2007 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

A Collaborative Approach to Biomarkers

Bethesda, Maryland October 17-19, 2007

Day One:  New Insights, Advances and Practical Considerations


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

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

Applications of Systems Biology to Biomarkers - Dr. Robert Balaban

Indicators of Risk in Patients with Type 2 DiabetesDr. Alan Garber

Novel Biomarkers of Arrhythmia and Sudden Death - Dr. Christine Albert

Novel Biomarker in Heart Failure - Dr. James DeLemos

The Genomics of InflammationDr. John Rioux

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

New Developments in Soluble Biomarkers for CAD - Dr. Jean-Claude Tardif

The Development of Novel In Vitro Diagnostics - Dr. Elizabeth Mansfield

The Critical Path Initiative and Priority List - Dr. Douglas Throckmorton

Questions and Answers – Faculty and PANEL DISCUSSIONS

Breakout sessions:

Session 1 – Cardiovascular Imaging - Session co-chairs: Jean-Claude Tardif and Zahi Fayad

CV Imaging Overview - Jean-Claude Tardif
CT/MRI - Zahi Fayad
Ultrasonography - Allen Taylor
Arterial Tonometry - Gary Mitchell
3-D Carotid Ultrasound - David Spence
Advances in Nuclear Med - Rory Hachamovitch

Panelists include: Joao Lima, Norman Stockbridge, Robert Balaban, Douglas Throckmorton, Bram Zuckerman, Michael Klimas, James Zhang, Joel Raichlen and Donald Black

Session 2 – Lipids, Lipoproteins, and Inflammation - Session co-chairs: Peter Libby and Ernst Schaefer

Overview - Peter Libby
High-density LipoproteinErnst Schaefer
Traditional Lipid MarkersJean Davignon
Post-Prandial Markers - Virgil Brown
Endothelial Progenitor CellsColin Berry
ApoB, LDL and particle size - Russell Warnick

Panelists include: Mary Parks, Alan Garber, James De Lemos, Paul Ridker, Michael Perelman, and Bill Sasiela

Day Two:  Biomarker Models and Applications - Best Practices for Validation and Decision-Making

Cardiovascular Molecular Imaging - Dr. Ralph Weissleder

Biomarker Qualification for Specific Applications - Dr. John Wagner

Markers of CV Disease:  Application to Clinical Practice and Public Health - Dr. George Mensah

Biomarkers in Model-Based Drug DevelopmentDr. Robert Powell

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

The Cardiac Safety Research Consortium and Markers in Cario-Renal - Dr. Norman Stockbridge

NIH Cardiovascular Genomic Initiatives - Dr. Christopher O'Donnell

NHLBI Biomarker Initiatives - Dr. Daniel Levy
Biomarker Challlenges and Opportunities - Dr. Steven Gutman

Diagnostic Challenges and New Directions - Dr. Jonathan Allis

Economic Evaluation of Biomarkers - Dr. David Meltzer

Questions and Answers – Faculty and PANEL DISCUSSIONS

Breakout sessions:

Session 1 – Genomics, Proteomics and Metabolomics - Session co-chairs: Christopher O'Donnell and  Felix Frueh

CV Pharmacogenomics - Michael Phillips
Collaborative Models - Vincent Mooser
Biomarker Discovery - David Smalley
Biomarker Development - Bruce McManus
Biomarker Development - Giora Feuerstein

Panelists include: John Rioux, Federico Goodsaid, George Mensah, Daniel Levy, Eric Brass, Jean-Jacques Garaud and Seigo Izumo

Session 2 – Advanced Trial Design, Drug/Diagnostic Development Strategies, and Case Studies

Advanced Trial Design - Robert Califf
Drug/Diag. Dvpt Strategies - Donald Black
Case Studies - Marc Pfeffer

Panelists include: Peter Libby, David Waters, David Orloff, Jean-Claude Tardif, Michele Mercuri, Amy Rudolph, Gurvaneet Randhawa, Mary Parks, and Douglas Throckmorton

Day Three:  Priorities, Perspectives, and Overcoming Challenges

Cardiovascular Biomakers – Defining the Need - Dr. David Waters

The Biomarker Consortium UpdateDr. Daniel Schultz

Drug Development Challenges - Dr. Jean-Jacques Garaud

Biomarkers - A Third Party Payer's ConsiderationsDr. Naomi Aronson

Challenges for Co-development of New Medical Products: A Regulatory PerspectiveDr. Felix Frueh

Regulatory Considerations and Nutritional Labeling - Dr. Paula Trumbo

Biomarkers in Cardiovascular Device Development - Dr. Bram Zuckerman

Biomarkers in FDA Regulatory Science – Metabolism and EndocrineDr. Mary Parks

Biomarker Applications in Health Canada – Radiopharmaceuticals and BiotherapeuticsDr. Agnes Klein

Cardiovascular Biomarker – the European Perspective - Dr. Eric Abadie

Biomarker Qualification in FDA Regulatory Science - Dr. Federico Goodsaid
Questions and Answers – Faculty

FDA Pilot Process for Biomarker Qualification - Panel Discussion

Prioritizing Biomarker Needs and Future Collaborations: All Faculty Members