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?



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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? 63

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64 GENOME-BASED DIAGNOSTICS WELCOMING REMARKS 8:30-8:35 A.M. Wylie Burke, Roundtable Chair Professor and Chair, Department of Bioethics and Humanities, University of Washington CHARGE TO WORKSHOP SPEAKERS AND 8:35-8:45 A.M. PARTICIPANTS Robert McCormack, Workshop Co-Chair Head of Technology Innovation and Strategy, Veridex, LLC REVIEW OF NOVEMBER 2010 WORKSHOP 8:45-9:15 A.M. “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 ADVANCING UTILITY AND ADOPTION OF 9:15-10:15 A.M. 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

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65 APPENDIX A Laura van ‘t Veer Angela and Shu Kai Chan Endowed Chair in Cancer Research; Leader, Breast 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 ADVANCING UTILITY AND ADOPTION OF 11:00 A.M.- CLINICAL GENOMIC DIAGNOSTICS—PART II 12:00 P.M. 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

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66 GENOME-BASED DIAGNOSTICS ADVANCING UTILITY AND ADOPTION OF 1:15-2:00 P.M. 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 EVALUATING PATHS FORWARD FOR 2:30-3:20 P.M. 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 & Medicaid Services 3:20-3:30 P.M. BREAK 3:30-4:15 P.M. Discussion with Speakers and Attendees

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67 APPENDIX A 4:15-5:30 P.M. FACILITATING CONVERGENCE Moderator: Wylie Burke, University of Washington Panel Discussion with Prior Speakers Concluding Remarks 5:30-5:45 P.M. Robert McCormack, Workshop Co-Chair 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 ADJOURN 6:00 P.M.

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