; Henry, Robert J.

    2013-01-01

    The Product Breakdown Structure is traditionally a method of identification of the products of a project in a tree structure. It is a tool used to assess, plan, document, and display the equipment requirements for a project. It is part of a product based planning technique, and attempts to break down all components of a project in as much detail as possible, so that nothing is overlooked. The PBS for ground systems at the Kennedy Space Center is being developed to encompass the traditional requirements including the alignment of facility, systems, and components to the organizational hierarchy. The Ground Operations Product Breakdown Structure is a hybrid in nature in that some aspects of a work breakdown structure will be incorporated and merged with the Architecture Concept of Operations, Master Subsystem List, customer interface, and assigned management responsibility. The Ground Operations Product Breakdown Structure needs to be able to identify the flexibility of support differing customers (internal and external) usage of ground support equipment within the Kennedy Space Center launch and processing complex. The development of the Product Breakdown Structure is an iterative activity Initially documenting the organization hierarchy structure and relationships. The Product Breakdown Structure identifies the linkage between the customer program requirements, allocation of system resources, development of design goals, and identification logistics products. As the Product Breakdown Structure progresses the incorporation of the results of requirement planning for the customer occurs identifying facility needs and systems. The mature Product Breakdown Structure is baselined with a hierarchical drawing, the Product Breakdown Structure database, and an associated document identifying the verification of the data through the life cycle of the program/product line. This paper will document, demonstrate, and identify key aspects of the life cycle of a Hybrid Product

  6. Developing and modelling of ohmic heating for solid food products

    DEFF Research Database (Denmark)

    Feyissa, Aberham Hailu; Frosch, Stina

    Heating of solid foods using the conventional technologies is time-consuming due to the fact that heat transfer is limited by internal conduction within the product. This is a big challenge to food manufactures who wish to heat the product faster to the desired core temperature and to ensure more...... uniform quality across the product. Ohmic heating is one of the novel technologies potentially solving this problem by allowing volumetric heating of the product and thereby reducing or eliminating temperature gradients within the product. However, the application of ohmic heating for solid food products...... such as meat and seafood is not industrially utilized yet. Therefore, the aim of the current work is to model and develop the ohmic heating technology for heating of solid meat and seafood. A 3D mathematical model of coupled heat transfer and electric field during ohmic heating of meat products has been...

  7. Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition.

    Science.gov (United States)

    Evens, Ronald P

    2016-01-01

    The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recombinant human insulin in 1982, originating from the Genentech company. The pharma industry in the early years of 1970s and 1980s engaged with biotechnology companies only to a small extent with their in-licensing of a few recombinant molecules, led by Roche, Eli Lilly, and Johnson and Johnson. However, subsequently and dramatically over the last 25 years, biotechnology has become a primary driver of product and technology innovation and has become a cornerstone in new product development by all biopharma companies. This review demonstrates these evolutionary changes regarding approved products, product pipelines, novelty of the products, FDA approval rates, product sales, financial R&D investments in biotechnology, partnerships, mergers and acquisitions, and patent issues. We now have about 300 biotechnology products approved in USA covering 16 medical disciplines and about 250 indications, with the engagement of 25 pharma companies, along with their biotechnology company innovators and partners. The biotechnology pipeline involves over 1000 molecules in clinical trials, including over 300 molecules associated with the top 10 pharma companies. Product approval rates by the FDA for biotechnology products are over double the rate for drugs. Yes, the R&D paradigm has changed with biotechnology now as one of the major focuses for new product development with novel molecules by the whole biopharma industry.

  8. User Experience Evaluation Methods in Product Development (UXEM'09)

    Science.gov (United States)

    Roto, Virpi; Väänänen-Vainio-Mattila, Kaisa; Law, Effie; Vermeeren, Arnold

    High quality user experience (UX) has become a central competitive factor of product development in mature consumer markets [1]. Although the term UX originated from industry and is a widely used term also in academia, the tools for managing UX in product development are still inadequate. A prerequisite for designing delightful UX in an industrial setting is to understand both the requirements tied to the pragmatic level of functionality and interaction and the requirements pertaining to the hedonic level of personal human needs, which motivate product use [2]. Understanding these requirements helps managers set UX targets for product development. The next phase in a good user-centered design process is to iteratively design and evaluate prototypes [3]. Evaluation is critical for systematically improving UX. In many approaches to UX, evaluation basically needs to be postponed until the product is fully or at least almost fully functional. However, in an industrial setting, it is very expensive to find the UX failures only at this phase of product development. Thus, product development managers and developers have a strong need to conduct UX evaluation as early as possible, well before all the parts affecting the holistic experience are available. Different types of products require evaluation on different granularity and maturity levels of a prototype. For example, due to its multi-user characteristic, a community service or an enterprise resource planning system requires a broader scope of UX evaluation than a microwave oven or a word processor that is meant for a single user at a time. Before systematic UX evaluation can be taken into practice, practical, lightweight UX evaluation methods suitable for different types of products and different phases of product readiness are needed. A considerable amount of UX research is still about the conceptual frameworks and models for user experience [4]. Besides, applying existing usability evaluation methods (UEMs) without

  9. In Chains? Automotive Suppliers and Their Product Development Activities

    NARCIS (Netherlands)

    F. von Corswant; J.Y.F. Wynstra (Finn); M. Wetzels (Alex)

    2003-01-01

    textabstractA conceptual framework is developed and tested in which supplier downstream position in the supply chain, supplier innovation strategy and customer development commitment are seen as the antecedents of supplier product development activity. Using partial least squares (PLS), we analyze

  10. Nature-Inspired Design : Strategies for Sustainable Product Development

    NARCIS (Netherlands)

    De Pauw, I.C.

    2015-01-01

    Product designers can apply different strategies, methods, and tools for sustainable product development. Nature-Inspired Design Strategies (NIDS) offer designers a distinct class of strategies that use ‘nature’ as a guiding source of knowledge and inspiration for addressing sustainability.

