Personal Genomics: Establishing the Scientific Foundation for Using Personal Genome Profiles for Risk Assessment, Health Promotion, and Disease Prevention

AGENDA
A workshop sponsored by the Centers for Disease Control and Prevention (CDC), the National Cancer Institute (NCI), the National Human Genome Research Institute (NHGRI), The Office of Behavioral and Social Sciences Research (OBSSR), and the National Heart, Lung and Blood Institute (NHLBI).

December 17, 2008
Session I:	Genome Profiles, Risk Assessment, and Personalized Health: The Basics Moderator: Gregory Downing, HHS
8:30 a.m. - 8:45 a.m.	Welcome Robert Croyle, NCI Alan Guttmacher, NHGRI Denise Simons-Morton, NHLBI
8:45 a.m. - 8:50 a.m.	Meeting Objectives Muin Khoury, CDC and NCI
8:50 a.m. - 9:10 a.m.	Personal Genomics: A Systematic Review of Current Practices Kenneth Offitt, Memorial Sloan-Kettering Cancer Center
9:10 a.m. - 9:30 a.m.	Health Risk Assessment: How It Works in Other Fields and Potential Impact of Genomics Mitchell Gail, NCI
9:30 a.m. - 9:50 a.m.	What Kind of Information Do Consumers Want? Sharon Terry, Genetic Alliance Susan Friedman, FORCE
9:50 a.m. - 10:10 a.m.	What Kind of Information Do Primary Care Providers Need? What Is the Role of Evidence-Based Guidelines? Gregory Feero, NHGRI
10:10 a.m. - 10:30 a.m.	Discussion
10:30 a.m. - 11:00 a.m.	Break

Session II:	Scientific Foundation for Which Genetic Variants Should Be Included in Genomic Profiles: The Credibility of Genetic Associations Moderator: Teri Manolio, NHGRI
11:00 a.m. - 11:20 a.m.	Navigating the Epidemiology of the Human Genome Marta Gwinn, CDC
11:20 a.m. - 11:40 a.m.	Assessing Cumulative Evidence in Genetic Associations John Ioannidis, University of Ioannina School of Medicine and Tufts-New England Medical Center
11:40 a.m. - 12:10 p.m.	Genome-Wide Meta Analysis: Promises and Pitfalls John Witte, University of California, San Francisco
12:10 p.m. - 12:45 p.m.	What Variants Are Included in Genomic Profiles and How Are Disease Risks Calculated: Is There an Industry-Wide Standard? Amy Miller, Personalized Medicine Coalition Michele Cargill, Navigenics Linda Avey, 23andMe Jeffrey Gulcher, deCODEme
12:45 p.m. - 1:30 p.m.	Lunch on your own

Session III:	Scientific Foundation for Establishing Clinical Validity and Utility of Genomic Profiles - Part 1 Moderator: Kay Wanke, OBSSR
1:30 p.m. - 1:50 p.m.	Inter-Disciplinary Evaluation of Genomic Profiles: How Should Clinical Validity and Utility Be Defined? What Kind of Evidence Is Needed to Establish Clinical Validity and Utility? Steven Teutsch, Merck & Co., Inc.
1:50 p.m. - 2:10 p.m.	How Do We Assess the Added Value of Genetic Information in Predicting Disease Compared to Traditional Risk Factors? Cecile Janssens, Erasmus University, the Netherlands
2:10 p.m. - 2:30 p.m.	Scientific Evaluation of the Impact of Interventions Associated With Genetic Risk Factor Information Barry Davis, University of Texas School of Public Health at Houston
2:30 p.m. - 3:00 p.m.	Discussion
3:00 p.m. - 3:30 p.m.	Break

Session IV:	Scientific Foundation for Establishing Clinical Validity and Utility of Genomic Profiles - Part 2 Moderator: Mark Greene, NCI
3:30 p.m. - 3:50 p.m.	How Can We Assess the Value of Genetic Information: Nondirective Counseling, Motivational Counseling, and Health Education for Common Diseases? Angela Trepanier, Wayne State University School of Medicine
3:50 p.m. - 4:10 p.m.	Principles of Health Marketing Research and Practice: How Do They Apply to Genomics? Jay Bernhardt, CDC
4:10 p.m. - 4:30 p.m.	Does Genetic Information Change Behavior? Examples of Clinical Utility Research Colleen McBride, NHGRI
4:30 p.m. - 5:00 p.m.	Discussion
7:00 p.m.	Dinner - Meritage Restaurant

