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Secretary’s Advisory Committee on Genetics, Health, and Society

Nineteenth Meeting
June 11-12, 2009
Washington, D.C.


Friday, June 12, 2009

8:30 a.m. – 8:35 a.m.               Opening Remarks (Real Video)
Dr. Teutsch

Report from the Direct-to-Consumer Genetic Testing Task Force

8:35 a.m. – 8:55 a.m.               Presentation of Draft Report on Direct-to-Consumer Genetic Testing (Real Video)
                                    Sylvia Au, M.S., CGC
                                    SACGHS Member

8:55 a.m. – 9:25 a.m.               Committee Discussion and Decisions Regarding Draft Report on Direct-to-Consumer Genomic Services (Real Video)

Session on Clinical Utility and Comparative Effectiveness

9:25 a.m. – 9:55 a.m.               Clinical Effectiveness, Clinical Utility, Comparative Effectiveness: An Evolving Landscape (Real Video)
Gurvaneet Randhawa, M.D., M.P.H.
Agency for Healthcare Research and Quality

9:55 a.m. – 10:25 a.m.             Future Directions and the Role of Genomics in Comparative Effectiveness (Real Video)
Harold Sox, M.D., M.A.C.P.
Institute of Medicine’s Committee on Comparative Effectiveness Research Priorities

10:25 a.m. – 10:40 a.m.                       BREAK

10:40 a.m. – 11:10 a.m.           Role of Genomics in Comparative Effectiveness Research, NIH Perspective (Real Video)
                                                Michael Lauer, M.D.
Director, Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
National Institutes of Health

11:10 a.m. – 11:40 a.m.                       Future Directions and Developments in Research Methodologies (Real Video)
Steven Goodman, M.D., M.H.S., Ph.D. (TBC)
Professor of Oncology
Johns Hopkins Kimmel Cancer Center

11:40 a.m. – 12:10 p.m.                      Impact of Comparative Effectiveness Findings on Clinical Practice (Real Video)
Marc Williams, M.D., SACGHS Member

12:10 p.m. – 1:10 p.m.                        LUNCH


Session on Clinical Utility and Comparative Effectiveness (continued)

Updates on Federal Activities Related to Genetics

1:40 p.m. – 2:00 p.m.              Report from the Centers for Medicare and Medicaid Services on Evidentiary Standards for Coverage Decisions on Genetic Tests (Real Video)
Jeffrey Roach, M.D., MPH
Medical Officer Division of Items and Devices
Coverage & Analysis Group, OCSQ

2:00 – 2:10                  Q&A (Real Video)


2:10 p.m. – 2:30 p.m.              Family History State-of-the Science Conference and Family History Tools (Real Video)
William (Greg) Feero, M.D., Ph.D.
Senior Advisor to the Director for Genomic Medicine
National Human Genome Research Institute  

2:30 – 2:40                  Q&A

2:40 p.m. – 2:55 p.m.              BREAK

2:55 p.m. – 3:10 p.m.              Activities Related to Genetic/Genomic Data Standards Development for Health Information Technology (Real Video)
                                                Jessica Nadler, Ph.D.
                                                AAAS Science & Technology Policy Fellow
                                                Personalized Health Care Initiative
                                               Department of Health & Human Services



3:10 p.m. – 3:40 p.m.              Public Comments (Real Video)

Update from the SACGHS Gene Patents Task Force

3:40 p.m. – 4:10 p.m.              Overview of Public Comments on the SACGHS Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests
                                                James P. Evans, M.D., Ph.D.
                                                Chair, SACGHS Task Force on Gene Patents and Licensing Practices

4:10 p.m. – 4:30 p.m.              Concluding Remarks – Dr. Teutsch (Real Video)