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Genomics and rare drug reactions

Executive Summary

Genomics are an important next step to improving predictive approaches to early testing for idiosyncratic, rare drug reactions, said C. George Rochester, lead mathematical statistician for the Quantitative Safety and Pharmacoepidemiology Group at CDER, at a recent drug safety meeting hosted by DIA and PhRMA. "If we look at the field of ... statistical genetics, that has a lot of big hope; there's a lot of emphasis on genomics and the hope that genomics is going to answer maybe almost all our questions," Rochester said. While admitting that genomics won't answer every question, looking at how proteins bond and behave has a lot of promise, he said. Rochester also stressed the importance of finding a multidisciplinary approach to improving predictive markers. Issam Zineh recently replaced Felix Frueh as FDA Associate Director for Genomics in the Office of Clinical Pharmacology in the Office of Translational Sciences (1"The Pink Sheet," Nov. 3, 2008, In Brief)

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