  11. Design models in the development of mechatronic products

    DEFF Research Database (Denmark)

    Habib, Tufail; Brunø, Thomas Ditlev; Nielsen, Kjeld

    2012-01-01

    In view of widespread application of mechatronic systems and the competition to offer customized products at high quality and low cost, there has been considerable attention to introduce new methods and models in this regard. This paper explores design process of mechatronic product development w...

  12. Modelling production system architectures in the early phases of product development

    DEFF Research Database (Denmark)

    Guðlaugsson, Tómas Vignir; Ravn, Poul Martin; Mortensen, Niels Henrik

    2016-01-01

    are needed and appropriate to enable determination of obtainable product quality. In order to meet this challenge, it is suggested that a visual modelling framework be adopted that clarifies which product and production features are known at a specific time of the project and which features will be worked...... on – leading to an improved basis for prioritizing activities in the project. Requirements for the contents of the framework are presented, and literature on production and system models is reviewed. The production system architecture modelling framework is founded on methods and approaches in literature......This article suggests a framework for modelling a production system architecture in the early phases of product development.The challenge in these phases is that the products to be produced are not completely defined and yet decisions need to be made early in the process on what investments...

  13. Uncovering product development competence by applying the laddering technique

    DEFF Research Database (Denmark)

    Jensen, Bjarne; Harmsen, Hanne

    This paper addresses companies' lack of implementation of success factors in new product development. Drawing on theories in the competence perspective and an exploratory empirical study, the paper points to two major areas that have not been covered by previous studies on new product development...... success factors. The two areas are individual employees' knowledge, skills, and values and norms. It is suggested that increased understanding of these two areas hold potential in making identified success factors more accessible to companies.......This paper addresses companies' lack of implementation of success factors in new product development. Drawing on theories in the competence perspective and an exploratory empirical study, the paper points to two major areas that have not been covered by previous studies on new product development...

  14. Conceptual Development af a 3D Product Configuration Model

    DEFF Research Database (Denmark)

    Skauge, Jørn

    2006-01-01

    in the development of IT-systems that support the procedures in companies and in the building industry. In other words, it is a knowledge-based system that helps companies in their daily work. The aim of the project has been to develop and examine conceptual ideas about 3D modelling configurator used in the company......’s production of steel fire sliding doors. The development of the 3D digital model is based on practical rather than theoretical research. The result of the research is a prototype digital 3D model to be presented live.......Paper. This project deals with 3D product configuration of a digital building element which has been developed as a prototype in cooperation between a product manufacturer and a research institution in Denmark. The project falls within the concept of product modelling which is more and more used...

  15. The role of new product development on export market share

    Directory of Open Access Journals (Sweden)

    Naser Azad

    2013-10-01

    Full Text Available There is an ongoing change on customers’ needs on selecting customers’ needs, which may influence requirements on designing products and services as well as export sale and company’s market shares in domestic and international market. In the present study, through descriptive approach with qualitative method and case study, we investigate important key factors influencing on new product development and products’ successive factors at overseas nutritional market. In addition by presenting a new model in accordance with the present condition of the organization we explore the closest product development model and affective factors influencing them. The study investigates 36 factors and extracts six important ones, which influence product development including intelligent information, process research and development, strategy introduced, participation strategy, market survey and differentiation strategy.

  16. Adding to Product Development Theory - A Language Perspective

    DEFF Research Database (Denmark)

    Hansen, Poul H. Kyvsgård; Berg, Pekka; Mabogunje, Ade

    2014-01-01

    The paper explores the effect that the languages associated with the applied methods have on product development processes. Product development does increasingly involve more diverse disciplines and expanded cross-disciplinary views. Most importantly, the new disciplines: Design Thinking, and......, Innovation Management have introduced new cross-disciplinary methods and approaches. Some of the most important cognitive processes involved in product development: perceiving, meaning making, conceptualizing, communicating, and learning have been reframed and expanded as new disciplines have been introduced...... of these new languages reveals that the traditional methods applied in product development are highly influenced and limited by the languages that are traditionally associated with the application of these methods. Though language plays an important part in these essential processes it is rarely addressed...

  17. The application of lean principles in product development

    DEFF Research Database (Denmark)

    Bjarnø, Ole-Christian

    2007-01-01

    Although Lean Manufacturing has been a megatrend for several years, its principles have not been broadly applied in product development processes. We have therefore found it useful to look into the theories of lean manufacturing and to discuss how and to what extent they could be applied in the p......Although Lean Manufacturing has been a megatrend for several years, its principles have not been broadly applied in product development processes. We have therefore found it useful to look into the theories of lean manufacturing and to discuss how and to what extent they could be applied...... in the product development processes, and this study is compared with industrial practices in several front running companies in Denmark. From this research a suggestion for a framework and a tool-box for lean product development is created and discussed from a HR management, an implementation, an operational...

  18. Incorporating Natural Products, Pharmaceutical Drugs, Self-Care and Digital/Mobile Health Technologies into Molecular-Behavioral Combination Therapies for Chronic Diseases

    Science.gov (United States)

    Bulaj, Grzegorz; Ahern, Margaret M.; Kuhn, Alexis; Judkins, Zachary S.; Bowen, Randy C.; Chen, Yizhe

    2016-01-01

    Merging pharmaceutical and digital (mobile health, mHealth) ingredients to create new therapies for chronic diseases offers unique opportunities for natural products such as omega-3 polyunsaturated fatty acids (n-3 PUFA), curcumin, resveratrol, theanine, or α-lipoic acid. These compounds, when combined with pharmaceutical drugs, show improved efficacy and safety in preclinical and clinical studies of epilepsy, neuropathic pain, osteoarthritis, depression, schizophrenia, diabetes and cancer. Their additional clinical benefits include reducing levels of TNFα and other inflammatory cytokines. We describe how pleiotropic natural products can be developed as bioactive incentives within the network pharmacology together with pharmaceutical drugs and self-care interventions. Since approximately 50% of chronically-ill patients do not take pharmaceutical drugs as prescribed, psychobehavioral incentives may appeal to patients at risk for medication non-adherence. For epilepsy, the incentive-based network therapy comprises anticonvulsant drugs, antiseizure natural products (n-3 PUFA, curcumin or/and resveratrol) coupled with disease-specific behavioral interventions delivered by mobile medical apps. The add-on combination of antiseizure natural products and mHealth supports patient empowerment and intrinsic motivation by having a choice in self-care behaviors. The incentivized therapies offer opportunities: (1) to improve clinical efficacy and safety of existing drugs, (2) to catalyze patient-centered, disease self-management and behavior-changing habits, also improving health-related quality-of-life after reaching remission, and (3) merging copyrighted mHealth software with natural products, thus establishing an intellectual property protection of medical treatments comprising the natural products existing in public domain and currently promoted as dietary supplements. Taken together, clinical research on synergies between existing drugs and pleiotropic natural products

  19. Control and Diagnosis in Integrated Product Development - Observations during the Development of an AGV

    Science.gov (United States)

    Stetter, R.; Simundsson, A.

