Commissioner’s Keynote Andrew C. von Eschenbach, MD Commissioner of the U.S. Food and Drug Administration FDA*Opening Keynote: Center for Drug Evaluation & Research Priorities for 2008 Steven Galson, MD Director, Center for Drug Evaluation and Research FDA Mary Pendergast Former Deputy Commissioner, FDA President, Pendergast Consulting Is FDA Ready to do its Job? Steven E. Nissen MD MACC Chairman, Department of Cardiovascular Medicine Cleveland Clinic Foundation What Should Industry Do to Prepare for Drug Safety Changes? Robert Clark VP-US Regulatory Affairs Pfizer Losing Sleep over REMS Scott Gottlieb, MD AEI Former Deputy Commissioner for Medical and Scientific Affairs, FDA Paying for Innovation Steve E. Phurrough, MD, MPA Director, Coverage and Analysis Group CMS Medicare Part D: The Outlook for 2008 and The Future of Pharmacy Larry Kocot Senior Advisor CMS* Robert Seidman, PharmD, MPH Founder, Doc Rock Presents Former Chief Pharmacy Officer, Wellpoint Health Networks What FDA Revitalization Means for Advertising and Promotion John Kamp Executive Director, Coalition for Healthcare Communications Follow-on Biologics: Biogenerics and the Future of the Generic Industry Kathleen Jaeger President and CEO, Generic Pharmaceutical Association (GPhA) Comparative Effectiveness Trials: Finding the Appropriate Role, and What it Means for Industry Sean S. Tunis, MD, MSc Founder and Director, Center for Medical Technology Policy CHP/PCOR Adjunct Associate Former CMS chief medical officer and director of the Office of Clinical Standards & Quality Industry’s View of the Current Political Environment The Hon. Alex M. Azar II Eli Lilly and Co.*
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