BIOMARKERS IN CANCER THERAPEUTICS

Objectives

• Assess the use of imaging modalities as correlates to physiologic markers
• Evaluate various approaches used to identify cellular markers of disease state, progression of disease, and therapeutic competence (efficacy)
• Determine research needs for the advancement of marker identification useful in the identification of early cancer detection and cancer therapeutic drug targets
• Identify other technological approaches that will provide opportunities for developing more and better biomarkers to measure therapeutic efficacy
• Examine the roles of industry, academia, and government in the development of toxicity biomarkers
• Determine the current barriers impeding the development of biomarkers for cancer therapeutics

Agenda

Introduction and Overview
Albert F. LoBuglio, M.D.

Biomarkers and the Impact on Drug Development

Biomarker Analysis in Human Carcinomas Subsequent to Epidermal Growth Factor-Receptor Blockade Therapy Alone and in Combination With Cytotoxic Agents
Robert Radinsky, Ph.D., University of Texas M.D. Anderson Cancer Center

Biochemical Endpoints in Mechanism-Based Clinical Cancer Trials
James K.V. Willson, M.D., University Hospitals of Cleveland and Case Western Reserve University

Practical Issues in Current Drug Development: The Gross Philadelphia Chromosome as a Chronic Myelogenous Leukemia Surrogate Endpoint; Progression-Free Survival as an Endpoint for Tumoristatic Therapies
Robert J. Spiegel, M.D., Schering-Plough Research Institute

HER2 Testing: Use of a Biomarker To Select Therapy
Susan D. Hellmann, M.D., M.P.H., Genentech, Inc.

Biomarker Application in the Assessment of Cellular Mechanisms

Biomarkers and Angiogenesis—A Tabula Rasa
Thomas Boehm, Ph.D., Children’s Hospital and Harvard Medical School

Prognostic Markers
Donald Berry, Ph.D., Duke University

Technology Interface With Pathophysiology

Radiolabeled Probes as a Tool for the Assessment of Receptor Expression or Vascularity
Albert F. LoBuglio, M.D.

Assessing the Effects of Antiangiogenic Therapy on Tumor Vasculature and Metabolism Using Functional Imaging
Steven K. Libutti, M.D., National Cancer Institute

Summary
James M. Pluda, M.D.
Albert F. LoBuglio, M.D.
S. Percy Ivy, M.D.

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