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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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Appendix A

Workshop Agenda

Facilitating Development and Utilization of Genome-Based Diagnostic
Technologies: A Workshop

November 15, 2011

The Keck Center of the National Academies

500 Fifth Street, NW

Washington, DC 20001

WORKSHOP OBJECTIVE

To address the differences in evidence required for clinical use, regulatory oversight, and coverage for a laboratory test, as well as laboratory test reimbursement, with the goal of clarifying a pathway for successfully bringing a test to clinical use for the benefit of patients.

Focal Questions:

•    What are your views of the described barriers to successful genomic test development?

•    What are potential solutions?

•    What are the obstacles to achieving those solutions?

•    How can we overcome those obstacles?

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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8:30-8:35 A.M. WELCOMING REMARKS
   
Wylie Burke, Roundtable Chair

Professor and Chair, Department of Bioethics and Humanities, University of Washington

8:35-8:45 A.M. CHARGE TO WORKSHOP SPEAKERS AND PARTICIPANTS
   
Robert McCormack, Workshop Co-Chair

Head of Technology Innovation and Strategy, Veridex, LLC

   
8:45-9:15 A.M. REVlEW OF NOVEMBER 2010 WORKSHOP “GENERATING EVIDENCE FOR GENOMIC DIAGNOSTIC TEST DEVELOPMENT” AND STATEMENT OF PROBLEM
   
  Debra Leonard, Workshop Co-Chair

Professor and Vice Chair, Department of Pathology and Laboratory Medicine; Director of the Clinical Laboratories, Weill Cornell Medical Center

   
9:15-10:15 A.M. ADVANCING UTILITY AND ADOPTION OF CLINICAL GENOMIC DIAGNOSTICS—PART I
   
  Moderator: Robert McCormack, Veridex, LLC
   
  Daniel Hayes

Clinical Director of the Breast Oncology Program and Stuart B. Padnos Professor in Breast Cancer Research, University of Michigan Comprehensive Cancer Center

   
  Muin Khoury

Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×
   
  Laura van‘t

Veer Angela and Shu Kai Chan Endowed Chair in Cancer Research; Leader, Breasr Oncology Program; Director, Applied Genomics, UCSF Helen Diller Family Comprehensive Cancer Center

   
  Russel K. Enns

Chief Regulatory Officer, Cepheid

   
10:15-10:45 A.M. Discussion with Speakers and Attendees
   
10:45-11:00 A.M. BREAK
   
11:00 A.M.-12:00 P.M. ADVANCING UTILITY AND ADOPTION OF CLINICAL GENOMIC DIAGNOSTICS—PART II
   
  Moderator: Debra Leonard, Weill Cornell Medical Center
   
  Steven Shak

Chief Medical Officer, Genomic Health, Inc.

   
  Mark Gorman

Director of Survivorship Policy, National Coalition for Cancer Survivorship

   
  Nicholas Conti

Vice President, Business Development, Quest Diagnostics

   
  Sue Siegel

General Partner, Mohr Davidow

   
12:00-12:30 P.M. Discussion with Speakers and Attendees
   
12:30-1:15 P.M. WORKING LUNCH
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×
   
1:15-2:00 P.M. ADVANCING UTILITY AND ADOPTION OF CLINICAL GENOMIC DIAGNOSTICS—PART III
   
  Moderator: Robert McCormack, Veridex, LLC
   
  Bruce Quinn

Senior Health Policy Specialist, Foley Hoag LLP

   
  Sean Tunis

Director, Center for Medical Technology Policy

   
  Louis Hochheiser

Medical Director Clinical Policy, Humana, Inc.

   
2:00-2:30 P.M. Discussion with Speakers and Attendees
   
2:30-3:20 P.M. EVALUATING PATHS FORWARD FOR ADVANCING MOLECULAR DIAGNOSTICS THROUGH REGULATORY AND REIMBURSEMENT POLICY
   
  Moderator: Debra Leonard, Weill Cornell Medical Center
   
  Alberto Gutierrez

Director, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration

   
  Louis Jacques

Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare 8c Medicaid Services

   
3:20-3:30 P.M. BREAK
   
3:30-4:15 P.M. Discussion with Speakers and Attendees
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×
   
4:15-5:30 P.M. FACILITATING CONVERGENCE
   
  Moderator: Wylie Burke, University of Washington
   
  Panel Discussion with Prior Speakers
   
5:30-5:45 P.M. Concluding Remarks
   
  Robert McCormack, Workshop Co-Chai

Head of Technology Innovation and Strategy, Veridex, LLC

   
  Debra Leonard, Workshop Co-Chair

Professor and Vice Chair, Department of Pathology and Laboratory Medicine; Director of the Clinical Laboratories; Weill Cornell Medical Center

   
6:00 P.M. ADJOURN
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic interventions, predict risk or onset of disease, or detect residual disease. As research progresses and an increasing number of associations are found, further tests will be developed that can aid in providing personalized treatment options for patients. However, the adoption of genomic diagnostic tests by health care providers has been limited due to a lack of evidence regarding the clinical utility of many tests. Health funders and practitioners lack the data necessary to distinguish which tests can improve practice or the clinical settings in which tests will provide the greatest value. The Roundtable on Translating Genomic-Based Research for Health held a workshop in November 2010 to determine what evidence is needed and how it is viewed by different stakeholders in order to develop genomic diagnostic tests of clinical value.

Genome-Based Diagnostics summarizes the presentations and discussions that took place throughout the workshop. Two presentations, in particular, sparked extensive discussion. One presentation proposed that all genomic diagnostic tests be reviewed and approved by the Food and Drug Administration. The other observed that venture capitalists are no longer investing substantially in the development of genomic diagnostic tests because of a lack of clarity surrounding regulatory and reimbursement pathways. Both presentations suggested the need for major changes in the systems used to develop, regulate, and reimburse genomic diagnostic tests. The report also presents the perspectives of different stakeholders in the development of genomic diagnostic tests. Each stakeholder group has a different set of needs and issues of importance, yet commonalities among them are apparent, such as the need to put patients and health outcomes at the center of discussion and action.

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