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Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine (2016)

Chapter: Appendix C: Information-Gathering Sessions and Speakers

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Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
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Appendix C

Information-Gathering Sessions and Speakers

COMMITTEE MEETING 1 – JANUARY 29, 2015

JEFFREY S. DLOTT, Medical Director, Coagulation and Immunohematology, Quest Diagnostics

LEVI GARRAWAY, Associate Professor, Department of Medicine, Harvard Medical School

BRUCE G. HAFFTY, Chair of the Board, American Society for Radiation Oncology

STANLEY R. HAMILTON, College of American Pathologists

DANIEL F. HAYES, Clinical Director, Breast Oncology Program, University of Michigan Comprehensive Cancer Center

LOUIS JACQUES, Senior Vice President and Chief Clinical Officer, ADVI Consulting

LARRY NORTON, Founder and Scientific Director, Breast Cancer Research Foundation

KIRSTEN PAULSON, Senior Director, Research, Medical Device Development, Pfizer Inc.

RICHARD L. SCHILSKY, Chief Medical Officer, American Society of Clinical Oncology

COMMITTEE MEETING 2 – APRIL 1, 2015

SAMUEL ARONSON, Executive Director, IT, Partners Personalized Medicine

Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

ROBERT CALIFF, Deputy Commissioner for Medical Products and Tobacco, Food and Drug Administration

BRIAN CAREY, Partner, Foley Hoag, LLP

JOSEPH CHIN, Senior Medical Advisor/Acting Deputy Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services

CURTIS HANSON, Professor of Laboratory Medicine and Pathology, Chief Medical Officer, Mayo Medical Laboratories, Mayo Clinic

JONATHAN W. HEUSEL, Chief Medical Officer, Genomics and Pathology Services and Medical Director of the Clinical Laboratory, The Genome Institute of Washington University, Washington University School of Medicine in St. Louis

ELIZABETH MANSFIELD, Deputy Office Director for Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health/Center for Devices and Radiological Health, Food and Drug Administration

LAWRENCE J. MEYER, Professor of Dermatology and Internal Medicine, University of Utah Health Sciences Center; Associate Chief of Staff, Research, Salt Lake City Veterans Affairs Medical Center; and National Director, Genomic Medicine, Veterans Health Administration

LEE N. NEWCOMER, Senior Vice President, Oncology, Genetics and Women’s Health, UnitedHealthCare

MARISA PAPALUCA, Senior Scientific Advisor, Human Medicines Research & Development Support Division, European Medicines Agency

SCOTT RAMSEY, Professor, School of Medicine, School of Pharmacy, and the Institute for Public Health Genetics, University of Washington

WILLIAM W. STEAD, Associate Vice Chancellor for Health Affairs; Chief Strategy Officer, McKesson Foundation Professor of Biomedical Informatics, Professor of Medicine, Vanderbilt University Medical Center

SUZANNE TOPALIAN, Professor of Surgery and Oncology, Director, Melanoma Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University

JOHN A. WAGNER, Senior Vice President, Head of Clinical and Translational Sciences, Takeda Pharmaceuticals

SHEILA WALCOFF, CEO and Founder, Goldbug Strategies, LLC

MARC S. WILLIAMS, Director, Genomic Medicine Institute, Geisinger Health System

JANET WOODCOCK, Director, Center for Drug Evaluation and Research, Food and Drug Administration

Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

COMMITTEE REIMBURSEMENT WEBINAR – MAY 4, 2015

ELAINE JETER, MolDx Medical Director, Palmetto GBA

ROBERT McDONOUGH, Head of Clinical Policy Research and Development, Aetna

LINCOLN NADAULD, Director, Cancer Genomics, Intermountain Healthcare

PAUL RADENSKY, Partner, McDermott, Will & Emery

ALAN ROSENBERG, Vice President, Medical and Clinical Pharmacy Policy, Anthem

COMMITTEE MEETING 3 – JUNE 11, 2015

STEPHEN FRIEND, President, Co-Founder, and Director, Sage Bionetworks

SARAH GARCIA, Clinical Genomics Applications Manager, Personalis, Inc.

CLIFFORD A. HUDIS, Chief, Breast Medicine Service, Memorial Sloan Kettering Cancer Center

ROBERT WILDIN, Chief, Genomic Healthcare Branch, National Human Genome Research Institute

Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

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Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 249
Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 250
Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 251
Suggested Citation:"Appendix C: Information-Gathering Sessions and Speakers." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Every patient is unique, and the evolving field of precision medicine aims to ensure the delivery of the right treatment to the right patient at the right time. In an era of rapid advances in biomedicine and enhanced understanding of the genetic basis of disease, health care providers increasingly have access to advanced technologies that may identify molecular variations specific to an individual patient, which subsequently can be targeted for treatment. Known as biomarker tests for molecularly targeted therapies, these complex tests have the potential to enable the selection of the most beneficial treatment (and also to identify treatments that may be harmful or ineffective) for the molecular underpinnings of an individual patient’s disease. Such tests are key to unlocking the promise of precision medicine.

Biomarker tests for molecularly targeted therapies represent a crucial area of focus for developing methods that could later be applicable to other areas of precision medicine. The appropriate regulatory oversight of these tests is required to ensure that they are accurate, reliable, properly validated, and appropriately implemented in clinical practice. Moreover, common evidentiary standards for assessing the beneficial impact of biomarker-guided therapy selection on patient outcomes, as well as the effective collection and sharing of information related to those outcomes, are urgently needed to better inform clinical decision making.

Biomarker Tests of Molecularly Targeted Therapies examines opportunities for and challenges to the use of biomarker tests to select optimal therapy and offers recommendations to accelerate progress in this field. This report explores regulatory issues, reimbursement issues, and clinical practice issues related to the clinical development and use of biomarker tests for targeting therapies to patients. Properly validated, appropriately implemented biomarker tests hold the potential to enhance patient care and improve outcomes, and therefore addressing the challenges facing such tests is critical.

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