title: Generating and weighing evidence in drug development and regulatory decision making: 5th US FDA-DIA workshop on pharmacogenomics.
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.
authors.affiliation: Merck & Co., Inc., Pharmacogenetics & Molecular Profiling, West Point, PA 19486, USA. peter_shaw3@merck.com
authors.forename: Peter M
authors.initials: PM
authors.lastname: Shaw
authors.forename: Issam
authors.initials: I
authors.lastname: Zineh
mesh_terms: D003657:Decision Making; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D033161:Government Regulation; D010597:Pharmacogenetics; D011050:Policy Making; D014481:United States; D014486:United States Food and Drug Administration