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Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA‐PWG‐PhRMA‐DruSafe Workshop
Author(s) -
Lesko Lawrence J.,
Salerno Ronald A.,
Spear Brian B.,
Anderson Donald C.,
Anderson Timothy,
Brazell Celia,
Collins Jerry,
Dorner Andrew,
Essayan David,
GomezMancilla Baltazar,
Hackett Joseph,
Huang ShiewMei,
Ide Susan,
Killinger Joanne,
Leighton John,
Mansfield Elizabeth,
Meyer Robert,
Ryan Stephen G.,
Schmith Virginia,
Shaw Peter,
Sistare Frank,
Watson Mark,
Worobec Alexandra
Publication year - 2003
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270003252244
Subject(s) - pharmacogenomics , pharmacogenetics , drug development , regulatory agency , medicine , regulatory science , pharmaceutical industry , drug , pharmacology , political science , biology , genetics , public administration , gene , genotype , pathology
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.