| 1 | FAIR Principles:Interpretations and Implementation Considerations显示文摘The FAIR principles have been widely cited,endorsed and adopted by a broad range of stakeholders since their publication in 2016.By intention,the 15 FAIR guiding principles do not dictate specific technological implementations,but provide guidance for improving Findability,Accessibility,Interoperability and Reusability of digital resources.This has likely contributed to the broad adoption of the FAIR principles,because individual stakeholder communities can implement their own FAIR solutions.However,it has also resulted in inconsistent interpretations that carry the risk of leading to incompatible implementations.Thus,while the FAIR principles are formulated on a high level and may be interpreted and implemented in different ways,for true interoperability we need to support convergence in implementation choices that are widely accessible and(re)-usable.We introduce the concept of FAIR implementation considerations to assist accelerated global participation and convergence towards accessible,robust,widespread and consistent FAIR implementations.Any self-identified stakeholder community may either choose to reuse solutions from existing implementations,or when they spot a gap,accept the challenge to create the needed solution,which,ideally,can be used again by other communities in the future.Here,we provide interpretations and implementation considerations(choices and challenges)for each FAIR principle. | Annika Jacobsen Ricardo de Miranda Azevedo Nick Juty Dominique Batista Simon Coles Ronald Cornet Melanie Courtot Merce Crosas Michel Dumontier Chris T.Evelo Carole Goble Giancarlo Guizzardi Karsten Kryger Hansen Ali Hasnain Kristina Hettne Jaap Heringa Rob W.W.Hooft Melanie Imming Keith G.Jeffery Rajaram Kaliyaperumal Martijn GKersloot Christine R.Kirkpatrick Tobias Kuhn Ignasi Labastida Barbara Magagna PeterMcQuilton Natalie Meyers Annalisa Montesanti Mirjam van Reisen Philippe Rocca-Serra Robert Pergl Susanna-Assunta Sansone Luiz Olavo Bonino da Silva Santos Juliane Schneider George Strawn Mark Thompson Andra Waagmeester Tobias Weigel Mark D.Wilkinson Egon L.Willighagen Peter Wittenburg Marco Roos Barend Mons Erik Schultes | 2020 | Data Intelligence2020，2，1： | 26 |
| 2 | Investigative safety strategies to improve success in drug development显示文摘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. | Franck Atienzar Annie Delaunois Frédéric Brouta Miranda Cornet Renaud Fleurance Helga Gerets Stéphanie Glineur Catrin Hasselgren Andrea Kiessling Andre Nogueira da Costa Marie-Luce Rosseels Karen Tilmant Jean-Pierre Valentin | 2016 | Journal of Medicines Development Sciences2016，2，1： | 0 |
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