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 OFBIOMARKERS 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
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;
to develop a prioritized questions list to address remaining obstacles; and
to discuss how to accelerate the efforts through public and private means.
8:00–8:15 | WELCOME AND INTRODUCTION OF WORKSHOPOBJECTIVES |
| ROBERT CALIFF (Forum Member) Duke University Medical Center |
8:15–10:15 | MORNING SESSION—ASSESSING THE CURRENT STATE OF BIOMARKERSTO PREDICT DRUG-INDUCED TOXICITY. |
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Moderator: | MIKHAIL GISHIZKY (Forum Member) Entelos |
8:15–8:30 | Overview ALASTAIR WOOD Symphony Capital, LLC |
8:30–8:45 | Cardiac Toxicity NORMAN STOCKBRIDGE U.S. Food and Drug Administration |
| DANIEL BLOOMFIELD Merck Research Laboratories |
8:45–9:00 | Hepatotoxicity PAUL WATKINS University of North Carolina at Chapel Hill |
9:00–9:15 | Nephrotoxicity FRANK SISTARE Merck Research Laboratories |
9:15–10:10 | Panel Discussion |
10:10–10:15 | Charge to the Breakout Groups ROBERT CALIFF (Forum Member) Duke University Medical Center |
10:15–10:30 | BREAK |
10:30–12:30 | BREAKOUT SESSION 1—PREDICTIVE BIOMARKERS FOR NEPHROTOXICITY Room 206 |
Moderators: | FRANK SISTARE Merck Research Laboratories |
| PRASAD DEVARAJAN Cincinnati Children’s Hospital Medical Center, University of Cincinnati |
Panelists: | JOSEPH BONVENTRE Harvard Medical School, Brigham and Women’s Hospital |
| FRANK DIETERLE Novartis Pharma |
| ROBERT STAR National Institute of Diabetes and Digestive and Kidney Diseases |
| MELANIE BLANK U.S. Food and Drug Administration |
| DAVID WARNOCK University of Alabama at Birmingham |
10:30–12:30 | BREAKOUT SESSION 2—PREDICTIVE BIOMARKERS FOR HEPATOTOXICITY Room 201 |
Moderators: | PAUL WATKINS University of North Carolina at Chapel Hill |
| CHRISTINE HUNT GlaxoSmithKline |
Panelists: | JOHN BLOOM Eli Lilly and Company |
| MARK AVIGAN U.S. Food and Drug Administration |
| LEONARD SEEFF National Institute of Diabetes and Digestive and Kidney Diseases |
| JAMES FRESTON University of Connecticut Health Center |
10:30–12:30 | BREAKOUT SESSION 3—PREDICTIVE BIOMARKERS FOR CARDIAC TOXICITY Room 109 |
Moderator: | JAY MASON University of Utah |
Panelists: | DANIEL BLOOMFIELD Merck Research Laboratories |
| NORMAN STOCKBRIDGE U.S. Food and Drug Administration |
| PAUL EISENBERG Amgen |
| MICHAEL DOMANSKI National Heart, Lung, and Blood Institute |
12:30–1:45 | LUNCH Room 100 |
1:45–3:15 | BREAKOUT SESSION REPORTS |
Moderator: | ROBERT CALIFF (Forum Member) Duke University Medical Center |
1:45–2:00 | Nephrotoxicity Breakout Report PRASAD DEVARAJAN Cincinnati Children’s Hospital Medical Center, University of Cincinnati |
2:00–2:15 | Hepatotoxicity Breakout Report JOHN BLOOM Eli Lilly and Company |
2:15–2:30 | Cardiac Toxicity Breakout Report ALASTAIR WOOD Symphony Capital, LLC |
2:30–3:15 | Panel Discussion |
3:15–3:30 | BREAK |
3:30–5:30 | AFTERNOON SESSION—COPING WITH THE INCREASED COMPLEXITYOF VALIDATING AND QUALIFYINGMULTIMARKER 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.
Moderator: | ROBERT CALIFF (Forum Member) Duke University Medical Center |
3:30–3:45 | Regulatory Considerations for Validation and Qualificationof Multimarker Panels JANET WOODCOCK (Forum Member) U.S. Food and Drug Administration |
3:45–4:00 | Systems Biology of Biomarkers RAVI IYENGAR Mount Sinai School of Medicine |
4:00–4:15 | A Future Direction of Drug Safety Assessment—North Carolina Biomarker Factory Project ROBERT CALIFF (Forum Member) Duke University Medical Center |
4:15–4:30 | Biomarkers for Psychiatric Drug Toxicity:Opportunities and Challenges THOMAS INSEL National Institute of Mental Health |
4:30–5:30 | Panel Discussion—Integration of New Science into DrugSafety Prediction and Assessment |
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5:30 | ADJOURN |
