Generating and weighing evidence in drug development and regulatory decision making: 5th US FDA–DIA workshop on pharmacogenomics. (December 2010)

• Record Type: Journal Article
• Authors: Shaw, Peter M; Zineh, Issam
• Is Part Of: Pharmacogenomics. Volume 11:Number 12(2010)
• Page Start: 1629
• Page End: 1635
• Publication Date: 2010-12
• Subjects: co-development -- diagnostics -- DNA sampling -- drug labels -- pharmaceutical company -- pharmacogenetics -- pharmacogenomics -- prospective/retrospective analysis -- regulatory -- US FDA -- workshop; Pharmacogenomics -- Periodicals; 615.1
• DOI: 10.2217/pgs.10.142
• Languages: English
• ISSNs: 1462-2416

Abstract

The 5th US FDA–Drug Industry Association (DIA) workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making', contained four major topics (tracks): 'Learning from Labels and Label Changes: How to Build Pharmacogenomics into Drug Development Programs'; 'Enabling Pharmacogenomic Clinical Trials Through Sampling'; 'Designing Pharmacogenomics Studies to be Fit for Purpose'; and 'Co-Development of Drugs and Diagnostics'. The meeting was attended by approximately 200 professionals, primarily involved in drug development and healthcare delivery. Several critical elements drove the success of the meeting: it was recognized that the enriched conversation at this workshop between regulators and drug developers was driven with less inhibition than before and with a greater scientific focus on the issues. Multiple examples in the field and broader collective experience helped more in-depth thinking of the pros and cons of implementing pharmacogenetic/genetic approaches during drug development, in the current environment. It was also noted that this field is still developing and nascent as illustrated by the paucity of actual diagnostic–drug co-development examples. Furthermore, the complexities of conducting pharmacogenetic research in global drug-development programs was acknowledged as was the need for rigorous research designs and methodologies despite these challenges.