Major collaboration by 8 pharma heavyweights

The Food and Drug Administration (FDA) of the United States has said that eight major pharmaceutical companies have agreed to share early-stage clinical data.

The Arizona-based Critical Path Institute (C-Path) revealed that Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and Schering-Plough have agreed to the Predictive Safety Testing Initiative.

“C-Path’s mission is to accelerate the development of safe medical products, and to foster education and training in applied research and regulatory sciences,” said Dr Raymond L Woosley, president and chief executive officer of C-Path.

“The Predictive Safety Testing Consortium is an excellent example of the value of the ‘neutral ground’ that C-Path creates for the industry and FDA to focus on the science that is important for drug development.”

Through the data and information sharing initiative, it is hoped that the companies involved will be able to determine which of the lab tests they have individually developed should be used by the FDA for safety screening before beginning clinical testing on humans.

C-Path was designed to confront important medical product development problems and identify where improvements could be made in public health concerns.

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