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about us 2008 Symposium and Agenda
| BUILDING A FRAMEWORK FOR BIOMARKER APPLICATION September 10—12, 2008 Bethesda, MD Bethesda North Marriott Hotel and Conference Center Ballroom |
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Agenda:
| September 10, 2008 | |
| 6:15 - 7:00 PM | Reception and Opening Remarks (Jean-Claude Tardif/Peter Libby) |
| 7:00 - 10:00 PM | Session 1 – HDL CONTROVERSIES |
| Session Leaders: | Philip Barter, M.D., University of Sydney H. Bryan Brewer, M.D., MedStar Research Institute Jay Heinecke, M.D., University of Washington |
| 7:00 - 7:30 PM | HDL Overview and Recent Trials Philip Barter, M.D., University of Sydney |
| 7:30 - 8:00 PM | HDL Mimetics H. Bryan Brewer, M.D., Medstar Research Institute |
| 8:00 - 8:30 PM | Anti-inflammatory Properties of HDL Kerry-Anne Rye, Ph.D., The Heart Research Institute |
| 8:30 - 9:00 PM | When Good Cholesterol Goes Bad Jay Heinecke, M.D., University of Washington |
| 9:00 - 9:30 PM | A Mechanistic Understanding of the Anti-Atherogenic Properties of HDL: Occam’s razor revisited Alan Tall, M.D., Columbia University |
| 9:30 - 10:00 PM | Panel Discussion Christie Ballantyne, M.D., Baylor College of MedicineCarl Sparrow, Ph.D., Merck Research Laboratories Alan Tall, M.D., Columbia University Philip Barter, M.D., University of Sydney H. Bryan Brewer, M.D., Medstar Research Institute Jay Heinecke, M.D., University of Washington Kerry-Anne Rye, M.D., The Heart Research Institute Jean-Claude Tardif, M.D., Montreal Heart Institute Peter Libby, M.D., Brigham and Women’s Hospital |
| September 11, 2008 | |
| 8:00 - 8:20 AM | Opening Remarks (Jean-Claude Tardif/Peter Libby) |
| 8:20 - 11:30 AM | Session 2 – PRODUCT DEVELOPMENT AND EVIDENTIARY STANDARDS |
| Session Leaders: | Wolfgang Koenig, M.D, University of Ulm Medical Center |
| 8:20 - 8:45 AM | Systems Biology Approach to ID New Targets and Markers Robert Balaban, M.D., NIH, NHLBI |
| 8:45 - 9:10 AM | Case Studies – Type II Diabetes |
| 9:10 - 9:35 AM | Product Development – Balancing Evidence and Risk in Decision-Making Jean-Jacques Garaud, M.D., F. Hoffmann-La Roche Ltd. |
| 9:35 - 10:00 AM | Biomarkers in Drug Development and Evaluation |
| 10:00 - 10:20 AM | BREAK |
| 10:20 - 10:40 AM | Biomarkers in Device Development and Evaluation Bram Zuckerman, M.D., US FDA, CDRH |
| 10:40 - 11:00 AM | Case Studies Wolfgang Koenig, M.D., University of Ulm Medical Center |
| 11:00 - 11:30 AM | Panel Discussion Elizabeth Mansfield, M.D., US FDA CDRHMichael Perelman, M.D., Schering-Plough Benjamin Eloff, Ph.D., US FDA Office of the Commissioner Jean-Claude Tardif, M.D., Montreal Heart Institute Peter Libby, M.D., Brigham and Women’s Hospital Wolfgang Koenig, M.D., University of Ulm Medical Center Bram Zuckerman, M.D., US FDA CDRH Jean-Jacques Garaud, M.D., F. Hoffmann-La Roche Jacques Mizrahi, M.D., F. Hoffmann-La Roche Robert Balaban, M.D., NIH, NHLBI |
| 11:30 - 12:00 PM | LUNCH |
| 12:00 - 12:30 PM | Session 3 – SPECIAL IMAGING WORKSHOP |
| Session Leaders: | Jean-Claude Tardif, M.D., Montreal Heart Institute |
| 12:00 - 12:25 PM | Regulatory Considerations in Central Image Analysis |
| 12:25-12:50 PM | Regulatory Considerations in Central Image Analysis |
| 12:50 - 1:05 PM | Central Image Analysis in An Academic Core Laboratory Setting |
| 1:05 - 1:20 PM | Central Imaging Issues in the Development of Diagnostic Agents |
