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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary (2009)
Board on Health Sciences Policy (HSP)

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. "Appendix A: Workshop Agenda." Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press, 2009.

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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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