JMDS, 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).
JMDS, 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.
JMDS, 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.
JMDS, 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.
JMDS, 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.
JMDS, Volume 2, pp 30-37; doi:10.18063/jmds.2016.01.002
Abstract:Numerous studies have demonstrated the role of uridine diphosphate (UDP) and its P2Y6 receptor in the inflammatory reaction and innate immunity. However, the importance of the P2Y6 receptor in the adaptive immune response remains unclear. In this study, we demonstrate that the P2Y6 receptor is functionally expressed in murine bone marrow dendritic cells (BMDC). UDP induced a Ca2+ transient in these cells that was decreased in P2Y6-deficient mice. UDP also increased the endocytosis of fluorescein isothiocyanate-dextran (FITC-dextran) and amplified the secretion of interleukin 12-p70 (IL-12p70) induced by CpG; these responses were abolished in P2Y6-deficient mice. In vivo experiments showed that the serum level of specific IgG2c after immunisation with ovalbumin was decreased in P2Y6-deficient mice, while the level of specific IgG1 was unchanged. These data suggest that the P2Y6-mediated effects of UDP on myeloid dendritic cells play a role in the in vivo Th1 skewing of the immune response.
JMDS, 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.
JMDS, Volume 1; doi:10.18063/jmds.2015.02.001
Abstract:This article describes LifeTrain — the European common framework for continuing professional development in the biomedical sciences. An important goal of LifeTrain is to support biomedical professionals to work collaborativelyacross disciplines, sectors and national boundaries. LifeTrain is an open community with a unifying goal; it brings together many excellent, but disparate, activities into a process towards establishing a focused and coherentframework for continuing professional development in the biomedical sciences. This collaborative approach provides the critical mass to make a major contribution to strengthen the skills and competencies of biomedical professionals in a rapidly changing environment. LifeTrain's signatories, which include multinational pharmaceutical companies, research infrastructures, professional and scientific bodies, higher-education institutes and research institutes, have agreed to the principles of the framework and to continue to collaborate to implement LifeTrain. We warmly invite others to join us.
JMDS, 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.
JMDS, 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.