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Opening Remarks |
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Steven Teutsch, M.D., M.P.H.
SACGHS Chair
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Session on Gene Patents and Licensing Practices |
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Review of SACGHS Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests |
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James P. Evans, M.D., Ph.D., Chair, SACGHS Task Force on Gene Patents and Licensing Practices
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Discussion of Public Consultation Draft Report and Range of Potential Policy Options for Public Consideration |
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Continued Discussion of Public Consultation Draft Report and Range of Potential Policy Options for Public Consideration |
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Public Comment Session |
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Session on Gene Patents and Licensing Practices (continued) |
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Continued Discussion and Consensus on Releasing Public Consultation Draft Report for Public Comment |
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Session on Standards Development Initiatives to Enhance Oversight and Advance Innovation of Genetic Technologies |
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Overview of Session |
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Dr. Teutsch |
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Initiatives of the National Institute of Standards and Technology (NIST) in Clinical Diagnostics Standards Development |
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Willie May, Ph.D., Director, Chemical Science and Technology Laboratory (CSTL), NIST |
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Q & A |
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Standards Development for New Technologies |
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Nucleic Acid Tests
John Butler, Ph.D., Biochemical Science Division, CSTL, NIST |
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Proteomic Tests
David Bunk, Ph.D., Analytical Chemistry Division, CSTL, NIST |
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Metabolomic Tests
Karen Phinney, Ph.D. Analytical Chemistry Division, CSTL, NIST |
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Standards Development Challenges Facing Stakeholders |
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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 |
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Clinical Perspective
Jeff Cossman, M.D., Chief Scientific Officer, Critical Path Institute |
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Q & A |
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Future Directions in Clinical Diagnostic Standards Development |
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Michael Amos, Ph.D., Scientific Advisor, CSTL, NIST, and SACGHS Ex Officio, NIST |
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Discussion |
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Closing Remarks - Dr. Teutsch |
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