Development and regulatory strategies for drug and diagnostic co-development. (December 2010)

• Record Type: Journal Article
• Authors: Hinman, Lois M; Carl, Kevin M; Spear, Brian B; Salerno, Ronald A; Becker, Robert L; Abbott, Brian M; Kelly, James F; Mansfield, Elizabeth; Katz, Russell G; Harper, Courtney; Day, Stephen P; Pacanowski, Michael A; Pignato, William
• Is Part Of: Pharmacogenomics. Volume 11:Number 12(2010)
• Page Start: 1669
• Page End: 1675
• Publication Date: 2010-12
• Subjects: biomarkers -- co-development pharmacogenomics -- companion diagnostics -- drug/diagnostic; Pharmacogenomics -- Periodicals; 615.1
• DOI: 10.2217/pgs.10.141
• Languages: English
• ISSNs: 1462-2416

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.