December 18, 2008
Session V:	Case Studies and General Discussion of Clinical Validity and Utility Moderator: Michael Lauer, NHLBI
8:30 a.m. - 8:50 a.m.	How Can We Assess Clinical Validity and Utility of Genome Profiles in Risk Assessment and Control of Colorectal Cancer? David Ransohoff, University of North Carolina Chapel Hill
8:50 a.m. - 9:10 a.m.	How Can We Assess Clinical Validity and Utility of Genome Profiles in Risk Assessment and Control of Alzheimer's Disease? Robert Green, Boston University
9:10 a.m. - 9:30 a.m.	How Can We Assess Clinical Validity and Utility of Genome Profiles in Risk Assessment and Control of Cardiovascular Disease? Philip Greenland, Northwestern University
9:30 a.m. - 9:50 a.m.	How Can We Assess Clinical Validity and Utility of Genome Profiles in Risk Assessment and Control of Prostate Cancer? Jianfeng Xu, Wake Forest University
9:50 a.m. - 10:15 a.m.	General Discussion How do we define clinical validity and utility for genome profiles? What scientific disciplines are needed for evaluation of clinical validity and utility of genome profiles? When do we need clinical trials? What kinds of trials are needed? Does genetic information provide more information than traditional risk factors? How about the use of family history as an alternative or complementary tool? What collaborative processes are needed to build this evidence base? What study designs are needed? Do these studies require return of results to participants?
10:15 a.m. - 10:30 a.m.	Break

Session VI:	Models for Conducting Translation Research on Genome Profiles Moderator: Gregory Feero, NHGRI
10:30 a.m. -10:50 a.m.	Scientific Evaluation of the Clinical Validity and Utility of Genetic and Genomic Risk Factor Information Geoffrey Ginsburg, Duke University
10:50 a.m. - 11:10 a.m.	National Institutes of Health GEI Genomics Translation Research Paul Kimmel, NIDDK
11:10 a.m. - 11:30 a.m.	CDC Genomics Translation Research and Programs Agenda Ralph Coates, CDC
11:30 a.m. - 11:50 a.m.	Implications for Public Engagement, Policy, and Oversight While the Science Accumulates Kathy Hudson, Johns Hopkins University
11:50 a.m. - 12:30 p.m.	Models for Conducting Translation Research on Genomic Profiles George Church, PersonalGenomes.org and the Broad Institute Jeffrey Gulcher, deCODEme Linda Avey, 23andMe Michele Cargill, Navigenics
12:30 p.m. - 1:30 p.m.	Lunch

Session VII:	Panel Discussion and Next Steps for Research and Practice Agenda Discussion Moderator: Muin Khoury, CDC and NCI
1:30 p.m. - 2:00 p.m.	Discussants: *Francis Collins, Former Director, NHGRI* *and Kari Stefansson, deCODEme*
2:00 p.m. - 2:45 p.m.	Reactive Panel: John Ioannidis , Colleen McBride, Stephen Chanock, Sharon Terry, and Sharon Kardia Is there a consensus scientific standard for what to include in a genomic profile? What kinds of research studies are needed (observational and clinical trials) to evaluate clinical validity and utility of genomic profiles? What should be the reporting guidelines to research participants in these studies? Is there a collaborative public-private model to use when conducting research on clinical validity and utility of genomic profiles? What are the steps needed to develop consumer and provider decision support tools? What should be the policy and oversight environment while research on genomic profiles is being conducted? What information should be given to providers and consumers before and after testing? What is the potential impact on health disparities? What are the next steps and action items?
2:45 p.m. - 3:00 p.m.	Short Recaps of What We Have Heard
3:00 p.m.	Adjournment

AGENDA