On 17 October 2016, the SAFE-T consortium of the Innovative Medicines Initiative (IMI) and the Critical Path Institute (C-Path) announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had each issued a Biomarker Letter of Support covering new biomarkers of liver safety.
These biomarkers were studied by the SAFE-T work package on drug-induced liver injury and by the Hepatotoxicity Working Group of C-Path’s Predictive Safety Testing Consortium (PSTC). The research received support from the Drug-Induced Liver Injury Network (DILIN), an expert network set up in the United States by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
According to the letters, the markers show potential for use in humans and call for more exploration and data. They encourage scientists to gather further results from nonclinical and exploratory clinical studies, while research continues on qualifying the markers for clinical trials, in addition to standard safety tests.
SAFE-T (Safer and Faster Evidence-based Translation) was launched at the EUROTOX 2009 conference in Dresden by Prof. Hüseyin Firat, president of Firalis. The letters were issued at consortium level.
Source SAFE-T consortium and C-Path announcement, 17 October 2016.