Truth Telling about Genetic Testing Summit Agenda
Eyes on the Prize:
Truth Telling About Genetic Testing
Renaissance M Street, Washington, DC
| Thursday, September 20, 2007 | |
| 8:00 a.m. | Registration/Continental breakfast |
| 9:00 a.m. | DHHS & Personalized HealthCare Greg Downing, Program Director, Personalized Health Care, U.S. Department of Health and Human Services (HHS) |
| 9:15 a.m. | Truth Telling About Genetic Testing Sharon Terry, President and CEO, Genetic Alliance |
| 9:30 a.m. | Survey of the Characteristics of a Range of Tests Howard McLeod, Director, University of North Carolina (UNC) Institute for Pharmacogenomics and Individualized Therapy |
| 10:00 a.m. | Q & A |
| 10:30 a.m. | Break |
| 11:00 a.m. | Research and Development Opportunities and Challenges Francis Collins, Director, National Human Genome Research Institute Brad Popovich, President and CEO, Sirius Genomics Randy Scott, Chairman and CEO, Genomic Health |
| 11:45 a.m. | Q & A |
| 12:15 p.m. | Summary of the morning Sharon Terry, President and CEO, Genetic Alliance |
| 12:30 p.m. | Lunch |
| 1:30 p.m. | Translation and Test Development Moderated by Christopher Austin, Director, NIH Chemical Genomics Center
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| 2:15 p.m. | Q & A |
| 3:00 p.m. | Break |
| 3:30 p.m. | Clinical Delivery/Commercialization Roundtable Moderated by Robert Egge, Executive Director of the Alzheimer’s Study Group, Center for Health Transformation
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| 4:15 p.m. | Q & A |
| 5:30 p.m. | Summary of the day, Overview of Friday’s agenda Sharon Terry, President and CEO, Genetic Alliance |
| 5:45 p.m. | Reception – open bar |
| 6:00 p.m. | Debate Dinner – “What needs oversight, and who should do the overseeing?” Moderated by Stuart Hogarth, Research Associate, Cambridge University David Mongillo, Vice President for Policy and Regulatory Affairs, american Clinical Laboratory Association Janet Woodcock, Deputy Commissioner, Chief Medical Officer, FDA |
| Friday, September 21, 2007 | |
| 8:00 a.m. | Continental breakfast |
| 8:30 a.m. | Ensuring Laboratory Quality Interviewer: Kathy Hudson, Director, Johns Hopkins Genetics and Public Policy Center (GPPC) Joe Boone, Associate Director for Science, National Center for Preparedness, Detection, and Control of Infectious Diseases (CDC) Gail Vance, Professor, Department of Medical and Molecular Genetics, College of american Pathology (CAP) Judy Yost, Director, Division of Laboratory Services, Centers for Medicare & Medicaid Services (CMS) |
| 9:00 a.m. | Q & A |
| 9:30 a.m. | Break |
| 10:00 a.m. | Discussion of the Role of FDA in Oversight Interviewer: Jonathan Rockoff, Reporter, Baltimore Sun Jeff Gibbs, Director, Hyman, Phelps & McNamara, P.C. James Kelly, Senior Director, Regulatory Affairs, Roche Diagnostics Paul Radensky, Partner, McDermott Will & Emery Bradley Thompson, Epstein Becker & Green PC Dan Troy, Partner, Sidley Austin Brown & Wood LLP |
| 11:00 a.m. | Q & A |
| 11:30 a.m. | Response, Q & A Janet Woodcock, Deputy Commissioner, Chief Medical Officer, FDA |
| 12:00 noon | Working Lunch: Breakout Groups (Self-assigned)
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| 1:30 p.m. | Reports from Breakouts: Opportunities and Challenges |
| 2:00 p.m. | Role of professional, laboratory, and patient guidelines & best practices; The Cystic Fibrosis guidelines testing story as told by: Deborah Driscoll, Professor and Chair, Dept. of Obstetrics and Gynecology University of Pennsylvania Medical Center Kathy Hudson, Director, Johns Hopkins Genetics and Public Policy Center Jeffrey A. Kant, Professor of Pathology and Human Genetics and Director of the Division of Molecular Diagnostics, University of Pittsburgh Medical Center |
| 3:00 p.m. | Practice of Medicine Andy Faucett, Chair, CETT Program and Emory University W. Gregory Feero, Chief, Genomic Healthcare Branch, National Human Genome Research Institute, NIH Margaret Gulley, Molecular Pathologist and Geneticist, UNC Department of Pathology & Laboratory Medicine |
| 4:00 p.m. | Wrap-up, next steps Sharon Terry, President and CEO, Genetic Alliance and members of the planning committee |
