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.

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

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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.

[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.

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

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.

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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.

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

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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.

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.

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

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.

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

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

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

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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.

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

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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.

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.

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

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.

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.

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...

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.

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

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.

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

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

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.

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).

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.

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

Why commercialization of gene therapy stalled; examining the life cycles of gene therapy technologies.

Science.gov (United States)

Ledley, F D; McNamee, L M; Uzdil, V; Morgan, I W

2014-02-01

This report examines the commercialization of gene therapy in the context of innovation theories that posit a relationship between the maturation of a technology through its life cycle and prospects for successful product development. We show that the field of gene therapy has matured steadily since the 1980s, with the congruent accumulation of >35 000 papers, >16 000 US patents, >1800 clinical trials and >$4.3 billion in capital investment in gene therapy companies. Gene therapy technologies comprise a series of dissimilar approaches for gene delivery, each of which has introduced a distinct product architecture. Using bibliometric methods, we quantify the maturation of each technology through a characteristic life cycle S-curve, from a Nascent stage, through a Growing stage of exponential advance, toward an Established stage and projected limit. Capital investment in gene therapy is shown to have occurred predominantly in Nascent stage technologies and to be negatively correlated with maturity. Gene therapy technologies are now achieving the level of maturity that innovation research and biotechnology experience suggest may be requisite for efficient product development. Asynchrony between the maturation of gene therapy technologies and capital investment in development-focused business models may have stalled the commercialization of gene therapy.

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

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.

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.

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.

[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.

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.

Translational research on advanced therapies

Directory of Open Access Journals (Sweden)

Filippo Belardelli

2011-01-01

Full Text Available Fostering translational research of advanced therapies has become a major priority of both scientific community and national governments. Advanced therapy medicinal products (ATMP are a new medicinal product category comprising gene therapy and cell-based medicinal products as well as tissue engineered medicinal products. ATMP development opens novel avenues for therapeutic approaches in numerous diseases, including cancer and neurodegenerative and cardiovascular diseases. However, there are important bottlenecks for their development due to the complexity of the regulatory framework, the high costs and the needs for good manufacturing practice (GMP facilities and new end-points for clinical experimentation. Thus, a strategic cooperation between different stakeholders (academia, industry and experts in regulatory issues is strongly needed. Recently, a great importance has been given to research infrastructures dedicated to foster translational medicine of advanced therapies. Some ongoing European initiatives in this field are presented and their potential impact is discussed.

Translational research on advanced therapies.

Science.gov (United States)

Belardelli, Filippo; Rizza, Paola; Moretti, Franca; Carella, Cintia; Galli, Maria Cristina; Migliaccio, Giovanni

2011-01-01

Fostering translational research of advanced therapies has become a major priority of both scientific community and national governments. Advanced therapy medicinal products (ATMP) are a new medicinal product category comprising gene therapy and cell-based medicinal products as well as tissue engineered medicinal products. ATMP development opens novel avenues for therapeutic approaches in numerous diseases, including cancer and neurodegenerative and cardiovascular diseases. However, there are important bottlenecks for their development due to the complexity of the regulatory framework, the high costs and the needs for good manufacturing practice (GMP) facilities and new end-points for clinical experimentation. Thus, a strategic cooperation between different stakeholders (academia, industry and experts in regulatory issues) is strongly needed. Recently, a great importance has been given to research infrastructures dedicated to foster translational medicine of advanced therapies. Some ongoing European initiatives in this field are presented and their potential impact is discussed.

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…

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.

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.

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....

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.…

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...

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.

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

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...

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…

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.

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.

Biomarkers in T cell therapy clinical trials

Directory of Open Access Journals (Sweden)

Kalos Michael

2011-08-01

Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

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.

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

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....

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.

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...

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

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.

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

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

Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

Science.gov (United States)

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

2015-04-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

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.

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.

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.

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

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.

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

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

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...

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

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...

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...

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.

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.

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...

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.

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.

[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.

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.

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…

Nonclinical safety strategies for stem cell therapies

Energy Technology Data Exchange (ETDEWEB)

Sharpe, Michaela E., E-mail: michaela_sharpe@yahoo.com [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom); Morton, Daniel [Exploratory Drug Safety, Drug Safety Research and Development, Pfizer Inc, Cambridge, 02140 (United States); Rossi, Annamaria [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom)

2012-08-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

Nonclinical safety strategies for stem cell therapies

International Nuclear Information System (INIS)

Sharpe, Michaela E.; Morton, Daniel; Rossi, Annamaria

2012-01-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

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.

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...

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.

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.

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...

[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.

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)

History of gene therapy.

Science.gov (United States)

Wirth, Thomas; Parker, Nigel; Ylä-Herttuala, Seppo

2013-08-10

Two decades after the initial gene therapy trials and more than 1700 approved clinical trials worldwide we not only have gained much new information and knowledge regarding gene therapy in general, but also learned to understand the concern that has persisted in society. Despite the setbacks gene therapy has faced, success stories have increasingly emerged. Examples for these are the positive recommendation for a gene therapy product (Glybera) by the EMA for approval in the European Union and the positive trials for the treatment of ADA deficiency, SCID-X1 and adrenoleukodystrophy. Nevertheless, our knowledge continues to grow and during the course of time more safety data has become available that helps us to develop better gene therapy approaches. Also, with the increased understanding of molecular medicine, we have been able to develop more specific and efficient gene transfer vectors which are now producing clinical results. In this review, we will take a historical view and highlight some of the milestones that had an important impact on the development of gene therapy. We will also discuss briefly the safety and ethical aspects of gene therapy and address some concerns that have been connected with gene therapy as an important therapeutic modality. Copyright © 2013 Elsevier B.V. All rights reserved.

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.

Report on the 1. research coordination meeting on 'Development of therapeutic radiopharmaceuticals based on 177Lu for radionuclide therapy'

International Nuclear Information System (INIS)

2006-01-01

Radionuclide therapy (RNT) employing radiopharmaceuticals labelled with emitting radionuclides is fast emerging as an important part of nuclear medicine. Radionuclide therapy is effectively utilized for bone pain palliation, thus providing significant improvement in quality of life of patients suffering from pain resulting from bone metastasis. Targeting primary diseases by using specific carrier molecules labelled with radionuclides is also widely investigated and efficacious products have been emerging for the treatment of Lymphoma and Neuroendocrine tumours. In order to ensure the wider use of radiopharmaceuticals, it is essential to carefully consider the choice of radionuclides that together with the carrier molecules will give suitable pharmacokinetic properties and therapeutic efficacy. The criteria for the selection of a radionuclide for radiotherapy are suitable decay characteristics and amenable chemistry. However, the practical considerations in selecting a radionuclide for targeted therapy are availability in high radionuclidic purity as well as high specific activity and low production cost and comfortable delivery logistics. 177 Lu is one of the isotopes emerging as a clear choice for therapy. Worldwide, the isotope is under investigation for approximately 30 different clinical applications, including treatment of colon cancer, metastatic bone cancer, non-Hodgkin's lymphoma, and lung cancer. 177 Lu decays with a half-life of 6.71 d by emission of particles with E max of 497 keV (78.6%), 384 keV (9.1%) and 176 keV (12.2%). It also emits photons of 113 keV (6.4%) and 208 keV (11%), that are ideally suited for imaging the in-vivo localization and dosimetric calculations applying a gamma camera. The physical half-life of 177 Lu is comparable to that of 131 I, the most widely used therapeutic radionuclide. The long halflife of 177 Lu provides logistic advantage for production, QA/QC of the products as well as feasibility to supply the products to places

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...

Role of the blood service in cellular therapy.

Science.gov (United States)

Rebulla, Paolo; Giordano, Rosaria

2012-05-01

Cellular therapy is a novel form of medical or surgical treatment using cells in place of or in addition to traditional chemical drugs. The preparation of cellular products - called advanced therapy medicinal products - ATMP in Europe, requires compliance with good manufacturing practices (GMP). Based on long-term experience in blood component manufacturing, product traceability and hemovigilance, selected blood services may represent ideal settings for the development and experimental use of ATMP. International harmonization of the protocols and procedures for the preparation of ATMP is of paramount importance to facilitate the development of multicenter clinical trials with adequate sample size, which are urgently needed to determine the clinical efficacy of ATMP. This article describes European regulations on cellular therapy and summarizes the activities of the 'Franco Calori' Cell Factory, a GMP unit belonging to the department of regenerative medicine of a large public university hospital, which acquired a certification for the GMP production of ATMP in 2007 and developed nine experimental clinical protocols during 2003-2011. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

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.

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...

Advanced Therapy Medicinal Products (ATMPand exemptions to the Regulation 1394/2007: how confident can we be? An exploratory analysis.

Directory of Open Access Journals (Sweden)

Philippe eVan Wilder

2012-02-01

Full Text Available The market authorisation procedure for medicinal products for human use is relying on their demonstrated efficacy, safety and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP has been authorised through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products.An appropriate ATMP- Regulation is dealing with ATMP requirements.Two exemptions are foreseen to the ATMP-Regulation: a. Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by 30 December 2012. b.the hospital exemption rule for non routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.

Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis.

Science.gov (United States)

Van Wilder, Philippe

2012-01-01

The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP) has been authorized through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products. An appropriate ATMP - Regulation is dealing with ATMP requirements. Two exemptions are foreseen to the ATMP Regulation: (a) Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by December 30, 2012. (b) The hospital exemption rule for non-routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.

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.

Cell Therapy in Dermatology

Science.gov (United States)

Petrof, Gabriela; Abdul-Wahab, Alya; McGrath, John A.

2014-01-01

Harnessing the regenerative capacity of keratinocytes and fibroblasts from human skin has created new opportunities to develop cell-based therapies for patients. Cultured cells and bioengineered skin products are being used to treat patients with inherited and acquired skin disorders associated with defective skin, and further clinical trials of new products are in progress. The capacity of extracutaneous sources of cells such as bone marrow is also being investigated for its plasticity in regenerating skin, and new strategies, such as the derivation of inducible pluripotent stem cells, also hold great promise for future cell therapies in dermatology. This article reviews some of the preclinical and clinical studies and future directions relating to cell therapy in dermatology, particularly for inherited skin diseases associated with fragile skin and poor wound healing. PMID:24890834

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....

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...

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

CERN Document Server

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

2016-01-01

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...

Traditional Therapies for Skin Wound Healing.

Science.gov (United States)

Pereira, Rúben F; Bártolo, Paulo J

2016-05-01

Significance: The regeneration of healthy and functional skin remains a huge challenge due to its multilayer structure and the presence of different cell types within the extracellular matrix in an organized way. Despite recent advances in wound care products, traditional therapies based on natural origin compounds, such as plant extracts, honey, and larvae, are interesting alternatives. These therapies offer new possibilities for the treatment of skin diseases, enhancing the access to the healthcare, and allowing overcoming some limitations associated to the modern products and therapies, such as the high costs, the long manufacturing times, and the increase in the bacterial resistance. This article gives a general overview about the recent advances in traditional therapies for skin wound healing, focusing on the therapeutic activity, action mechanisms, and clinical trials of the most commonly used natural compounds. New insights in the combination of traditional products with modern treatments and future challenges in the field are also highlighted. Recent Advances: Natural compounds have been used in skin wound care for many years due to their therapeutic activities, including anti-inflammatory, antimicrobial, and cell-stimulating properties. The clinical efficacy of these compounds has been investigated through in vitro and in vivo trials using both animal models and humans. Besides the important progress regarding the development of novel extraction methods, purification procedures, quality control assessment, and treatment protocols, the exact mechanisms of action, side effects, and safety of these compounds need further research. Critical Issues: The repair of skin lesions is one of the most complex biological processes in humans, occurring throughout an orchestrated cascade of overlapping biochemical and cellular events. To stimulate the regeneration process and prevent the wound to fail the healing, traditional therapies and natural products have been used

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.

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.

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...

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

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

TU-G-BRB-04: Digital Phantoms for Developing Protocols in Particle Therapy

International Nuclear Information System (INIS)

Lee, C.

2015-01-01

Proton therapy, in particular, and ion therapy, just beginning, are becoming an increasing focus of attention in clinical radiation oncology and medical physics. Both modalities have been criticized of lacking convincing evidence from randomized trials proving their efficacy, justifying the higher costs involved in these therapies. This session will provide an overview of the current status of clinical trials in proton therapy, including recent developments in ion therapy. As alluded to in the introductory talk by Dr. Schulte, opinions are diverging widely as to the usefulness and need for clinical trials in particle therapy and the challenge of equipoise. The lectures will highlight some of the challenges that surround clinical trials in particle therapy. One, presented by Dr. Choy from UT Southwestern, is that new technology and even different types of particles such as helium and carbon ions are introduced into this environment, increasing the phase space of clinical variables. The other is the issue of medical physics quality assurance with physical phantoms, presented by Mrs. Taylor from IROC Houston, which is more challenging because 3D and 4D image guidance and active delivery techniques are in relatively early stages of development. The role of digital phantoms in developing clinical treatment planning protocols and as a QA tool will also be highlighted by Dr. Lee from NCI. The symposium will be rounded off by a panel discussion among the Symposium speakers, arguing pro or con the need and readiness for clinical trials in proton and ion therapy. Learning Objectives: To get an update on the current status of clinical trials allowing or mandating proton therapy. Learn about the status of planned clinical trials in the U.S. and worldwide involving ion therapy. Discuss the challenges in the design and QA of clinical trials in particle therapy. Learn about existing and future physical and computational anthropomorphic phantoms for charged particle clinical trial

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…

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....

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…

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...

Natural Product-Derived Treatments for Attention-Deficit/Hyperactivity Disorder: Safety, Efficacy, and Therapeutic Potential of Combination Therapy

Science.gov (United States)

Ahn, James; Ahn, Hyung Seok; Cheong, Jae Hoon; dela Peña, Ike

2016-01-01

Typical treatment plans for attention-deficit/hyperactivity disorder (ADHD) utilize nonpharmacological (behavioral/psychosocial) and/or pharmacological interventions. Limited accessibility to behavioral therapies and concerns over adverse effects of pharmacological treatments prompted research for alternative ADHD therapies such as natural product-derived treatments and nutritional supplements. In this study, we reviewed the herbal preparations and nutritional supplements evaluated in clinical studies as potential ADHD treatments and discussed their performance with regard to safety and efficacy in clinical trials. We also discussed some evidence suggesting that adjunct treatment of these agents (with another botanical agent or pharmacological ADHD treatments) may be a promising approach to treat ADHD. The analysis indicated mixed findings with regard to efficacy of natural product-derived ADHD interventions. Nevertheless, these treatments were considered as a “safer” approach than conventional ADHD medications. More comprehensive and appropriately controlled clinical studies are required to fully ascertain efficacy and safety of natural product-derived ADHD treatments. Studies that replicate encouraging findings on the efficacy of combining botanical agents and nutritional supplements with other natural product-derived therapies and widely used ADHD medications are also warranted. In conclusion, the risk-benefit balance of natural product-derived ADHD treatments should be carefully monitored when used as standalone treatment or when combined with other conventional ADHD treatments. PMID:26966583

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...

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.

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.

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...

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...

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.

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...

Engineering toxins for 21st century therapies.

