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about us 2007 Cardiovascular Biomarkers and Surrogate Endpoints Symposium
N. Bethesda, Maryland, USA
October 17-19, 2007
As a service to our meeting attendees, the following presentation materials are available for viewing. Please note that material availability is at the discretion of our participating faculty.
Day 1 - Oct. 17th
Day 2 - Oct. 18th
Day 3 - Oct. 19th
Login Required to View Materials - Symposium Registrants will receive a username and password at the time of registration
Introduction Pathogenesis of Atherothrombotic Disease and Biomarker Identification Applications of Systems Biology to Biomarkers Indicators of Risk in Patients with Type 2 Diabetes Novel Biomarkers of Arrhythmia and Sudden Death Novel Biomarkers in Heart Failure The Genomics of Inflammation Novel Biomarker Approaches for CAD The Development of Novel In Vitro Diagnostics The Critical Path Initiative and Priority List Questions and Answers – Faculty and PANEL DISCUSSIONS PARALLEL BREAKOUT SESSIONS |
Session 1 – Cardiovascular Imaging PRESENTATIONS Imaging Overview Magnetic Resonance Imaging and Computed Tomography Arterial Tonometry 3-D Carotid Ultrasound Nuclear Imaging Micro-Ultrasound EXPERT PANEL Dr. Norman Stockbridge, Division of Cardio-Renal, CDER, US FDA Dr. Robert Balaban, National Heart, Lung, and Blood Institute, NIH Dr. Douglas Throckmorton, CDER, US FDA Dr. Bram Zuckerman, Division of CV Devices, CDRH, US FDA Dr. Michael Klimas, Imaging, Merck & Co. Dr. James Zhang, Siemens Molecular Imaging Dr. Donald Black, Research and Development, GE Healthcare |
Session 2 – Lipids and Inflammation PRESENTATIONS HDL Overview Novartis-Framingham HDL Projects Traditional Lipid Biomarkers Change in Inflam. Markers in the Postprandial State Endothelial Progenitor Cells ApoB, LDL, and Particle Size EXPERT PANEL Dr. Mary Parks, Division of Metabolism and Endocrine,CDER, US FDA Dr. Alan Garber, Baylor College of Medicine Dr. James De Lemos, University of Texas-Southwestern Medical School Dr. Paul Ridker, Brigham and Women’s Hospital Dr. Michael Perelman, Schering-Plough Research Institute Dr. Bill Sasiela, Aegerion Pharmaceuticals |
Cardiovascular Molecular Imaging Markers of CV Disease: Biomarkers in Clinical Practice and Public Health Biomarkers in Model-Based Drug Development The Balance Between Safety and Efficacy: Biomarkers and Drug Safety The Cardiac Safety Research Consortium and Markers in Cario-Renal NIH Cardiovascular Genomic Initiatives NHLBI Biomarker Initiatives Biomarker Challlenges and Opportunities Diagnostic Challenges and New Directions Economic Evaluation of Biomarkers PARALLEL BREAKOUT SESSIONS |
Session 1 – Genomics, Proteomics, and Metabolomics Co-chairs: PRESENTATIONS Pharmacogenomics Collaborative Models for Biomarker Development Examining the Plasma Microparticle Proteome for Biomarker Discovery Biomarker Development EXPERT PANEL Dr. John Rioux, Montreal Heart Institute Dr. Federico Goodsaid, Office of Clinical Pharmacology, CDER, US FDA Dr. George Mensah, Centers for Disease Control and Prevention Dr. Daniel Levy, NHLBI, NIH Dr. Eric Brass, Harbor-UCLA Medical Center Dr. Jean-Jacques Garaud, Drug Development, Hoffmann-La Roche Dr. Seigo Izumo, Cardiovascular Research, Novartis |
Session 2 – Trial Design, Drug/Diagnostic Development, Case Studies PRESENTATIONS Advanced Trial Design Drug/Diagnostic Development Strategies Collaborative Model for Enhanced Drug Discovery and Development Case Studies EXPERT PANEL Dr. Mary Parks, Division of Met. and Endocrine, CDER, US FDA Dr. David Waters, University of California Dr. Douglas Throckmorton, CDER, US FDA Dr. David Orloff, Medpace Dr. Michele Mercuri, Novartis Dr. Amy Rudolph, Pfizer Dr. Gurvaneet Randhawa, Agency of Healthcare Res. and Quality Dr. Joao Lima, Johns Hopkins University |
Cardiovascular Biomarkers – Defining the Need Drug Development Challenges Challenges for Co-development of New Medical Products: A Regulatory Perspective Regulatory Considerations and Nutritional Labeling Biomarkers in Cardiovascular Device Development Biomarkers in FDA Regulatory Science – Metabolism and Endocrine Biomarker Applications in Health Canada – Radiopharmaceuticals and Biotherapeutics Biomarkers - A Third Party Payer's Considerations The European Perspective on Biomarkers and Surrogates Biomarker Qualification in FDA Regulatory Science FDA Pilot Process for Biomarker Qualification Questions and Answers/Prioritizing Biomarker Needs and Future Collaborations
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International Partnership for Critical Markers of Disease
PO Box 132200 • Ann Arbor, MI 48113
Phone: 734.929.2095
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