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?
8:30-8:35 A.M. | WELCOMING REMARKS |
Wylie Burke, Roundtable Chair
Professor and Chair, Department of Bioethics and Humanities, University of Washington |
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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 |
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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 |
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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 |
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Muin Khoury
Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention |
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 |
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Russel K. Enns
Chief Regulatory Officer, Cepheid |
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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. |
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Mark Gorman
Director of Survivorship Policy, National Coalition for Cancer Survivorship |
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Nicholas Conti
Vice President, Business Development, Quest Diagnostics |
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Sue Siegel
General Partner, Mohr Davidow |
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12:00-12:30 P.M. | Discussion with Speakers and Attendees |
12:30-1:15 P.M. | WORKING LUNCH |
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 |
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Sean Tunis
Director, Center for Medical Technology Policy |
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Louis Hochheiser
Medical Director Clinical Policy, Humana, Inc. |
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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 |
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Louis Jacques
Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare 8c Medicaid Services |
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3:20-3:30 P.M. | BREAK |
3:30-4:15 P.M. | Discussion with Speakers and Attendees |
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 |
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Debra Leonard, Workshop Co-Chair
Professor and Vice Chair, Department of Pathology and Laboratory Medicine; Director of the Clinical Laboratories; Weill Cornell Medical Center |
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6:00 P.M. | ADJOURN |