The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path

The qualification of biomarkers of drug safety requires data on many compounds and nonclinical and clinical studies. The cost and effort associated with these qualifications cannot be easily covered by a single pharmaceutical company. Intellectual property associated with safety biomarkers is also held by many different companies. Consortia between different pharmaceutical companies can overcome cost and intellectual property hurdles to biomarker qualification. The Predictive Safety Testing Consortium (PSTC) is a collaborative effort between 16 different pharmaceutical companies to generate data supporting biomarker qualification. This Consortium is coordinated through the C-Path Institute, and currently has five biomarker qualification working groups engaged in this collaboration: nephrotoxicity, hepatotoxicity, vascular injury, myopathy, and non-genotoxic carcinogenicity. These working groups are aided by a data management team and a translational strategy team. Qualification studies of promising biomarkers are already progressing in several of the working groups, and results in the nephrotoxicity working group warranted a data submission to the FDA and EMEA for regulatory qualification of new nephrotoxicity biomarkers.

Section editor:Janet Woodcock – Food and Drug Administration, Rockville, MD, USA