ABSTRACT
At the 5th FDA-Drug Industry Association (DIA) Workshop on 'Pharmacogenomics in Drug Development and Regulatory Decision Making', track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit-risk paradigm for new drugs.
Subject(s)
Biomarkers, Pharmacological , Diagnostic Techniques and Procedures , Drug Design , Drug Industry , Government Regulation , Pharmacogenetics/methods , Biomarkers, Pharmacological/analysis , Diagnostic Techniques and Procedures/standards , Drug Industry/standards , Pharmacogenetics/legislation & jurisprudence , United States , United States Food and Drug AdministrationABSTRACT
The 4th US FDA/Industry workshop, in a series on Pharmacogenomics, was on 'Biomarkers and Pharmacogenomics in Drug Development and Regulatory Decision Making' and was held on December 10-12, 2007 in Bethesda, MD, USA, with clear objectives to continue the dialogue that began in 2002 for enabling the use of biomarkers and pharmacogenomics in drug development and regulatory decision-making. This brief commentary will highlight the major topics and outcomes discussed at this meeting that was jointly sponsored by the FDA, The Pharmacogenomics Working Group (PWG), The Pharmaceutical Research and Manufacturers of America (PhRMA), The Biotechnology Industry Organization (BIO) and The Drug Information Association (DIA).
Subject(s)
Drug Design , Pharmacogenetics , Animals , Biomarkers, Pharmacological/analysis , Humans , United States , United States Food and Drug AdministrationSubject(s)
Drug Approval/legislation & jurisprudence , Pharmacogenetics/legislation & jurisprudence , United States Food and Drug Administration/legislation & jurisprudence , Animals , Drug Approval/methods , Humans , Pharmacogenetics/standards , United States , United States Food and Drug Administration/standardsSubject(s)
Decision Making , Drug Design , Genomics , Research Design/standards , Animals , Clinical Trials as Topic/standards , Genomics/legislation & jurisprudence , Genomics/methods , Genomics/standards , Government Regulation , Humans , Pharmacogenetics/legislation & jurisprudence , Pharmacogenetics/methods , Pharmacogenetics/standards , Policy Making , United States , United States Food and Drug AdministrationABSTRACT
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.