Science.gov (United States)

Chaddock, John A; Acharya, K Ravi

2011-04-01

'Engineering Toxins for 21st Century Therapies' (9-10 September 2010) was part of the Royal Society International Seminar series held at the Kavli International Centre, UK. Participants were assembled from a range of disciplines (academic, industry, regulatory, public health) to discuss the future potential of toxin-based therapies. The meeting explored how the current structural and mechanistic knowledge of toxins could be used to engineer future toxin-based therapies. To date, significant progress has been made in the design of novel recombinant biologics based on domains of natural toxins, engineered to exhibit advantageous properties. The meeting concluded, firstly that future product development vitally required the appropriate combination of creativity and innovation that can come from the academic, biotechnology and pharma sectors. Second, that continued investigation into understanding the basic science of the toxins and their targets was essential in order to develop new opportunities for the existing products and to create new products with enhanced properties. Finally, it was concluded that the clinical potential for development of novel biologics based on toxin domains was evident. © 2011 The Authors Journal compilation © 2011 FEBS.

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...

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.

Clinical application of cell, gene and tissue therapies in Spain.

Science.gov (United States)

Gálvez-Martín, P; Ruiz, A; Clares, B

2018-05-01

Scientific and technical advances in the areas of biomedicine and regenerative medicine have enabled the development of new treatments known as "advanced therapies", which encompass cell therapy, genetics and tissue engineering. The biologic products that can be manufactured from these elements are classified from the standpoint of the Spanish Agency of Medication and Health Products in advanced drug therapies, blood products and transplants. This review seeks to provide scientific and administrative information for clinicians on the use of these biologic resources. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

[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.

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...

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

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

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...

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

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.

Effect of Sandplay Therapy on Cognitive Development of Educable Mentally Retarded

Directory of Open Access Journals (Sweden)

*M. Malekpour

2014-12-01

Full Text Available The purpose of this research was to determine the effect of sandplay therapy on cognitive development of educable mentally disabled children. The statistical population of this study included all children with educable mental disability in preschool and children in grades 1, 2, 3 in city of Isfahan. The sample included 32 children (16 boys and 16 girls who were randomly selected from 2 schools. Then they were randomaly assigned to 2 groups: the experimental and control groups. The material used in this research was: Kay Cognitive Diagnostic Test. A pretest was administered to both the experimental and control groups. Then sandplay therapy employed on experimental group. There post test was administered to both groups at the end of the training. The results analysis of covariance show that sandplay therapy significantly increased cognitive development among the experimental group as compared to the experimental group. The results also showed that there was a significant difference between the mean scores of Kay Cognitive Diagnostic Test of cognitive development in the experimental and the control group in the post test (P<0.001, and that sand play therapy intervention had a significant effect on conceptualization, symbolic thinking, social cognition, visuo_motor perception, attention span and mental_motor speed development (P<0.001.

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.)

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...

Report on the 1. research coordination meeting on 'Development of therapeutic radiopharmaceuticals based on {sup 177}Lu for radionuclide therapy'

Energy Technology Data Exchange (ETDEWEB)

NONE

2006-07-01

Radionuclide therapy (RNT) employing radiopharmaceuticals labelled with emitting radionuclides is fast emerging as an important part of nuclear medicine. Radionuclide therapy is effectively utilized for bone pain palliation, thus providing significant improvement in quality of life of patients suffering from pain resulting from bone metastasis. Targeting primary diseases by using specific carrier molecules labelled with radionuclides is also widely investigated and efficacious products have been emerging for the treatment of Lymphoma and Neuroendocrine tumours. In order to ensure the wider use of radiopharmaceuticals, it is essential to carefully consider the choice of radionuclides that together with the carrier molecules will give suitable pharmacokinetic properties and therapeutic efficacy. The criteria for the selection of a radionuclide for radiotherapy are suitable decay characteristics and amenable chemistry. However, the practical considerations in selecting a radionuclide for targeted therapy are availability in high radionuclidic purity as well as high specific activity and low production cost and comfortable delivery logistics. {sup 177}Lu is one of the isotopes emerging as a clear choice for therapy. Worldwide, the isotope is under investigation for approximately 30 different clinical applications, including treatment of colon cancer, metastatic bone cancer, non-Hodgkin's lymphoma, and lung cancer. {sup 177}Lu decays with a half-life of 6.71 d by emission of particles with E{sub max} of 497 keV (78.6%), 384 keV (9.1%) and 176 keV (12.2%). It also emits photons of 113 keV (6.4%) and 208 keV (11%), that are ideally suited for imaging the in-vivo localization and dosimetric calculations applying a gamma camera. The physical half-life of {sup 177}Lu is comparable to that of {sup 131}I, the most widely used therapeutic radionuclide. The long halflife of {sup 177}Lu provides logistic advantage for production, QA/QC of the products as well as feasibility to

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...

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.

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...

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

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...

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

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

Automation of cellular therapy product manufacturing: results of a split validation comparing CD34 selection of peripheral blood stem cell apheresis product with a semi-manual vs. an automatic procedure

OpenAIRE

H?mmer, Christiane; Poppe, Carolin; Bunos, Milica; Stock, Belinda; Wingenfeld, Eva; Huppert, Volker; Stuth, Juliane; Reck, Kristina; Essl, Mike; Seifried, Erhard; Bonig, Halvard

2016-01-01

Background Automation of cell therapy manufacturing promises higher productivity of cell factories, more economical use of highly-trained (and costly) manufacturing staff, facilitation of processes requiring manufacturing steps at inconvenient hours, improved consistency of processing steps and other benefits. One of the most broadly disseminated engineered cell therapy products is immunomagnetically selected CD34+?hematopoietic ?stem? cells (HSCs). Methods As the clinical GMP-compliant autom...

Effect of CPAP therapy on job productivity and psychosocial occupational health in patients with moderate to severe sleep apnea.

Science.gov (United States)

Jurádo-Gámez, Bernabé; Guglielmi, Ottavia; Gude-Sampedro, Francisco; Buela-Casal, Gualberto

2015-12-01

The aim of the present study was to assess the effect of continuous positive airflow pressure (CPAP) therapy on burnout symptoms and job productivity, stress, and satisfaction in patients with obstructive sleep apnea syndrome. The sample was composed of 55 patients (mean age 48.5 ± 8.9, BMI 31.1 ± 5.7, AIH 56.8 ± 22.1), diagnosed with obstructive sleep apnea syndrome (OSAS) using polysomnography (PSG) with a therapeutic indication of CPAP. Before and after 6 months of receiving CPAP therapy, participants completed the following questionnaires: the index of the impact of the disease on job productivity (IMPALA), the job content questionnaire(JCQ), the Maslach burnout inventory-general survey (MBI-GS), the Shirom-Melamed burnout questionnaire (SMBQ), the index of job satisfaction, the Epworth sleepiness scale (ESS), and the Pittsburgh sleep quality index (PSQI). We explored the efficacy of CPAP therapy at improving the indices of severity of OSAS using therapeutic PSG. CPAP therapy was associated with a beneficial effect on job productivity (IMPALA) (p = 0.000) and decreasing burnout symptoms such as physical fatigue (SMBQ) (p = 0.000), emotional exhaustion (SMBQ) (p = 0.014), cognitive weariness (SMBQ) (p = 0.004), exhaustion (MBI) (p = 0.000), and cynicism (MBI) (p = 0.002). However, CPAP did not decrease job stress or job dissatisfaction. In patients with severe OSAS, CPAP therapy has a beneficial effect on patients' occupational well-being and job productivity.

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

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...

[Art therapy and the promotion of child development in a hospitalization context].

Science.gov (United States)

Valladares, Ana Cláudia Afonso; da Silva, Mariana Teixeira

2011-09-01

This study aimed to evaluate and compare the development of hospitalized children before and after art therapy interventions. Qualitative case studies were undertaken in this descriptive-exploratory research, based on the developmental evaluation of the children. The study participants were five children between seven and ten years old, in the Hospital of Tropical Illnesses (HDT) in the city of Goiânia, state of Goiás, Brazil, in 2006. Results showed that art therapy interventions efficiently promoted children's development. Art therapy is a resource for positively channeling the variables of hospitalized children's development and for neutralizing affective factors that naturally appear, as well as for exposing the child's healthier potentials, which sometimes receive little stimulus in the context of hospitalization.

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.

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...

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...

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)

Ozone Therapy in Dentistry

Science.gov (United States)

Domb, William C

2014-01-01

Summary The 21st century dental practice is quite dynamic. New treatment protocols and new materials are being developed at a rapid pace. Ozone dental therapy falls into the category of new treatment protocols in dentistry, yet ozone is not new at all. Ozone therapy is already a major treatment modality in Europe, South America and a number of other countries. What is provided here will not be an exhaustive scientific treatise so much as a brief general introduction into what dentists are now doing with ozone therapies and the numerous oral/systemic links that make this subject so important for physicians so that, ultimately, they may serve their patients more effectively and productively. PMID:25363268

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.

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.

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.

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...

Developing Home-Based Virtual Reality Therapy Interventions.

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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.

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.

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.

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

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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.

Dendritic cells for active immunotherapy: optimizing design and manufacture in order to develop commercially and clinically viable products.

Science.gov (United States)

Nicolette, C A; Healey, D; Tcherepanova, I; Whelton, P; Monesmith, T; Coombs, L; Finke, L H; Whiteside, T; Miesowicz, F

2007-09-27

Dendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximum clinical efficacy within manufacturing processes that permit quality control and scale-up of consistent products. In this review we discuss the critical issues that must be addressed in order to optimize DC-based product design and manufacture, and highlight the DC based platforms currently addressing these issues. Variables in DC-based product design include the type of antigenic payload used, DC maturation steps and activation processes, and functional assays. Issues to consider in development include: (a) minimizing the invasiveness of patient biological material collection; (b) minimizing handling and manipulations of tissue at the clinical site; (c) centralized product manufacturing and standardized processing and capacity for commercial-scale production; (d) rapid product release turnaround time; (e) the ability to manufacture sufficient product from limited starting material; and (f) standardized release criteria for DC phenotype and function. Improvements in the design and manufacture of DC products have resulted in a handful of promising leads currently in clinical development.

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.

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...

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....

New developments in breast cancer therapy: role of iron oxide nanoparticles

Science.gov (United States)

Thoidingjam, Shivani; Bhan Tiku, Ashu

2017-06-01

Breast cancer is one of the leading causes of deaths in females worldwide. The high metastatic rate and drug resistance makes it one of the difficult cancers to treat. Early diagnosis and treatment are keys to better survival of breast cancer patients. Conventional treatment approaches like chemotherapy, radiotherapy and surgery suffer from major drawbacks. Novel approaches to improve cancer therapy with minimal damage to normal tissues and better quality of life for cancer patients need to be developed. Among various approaches used for treatment and diagnosis of breast cancer, use of nanoparticles (NPs) is coming up as a new and promising treatment regime. It can help overcome various limitations of conventional therapies like non-targeted effects, resistance to treatment, late diagnosis, etc. Among various nanoparticles studied for their biomedical applications, especially for breast cancer therapy, iron oxide nanoparticles (IONPs) are perhaps the most exciting due to their biocompatibility, biodegradability, size and properties like superparamagnetism. Besides, IONPs are also the only metal oxide nanoparticles approved for clinical use in magnetic resonance imaging (MRI) which is an added advantage for early detection. Therefore in this mini review, we are discussing the developments made in the use of IONPs for breast cancer therapy over the short span of the last five years i.e. 2010-2015. Since late diagnosis and therapy resistance are important drawbacks in breast cancer therapy, the potential of IONPs to overcome these limitations are also evaluated.

Palliative radiation therapy for overloading radiotherapy centre, especially for developing country

International Nuclear Information System (INIS)

Myo, M.; Susworo; San, T.

2001-01-01

In a developing country, most of the cancer cases are diagnosed in the advanced stages. So, the palliative radiation therapy is the only choice of therapy for these inoperable cases where chemotherapy is not effective or affordable. In conventional radiation therapy, a daily dose of 200 cGy for total 4000 cGy in more than 20 fractions (sometimes, up to 6000 cGy) is used. By using linear-quadratic model theory of cell killing by radiation, it can be calculated early and late effects by using alpha and beta ratio. This theory is still the best for radiation cell killing until the new detail one is discovered. These data are obtained by experimental as well as clinical results. The effective radiation dose can be calculated by using the data to different organs which is involved in the radiation fields. This can change the daily dose to palliative cases in which the late effect is unnecessary. The daily doses can be 300, 400, 500, and sometimes 1000 cGy per single fraction. These modalities are well documented. It is recommend to change the short term high-dose palliative radiation therapy instead of using conventional palliative radiation therapy in overloading radiotherapy centre, especially for developing country. The reasons are mainly radiation protection aspect, not only for the patients and those who involved with the radiation therapy but also to reduce the unnecessary radiation exposure to the environment. (author)

Impact of gastro-oesophageal reflux disease on work productivity despite therapy with proton pump inhibitors in Germany

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Gross M

2010-03-01

Full Text Available Abstract Background Gastro-oesophageal reflux disease (GERD is a common disorder with consequences for the patient's health-related quality of life (HRQoL. In Germany, few data are available on the impact of GERD on work-related productivity. Aim To study the impact of GERD on work productivity despite proton pump inhibitor (PPI therapy and the association between productivity and symptom duration, severity, and HRQoL. Methods Retrospective data from randomly selected patients with chronic GERD symptoms, treated by office-based general practitioners or general internists with routine clinical care, were analyzed together with information from self-administered instruments assessing work productivity (WPAI-GERD, symptoms (RDQ, and HRQoL (QOLRAD. Results Reduced productivity was reported by 152 of 249 patients (61.0%, although 89.5% of them were treated with PPI. The reduction in work productivity was 18.5% in all patients and 30.3% in those with reduced productivity. Patients with impaired productivity showed a significantly lower HRQoL and more-severe symptoms of reflux disease. In all patients, the mean sick leave attributable to reflux symptoms was 0.6 hours in the previous seven days and 1.4 work days in the previous three months. Conclusion GERD has a substantial impact on work productivity in Germany, even in patients receiving routine clinical care and PPI therapy.

Tumor targeted gene therapy

International Nuclear Information System (INIS)

Kang, Joo Hyun

2006-01-01

Knowledge of molecular mechanisms governing malignant transformation brings new opportunities for therapeutic intervention against cancer using novel approaches. One of them is gene therapy based on the transfer of genetic material to an organism with the aim of correcting a disease. The application of gene therapy to the cancer treatment had led to the development of new experimental approaches such as suicidal gene therapy, inhibition of oncogenes and restoration of tumor-suppressor genes. Suicidal gene therapy is based on the expression in tumor cells of a gene encoding an enzyme that converts a prodrug into a toxic product. Representative suicidal genes are Herpes simplex virus type 1 thymidine kinase (HSV1-tk) and cytosine deaminase (CD). Especially, physicians and scientists of nuclear medicine field take an interest in suicidal gene therapy because they can monitor the location and magnitude, and duration of expression of HSV1-tk and CD by PET scanner

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.

