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
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
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
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

From: A, Workshop Agenda

Cover of Generating Evidence for Genomic Diagnostic Test Development
Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary.
Institute of Medicine (US) Roundtable on Translating Genomic-Based Research for Health.
Washington (DC): National Academies Press (US); 2011.
Copyright © 2011, National Academy of Sciences.

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