2004 Cardiovascular Biomarkers and Surrogate Endpoints Sympoium

Assessing Cardiovascular Risk and Progression

September 10-11, 2004 Bethesda, Maryland


Introduction - The Need for Biomarkers in Drug Development - Dr. Therese Heinonen

Providing a forum for leaders in academia, industry and regulatory affairs to review and discuss  evidence regarding the use of cardiovascular biomarkers as surrogate endpoints.

CO-CHAIRS: Peter Libby, M.D. Mallinckrodt Professor of Medicine Harvard Medical School and
Chief Cardiovascular Medicine Brigham and Women’s Hospital Boston, Massachusetts; Jean-Claude Tardif, M.D. Director of Research CIHR Research Chair in Atherosclerosis Montreal Heart Institute Montreal, Quebec

objectives of this program are to: 
1) Examine the biology of plaque, and tools to assess cardiovascular risk
2) Identify current issues surrounding the application of biomarkers in a setting of drug development
3) Provide an opportunity for representatives from academia, government and industry to address and debate various aspects of cardiovascular biomarker utility
4) Identify new perspectives on biological markers of cardiovascular risk and disease progression


Eric Abadie, M.D., European Medicines Agency (EMEA) Paris, France - EU view on surrogate endpoints
Todd Anderson, M.D., Foothills Hospital -  Characteristics of a Biomarker The working hypotheses for the study of endothelial function in humans:
Guy Beaulieu, M.D., Health Canada
B. Greg Brown, M.D., Ph.D., University of Washington Medical Center
Chris Cannon, M.D., Brigham and Women’s Hospital
Pim de Feyter, M.D., University Hospital Rotterdam
Thomas Hatsukami, M.D., University of Washington - Magnetic Resonance Imaging of the High-Risk Atherosclerotic Plaque

Stanley Hazen, M.D., Ph.D., The Cleveland Clinic -  Linking Inflammation, Oxidation and Cardiovascular Disease: Myeloperoxidase and NO-derived Oxidants

Jay Heinecke, M.D., University of Washington School of Medicine -  Oxidized HDL in Atherogenesis

Robert A. Harrington, M.D., Duke University Medical Center -  Acute Coronary Syndromes

John Kastelein, M.D., Ph.D., University of Amsterdam -  Carotid IMT – A CAD surrogate?
Claude Lenfant, M.D., Former Director National Heart, Lung, and Blood Institute - A Tale of two Clinical Trials
Ray Lipicky, M.D., Former Director U.S. Food and Drug Administration -  The Pharma/Regulatory Interface

George Mensah, M.D., Centers for Disease Control and Prevention -   Application to Clinical Practice & Public Health

Elizabeth Nabel, National Institutes of Health
Steve Nissen, M.D., The Cleveland Clinic Foundation
David Orloff, M.D., U.S. Food and Drug Administration -  DMEDP view of surrogates

Michael Phillips, Ph.D., Genome Québec/McGill Univ. Innovation Centre - Pharmacogenomics: Medicine and Genetics - Future or Present? 

Daniel Rader, M.D., University of Pennsylvania School of Medicine -  Lipoproteins and other related risk factors
Paolo Raggi, M.D., Tulane University School of Medicine
Paul Ridker, M.D., Brigham and Women’s Hospital
George Steiner, M.D., Toronto General Hospital
Douglas Throckmorton, M.D., U.S. Food and Drug Administration -  A Regulator’s View
Bram Zuckerman, M.D., U.S. Food and Drug Administration - Vulnerable Plaque and Device Development - FDA CDRH Perspective