Drug-metabolizing enzymes: evidence for clinical utility of pharmacogenomic tests.

D h n a p F s i ( t m s p t n t n d f r C i i l rom Clinical Pharmacology, AstraZeneca, Mölndal; Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis; Department of Biology (Galton Lab), University College London, London; Center for Drug Evaluation and Research, Food and Drug Administration, Rockville; School of Pharmacy, University of California San Francisco, San Francisco; Pharmacogenomics, Pfizer Global Research and Development, Groton; University of Chicago, Chicago; and University of Washington, Seattle. his commentary was based on presentations made at a Food and Drug Administration/Johns Hopkins University/Pharmaceutical Research and Manufacturers of America educational workshop, September 13, 2004, Rockville, Md. he views presented in this article do not necessarily reflect those of the Food and Drug Administration. eceived for publication June 6, 2005; accepted Aug 12, 2005. eprint requests: Shiew-Mei Huang, PhD, FCP, Deputy Office Director for Science, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002. -mail: [email protected] lin Pharmacol Ther 2005;78:559-81. 009-9236/$30.00 opyright © 2005 by the American Society for Clinical Pharmacology and Therapeutics. u oi:10.1016/j.clpt.2005.08.013 rug research and development have recently been ampered by high costs, notably high investigational ew drug (IND) failure rates and multiple new drug pplication (NDA) review cycles. The number of aplications for new molecular entities submitted to the ood and Drug Administration (FDA) has declined teadily. As part of the FDA’s strategic plan, the FDA s developing standards to apply emerging technologies eg, pharmacogenomics) to provide effective translaion of new scientific discoveries into safe and effective edical products. A recent document by the FDA tressed the following: “The product development roblems we are seeing today can be addressed, in part, hrough an aggressive, collaborative effort to create a ew generation of performance standards and predicive tools. The new tools will match and move forward ew scientific innovations and will build on knowledge elivered by recent advances in science, such as bioinormatics, genomics, imaging technologies, and mateials science.” There are various initiatives within the enter for Drug Evaluation and Research to address ssues in the area of pharmacogenomics. A guidance for ndustry on genomic data submission has been pubished. The guidance was intended to encourage volntary genomic data submission by sponsors using