Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary (2009)
Chapter: Appendix A: Workshop Agenda
Appendix A
Workshop Agenda
ASSESSING AND ACCELERATING THE DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY
NAS Keck Center, Room 100
500 Fifth Street NW, Washington DC
October 24, 2008
Objectives: The primary goals of this workshop are
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to assess the current state of the art for screening technologies to find off-target effects early in drug development—what have we been able to accomplish, and what remains to be done;
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to develop a prioritized questions list to address remaining obstacles; and
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to discuss how to accelerate the efforts through public and private means.
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8:00–8:15 |
WELCOME AND INTRODUCTION OF WORKSHOP OBJECTIVES |
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ROBERT CALIFF (Forum Member) Duke University Medical Center |
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8:15–10:15 |
MORNING SESSION—ASSESSING THE CURRENT STATE OF BIOMARKERS TO PREDICT DRUG-INDUCED TOXICITY. |
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Moderator: |
MIKHAIL GISHIZKY (Forum Member) Entelos |
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8:15–8:30 |
Overview ALASTAIR WOOD Symphony Capital, LLC |
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8:30–8:45 |
Cardiac Toxicity NORMAN STOCKBRIDGE U.S. Food and Drug Administration |
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DANIEL BLOOMFIELD Merck Research Laboratories |
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8:45–9:00 |
Hepatotoxicity PAUL WATKINS University of North Carolina at Chapel Hill |
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9:00–9:15 |
Nephrotoxicity FRANK SISTARE Merck Research Laboratories |
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9:15–10:10 |
Panel Discussion |
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10:10–10:15 |
Charge to the Breakout Groups ROBERT CALIFF (Forum Member) Duke University Medical Center |
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10:15–10:30 |
BREAK |
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10:30–12:30 |
BREAKOUT SESSION 1—PREDICTIVE BIOMARKERS FOR NEPHROTOXICITY Room 206 |
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Moderators: |
FRANK SISTARE Merck Research Laboratories |
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PRASAD DEVARAJAN Cincinnati Children’s Hospital Medical Center, University of Cincinnati |
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Panelists: |
JOSEPH BONVENTRE Harvard Medical School, Brigham and Women’s Hospital |
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FRANK DIETERLE Novartis Pharma |
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ROBERT STAR National Institute of Diabetes and Digestive and Kidney Diseases |
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MELANIE BLANK U.S. Food and Drug Administration |
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DAVID WARNOCK University of Alabama at Birmingham |
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10:30–12:30 |
BREAKOUT SESSION 2—PREDICTIVE BIOMARKERS FOR HEPATOTOXICITY Room 201 |
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Moderators: |
PAUL WATKINS University of North Carolina at Chapel Hill |
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CHRISTINE HUNT GlaxoSmithKline |
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Panelists: |
JOHN BLOOM Eli Lilly and Company |
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MARK AVIGAN U.S. Food and Drug Administration |
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LEONARD SEEFF National Institute of Diabetes and Digestive and Kidney Diseases |
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JAMES FRESTON University of Connecticut Health Center |
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10:30–12:30 |
BREAKOUT SESSION 3—PREDICTIVE BIOMARKERS FOR CARDIAC TOXICITY Room 109 |
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Moderator: |
JAY MASON University of Utah |
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Panelists: |
DANIEL BLOOMFIELD Merck Research Laboratories |
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NORMAN STOCKBRIDGE U.S. Food and Drug Administration |
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PAUL EISENBERG Amgen |
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MICHAEL DOMANSKI National Heart, Lung, and Blood Institute |
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12:30–1:45 |
LUNCH Room 100 |
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1:45–3:15 |
BREAKOUT SESSION REPORTS |
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Moderator: |
ROBERT CALIFF (Forum Member) Duke University Medical Center |
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1:45–2:00 |
Nephrotoxicity Breakout Report PRASAD DEVARAJAN Cincinnati Children’s Hospital Medical Center, University of Cincinnati |
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2:00–2:15 |
Hepatotoxicity Breakout Report JOHN BLOOM Eli Lilly and Company |
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2:15–2:30 |
Cardiac Toxicity Breakout Report ALASTAIR WOOD Symphony Capital, LLC |
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2:30–3:15 |
Panel Discussion |
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3:15–3:30 |
BREAK |
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3:30–5:30 |
AFTERNOON SESSION—COPING WITH THE INCREASED COMPLEXITY OF VALIDATING AND QUALIFYING MULTIMARKER PANELS. |
Until recently biomarkers have been developed one at a time, and at times the scientific community has debated their utility. The advent of large-scale genomic, proteomic, metabolomic, and advanced imaging technologies is changing the environment in which biomarkers are identified and assessed. During this session speakers will: explore the potential of applying cutting-edge scientific technologies to enhance prediction and detection of drug-induced toxicity; discuss integration of systems biology and computational biology into toxicity assessment in early drug development; and consider the regulatory and scientific challenges involved in the validation and qualification of multimarker panels.
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Moderator: |
ROBERT CALIFF (Forum Member) Duke University Medical Center |
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3:30–3:45 |
Regulatory Considerations for Validation and Qualification of Multimarker Panels JANET WOODCOCK (Forum Member) U.S. Food and Drug Administration |
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3:45–4:00 |
Systems Biology of Biomarkers RAVI IYENGAR Mount Sinai School of Medicine |
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4:00–4:15 |
A Future Direction of Drug Safety Assessment—North Carolina Biomarker Factory Project ROBERT CALIFF (Forum Member) Duke University Medical Center |
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4:15–4:30 |
Biomarkers for Psychiatric Drug Toxicity: Opportunities and Challenges THOMAS INSEL National Institute of Mental Health |
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4:30–5:30 |
Panel Discussion—Integration of New Science into Drug Safety Prediction and Assessment |
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5:30 |
ADJOURN |