| 1:20 - 1:40 PM | BREAK |
| 1:40 - 1:50PM | The Qualification of Imaging Surrogate Criteria George Mills, M.D., Perceptive Informatics |
| 1:50 - 2:15 PM | The Quality Requirements for Successful Imaging in Clinical Trials: Standardization of Imaging at Clinical Sites & Harmonization of Imaging Across Multicenter Clinical Trials George Mills, M.D., Perceptive Informatics |
| 2:15 - 2:45 PM | Panel Discussion Joao Lima, M.D., Johns Hopkins UniversityZahi Fayad, Ph.D., Mount Sinai Marcelo Di Carli, M.D., Brigham and Women’s Hospital Pamela Douglas, M.D., Duke University Eric Stroes, M.D., Academic Medical Center Joel Raichlen, M.D., Astra-Zeneca Norman Stockbridge, M.D., US FDA, CDER Douglas Throckmorton, M.D., US FDA, CDER Dwaine Rieves, M.D., US FDA, CDER Robert Balaban, M.D., NIH, NHLBI Jean-Claude Tardif, M.D., Montreal Heart Institute Jonathan Allis, M.D., GE Healthcare Brandon Gallas, Ph.D., US FDA, CDRH George Mills, M.D., Perceptive Informatics |
| 3:00 - 6:00 PM | Session 4 – SAFETY BIOMARKERS |
| Session Leaders: | Norman Stockbridge, M.D., US FDA, CDER Eric P. Brass, M.D., Ph.D., Harbor-UCLA Medical Center |
| 3:00 - 3:25 PM | Biomarkers of Skeletal Muscle Injury |
| 3:25 - 3:50 PM | Differentiating Biomarkers for Drug-Induced Liver Injury |
| 3:50 - 4:15 PM | Markers of Renal Toxicity |
| 4:15 - 4:30 PM | BREAK |
| 4:30 - 4:55 PM | Biomarkers and Thrombosis |
| 4:55 - 5:20 PM | Educating Patients and Physicians About Medical Risk/Benefit Decisions |
| 5:20 - 5:50 PM | Panel Discussion Philip Sager, M.D., CardioDx, Inc.Amy Rudolph, Ph.D., Pfizer, Inc. Norman Stockbridge, M.D., US FDA, CDER Eric Brass, M.D., Ph.D., Harbor-UCLA Medical Center Peter Libby, M.D., Brigham and Women’s Hospital Jean-Claude Tardif, M.D., Montreal Heart Institute Roger Ulrich, Ph.D., Calistoga Pharmaceuticals Federico Goodsaid, M.D., US FDA, CDER Jeff Leiden, M.D., Clarus Ventures Bram Zuckerman, M.D., US FDA, CDRH James DeLemos, M.D., University of Texas – Southwestern Medical School |
| 7:00 - 10:00 PM | Session 5 – SURROGATES FOR REGULATORY APPROVAL “A 360 Degree Perspective” |
| Session Leaders: | Mary Parks, M.D., US FDA, CDER David Waters, M.D., University of California, San Francisco Allen Taylor, M.D., Walter Reed Army Medical Center |
| 7:00 - 7:10 PM | Introductory Remarks David Waters, M.D., University of California, San Francisco |
| 7:10 - 8:10 PM | FDA Case Studies (LDL-C, HDL-C, Glucose, Imaging) Mary Parks, M.D., US FDA, CDER Hylton Joffe, M.D., US FDA, CDER Eric Colman, M.D. US FDA, CDER |
| 8:10 - 9:00 PM | Clinicians’ Perspectives – Biomarker Utility and Limitations |
| 9:00 - 9:15 PM | How Does Health Canada View the Risk/Rewards of Surrogacy? Agnes Klein, M.D., Health Canada |
| 9:15 - 9:30 PM | FDA Policy on Surrogates for Regulatory Approval Robert Temple, M.D., US FDA Office of Medical Policy |
| 9:30 - 10:00 PM | Panel Discussion |
September 12, 2008 |
|
| 8:00 – 8:10 AM | Opening Remarks (Jean-Claude Tardif/Peter Libby) |
| 8:10 – 11:15 AM | Session 6 – PRODUCT DEVELOPMENT AND EVIDENTIARY STANDARDS |
| Session Leaders: | Federico Goodsaid, M.D., US FDA, CDER Christopher Cannon, M.D., Brigham and Women’s Hospital Christopher O’Donnell, M.D., NIH, NHLBI |
| 8:10 – 8:30 AM | Getting Biomarkers from There to Here: Understanding Test Performance |
| 8:30 – 8:50 AM | Biospecimens Best Practices – What are they and why do we need them? |
| 8:50 – 9:10 AM | Imaging and Analysis Methods |
