Journal Journal of Medicines Development Sciences

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29 articles
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Alan Boyd, Peter Stonier, Konrad Obiora, Ben Cottam
Journal of Medicines Development Sciences, Volume 3; doi:10.18063/jmds.v3i1.193

Abstract:The Faculty of Pharmaceutical Medicine was established in the United Kingdom (UK) in 1989 to develop and maintain competence, ethics and the highest professional standards of practice in the discipline. This article charts the founding principles and history of the Faculty, details its composition and membership, and outlines the major functions and achievements of the organisation in the context of the development of the discipline of pharmaceutical medicine. The recognition of pharmaceutical medicine as a medical specialty in the UK is described together with the associated certification programme Pharmaceutical Medicine Specialty Training, which enables pharmaceutical physicians to become certified practitioners in the specialty with the UK General Medical Council (UK GMC).
Akiko Kishi, Ichiro Uchida, Daisuke Koide, Kyoko Imamura
Journal of Medicines Development Sciences, Volume 3; doi:10.18063/jmds.v3i1.166

Abstract:Development of new medicines has become increasingly difficult with less possibility of success in seeds-finding and ever rising operational costs. Failure to comply with ethical standards for human research protection also erodes social trust in clinical development. In order to develop competence of professionals in medicines development such as clinical investigators and drug development scientists, a variety of educational courses and training programs have been developed and executed worldwide. As Japan is no exception and shares the same concerns, significant governmental and non-governmental efforts have been made to invest in the development of academic educational courses and adherence to international standards. This article introduces examples of the adoption of technologies to realize a user-friendly and sustainable learning management as well as an adaptation of syllabuses and core curricula to meet international standards in the era of global medicines development.
Anita Aperia, Jorgen Dirach, Mike Hardman, Christa Janko, Jeff Kipling, Rosan Kreeftmeijer-Vegter, Rebecca Ludwig, Lena Scott, Armel Stockis
Journal of Medicines Development Sciences, Volume 3; doi:10.18063/jmds.v3i1.163

Abstract:“No research without trained researchers” has become the mantra of the EU-funded Innovative Medicines Initiative (IMI) education and training projects. However, it is often hard to determine the type of training required at different stages of a scientist’s career. The situation is further complicated by the constantly changing environment, e.g. the growth of disruptive technologies, societal expectations of biomedical sciences, the greater need for multi-disciplinary collaborations, and conservative or changing regulatory requirements. This article summarises the experience from a series of five EMTRAIN Public Private Partnership PhD workshops that included both scientific and transferrable skill training. This is followed by an example of a recently developed training programme, including a competency profile, for translational research and medicines development; the C-COMEND teaching programme. The emphasis is on competencies as a new currency for continuing professional development. Finally, this paper describes what we consider to be the next steps required by the scientific community to address solutions to the current training challenges so that society can benefit from the innovations that only science can provide.
Dipak Kalra, Mats Sundgren, Brecht Claerhout, Pierre Meulien, Bart Vannieuwenhuyse, Peter Singleton, Terje Peetso, Veli Stroetmann, Petra Wilson, Mary Baker, et al.
Journal of Medicines Development Sciences, Volume 3; doi:10.18063/jmds.v3i1.165

Abstract:The European Institute for Innovation through Health Data (i~HD) has been formed as one of the sustainable entities arising from the Electronic Health Records for Clinical Research (EHR4CR) and SemanticHealthNet projects, in collaboration with other European Commission projects and initiatives. The vision of i~HD is to become the European organisation of reference for guiding and catalysing the best, most efficient and trustworthy uses of health data and interoperability, for optimizing health and knowledge discovery.i~HD has been established in recognition that there is a need to tackle areas of challenge in the successful scaling up of innovations that rely on high-quality and interoperable health data, to sustain and propagate the results of eHealth research, and to address current-day obstacles to using health data. i~HD was launched at an inaugural conference in Paris, in March 2016. This was attended by over 200 European clinicians, healthcare providers and researchers, representatives of the pharma industry, patient associations, health professional associations, the health ICT industry and standards bodies. The event showcased issues and approaches, that are presented in this paper to highlight the activities that i~HD intends to pursue as enablers of the better uses of health data, for care and research.
Elyse I. Summers
Journal of Medicines Development Sciences, Volume 2, pp 38-42; doi:10.18063/jmds.2016.01.003

