FDA Prepares To Issue Draft Biomarker Qualifications Guidance
This article was originally published in The Pink Sheet Daily
Executive Summary
The document should provide an "important boost" to employing genetic, genomic and protein-based markers to improve the efficiency of preclinical and clinical drug studies and make them more likely to succeed, Commissioner Hamburg told the Personalized Medicine Coalition.
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FDA will issue draft guidance on qualifying biomarkers for use in drug development studies within the next few months, according to Commissioner Margaret Hamburg. The document should provide an "important boost" to employing genetic, genomic and protein-based markers to improve the efficiency of preclinical and clinical drug studies and make them more likely to succeed, she told the Personalized Medicine Coalition at their Feb. 25 luncheon in Washington, D.C. The practice of, for instance, stratifying patients in a trial based on a safety or efficacy biomarker has picked up a bit in recent years, but still a small minority of markers associated with drug response have sufficient clinical validation to form the basis of a regulatory decision, FDA says. Hamburg suggested the pending draft guidance could help accelerate the growth of accepted markers. The document will "enable developers to get a clearer picture of the criteria the FDA will use to vet the usefulness of biomarkers and evaluation of clinical trial data," she said. "When you can identify biomarkers and help us set the standards for their use, then there's a whole gamut of potential promising products that can benefit." The guidelines also have important implications for development of companion diagnostics, as biomarkers applied in clinical trials may be put to use if the new medicine enters clinical practice. FDA's thinking on going from a qualified biomarker to more formal co-development of a companion diagnostic will be more directly addressed in a separate co-development draft guidance expected out this year (Also see "FDA Plans Guidance This Year On Co-Development Of Diagnostics And Drugs" - Medtech Insight, 1 Mar, 2010.). The biomarker qualification guidelines represent a next step to the agency's 2005 pharmacogenomic data submissions guidance, providing a route for drug firms to voluntarily submit exploratory genomic data to allow FDA to gain familiarity with possible marker-drug effect associations. -Sue Darcey ([email protected]) [Editor's note: This story appears courtesy of the editorial staff of 'The Gray Sheet,' your source for coverage of devices and diagnostics. For a free trial, call customer service at 800-332-2181.] |