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Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary
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 forLaboratory Medicine, Director of the ClinicalLaboratories, Director of the PathologyResidency Training Program, Weill CornellMedical Center of Cornell University
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Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary
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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Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary
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. – 12:55 P.M.
NEW MODELS FOR EVIDENCE GENERATION: 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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Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary
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. – 12:10 P.M.
Constructing Chains of Evidence
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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Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary
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
