HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (52) Citing Articles via Google Scholar Google Scholar Articles by Lesko, L. J. Articles by Worobec, A. Search for Related Content PubMed PubMed Citation Articles by Lesko, L. J. Articles by Worobec, A. Social Bookmarking                         What's this?

Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop

From Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, Office of Clinical Pharmacology and Biopharmaceutics (Dr. Lesko, Dr. Huang), Office of Testing and Research (Dr. Collins, Dr. Sistare), Office of New Drugs (Dr. Leighton, Dr. Meyer); WorldWide Regulatory Affairs, Wyeth Research, St. Davids, Pennsylvania (Dr. Salerno); Pharmacogenetics, Abbott Laboratories, Abbott Park, Illinois (Dr. Spear); Pharmacia Corporation, Kalamazoo, Michigan (Dr. D. Anderson, Dr. Gomez-Mancilla); Pfizer, Inc., Groton, Connecticut (Dr. T. Anderson); Genetics Research, GlaxoSmithKline, Greenford, Middlesex, England (Dr. Brazell); Wyeth Research, Andover, Massachusetts (Dr. Dorner); Wyeth Research, Chazy, New York (Dr. Killinger); Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Therapeutics, Division of Clinical Trial Design and Analysis, Rockville, Maryland (Dr. Essayan, Dr. Worobec); Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Rockville, Maryland (Dr. Hackett, Dr. Mansfield); National Institute of Health, NHGRI, and Novartis, Gaithersburg, Maryland (Dr. Ide); AstraZeneca Pharmaceuticals, Wilmington, Delaware (Dr. Ryan); GlaxoSmithKline, Research Triangle Park, North Carolina (Dr. Schmith); Pharmacogenomics and Human Genetics, Bristol-Meyers Squibb, Princeton, New Jersey (Dr. Shaw); and Clinical Genomics, Merck and Co., Inc., West Point, Pennsylvania (Dr. Watson).

The use of pharmacogenetics and pharmacogenomics in the drug development process, and in the assessment of such data submitted to regulatory agencies by industry, has generated significant enthusiasm as well as important reservations within the scientific and medical communities. This situation has arisen because of the increasing number of exploratory and confirmatory investigations into variations in RNA expression patterns and DNA sequences being conducted in the preclinical and clinical phases of drug development, and the uncertainty surrounding the acceptance of these data by regulatory agencies. This report summarizes the outcome of a workshop cosponsored by the Food and Drug Administration (FDA), the Pharmacogenetics Working Group (PWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the PhRMA Preclinical Safety Committee (DruSafe). The specific aim of the workshop was to identify key issues associated with the application of pharmacogenetics and pharmacogenomics, including the feasibility of a regulatory "safe harbor" for exploratory genome-based data, and to provide a forum for industry-regulatory agency dialogue on these important issues.

Key Words: Pharmacogenetics • pharmacogenomics • drug development process • regulatory agencies • safe harbor

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				G. Sandusky, C. Dumaual, and L. Cheng REVIEW PAPER: Human Tissues for Discovery Biomarker Pharmaceutical Research: The Experience of the Indiana University Simon Cancer Center-Lilly Research Labs Tissue/Fluid BioBank Vet. Pathol., January 1, 2009; 46(1): 2 - 9. [Full Text] [PDF]

				M. K. Pendergast Regulatory Agency Consideration of Pharmacogenomics Experimental Biology and Medicine, December 1, 2008; 233(12): 1498 - 1503. [Abstract] [Full Text] [PDF]

				D. Zhang, D. Zhang, D. Cui, J. Gambardella, L. Ma, A. Barros, L. Wang, Y. Fu, S. Rahematpura, J. Nielsen, et al. Characterization of the UDP Glucuronosyltransferase Activity of Human Liver Microsomes Genotyped for the UGT1A1*28 Polymorphism Drug Metab. Dispos., December 1, 2007; 35(12): 2270 - 2280. [Abstract] [Full Text] [PDF]

				V. L. Ellingrod and J. Moline Incorporating Pharmacogenomics into Practice Journal of Pharmacy Practice, June 1, 2007; 20(3): 277 - 282. [Abstract] [PDF]

				K. A. Phillips and S. L. Van Bebber Regulatory Perspectives on Pharmacogenomics: A Review of the Literature on Key Issues Faced by the United States Food and Drug Administration Med Care Res Rev, June 1, 2006; 63(3): 301 - 326. [Abstract] [PDF]

				D. R. Boverhof and T. R. Zacharewski Toxicogenomics in Risk Assessment: Applications and Needs Toxicol. Sci., February 1, 2006; 89(2): 352 - 360. [Abstract] [Full Text] [PDF]

				A. D McCarthy, J. L Kennedy, and L. T Middleton Pharmacogenetics in drug development Phil Trans R Soc B, August 29, 2005; 360(1460): 1579 - 1588. [Abstract] [Full Text] [PDF]

				M. Cronin, K. Ghosh, F. Sistare, J. Quackenbush, V. Vilker, and C. O'Connell Universal RNA Reference Materials for Gene Expression Clin. Chem., August 1, 2004; 50(8): 1464 - 1471. [Abstract] [Full Text] [PDF]