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NIH, FDA Start $6.8M 'Microscope to Marketplace' Effort

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Institutes of Health and the US Food and Drug Administration today unveiled a new joint effort aimed at developing ways to translate new biomedical discoveries through regulation and into pharmacies and hospitals.

Focused on advancing and intertwining translational and regulatory science, the initiative will include the formation of a joint NIH-FDA Leadership Council to explore ways to move scientific breakthroughs "from the microscope to the marketplace," Health and Human Services Secretary Kathleen Sebelius said at a press conference at NIH today.

To support this effort, NIH and FDA have jointly pledged nearly $6.8 million over the next three years to fund research into the applicability of new technologies and approaches for development and regulatory review of medical products in areas including 'omics, systems biology, bioinformatics, rare diseases, and others.

"For more than two decades, the NIH and the FDA have been partners in many initiatives designed to improve the health of millions of Americans," NIH Director Francis Collins said in a statement today. "This collaboration, however, is the first of its kind and will use the NIH's breadth of experience as a leader in biomedical sciences to help make the translation of biomedical discoveries into effective treatments as seamless as possible."

"We've all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years," Sebelius added in the statement.

"However, much more can be done to speed the progress from new scientific discoveries to treatments for patients. Collaboration between NIH and FDA, including support for regulatory science, will go a long way to foster access to the safest and most effective therapies for the American people," she continued.

Collins said that the new Leadership Council will include six senior scientists from both of the agencies, and that the effort will "involve connectivity at NIH down through the ranks"

Over the three years of the effort, NIH will provide $2 million each year and FDA will provide $250,000 per year, Collins said.

He said that an important part of the effort will be seeking public participation from stakeholders, academics, and industry, and the NIH-FDA Leadership Council will hold a public meeting in the spring to listen to input about how the two agencies might work better together.

One stakeholder interested in new biomedical research on genetic and rare diseases, Sharon Terry, president and CEO of the Genetic Alliance, told GenomeWeb Daily News in an e-mail that such a "meaningful interagency collaboration is very significant," and that the "authenticity and vision" of Collins and Hamburg will "make this a solid foundation for real advances."

Genetic testing and pharmacogenomics are particularly ripe areas for such an effort, Terry said, because they are "both qualitative and complex."

"The exercise of understanding how to endow discovery science with regulatory sufficiency, and retool the regulatory system to be flexible, iterative, and adaptive, will yield great fruit," she added.

The research scope of the RFA "Advancing Regulatory Science through Novel Research and Science-based Technologies," will fall into five broad categories.

These categories include development of new tools for assessing medical product safety and efficacy, including point-of-care diagnostics and others; novel information technologies and statistical models that can improve product evaluation and inform regulatory decisions; strategic design of research in 'omics and systems biology to better inform regulatory decision-making and support product development; research on rare diseases and small sample size populations; and novel approaches addressing optimal study designs for clinical trials.

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