The mapping of the human genome has opened the gate for developing therapies that benefit select subsets of the population.  This plenary session will provide an introduction to pharmacogenomics and pharmacogenetics, debate the role of genotyping, present case studies where therapies are being tailored to specific genetic disposition, and discuss the role of pharmacoeconomics and outcomes research in defining the value of personalized medicine.

9:00 – 9:20 AM		Moderator/Speaker: Scott D. Ramsey MD, PhD, Full Member and Professor, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA
9:20 – 9:40 AM		Speaker: Lawrence J. Lesko PhD, FCP, Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
9:40 – 10:00 AM		Speaker: Ralph J. Coates PhD, Associate Director for Science, Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA, USA
10:00 – 10:20 AM		Speaker: Robert S. Epstein MD, MS, Chief Medical Officer and President, Medco Research Institute, Medco Health Solutions Inc., Franklin Lakes, NJ, USA
10:20 – 10:30 AM		DISCUSSION

SECOND PLENARY SESSION

Despite its tremendous growth over the past 20 years, our field has not achieved the expected impact on health technology decisions in the United States and elsewhere. A panel of medical and pharmacy directors will be asked to provide their perspective on the value of health outcomes research, including where and how research findings are being used to make coverage decisions. Panelists will also provide recommendations on the use of health outcomes research in real decisions.

11:15 – 11:20 AM		Moderator: J. Jaime Caro MDCM, FRCPC, FACP, Senior Vice President of Health Economics, United BioSource Corporation, Lexington, MA, USA
11:20 – 11:30 AM		Speaker: Albert J. Rizzoli MD, Medical Director, Presbyterian Health Plan, Albuquerque, NM, USA
11:30 – 11:40 AM		Speaker: Kenneth L. Schaecher MD, Medical Director, SelectHealth, Salt Lake City, UT, USA
11:40 – 11:50 AM		Speaker: John Watkins RPh, MPH, BCPS, Pharmacy Manager, Formulary Development, Premera Blue Cross and Clinical Associate Professor of Pharmacy, University of Washington, Seattle, WA, USA
11:50 – 12:00 PM		Speaker: Harold “Hank” H. Gardner MD, Founder, HCMS Group, Cheyenne, WY, USA
12:00 – 12:45 PM		DISCUSSION

THIRD PLENARY SESSION

Although comparative effectiveness research (CER) can be informed by synthesis of existing clinical information and analysis of observational data, randomized clinical trials (RCTs) are often needed to address real world evidence questions. However, traditionally designed RCTs are ill suited to address real world issues.  Bayesian and adaptive approaches incorporate existing pivotal trials, systematic reviews, models, observational studies into the trial design and change [or "adapt"] in response to information generated during the trial allowing for focusing on subpopulations who respond differentially. This session will provide a critical overview of these techniques and discuss the opportunities and challenges in the evolving CER environment.

10:00AM – 10:15 AM		Moderator/Speaker: Bryan R. Luce PhD, MBA, Senior Vice President, Science Policy, United BioSource Corporation, Bethesda, MD, USA
10:15AM – 10:45AM		Speaker: Keaven M. Anderson PhD, Executive Director, Clinical Biostatistics and Research Decision Sciences, Merck Research Laboratories, North Wales, PA, USA
10:45AM – 11:00AM		Speaker: Steve Slovick MBA, Partner/President, PriceSpective LLC, Blue Bell, PA, USA
11:00AM – 11:10AM		Respondent: Laurie B. Burke RPh, MPH, Director, Study Endpoint and Label Development, Center for Drug Evaluation and Research, Food & Drug Administration, Silver Spring, MD, USA
11:10AM – 11:30AM		DISCUSSION