2005 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

Assessing Cardiovascular Risk and Progression

September 23-24, 2005 Bethesda, Maryland


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., FRCPC, FACC, Director, MHI Research Center Associate Professor of Medicine CIHR Chair in Atherosclerosis Montreal Heart Institute Montreal, Quebec

Welcome and Conference Objectives - Dr. Jean-Claude Tardif and Dr. Therese Heinonen

Pathogenesis of Atherothrombotic Disease and Biomarker identification - Dr. Peter Libby

Is CRP a Validated Biomarker of CV Disease? - Dr. Paul Ridker

The Role of Imaging in Disease Detection and Treatment - Dr. Jean-Claude Tardif

Markers of Aging and Dementia - Dr. Lewis Kuller

Questions and Answers- Faculty

The Need for Biomarkers in Drug DevelopmentDr. Bill Sasiela

The FDA Critical Path Initiative – Opportunities and ChallengesDr. Douglas Throckmorton

How Does the FDA Metabolism and Endocrine Department View Surrogate Endpoints? - Dr. David Orloff

Questions and Answers – Faculty and PANEL DISCUSSION

The role of Lipoproteins in Inflammation - Dr. Philip Barter

Oxidation in the Pathogenesis of Atherosclerosis - Dr. Jay Heinecke

Special Considerations in Diabetes and Metabolic Syndrome - Dr. Steven Haffner

Opportunities for the use of Biomarkers and Surrogate endpoints in the European Union - Dr. Eric Abadie

The Balance Between Safety and Efficacy:  Biomarkers as Safety Surrogates - Dr. Eric Brass

Questions and Answers – Faculty and PANEL DISCUSSION

Summary and Introduction - Dr. Jean-Claude Tardif and Dr. Peter Libby

Diagnostic and Therapeutic Synergies - Dr. Donald Black

Current Status of Disease Assessment with Carotid Ultrasound - Dr. Allen Taylor

IVUS As a Surrogate Endpoint - Dr. Steve Nissen

Palpography and Elastography as Biomarkers of Cardiovascular Disease - Dr. Ton van der Steen

Advances in Cardiovascular Imaging - Dr. Minh Nguyen

Questions and Answers- Faculty

Combined Blood Biomarkers:  Diminishing Returns or are More BetterDr. Wolfgang Koenig

Applying Genomics, Proteomics and Metabolomics Technology to Development Programs - Dr. Michael Phillips          

Questions and Answers – Faculty and PANEL DISCUSSIONS

Summary of 2 day Breakout Sessions (Session Leaders)

How should pharmacogenomics be used prospectively in clinical studies of drug safety and efficacy?

The future of diagnostics – who are the drivers?

How can we maximize the application and utility of safety biomarkers?

How should biomarkers be used in pre-clinical modeling and early dose selection?

What is a rational approach to biomarker validation?

How do you develop a drug that does not target an accepted surrogate endpoint?

Vascular imaging technologies – technical and clinical considerations?

Questions and Answers – Faculty and PANEL DISCUSSIONS

Closing Remarks - Dr. Peter Libby and Dr. Jean-Claude Tardif