FDA and Bioinfogate agree to extend the material transfer agreement (MTA) to access the OFF-x translational safety intelligence portal. The agreement aims to evaluate new approaches to enhance safety assessments of human pharmaceuticals and their associated molecular targets, supporting the FDA's mission of protecting public health. Under this MTA, the FDA has agency-wide access to Bioinfogate's translational safety intelligence portal, OFF-X. The primary objective of the agreement is to evaluate the potential use of Bioinfogate OFF-X™ as a research tool to anticipate adverse events associated with molecular targets and evaluate its utility in the regulatory review process. Under the recently extended agreement, the FDA will continue to provide feedback on the utility of the OFF-X database and/or any aspects related to its functioning and use. Unexpected safety issues constitute one of the most disruptive events in clinical research. A translational approach to drug safety that integrates preclinical and clinical data can significantly reduce patient burden and avoid costly failures. In this context, it is essential to detect as early as possible in the drug R&D process the potential safety liabilities associated to both new targets and drugs under development. Today (9th May 2019), Medicines Discovery Catapult and LifeArc, leading forces driving UK innovation in drug discovery, announce their strategic partnership. The identification and development of novel biomarkers that detect efficacy and safety of novel drug molecules, which can be used in human trials, will be the focus of the partnership. LifeArc has a growing portfolio of innovative therapeutic candidates across priority disease areas where there is high patient need. Medicines Discovery Catapult has established platforms and expertise in the discovery and validation of new biomarker approaches. The partnership will use the expertise of both organisations to progress candidate molecules towards clinical evaluation with an optimised biomarker strategy. LifeArc will fund a select number of full-time employees, who will be embedded within the Catapult to provide strategic biomarker discovery and development.