The treatment of apraxia of speech : Speech and music therapy, an innovative joint effort

NARCIS (Netherlands)

Hurkmans, Josephus Johannes Stephanus

2016-01-01

Apraxia of Speech (AoS) is a neurogenic speech disorder. A wide variety of behavioural methods have been developed to treat AoS. Various therapy programmes use musical elements to improve speech production. A unique therapy programme combining elements of speech therapy and music therapy is called

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

Developing, maintaining, and using a body of knowledge for the massage therapy profession.

Science.gov (United States)

Sefton, Joellen M; Shea, Michael; Hines, Chip

2011-01-01

The diverse field of massage therapy has lacked a formal body of knowledge to serve as a practice and educational foundation and to guide future development. This deficit has hampered the growth of the profession and its acceptance and recognition by the medical and allied health care community. To provide massage therapists, bodyworkers, physicians, educators, and associated allied health care professionals in the United States with a description of the purpose and development of the massage therapy body of knowledge (MTBOK) and recommendations for its future development and utilization. Professional groups in the massage therapy community came together and established a task force to develop a body of knowledge for the profession. Five groups became the stewards for this effort. A nationwide search produced a task force of eight volunteers from diverse areas of the profession charged with the responsibility of researching and developing the MTBOK document. Review of documents, curricula, state laws and regulations, certification exam content, interviews, and public comment resulted in the development of the MTBOK. During development multiple opportunities for comment and discussion by stakeholders (public) were provided in an effort to create a professional consensus. The resulting MTBOK document establishes professional descriptions of the field; scope of practice; knowledge, skills, and abilities for entry-level massage therapists; and definitions for terminology to insure standardization, in order to provide a foundation for future discussion and growth. The MTBOK fulfills the goal for which it was developed, to serve as a foundation for the growth and development of the massage therapy profession as a whole. A living document, it should continue to evolve and grow with the profession. Maintenance and continued stewardship of this document by the massage therapy community is vital for continued professional progress.

Managing Virtual Product Development team: A Review

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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.

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.

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...

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

Development of Viral Vectors for Gene Therapy for Chronic Pain

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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.

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

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...

Possibilities of development photodynamic therapy under high temperature superconductor magnetic field

International Nuclear Information System (INIS)

Sen, Mihir

1996-01-01

After a long extensive research work neutron photon therapy for treatment of acquired immuno-deficiency syndrome (AIDS) was developed. High temperature superconductor magnet was developed and fitted in magnetic resonance imaging system to guide the patient. By this neutron-photon therapy AIDS effected cells are identified prominently. Patient is then injected with light sensitive drug molecules, which only AIDS cell retain. Light from photon (laser) then energizes the drug, which passes that energy to oxygen, which then leads a biochemical attack on the AIDS cells. If all goes well, the AIDS affected cells die. 10 refs., 1 fig

Approaches and Recent Developments for the Commercial Production of Semi-synthetic Artemisinin.

Science.gov (United States)

Kung, Stephanie H; Lund, Sean; Murarka, Abhishek; McPhee, Derek; Paddon, Chris J

2018-01-01

The antimalarial drug artemisinin is a natural product produced by the plant Artemisia annua . Extracts of A. annua have been used in Chinese herbal medicine for over two millennia. Following the re-discovery of A. annua extract as an effective antimalarial, and the isolation and structural elucidation of artemisinin as the active agent, it was recommended as the first-line treatment for uncomplicated malaria in combination with another effective antimalarial drug (Artemisinin Combination Therapy) by the World Health Organization (WHO) in 2002. Following the WHO recommendation, the availability and price of artemisinin fluctuated greatly, ranging from supply shortfalls in some years to oversupply in others. To alleviate these supply and price issues, a second source of artemisinin was sought, resulting in an effort to produce artemisinic acid, a late-stage chemical precursor of artemisinin, by yeast fermentation, followed by chemical conversion to artemisinin (i.e., semi-synthesis). Engineering to enable production of artemisinic acid in yeast relied on the discovery of A. annua genes encoding artemisinic acid biosynthetic enzymes, and synthetic biology to engineer yeast metabolism. The progress of this effort, which resulted in semi-synthetic artemisinin entering commercial production in 2013, is reviewed with an emphasis on recent publications and opportunities for further development. Aspects of both the biology of artemisinin production in A. annua , and yeast strain engineering are discussed, as are recent developments in the chemical conversion of artemisinic acid to artemisinin.

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.

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.

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.

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

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...

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...

Vector Production in an Academic Environment: A Tool to Assess Production Costs

Science.gov (United States)

Boeke, Aaron; Doumas, Patrick; Reeves, Lilith; McClurg, Kyle; Bischof, Daniela; Sego, Lina; Auberry, Alisha; Tatikonda, Mohan

2013-01-01

Abstract Generating gene and cell therapy products under good manufacturing practices is a complex process. When determining the cost of these products, researchers must consider the large number of supplies used for manufacturing and the personnel and facility costs to generate vector and maintain a cleanroom facility. To facilitate cost estimates, the Indiana University Vector Production Facility teamed with the Indiana University Kelley School of Business to develop a costing tool that, in turn, provides pricing. The tool is designed in Microsoft Excel and is customizable to meet the needs of other core facilities. It is available from the National Gene Vector Biorepository. The tool allows cost determinations using three different costing methods and was developed in an effort to meet the A21 circular requirements for U.S. core facilities performing work for federally funded projects. The costing tool analysis reveals that the cost of vector production does not have a linear relationship with batch size. For example, increasing the production from 9 to18 liters of a retroviral vector product increases total costs a modest 1.2-fold rather than doubling in total cost. The analysis discussed in this article will help core facilities and investigators plan a cost-effective strategy for gene and cell therapy production. PMID:23360377

Current perspectives on the use of ancillary materials for the manufacture of cellular therapies.

Science.gov (United States)

Solomon, Jennifer; Csontos, Lynn; Clarke, Dominic; Bonyhadi, Mark; Zylberberg, Claudia; McNiece, Ian; Kurtzberg, Joanne; Bell, Rosemarie; Deans, Robert

2016-01-01

Continued growth in the cell therapy industry and commercialization of cell therapies that successfully advance through clinical trials has led to increased awareness around the need for specialized and complex materials utilized in their manufacture. Ancillary materials (AMs) are components or reagents used during the manufacture of cell therapy products but are not intended to be part of the final products. Commonly, there are limitations in the availability of clinical-grade reagents used as AMs. Furthermore, AMs may affect the efficacy of the cell product and subsequent safety of the cell therapy for the patient. As such, AMs must be carefully selected and appropriately qualified during the cell therapy development process. However, the ongoing evolution of cell therapy research, limited number of clinical trials and registered cell therapy products results in the current absence of specific regulations governing the composition, compliance, and qualification of AMs often leads to confusion by suppliers and users in this field. Here we provide an overview and interpretation of the existing global framework surrounding AM use and investigate some common misunderstandings within the industry, with the aim of facilitating the appropriate selection and qualification of AMs. The key message we wish to emphasize is that in order to most effectively mitigate risk around cell therapy development and patient safety, users must work with their suppliers and regulators to qualify each AM to assess source, purity, identity, safety, and suitability in a given application. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

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...

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.

Effect of 2 herbal intramammary products on milk quantity and quality compared with conventional and no dry cow therapy.

Science.gov (United States)

Mullen, K A E; Anderson, K L; Washburn, S P

2014-01-01

Dry cow therapy, administered at the end of lactation, is aimed at eliminating current and preventing future intramammary (IMM) bacterial infections and typically involves intramammary administration of antibiotics. Certified organic dairies in the United States are restricted from using antibiotics and must consider an alternative therapy or no dry cow therapy. The current study compared 2 herbal products to conventional dry cow therapy and no treatment for a total of 5 treatments over 2 trials. Trial 1 was conducted over 3 yr on 1 research farm and trial 2 included 4 commercial farms plus the research herd over 2 yr. Treatments included (1) a conventional IMM antibiotic and internal teat sealant (penicillin-dihydrostreptomycin and bismuth subnitrate; CON); (2) an herbal IMM product purported to act as a teat sealant (Cinnatube, New AgriTech Enterprises, Locke, NY; CIN); (3) an herbal IMM product (Phyto-Mast, Bovinity Health LLC, Narvon, PA; P-M); (4) Phyto-Mast and Cinnatube (PC); or (5) no dry cow therapy (NT). Each treatment group was balanced by breed, lactation number, due date, herd, and year. However, the CON treatment was used only in the research herd because of the intent to avoid antibiotic usage on the other 4 farms. Comparisons among treatments included the difference between pre- and posttreatment 305-d mature equivalent milk production (trial 1), somatic cell score change from dry-off to freshening at the cow and quarter levels (trials 1 and 2), and milk microbiology change over the dry period (trial 2). We detected no significant differences among treatments for milk yield differences between the lactation following treatment and the lactation preceding treatment. Changes in somatic cell score from one lactation to the next also did not differ significantly among treatments in either trial. Cure rates were not significantly different among treatments; only 19.6% of all quarters were infected at dry off. The proportion of quarters with new

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...

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.

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.

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...

Development and operation of a quality assurance system for deviations from standard operating procedures in a clinical cell therapy laboratory.

Science.gov (United States)

McKenna, D; Kadidlo, D; Sumstad, D; McCullough, J

2003-01-01

Errors and accidents, or deviations from standard operating procedures, other policy, or regulations must be documented and reviewed, with corrective actions taken to assure quality performance in a cellular therapy laboratory. Though expectations and guidance for deviation management exist, a description of the framework for the development of such a program is lacking in the literature. Here we describe our deviation management program, which uses a Microsoft Access database and Microsoft Excel to analyze deviations and notable events, facilitating quality assurance (QA) functions and ongoing process improvement. Data is stored in a Microsoft Access database with an assignment to one of six deviation type categories. Deviation events are evaluated for potential impact on patient and product, and impact scores for each are determined using a 0- 4 grading scale. An immediate investigation occurs, and corrective actions are taken to prevent future similar events from taking place. Additionally, deviation data is collectively analyzed on a quarterly basis using Microsoft Excel, to identify recurring events or developing trends. Between January 1, 2001 and December 31, 2001 over 2500 products were processed at our laboratory. During this time period, 335 deviations and notable events occurred, affecting 385 products and/or patients. Deviations within the 'technical error' category were most common (37%). Thirteen percent of deviations had a patient and/or a product impact score > or = 2, a score indicating, at a minimum, potentially affected patient outcome or moderate effect upon product quality. Real-time analysis and quarterly review of deviations using our deviation management program allows for identification and correction of deviations. Monitoring of deviation trends allows for process improvement and overall successful functioning of the QA program in the cell therapy laboratory. Our deviation management program could serve as a model for other laboratories in

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...

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...

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

Current status of the clinical development and implementation of paediatric artemisinin combination therapies in Sub-Saharan Africa.

Science.gov (United States)

Agnandji, Selidji Todagbe; Kurth, Florian; Bélard, Sabine; Mombo-Ngoma, Ghyslain; Basra, Arti; Fernandes, José Francisco; Soulanoudjingar, Solange Solmeheim; Adegnika, Akim Ayola; Ramharter, Michael

2011-10-01

Timely treatment of infected children with artemisinin based combination therapies is an essential tool for the effective control and potential elimination of malaria. Until recently only tablet formulations have been available for the treatment of children leading to problems of swallowability, palatability and dosing. In consequence, paediatric drug formulations of artemisinin-based combination therapy (ACT) have been developed, showing a clinically significant improvement of tolerability in young children and of their implementation is an increasingly important public health issue. In this mini-review, we focus on the recent development of paediatric ACTs and their use in practice. Paediatric ACTs are formulated as syrup, powder for suspension, dispersible tablets and granules. Overall, the use of paediatric formulation results in an improved management of clinical malaria in young children. To date, only two paediatric ACTs have been certified with WHO prequalification status as an internationally accepted quality standard. Many more paediatric ACTs are available and in use in sub-Saharan Africa despite a lack of publicly available evidence from stringent clinical development programs. The conduct of effectiveness studies to support the introduction of paediatric ACTs in official treatment recommendations is crucial in the global strategy of malaria elimination and quality assurance of available products is a public health priority.

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.

Automation of cellular therapy product manufacturing: results of a split validation comparing CD34 selection of peripheral blood stem cell apheresis product with a semi-manual vs. an automatic procedure.

Science.gov (United States)

Hümmer, Christiane; Poppe, Carolin; Bunos, Milica; Stock, Belinda; Wingenfeld, Eva; Huppert, Volker; Stuth, Juliane; Reck, Kristina; Essl, Mike; Seifried, Erhard; Bonig, Halvard

2016-03-16

Automation of cell therapy manufacturing promises higher productivity of cell factories, more economical use of highly-trained (and costly) manufacturing staff, facilitation of processes requiring manufacturing steps at inconvenient hours, improved consistency of processing steps and other benefits. One of the most broadly disseminated engineered cell therapy products is immunomagnetically selected CD34+ hematopoietic "stem" cells (HSCs). As the clinical GMP-compliant automat CliniMACS Prodigy is being programmed to perform ever more complex sequential manufacturing steps, we developed a CD34+ selection module for comparison with the standard semi-automatic CD34 "normal scale" selection process on CliniMACS Plus, applicable for 600 × 10(6) target cells out of 60 × 10(9) total cells. Three split-validation processings with healthy donor G-CSF-mobilized apheresis products were performed; feasibility, time consumption and product quality were assessed. All processes proceeded uneventfully. Prodigy runs took about 1 h longer than CliniMACS Plus runs, albeit with markedly less hands-on operator time and therefore also suitable for less experienced operators. Recovery of target cells was the same for both technologies. Although impurities, specifically T- and B-cells, were 5 ± 1.6-fold and 4 ± 0.4-fold higher in the Prodigy products (p = ns and p = 0.013 for T and B cell depletion, respectively), T cell contents per kg of a virtual recipient receiving 4 × 10(6) CD34+ cells/kg was below 10 × 10(3)/kg even in the worst Prodigy product and thus more than fivefold below the specification of CD34+ selected mismatched-donor stem cell products. The products' theoretical clinical usability is thus confirmed. This split validation exercise of a relatively short and simple process exemplifies the potential of automatic cell manufacturing. Automation will further gain in attractiveness when applied to more complex processes, requiring frequent interventions or handling at

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

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.

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...

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.

[Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability].

Science.gov (United States)

Klug, B; Reinhardt, J; Schröder, C

2010-01-01

Advanced therapy medicinal products (ATMPs) are an innovative treatment option. To promote timely access of the innovative medicinal product and to safeguard public health, new elements have been introduced into legislation. A key element of the ATMP regulation is the requirement for long-term follow-up on safety and efficacy of patients enrolled in clinical trials with ATMPs, which is beyond the routine requirements on pharmacovigilance. For gene therapy medicinal products, a guideline on long-term follow-up, which lays down the technical requirements, is available. A further key element of the ATMP regulation is the traceability of the starting materials used to manufacture the ATMP. A common European coding system is imperative to ensure the traceability of starting materials, especially across the borders of European Member States.

