Overcoming Hurdles to Develop Clinically Validated Standardized, Quantitative, Quality Controlled, Next Generation, Multi-gene Expression Biomarker Assays Suitable for Clinical Trials

Pharmacogenomics is clearly an area of great promise, but how do we turn tomorrow's promise into today's reality? This session addresses some of the fundamental questions and regulatory hurdles that need to be addressed in the development of clinically validated and successful multi-gene expression assays for biomarkers for use in clinical trials. A comparison of three different cancer tissues analyzed with different quantitative gene expression methods. Biomarker assays to diagnose lung cancer and to evaluate a multi-gene set in normal subjects will be described.

Learning Objectives: 1. Understand the regulatory hurdles to be overcome to validate a biomarker assay for application in clinical trial assessment of new drugs and/or diagnostic tests. 2. Understand the assay development method: Measurement of gene expression using a standardized method with internal controls, application of analytical software to identify multi-gene equations, and mathematically converting gene expression numerical values into Interactive Gene Expression Indices that have higher discriminatory power than single gene expression measurements. 3. Gain exposure to studies in which biomarkers suitable for segmentation of patients in clinical trials were developed through application of a proven, standardized, quantitative, next generation, multi-gene expression assay.

Review of FDA Guidance for Pharmacogenomic Biomarker Data Submission Relative to Strengths and Weaknesses of Gene Expression Measurement Technologies
James C. Willey, MD
Professor of Medicine and Pathology
Medical College of Ohio
UNITED STATES

Controlled Human Clinical Trial to Measure a Gene Set with a Standardized and Quantitative Multi-gene Expression Measurement Assay to Determine the Normal Gene Expression Levels of These Genes in Normal Human Whole Blood Samples
Shelley Ann des Etages PhD
Principal Scientist
Pfizer Global Research and Development
UNITED STATES

Comparison of a Five-gene Biomarker in Three Different Cancer Tumor Tissues with Different Quantitative Gene Expression Methods to Meet Reproducibility, Robustness, and the Other Characteristics of the New FDA Pharmacogenomic Biomarker Guidance
Richard Deane Hockett, MD
Medical Fellow
Lilly Research Laboratories
UNITED STATES