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Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
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Page 99
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
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Page 100
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
×
Page 101
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
×
Page 102
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
×
Page 103
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
×
Page 104
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
×
Page 105
Suggested Citation:"Appendix D: Registered Attendees." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
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Page 106

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Appendix D Registered Attendees Diane Allingham-Hawkins Bruce Blumberg Hayes, Inc. Kaiser Permanente Northern California Euan Ashley Stanford University Jan Blusztajn Boston University James Battle University of California, Khaled Bouri Santa Cruz U.S. Food and Drug Administration Judith Benkendorf American College of Medical Pam Bradley Genetics and Genomics U.S. Food and Drug Administration Jonathan Berg University of North Carolina at Ruth Brenner Chapel Hill Air Force Medical Support Agency Barbara Biesecker National Human Genome P. J. Brooks Research Institute, National Office of Rare Diseases Institutes of Health Research, National Institutes of Health Paul Billings Life Technologies 99

100 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS Susie Calhoun Maria DeTolve Donoghue Blue Cross and Blue Shield G&M Consulting Association Federal Employee Program Michael Dougherty American Society of Human Khatereh Calleja Genetics Advanced Medical Technology Association Tonya Dowd Quorum Consulting Kathryn Camp Office of Dietary Supplements Lynn Dressler National Institutes of Health Mission Health Sarah Carter Jennifer Dreyfus J. Craig Venter Institute Dreyfus Consulting, LLC Ann Cashion Emily Edelman National Institute of Nursing Jackson Laboratory Research National Institutes of Health Stanley Edlavitch University of Missouri–Kansas Robert Cook-Deegan City, School of Medicine Duke University Raith Erickson Michael Crossey Complete Genomics TriCore Reference Laboratories Jessica Everett Bob Darnell University of Michigan New York Genome Center Howard Hughes Medical Altovise Ewing Institute Rockefeller University Johns Hopkins University Patricia Deverka Greg Feero Center for Medical Technology Journal of the American Policy Medical Association Jordan Dimitrakoff Brady Urological Institute

APPENDIX D 101 Tamara Feldblyum Gabriela Gomez Office of In Vitro Diagnostics Innova Translational Medicine and Radiological Health Institute Center for Devices and Radiological Health Peter Goodhand U.S. Food and Drug Global Alliance for Genomics Administration and Health Lynn Fellman Kristi Graves Fellman Studios Georgetown University Shannon Firth Robert Green U.S. News & World Report Brigham & Women’s Hospital and Harvard Medical School Mark Fleury American Cancer Society, Paula Grossman Cancer Action Network Blue Cross and Blue Shield Association Phyllis Frosst Personalized Medicine Pertti Hakkinen Coalition National Library of Medicine National Institutes of Health Michael Gambello Emory University School of Jennifer Hall Medicine Lillehei Heart Institute University of Minnesota Jonn Gardenier Retired Alyson Hanish National Institutes of Health Turkan Gardenier Pragmatica Corporation Madhuri Hegde Emory University Geoff Ginsburg Duke University Kathleen Hickey Columbia University Katrina Goddard Kaiser Center for Health Amy Hower Research Stanford University

102 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS Louis Jacques Maggie Linak Centers for Medicare & U.S. Agency for International Medicaid Services Development Samuel Johnson David Litwack Kaiser Permanente Colorado U.S. Food and Drug Administration Kristina Krasnov U.S. Department of State Suzanne Luther Social Security Administration Shashikant Kulkarni Washington University Gary Lyman Fred Hutchinson Cancer Gabriela Lavezzari Research Center Pharmaceutical Research and Manufacturers of America Julie Lynch Veterans Health Administration Thomas Lehner National Institute of Mental Jennifer Madsen Health College of American National Institutes of Health Pathologists Debra G. B. Leonard Teri Manolio Fletcher Allen Health Care National Human Genome University of Vermont College Research Institute of Medicine Saralyn Mark Laura Levit National Aeronautics and Space Institute of Medicine Administration Emily Levy Anna Mazzucco Synergy Partners National Research Center for Women and Families Mark Lim FasterCures Bob McCormack Veridex, LLC Mel Limson Association for Molecular Robert McDonough Pathology Aetna

