Clinical
Pharmacology Subcommittee (CPSC)
of the
Advisory
Committee for Pharmaceutical Science (ACPS)
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 |
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 |
Shiew-Mei Huang, Ph.D. Deputy Director for
Science, OCPB |
FDA Pharmacogenetic
Labels: A Clinical Perspective |
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 |
Brian F. Gage, M.D.,
M.Sc. |
Commentary on Current
Status and Next Steps with Integrating PGx Information into Safe and
Effective Prescribing of Warfarin |
Michael
D. Caldwell, M.D., Ph.D. |
Timeline for Selected
Studies Reflecting on the Use of Genotype in Dosing Warfarin [PDF] |
Michael D. Caldwell,
M.D., Ph.D. |
Committee Discussion of
Questions |
|
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 |
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 |
Yaning Wang, Ph.D. |