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 Objectives - Dr. 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 Diabetes - Dr. Alan Garber
Novel Biomarkers of Arrhythmia and Sudden Death - Dr. Christine Albert
Novel Biomarker in Heart Failure - Dr. James DeLemos
The Genomics of Inflammation - Dr. 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 Lipoprotein - Ernst Schaefer
Traditional Lipid Markers - Jean Davignon
Post-Prandial Markers - Virgil Brown
Endothelial Progenitor Cells - Colin 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 Development - Dr. 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 Update - Dr. Daniel Schultz
Drug Development Challenges - Dr. Jean-Jacques Garaud
Biomarkers - A Third Party Payer's Considerations - Dr. Naomi Aronson
Challenges for Co-development of New Medical Products: A Regulatory Perspective - Dr. 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 Endocrine - Dr. Mary Parks
Biomarker Applications in Health Canada – Radiopharmaceuticals and Biotherapeutics - Dr. 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