Over the next few weeks, the FDA will identify several priority Critical Path research opportunities. Some of the projects in the list could be undertaken by one organization; some will require collaborations coordinated and supported by the FDA. For example, a major Critical Path undertaking announced today, which seeks to develop guidance on the use of standard biomarkers to predict safety in drug development, will be coordinated by the Critical Path (C-Path) Institute and carried out by a newly formed Predictive Safety Testing Partnership including: Bristol Meyers Squibb, Johnson & Johnson, Merck, Novartis and Pfizer. The FDA, while not a member of the Partnership, will assist it in an advisory capacity (see a separate press release).

"It is important to note that the list released today is meant to spur a continued dialog among industry, academia, patient and professional groups and government organizations about the research priorities that need to be accomplished in our effort to modernize the medical product development process," added Woodcock. "We believe it is crucial to build a national infrastructure to support and continually improve the Critical Path Initiative. Therefore, we must reach beyond specific opportunities and build collaborations to work together to encourage continued development of the Critical Path sciences."


About the Critical Path Initiative

Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments by creating new tools to find answers about how the safety and effectiveness of new medical products can be demonstrated in faster timeframes with more certainty, at lower costs, and with better information.

Today's report, as well as other information on the Critical Path Initiative, is available at http://www.fda.gov/oc/initiatives/criticalpath/.

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