Public Interest/Private Sector: Collaboration and Conflict in Drug Development

Freda C. Lewis-Hall
Senior Vice President and Chief Medical Officer, Pfizer Inc.

As the most senior physician at Pfizer, Dr. Lewis-Hall leads medical, patient safety, regulatory affairs and quality assurance efforts throughout the company, as well as outreach to doctors and other medical professionals.

Prior to joining Pfizer, Dr. Lewis-Hall was at Vertex Pharmaceuticals where she was responsible for clinical and nonclinical development and both medical and regulatory affairs. Dr. Lewis-Hall managed a number of key functions, including regulatory affairs, clinical and nonclinical development, medical affairs and commercial development.

Dr. Lewis-Hall has diverse experience across multiple areas of the pharmaceutical industry. She has served as the Senior Vice President, U.S. Pharmaceuticals, Medical Affairs at Bristol-Myers Squibb. Prior to her position at Bristol-Myers Squibb, Dr. Lewis-Hall held leadership positions at Pharmacia Corporation, Eli Lilly and Company, the National Institute of Mental Health and at the Howard University College of Medicine Department of Psychiatry. Dr. Lewis-Hall received a Bachelor of Arts and Sciences in Natural Sciences from The Johns Hopkins University and her Medical Doctorate from Howard University Hospital and College of Medicine.

Jill Hartzler Warner, J. D.
Acting Associate Commissioner for Special Programs Office of the Commissioner, U.S. Food and Drug Administration

Dr. Steven E. Nissen, MACC
Chairman, Department of Cardiovascular Medicine Cleveland Clinic Foundation and Professor of Medicine at Case Western Reserve University

Steven Nissen is Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Previously, he served nine years as Vice Chairman of the Department and five years as Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center (C5), an organization that directs multicenter clinical trials.

Dr. Nissen has authored more than 300 journal articles, book chapters, and CD-ROMS, most in the field of cardiovascular imaging. He was one of the pioneers in the development of intravascular ultrasound (IVUS) and his research during the last two decades has focused on this imaging technique. Specifically, he developed the methods used to employ IVUS in the assessment of the progression and regression of coronary atherosclerosis. Dr. Nissen has served as principal investigator for 6 major trials using IVUS to assess coronary disease and is currently conducting several additional atherosclerosis studies.

Additional contributions to scientific literature include being Editor of Current Cardiology Report, Senior Consulting Editor to the Journal of the American College of Cardiology and Consulting Editor Texas Heart Institute Journal in addition to several journal board memberships and service to numerous medical journals as reviewer.  

A number of honors and recognitions have been bestowed on Dr. Nissen, including the Outstanding Scientist Award by the Cleveland Clinic in 2004. On three occasions, he received the Outstanding Teacher Award presented by the Fellows of Cardiovascular Medicine at the Cleveland Clinic. He also received an Award for Outstanding Contributions to Cardiovascular Research from the Gill Heart Institute of the University of Kentucky in 2004. In 2007, Dr. Nissen was named by Time Magazine “one of the 100 most influential people in the world” and Smart Money Magazine named him “Country’s 30 most powerful forces in business and finance”.

From March 2006 thru March 2007, Dr. Nissen served as President of the American College of Cardiology (ACC), a 34,000 member, non-profit, professional medical society, whose mission is to advocate for quality cardiovascular care - through education, research promotion, development and application of standards and guidelines - and to influence health care policy.

Dr. Nissen received his medical degree from the University of Michigan’s School of Medicine in Ann Arbor.  He completed his Internal Medicine internship and residency at the University of California, Davis in Sacramento, thereafter completing his Cardiology Fellowship at the University of Kentucky Medical Center in Lexington.

Dr. Nissen served as a member of the CardioRenal Advisory Panel of FDA for 5yrs, and as Chairman of the final year of his membership. He continues to serve as a periodic advisor to several FDA committees as a Special Government Employee.

Dr. Nissen is also known for his role in public policy discussions, particularly in the area of drug safety. He has testified in both the Senate and House of Representatives on this issue and the need to reform the Food and Drug Administration (FDA).

Michael Weber
Professor of Medicine and Associate Dean for Research, SUNY Downstate College of Medicine

He received his medical degree from Sydney University in Australia.  

His career has been focused primarily on hypertension and preventive cardiology.  He has published numerous research articles in the medical literature and has authored or edited 16 books.  Together with Dr. Suzanne Oparil, he is responsible for the widely used reference volume, Hypertension.

Dr. Weber is the Editor-in-Chief of The Journal  of Clinical Hypertension.  Dr. Weber was one of the founders of The American Society of Hypertension and has served as its President.  He also served as Chair of the ASH Hypertension Specialists Program.  He is a Fellow of The American College of Physicians, The American College of Cardiology and The American Heart Association.  He has served on the Cardiovascular and Renal Drugs Advisory Board of the Food and Drug Administration, and continues as a consultant to that Agency.  He has also served for ten years as Chairman of the Formulary Committee of a major pharmacy benefits provider serving many of the leading health plans in the United States.

His main current research interests are in clinical trials of patients at high risk of cardiovascular events or strokes.  He is also participating actively in trials in patients with metabolic disorders such as diabetes and kidney disease.   Dr. Weber currently serves on the Steering Committees of several national and international clinical outcomes trials.