APPENDIX D 103 Andrew Meltzer Ron Przygodzki George Washington University Department of Veterans Affairs Ronald Miller Nalini Raghavachari Air Force Medical Support National Institutes of Health Agency Kate Reed Suman Mukherjee Jackson Laboratory Genetic Alliance Heidi Rehm Padmaja Mummaneni Partners Center for Personalized Center for Drug Evaluation and Genetic Medicine Research U.S. Food and Drug Kris Rickhoff Administration Washington University School of Medicine Becky Nagy Ohio State Mark Robson Memorial Sloan–Kettering Shelley Fuld Nasso Cancer Center National Coalition for Cancer Survivorship Allen Roses Duke University Ernie Niblack WaferGen Biosystems, Inc. Julie Rousseau Claritas Genomics Casey Overby University of Maryland Howard Saal Cincinnati Children’s Hospital Erin Payne Medical Center Northrop Grumman Health IT Sarah Savage Michelle Penny Boston Children’s Hospital Eli Lilly and Company Mari Savickis Vicky Pratt American Medical Association Association for Molecular Kate Saylor Pathology National Human Genome Research Institute

104 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS Derek Scholes Zivana Tezak National Human Genome U.S. Food and Drug Research Institute Administration Joan Scott Lyubov Tmanova Health Resources and Services Weill Cornell Medical College Administration Kemi Tomobi Prashant Shah Student National Medical Intel Corporation Association Fay Shamanski Hoang-Lan Tran College of American Quorum Consulting Pathologists Sylvia Trujillo Sam Shekar American Medical Association Northrop Grumman Health IT Lois Tully Deborah Smith National Institute of Nursing Blue Cross and Blue Shield Research Association National Institutes of Health Federal Employee Program David Veenstra Allen Spiegel University of Washington Albert Einstein College of Medicine Catharine Wang Boston University School of Kimberly Strong Public Health Center for Bioethics and Medical Humanities Michael Watson Medical College of Wisconsin American College of Medical Genetics and Genomics Katie Johansen Taber American Medical Association Meredith Weaver American College of Medical Darius Tahir Genetics and Genomics “The Gray Sheet” Jennifer Weisman Strategic Analysis, Inc.

APPENDIX D 105 Jon White Agency for Healthcare Research and Quality Janet Williams University of Iowa Mary Steele Williams Association for Molecular Pathology Catherine Witkop U.S. Air Force Rina Wolf XIFIN, Inc.

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Rapid advances in technology have lowered the cost of sequencing an individual's genome from the several billion dollars that it cost a decade ago to just a few thousand dollars today and have correspondingly greatly expanded the use of genomic information in medicine. Because of the lack of evidence available for assessing variants, evaluation bodies have made only a few recommendations for the use of genetic tests in health care. For example, organizations, such as the Evaluation of Genomic Applications in Practice and Prevention working group, have sought to set standards for the kinds of evaluations needed to make population-level health decisions. However, due to insufficient evidence, it has been challenging to recommend the use of a genetic test. An additional challenge to using large-scale sequencing in the clinic is that it may uncover "secondary," or "incidental," findings - genetic variants that have been associated with a disease but that are not necessarily related to the conditions that led to the decision to use genomic testing. Furthermore, as more genetic variants are associated with diseases, new information becomes available about genomic tests performed previously, which raises issues about how and whether to return this information to physicians and patients and also about who is responsible for the information.

To help develop a better understanding of how genomic information is used for healthcare decision making, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine held a workshop in Washington,DC in February 2014. Stakeholders, including clinicians, researchers, patients, and government officials, discussed the issues related to the use of genomic information in medical practice. Assessing Genomic Sequencing Information for Health Care Decision Making is the summary of that workshop. This report compares and contrasts evidence evaluation processes for different clinical indications and discusses key challenges in the evidence evaluation process.

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