C-Path’s Predictive Safety Testing Consortium announces special issue of Nature Biotechnology

May 12, 2010

By Flinn Foundation

[Source: Market Watch] – A special May 10, 2010 issue of Nature Biotechnology (NBT) includes ten scientific publications from Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium’s (PSTC) evaluation of seven kidney biomarkers for use in drug safety assessment. The seven urinary proteins (KIM-1, Albumin, Total Protein, B2-microglobulin, Cystatin C, Clusterin, Trefoil Factor-3) were evaluated for their utility to outperform current tests to detect drug-induced kidney injury, i.e., BUN and serum creatinine. PSTC submitted the data to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japanese Pharmaceutical and Medical Devices Agency (PMDA) for evaluation. The FDA and EMA reached the formal conclusion that the biomarkers are considered qualified for use in regulatory decision-making for drug safety to detect acute drug-induced kidney injury in preclinical studies and, on a case by case basis after discussion with agencies, in early clinical studies in combination with standard biomarkers. A final conclusion from the PMDA is expected imminently. The biomarkers are now being used successfully to more efficiently advance or terminate drug development programs. The scientific details of the studies and analyses, as well as a description of the evolution of the qualification process at the regulatory agencies, will be reported publicly for the first time in this issue of Nature Biotechnology.

For more information: Critical Path Institute’s Predictive Safety Testing Consortium Announces Special Issue of Nature Biotechnology Dedicated to Newly Qualified Kidney Safety Biomarkers