FDA, NIH Weigh Calls For Focus On Biomarkers, Clinical Trial Design
Inside Health Policy
June 3, 2010
Michael J. Werner- Washington
Healthcare & Life Sciences Partner Michael Werner was mentioned in an Inside Health Policy article titled, "FDA, NIH Weigh Calls For Focus On Biomarkers, Clinical Trial Design."
The article reports that FDA and the National Institutes of Health (NIH) will hold internal talks on proposals they received to accelerate the translation of biomedical research discoveries into new medical therapies, with stakeholders calling for a focus on biomarker qualification, adaptable clinical trial design and challenges surrounding co-development of drugs and diagnostics. The two agencies will also likely discuss ways to continue engaging stakeholders as they move forward on a collaborative effort they launched earlier this year to improve regulatory science. At a recent public meeting, Mr. Werner, a representative of the Alliance for Regenerative Medicine, recommended the initiative be used to promote research and commercial development of regenerative medicine.
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