Workshop Agenda

Roundtable on Translating Genomic-Based Research for Health; Board on Health Sciences Policy; Institute of Medicine; Center for Medical Technology Policy

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
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
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.-12:35 P.M.	LUNCH
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
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
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
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

Bookshelf ID: NBK195910

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Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary.

Appendix AWorkshop Agenda

Workshop Objectives

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