Development of Extracorporeal Shock Wave Therapy for the Treatment for Ischemic Cardiovascular Diseases

Science.gov (United States)

Shimokawa, Hiroaki

Cardiovascular diseases, such as coronary artery disease and peripheral artery disease, are the major causes of death in developed countries, and the number of elderly patients has been rapidly increasing worldwide. Thus, it is crucial to develop new non-invasive therapeutic strategies for these patients. We found that a low-energy shock wave (SW) (about 10% of the energy density that is used for urolithiasis) effectively increases the expression of vascular endothelial growth factor (VEGF) in cultured endothelial cells. Subsequently, we demonstrated that extracorporeal cardiac SW therapy with low-energy SW up-regulates the expression of VEGF, enhances angiogenesis, and improves myocardial ischemia in a pig model of chronic myocardial ischemia without any adverse effects in vivo. Based on these promising results in animal studies, we have subsequently developed a new, non-invasive angiogenic therapy with low-energy SW for cardiovascular diseases. Our extracorporeal cardiac SW therapy improved symptoms and myocardial perfusion evaluated with stress-scintigraphy in patients with severe coronary artery disease without indication of percutaneous coronary intervention or coronary artery bypass surgery. Importantly, no procedural complications or adverse effects were noted. The SW therapy was also effective in ameliorating left ventricular remodeling after acute myocardial infarction in pigs and in enhancing angiogenesis in hindlimb ischemia in animals and patients with coronary artery disease. Furthermore, our recent experimental studies suggest that the SW therapy is also effective for indications other than cardiovascular diseases. Thus, our extracorporeal cardiac SW therapy is an effective, safe, and non-invasive angiogenic strategy for cardiovascular medicine.

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...

The physical therapy profile questionnaire (PTPQ): development, validation and pilot testing.

Science.gov (United States)

Dizon, Janine Margarita R; Grimmer-Somers, Karen; Kumar, Saravana

2011-09-19

Country by country similarities and differences in physical therapy practice exists. Therefore, before updates in practice can be provided, such as trainings in evidence-based practice, it is necessary to identify the profile and nature of practice in a given country or setting. Following a search of the international literature, no appropriate tool was identified to collect and establish data to create the profile of physical therapy practice in the Philippines. We therefore developed, validated and pilot tested a survey instrument which would comprehensively describe the practice of physical therapy in the Philippines We used a mixed methods design to answer our study aims. A focus group interview was conducted among a group of physical therapists to establish the content and contexts of items to be included in the survey instrument. Findings were amalgamated with the information from the literature on developing survey instruments/questionnaires. A survey instrument was drafted and named as the Physical Therapy Profile Questionnaire (PTPQ). The PTPQ was then validated and pilot tested to a different group of physical therapists.The final version consisted of five separate parts namely (A) General information and demographics, (B) Practice Profile, (C) Treatment Preferences, (D) Bases for clinical work and (E) Bases for educational/research work. At present the PTPQ is relevant to the Philippines and could be used by any country which has a similar nature of practice with the Philippines. The Physical Therapy Practice Questionnaire (PTPQ) was shown to have good face and content validity among the Filipino physical therapists and their context of practice. It has also been found to be useful, easy to administer tool and in a format appealing to respondents. The PTPQ is expected to assist comprehensive data collection to create a profile of physical therapy practice in the Philippines.

The physical therapy profile questionnaire (PTPQ: development, validation and pilot testing

Directory of Open Access Journals (Sweden)

Grimmer-Somers Karen

2011-09-01

Full Text Available Abstract Background Country by country similarities and differences in physical therapy practice exists. Therefore, before updates in practice can be provided, such as trainings in evidence-based practice, it is necessary to identify the profile and nature of practice in a given country or setting. Following a search of the international literature, no appropriate tool was identified to collect and establish data to create the profile of physical therapy practice in the Philippines. We therefore developed, validated and pilot tested a survey instrument which would comprehensively describe the practice of physical therapy in the Philippines Findings We used a mixed methods design to answer our study aims. A focus group interview was conducted among a group of physical therapists to establish the content and contexts of items to be included in the survey instrument. Findings were amalgamated with the information from the literature on developing survey instruments/questionnaires. A survey instrument was drafted and named as the Physical Therapy Profile Questionnaire (PTPQ. The PTPQ was then validated and pilot tested to a different group of physical therapists. The final version consisted of five separate parts namely (A General information and demographics, (B Practice Profile, (C Treatment Preferences, (D Bases for clinical work and (E Bases for educational/research work. At present the PTPQ is relevant to the Philippines and could be used by any country which has a similar nature of practice with the Philippines. Conclusion The Physical Therapy Practice Questionnaire (PTPQ was shown to have good face and content validity among the Filipino physical therapists and their context of practice. It has also been found to be useful, easy to administer tool and in a format appealing to respondents. The PTPQ is expected to assist comprehensive data collection to create a profile of physical therapy practice in the Philippines.

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

Toward precision manufacturing of immunogene T-cell therapies.

Science.gov (United States)

Xu, Jun; Melenhorst, J Joseph; Fraietta, Joseph A

2018-05-01

Cancer can be effectively targeted using a patient's own T cells equipped with synthetic receptors, including chimeric antigen receptors (CARs) that redirect and reprogram these lymphocytes to mediate tumor rejection. Over the past two decades, several strategies to manufacture genetically engineered T cells have been proposed, with the goal of generating optimally functional cellular products for adoptive transfer. Based on this work, protocols for manufacturing clinical-grade CAR T cells have been established, but these complex methods have been used to treat only a few hundred individuals. As CAR T-cell therapy progresses into later-phase clinical trials and becomes an option for more patients, a major consideration for academic institutions and industry is developing robust manufacturing processes that will permit scaling-out production of immunogene T-cell therapies in a reproducible and efficient manner. In this review, we will discuss the steps involved in cell processing, the major obstacles surrounding T-cell manufacturing platforms and the approaches for improving cellular product potency. Finally, we will address the challenges of expanding CAR T-cell therapy to a global patient population. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

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...

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study

Science.gov (United States)

2010-01-01

Background Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. Methods A total of 18 children aged 3.5 to 6 years with delayed speech development took part in this observational study in which music therapy and no treatment were compared to demonstrate effectiveness. Individual music therapy was provided on an outpatient basis. An ABAB reversal design with alternations between music therapy and no treatment with an interval of approximately eight weeks between the blocks was chosen. Before and after each study period, a speech development test, a non-verbal intelligence test for children, and music therapy assessment scales were used to evaluate the speech development of the children. Results Compared to the baseline, we found a positive development in the study group after receiving music therapy. Both phonological capacity and the children's understanding of speech increased under treatment, as well as their cognitive structures, action patterns, and level of intelligence. Throughout the study period, developmental age converged with their biological age. Ratings according to the Nordoff-Robbins scales showed clinically significant changes in the children, namely in the areas of client-therapist relationship and communication. Conclusions This study suggests that music therapy may have a measurable effect on the speech development of children through the treatment's interactions with fundamental aspects of speech development, including the ability to form and maintain relationships and prosodic abilities. Thus, music therapy may provide a basic and supportive therapy for

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study

Directory of Open Access Journals (Sweden)

Linden Ulrike

2010-07-01

Full Text Available Abstract Background Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. Methods A total of 18 children aged 3.5 to 6 years with delayed speech development took part in this observational study in which music therapy and no treatment were compared to demonstrate effectiveness. Individual music therapy was provided on an outpatient basis. An ABAB reversal design with alternations between music therapy and no treatment with an interval of approximately eight weeks between the blocks was chosen. Before and after each study period, a speech development test, a non-verbal intelligence test for children, and music therapy assessment scales were used to evaluate the speech development of the children. Results Compared to the baseline, we found a positive development in the study group after receiving music therapy. Both phonological capacity and the children's understanding of speech increased under treatment, as well as their cognitive structures, action patterns, and level of intelligence. Throughout the study period, developmental age converged with their biological age. Ratings according to the Nordoff-Robbins scales showed clinically significant changes in the children, namely in the areas of client-therapist relationship and communication. Conclusions This study suggests that music therapy may have a measurable effect on the speech development of children through the treatment's interactions with fundamental aspects of speech development, including the ability to form and maintain relationships and prosodic abilities. Thus, music therapy may provide a basic

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study.

Science.gov (United States)

Gross, Wibke; Linden, Ulrike; Ostermann, Thomas

2010-07-21

Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. A total of 18 children aged 3.5 to 6 years with delayed speech development took part in this observational study in which music therapy and no treatment were compared to demonstrate effectiveness. Individual music therapy was provided on an outpatient basis. An ABAB reversal design with alternations between music therapy and no treatment with an interval of approximately eight weeks between the blocks was chosen. Before and after each study period, a speech development test, a non-verbal intelligence test for children, and music therapy assessment scales were used to evaluate the speech development of the children. Compared to the baseline, we found a positive development in the study group after receiving music therapy. Both phonological capacity and the children's understanding of speech increased under treatment, as well as their cognitive structures, action patterns, and level of intelligence. Throughout the study period, developmental age converged with their biological age. Ratings according to the Nordoff-Robbins scales showed clinically significant changes in the children, namely in the areas of client-therapist relationship and communication. This study suggests that music therapy may have a measurable effect on the speech development of children through the treatment's interactions with fundamental aspects of speech development, including the ability to form and maintain relationships and prosodic abilities. Thus, music therapy may provide a basic and supportive therapy for children with delayed speech development

Diabetic Macular Edema: Current Understanding, Pharmacologic Treatment Options, and Developing Therapies.

Science.gov (United States)

Miller, Kevin; Fortun, Jorge A

2018-01-01

Diabetic retinopathy and diabetic macular edema comprise a major source of visual disability throughout the developed world. The etiology and pathogenesis of macular edema is intricate and multifactorial, in which the hyperglycemic state in diabetes induces a microangiopathy. Through several inflammatory and vasogenic mediators, including vascular endothelial growth factor (VEGF) upregulation and inflammatory cytokines and chemokines, pathologic changes are induced in the vascular endothelium triggering breakdown of the blood retinal barrier, causing extravasation of fluid into the extracellular space and manifesting clinically as macular edema, resulting in visual loss. The advent of medications targeting the VEGF pathway has led to great clinical improvements compared with the previous standard of care of laser therapy alone, as shown in studies such as RISE, RIDE, VIVID, VISTA, and DRCR. However, analyses have shown that many patients have inadequate response or are nonresponders to anti-VEGF therapy, demonstrating the need for additional therapies to more comprehensively treat this disease. Although corticosteroid treatments and implants have demonstrated some efficacy in adjunctive and supplemental treatment, the need to more adequately treat macular edema remains. Our knowledge of diabetic macular edema continues to grow, leading to new currently available and emerging pharmacotherapies to further enhance our treatment and restore vision in those affected by diabetic macular edema. This review will discuss the pathogenesis of diabetic macular edema and the pharmacologic therapies available for its treatment, including anti-VEGF, steroids, and newer therapies still in development, such as angiopoietin antagonists, Tie2 agonists, kallikrein inhibitors, interleukin inhibitors, and others. Copyright 2018 Asia-Pacific Academy of Ophthalmology.

ALS Biomarkers for Therapy Development: State of the Field & Future Directions

Science.gov (United States)

Benatar, Michael; Boylan, Kevin; Jeromin, Andreas; Rutkove, Seward B.; Berry, James; Atassi, Nazem; Bruijn, Lucie

2015-01-01

Biomarkers have become the focus of intense research in the field of amyotrophic lateral sclerosis (ALS), with the hope that they might aid therapy development efforts. Notwithstanding the discovery of many candidate biomarkers, none have yet emerged as validated tools for drug development. In this review we present a nuanced view of biomarkers based on the perspective of the FDA; highlight the distinction between discovery and validation; describe existing and emerging resources; review leading biological fluid-based, electrophysiological and neuroimaging candidates relevant to therapy development efforts; discuss lessons learned from biomarker initiatives in related neurodegenerative diseases; and outline specific steps that we, as a field, might take in order to hasten the development and validation of biomarkers that will prove useful in enhancing efforts to develop effective treatments for ALS patients. Most important among these perhaps is the proposal to establish a federated ALS Biomarker Consortium (ABC) in which all interested and willing stakeholders may participate with equal opportunity to contribute to the broader mission of biomarker development and validation. PMID:26574709

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...

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....

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.

Development of a Beam Trajectory Monitoring System Using e+/e- Pair Production Events

Science.gov (United States)

Kimura, Shota; Emoto, Yusaku; Fujihara, Kento; Ito, Hiroshi; Kawai, Hideyuki; Kobayashi, Atsushi; Mizuno, Takahiro

2018-01-01

In particle therapy, it is important to monitor the Bragg-peak position. It was simulated by GEANT4 Monte Carlo Simulation Code that the distribution of secondary generated gamma rays on the carbon beam therapy and the proton beam therapy. This simulation shows that gamma rays whose energy is 10 MeV or more are intensively generated at the Bragg-peak position. We are developing the system to monitor the Bragg-peak position which can measure pair production events occurred in the detector by gamma rays from irradiation points. The momentum direction of the gamma ray can be determined by measuring passing points and energy of e+ and e- generated by pair production. This system has 5 parts. The first is the conversion part. This part consists of several layers. Each layer is composed of a La-GPS ((Gd0.75La0.24Ce0.01)2Si2O7) scintillator plate and wavelength-shifting fibre (WLSF) sheets. The scintillator plate is sandwiched between sheets, where the directions of the sheets are in orthogonally x and y directions. In this part, gamma rays are converted to e+ e- pairs and the position where the conversion occured is determined. The second is the tracking part. This part consists of 2 layers of scintillating fibre tracker. Each layer has 6 scintillating fibre sheets for x, x', u, u', v, and v'. The third is the energy measurement part. It measures the energy of e+ and e- by scintillator array and Silicon Photomultipliers. The fourth is the veto counter for bremsstrahlung gamma rays from e+ and e-. The fifth is the beam monitor. By experiment, the number of photoelectrons of La-GPS with a WLSF (B-3(300)MJ, Kuraray) sheet and scintillating fibre (SCSF-78, Kuraray) when charged particle passed was measured as 9.7 and 7.6 respectively.

Development of a Beam Trajectory Monitoring System Using e+/e− Pair Production Events

Directory of Open Access Journals (Sweden)

KIMURA Shota

2018-01-01

Full Text Available In particle therapy, it is important to monitor the Bragg-peak position. It was simulated by GEANT4 Monte Carlo Simulation Code that the distribution of secondary generated gamma rays on the carbon beam therapy and the proton beam therapy. This simulation shows that gamma rays whose energy is 10 MeV or more are intensively generated at the Bragg-peak position. We are developing the system to monitor the Bragg-peak position which can measure pair production events occurred in the detector by gamma rays from irradiation points. The momentum direction of the gamma ray can be determined by measuring passing points and energy of e+ and e− generated by pair production. This system has 5 parts. The first is the conversion part. This part consists of several layers. Each layer is composed of a La-GPS ((Gd0.75La0.24Ce0.012Si2O7 scintillator plate and wavelength-shifting fibre (WLSF sheets. The scintillator plate is sandwiched between sheets, where the directions of the sheets are in orthogonally x and y directions. In this part, gamma rays are converted to e+ e- pairs and the position where the conversion occured is determined. The second is the tracking part. This part consists of 2 layers of scintillating fibre tracker. Each layer has 6 scintillating fibre sheets for x, x’, u, u’, v, and v’. The third is the energy measurement part. It measures the energy of e+ and e− by scintillator array and Silicon Photomultipliers. The fourth is the veto counter for bremsstrahlung gamma rays from e+ and e-. The fifth is the beam monitor. By experiment, the number of photoelectrons of La-GPS with a WLSF (B-3(300MJ, Kuraray sheet and scintillating fibre (SCSF-78, Kuraray when charged particle passed was measured as 9.7 and 7.6 respectively.