Abstract:This year marks the 15th anniversary of the founding of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an organization that has been instrumental in strengthening protections for research participants. AAHRPP was established by seven Founding Members in response to a series of high-profile incidents that shook the foundation of the U.S. research enterprise. The Founding Members viewed voluntary accreditation as one way to strengthen research protections and restore and preserve public trust. Today, AAHRPP accreditation is widely regarded as the gold standard for research protections. To attain accreditation, organizations must demonstrate that they adhere to rigorous standards covering three domains: The Organization, The Institutional Review Board or Ethics Committee, and Researcher and Research Staff. The emphasis is on system-wide policies and procedures that strengthen an organization’s commitment to participants and help ensure a more consistent, more effective approach to protecting them. Because AARHPP accreditation is considered an objective indicator of quality, the benefits to accredited organizations can be considerable. Their accreditation status sends a signal — to potential research partners, to sponsors and other funders, and to research participants — that the organization has the systems in place to conduct research in a scientifically and ethically sound manner.
Franck Atienzar, Annie Delaunois, Frédéric Brouta, Miranda Cornet, Renaud Fleurance, Helga Gerets, Stephanie Glineur, Catrin Hasselgren, Andrea Kiessling, Andre Nogueira Da Costa, et al.
Journal of Medicines Development Sciences, Volume 2, pp 2-29; doi:10.18063/jmds.2016.01.001

Abstract:Understanding and reducing attrition rate remains a key challenge in drug development. Preclinical and clinical safety issues still represent about 40% of drug discontinuation, of which cardiac and liver toxicities are the leading reasons. Reducing attrition rate can be achieved by various means, starting with a comprehensive evaluation of the potential safety issues associated to the primary target followed by an evaluation of undesirable secondary targets. To address these risks, a risk mitigation plan should be built at very early development stages, using a panel of in silico, in vitro, and in vivo models. While most pharmaceutical companies have developed robust safety strategies to de-risk genotoxicity and cardiotoxicity issues, partly driven by regulatory requirements; safety issues affecting other organs or systems, such as the central nervous system, liver, kidney, or gastro-intestinal system are less commonly addressed during early drug development. This paper proposes some de-risking strategies that can be applied to these target organ systems, including the use of novel biomarkers that can be easily integrated in both preclinical and clinical studies. Experiments to understand the mechanisms’ underlying toxicity are also important. Two examples are provided to demonstrate how such mechanistic studies can impact drug development. Novel trends in investigative safety are reviewed, such as computational modeling, mitochondrial toxicity assessment, and imaging technologies. Ultimately, understanding the predictive value of non-clinical safety testing and its translatability to humans will enable to optimize assays in order to address the key objectives of the drug discovery process, i.e., hazard identification, risk assessment, and mitigation.
Victoria Elegant
Journal of Medicines Development Sciences, Volume 2, pp 43-50; doi:10.18063/jmds.2016.01.004

Abstract:The Asia Pacific region is an extremely diverse region, characterized by heterogeneity from a number of aspects, including culture, religion, economics, landscapes, and languages. This also applies to the standard of medical care and the regulatory requirements for approval of drugs in the region. Developed economies such as Japan and Australia have requirements which are not dissimilar to those of the EU and USA, but still have their own unique requirements. The developing economies all have their own requirements. In the ASEAN region there is harmonization of the dossier format, but each country still has local requirements. The region has seen significant growth in clinical trial activity, both to satisfy local registration and safety requirements and to help accelerate global trial patient recruitment. There is a clear need for training in all aspects of medical, regulatory, clinical and safety aspects of medicines development, which is being addressed through several organizations and at different locations in the region.
Jean-Marie Boeynaems
Journal of Medicines Development Sciences, Volume 2; doi:10.18063/jmds.2016.01.006

Abstract:Welcome to the 3rd issue of the Journal of Medicines Development Sciences. Like previous issues it contains articles covering the entire process of drug development from target identification to drug registration.
Ana Paula Ruenis, João Massud Filho
Journal of Medicines Development Sciences, Volume 2, pp 51-54; doi:10.18063/jmds.2016.01.005

Abstract:Brazil is one of the world´s largest economies and pharmaceutical markets, having the Brazilian government as an important purchaser. There are strong local companies that have grown sustainably after the introduction of generics and are investing in both incremental and radical innovation. However, research and development (R&D) expenditures are still modest; this could be explained by a combination of economic and political uncertainty in the past few years and a bureaucratic, complex regulatory framework. New regulations, efforts to reduce ethical and regulatory review timelines, and a Senate bill aimed to accomplish that goal should constitute the definitive regulatory landmark for boosting clinical research. In addition to government investments they have given a breath of relief in the market, as Brazil is trying to, once again, gain momentum as a “must-go” country for clinical development. Non-profit associations such as the Brazilian Society of Pharmaceutical Medicine (Sociedade Brasileira de Medicina Farmacêutica-SBMF), the Brazilian Association of CROs (Associação Brasileira de Organizações Representativas de Pesquisa Clínica-ABRACRO), the Brazilian Clinical Research Alliance (Aliança Pesquisa Clínica Brasil), amongst others, helped to give the impulse to trigger such changes. It is time to invest heavily in developing educational programs to address the growing need for clinical development scientists and physicians.
Jean-Marie Boeynaems
Journal of Medicines Development Sciences, Volume 1; doi:10.18063/jmds.2015.02.007

Abstract:We are glad to publish the second issue of the Journal of Medicines Development Sciences. It illustrates three current trends in medicines development:• The rising role of small biotech companies,• The initiatives launched in many countries to boost clinical research,• The importance of an adequate education and training of physicians and scien-tists involved in medicines development.
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