Reactions 1095 - 1 Apr 2006

New consortium to share drugsafety testing secrets

The formation of the Predictive Safety TestingConsortium (PSTC) between The Critical Path Institute(C-Path) and five major pharmaceutical companies hasbeen announced by the US FDA. The FDA, which willassist the PSTC in an advisory capacity, says that thePSTC’s goal is to "enable pharmaceutical companies toshare knowledge and resources".

This ‘unprecedented’ sharing of internally developedpreclinical laboratory methods designed to predict thesafety of a new drug may streamline the cost and timeassociated with this process and better inform‘personalized medicine’ use, says the agency. Theannouncement detailed 76 initial research priorities onthe C-Path Opportunities List that, the FDA says, "ifaccomplished, will modernize the drug developmentprocess by 2010". The FDA says that C-Path and otherConsortium members will validate the sharedinformation, enabling the agency to form guidelines onwhich safety tests to use in the drug developmentprocess.

Dr Janet Woodcock, the FDA’s Deputy Commissionerfor Operations, says that through this collaboration,companies "will be able to learn more from smallerclinical trials, and get new, safer therapies to patientsfaster and at a lower cost".US Food and Drug Administration. FDA and the Critical Path Institute AnnouncePredictive Safety Testing Consortium. Media Release : 16 Mar 2006. Availablefrom: URL: http://www.fda.gov 809061448

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Reactions 1 Apr 2006 No. 10950114-9954/10/1095-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved