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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
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
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 WORKSHOP OBJECTIVES
ROBERT CALIFF (Forum Member)
Duke University Medical Center
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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
8:15–10:15
MORNING SESSION—ASSESSING THE CURRENT STATE OF BIOMARKERS TO PREDICT DRUG-INDUCED TOXICITY.
What is the current state of the art for screening technologies to find off-target effects early in development—what have we been able to accomplish, and what remains to be done?
What are the obstacles impeding progress?
How can these efforts be accelerated through public and private means?
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
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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
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
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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
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
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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
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 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.
Moderator:
ROBERT CALIFF (Forum Member)
Duke University Medical Center
3:30–3:45
Regulatory Considerations for Validation and Qualification of 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
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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
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 Drug Safety Prediction and Assessment
How can we develop more efficient approaches to biomarker evaluation and qualification in animals and humans?
What potential policies could be enacted to help guide this effort?
How could these efforts be advanced through public or private means?
5:30
ADJOURN
