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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