Objectives

• Review the current status of toxicology biomarkers in drug development and clinical safety assessments
  • Do we need more information on biomarkers, and are we using our current information wisely?
• Demonstrate that biomarkers can serve as early predictors of insidious adverse effects related to chronic drug exposures
  • What is needed to establish the utility of a biomarker as an indicator of clinically significant toxicology?
• Discuss the development of genetically modified rodent models as better predictors of drug effects in humans
  • Can or should transgenic humanized models be developed in other species besides the mouse?
• Discuss the clinical application of pharmacogenetics to predict and prevent adverse drug effects
  • Do the benefits outweigh the costs/risks associated with clinical pharmacogenetic profiling?
• Identify technological approaches that will provide opportunities for developing more and better toxicology biomarkers
  • What are the roles of industry, academia, and the government in the development of toxicology biomarkers?
  • What are the current barriers to the development of toxicology biomarkers?

Agenda

Introduction
Kenneth Olden, Ph.D., Director, National Institute of Environmental Health Sciences

Presentation I
The Status of Toxicology Biomarkers and Safety Evaluation Approaches
James T. MacGregor, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Presentation II
Cardiac Troponin T as a Biomarker for Monitoring Chronic Doxorubicin Cardiomyopathy
Eugene H. Herman, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Steven Lipshultz, M.D., University of Rochester Medical Center

Presentation III
Preclinical Toxicology Model: Comparing Different Human Variant Alleles in a Mouse Model
Daniel W. Nebert, M.D., University of Cincinnati Medical Center

Pharmacogenetics as Applied to Human Drug Safety Testing
Richard M. Weinshilboum, M.D., Mayo Clinic and Foundation

The Role of Mass Spectrometry in the Development of Biomarkers
Ian A. Blair, Ph.D., University of Pennsylvania

Toxicogenomics in Safety Assessment
Ronald D. Tyler, D.V.M., Ph.D., GlaxoWellcome Company, United Kingdom

Presentation IV
Gene Expression Analysis for Toxicology: Moving Beyond Phenomenology
Spencer B. Farr, Ph.D., Phase I Toxicology

Summary of Session Recommendations
Jason D. Morrow, M.D.
Frank Sistare, Ph.D.

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