A
Workshop Agenda

Generating Evidence for Genomic Diagnostic Test Development: A Workshop


November 17, 2010


The Keck Center, Room 100

500 Fifth Street, N.W.

Washington, DC 20001

MEETING OBJECTIVE

To explore the strengths and limitations of the evidence that is being generated for the clinical validity and utility of genomic diagnostic tests.

  • What evidence is required from stakeholders?

  • How is evidence currently being generated?

  • Are there innovative ways to generate higher-quality evidence more efficiently?

  • What are the barriers to generating this evidence and how can they be overcome?

7:45 – 8:30 A.M.

WORKING BREAKFAST

8:30 – 8:45 A.M.

PUBLIC WORKSHOP BEGINS

8:30 – 8:45 A.M.

WELCOME AND INTRODUCTORY REMARKS

 

Debra Leonard, Professor and Vice Chair for Laboratory Medicine, Director of the Clinical Laboratories, Director of the Pathology Residency Training Program, Weill Cornell Medical Center of Cornell University



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A Workshop Agenda Generating Evidence for Genomic Diagnostic Test Development: A Workshop November 17, 2010 The Keck Center, Room 100 500 Fifth Street, N.W. Washington, DC 20001 MEETING OBJECTIVE To explore the strengths and limitations of the evidence that is being generated for the clinical validity and utility of genomic diagnostic tests. • What evidence is required from stakeholders? • How is evidence currently being generated? • re there innovative ways to generate higher-quality evidence more A efficiently? • hat are the barriers to generating this evidence and how can they W be overcome? 7:45 – 8:30 A.M. WORKING BREAKFAST 8:30 – 8:45 A.M. PUBLIC WORKSHOP BEGINS 8:30 – 8:45 A.M. WELCOME AND INTRODUCTORY REMARKS Debra Leonard, Professor and Vice Chair for Laboratory Medicine, Director of the Clinical Laboratories, Director of the Pathology Residency Training Program, Weill Cornell Medical Center of Cornell University 67

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68 GENOMIC DIAGNOSTIC TEST DEVELOPMENT 8:45 – 10:50 A.M. EVIDENCE Moderator: Roger Klein, Director, Molecular Oncology Laboratory at BloodCenter of Wisconsin and Clinical Assistant Professor of Pathology at the Medical College of Wisconsin 8:45 – 9:05 A.M. FDA Perspective Robert L. Becker, Jr., Chief Medical Officer for the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration 9:05 – 9:25 A.M. Payer Perspective Margaret Piper, Director of Genomics Resources for the Blue Cross and Blue Shield Technology Evaluation Center 9:25 – 9:45 A.M. Evidence-Based Review Group Perspective Ned Calonge, President and CEO of the Colorado Trust 9:45 – 10:05 A.M. Health-Care Provider Perspective Dan Hayes, Clinical Director of the Breast Oncology Program and Stuart B. Padnos Professor in Breast Cancer Research, University of Michigan Comprehensive Cancer Center 10:05 – 10:35 A.M. Panel Discussion 10:35 – 10:50 A.M. BREAK 10:50 A.M. – NEW MODELS FOR EVIDENCE GENERATION: 12:55 P.M. APPLIED SCIENCE Moderator: Elizabeth Mansfield, Director of the Personalized Medicine Staff, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration

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69 APPENDIX A 10:50 – 11:10 A.M. Randomized Clinical Trials and Practical Clinical Trials in Pharmacogenomics Caryn Lerman, Mary W. Calkins Professor and Director of the Tobacco Use Research Center; Deputy Director of the Abramson Cancer Center, University of Pennsylvania 11:10 – 11:30 A.M. Utilizing Archived Samples to Generate New Evidence Richard Simon, Chief of the Biometric Research Branch, National Cancer Institute 11:30 – 11:50 A.M. Coverage with Evidence Development Leslie Levin, Head of the Medical Advisory Secretariat and Senior Medical, Scientific and Health Technology Advisor for the Ministry of Health and Long-Term Care, Ontario, CANADA 11:50 A.M. – Constructing Chains of Evidence 12:10 P.M. David F. Ransohoff, Professor, Departments of Medicine and Epidemiology, University of North Carolina at Chapel Hill 12:10 – 12:55 P.M. Discussion 12:55 – 1:55 P.M. WORKING LUNCH 1:55 – 4:20 p.M. OVERCOMING BARRIERS FOR EVIDENCE GENERATION Moderator: Sean Tunis, Director of the Center for Medical Technology Policy 1:55 – 2:35 P.M. Panelist Remarks Aled Edwards, Director and CEO of the Structural Genomics Consortium; Professor, Department of Medical Biophysics, University of Toronto Robert S. Epstein, Chief Medical Officer and President of the Medco Research Institute Gregory G. Germino, Deputy Director of the National Institute for Diabetes, Digestive, and Kidney Diseases

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70 GENOMIC DIAGNOSTIC TEST DEVELOPMENT Eric Larson, Executive Director of the Group Health Research Institute 2:35 – 3:25 P.M. Panel Discussion 3:25 – 4:05 P.M. Roundtable and Audience Discussion 4:05 – 4:20 P.M. BREAK 4:20 – 5:20 P.M. STRATEGIES FOR MOVING FORWARD Moderator: Sharon Terry, President and Chief Executive Officer of Genetic Alliance 4:20 – 5:20 P.M. Stakeholder Reaction Panelists Robert L. Becker, Jr., Chief Medical Officer for the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration Dan Hayes, Clinical Director of the Breast Oncology Program and Stuart B. Padnos Professor in Breast Cancer Research, University of Michigan Comprehensive Cancer Center Roger Klein, Director of the Molecular Oncology Laboratory at BloodCenter of Wisconsin and Clinical Assistant Professor of Pathology at the Medical College of Wisconsin Margaret Piper, Director of Genomics Resources for the Blue Cross and Blue Shield Technology Evaluation Center 5:20 – 5:50 P.M. SUMMARY AND CONCLUSIONS 5:20 – 5:50 P.M. Review and Conclusions Debra Leonard, Professor and Vice Chair for Laboratory Medicine, Director of the Clinical Laboratories, Director of the Pathology Residency Training Program, Weill Cornell Medical Center of Cornell University