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Pharmacogenomics
  This page provides information concerning the Pharmacogenomics study topic.  
  A list of reports and correspondence related to this topic are provided below. This page also provides a summary of the sessions concerning this topic that have been held at SACGHS meetings so you can review the transcripts, presentation materials, and webcasts for the sessions that dealt with the topic.  
 
Reports and Correspondence  
   Realizing the Potential of Pharmacogenomics: Opportunities and Challenges   
   Public Comments on Draft Report   
   SACGHS letter to the Secretary of Health and Human Services (August 18, 2008)   

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SACGHS Meetings  
 

November 19, 2007 - Session on Pharmacogenomics  
  Overview of Final Draft SACGHS Report on Pharmacogenomics  
  Kevin T. FitzGerald, S.J., Ph.D., Ph.D.
SACGHS Pharmacogenomics Task Force Chair
 
  Slides  Webcast   
 
  Discussion and Consensus on Final Draft Report  
  Facilitators: Dr. Tuckson and Dr. FitzGerald  
  Webcast before Lunch  Webcast after Lunch   
 

July 10, 2007 - Update on the Development of the SACGHS Pharmacogenomics Report  
  Kevin T. FitzGerald, S.J., Ph.D., Ph.D.
SACGHS Pharmacogenomics Task Force Chair
 
  Slides  Webcast   
 

November 13, 2006 - Pharmacogenomics Session  
  Update on Efforts of the SACGHS Pharmacogenomics Task Force and Review of Draft Report  
  Kevin T. FitzGerald, S.J., Ph.D., Ph.D.
Chair
SACGHS Task Force on Pharmacogenomics
 
  Slides  - Webcast  - Transcript   
 

June 26, 2006 - Pharmacogenomics Session  
 
  Overview of Pharmacogenomics Session and Update on Efforts of the SACGHS Pharmacogenomics Task Force  
  Emily Winn-Deen, Ph.D.
Chair
SACGHS Task Force on Pharmacogenomics
 
  Slides  Webcast  Transcript   
 
  Critical Path Initiative and FDA's Vision for Personalized Medicine  
  Janet Woodcock, M.D.
Deputy Commissioner for Operations
FDA
 
  Slides  Webcast  Transcript   
 
  Q &A  
  Facilitator: Dr. Winn-Deen  
  Webcast   
 
  Full Committee Discussion  
  Facilitator: Dr. Winn-Deen  
  Webcast Part 1  Webcast Part 2  Transcript   
 
  Public Comments  
  Webcast  Transcript   
 

March 27, 2006 - Pharmacogenomics Session  
 
  Update from the Pharmacogenomics Task Force  
  Emily Winn-Deen, Ph.D.
Chair, SACGHS Task Force on Pharmacogenomics
 
  Slides  Webcast  Transcript   
 
  FDA Draft Guidance for Industry and FDA Staff on Pharmacogenetic Tests and Genetic Tests for Heritable Markers  
  Steve Gutman, M.D., MBA
Director, Office of In Vitro Diagnostic Device Evaluation and Safety, FDA
 
  Slides  Webcast  Transcript   
 
  Full Committee Discussion  
  Webcast  Transcript   
 
  Public Comments  
  Transcript   
 

October 20, 2005 - Pharmacogenomics Session  
 
  Update from the SACGHS Task Force on Pharmacogenomics  
  Emily S. Winn-Deen, Ph.D.
SACGHS Task Force Chair
 
  Slides  Webcast  Transcript   
 
  Update from FDA  
  Steven I. Gutman, M.D., M.B.A.
Director, Office of In Vitro Diagnostics
U.S. Food and Drug Administration
 
  Webcast  Transcript   
 
  Allen Rudman, Ph.D.
Associate Director, Office of Clinical Pharmacology and
Biopharmaceutics
Center for Drug Evaluation and Research, FDA
 
  Slides  Webcast  Transcript   
 
  Q&A and Committee Discussion  
  Facilitator: Dr. Winn-Deen  
  Webcast  Transcript   
 
  Public Comments  
  Webcast  Transcript   
 
  Feasibility of Integrating Pharmacogenomics into Drug Development from an Economic Perspective  
  Thomas A. Metcalfe
Head of Biomarker Program
F. Hoffmann-La Roche Ltd
 