    2015-11-01

    This paper is concerned with the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of integrated product development have attracted significant attention during the last decades. Today, it is generally observed that product development processes of complex systems can only be successful if the activities in the different domains are well connected and synchronised and if an ongoing communication is present - an ongoing communication spanning the technical domains and also including functions such as production planning, marketing/distribution, quality assurance, service and project planning. Obviously, numerous approaches to tackle this challenge are present in scientific literature and in industrial practice, as well. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The main source of insight of the presented research is the product development process of an Automated Guided Vehicle (AGV) which is intended to be used on rough terrain. The paper starts with a background describing Integrated Product Development. The second section deals with the product development of the sample product. The third part summarizes some insights and formulates first hypotheses concerning control and diagnosis in Integrated Product Development.

  20. Communication practices in inter-organisational product development

    OpenAIRE

    Paasivaara, Maria

    2005-01-01

    Geographically distributed, inter-organisational product development projects are becoming increasingly common. However, companies face challenges in managing this kind of complicated projects. Most of the challenges are related to communication. This study focused on communication needs, problems and practices in distributed inter-organisational product development projects. The main objective was to identify and describe successful communication practices. In addition, the study aimed t...

  1. Ground-breaking virtual research in product development

    DEFF Research Database (Denmark)

    Søndergaard, Helle Alsted; Jespersen, Kristina Risom; Buck, Nuka

    2008-01-01

    MAPP also focuses on virtual reality. In the research project RIPS - the Role of Information Processing in NPD Strategy - a simulation of a product development process was used as a data collection instrument.......MAPP also focuses on virtual reality. In the research project RIPS - the Role of Information Processing in NPD Strategy - a simulation of a product development process was used as a data collection instrument....

  2. New product- Electric bike’s development in Finland

    OpenAIRE

    Pan, Yiding

    2010-01-01

    ABSTRACT The thesis highlights the development of a new product in Finnish market. According to international marketing knowledge, a marketing plan should be made to improve the strategy of the product’s development in four aspects. These are product, price, promotion and place. After a failing business experience in Nordic China Centre, Nordic Interflow wants to do the marketing research for the Chinese market, Finnish customers and Finnish competitors. The purpose of this thesis was...

  3. Product development alliances: factors influencing formation and success

    DEFF Research Database (Denmark)

    Olsen, Johanne Rønnow; Harmsen, Hanne; Friis, Alan

    2008-01-01

    , results indicate that success factors are rather universal across industries and types of alliances. Research limitations/implications - Further research should explore the findings further, both within the food industry context, as well as more broadly in terms of geography and industry. Practical...... implications - Managers obtain a tool for planning and refining their innovation strategy and actions regarding product development alliances. Originality/value - This research contributes to the presently limited literature on product development alliances, specifically in the food industry context....

  4. INFLUENCES ON ORGANISATIONAL SLACK IN NEW PRODUCT DEVELOPMENT PROJECTS

    OpenAIRE

    ANDERS RICHTNÉR; PÄR ÅHLSTRÖM

    2006-01-01

    Programs to decrease cost and to increase operational efficiency may reduce a company's ability to innovate, by reducing organisational slack. Previous research on the relationship between organisational slack and innovation has been at level of the firm and has neglected the processes underlying the relationship, which takes place at the level of product development projects. In this paper, we identify organisational slack and its influences at the level of the product development project. T...

  5. New Sustainable Tourism Product Development for Russian Customers

    OpenAIRE

    Racheeva, Polina

    2015-01-01

    Sustainable tourism is a new concept for tourism sector; it is tourism that reduces negative tourism impacts and brings benefits instead. The current problem of sustainable tourism is lack of attractive tourism products. Their development is crucial since customers seek for experiences at a destination. Russians are an important segment for Finnish tourism, therefore their consumer behaviours has to be studied. The aim of this research is to find how to develop a tourism product for susta...

  6. Distributed team innovation - a framework for distributed product development

    OpenAIRE

    Larsson, Andreas; Törlind, Peter; Karlsson, Lennart; Mabogunje, Ade; Leifer, Larry; Larsson, Tobias; Elfström, Bengt-Olof

    2003-01-01

    In response to the need for increased effectivity in global product development, the Polhem Laboratory at Luleå University of Technology, Sweden, and the Center for Design Research at Stanford University, USA, have created the concept of Distributed Team Innovation (DTI). The overall aim of the DTI framework is to decrease the negative impact of geographic distance on product development efforts and to further enhance current advantages of worldwide, multidisciplinary collaboration. The DTI ...

