Journal Journal of Medicines Development Sciences

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Mike Hardman
Journal of Medicines Development Sciences, Volume 1; doi:10.18063/jmds.2015.01.001

Abstract:In the last decade, the environment for medicines development has undergone unprecedented change, including: a shift from predominantly big Pharma to one of extensive industry–academia and SME partnerships and collaborations, greater emphasis on understanding the molecular basis of disease for stratified and personalised medicine, and a focus on societal/patients’ needs and priorities.A variety of European initiatives have been established to support the training of scientists/professionals involved in medicines development in order to respond to this constantly changing, demanding, and chaotic landscape. Some of these initiatives are directed specifically at medicines development, some address scientific research including training relevant to medicines development, and some support general training needs which can include medicines development.There are a number of European initiatives supporting better training in medicines development. They differ in their approach, ranging from IMI (specific to medicines development) to Erasmus+ (boosting skills and employability in all areas). The scope, budgets, and requirements differ considerably and they each have to be reviewed in detail to decide which might be the most appropriate for a particular target group. The common theme is to support the aims of the European Research Area (ERA), i.e., a significant improvement in Europe’s research performance to promote growth and job creation.
Journal of Medicines Development Sciences; doi:10.18063/jmds

Deborah Chee, Minsoo Park, Sylvie Kim, Ji-Hoon Sohn
Journal of Medicines Development Sciences, Volume 1; doi:10.18063/jmds.2015.02.003

Abstract:Korea has continuously sought to improve its regulatory environment for clinical trials and has invested heavily in clinical trial infrastructure and technology since the early 2000’s. A strategic investment through the Korea National Enterprise for Clinical Trials (KoNECT) program began in 2007 and grew to encompass a network of regional clinical trial centers to promote clinical trial capabilities and human resource development. In early 2014, KoNECT became a permanent organization focused on the advancement of the country's clinical trial industry. This was followed by the establishment of the Korea Clinical Trials Global Initiative (KCGI) and the KoNECT Collaboration Center for global clinical trials (KCC). KCGI and KCC are now at the forefront of KoNECT’s efforts to promote higher operational efficiency in the country’s clinical trials. These new initiatives in clinical research are undertaking multichannel approaches to pursue a cohesive international collaboration model between government, industry and academia for the development of new treatments and improved patient care.
Sabrina Lucia Ena, Julia Ino, Aurelie Neirinck, Sandra Magali Pietri, Anna Tury, Enrico Bastianelli
Journal of Medicines Development Sciences, Volume 1; doi:10.18063/jmds.2015.02.004

Abstract:Over the last decade, there has been an increasing interest among researchers for human mesenchymal stromal cells (MSC). Their regenerative properties, multilineage differentiation capacity and immunomodulatory properties make them promising candidates for treatment in various conditions. Emerging biotechnology companies specialized in cellular and regenerative therapies have been focusing their interest on MSC-based therapies, and their use in clinical trials has steadily increased. Notably, MSC are currently tested in clinical trials addressing unmet medical needs in the field of bone fracture repair and more specifically in non-union and delayed union fractures where the bone repair process is impaired. Although MSC can be isolated from various tissues, the most commonly studied sources are bone marrow (BM) and adipose tissue (Ad). In this article, we reviewed the literature directly comparing BM- and Ad-MSC for their in vitro characteristics and in vivo osteogenic potential to determine which source of MSC would be more appropriate for bone fracture repair. As considerable variations in experimental settings between studies were found, our review was based on studies meeting specific sets of criteria, notably regarding donors’ age and gender. This review of side-by-side comparisons suggests that while BM-and Ad-MSC share common general characteristics, BM-MSC have a higher intrinsic osteogenic capacity in vitro and bone repair potential in vivo.
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.
Ronald Barbaras
Journal of Medicines Development Sciences, Volume 1; doi:10.18063/jmds.2015.02.005

Abstract:For a number of years, high-density lipoprotein (HDL) has been recognized to have an athero-protective role by promoting reverse lipid transport, a process facilitating the cholesterol efflux from atherosclerotic plaques in the artery wall and its elimination by the liver via biliary excretion. On the contrary, low-density lipoprotein (LDL) particles carry cholesterol to the organs and tissues where it can be used to produce hormones or maintain cell metabolism. When an imbalance develops, as a result of either an excess level of cholesterol associated with LDL (LDL-C) or a less effective cholesterol elimination by HDL (HDL-C), this causes an excess of cholesterol to be transported to the tissues and promotes the deposition of cholesterol. This often occurs in the artery walls, particularly in the coronary arteries. There is no approved medical treatment for directly suppressing or treating the atherosclerotic plaque once it is formed. Epidemiological studies have shown that the risk of developing cardio-vascular disease (CVD) is higher in patients with low levels of HDL-C regardless of LDL-C levels, even in patients optimally treated with LDL-C-lowering therapies. These data highlight that low HDL-C and low HDL particle number is an important target of therapies aiming to reduce the residual risk of CVD.
Anita Aperia, Jorgen Dirach, Mike Hardman, Christa Janko, Jeff Kipling, Rebecca Ludwig, Lena Scott, Armel Stockis
Journal of Medicines Development Sciences, Volume 1; doi:10.18063/jmds.2015.02.002

Abstract:The prosperity of a country is closely related to its level of education to fuel research and innovation. Doctoral graduates have attained the highest education level and should be the key players in research and innovation. The number of doctoral graduates is increasing rapidly in most/many countries, but is less well correlated to changes in prosperity of a country.The innovative medicines initiative (IMI) was established to help Europe strengthen its position in biomedical research and development. During its planning stage IMI observed large gaps in the scientific interaction between academia and industry in Europe, and that undergraduate students were not realizing the career opportunities within biomedical R&D. A major objective for the education and training section of IMI, the European Medicines Research Training Network (EMTRAIN, http://www.emtrain.eu), has therefore been to work out a framework for public private partnership PhD (PPP-PhD) and to create a cohort of networking, industry-aware scientists.
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.
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.
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