Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline

One of the key challenges for prediction and assessment of idiosyncratic DILI in drug development is the lack of suitable models and safety biomarkers. This session will present examples on recent advances in both areas based on collaborative research. The first talk will focus on a mechanistic simulation platform being developed at the Hamner Institute, supporting decision-making at transition from preclinical to clinical development. The second talk will present an overview on current work surrounding the development of in vitro models using induced pluripotent stem cells to investigate human diversity as a basis of idiosyncratic DILI. It is hoped that such cell systems will be eventually applied as screening tools for new drugs in development regards their potential to induce DILI. The third speaker will provide background information on and discuss initial results of the work of the Predictive Safety Testing Consortium (PSTC) in the US and the IMI SAFE-T consortium in Europe, both precompetitive consortia collaborating closely on preclinical and clinical qualification of new safety biomarkers for DILI.