FDA is going to fund research projects aimed at eliminating barriers to product development as part of its "critical path" initiative.

"At FDA, we are going to be reallocating and redirecting some of our limited applied research funding to reflect these new challenges," Commissioner McClellan told Research!America's annual meeting in Washington, D.C. March 16.

The initiative, outlined in a March 16 ¹ report, aims to identify the key problems that prevent products from reaching market.

The agency appears interested in modeling critical path programs after the "major success" of the orphan products grant program.

"FDA is conducting an internal review of how the successes of the orphan products development research might be applied to other kinds of critical path problems," the report says.

The report lists several areas of "opportunity" in the critical path program: pharmacogenomics and proteomics, use of pharmaco-statistical models for drug development, tools to detect heart rhythm abnormalities, and proteomic and toxicogenomic approaches to predictive safety assessment.

While there were some questions regarding industry's interest in supplying FDA with additional data concerning obstacles to drug development, Lilly CEO Sidney Taurel suggested industry would benefit from the arrangement.

"FDA is in a unique position of having access in a holistic way to all the information coming from companies on new platforms for pharmaceutical products" Taurel told Research!America. Such information could help other companies avoid "the same pitfalls," he said.

"This would result in a significant improvement in the efficiency and efficacy of clinical trials," he said.

"Our plan at FDA is to identify opportunities for targeted investment in research, gathering information internally and from outside stakeholders, our public and private partners in this process. We think that by focusing on these concrete and specific problems, we can help target the needed applied research as effectively as possible," McClellan said.

- Adam Eckstein

Agency Will Fund Research On Development Roadblocks; Orphan Drug Grants Are Model

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