Day 1

Main Conference

Wednesday, May 27

3:00-4:00 Conference Registration

4:00-4:15 Welcoming Remarks from Conference Director

Julia Boguslavsky, Cambridge Healthtech Institute

Lawrence J. Lesko, Ph.D., F.C.P., Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Biomarker discovery and qualification remains a complex issue in the drug development and approval process.  There is an intuitive sense that biomarker-driven decisions can have a positive effect on productivity and diagnostic tests can stratify patients into subgroups with different benefit/risk ratios.  Thus, looking at past research examples can provide a solid foundation for future biomarker development strategies.  One key and very basic question is:  what does experience with biomarker development tell us about the differences between their use in efficacy, safety and dosing?

C. Thomas Caskey, M.D., F.A.C.P., Director & Chief Executive Officer, The Brown Foundation Institute of Molecular Medicine and Genetics, The University of Texas, Health Science Center at Houston

Diagnostic indicators of disease risk and pathology can be accessed with differing technologies.  Genetic risk is measured by actual causative mutations in cases of cancer and cardiovascular disease.  More recently, Genetic Association studies have identified disease risk allele associations which confirm low risk as a single determinate but in aggregate have significant risk diagnostic accuracy.  Dynamic measurements of disease risk, pathology, and therapeutic response has been made possible by serum and tissue analyte measurements by mass spectroscopy.  They have been found particularly useful in vascular disease, diabetes and cancer.  Collectively, these new approaches offer the opportunity to measure risk and its modification.

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5:15-6:30 Opening Reception in the Exhibit Hall