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American College of Clinical Pharmacology:
Symposium 1
September 9, 2007 "FDA Critical Path: An Update from the FDA Perspective"
8:40 AM - 9:40 AM
Keynote Speaker: How the Critical Path is beginningto transform drug development and
regulatory decision: Report Card and Future Direction
Janet Woodcock, M.D., Food and Drug Administration, Rockville, MD
C. Anthony Altar, Ph.D., The Biomarkers Consortium, Foundation for the NIH,
10:45 AM - 11:30 AM
Predictive Safety Testing Consortium (PSTC) and the Molecular Assays and Targeted Therapeutics
(MATT) Consortium: Facilitating New Relationships to Solve Clinical Drug Development Problems
Raymond L. Woosley, M.D., Ph.D., The Critical Path Institute,
11:30 AM - 12:00 PM
Panel Discussion (Powell, Woodcock, Altar, and Woosley)
development and patients?
Felix Frueh, Ph.D., Food and Drug Administration,
Arthur L. Holden, Pharmaceutical Biomedical Research Consortium, Ltd.,
(Stanski, Cabell, Frueh, and Holden) 
J. Robert Powell, Pharm.D., FCP, Associate Director for Science, Office of Translational Sc., Food and Drug Administration, Silver Spring, MD Janet Woodcock, M.D., Deputy Commissioner and the Chief Medical Officer, Food and Drug Administration, Rockville, MD C. Anthony Altar, Ph.D., Director, The Biomarkers Consortium, Foundation for the NIH, Bethesda, MD Raymond L. Woosley, President & CEO, The Critical Path Institute, Tucson, AZ Donald R. Stanski, M.D., Global Head of Modeling and Simulation, Novartis Pharma AG, Basel, Switzerland Christopher H. Cabell, M.D., Director/Duke Core Echocardiography Laboratory, Duke Clinical Research Institute, Durham, NC Felix Frueh, Ph.D., Associate Director for Genomics, Food and Drug Administration (CDER), Silver Spring, MD Arthur L. Holden, Chairman & CEO, The Serious Adverse Event Consortium, Ltd., Founder, The Pharmaceutical Biomedical Research Consortium, Ltd., Deerfield, IL
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