2006 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

September 18-20, 2006

Program

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

Keynote address -  Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs, United States Food and Drug Administration

Pathogenesis of Atherothrombotic Disease and Biomarker identification -  Dr. Peter Libby (Brigham and Women’s Hospital)

Biomarkers in Acute Coronary Syndrome - Dr. David Morrow (TIMI Study Group, Brigham and Women’s Hospital)

Thrombosis: New Strategies for Anti-thrombotic Therapies - Dr. Bruce Furie (Harvard Medical School)

Biomarkers in Diabetes, Metabolic Syndrome and Renal Disease - Dr. Steven Haffner (University of Texas Health Centers)

Biomarkers in Heart Failure - Dr. James De Lemos (University of Texas-Southwestern Medical School)

Novel Cardiovascular Biomarkers - Dr. Marc Pfeffer (Brigham and Women’s Hospital)

Biomarkers in Cerebrovascular Disease - Dr. Pierre Amarenco (Bichat- Claude Bernard University Hospital)

EXPERT PANEL DISCUSSIONS –Moderators: Peter Libby and Allan Jaffe (panelists include J.C. Tardif, D. Morrow, B. Furie, S. Haffner, J. De Lemos, M. Pfeffer, P. Amarenco, and E. Rimm)

Tuesday, September 19th

Biomarker Discovery and The Challenges of Validation - Dr. Robert Gerszten (Massachusetts General Hospital)

Surrogate Endpoints in Clinical Trials - Dr. Paul Ridker (Brigham and Women’s Hospital)

Markers of Dysfunctional HDL in Coronary Artery Disease - Dr. Jay Heinecke (University of Washington)

Lipoproteins and Other Related Risk Factors - Dr. H. Bryan Brewer (Cardiovascular Research Institute)

Genomic Biomarker Validation and Pharmacogenomic Initiatives at the FDA - Dr. Federico Goodsaid (FDA Office of Clinical Pharmacology)

Targeted Molecular and Cellular Imaging - Dr. Jonathan Lindner (Division of Cardiovascular Medicine)

EXPERT PANEL DISCUSSIONS – Moderators: Philip Greenland and Paul Ridker (panelists include R. Gerszten, J. Heinecke, H. B. Brewer, F. Goodsaid, J. Lindner, J. C. Tardif, P. Libby, R. Krauss, and F. Sacks)

The Role of Imaging in Disease Detection and Treatment - Dr. Jean-Claude Tardif (Montreal Heart Institute)

Measures of Cardiac Structure and Function by MRI - Dr. Joao Lima (Johns Hopkins Medical School)

Current Status of Disease Assessment with Carotid Ultrasound - Dr. Allen Taylor (Walter Reed Army Medical Center)

Cardiac CT and CT/PET - Dr. Zahi Fayad (Mount Sinai School of Medicine)

Special Considerations Based on Gender, Age and Ethnicity - Dr. Michelle Albert (Harvard Medical School)

New Insights Based on Technological Advances and Landmark Trials - Dr. Robert Harrington (Duke University)

EXPERT PANEL DISCUSSIONS – Moderators: Jean-Claude Tardif and Joao Lima (panelists include A. Taylor, Z. Fayad, M. Albert, R. Harrington, P. L’Allier, P. Libby, and L. Appel)

Wednesday, September 20th

The FDA Critical Path Initiative – Opportunities and Challenges - Dr. Douglas Throckmorton (FDA Cardio-Renal)

The Need for Biomarkers in Drug Development - Dr. David G. Orloff (former FDA/Medpace)

The Use of Biomarkers for FDA Regulatory Decision Making – Metabolism and Endocrine - Dr. Mary Parks (FDA Metabolism and Endocrine)

The Use of Biomarkers for FDA Regulatory Decision Making – Cardio-Renal - Dr. Norman Stockbridge (FDA Cardio-Renal)

Canadian Regulatory View on Cardiovascular Biomarkers and Surrogate Endpoints in Clinical Trials - Dr. Timao Li (Health Canada Cardio-Renal)

European Regulatory View on Cardiovascular Biomarkers and Surrogate Endpoints in Clinical Trials - Dr. Clemens Mittmann (Federal Institute for Drug and Medical Devices)

The Use of Biomarkers for FDA Regulatory Decision Making - Health Claims - Dr. Paula Trumbo (FDA Nutrition Science Evaluation)

EXPERT PANEL DISCUSSIONS – Moderators: Robert Harrington and Eric Brass (panelists include D. Throckmorton, D. Orloff, M. Parks, N. Stockbridge, T. Li, C. Mittmann, and P. Trumbo)

Integrating Biomarkers into Practice: The Need for Data on Clinical Outcomes - Dr. Gurvaneet Randhawa (US Agency for Healthcare Research and Quality)

Clinical Application of Biomarkers - Dr. Robert Balaban (NHLBI/NIH)

NIH Cardiovascular Biomarker Initiatives - Dr. Christopher O’Donnell (NHLB I/NIH)

The Balance Between Safety and Efficacy: Biomarkers as Safety Surrogates - Dr. Eric Brass (UCLA Medical Center)

EXPERT PANEL DISCUSSIONS – Moderators: Jean-Claude Tardif and Peter Libby (panelists include G. Randhawa, R. Balaban, C. O’Donnell, E. Brass, P. Greenland, and M. Prescott)

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