| 9:10 – 9:30 AM | Statistical Considerations Gregory Campbell, Ph.D., US FDA, CDRH |
| 9:30 – 9:45 AM | BREAK |
| 9:45 – 10:05 AM | Non-Clinical Evidentiary Standards Patricia Harlow, Ph.D., US FDA, CDER |
| 10:05 – 10:25 AM | Biomarker Data – From Observational Studies to Clinical Trials Christopher O’Donnell, M.D., NIH, NHLBI |
| 10:25 - 10:45 AM | Impact of the Biomarker Qualification Project on Drug Development Federico Goodsaid, M.D, US FDA, CDER |
| 10:45 – 11:15 AM | Panel Discussion Michael Davidson, M.D., University of ChicagoChris Cannon, M.D., Brigham and Women’s Hospital Giora Feuerstein, M.D., Wyeth Research Federico Goodsaid, Ph.D., US FDA, CDER Christopher O’Donnell, M.D., NIH, NHLBI Peter Libby, M.D., Brigham and Women’s Hospital Jean-Claude Tardif, M.D., Montreal Heart Institute Elizabeth Mansfield, M.D., US FDA, CDRH Carolyn Compton, M.D., Ph.D., NIH, NCI David Brown, Ph.D., US FDA, CDER Greg Campbell, Ph.D., US FDA, CDER Paula Trumbo, Ph.D., US FDA, CFSAN Patricia Harlow, Ph.D., US FDA, CDER |
| 10:45 – 11:15 AM | BREAK |
| 11:15 - 2:00 PM | Session 7 – BIOMARKERS IN CLINICAL PRACTICE AND PUBLIC HEALTH |
| Session Leaders: | George Mensah, M.D., Centers for Disease Control and Prevention James De Lemos, M.D., University of Texas – Southwestern Medical School Gurvaneet Randhawa, M.D., US Agency for Healthcare Research and Quality |
| 11:15 – 11:30 AM | Mapping the Translation Process Gurvaneet Randhawa, M.D., US AHRQ |
| 11:30 – 11:50 AM | Challenges in Translating the Science George Mensah, M.D., CDC |
| 11:50 – 12:10 PM | Biomarkers in Population Screening and Surveillance |
| 12:10 – 12:30 PM | Individualized and Personalized Healthcare |
| 12:30 – 12:50 PM | Biomarkers and Evidence Informing Policy Decisions Mark Grant, M.D., Technology Evaluation Center, Blue Cross Blue Shield Association |
| 12:50 – 1:30 PM | Panel Discussion Colin Berry, M.D., Ph.D., NIH, NHLBI |
| 1:30 – 2:00 PM | Concluding Remarks – Peter Libby and Jean-Claude Tardif |
List of Topics:
Evaluating Biomarkers in Light of New Clinical Trial Data
Recent data on HbA1c, LDL-C, HDL-C, CRP, and BNP
Translating Science into Clinical Applications
Population Screening and Risk Stratification
Biomarker Guided Therapeutic Targets
Established and Emerging In-vitro Biomarkers and Diagnostics
Established and Emerging Imaging Technologies
Proteomics and Genomics
Lipoproteins, Inflammation, and Other Related Risk Factors
Biomarker Economics
Evidentiary Standards and Validation
Maximizing Biomarker Utility
Drug/Diagnostic Development Strategies
Biomarkers in Risk and Therapeutic Assessment
Biomarkers as Safety Surrogates
Atherothrombosis, Hypertension and Heart Failure
Use of Biomarkers and Surrogates for Regulatory Decision-Making
Cardiovascular Markers in Food Safety and Nutrition
Biomarkers in Model-Based Drug Development
NIH/NHLBI Biomarker Initiatives
Statistical Considerations in Biomarker Evaluation
Application of Systems Biology to Biomarkers
Diabetes, Obesity and Metabolic Syndrome
Molecular Imaging
Biomarker Qualification in Regulatory Science
Application of CV Markers to Clinical Practice and Public Health
Regulatory Considerations for Soluble and Imaging Biomarker Applications
Pathogenesis of Atherothrombotic Disease and Biomarker Identification
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International Partnership for Critical Markers of Disease
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