Clinical Pharmacology Subcommittee (CPSC)

of the

Advisory Committee for Pharmaceutical Science (ACPS)


November 15, 2005

CDER Advisory Committee Conference Room

5630 Fishers Lane, Rockville, MD


Slides presented during meeting


Topic 3:
Biomarkers in the Critical Path and Their Use in Drug Development and Drug Product Labels


Update on the Critical Path Biomarker-Surrogate Endpoint Project

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Janet Woodcock, M.D.

Deputy Commissioner for Operations, FDA


Use of Biomarker Information in Drug Product Labels to Individualize Pharmacotherapy

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Lawrence Lesko, Ph.D.

Director, OCPB, CDER, FDA


Use of Biomarkers in Clinical Development and Labeling:  An Industry Perspective

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Douglas Mayers, M.D.

Boehringer Ingelheim Pharmaceuticals, Inc.


CDRH Perspective on Analytical and Clinical

Considerations that go into a a “diagnostic test”.  Presentation of Case Studies FDA Approval of

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Steven Gutman, M.D.

Director, Office of In Vitro Diagnostics (OIVD)

Center for Devices and Radiological Health (CDRH)