Appendix A

Workshop Agenda

Evidence for Clinical Utility of Molecular Diagnostics in Oncology: A Workshop

May 24, 2012

PEW DC Conference Center
901 E Street, NW
Washington, DC 20004

Workshop Objectives:

  • To assess the evidentiary requirements for clinical validity and clinical utility of molecular diagnostics that are used to guide treatment decisions for patients with cancer.
  • To discuss methodologies, including innovative models related to demonstrating the evidentiary requirements that meet the needs of all stakeholders.
  • To consider innovative, sustainable research collaborations for generating evidence of clinical utility that involve multiple stakeholders.
8:30 A.M.

Welcoming Remarks and Charge to Workshop Speakers and Participants

Robert McCormack, Workshop Co-Chair

Head of Technology Innovation and Strategy

Veridex, LLC

8:50 A.M.

Stakeholder-Informed Methods for Evaluating Clinical Utility

Sean Tunis

Director

Center for Medical Technology Policy



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Appendix A Workshop Agenda Evidence for Clinical Utility of Molecular Diagnostics in Oncology: A Workshop May 24, 2012 PEW DC Conference Center 901 E Street, NW Washington, DC 20004 Workshop Objectives: • To assess the evidentiary requirements for clinical validity and clini- cal utility of molecular diagnostics that are used to guide treatment decisions for patients with cancer. • To discuss methodologies, including innovative models related to demonstrating the evidentiary requirements that meet the needs of all stakeholders. • To consider innovative, sustainable research collaborations for gen- erating evidence of clinical utility that involve multiple stakeholders. 8:30 a.m.  Remarks and Charge to Workshop Welcoming Speakers and Participants Robert McCormack, Workshop Co-Chair Head of Technology Innovation and Strategy Veridex, LLC 8:50 A.M. Stakeholder-Informed Methods for Evaluating Clinical Utility Sean Tunis Director Center for Medical Technology Policy 75

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76 GENOME-BASED DIAGNOSTICS 9:05–11:50 A.M. Evidence Utilization Session Moderator: Elizabeth Mansfield, U.S. Food and Drug Administration 9:05–9:35 A.M. Guideline Development Gary H. Lyman  Professor of Medicine; Director, Comparative Effectiveness and Outcomes Research–Oncology  Duke University School of Medicine and the Duke Cancer Institute Al B. Benson III Professor of Medicine Associate Director for Clinical Investigations Robert H. Lurie Comprehensive Cancer Center Northwestern University 9:35–10:05 A.M. Payer Perspectives Elaine Jeter Medical Director Palmetto GBA Lee Newcomer Senior Vice President, Oncology United HealthCare Corporation 10:05–10:20 A.M. BREAK 10:20–10:35 A.M. Provider Perspective Lloyd Everson Vice Chairman and Founder The U.S. Oncology Network

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APPENDIX A 77 10:35–10:50 A.M. Academic Health System Perspective Robert Bast  Vice President for Translational Research; Internist and Professor of Medicine, Department of Experimental Therapeutics, Division of Cancer Medicine; Harry Carothers Wiess Distinguished University Chair for Cancer Research, University of Texas MD Anderson Cancer Center 10:50–11:05 A.M. Patient Perspective Deborah E. Collyar President Patient Advocates in Research 11:05–11:50 A.M. Discussion with Speakers and Participants 11:50 A.M.– LUNCH 12:35 P.M. 12:35–3:00 P.M. STudy Design and analysis Session Moderator:  Patricia Deverka, Center for Medical Technology Policy 12:35–12:55 P.M. Evolution of Translational Omics: Lessons Learned and the Path Forward Debra Leonard  Professor and Vice Chair, Department of Pathology and Laboratory Medicine; Director of the Clinical Laboratories Weill Cornell Medical Center

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78 GENOME-BASED DIAGNOSTICS 12:55–1:15 P.M. Comparative-Effectiveness Research Methodologies for Generating and Synthesizing Evidence for Cancer Genomics Andrew N. Freedman  Chief, Clinical and Translational Epidemiology Branch Epidemiology and Genomics Research Program  Division of Cancer Control and Population Sciences National Cancer Institute 1:15–1:35 P.M. Designing Studies to Evaluate Biomarkers for Clinical Applications Lisa M. McShane Senior Mathematical Statistician Biometric Research Branch Division of Cancer Treatment and Diagnosis National Cancer Institute 1:35–1:55 P.M. Assessing Cost-Effectiveness for Oncology-Based Molecular Diagnostics Kathryn Phillips  Professor of Health Economics and Health Services Research  Director and Founder, University of California, San Francisco (UCSF), Center for Translational and Policy Research on Personalized Medicine  Department of Clinical Pharmacy/School of Pharmacy, UCSF Institute for Health Policy Studies, and UCSF Comprehensive Cancer Center UCSF 1:55–2:15 P.M. Advancing the Utility of Oncology Diagnostics Noel Doheny Chief Executive Officer Epigenomics, Inc. 2:15–3:00 P.M. Discussion with Speakers and Participants

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APPENDIX A 79 3:00–3:15 P.M. BREAK 3:15–5:15 P.M Advancing Molecular Diagnostics for Oncology Session Moderator:  Margaret Piper, Blue Cross and Blue Shield Association 3:15–3:30 P.M. Biomarker Studies in Multi-Center Cancer Clinical Trials: The Role of Cooperative Groups Richard Schilsky Professor of Medicine Chief, Section of Hematology-Oncology Deputy Director, Comprehensive Cancer Center University of Chicago  3:30–3:45 P.M. Partnering for the Cure: An Innovative Role for Academia in Oncology Drug and Diagnostic Development Howard I. Scher D. Wayne Calloway Chair in Urologic Oncology  Sidney Kimmel Center for Prostate and Urologic Cancers Chief, Genitourinary Oncology Service Memorial Sloan-Kettering Cancer Center 3:45–4:00 P.M. Patient Approaches to Generating Evidence Deborah E. Collyar President Patient Advocates in Research 4:00–4:15 P.M. Novel Partnership Strategies for Using Outcomes Data to Develop Clinical Utility Evidence Gabriela Lavezzari Director of Development, Diagnostics Express Scripts

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80 GENOME-BASED DIAGNOSTICS 4:15–4:30 P.M. Assessing Clinical Utility with Real-World Evidence Greg Rossi Vice President, Payer and Real-World Evidence AstraZeneca UK 4:30–5:15 P.M. Discussion with Speakers and Participants on Paths Forward 5:15–5:30 P.M. final remarks 5:15–5:30 P.M. Concluding Remarks Robert McCormack, Workshop Co-Chair Head of Technology Innovation and Strategy Veridex, LLC 5:30 P.M. ADJOURN