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

 

Seventeenth Meeting

December 1-2, 2008

Washington, D.C.

 

 

Morning Session Before Break  (Real Video)

Morning Session After Break  (Real Video)

Afternoon Session After Lunch  (Real Video)

Afternoon Session After Break  (Real Video)

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AGENDA

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Monday, December 1, 2008

 

8:00 a.m. – 8:30 a.m.                 Opening Remarks  

Steven Teutsch, M.D., M.P.H.

SACGHS Chair

 

Session on Gene Patents and Licensing Practices

 

8:30 a.m. – 9:45 a.m.                  Review of SACGHS Public 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

 

9:45 a.m. – 10:30 a.m.                Discussion of Public Consultation Draft Report and Range of Potential Policy Options for Public Consideration

 

10:30 a.m. – 10:45 a.m.              BREAK

 

10:45 a.m. – 12:15 p.m.              Continued Discussion of Public Consultation Draft Report and Range of Potential Policy Options for Public Consideration

 

12:15 p.m. – 1:00 p.m.                LUNCH

 

Public Comment Session

 

1:00 p.m. – 1:30 p.m.                Public Comments

 

Session on Gene Patents and Licensing Practices (continued)

 

1:30 p.m. – 3:15 p.m.                 Continued Discussion and Consensus on Releasing Public Consultation Draft Report for Public Comment

 

3:15 p.m. – 3:30 p.m.                  BREAK

 

 

Session on Standards Development Initiatives to Enhance Oversight and Advance Innovation of Genetic Technologies

 

3:30 p.m. – 3:35 p.m.              Overview of Session – Dr. Teutsch

                                               

3:35 p.m. – 3:50 p.m.                Initiatives of the National Institute of Standards and Technology (NIST) in Clinical Diagnostics Standards Development – Willie May, Ph.D., Director, Chemical Science and Technology Laboratory (CSTL), NIST  (Real Video)

 

            3:45 – 3:50                  Q&A

 

3:50 p.m. – 4:30 p.m.               Standards Development for New Technologies

 

3:50 – 4:00                  Nucleic Acid Tests – John Butler, Ph.D., Biochemical Science Division, CSTL, NIST

 

4:00 – 4:10                  Proteomic Tests, David Bunk, Ph.D. – Analytical Chemistry Division, CSTL, NIST

 

4:10 – 4:20                  Metabolomic Tests, Karen Phinney, Ph.D. – Analytical Chemistry Division, CSTL, NIST

           

4:20 – 4:30                  Q&A

 

 4:30 p.m. – 5:00 p.m.              Standards Development Challenges Facing Stakeholders

 

4:30 – 4:40                  Regulatory Agency Perspective – Steven Gutman, M.D., M.B.A., Director, Office for In Vitro Diagnostic Device Evaluation and Safety, Food and Drug Administration, SACGHS Ex Officio, FDA

 

4:40 – 4:50                  Clinical Perspective – Jeff Cossman, M.D., Chief Scientific Officer, Critical Path Institute

 

            4:50 – 5:00                  Q&A

 

5:00 p.m. – 5:10 p.m.                 Future Directions in Clinical Diagnostic Standards Development – Michael Amos, Ph.D., Scientific Advisor, CSTL, NIST, and SACGHS Ex Officio, NIST

 

5:10 – 5:30                               Discussion

           

5:30 p.m. – 5:35 p.m.               Closing Remarks – Dr. Teutsch

 

 

 

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