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Biomarker Development Tops Priorities for FDA s Critical Path Opportunities

NEW YORK, March 17 (GenomeWeb News) - The US Food and Drug Administration yesterday released a list of high-priority research projects for its Critical Path Initiative and highlighted biomarker development as one of the "most important areas for improving medical product development."

 

In particular, it empowered a newly formed Predictive Safety Testing Partnership to develop guidelines for biomarker use. The Partnership includes Bristol Myers Squibb, Johnson & Johnson, Merck, Novartis, and Pfizer and will be coordinated by the Critical Path Institute.

 

The Critical Path Opportunity Report  is the first specific blueprint for the agency's Critical Path Initiative, an effort to streamline the drug-approval process by applying new strategies and technologies.

 

Among the 76 projects outlined, biomarker development and clinical trial reform were areas cited by researchers as most likely to improve the efficiency of product development.

 

In a statement announcing the priority list, the FDA said it would rely on "partnerships and consortia to accomplish a majority of the projects," as well as "a new, cooperative partnership among the primary ... divisions of HHS."

 

The agency said it would identify additional specific research projects for the initiative over the next few weeks.

 

Jim Greenwood, president and CEO of the Biotechnology Industry Organization, said the Report "cited substantial opportunities for better diagnoses, more efficient drug development, and safer and more effective therapies, such as the identification and qualification of new safety and efficacy biomarkers. These advances will play an essential role in helping industry, regulators and other stakeholders deliver on the promise of personalized medicine."

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