  7. Development of lithium target for accelerator based neutron capture therapy

    International Nuclear Information System (INIS)

    Taskaev, Sergey; Bayanov, Boris; Belov, Victor; Zhoorov, Eugene

    2006-01-01

    Pilot innovative accelerator based neutron source for neutron capture therapy of cancer is now of the threshold of its operation at the BINP, Russia. One of the main elements of the facility is lithium target producing neutrons via threshold 7 Li(p,n) 7 Be reaction at 25 kW proton beam with energies 1.915 MeV or 2.5 MeV. The main problems of lithium target were determined to be: 7 Be radioactive isotope activation keeping lithium layer solid, presence of photons due to proton inelastic scattering on lithium nuclei, and radiation blistering. The results of thermal test of target prototype were presented as previous NCT Congress. It becomes clear that water is preferable for cooling the target, and that lithium target 10 cm in diameter is able to run before melting. In the present report, the conception of optimal target is proposed: thin metal disk 10 cm in diameter easy for detaching, with evaporated thin layer of pure lithium from the side of proton beam exposure, its back being intensively cooled with turbulent water flow to maintain lithium layer solid. Design of the target for the neutron source constructed at BINP is shown. The results of investigation of radiation blistering and lithium layer are presented. Target unit of facility is under construction now, and obtaining neutrons is expected in nearest future. (author)

  8. Customized products and cloud service information system development research

    Directory of Open Access Journals (Sweden)

    Hung Chien-Wen

    2017-01-01

    Full Text Available This study presents a cloud service customized product information system to enable businesses to provide customized product marketing on the Internet to meet consumer demand for customized products. The cloud service of the information system development strategic framework proposed in this study contains three elements: (1 e-commerce services, (2 promotion type modules, and (3 cloud services customized promotional products. In this study, a mining cloud information system to detect customer behavior is proposed. The association rules from relational database design are utilized to mine consumer behavior to generate cross-selling proposals for customer products and marketing for a retailing mall in Taiwan. The study is composed of several parts, as follows. A market segment and application of association rules in data exploration techniques (Association Rule Mining and sequence-like exploration (Sequential Pattern Mining, efficient analysis of customers, consumer behavior, identification of candidates for promotional products, and using cloud service delivery and evaluation of targets to evaluate candidates for promotional products for production. However, in addition to cloud service customized promotional products, the quantity of promotional products sales varies for different customers. We strive to achieve increased customer loyalty and profits through the use of active cloud service customized promotional products.

  9. Selection and development of advanced nuclear fuel products

    International Nuclear Information System (INIS)

    Stucker, David L.; Miller, Richard S.; Arnsberger, Peter L.

    2004-01-01

    The highly competitive international marketplace requires a continuing product development commitment, short development cycle times and timely, on-target product development to assure customer satisfaction and continuing business. Westinghouse has maintained its leadership position within the nuclear fuel industry with continuous developments and improvements to fuel assembly materials and design. This paper presents a discussion of the processes used by Westinghouse in the selection and refinement of advanced concepts for deployment in the highly competitive US and international nuclear fuel fabrication marketplace. (author)

  10. Development of a Creative Arts Therapies Center for People with Developmental Disabilities

    Science.gov (United States)

    Lister, Suzanne; Tanguay, Denise; Snow, Stephen; D'Amico, Miranda

    2009-01-01

    The Centre for the Arts in Human Development in Montreal has provided art, drama, music, and dance/movement therapies to adults with developmental disabilities for over 10 years with the goals of developing and enhancing self-esteem, social skills, and communication abilities. This report describes the development and purpose of the center,…

  11. Safety of Sofosbuvir and Ribavirin Combination Therapy in a Patient Who Developed Anemia due to Ribavirin

    Directory of Open Access Journals (Sweden)

    Hirokazu Suii

    2017-01-01

    Full Text Available Interferon (IFN and ribavirin (RBV combination therapy was previously the standard of care for treatment of hepatitis C virus (HCV genotype 2 infection. But, it often induced hemolytic anemia. In 2014, sofosbuvir (SOF was approved for the treatment of chronic HCV genotype 2 in Japan. SOF/RBV therapy is more effective against genotype 2 than IFN/RBV therapy. We report a case of a 74-year-old woman with chronic HCV genotype 2b infection. She received five treatments including RBV and IFN therapy before SOF was approved and all of them were ineffective. Therapies that included RBV induced severe anemia and led to discontinuation of treatment. With pegylated IFN/RBV therapy, the maximum change in hemoglobin (Hb from baseline was −3.7 g/dL. However, SOF/RBV therapy was effective and she achieved sustained virologic response (SVR with a maximum change in Hb from baseline of only −1.2 g/dL. We also found reticulocyte count was very low during treatment in this case and speculate it was one of the reasons that she developed hemolytic anemia with RBV. In conclusion, SOF/RBV therapy is effective and allowed the patient to achieve SVR. An SOF/RBV regimen is safe and effective for patients who have or are at risk of anemia induced by RBV.

  12. The development of regional markets of eggs production in Russia

    Directory of Open Access Journals (Sweden)

    Natal'ya Anatol'evna Alekseeva

    2011-12-01

    Full Text Available The current state of regional markets development and the production of eggs and egg products for a long period — from 1990 to 2009 — is reviewed in this paper. The main research method is the method of statistical groupings. The variable amount of egg production was chosen as the grouping characteristic, since this figure fits well into research goals and has the property of the prevalence in the aggregate / total. To analyze the trends of the Russian regional markets involved into egg production, official statistics on consumer prices was used as well as producer prices, the volume of egg production per capita based on food import and export products. This allowed to group regions for comparison with average values of indicators carried out by different criteria, and to draw conclusions about trends in the development of regional markets. The most relevant factors influencing the development of egg production, among which the factor of vertical integration of production was especially noticed: building own plants and feed mills, joining the land in order to ensure the needs for higher quality raw materials and other activities were identified.

  13. Developing of milled peat production control in Turveruukki Oy

    Energy Technology Data Exchange (ETDEWEB)

    Ljokkoi, R

    1985-01-01

    Control research on the production of milled peat has as its primary aim the ability to control the peat drying process under different weather and field conditions. Actual development work connected with production control was begun in 1982 with the clear aim of developing and applying in practice a monitoring adn control system complete with measuring equipment which would permit the drying process to be measured indirectly and weather forecasts to be used systematically in the planning of production at each individual peat site. During the 1984 production season development work reached the stage of experimental use. Experiences gained from trial use have been mainly positive and trial use of the manual system can be considered the first step in the application o the system. As regards the measuring technique, it is justified to say that an adequate technical level has already been attained and the correlation of the indirect measuring method with peat drying can be further improved by adjusting the location height of the evaporation meter. On the other hand, calculation of the length of the harvesting cycle requires further research, which from the point of view of practice must be orientated towards control of field conditions and changes in them during the production season. Although the application of the production control system is informative in nature, it is clearly of assistance when deciding how to carry out production. By means of this system iy id possible to achieve financial benefit in the form of lowered production costs and a larger harvest per hectare.

