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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
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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?

  • 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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
×

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
×

 

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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
×
Page 67
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
×
Page 68
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
×
Page 69
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13133.
×
Page 70
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Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients' health.

The Institute of Medicine (IOM) held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests. Generating Evidence for Genomic Diagnostic Test Development compares the evidence that is required for decisions regarding clearance, use, and reimbursement, to the evidence that is currently generated. The report also addresses innovative and efficient ways to generate high-quality evidence, as well as barriers to generating this evidence.

Generating Evidence for Genomic Diagnostic Test Development contains information that will be of great value to regulators and policymakers, payers, health-care providers, researchers, funders, and evidence-based review groups.

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