Eyes on the Prize: Truth Telling about Genetic Testing
Renaissance M Street, Washington, DC

 
Draft Agenda

Thursday, September 20, 2007

8 AM           Registration/Continental breakfast

9 AM           DHHS & Personalized Health Care
                   Greg Downing, Program Director, Personalized Health Care,
                   U.S. Department of Health and Human Services (HHS)

9:15 AM       Truth Telling about Genetic Testing
                   Sharon Terry, President and CEO, Genetic Alliance

9:30 AM       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 AM     Q & A

10:30 AM     Break

11:00 AM     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 AM     Q & A

12:15 PM     Summary of the morning
                   Sharon Terry, President and CEO, Genetic Alliance

12:30 PM     Lunch

1:30 PM       Translation and Test Development
                   Moderated by Christopher Austin, Director, NIH Chemical Genomics
                   Center
                   - ANALYTICAL VALIDITY, CLINICAL VALIDITY, CLINICAL UTILITY
                       Linda Bradley, Evaluation of Genomic Applications in Practice and
                       Prevention, Geneticist, National Office of Public Health Genomics, CDC
                   - CLINICAL SIGNIFICANCE: SO YOU CAN DO IT, DOES IT MATTER?
                       Elda Railey, Co-founder, Research Advocacy Network
                   - CHALLENGES IN APPLYING GENOMIC TECHNOLOGY TO
                     MOLECULAR DIAGNOSTICS
                       Janet A. Warrington, Vice President, Standards and Government
                       Policy, Affymetrix

2:15 PM      Q & A

3:00 PM      Break

3:30 PM      Clinical Delivery/Commercialization Roundtable
                  Moderated by Robert Egge, Executive Director of the Alzheimer’s Study Group,
                  Center for Health Transformation
                  - GOVERNMENT: Steven Ferguson, Director, Division of
                       Technology Development and Transfer, NIH
                  - INSTITUTIONAL: Raju Kucherlapati, Scientific Director,
                       Harvard-Partners Center for Genetics and Genomics
                  - INDUSTRY: Timothy Stenzel, Medical Director, Abbott Molecular

4:15 PM      Q & A

5:30 PM      Summary of the day, Overview of Friday’s agenda
                  Sharon Terry, President and CEO, Genetic Alliance

5:45 PM      Reception – open bar

6:00 PM      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, and
                  Janet Woodcock, Deputy Commissioner, Chief Medical Officer, FDA

Friday, September 21, 2007

8:00 AM      Continental Breakfast

8:30 AM      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 AM       Q & A

9:30 AM       Break

10:00 AM     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 AM     Q & A

11:30 AM     Response, Q & A
                   Janet Woodcock, Deputy Commissioner, Chief Medical Officer, FDA

12:00 PM     Working Lunch: Breakout Groups (Self assigned)
                   - Reimbursement
                   - Regulation
                   - Policy and legislation

1:30 PM      Reports from Breakouts: Opportunities and Challenges

2:00 PM      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 PM      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 PM      Wrap up, next steps
                  Sharon Terry, President and CEO, Genetic Alliance and members of the
                  planning committee