Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 4, 2004


Presentation by Dr. Terry Blaschke, MD (HTM) (PPT)

Transition of Biomarkers to Surrogate Endpoints: A Critical Path Initiative.....Introduction, Dr. Lawrence Lesko, PhD, FCP, FDA (HTM)(PPT)

A Framework for Biomarker and Surrogate Endpoint Use in Drug Development, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)

Development of Biomarkers for Decision-Making in the Development and Regulatory Evaluation of New Drugs, Dr. John Wagner, MD, PnD, PhRMA Biomarker and Genomics Working Groups (HTM) (PPT)

Presentation by Dr. Terry Blaschke, MD (HTM) (PPT)