Developing antigen-specific therapies in multiple sclerosis: a tale of Tantalus or Ulysses?

Science.gov (United States)

van Noort JM

1999-10-01

Autoreactive T-cell responses directed to myelin proteins in the central nervous system are widely believed to be crucial in the pathology of multiple sclerosis (MS). However, effective ways of selectively targeting these T-cells in order to alter the clinical course of MS in a predictable manner has yet to be demonstrated. This review discusses two recent developments of crucial importance to the rational development of antigen-specific therapy in MS. The very idea of antigen-specific therapy in MS has long faced the challenge of determinant spreading, i.e., the development of novel autoimmune responses as the consequence of tissue damage. This phenomenon has led many to expect that in ongoing MS, many different pathogenic specificities would accumulate. Obviously, this would render antigen-specific therapy very difficult. Recent data now suggest that determinant spreading is most likely to be a transient phenomenon limited only to the first stages of tissue damage. A second development has changed our perspective on the specificity of individual T-cells and, thus, on the suitability of various ways to implement antigen-specific therapy. Evidence is rapidly accumulating that T-cell receptors are much more cross-reactive than previously assumed. This notion poses unexpected challenges to therapeutic approaches in MS that are based on selective targeting of autoreactive TCR. Vaccination with TCR peptides, administration of anti-TCR antibodies and development of therapeutically altered peptide ligands all depend on a significant level of predictability of pathogenic TCR. With such predictability now turning out to be much lower than was previously hoped, selective TCR-directed strategies for intervention may therefore turn out to be much less effective than anticipated. In the development of antigen-specific therapies, the use of whole protein tolerogens now seems to be the most promising route. Oral, intranasal or iv. administration of antigen remain viable options

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.

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...

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...

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...

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.

Guidelines for Bacteriophage Product Certification.

Science.gov (United States)

Fauconnier, Alan

2018-01-01

Following decades in the wilderness, bacteriophage therapy is now appearing as a credible antimicrobial strategy. However, this reemerging therapy does not rekindle without raising sensitive regulatory concerns. Indeed, whereas the European regulatory framework has been basically implemented to tackle ready-to-use pharmaceuticals produced on a large scale, bacteriophage therapy relies on a dynamic approach requiring a regulation on personalized medicine, nonexistent at present. Because of this, no guideline are currently available for addressing the scientific and regulatory issues specifically related to phage therapy medicinal products (PTMP).Pending to the implementation of an appropriate regulatory framework and to the development of ensuing guidelines, several avenues which might lead to PTMP regulatory compliance are explored here. Insights might come from the multi-strain dossier approach set up for particular animal vaccines, from the homologous group concept developed for the allergen products or from the licensing process for veterinary autogenous vaccines. Depending on national legislations, customized preparations prescribed as magistral formulas or to be used on a named-patient basis are possible regulatory approaches to be considered. However, these schemes are not optimal and should thus be regarded as transitional.

Musicoterapia institucional na saúde do trabalhador: conexões, interfaces e produções Institutional music therapy in workers' health: connections, interfaces and production

Directory of Open Access Journals (Sweden)

Laize Guazina

2009-04-01

Full Text Available Este trabalho propõe e analisa a Musicoterapia como estratégia de produção de saúde do trabalhador, em estudo desenvolvido junto a profissionais técnicas de enfermagem de uma Unidade de Terapia Intensiva infantil de um hospital público da cidade de Porto Alegre. A atenção à saúde dos trabalhadores produz novas questões teórico-conceituais, práticas, éticas e políticas no campo da Musicoterapia, ligadas ao território do trabalho e suas configurações contemporâneas, ao "ser" trabalhador e à saúde, e que têm implicações sobre a Musicoterapia e o musicoterapeuta na contemporaneidade. À luz das contribuições de Foucault, este trabalho centraliza-se na discussão do hospital como território de produção de subjetividades, a partir do desenvolvimento do conceito de 'Panáudio', mapeando e analisando efeitos deste dispositivo, que se efetivam pelos contextos sonoros. Aponta controles e resistências possíveis e propõe a produção de novas subjetividades pelo uso das práticas musicais em Musicoterapia em uma proposta de abordagem institucional.This paper proposes and analyzes Music Therapy as a production strategy towards workers' health in a study developed with nurse technicians from a Children's Intensive Care Center of a public hospital in Porto Alegre. The concern with workers' health brings about new theoretical, conceptual, ethical and political queries in the field of Music Therapy, such queries are related with the working field and its contemporary features, with the working being and with health; these queries produce consequences on Music Therapy and Music therapists contemporarily. Based on Foucault's contributions, this paper focuses on the discussion about hospitals being a field for subjectivities production, from the development of the 'Panaudio' concept, mapping and analyzing its effects, which are effective by sound contexts. This paper also points out possible controls and resistances and proposes the

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

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. 

Greater loss of productivity among Japanese workers with gastro-esophageal reflux disease (GERD) symptoms that persist vs resolve on medical therapy.

Science.gov (United States)

Suzuki, H; Matsuzaki, J; Masaoka, T; Inadomi, J M

2014-06-01

Gastro-esophageal reflux disease (GERD) impairs quality of life; however, the association between GERD and work productivity has not been well investigated in Japan. This study was designed to compare the impact of GERD on productivity between Japanese workers with GERD symptoms that persisted vs resolved on medical therapy. A cross-sectional Web-based survey was conducted in workers. The impact of GERD on work and daily productivity was evaluated using a Web-reported Work Productivity and Activity Impairment Questionnaire for patients with GERD and a GERD symptom severity Questionnaire. Demographic information, clinical history, and satisfaction with GERD medication were also ascertained. A total of 20 000 subjects were invited to the survey. After the exclusion of patients with a history of gastrointestinal (GI) malignancy, peptic ulcer, upper GI surgery, and unemployment, 650 participants were included in the analysis. Participants with persistent GERD symptoms reported a significantly greater losses of work productivity (11.4 ± 13.4 h/week), absenteeism (0.7 ± 3.1 h/week), presenteeism (10.7 ± 12.6 h/week), costs (20 100 ± 26 800 JPY/week), and lower daily productivity (71.3% [95% confidence interval, 69.0-73.7]) than those whose symptoms were alleviated with medications. The level of dissatisfaction with GERD medications among participants with persistent GERD symptoms was significantly correlated with loss of work and daily productivity (p < 0.001). GERD places a significant burden on work and daily productivity despite medical therapy. Ineffective GERD therapy is associated with greater productivity loss. © 2014 John Wiley & Sons Ltd.

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.

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...

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...

A patient with squamous cell carcinoma developing as a secondary cancer after radiation therapy and carbon dioxide snow-freezing therapy

International Nuclear Information System (INIS)

Yoshida, Akihiro; Miki, Hirotoshi; Yokoyama, Toshiya; Katori, Nobutada

2004-01-01

We report on a 59-year-old male who developed skin cancer many years after receiving radiation therapy and carbon dioxide snow-freezing therapy. About 50 years ago, the patient underwent radiation therapy and carbon dioxide snow-freezing therapy for nevus of the Ota of the left buccal region, the orbital region, and the forehead (fractional dose and total dose unknown). About 6 months prior to evaluation at this hospital, the patient noted tumor growth on the skin in the areas previously treated, and protruding lesions were observed on the left buccal region, the orbital region, and the forehead. Histopathological examination showed squamous cell carcinoma. At surgery, protruding lesions and scar tissue were completely excised, and split-thickness skin graft was used in the areas of skin loss. After 2 years of follow-up, no local recurrence or metastasis has been observed. (author)

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.

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

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...

Enhancing the Pediatric Drug Development Framework to Deliver Better Pediatric Therapies Tomorrow.

Science.gov (United States)

Bucci-Rechtweg, Christina

2017-10-01

Health care professionals involved in the clinical management of children have long appreciated the limited number of therapies suitably evaluated for their optimal use in the pediatric population. In the past century, advances in regulatory policy significantly evolved adult drug evaluation. The scarcity of available patient populations, practical complexities of drug development research, and minimal financial returns have hampered pharmaceutical investment in the study of therapies for children. More recently, pediatric policy and legislation in the United States and Europe have instituted a system of obligations and incentives to stimulate investment in pediatric drug development. These initiatives, in conjunction with a more sophisticated process of drug discovery and development, have led to significant advancements in the labeling of drugs for pediatric use. Facilitated by the emergence of new targets, precision medicine, and innovations in regulatory science, there is now a subtle shift in focus toward drug development research for children rather than simply in children. Although there has been an increase in pediatric studies of investigational agents and labeling of pediatric information for use, there have been unintended consequences of existing policies. As a result, limited progress has been made in certain therapeutic areas and for off-patent therapies. Future policy reform to enhance the availability and accessibility of pediatric medicines should not only reflect an understanding not only of the successes of existing policy and legislative initiatives but also constructively address failures and unintended consequences. Taken together, policy reform, global cooperation, and innovation in regulatory science will more ably deliver better pediatric therapies tomorrow. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

The advanced therapy classification procedure. Overview of experience gained so far.

Science.gov (United States)

Voltz-Girolt, C; Celis, P; Boucaumont, M; D'Apote, L; Pinheiro, M-H; Papaluca-Amati, M

2011-07-01

The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs. This procedure gives companies the opportunity to verify whether or not the product they are developing can be considered an ATMP and can therefore benefit from the new regulatory pathway introduced in the European Union for these types of medicinal products. This procedure is optional, free of charge and may take place at any stage of the development of an ATMP in advance of applying for a marketing authorisation. In case of doubt, briefing meetings organised by the European Medicines Agency Innovation Task Force may help preparing for an ATMP classification and are a starting point for the interactions between the Agency and the developers of ATMPs. This article reviews the advantages of the classification procedure for both the developers of ATMPs and the European regulatory network. Since the introduction of this procedure and up to 10 November 2010, the Committee for Advanced Therapies (CAT) has finalised 38 applications for classification.

Development of Personalized Cancer Therapy for Men with Advanced Prostate Cancer

Science.gov (United States)

2017-10-01

of this study is to develop a strategy to identify molecular markers of response of advanced prostate cancer to specific therapies using clinically...combination treatment strategies are urgently needed. The purpose of this study is to develop a strategy for identifying molecular markers of response of...PENDING) Level of Funding: $125,978 annual direct Project Goals: To develop a strategy for identifying molecular therapeutic response markers of

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...

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.

Development of light ion therapy at the Karolinska Hospital and Institute.

Science.gov (United States)

Svensson, Hans; Ringborg, Ulrik; Näslund, Ingemar; Brahme, Anders

2004-12-01

Recent developments in radiation therapy have made it possible to optimize the high dose region to cover almost any target volume and shape at the same time as the dose level to adjacent organs at risk is acceptable. Further implementations of IMRT (Intensity Modulated Radiation Therapy), and inverse treatment planning using already available technologies but also foreseeable improved design of therapy accelerators delivering electron- and photon beams, will bring these advances to the benefit of a broad population of cancer patients. Protons will therefore generally not be needed since in most situations the improvement will be insignificant or moderate due to the large lateral penumbra with deep proton therapy. A further step would be to use He-ions, which have only half the penumbra width of protons and still a fairly low-LET in the spread-out Bragg peak. There is however still a group of patients that cannot be helped by these advances as the tumor might be radioresistant for the presently utilized low ionization density beam qualities. The ultimate step in the therapy development process should therefore be to optimize the beam quality for each tumor-normal tissue situation. To facilitate beam quality optimization light ions are needed. It is argued that in many radioresistant tumors a dose-mean LET of 25-50 eV/nm in the target would be optimum as then tumor cells will be lost in the highest proportion through apoptotic cell kill and the superficial tissues will still be irradiated with a fairly low LET. Light ions using Li, Be, B, and C would then be the ideal choice. In this paper a light ion facility is outlined for the Karolinska University Hospital facilitating both dose distribution and beam quality optimization.

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....

The development of molecularly targeted anticancer therapies: an Eli Lilly and Company perspective.

Science.gov (United States)

Perry, William L; Weitzman, Aaron

2005-03-01

The ability to identify activated pathways that drive the growth and progression of cancer and to develop specific and potent inhibitors of key proteins in these pathways promises to dramatically change the treatment of cancer: A patient's cancer could be characterized at the molecular level and the information used to select the best treatment options. The development of successful therapies not only requires extensive target validation, but also new approaches to evaluating drug efficacy in animal models and in the clinic compared to the development of traditional cytotoxic agents. This article highlights Eli Lilly and Company's approach to developing targeted therapies, from target identification and validation through evaluation in the clinic. A selection of drugs in the Lilly Oncology pipeline is also discussed.

Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

Science.gov (United States)

Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

2010-01-01

The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

The development of CAR design for tumor CAR-T cell therapy.

Science.gov (United States)

Xu, Dandan; Jin, Guoliang; Chai, Dafei; Zhou, Xiaowan; Gu, Weiyu; Chong, Yanyun; Song, Jingyuan; Zheng, Junnian

2018-03-02

In recent years, the chimeric antigen receptor modified T cells (Chimeric antigen receptor T cells, CAR-T) immunotherapy has developed rapidly, which has been considered the most promising therapy. Efforts to enhance the efficacy of CAR-based anti-tumor therapy have been made, such as the improvement of structures of CAR-T cells, including the development of extracellular antigen recognition receptors, intracellular co-stimulatory molecules and the combination application of CARs and synthetic small molecules. In addition, effects on the function of the CAR-T cells that the space distance between the antigen binding domains and tumor targets and the length of the spacer domains have are also being investigated. Given the fast-moving nature of this field, it is necessary to make a summary of the development of CAR-T cells. In this review, we mainly focus on the present design strategies of CAR-T cells with the hope that they can provide insights to increase the anti-tumor efficacy and safety.

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,…

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.

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.

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

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

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....

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.

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.

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

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).

Progress toward Gene Therapy for Duchenne Muscular Dystrophy.

Science.gov (United States)

Chamberlain, Joel R; Chamberlain, Jeffrey S

2017-05-03

Duchenne muscular dystrophy (DMD) has been a major target for gene therapy development for nearly 30 years. DMD is among the most common genetic diseases, and isolation of the defective gene (DMD, or dystrophin) was a landmark discovery, as it was the first time a human disease gene had been cloned without knowledge of the protein product. Despite tremendous obstacles, including the enormous size of the gene and the large volume of muscle tissue in the human body, efforts to devise a treatment based on gene replacement have advanced steadily through the combined efforts of dozens of labs and patient advocacy groups. Progress in the development of DMD gene therapy has been well documented in Molecular Therapy over the past 20 years and will be reviewed here to highlight prospects for success in the imminent human clinical trials planned by several groups. Copyright © 2017 The American Society of Gene and Cell Therapy. Published by Elsevier Inc. All rights reserved.

