Reactions 1095 - 1 Apr 2006 New consortium to share drug safety testing secrets The formation of the Predictive Safety Testing Consortium (PSTC) between The Critical Path Institute (C-Path) and five major pharmaceutical companies has been announced by the US FDA. The FDA, which will assist the PSTC in an advisory capacity, says that the PSTC’s goal is to "enable pharmaceutical companies to share knowledge and resources". This ‘unprecedented’ sharing of internally developed preclinical laboratory methods designed to predict the safety of a new drug may streamline the cost and time associated with this process and better inform ‘personalized medicine’ use, says the agency. The announcement detailed 76 initial research priorities on the C-Path Opportunities List that, the FDA says, "if accomplished, will modernize the drug development process by 2010". The FDA says that C-Path and other Consortium members will validate the shared information, enabling the agency to form guidelines on which safety tests to use in the drug development process. Dr Janet Woodcock, the FDA’s Deputy Commissioner for Operations, says that through this collaboration, companies "will be able to learn more from smaller clinical trials, and get new, safer therapies to patients faster and at a lower cost". US Food and Drug Administration. FDA and the Critical Path Institute Announce Predictive Safety Testing Consortium. Media Release : 16 Mar 2006. Available from: URL: http://www.fda.gov 809061448 1 Reactions 1 Apr 2006 No. 1095 0114-9954/10/1095-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

New consortium to share drug safety testing secrets

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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