Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug or device for its safety.
-Raymond Woosley, MD, PhD
C-Path
Predictive Safety Testing Consortium (PSTC)
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PSTC special issue of Nature Biotechnology
The PSTC is a unique public-private partnership, led by the non-profit Critical Path Institute (C-Path), that brings together pharmaceutical companies to share and validate each other's safety testing methods under advisement of the Food and Drug Administration ("FDA") and its European counterpart, the European Medicines Agency ("EMA"). The 17 corporate members of the consortium share internal experience with pre-clinical and clinical safety biomarkers in six working groups: cardiac hypertrophy, kidney, liver, skeletal muscle, testicular toxicity, and vascular injury. All biomarker research programs have a strong translational focus to select new safety tools that are applicable across the drug development spectrum.
The PSTC was officially announced on March 16, 2006 by Health and Human Services Secretary Michael Leavitt, FDA Commissioner Dr. Andrew von Eschenbach, and FDA Deputy Commissioner Dr. Janet Woodcock, who identified the consortium as "unprecedented" and a "shining example" of the type of work the FDA would like to see conducted.
Background
The tests that are used to determine drug safety today have not changed in decades. Companies have developed newer safety testing methods, but these are not generally accepted by the FDA or EMA as proof of safety because the tests have not been independently validated by a third party. Also, the methods used by companies are often different, leaving regulatory scientists unclear about which methods should be preferred.
In order to find improved testing methods, C-Path has invited pharmaceutical companies to join the PSTC in which they share their internally developed methods and then test the methods developed by another member of the Consortium. Ten EMA and twenty-eight FDA scientists participate as advisors, along with more than 250 participating scientists, with C-Path serving as the "trusted third party," leading the collaborative process, collecting and summarizing the data.
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C-Path Leadership of PSTC
- Eslie Dennis, MBChB, FCP, Executive Director
- Elizabeth Gribble Walker, PhD, Director, Regulatory Strategy and Submissions
- Amanda Baker, PhD, Pharm D, Research Scientist
- Gary Lundstrom, Senior Project Manager
- Nicholas M.P. King, MS, Project Manager
- Krystal Short, Administrative Coordinator