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.REVIEW 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

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
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
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 & Medicaid Services
3:20–3:30 P.M.BREAK
3:30–4:15 P.M.Discussion with Speakers and Attendees
4:15–5:30 P.MFACILITATING CONVERGENCE

Moderator: Wylie Burke, University of Washington

Panel Discussion with Prior Speakers
5:30–5:45 P.M.Concluding Remarks

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
6:00 P.M.ADJOURN

From: Appendix A, Workshop Agenda

Cover of Genome-Based Diagnostics
Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary.
Institute of Medicine (US).
Washington (DC): National Academies Press (US); 2012.
Copyright © 2012, National Academy of Sciences.

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