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)
 |
The PSTC brings together pharmaceutical companies to share and validate each other's safety testing methods under the advisement of the FDA (Food and Drug Administration), its European counterpart, the EMA (European Medicines Agency), the PMDA (Japanese Pharmaceutical and Medical Devices Agency).
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.
The tests used to determine drug safety have not changed in decades. Although companies have developed newer safety testing methods, these are not generally accepted by the FDA or EMA as proof of safety. This is due, in part, because the methods used for testing are often different from company to company. That discrepancy leaves regulatory scientists uncertain about which methods should be preferred. Another key factor is that the tests have not, in the past, been independently validated. PSTC now fills that important role and serves as a neutral third party to assess drug safety tests.
PSTC's eighteen corporate members have the same goal: to find improved safety testing methods. The members share their internally developed methods and test these methods developed by one another across the Consortium. Ten EMA and twenty-eight FDA scientists serve as advisors along with more than 250 participating scientists. C-Path leads the collaborative process and collects and summarizes the data.
The testing is done 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.
C-Path Leadership of PSTC
- Elizabeth Gribble Walker, PhD, Interim Director of PSTC
- Amanda Baker, PhD, Pharm D, Research Scientist
- Martin R. Cisneroz, MPH, Data Manager
- Nicholas M.P. King, MS, Project Manager
- Gary Lundstrom, Senior Project Manager
- Krystal Short, BS, Project Coordinator
The FNIH Biomarkers Consortium Launches Project to
Improve Diagnosis of Kidney Injury
Syapse to Work With Predictive Safety Testing Consortium Working Group
Critical Path Institute and Innovative Medicines Initiative
Announce Formal Collaboration
Japanese PMDA announces first ever biomarker qualification decision
PSTC special issue of Nature Biotechnology
This material is based upon works supported by Science Foundation Arizona under grant No. SRG 0335-08.
The opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Science Foundation Arizona.