  14. The sustainable utilization of human resources in global product development

    DEFF Research Database (Denmark)

    Hansen, Zaza Nadja Lee; Rasmussen, Lauge Baungaard; Hansen, Mette Sanne

    2010-01-01

    This empirical paper investigates the challenges global product development faces in regard to a sustainable utilization of resources through case studies and interviews in six Danish multinational corporations. Findings revealed 3 key challenges, which relates to increased rework in product...... development and production, overlapping work and a lack of utilization of knowledge and information at the supplier or subsidiary. The authors suggest the use of strategic simulation in order to gain greater transparency in the global network and thus utilize resources better. Strategic simulation...

  15. Innovation in the product development process and performance of firm

    DEFF Research Database (Denmark)

    Oliveira, Selma R.M.; Alves, Jorge L.; Boer, Harry

    2017-01-01

    This article aims to show the influence of the incorporation of technological innovations based on 3D modeling and additive manufacturing on the performance of firm and value co-creation for client , in the perspective of product development process (PDP), systematized in two phases: elaboration...... that it is possible to combine additive manufacturing techniques and traditional processes of production of components in pewter and the incorporation of other components in composite materials and other metallic alloys, allowing to develop innovative products in very short time frames, with market acceptance...

  16. New Products and Technologies, Based on Calculations Developed Areas

    Directory of Open Access Journals (Sweden)

    Gheorghe Vertan

    2013-09-01

    Full Text Available Following statistics, currently prosperous and have high GDP / capita, only countries that have and fructify intensively large natural resources and/or produce and export products massive based on patented inventions accordingly. Without great natural wealth and the lowest GDP / capita in the EU, Romania will prosper only with such products. Starting from the top experience in the country, some patented, can develop new and competitive technologies and patentable and exportable products, based on exact calculations of developed areas, such as that double shells welded assemblies and plating of ships' propellers and blade pump and hydraulic turbines.

  17. Cooperation Between Suppliers and Retail Chains in Developing Systemic Products

    Directory of Open Access Journals (Sweden)

    Katarzyna Bilińska-Reformat

    2016-01-01

    Full Text Available Seeking a competitive advantage, retail chains develop systemic products. Introducing systemic products to retailers' offer requires establishment of close cooperation with their suppliers. In the paper the assumption has been made that offering systemic products makes the offer more attractive for customer. It is also reason for development of cooperation between retail chains and suppliers. Selected commercial enterprises were research objects in the study. Analyses included in the paper concern the years between 2009 and 2015. Research methods: critical analysis of the literature, results of own research method concerning cooperation between retail chains and suppliers, and the case research method.

  18. New Product Development in Traditional Industries: Decision-Making Revised

    Directory of Open Access Journals (Sweden)

    Jon Mikel Zabala-Iturriagagoitia

    2012-02-01

    Full Text Available This paper investigates whether decisions considered as common in new product development literature are also valid in a region characterized by traditional industries. The research is grounded on innovative companies in the Valencian Region (Spain. Using the statistical tool of factor analysis, we test if the groups of decisions identified by the literature can be confirmed in our empirical sample. Therewith, we aim to link the theoretical and empirical fields in the context of new product development and product innovation management.

  19. Developments in radioisotope production and labelling of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lambrecht, R.M.

    1998-01-01

    Recent developments in both reactor and accelerator production of radioisotopes finding applications in nuclear medicine and in biomedical research are summarised. The priorities for the production of 48 different cyclotron radioisotopes; and for 42 reactor produced radioisotopes finding biomedical applications are identified. Each includes 5 generator systems. The rapid expansion of cyclotron based radioisotope production and automated synthesis of short-lived radiopharmaceuticals with the position-emitting radionuclides continues to gain momentum. Recent feasibility studies of the cyclotron production of 186 Re, 99m Tc and of 99 Mo are cited as examples of motivation to develop accelerator alternatives to use of nuclear reactors for medical radioisotope production. Examples of SPET and PET radiopharmaceuticals labelled with 131 I, 123 I, 124 I, 18 F, and with therapeutic radionuclides are highlighted. (author)

  20. Using Boundary Management for More Effective Product Development

    Directory of Open Access Journals (Sweden)

    John Thomson

    2013-10-01

    Full Text Available Twenty years ago, most companies developed their own products in a single location and brought them to market themselves. Today, original equipment manufacturers (OEMs are enlisting partners on a global scale as subsystem designers and producers in order to create and deliver new products into the market more rapidly and more frequently. This is especially true for large, complex products from the aerospace, telecommunications, electronics, and software industries. To assure the delivery of information across organizational boundaries, new coordination mechanisms need to be adopted (boundary management. In this article, best practices are described on how OEMs and partners self-organize and use agile, cooperative techniques to maintain daily communication among numerous internal and partner engineers to better coordinate product design and system integration. This article focuses on examples from the aerospace industry; however; these tactics can be applied in any organization to innovate at faster rates, to make delivery times more predictable, and to realize shorter product development timelines.

  1. Opportunity parameters in the development of Product/Service-Systems

    DEFF Research Database (Denmark)

    Matzen, Detlef; Andreasen, Mogens Myrup

    2006-01-01

    In the light of the current focus on innovative business development throughout industry and society, the concept of product/service-systems (PSS) is a promising approach to product development, which may yield product offers that benefit the company, customer and society alike. Only recently...... while maintaining a high level of need satisfaction [Mont 2004]. The enhancement of goods with the provision of services has been practised in some industrial sectors for decades, mainly based on maintenance deliveries to capital investments in B2B settings. Researchers working with these business....../service-oriented strategy we believe companies can deliver superior value solutions and ensure more optimal utilisation of resources by aligning operations with their customers compared to traditional product-oriented offers. The corresponding integration is not reflected in existing models and processes of product...

