Statistical and Genomic Challenges for Clinical Studies and Practice

Hosted by the University of Michigan Center for Statistical Genetics and GlaxoSmithKline
October 1, 2009 Michigan League Ballroom

The goal of this symposium is to educate and excite genetic researchers about genomic and statistical research questions which will further the field of pharmacogenetics. These questions include identifying genetic markers that predict drug efficacy and safety, strategies for translating discoveries into practice, and harnessing our understanding of HLA and rare variation to identify new drug targets. We hope that attendees will leave with an increased understanding of 1) the field of pharmacogenetics, 2) the hypotheses being tested and opportunities for translating findings into clinical practice, and 3) key research areas that will directly benefit pharmacogenetics research.

8:00 am	Breakfast
8:20 am	Welcome, Gonçalo Abecasis, University of Michigan and Meg Ehm, GlaxoSmithKline
8:30 am	Introduction State of the Field: How Genetics Contributes to Drug Discovery and Treatment Vincent Mooser, GlaxoSmithKline (30 min + 10 min questions), slides Pharmacogenetics in medicine: Barriers, Critical Factors and a Framework for Dialogue Issam Zineh, Food and Drug Administration (30 min + 10 min questions), slides
9:50 am	Break
10:20 am	Cutting Edge Tools for Genetic Research Large Scale Association Studies and Mendelian Randomization: Lipid Levels and Cardiovascular Disease Sekar Kathiresan, Massachusetts General Hospital (30 min + 10 min questions) Using Transcript Levels and Cell Culture Phenotypes to Extend Association Studies: Applications to Clinical Trials Nancy Cox, University of Chicago (30 min + 10 min questions), slides Large Scale Sequencing of Whole Genomes Gonçalo Abecasis, University of Michigan (30 min + 10 min questions), slides
12:20 pm	Lunch
1:20 pm	Designing Studies of the Impact of Genetics on Treatment Response Designing Cohorts to Study Genetics of Drug Safety Mariam Molokhia, London School of Hygiene and Tropical Medicine (30 min + 10 min questions), no slides Interpretation of Genomic Data: Problems and Pitfalls in Translating Laboratory Observations to Clinical Utility Richard Simon, National Cancer Institute (30 min + 10 min questions), slides
2:40 pm	Break
3:00 pm	Genetic Markers of Drug Efficacy and Safety Recent Research Advances in Drug-Induced Liver Injury Timothy Wright, Novartis Institutes of BioMedical Research (30 min + 10 min questions), slides What Have We Learned from the Study of HIV Susceptibility and Treatment Amalio Telenti, University of Lausanne and Ragon Institute, Boston (30 min + 10 min questions, slides)
4:20 pm	Closing Discussion Michael Boehnke, University of Michigan Possible topics for discussion: Can genetics deliver beyond new biological targets? How can we improve the utility of targets discovered in genetic studies? When will it be useful to use genetic data to tailor individual treatment? What methodological developments will expand use of genetic data in clinical settings? What is needed to facilitate the use of genetic data in clinical trial design? What tools, methodological or study design advances, are needed to turn findings into clinical practice? What are the key scientific questions to be addressed which would have an impact on labeling or reimbursement? What are some of the limitations/gaps of our knowledge and what would we gain by filling them?
5:00 pm	Reception
6:00 pm	Adjourn