Development of gene therapy: potential in severe combined immunodeficiency due to adenosine deaminase deficiency

Directory of Open Access Journals (Sweden)

Claudia A Montiel-Equihua

2009-12-01

Full Text Available Claudia A Montiel-Equihua, Adrian J Thrasher, H Bobby GasparCentre for Immunodeficiency, Molecular Immunology Unit, UCL Institute of Child Health, London, UKAbstract: The history of stem cell gene therapy is strongly linked to the development of gene therapy for severe combined immunodeficiencies (SCID and especially adenosine deaminase (ADA-deficient SCID. Here we discuss the developments achieved in over two decades of clinical and laboratory research that led to the establishment of a protocol for the autologous transplant of retroviral vector-mediated gene-modified hematopoietic stem cells, which has proved to be both successful and, to date, safe. Patients in trials in three different countries have shown long-term immunological and metabolic correction. Nevertheless, improvements to the safety profile of viral vectors are underway and will undoubtedly reinforce the position of stem cell gene therapy as a treatment option for ADA-SCID.Keywords: adenosine deaminase, severe combined immunodeficiency, gene therapy, hematopoietic stem cell, retrovirus, clinical trial

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...

Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale.

Science.gov (United States)

Kaiser, Karen; Beaumont, Jennifer L; Webster, Kimberly; Yount, Susan E; Wagner, Lynne I; Kuzel, Timothy M; Cella, David

2015-05-01

The Functional Assessment of Cancer Therapy (FACT)-Antiangiogenesis (AntiA) Subscale was developed and validated to enhance treatment decision-making and side effect management for patients receiving anti-angiogenesis therapies. Side effects related to anti-angiogenesis therapies were identified from the literature, clinician input, and patient input. Fifty-nine possible patient expressions of side effects were generated. Patient and clinician ratings of the importance of these expressions led us to develop a 24-item questionnaire with clinical and research potential. To assess the scale's reliability and validity, 167 patients completed the AntiA Subscale, the Functional Assessment of Cancer Therapy-general (FACT-G), the FACT-Kidney Symptom Index (FKSI), the FACIT-Fatigue Subscale, the Global Rating of Change Scale (GRC), and the PROMIS Global Health Scale. Patient responses to the AntiA were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. All tested scales were found to have good internal consistency reliability (Cronbach's alpha 0.70-0.92). Test-retest reliability was also good (0.72-0.88) for total and subscale scores and lower for individual items. The total score, subscale scores, and all single items (except nosebleeds) significantly differentiated between groups defined by level of side effect bother. Evaluation of responsiveness to change in this study was not conclusive, suggesting an area for further research. The AntiA is a reliable and valid measure of side effects from anti-angiogenesis therapy. © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

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

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.

Gene and cell therapy for children--new medicines, new challenges?

Science.gov (United States)

Buckland, Karen F; Bobby Gaspar, H

2014-06-01

The range of possible gene and cell therapy applications is expanding at an extremely rapid rate and advanced therapy medicinal products (ATMPs) are currently the hottest topic in novel medicines, particularly for inherited diseases. Paediatric patients stand to gain enormously from these novel therapies as it now seems plausible to develop a gene or cell therapy for a vast number of inherited diseases. There are a wide variety of potential gene and cell therapies in various stages of development. Patients who received first gene therapy treatments for primary immune deficiencies (PIDs) are reaching 10 and 15 years post-treatment, with robust and sustained immune recovery. Cell therapy clinical trials are underway for a variety of tissues including corneal, retinal and muscle repair and islet cell transplantation. Various cell therapy approaches are also being trialled to enhance the safety of bone marrow transplants, which should improve survival rates in childhood cancers and PIDs. Progress in genetic engineering of lymphocyte populations to target and kill cancerous cells is also described. If successful these ATMPs may enhance or replace the existing chemo-ablative therapy for several paediatric cancers. Emerging applications of gene therapy now include skin and neurological disorders such as epidermolysis bullosa, epilepsy and leukodystrophy. Gene therapy trials for haemophilia, muscular dystrophy and a range of metabolic disorders are underway. There is a vast array of potential advanced therapy medicinal products (ATMPs), and these are likely to be more cost effective than existing medicines. However, the first clinical trials have not been without setbacks and some of the key adverse events are discussed. Furthermore, the arrival of this novel class of therapies brings many new challenges for the healthcare industry. We present a summary of the key non-clinical factors required for successful delivery of these potential treatments. Technological advances

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…

Development of a Hospital-based Massage Therapy Course at an Academic Medical Center.

Science.gov (United States)

Dion, Liza J; Cutshall, Susanne M; Rodgers, Nancy J; Hauschulz, Jennifer L; Dreyer, Nikol E; Thomley, Barbara S; Bauer, Brent

2015-03-01

Massage therapy is offered increasingly in US medical facilities. Although the United States has many massage schools, their education differs, along with licensure and standards. As massage therapy in hospitals expands and proves its value, massage therapists need increased training and skills in working with patients who have various complex medical concerns, to provide safe and effective treatment. These services for hospitalized patients can impact patient experience substantially and provide additional treatment options for pain and anxiety, among other symptoms. The present article summarizes the initial development and description of a hospital-based massage therapy course at a Midwest medical center. A hospital-based massage therapy course was developed on the basis of clinical experience and knowledge from massage therapists working in the complex medical environment. This massage therapy course had three components in its educational experience: online learning, classroom study, and a 25-hr shadowing experience. The in-classroom study portion included an entire day in the simulation center. The hospital-based massage therapy course addressed the educational needs of therapists transitioning to work with interdisciplinary medical teams and with patients who have complicated medical conditions. Feedback from students in the course indicated key learning opportunities and additional content that are needed to address the knowledge and skills necessary when providing massage therapy in a complex medical environment. The complexity of care in medical settings is increasing while the length of hospital stay is decreasing. For this reason, massage provided in the hospital requires more specialized training to work in these environments. This course provides an example initial step in how to address some of the educational needs of therapists who are transitioning to working in the complex medical environment.

Using Typical Infant Development to Inform Music Therapy with Children with Disabilities

Science.gov (United States)

Wheeler, Barbara L.; Stultz, Sylvia

2008-01-01

This article illustrates some ways in which observations of typically-developing infants can inform music therapy and other work with children with disabilities. The research project that is described examines typical infant development with special attention to musical relatedness and communication. Videotapes of sessions centering on musical…

Molecular insights of Gas6/TAM in cancer development and therapy.

Science.gov (United States)

Wu, Guiling; Ma, Zhiqiang; Hu, Wei; Wang, Dongjin; Gong, Bing; Fan, Chongxi; Jiang, Shuai; Li, Tian; Gao, Jianyuan; Yang, Yang

2017-03-23

Since growth arrest-specific gene 6 (Gas6) was discovered in 1988, numerous studies have highlighted the role of the Gas6 protein and its receptors Tyro3, Axl and Mer (collectively referred to as TAM), in proliferation, apoptosis, efferocytosis, leukocyte migration, sequestration and platelet aggregation. Gas6 has a critical role in the development of multiple types of cancers, including pancreatic, prostate, oral, ovarian and renal cancers. Acute myelocytic leukaemia (AML) is a Gas6-dependent cancer, and Gas6 expression predicts poor prognosis in AML. Interestingly, Gas6 also has a role in establishing tumour dormancy in the bone marrow microenvironment and in suppressing intestinal tumorigenesis. Numerous studies regarding cancer therapy have targeted Gas6 and TAM receptors with good results. However, some findings have suggested that Gas6 is associated with the development of resistance to cancer therapies. Concerning these significant effects of Gas6 in numerous cancers, we discuss the roles of Gas6 in cancer development in this review. First, we introduce basic knowledge on Gas6 and TAM receptors. Next, we describe and discuss the involvement of Gas6 and TAM receptors in cancers from different organ systems. Finally, we highlight the progress in therapies targeting Gas6 and TAM receptors. This review presents the significant roles of Gas6 in cancers from different systems and may contribute to the continued promotion of Gas6 as a therapeutic target.

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...

Optimizing antiretroviral product selection: a sample approach to improving patient outcomes, saving money, and scaling-up health services in developing countries.

Science.gov (United States)

Amole, Carolyn D; Brisebois, Catherine; Essajee, Shaffiq; Koehler, Erin; Levin, Andrew D; Moore, Meredith C; Brown Ripin, David H; Sickler, Joanna J; Singh, Inder R

2011-08-01

Over the last decade, increased funding to support HIV treatment programs has enabled millions of new patients in developing countries to access the medications they need. Today, although demand for antiretrovirals continues to grow, the financial crisis has severely constrained funding leaving countries with difficult choices on program prioritization. Product optimization is one solution countries can pursue to continue to improve patient care while also uncovering savings that can be used for further scale up or other health system needs. Program managers can make procurement decisions that actually reduce program costs by considering additional factors beyond World Health Organization guidelines when making procurement decisions. These include in-country product availability, convenience, price, and logistics such as supply chain implications and laboratory testing requirements. Three immediate product selection opportunities in the HIV space include using boosted atazanavir in place of lopinovir for second-line therapy, lamivudine instead of emtricitabine in both first-line and second-line therapy, and tenofovir + lamivudine over abacavir + didanosine in second-line therapy. If these 3 opportunities were broadly implemented in sub-Saharan Africa and India today, approximately $300 million of savings would be realized over the next 5 years, enabling hundreds of thousands of additional patients to be treated. Although the discussion herein is specific to antriretrovirals, the principles of product selection are generalizable to diseases with multiple treatment options and fungible commodity procurement. Identifying and implementing approaches to overcome health system inefficiencies will help sustain and may expand quality care in resource-limited settings.

Development of a music therapy assessment tool for patients in low awareness states.

Science.gov (United States)

Magee, Wendy L

2007-01-01

People in low awareness states following profound brain injury typically demonstrate subtle changes in functional behaviors which challenge the sensitivity of measurement tools. Failure to identify and measure changes in functioning can lead to misdiagnosis and withdrawal of treatment with this population. Thus, the development of tools which are sensitive to responsiveness is of central concern. As the auditory modality has been found to be particularly sensitive in identifying responses indicating awareness, a convincing case can be made for music therapy as a treatment medium. However, little has been recommended about protocols for intervention or tools for measuring patient responses within the music therapy setting. This paper presents the rationale for an assessment tool specifically designed to measure responses in the music therapy setting with patients who are diagnosed as minimally conscious or in a vegetative state. Developed over fourteen years as part of interdisciplinary assessment and treatment, the music therapy assessment tool for low awareness states (MATLAS) contains fourteen items which rate behavioral responses across a number of domains. The tool can provide important information for interdisciplinary assessment and treatment particularly in the auditory and communication domains. Recommendations are made for testing its reliability and validity through research.

The effect of beta-interferon therapy on myelin basic protein-elicited CD4+ T cell proliferation and cytokine production in multiple sclerosis

DEFF Research Database (Denmark)

Hedegaard, Chris J; Krakauer, Martin; Bendtzen, Klaus

2008-01-01

Interferon (IFN)-beta therapy has well-established clinical benefits in multiple sclerosis (MS), but the underlying modulation of cytokine responses to myelin self-antigens remains poorly understood. We analysed the CD4+ T cell proliferation and cytokine responses elicited by myelin basic protein...... (MBP) and a foreign recall antigen, tetanus toxoid (TT), in mononuclear cell cultures from fourteen MS patients undergoing IFN-beta therapy. The MBP-elicited IFN-gamma-, TNF-alpha- and IL-10 production decreased during therapy (p...

Sustainable Industrial Product Systems. Integration of Life Cycle Assessment in Product development and Optimization of Product Systems

Energy Technology Data Exchange (ETDEWEB)

Hanssen, Ole Joergen

1997-12-31

This thesis contributes to the development and testing of environmental life cycle assessment (LCA) in product development and management in industry. It is based on systems theory and systems engineering. It develops a method for sustainable product development that has been successfully tested in the Nordic project called NEP. The LCA method is also a basis for an optimization model, where life cycle economy and environmental impacts from product systems are optimized with a non-linear model. A more complete mathematical model for LCA, based on the functional requirements on a product system, is also developed. The statistical properties of emission factors are studied using a data set from the Swedish Kraft Mill industry. It is shown that emission factors may be assumed constants in the LCA model, but with rather large variations within a population of Kraft mills. It is shown that there are a few environmental impacts which are important for most types of products under Scandinavian conditions, especially global warming potential, acidification, human toxicity and fossil energy depletion. There are significant differences between the contribution to these impacts from different life cycle stages, where raw material processing and use of products are generally more important than the other stages. Test cases indicate that there are no large conflicts between improvements in environmental impacts and customer requirements. Environmental improvements seem to increase purchase cost of products in some cases, but the life cycle cost of the products seem in most cases to be reduced. It is concluded that there are opportunities for 30-50% improvements in product system, based on relatively simple modifications of the systems. 246 refs., 63 figs., 19 tabs.

Postoperative radiation therapy after hip replacement in high-risk patients for development of heterotopic bone formation

International Nuclear Information System (INIS)

Hashem, R.; Rene, N.; Souhami, L.; Tanzer, M.; Evans, M.

2011-01-01

Purpose. - To report the results of postoperative radiation therapy in preventing the development of heterotopic bone formation after hip replacement surgery in high-risk patients. Patients and methods. - Between 1991 and 2007, 44 patients were preventively treated with postoperative RT after total hip replacement. In total, 47 hips were treated. All patients were considered at high risk for developing heterotopic bone formation. Most patients (63.5%) were treated because of a history of severe osteoarthritis or ankylosing spondylitis. All patients were treated with shaped parallel-opposed fields with a single fraction of 7 Gy using 6 or 18 MV photons. Most patients (94%) received radiation therapy within 72 hours postoperative and in only three patients radiation therapy was delivered after 72 hours post-surgery (5-8 days). Results. - Minimum follow-up was 1 year. There were 18 females and 26 males. Median age was 63 years (range: 18-80). Treatments were well tolerated and no acute toxicity was seen post-radiation therapy. Only one of the 47 hips (2%) developed heterotopic bone formation. This patient received postoperative radiation therapy to both hips but only developed heterotopic bone formation in one of them. None of the three patients treated beyond 72 hours failed. To date no late toxicity has been observed. Conclusion. - The use of postoperative radiation therapy was an effective and safe treatment in the prevention of heterotopic bone formation in a high-risk group of patients undergoing total hip replacement. (authors)

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 ...

Development of Multiexon Skipping Antisense Oligonucleotide Therapy for Duchenne Muscular Dystrophy

Science.gov (United States)

Yokota, Toshifumi; Wood, Matthew J. A.

