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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
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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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×

 

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×
Page 65
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×
Page 66
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×
Page 67
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×
Page 68
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×
Page 69
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12587.
×
Page 70
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Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development.

On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

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