Clinical Pharmacology Subcommittee (CPSC)

of the

Advisory Committee for Pharmaceutical Science (ACPS)

November 14, 2005

Slides presented at meeting

Issues: Update on previous Clinical Pharmacology Subcommittee meeting recommendations;
Topic 1A: evidence and process for translation of pharmacogenetic information
(e.g., CYP 2C9 polymorphisms) into label updates for approved products; Topic 1B: current
evidence related to the pharmacogenetics of warfarin as a potential basis for
label updates; Topic 2: a critical path pilot project in pharmacometrics (quantitative methods);
Topic 3: biomarkers in the critical path and their use in drug development and drug product labels

Update on Previous Meeting Recommendations and Background to the Topics of this Meeting [HTML] [PPT]	Lawrence Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics (OCPB), CDER, FDA
Topic 1: Translation of Pharmacogenomics (PGx) Information Into Label Updates for Approved Products
Topic 1A: Evidence and Process for Translation of Pharmacogenetic Information (e.g., CYP 2C9 polymorphisms) into Label Updates for Approved Products
How New Insights into Pharmacogenetics Lead to Revisions of Product Labels [HTML] [PPT]	Shiew-Mei Huang, Ph.D. Deputy Director for Science, OCPB
FDA Pharmacogenetic Labels: A Clinical Perspective [HTML] [PPT]	David A. Flockhart, M.D., Ph.D.
Topic 1B: Current Evidence Related to the Pharmacogentics of Warfarin as a Potential Basis for Label Updates
Evidence Supporting Relabeling of Warfarin [HTML] [PPT]	Shiew-Mei Huang, Ph.D. Deputy Director for Science, OCPB
New Insights on Warfarin: How CYP 2C9 and VKORC1 Information May Improve Benefit-Risk Ratio [HTML] [PPT]	Brian F. Gage, M.D., M.Sc. Washington University School of Medicine
Commentary on Current Status and Next Steps with Integrating PGx Information into Safe and Effective Prescribing of Warfarin [HTML] [PPT]	Michael D. Caldwell, M.D., Ph.D. Marshfield Clinic Research Foundation
Timeline for Selected Studies Reflecting on the Use of Genotype in Dosing Warfarin [PDF]	Michael D. Caldwell, M.D., Ph.D. Marshfield Clinic Research Foundation
Committee Discussion of Questions [HTML] [PPT]
Topic 2: A Critical Path Pilot Project in Pharmacometrics (Quantitative Methods)
FDA Experience with End of Phase IIa Meetings: An Attempt to Improve Drug Development Decisions [HTML] [PPT]	Robert Powell, Pharm.D. OCPB, CDER, FDA
Case Study: A Quantitative Approach to Assess a Genomic Design and a Biomarker Titration Design for a Phase III Clinical Study [HTML] [PPT]	Yaning Wang, Ph.D. OCPB, CDER, FDA