2013-01-01

Duchenne muscular dystrophy (DMD) is an incurable, X-linked progressive muscle degenerative disorder that results from the absence of dystrophin protein and leads to premature death in affected individuals due to respiratory and/or cardiac failure typically by age of 30. Very recently the exciting prospect of an effective oligonucleotide therapy has emerged which restores dystrophin protein expression to affected tissues in DMD patients with highly promising data from a series of clinical trials. This therapeutic approach is highly mutation specific and thus is personalised. Therefore DMD has emerged as a model genetic disorder for understanding and overcoming of the challenges of developing personalised genetic medicines. One of the greatest weaknesses of the current oligonucleotide approach is that it is a mutation-specific therapy. To address this limitation, we have recently demonstrated that exons 45–55 skipping therapy has the potential to treat clusters of mutations that cause DMD, which could significantly reduce the number of compounds that would need to be developed in order to successfully treat all DMD patients. Here we discuss and review the latest preclinical work in this area as well as a variety of accompanying issues, including efficacy and potential toxicity of antisense oligonucleotides, prior to human clinical trials. PMID:23984357

Alpha-1 antitrypsin protein and gene therapies decrease autoimmunity and delay arthritis development in mouse model

Directory of Open Access Journals (Sweden)

Atkinson Mark A

2011-02-01

Full Text Available Abstract Background Alpha-1 antitrypsin (AAT is a multi-functional protein that has anti-inflammatory and tissue protective properties. We previously reported that human AAT (hAAT gene therapy prevented autoimmune diabetes in non-obese diabetic (NOD mice and suppressed arthritis development in combination with doxycycline in mice. In the present study we investigated the feasibility of hAAT monotherapy for the treatment of chronic arthritis in collagen-induced arthritis (CIA, a mouse model of rheumatoid arthritis (RA. Methods DBA/1 mice were immunized with bovine type II collagen (bCII to induce arthritis. These mice were pretreated either with hAAT protein or with recombinant adeno-associated virus vector expressing hAAT (rAAV-hAAT. Control groups received saline injections. Arthritis development was evaluated by prevalence of arthritis and arthritic index. Serum levels of B-cell activating factor of the TNF-α family (BAFF, antibodies against both bovine (bCII and mouse collagen II (mCII were tested by ELISA. Results Human AAT protein therapy as well as recombinant adeno-associated virus (rAAV8-mediated hAAT gene therapy significantly delayed onset and ameliorated disease development of arthritis in CIA mouse model. Importantly, hAAT therapies significantly reduced serum levels of BAFF and autoantibodies against bCII and mCII, suggesting that the effects are mediated via B-cells, at least partially. Conclusion These results present a new drug for arthritis therapy. Human AAT protein and gene therapies are able to ameliorate and delay arthritis development and reduce autoimmunity, indicating promising potential of these therapies as a new treatment strategy for RA.

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.

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

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

Market access pathways for cell therapies in France.

Science.gov (United States)

Rémuzat, Cécile; Toumi, Mondher; Jørgensen, Jesper; Kefalas, Panos

2015-01-01

Cell therapies can be classified into three main categories of products: advanced therapy medicinal products (ATMPs), ATMPs prepared on a non-routine basis (hospital exemptions), and minimally manipulated cells. Despite the benefits that cell therapies can bring to patients, they are subject to complex pathways to reach the market in France. The objective of this study was to identify and describe routes to market access for cell therapies in France and how these vary by regulatory status. The research was structured following five main steps: (1) identification of the French regulatory framework for cell therapies; (2) identification of the health products categorised as cell therapies in France; (3) mapping of the market access pathways per category of cell therapy; (4) validation of findings by interviewing experts; and (5) development of a roadmap summarising market access pathways for cell therapies in France. The secondary research methodology included a comprehensive literature review conducted on websites of French public health institutions, complemented by a research for peer-reviewed articles, abstracts, and grey literature. Different market access pathways are possible depending on the cell therapy category. For ATMPs, market access pathways depend on the licensing status of the therapy. Licensed ATMPs followed the same market access pathways as 'conventional' pharmaceuticals, whereas not-yet-licensed ATMPs can be funded via a specific financial allowance under the framework of a Temporary Authorisation for Use procedure or various research programmes. For new ATMPs that are associated with a separate medical device (not considered as 'combined ATMPs') or associated with a new medical procedure, additional pathways will apply for the medical device and/or medical procedure to be reimbursed in the ambulatory settings or at hospital. The most likely funding option for ATMPs prepared on a non-routine basis is outside the diagnosis-related group (DRG

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...

Accelerating cancer therapy development: the importance of combination strategies and collaboration. Summary of an Institute of Medicine workshop.

Science.gov (United States)

LoRusso, Patricia M; Canetta, Renzo; Wagner, John A; Balogh, Erin P; Nass, Sharyl J; Boerner, Scott A; Hohneker, John

2012-11-15

Cancer cells contain multiple genetic changes in cell signaling pathways that drive abnormal cell survival, proliferation, invasion, and metastasis. Unfortunately, patients treated with single agents inhibiting only one of these pathways--even if showing an initial response--often develop resistance with subsequent relapse or progression of their cancer, typically via the activation of an alternative uninhibited pathway. Combination therapies offer the potential for inhibiting multiple targets and pathways simultaneously to more effectively kill cancer cells and prevent or delay the emergence of drug resistance. However, there are many unique challenges to developing combination therapies, including devising and applying appropriate preclinical tests and clinical trial designs, prioritizing which combination therapies to test, avoiding overlapping toxicity of multiple agents, and overcoming legal, cultural, and regulatory barriers that impede collaboration among multiple companies, organizations, and/or institutions. More effective strategies to efficiently develop combination cancer therapies are urgently needed. Thus, the Institute of Medicine's National Cancer Policy Forum recently convened a workshop with the goal of identifying barriers that may be impeding the development of combination investigational cancer therapies, as well as potential solutions to overcome those barriers, improve collaboration, and ultimately accelerate the development of promising combinations of investigational cancer therapies. ©2012 AACR.

Development and Validation of the Cognitive-Behavioral Therapy Skills Questionnaire

Science.gov (United States)

Jacob, Karen L.; Christopher, Michael S.; Neuhaus, Edmund C.

2011-01-01

Although several theories exist to describe why patients improve in cognitive-behavioral therapy (CBT), in only a limited number of studies has CBT skill acquisition been examined, particularly among patients with complex clinical profiles. Thus, the overarching aim of this research was to develop a tool to measure patients' use of CBT skills,…

[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

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.

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....

Effective treatment of steroid and therapy-refractory acute graft-versus-host disease with a novel mesenchymal stromal cell product (MSC-FFM).

Science.gov (United States)

Bader, Peter; Kuçi, Zyrafete; Bakhtiar, Shahrzad; Basu, Oliver; Bug, Gesine; Dennis, Michael; Greil, Johann; Barta, Aniko; Kállay, Krisztián M; Lang, Peter; Lucchini, Giovanna; Pol, Raj; Schulz, Ansgar; Sykora, Karl-Walter; von Luettichau, Irene; Herter-Sprie, Grit; Uddin, Mohammad Ashab; Jenkin, Phil; Alsultan, Abdulrahman; Buechner, Jochen; Stein, Jerry; Kelemen, Agnes; Jarisch, Andrea; Soerensen, Jan; Salzmann-Manrique, Emilia; Hutter, Martin; Schäfer, Richard; Seifried, Erhard; Klingebiel, Thomas; Bonig, Halvard; Kuçi, Selim

2018-01-29

The inability to generate mesenchymal stromal cells (MSCs) of consistent potency likely is responsible for inconsistent clinical outcomes of patients with aGvHD receiving MSC products. We developed a novel MSC manufacturing protocol characterized by high in vitro potency and near-identity of individual doses, referred to as "MSC-Frankfurt am Main (MSC-FFM)". Herein, we report outcomes of the 69 patients who have received MSC-FFM. These were 51 children and 18 adults with refractory aGvHD grade II (4%), III (36%) or IV (59%). Patients were refractory either to frontline therapy (steroids) (29%) or to steroids and 1-5 additional lines of immunosuppressants (71%) were given infusions in four weekly intervals. The day 28 overall response rate was 83%; at the last follow-up, 61% and 25% of patients were in complete or partial remission. The median follow-up was 8.1 months. Six-month estimate for cumulative incidence of non-relapse mortality was 27% (range, 16-38); leukemia relapse mortality was 2% (range, 0-5). This was associated with a superior six-month overall survival (OS) probability rate of 71% (range, 61-83), compared to the outcome of patients not treated with MSC-FFM. This novel product was effective in children and adults, suggesting that MSC-FFM represents a promising therapy for steroid refractory aGvHD.

Perceptions about Authentic Leadership Development: South African Occupational Therapy Students’ Camp Experience

Directory of Open Access Journals (Sweden)

Fatima Hendricks

2018-01-01

Full Text Available Background. Twenty-three years into democracy, concern is deepening regarding the slow progress of Occupational Therapy (OT in South Africa, especially with regard to diversity and inclusion within OT. Methods. This study explores authentic leadership development primarily among Black OT students attending a pilot Occupational Therapy Association of South Africa (OTASA National Student Leadership Camp. It seeks to ascertain their perceptions on leadership and leadership development. This descriptive pilot study employs in-depth interviews and subsequent content analysis, with 12 OT students from six university OT programs in South Africa. Findings. Four categories of participant perceptions on authentic leadership development emerged from the analysis: (1 perceptions about oneself as a leader based on personal narrative, self-awareness, self-control, and psychological capital; (2 perceptions about others, specifically current leaders, with regard to their moral crisis, including continuing inequality, insincerity, greed, and selfishness; (3 goals and aspirations for leadership development via student camps; and (4 effects of leadership on the system. Conclusions. Recommendations for future practice include promotion of storytelling as a means of personal reflection for authentic leadership development and focused investment in camps for developing student leadership skills and building authentic leadership knowledge.

Perceptions about Authentic Leadership Development: South African Occupational Therapy Students' Camp Experience.

Science.gov (United States)

Hendricks, Fatima; Toth-Cohen, Susan

2018-01-01

Twenty-three years into democracy, concern is deepening regarding the slow progress of Occupational Therapy (OT) in South Africa, especially with regard to diversity and inclusion within OT. This study explores authentic leadership development primarily among Black OT students attending a pilot Occupational Therapy Association of South Africa (OTASA) National Student Leadership Camp. It seeks to ascertain their perceptions on leadership and leadership development. This descriptive pilot study employs in-depth interviews and subsequent content analysis, with 12 OT students from six university OT programs in South Africa. Four categories of participant perceptions on authentic leadership development emerged from the analysis: (1) perceptions about oneself as a leader based on personal narrative, self-awareness, self-control, and psychological capital; (2) perceptions about others, specifically current leaders, with regard to their moral crisis, including continuing inequality, insincerity, greed, and selfishness; (3) goals and aspirations for leadership development via student camps; and (4) effects of leadership on the system. Recommendations for future practice include promotion of storytelling as a means of personal reflection for authentic leadership development and focused investment in camps for developing student leadership skills and building authentic leadership knowledge.

New clinical developments in histone deacetylase inhibitors for epigenetic therapy of cancer

Directory of Open Access Journals (Sweden)

Ma Yuehua

2009-06-01

Full Text Available Abstract DNA methylation and histone acetylation are two well known epigenetic chromatin modifications. Epigenetic agents leading to DNA hypomethylation and histone hyperacetylation have been approved for treatment of hematological disorders. The first histone deacetylase inhibitor, vorinostat, has been licensed for cutaneous T cell lymphoma treatment. More than 11 new epigenetic agents are in various stages of clinical development for therapy of multiple cancer types. In this review we summarize novel histone deacetylase inhibitors and new regimens from clinical trials for epigenetic therapy of cancer.

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...

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...

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.

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.

Pharmaceutical product development: A quality by design approach

Science.gov (United States)

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Pharmaceutical product development: A quality by design approach.

Science.gov (United States)

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

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)

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...

Research productivity of doctor of physical therapy faculty promoted in the southeastern United States.

Science.gov (United States)

Littman, Marissa A; Sonne, James W; Smith, Gerald V

2017-01-01

Little information exists on the research productivity of successfully promoted tenure-track Doctor of Physical Therapy (DPT) faculty. To determine the research productivity that typically results in successful promotion. We collected publicly available curriculum vitae (CVs) from faculty currently in accredited DPT programs and who had been successfully promoted from an institution in the southeastern USA from 2000 through 2016. Total publication count, journal impact factor, funding, citations, and other metrics were analysed from 45 subjects of 22 of the 64 CAPTE-accredited DPT programs in the southeast. None of the studied metrics were normally distributed with time to promotion as determined by a Shapiro-Wilk test. These faculty exhibited a median publication count of 4, range 0 to 43; median of average citation count of 12.4, range 0 to 87.25; median of average journal impact factor of 2.866, range 0 to 6.280; median external funding received of $9910, range $0.00 to $19 543 198; and median author h-index of 3, range 0 to 17. The median number of years before promotion was 6, ranging from 3 to 13 years. Linear regression analysis indicates a poor fit with no significant correlation between years before promotion and any of the studied metrics. No correlation between journal impact factor and number of citations was observed (m = -0.22, p = 0.728, R 2  = 0.0003). Prior to promotion 31% (14 of 45) did not receive external funding and 24% (11 of 45) had a 0 h-index. The Carnegie Classification of the institution did not significantly correlate with research productivity metrics in this dataset (p = 0.213). While faculty unsuccessful in promotion were not identifiable using this method, this research can be used by faculty and committees to evaluate research productivity against regional data and promote competitive standards with peer institutions. CAPTE: Commission on Accreditation in Physical Therapist Education; DPT: Doctor of Physical Therapy.

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.

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...

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.

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...

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...

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

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...

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.

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....

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

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.

Current status of gene therapy for breast cancer: progress and challenges

Directory of Open Access Journals (Sweden)

McCrudden CM

2014-11-01

Full Text Available Cian M McCrudden, Helen O McCarthySchool of Pharmacy, Queen’s University Belfast, Belfast, UKAbstract: Breast cancer is characterized by a series of genetic mutations and is therefore ideally placed for gene therapy intervention. The aim of gene therapy is to deliver a nucleic acid-based drug to either correct or destroy the cells harboring the genetic aberration. More recently, cancer gene therapy has evolved to also encompass delivery of RNA interference technologies, as well as cancer DNA vaccines. However, the bottleneck in creating such nucleic acid pharmaceuticals lies in the delivery. Deliverability of DNA is limited as it is prone to circulating nucleases; therefore, numerous strategies have been employed to aid with biological transport. This review will discuss some of the viral and nonviral approaches to breast cancer gene therapy, and present the findings of clinical trials of these therapies in breast cancer patients. Also detailed are some of the most recent developments in nonviral approaches to targeting in breast cancer gene therapy, including transcriptional control, and the development of recombinant, multifunctional bio-inspired systems. Lastly, DNA vaccines for breast cancer are documented, with comment on requirements for successful pharmaceutical product development.Keywords: breast cancer, gene therapy, nonviral, clinical trial

As Technologies for Nucleotide Therapeutics Mature, Products Emerge.

Science.gov (United States)

Beierlein, Jennifer M; McNamee, Laura M; Ledley, Fred D

2017-12-15

The long path from initial research on oligonucleotide therapies to approval of antisense products is not unfamiliar. This lag resembles those encountered with monoclonal antibodies, gene therapies, and many biological targets and is consistent with studies of innovation showing that technology maturation is a critical determinant of product success. We previously described an analytical model for the maturation of biomedical research, demonstrating that the efficiency of targeted and biological development is connected to metrics of technology growth. The present work applies this model to characterize the advance of oligonucleotide therapeutics. We show that recent oligonucleotide product approvals incorporate technologies and targets that are past the established point of technology growth, as do most of the oligonucleotide products currently in phase 3. Less mature oligonucleotide technologies, such as miRNAs and some novel gene targets, have not passed the established point and have not yielded products. This analysis shows that oligonucleotide product development has followed largely predictable patterns of innovation. While technology maturation alone does not ensure success, these data show that many oligonucleotide technologies are sufficiently mature to be considered part of the arsenal for therapeutic development. These results demonstrate the importance of technology assessment in strategic management of biomedical technologies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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...

