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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
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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 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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
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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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 75
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 76
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 77
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 78
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 79
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 80
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Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology is the summary of a workshop convened in May 2012 by the Roundtable on Translating Genomic-Based Research for Health and the Center for Medical Technology Policy of the Institute of Medicine to foster the identified need for further sustained dialogue between stakeholders regarding the clinical utility of molecular diagnostics. The workshop brought together a wide range of stakeholders, including patients, health care providers, policy makers, payers, diagnostic test developers, researchers, and guideline developers, to identify the challenges and opportunities in advancing the development and use of molecular diagnostic tests designed to guide the treatment and management of patients with cancer.

The sequencing of the human genome has greatly accelerated the process of linking specific genetic variants with disease. These findings have yielded a rapidly increasing number of molecular diagnostic tests designed to guide disease treatment and management. Many of these tests are aimed at determining the best treatments for specific forms of cancer, making oncology a valuable testing ground for the use of molecular diagnostic tests in medicine in general. Nevertheless, many questions surround the clinical value of molecular diagnostic tests, and their acceptance by clinicians, payers, and patients has been unpredictable. A major limiting factor for the use of these tests has been the lack of clear evidence of clinical utility. Genome-Based Diagnostics assesses the evidentiary requirements for clinical utility of molecular diagnostics used to guide treatment decisions for patients with cancer; discusses methodologies related to demonstrating these evidentiary requirements that meet the needs of all stakeholders; and considers innovative, sustainable research collaborations for generating evidence of clinical utility involving multiple stakeholders.

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