  2. Improving the quality of pork and pork products for the consumer : development of innovative, integrated, and sustainable food production chains of high quality pork products matching consumer demands

    NARCIS (Netherlands)

    Heimann, B.; Christensen, M.; Rosendal Rasmussen, S.; Bonneau, M.; Grunert, K.G.; Arnau, J.; Trienekens, J.H.; Oksbjerg, N.; Greef, de K.H.; Petersen, B.

    2012-01-01

    Improving the quality of pork and pork products for the consumer: development of innovative, integrated, and sustainable food production chains of high quality pork products matching consumer demands.

  3. A new concept for the modeling of the positron emitter production for the particle therapy

    International Nuclear Information System (INIS)

    Priegnitz, Marlen

    2012-01-01

    One of the three main tumour treatment forms is radiation therapy. Here, the application of ion beams, in particular protons and carbon ions, is of growing importance. This high precision therapy requires a consequent monitoring of the dose delivery since the induced dose deposition is very sensitive to density changes in the irradiated tissue. Up to now, positron emission tomography (PET) is the only in vivo method in clinical use for monitoring the dose deposition in ion beam therapy. It allows for the verification of the particle range as well as the position of the irradiation field. The distribution of activity measured by means of PET cannot be compared directly to the planned dose distribution. Thus, a calculation of the expected activity distribution is required which then can be compared to the measurement. Simulation of the expected activity distribution requires the exact knowledge of various cross sections. Only a few of them have been measured in the required energy range so far. Therefore, in Monte Carlo simulations often intrinsic nuclear models or semi-empirical parametrization are used which often exhibit insufficient accuray. Among experts the question on the optimum ion species for tumour therapy is still open. Especially lithium ions exhibit a great potential due to their favourable physical and radiobiological properties. Also for these ions a PET monitoring is highly desirable. The presented work shows the feasibility of range verification by means of PET for lithium irradiation. Furthermore, a concept for modeling positron emitter distributions without the knowledge of cross sections is developed. This prediction is based on depth-dependent positron emitter yields measured in reference materials (water, graphite and polyethylene). With these data the positron emitter distribution in any material of known stoichiometry can be calculated by means of an appropriate linear combination. The feasibility of the yield concept is shown for lithium and

  4. Improving occupational safety and health by integration into product development

    DEFF Research Database (Denmark)

    Broberg, Ole

    1996-01-01

    A cross-sectional case study was performed in a large company producing electro-mechanical products for industrial application. The objectives were: (i) to study the product development process and the role of key actors', (ii) to identify current practice on integrating occupational safety and h...... and studies of documents. A questionnaire regarding product development tasks and occupational safety and health were distributed to 30 design and production engineers. A total of 27 completed the questionnaire corresponding to a response rate of 90 per cent.......A cross-sectional case study was performed in a large company producing electro-mechanical products for industrial application. The objectives were: (i) to study the product development process and the role of key actors', (ii) to identify current practice on integrating occupational safety...... and health into the development process, especially the efforts and attitudes of design and production engineers', and (iii) to identify key actors'reflections on how to improve this integration. The study was based on qualitative as well as quantitative methods including interviews, questionnaires...

  5. Evaluation of current trends and recent development in insulin therapy for management of diabetes mellitus.

    Science.gov (United States)

    Nawaz, Muhammad Sarfraz; Shah, Kifayat Ullah; Khan, Tahir Mehmood; Rehman, Asim Ur; Rashid, Haroon Ur; Mahmood, Sajid; Khan, Shahzeb; Farrukh, Muhammad Junaid

    2017-12-01

    Diabetes mellitus is a major health problem in developing countries. There are various insulin therapies to manage diabetes mellitus. This systematic review evaluates various insulin therapies for management of diabetes mellitus worldwide. This review also focuses on recent developments being explored for better management of diabetes mellitus. We reviewed a number of published articles from 2002 to 2016 to find out the appropriate management of diabetes mellitus. The paramount parameters of the selected studies include the insulin type & its dose, type of diabetes, duration and comparison of different insulin protocols. In addition, various newly developed approaches for insulin delivery with potential output have also been evaluated. A great variability was observed in managing diabetes mellitus through insulin therapy and the important controlling factors found for this therapy include; dose titration, duration of insulin use, type of insulin used and combination therapy of different insulin. A range of research articles on current trends and recent advances in insulin has been summarized, which led us to the conclusion that multiple daily insulin injections or continuous subcutaneous insulin infusion (insulin pump) is the best method to manage diabetes mellitus. In future perspectives, development of the oral and inhalant insulin would be a tremendous breakthrough in Insulin therapy. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  6. Lean Startup and Lean Canvas Using for Innovative Product Development

    Directory of Open Access Journals (Sweden)

    Alena Buchalcevová

    2016-06-01

    Full Text Available Recently, new approaches to product development have emerged that focus on idea generation techniques and customer itself. One of them is the Lean Startup method that is described in this article along with the Lean Canvas method. The main goal of the article is to demonstrate the application of both methods to an innovative product development focused on providing interactive trips for families with children. The development of the product during individual phases is described and application of the Lean Startup and Lean Canvas principles is demonstrated. Finally, benefits of both methods contributing to the product success are discussed. Similar case studies start emerging worldwide, however in the Czech context are quite rare.

  7. A systematic apporach to service oriented product development

    DEFF Research Database (Denmark)

    Matzen, Detlef

    Throughout the last years, manufacturing industry has experienced a trend towards a higher level of operational integration with their customers, i.e. manufacturers differentiate their offer from competitors by combining physical and software products with service plans and service support...... operations. This integration of manufacturing and service business holds a number of potential advantages, such as optimised operational performance and improved insights into use phase processes. To realise these potential advantages, products and service operations must fit to and support each other, which...... calls for an integrated approach to their development. The integrated development of solution concepts spanning products, service delivery systems and matching delivery business models is the theme of this thesis. A design based approach - service oriented product development - is proposed...