  Slides  Webcast  Transcript   
 
  Economic Challenges of Integrating Pharmacogenomics into Clinical Practice  
  Kathryn Phillips, Ph.D.
Professor of Health Economics and Health Services Research
Director, Program in Pharmacogenomics and Population Screening
University of California, San Francisco
 
  Slides  Webcast  Transcript   
 
  Q&A and Committee Discussion  
  Facilitator: Dr. Winn-Deen  
  Webcast  Transcript   
 
  Ethical and Social Issues Associated with Using Race and Genetics in the Study of Differential Drug Response  
  Wylie Burke, M.D., Ph.D.
Professor and Chair, Department of Medical History and Ethics
University of Washington
 
  Slides  Webcast  Transcript   
 
  Q&A and Committee Discussion  
  Facilitator: Dr. Winn-Deen  
  Webcast  Transcript   
 
  Discussion of Next Steps, Work Plan, and Final Work Product for Pharmacogenomics  
  Facilitators: Dr. Winn-Deen and Ms. Berry  
  Webcast  Transcript   
 

June 16, 2005 - Current Issues in Pharmacogenomics (all day)  
 
  Session Overview and Goals  
  Emily Winn-Deen, Ph.D.
Chair, SACGHS Pharmacogenomics Task Force
 
  Slides  Webcast  Transcript   
 
  Fundamentals of Pharmacogenomics: Origins, Definitions and Concepts  
  Richard M. Weinshilboum, M.D.
Professor of Molecular Pharmacology and Experimental Therapeutics
and Medicine
Mayo Clinic College of Medicine
 
  Slides  Webcast  Transcript   
 
  Q&A and Discussion  
  Webcast  Transcript   
 
  Pharmacogenomics: The Public Health Perspective  
  Robert L. Davis, M.D., M.P.H.
Professor, Department of Epidemiology
University of Washington School of Public Health
 
  Slides  Webcast  Transcript   
 
  Q & A and Discussion  
  Webcast  Transcript   
 
  Pharmacogenomics in the Practice of Medicine  
  Dr. Weinshilboum  
  Slides  Webcast  Transcript   
 
  Q&A and Discussion  
  Dr. Weinshilboum  
  Webcast  Transcript   
 
  Perspectives from Industry  
  Webcast  Transcript   
 
  Eric Lai, Ph.D.
Vice President
Discovery and Pipeline Genetics
GlaxoSmithKline
 
  Slides   
 
  Walter Koch, Ph.D.
Vice President and Head of Research
Roche Molecular Systems
 
  Slides   
 
  Q&A and Discussion  
  Webcast  Transcript   
 
  Public Comments  
  Webcast  Transcript   
 
  HHS Efforts and Future Directions in Pharmacogenomics  
 
  Rochelle Long, Ph.D.
Chief, Pharmacological & Physiological Sciences Branch
National Institute of General Medical Sciences, NIH
 
  Slides  Webcast  Transcript   
 
  Felix Frueh, Ph.D.
Associate Director for Genomics
Office of Clinical Pharmacology and Biopharmaceutics
Center for Drug Evaluation and Research, FDA
 
  Slides  Webcast  Transcript   
 
  Muin Khoury, M.D., Ph.D.
Associate Director for Genomics
Director
Office of Genomics and Disease Prevention, CDC
 
  Slides  Webcast  Transcript   
 
  Q&A and Discussion  
  Webcast  Transcript   
 
  Ethical, Legal and Social Implications of Pharmacogenomics  
  Patricia Deverka, M.D., M.S., M.B.E.
Fellow
Center for Genome Ethics, Law & Policy
Institute for Genome Sciences & Policy
Duke University
 
  Slides  Webcast  Transcript   
 
  Q&A and Discussion  
  Webcast  Transcript   
 
  Full Committee Discussion and Next Steps for Pharmacogenomics  
  Facilitators: Dr. Willard and Dr. Winn-Deen  
  Webcast  Transcript   
 

October 19, 2004 - Discussion of Proposed Plans for Addressing SACGHS Priority Issues  
 
  Pharmacogenomics  
  Emily Winn-Deen, Ph.D.
Chair, SACGHS Task Force on Pharmacogenomics
 
  Webcast  Transcript   
 

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