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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?
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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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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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