  8. Entropy production in a cell and reversal of entropy flow as an anticancer therapy

    Institute of Scientific and Technical Information of China (English)

    Liao-fu LUO

    2009-01-01

    The entropy production rate of cancer cells is always higher than healthy cells in the case where no external field is applied. Different entropy production between two kinds of cells determines the direction of entropy flow among cells. The entropy flow is the carrier of information flow. The entropy flow from cancerous cells to healthy cells takes along the harmful information of cancerous cells, propagating its toxic action to healthy tissues. We demonstrate that a low-frequency and low- intensity electromagnetic field or ultrasound irradiation may increase the entropy production rate of a cell in normal tissue than that in cancer and consequently re- verse the direction of entropy current between two kinds of cells. The modification of the PH value of cells may also cause the reversal of the direction of entropy flow between healthy and cancerous cells. Therefore, the bio- logical tissue under the irradiation of an electromagnetic field or ultrasound or under the appropriate change of cell acidity can avoid the propagation of harmful infor- marion from cancer cells. We suggest that this entropy mechanism possibly provides a basis for a novel approach to anticancer therapy.

  9. Speech production gains following constraint-induced movement therapy in children with hemiparesis.

    Science.gov (United States)

    Allison, Kristen M; Reidy, Teressa Garcia; Boyle, Mary; Naber, Erin; Carney, Joan; Pidcock, Frank S

    2017-01-01

    The purpose of this study was to investigate changes in speech skills of children who have hemiparesis and speech impairment after participation in a constraint-induced movement therapy (CIMT) program. While case studies have reported collateral speech gains following CIMT, the effect of CIMT on speech production has not previously been directly investigated to the knowledge of these investigators. Eighteen children with hemiparesis and co-occurring speech impairment participated in a 21-day clinical CIMT program. The Goldman-Fristoe Test of Articulation-2 (GFTA-2) was used to assess children's articulation of speech sounds before and after the intervention. Changes in percent of consonants correct (PCC) on the GFTA-2 were used as a measure of change in speech production. Children made significant gains in PCC following CIMT. Gains were similar in children with left and right-sided hemiparesis, and across age groups. This study reports significant collateral gains in speech production following CIMT and suggests benefits of CIMT may also spread to speech motor domains.

  10. Understanding International Product Strategy in Multinational Corporations through New Product Development Approaches and Evolution

    OpenAIRE

    Liu, Yang; Shi, Yongjiang

    2017-01-01

    International product strategy regarding global standardisation and local adaptation is one of the challenges faced by multinational corporations (MNCs). Studies in this area have tested the antecedents and consequences of standardisation/adaptation, but lack a new product development (NPD) perspective. In this study, we explore how product standardisation/adaptation is determined in the NPD context. Through a qualitative case study of four MNCs, we found three NPD approaches: multi-local, ad...

  11. Improving the Safety of Cell Therapy Products by Suicide Gene Transfer

    Directory of Open Access Journals (Sweden)

    Antonio eDi Stasi

    2014-11-01

    Full Text Available Adoptive T-cell therapy can involve donor lymphocyte infusion (DLI after allogeneic hematopoietic stem cell transplantation, the administration of tumor infiltrating lymphocyte (TILs expanded ex-vivo, or more recently the use of T cell receptor (TCR or chimeric antigen receptor (CAR redirected T cells. However cellular therapies can pose significant risks, including graft-versus-host-disease and other on and off-target effects, and therefore strategies need to be implemented to permanently reverse any sign of toxicity. A suicide gene is a genetically encoded molecule that allows selective destruction of adoptively transferred cells. Suicide gene addition to cellular therapeutic products can lead to selective ablation of gene-modified cells, preventing collateral damage to contiguous cells and/or tissues. The ‘ideal’ suicide gene would ensure the safety of gene modified cellular applications by granting irreversible elimination of ‘all’ and ‘only’ the cells responsible for the unwanted toxicity. This review presents the suicide gene safety systems reported to date, with a focus on the state-of-the-art and potential applications regarding two of the most extensively validated suicide genes, including the clinical setting: herpes-simplex-thymidine-kinase (HSV-TK and inducible-caspase-9 (iCasp9.

  12. Method for Developing Descriptions of Hard-to-Price Products: Results of the Telecommunications Product Study

    Energy Technology Data Exchange (ETDEWEB)

    Conrad, F.; Tonn, B.

    1999-05-01

    This report presents the results of a study to test a new method for developing descriptions of hard-to-price products. The Bureau of Labor Statistics (BLS) is responsible for collecting data to estimate price indices such as the Consumers Price Index (BLS) is responsible for collecting data to estimate price indices such as the Consumers Price Index (CPI). BLS accomplishes this task by sending field staff to places of business to price actual products. The field staff are given product checklists to help them determine whether products found today are comparable to products priced the previous month. Prices for non-comparable products are not included in the current month's price index calculations. A serious problem facing BLS is developing product checklists for dynamic product areas, new industries, and the service sector. It is difficult to keep checklists up-to-date and quite often simply to develop checklists for service industry products. Some people estimates that upwards of 50 % of US economic activity is not accounted for in the CPI

  13. Toward developing recombinant gonadotropin-based hormone therapies for increasing fertility in the flatfish Senegalese sole.

    Directory of Open Access Journals (Sweden)

    François Chauvigné

    Full Text Available Captive flatfishes, such as the Senegalese sole, typically produce very low volumes of sperm. This situation is particularly prevalent in the first generation (F1 of reared sole males, which limits the development of artificial fertilization methods and the implementation of selective breeding programs. In this study, we investigated whether combined treatments with homologous recombinant follicle-stimulating (rFsh and luteinizing (rLh hormones, produced in a mammalian host system, could stimulate spermatogenesis and enhance sperm production in Senegalese sole F1 males. In an initial autumn/winter experiment, weekly intramuscular injections with increasing doses of rFsh over 9 weeks resulted in the stimulation of gonad weight, androgen release, germ cell proliferation and entry into meiosis, and the expression of different spermatogenesis-related genes, whereas a subsequent single rLh injection potentiated spermatozoa differentiation. In a second late winter/spring trial corresponding to the sole's natural prespawning and spawning periods, we tested the effect of repeated rLh injections on the amount and quality of sperm produced by males previously treated with rFsh for 4, 6, 8 or 10 weeks. These latter results showed that the combination of rFsh and rLh treatments could increase sperm production up to 7 times, and slightly improve the motility of the spermatozoa, although a high variability in the response was found. However, sustained administration of rFsh during spawning markedly diminished Leydig cell survival and the steroidogenic potential of the testis. These data suggest that in vivo application of rFsh and rLh is effective at stimulating spermatogenesis and sperm production in Senegalese sole F1 males, setting the basis for the future establishment of recombinant gonadotropin-based hormone therapies to ameliorate reproductive dysfunctions of this species.

