Vol 1, No 2 (2015)

Table of Contents

Editorial

by Jean-Marie Boeynaems
31 Views, 16 PDF Downloads

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.

PDF

Review Article

by Ronald Barbaras
50 Views, 42 PDF Downloads
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.
PDF

Review Article

by Sabrina Ena, Julia Ino, Aurelie Neirinck, Sandra Pietri, Anna Tury, Enrico Bastianelli
66 Views, 47 PDF Downloads
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.
PDF

Review Article

by Deborah Chee, Min Soo Park, Ji-Hoon Sohn
42 Views, 58 PDF Downloads
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.
PDF

Review Article

by Bernd Rosenkranz, Michael Reid, Elizabeth Allen
52 Views, 41 PDF Downloads
Africa is one of the world’s fastest-growing economic regions, with a rise in its pharmaceutical industry value from $4.7 billion in 2003 to $20.8 billion in 2013. Multinational pharmaceutical companies are becoming more active in drug production and clinical trials across Africa, and there is an increase in the number of local companies engaged in medicines development and marketing. Such expansion of the local pharmaceutical industry requires trained pharmaceutical specialists to support it. The current situation and future requirements for local medicines development, regulation, education and training needs are discussed.
PDF

Position Article

by Anita Aperia, Jorgen Dirach, Mike Hardman, Christa Janko, Jeff Kipling, Rebecca Ludwig, Lena Scott, Armel Stockis
42 Views, 34 PDF Downloads

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.

PDF

Position Article

by Cath Brooksbank, Christa Janko, Claire Johnson, Wolf See, Hans H. Lindén, Mike Hardman
39 Views, 26 PDF Downloads

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 collaboratively
across 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 coherent
framework 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.

PDF