Briggs, Katahrine, Camara, Tima, Diaz, Carlos, Drew, Phil, Drewe, Will, Kors, Jan, van Mulligen, Erik, Pognan, Francois, Quintana, Jordi Ramon, Sarntivijai, Sirarat and Steger-Hartmann, Thomas (2021) Guidelines for FAIR sharing of preclinical safety and off-target pharmacology data. ALTEX, 38 (2). pp. 187-197. ISSN 1868596X

Abstract

Pre-competitive data sharing can offer the pharmaceutical industry significant benefits in terms of reducing the time and costs involved in getting a new drug to market through more informed testing strategies and knowledge gained by pooling data. Data sharing benefits can be further enhanced by applying the FAIR Guiding Principles to make data more Findable, Accessible, Interoperable and Reusable, reducing time spent curating, transforming and aggregating datasets and allowing more time for data mining and analysis. The Enhancing TRANslational SAFEty Assessment through Integrative Knowledge Management (eTRANSAFE) project is an Innovative Medicines Initiative (IMI) which aims to integrate publicly available data sources with proprietary preclinical and clinical data donated by pharmaceutical organisations participating in the consortium. A key deliverable which supports the sustainability of the project output is the development of policies and guidelines for the safe sharing of proprietary data. Beyond developing guidelines that can be practically implemented within the project and used to overcome company internal resistance to data sharing, the eTRANSAFE project also aims to publicise them in order to gain widespread adoption and reuse by other data sharing initiatives, regulatory bodies and international standard-setting organisations. This article is focussed on how the FAIR Guiding Principles can be applied to the general framework for data sharing guidelines which were developed in eTRANSAFE.

Item Type:	Article
Date Deposited:	17 Aug 2021 00:45
Last Modified:	17 Aug 2021 00:45
URI:	https://oak.novartis.com/id/eprint/43355