How we make cell therapy in Italy

Directory of Open Access Journals (Sweden)

Montemurro T

2015-08-01

Full Text Available Tiziana Montemurro, Mariele Viganò, Silvia Budelli, Elisa Montelatici, Cristiana Lavazza, Luigi Marino, Valentina Parazzi, Lorenza Lazzari, Rosaria GiordanoCell Factory, Unit of Cell Therapy and Cryobiology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milano, ItalyAbstract: In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.Keywords: advanced therapy medicinal product, good manufacturing practices, stem cells

Expected Influence of Ethics on Product Development Process

Directory of Open Access Journals (Sweden)

Stig Larsson

2008-07-01

Full Text Available Product development efficiency and effectiveness is depending on a process being well executed. The actions of individuals included in the processes are influenced by the ethical and moral orientations that have been selected by each individual, whether this selection is conscious or not. This paper describes different ethical choices and the expected effects they may have on the development process exemplified by the product integration process for software products. The different frameworks analyzed are utilitarianism, rights ethics, duty ethics, virtue ethics and ethical egoism. The expected effects on the goals for product integration may be debated. This is a result in it self as it triggers discussions about ethical considerations and increase the awareness of the influence of moral decisions. Our conclusion is that the adherence to specific moral frameworks simplifies the alignment of actions to the practices described in product development models and standards and through this supports a more successful execution of product development projects. This conclusion is also confirmed through a comparison between the different directions and several codes of ethics for engineers issued by organizations such as IEEE as these combine features from several of the discussed ethical directions.

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...

For the development of therapy with ionising radiation in tooth, mouth and jaw medicine. An historical summary

International Nuclear Information System (INIS)

Halbleib, T.

1983-01-01

Based on the corresponding literature study, the development of therapy with ionising radiation, especially in the areas of tooth, mouth and jaw medicine, is reported from the discovery of X-rays up till the present. First from 1915 on did the X-ray antiphlogistic irradiation with in importance, from 1925 to about 1940 it played a domineering role, after the war was hardly still in use and since 1970 is considered in the stomatological sector obsolete. In comparison, already in 1905 there were individual successes in tumor therapy using X radiation. After many failures and competition with the method of radium therapy in the following years, a new upswing in X-radiation came starting in around 1930 with the introduction of the Chaoul contact therapy. The high point of this development is the introduction of supervolt therapy starting around 1965. It is the result of comprehensive research in the area of radiation physics. As a result of further developed techniques there were soon combined and competing procedures available, whose results, however, have not been adequately compared and documented. From 1970 on electronic data processing has primarily taken over individual irradiation planning (cobalt 60 and electron irradiation), predictions about clinically relevant therapy successes are not present at this time. (TRV) [de

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.

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...

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...

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.)

Stem Cell Gene Therapy for Fanconi Anemia: Report from the 1st International Fanconi Anemia Gene Therapy Working Group Meeting

Science.gov (United States)

Tolar, Jakub; Adair, Jennifer E; Antoniou, Michael; Bartholomae, Cynthia C; Becker, Pamela S; Blazar, Bruce R; Bueren, Juan; Carroll, Thomas; Cavazzana-Calvo, Marina; Clapp, D Wade; Dalgleish, Robert; Galy, Anne; Gaspar, H Bobby; Hanenberg, Helmut; Von Kalle, Christof; Kiem, Hans-Peter; Lindeman, Dirk; Naldini, Luigi; Navarro, Susana; Renella, Raffaele; Rio, Paula; Sevilla, Julián; Schmidt, Manfred; Verhoeyen, Els; Wagner, John E; Williams, David A; Thrasher, Adrian J

2011-01-01

Survival rates after allogeneic hematopoietic cell transplantation (HCT) for Fanconi anemia (FA) have increased dramatically since 2000. However, the use of autologous stem cell gene therapy, whereby the patient's own blood stem cells are modified to express the wild-type gene product, could potentially avoid the early and late complications of allogeneic HCT. Over the last decades, gene therapy has experienced a high degree of optimism interrupted by periods of diminished expectation. Optimism stems from recent examples of successful gene correction in several congenital immunodeficiencies, whereas diminished expectations come from the realization that gene therapy will not be free of side effects. The goal of the 1st International Fanconi Anemia Gene Therapy Working Group Meeting was to determine the optimal strategy for moving stem cell gene therapy into clinical trials for individuals with FA. To this end, key investigators examined vector design, transduction method, criteria for large-scale clinical-grade vector manufacture, hematopoietic cell preparation, and eligibility criteria for FA patients most likely to benefit. The report summarizes the roadmap for the development of gene therapy for FA. PMID:21540837

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....

Combination of nitric oxide therapy, anti-oxidative therapy, low level laser therapy, plasma rich platelet therapy and stem cell therapy as a novel therapeutic application to manage the pain and treat many clinical conditions

Science.gov (United States)

Halasa, Salaheldin; Dickinson, Eva

2014-02-01

From hypertension to diabetes, cancer to HIV, stroke to memory loss and learning disorders to septic shock, male impotence to tuberculosis, there is probably no pathological condition where nitric oxide does not play an important role. Nitric oxide is an analgesic, immune-modulator, vasodilator, anti-apoptotic, growth modulator, angiogenetic, anti-thrombotic, anti-inflammatory and neuro-modulator. Because of the above actions of nitric oxide, many clinical conditions associated with abnormal Nitric oxide (NO) production and bioavailability. Our novel therapeutic approach is to restore the homeostasis of nitric oxide and replace the lost cells by combining nitric oxide therapy, anti-oxidative therapy, low level laser therapy, plasma rich platelet therapy and stem cell therapy.

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

Stem cell therapy clinical research: A regulatory conundrum for academia.

Science.gov (United States)

Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A

2017-12-01

The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

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...

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...

Development of special medical foods and botanical drugs using HemoHIM for cancer patients during radiation therapy

International Nuclear Information System (INIS)

Jo, Sung Kee; Jung, U Hee; Park, Hae Ran

2010-02-01

In vivo evaluation on the reductive effects of HemoHIM on the side-effects of radiation and anticancer drug treatment. - Evaluation on the promoting effects of HemoHIM on the tumor growth inhibitory activities of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of the reductive effects of HemoHIM on the immune suppressive side-effects of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of reductive effects of HemoHIM on the self-renewal tissue(intestine) damage of radiation and anticancer drug(5-FU) in mice. · Assessment of toxicological safety of HemoHIM (GLP) and establishment of analytical methods for active/index components of HemoHIM - Assurance of toxicological safety in single-dose and 3 month repeat-dose toxicity test in rats - Establishment of analytical methods for active/index compounds and content analysis result in various production lots. · Production of Special Medical Food pilot products for cancer patients and development of dosage forms for the natural new drugs. - Establishment of optimal formulations including HemoHIM for the Special Medical Food - Production of Special Medical Food pilot products for clinical test, analysis of nutrients, and official declaration of food production - Establishment of production process of HemoHIM for natural drug and production of pilot products for toxicity tests - Development of drug dosage forms of HemoHIM (tablet, granule, capsule) · Clinical evaluation of HemoHIM on reduction of side-effects of radiation and chemotherapy in cancer patients - Subjects: breast cancer patients who completed surgical operation and chemotherapy, HemoHIM administration during and after the radiation therapy (HemoHIM group: 15, placebo group 13) - Administration period: 3 months from few days before RT commencement - Results - Improvement of immunological biomarkers (immune cell subpopulations, cytokine production) - Reduction of and enhanced recovery from radiation skin

Development of special medical foods and botanical drugs using HemoHIM for cancer patients during radiation therapy

Energy Technology Data Exchange (ETDEWEB)

Jo, Sung Kee; Jung, U Hee; Park, Hae Ran

2010-02-15

In vivo evaluation on the reductive effects of HemoHIM on the side-effects of radiation and anticancer drug treatment. - Evaluation on the promoting effects of HemoHIM on the tumor growth inhibitory activities of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of the reductive effects of HemoHIM on the immune suppressive side-effects of radiation and anticancer drug(cisplatin) in tumor-bearing mice. - Evaluation of reductive effects of HemoHIM on the self-renewal tissue(intestine) damage of radiation and anticancer drug(5-FU) in mice. {center_dot} Assessment of toxicological safety of HemoHIM (GLP) and establishment of analytical methods for active/index components of HemoHIM - Assurance of toxicological safety in single-dose and 3 month repeat-dose toxicity test in rats - Establishment of analytical methods for active/index compounds and content analysis result in various production lots. {center_dot} Production of Special Medical Food pilot products for cancer patients and development of dosage forms for the natural new drugs. - Establishment of optimal formulations including HemoHIM for the Special Medical Food - Production of Special Medical Food pilot products for clinical test, analysis of nutrients, and official declaration of food production - Establishment of production process of HemoHIM for natural drug and production of pilot products for toxicity tests - Development of drug dosage forms of HemoHIM (tablet, granule, capsule) {center_dot} Clinical evaluation of HemoHIM on reduction of side-effects of radiation and chemotherapy in cancer patients - Subjects: breast cancer patients who completed surgical operation and chemotherapy, HemoHIM administration during and after the radiation therapy (HemoHIM group: 15, placebo group 13) - Administration period: 3 months from few days before RT commencement - Results - Improvement of immunological biomarkers (immune cell subpopulations, cytokine production) - Reduction of and enhanced

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...

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...

The translation of product concept to bone products: a partnership of therapeutic effectiveness and commercialization.

Science.gov (United States)

Ratcliffe, Anthony

2011-12-01

The fields of tissue engineering and regenerative medicine have the capacity to substantially impact clinical care through the introduction of new products that can address unmet clinical needs, or significantly improve on present therapies. These products will be developed through the demonstration of therapeutic effectiveness, adequate safety, and meeting regulatory requirements. The technology used in the product will dictate the product development and manufacturing costs; the regulatory pathway; and the time taken to complete clinical trials, gain regulatory approval, and become commercialized. A comparison of the required investment of time and funds, with the potential revenue generated, allows for a determination of the likely commercialization opportunity. Ultimately, the long-term success of a product will be dependent on its clinical effectiveness and commercial viability. © Mary Ann Liebert, Inc.

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...

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.

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)

Gene and cell therapy for children — New medicines, new challenges?☆

Science.gov (United States)

Buckland, Karen F.; Bobby Gaspar, H.

2014-01-01

The range of possible gene and cell therapy applications is expanding at an extremely rapid rate and advanced therapy medicinal products (ATMPs) are currently the hottest topic in novel medicines, particularly for inherited diseases. Paediatric patients stand to gain enormously from these novel therapies as it now seems plausible to develop a gene or cell therapy for a vast number of inherited diseases. There are a wide variety of potential gene and cell therapies in various stages of development. Patients who received first gene therapy treatments for primary immune deficiencies (PIDs) are reaching 10 and 15 years post-treatment, with robust and sustained immune recovery. Cell therapy clinical trials are underway for a variety of tissues including corneal, retinal and muscle repair and islet cell transplantation. Various cell therapy approaches are also being trialled to enhance the safety of bone marrow transplants, which should improve survival rates in childhood cancers and PIDs. Progress in genetic engineering of lymphocyte populations to target and kill cancerous cells is also described. If successful these ATMPs may enhance or replace the existing chemo-ablative therapy for several paediatric cancers. Emerging applications of gene therapy now include skin and neurological disorders such as epidermolysis bullosa, epilepsy and leukodystrophy. Gene therapy trials for haemophilia, muscular dystrophy and a range of metabolic disorders are underway. There is a vast array of potential advanced therapy medicinal products (ATMPs), and these are likely to be more cost effective than existing medicines. However, the first clinical trials have not been without setbacks and some of the key adverse events are discussed. Furthermore, the arrival of this novel class of therapies brings many new challenges for the healthcare industry. We present a summary of the key non-clinical factors required for successful delivery of these potential treatments. Technological advances

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)

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.

RNA-Targeted Therapies and Amyotrophic Lateral Sclerosis

Directory of Open Access Journals (Sweden)

Stéphane Mathis

2018-01-01

Full Text Available Amyotrophic lateral sclerosis (ALS is a fatal motor disease in adults. Its pathophysiology remains mysterious, but tremendous advances have been made with the discovery of the most frequent mutations of its more common familial form linked to the C9ORF72 gene. Although most cases are still considered sporadic, these genetic mutations have revealed the role of RNA production, processing and transport in ALS, and may be important players in all ALS forms. There are no disease-modifying treatments for adult human neurodegenerative diseases, including ALS. As in spinal muscular atrophy, RNA-targeted therapies have been proposed as potential strategies for treating this neurodegenerative disorder. Successes achieved in various animal models of ALS have proven that RNA therapies are both safe and effective. With careful consideration of the applicability of such therapies in humans, it is possible to anticipate ongoing in vivo research and clinical trial development of RNA therapies for treating ALS.

RNA-Targeted Therapies and Amyotrophic Lateral Sclerosis.

Science.gov (United States)

Mathis, Stéphane; Le Masson, Gwendal

2018-01-15

Amyotrophic lateral sclerosis (ALS) is a fatal motor disease in adults. Its pathophysiology remains mysterious, but tremendous advances have been made with the discovery of the most frequent mutations of its more common familial form linked to the C9ORF72 gene. Although most cases are still considered sporadic, these genetic mutations have revealed the role of RNA production, processing and transport in ALS, and may be important players in all ALS forms. There are no disease-modifying treatments for adult human neurodegenerative diseases, including ALS. As in spinal muscular atrophy, RNA-targeted therapies have been proposed as potential strategies for treating this neurodegenerative disorder. Successes achieved in various animal models of ALS have proven that RNA therapies are both safe and effective. With careful consideration of the applicability of such therapies in humans, it is possible to anticipate ongoing in vivo research and clinical trial development of RNA therapies for treating ALS.

On the Origin and Development of the Medical Nutrition Industry

NARCIS (Netherlands)

T.C. Weenen (Tamar)

2014-01-01

markdownabstract__Abstract__ Product development in the health and life sciences is shifting from the development of target-specific pharmaceutical products to multi-target therapies, including medical nutrition. Medical nutrition consists of nutritional compositions, prescribed by medical

Developing Emotional Literacy through Individual Dance Movement Therapy: A Pilot Study

Science.gov (United States)

Meekums, Bonnie

2008-01-01

This paper reports a pragmatic mixed methods pilot study of teacher perceptions regarding a school-based Dance Movement therapy (DMT) service for six children aged four to seven in a North of England primary school. No previous studies have systematically evaluated DMT in terms of the development of Emotional Literacy (EL), though theoretical…

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...

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.

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

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.)

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study

OpenAIRE

Linden Ulrike; Groß Wibke; Ostermann Thomas

2010-01-01

Abstract Background Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. Methods A total of 18 childr...

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

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.

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...

A strategy to develop and implement Canadian standards for quality assurance in radiation therapy

International Nuclear Information System (INIS)