  14. Supplier integration for new product developments: antecedents for supplier integration in modular product designs

    NARCIS (Netherlands)

    Eggers, Justus Erich

    2016-01-01

    Original equipment manufacturers (OEMs) increasingly integrate supplier resources in new product developments (NPD) to overcome bottlenecks of resource and to create competitive advantages. At the same time, OEMs react to the new market challenges by implementing modular product designs. Despite the

  15. Development of small-scale peat production; Pienturvetuotannon kehittaeminen

    Energy Technology Data Exchange (ETDEWEB)

    Erkkilae, A.; Kallio, E. [VTT Energy, Jyvaeskylae (Finland)

    1997-12-01

    The aim of the project is to develop production conditions, methods and technology of small-scale peat production to such a level that the productivity is improved and competitivity maintained. The aim in 1996 was to survey the present status of small-scale peat production, and research and development needs and to prepare a development plan for small-scale peat production for a continued project in 1997 and for the longer term. A questionnaire was sent to producers by mail, and its results were completed by phone interviews. Response was obtained from 164 producers, i.e. from about 75 - 85 % of small-scale peat producers. The quantity of energy peat produced by these amounted to 3.3 TWh and that of other peat to 265 000 m{sup 3}. The total production of energy peat (large- scale producers Vapo Oy and Turveruukki Oy included) amounted to 25.0 TWh in 1996 in Finland, of which 91 % (22.8 TWh) was milled peat and 9 % (2.2 TWh) of sod peat. The total production of peat other than energy peat amounted to 1.4 million m{sup 3}. The proportion of small-scale peat production was 13 % of energy peat, 11 % of milled peat and 38 % of sod peat. The proportion of small-scale producers was 18 % of other peat production. The results deviate clearly from those obtained in a study of small-scale production in the 1980s. The amount of small-scale production is clearly larger than generally assessed. Small-scale production focuses more on milled peat than on sod peat. The work will be continued in 1997. Based on development needs appeared in the questionnaire, the aim is to reduce environmental impacts and runoff effluents from small- scale production, to increase the efficiency of peat deliveries and to reduce peat production costs by improving the service value of machines by increasing co-operative use. (orig.)

  16. Animal-assisted dyadic therapy: A therapy model promoting development of the reflective function in the parent-child bond.

    Science.gov (United States)

    Shani, Liat

    2017-01-01

    Animal-assisted psychotherapy (AAP) inherently incorporates standpoints, interventions, and ways of action promoting the development of the reflective function and mentalization, and thus has special value for parent-child psychotherapy. Two central tools in AAP contribute to this process. The first is the ethical stance of the therapist, who sees the animals as full partners in the therapy situation, respecting them as subjects with needs, desires, and thoughts of their own. The second tool combines nonverbal communication with animals together with the relating, in the here and now, to the understanding and decoding of body language of everyone in the setting. Nonverbal communication in AAP enables access to implicit communication patterns occurring between parent and child. This article provides a survey of theoretical development and research constituting a basis for the development of therapeutic approaches for the improvement of parent-children dynamics, followed by a description of a dyadic therapy model of a mentalization-based treatment originating from a psychoanalytic-relational orientation. Clinical examples are provided to illustrate AAP processes in parent-child psychotherapy (consent was received for examples that were not aggregated).

  17. Development of interface technology for nuclear hydrogen production system

    International Nuclear Information System (INIS)

    Lee, Ki Young; Park, J. K.; Chang, J. H.

    2012-06-01

    These works focus on the development of attainment indices for nuclear hydrogen key technologies, the analysis of the hydrogen production process and the performance estimation for hydrogen production systems, and the assessment of the nuclear hydrogen production economy. The codes for analyzing the hydrogen production economy are developed for calculating the unit production cost of nuclear hydrogen. We developed basic R and D quality management methodology to meet design technology of VHTR's needs. By putting it in practice, we derived some problems and solutions. We distributed R and D QAP and Q and D QAM to each teams and these are in operation. Computer simulations are performed for estimating the thermal efficiency for the electrodialysis component likely to adapting as one of the hydrogen production system in Korea and EED-SI process known as the key components of the hydrogen production systems. Using the commercial codes, the process diagrams and the spread-sheets were produced for the Bunsen reaction process, Sulphuric Acid dissolution process and HI dissolution process, respectively, which are the key components composing of the SI process

  18. A dynamic model for managing overlapped iterative product development

    NARCIS (Netherlands)

    Lin, J.; Chai, K.H.; Wong, Y.S.; Brombacher, A.C.

    2008-01-01

    Intense competition in many industries impels firms to develop more products in less time. Overlapping of development activities is regarded as one of the most promising strategies to reduce project cycle time. However, the gain from overlapping must be weighed against the additional resource and

  19. A Comparison of New Service versus New Product Development

    DEFF Research Database (Denmark)

    Schleimer, Stephanie Christine; Schulman, Arthur

    2011-01-01

    Collaboration among firms for innovation has received considerable attention. However, little is known about how firm-to-firm collaboration is configured in new service development (NSD) versus new product development (NPD). This study takes a multidimensional approach and measures firm-to-firm c...

  20. System Development of Estimated Figures of Volume Production Plan

    Science.gov (United States)

    Brazhnikov, Maksim A.; Khorina, Irina V.; Minina, Yulia I.; Kolyasnikova, Lyudmila V.; Streltsov, Aleksey V.

    2016-01-01

    The relevance of this problem is primarily determined by a necessity of improving production efficiency in conditions of innovative development of the economy and implementation of Import Substitution Program. The purpose of the article is development of set of criteria and procedures for the comparative assessment of alternative volume production…