Genomic Biomarkers Impact on Drug Discovery and Clinical Practice

Organizer(s): Stephen H. Friend and Lawrence J. Lesko

Sponsored by Merck Research Laboratories

Summary of Meeting:

The past five years has seen a series of advances in the development of various DNA, RNA and protein biomarkers. Many of these biomarkers have evolved past simply being evidence in proof-of concept studies. Starting from variations in DNA, to alterations in the levels of genes expressed and functional proteins, investigators are now shifting attention to the implementation of these emerging technologies in drug development, academic research and clinical practice. This symposium will focus on bringing the developers of these genomic technologies together with the scientists and clinicians expecting to use them in research and in drug development, and the regulatory scientists charged with assessing their appropriate usage in the marketplace. We will focus on two themes. The first theme will be to exemplify how diverse methods to track DNA, RNA, and protein changes have come to rely on sophisticated techniques of pattern recognition bringing up questions of how best to validate these methods and present their results. The second theme is to compare and contrast the strategies needed to develop biomarkers of disease phenotype from intermediate genomic response markers, from other markers such as genome-based predictive markers. We will discuss the similarities and differences between genomic biomarkers and traditional non-genomic biomarkers that are important to clinical research, drug development and regulatory decision-making.

Discounted Abstract Deadline: September 25 2003

Discounted Registration Deadline: November 26 2003

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