Appendix C

Registered Workshop Attendees

Patrick Archdeacon

Medical Officer

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Deborah Ascheim

Associate Professor, Clinical Director of Research, InCHOIR

Mount Sinai School of Medicine

Christopher Beardmore

Chief Executive Officer

Translational Research Management, LLC

Stefano Bertuzzi

Director, Office of Science Policy, Planning and Communications

National Institutes of Mental Health

Sue Bogner

Chief Scientist

Institute for the Study of Human Error, LLC

Pamela Bradley

Director, Science Policy

American Association for Cancer Research

Linda Brady

Director, Division of Neuroscience and Basic Behavioral Science

National Institute of Mental Health

P. J. Brooks

Health Science Administrator

Office of Rare Diseases Research

National Institutes of Health



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Appendix C Registered Workshop Attendees Patrick Archdeacon Sue Bogner Medical Officer Chief Scientist Center for Drug Evaluation and Institute for the Study of Human Research Error, LLC U.S. Food and Drug Administration Pamela Bradley Director, Science Policy American Association for Cancer Deborah Ascheim Associate Professor, Clinical Research Director of Research, InCHOIR Mount Sinai School of Medicine Linda Brady Director, Division of Neuroscience and Basic Behavioral Science Christopher Beardmore Chief Executive Officer National Institute of Mental Translational Research Health Management, LLC P. J. Brooks Health Science Administrator Stefano Bertuzzi Director, Office of Science Policy, Office of Rare Diseases Research Planning and Communications National Institutes of Health National Institutes of Mental Health 123

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124 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Steven Brotman Christine Carter Senior Vice President, Payment Vice President, Scientific Affairs and Health Care Delivery Society for Women’s Health Policy Research AdvaMed Dorothy Castille National Institute on Minority Suanna Bruinooge Director, Research Policy Health and Health Disparities American Society of Clinical National Institutes of Health Oncology Carroll Child Clinical Research Risk Manager Barbara Buch U.S. Food and Drug University of California, San Administration Francisco Liza Bundesen Charles Clayton Acting Chief, Science Policy and Director of Training Evaluation Branch American Society of Hematology Office of Science Policy, Planning, and Communications Elaine Collier National Institute of Mental Senior Advisor to Director Health National Center for Research Resources National Institutes of Health Robert Califf Director, Duke Translational Medicine Institute Doug Cropper Vice Chancellor for Clinical and President and Chief Executive Translational Research Officer Professor of Medicine Genesis Health System Duke University Medical Center Dennis Cryer Chief Medical Officer Scott Campbell Executive Director & CEO CryerHealth Foundation for the National Institutes of Health Donna Cryer CEO CryerHealth Tanisha Carino Senior Vice President Avalere Health Ulyana Desiderio Senior Manager for Scientific Affairs Kelli Carrington Lead, Public Affairs American Society of Hematology National Institutes of Health Clinical Center

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125 APPENDIX C Dinora Dominguez J. Michael Fitzmaurice Chief, Patient Recruitment and Senior Science Advisor for Public Liasion Information Technology National Institutes of Health Agency for Healthcare Research Clinical Center and Quality James Doroshow Mark Fleury Director, Division of Cancer Associate Director, Science Policy Treatment and Diagnosis American Association for Cancer National Cancer Institute Research National Institutes of Health Sherine Gabriel William J. and Charles H. Mayo Jeffrey Drazen Editor-in-Chief Professor of Medicine & Epidemiology, Mayo Medical New England Journal of Medicine School Co-Principal Investigator Peggy Eastman Oncology Times and Director of Education, Mayo Clinical Center for Translational Scientific Paul Eisenberg Senior Vice President, Global Activities (CTSA) Regulatory Affairs and Safety Amgen Inc. Jenny Gaffney Senior Manager Avalere Health Lynn Etheredge Consultant, Rapid Learning Project Elaine Gallin George Washington University Principal QE Philanthropic Advisors Gary Filerman President John Gallin Atlas Health Foundation Director, Clinical Center National Institutes of Health Louis Fiore Principal Investigator, VA Annetine Gelijns Cooperative Studies Program Professor of Health Policy Director, VA Cooperative Studies Co-Chair, Department of Health Program Coordinating Center, Evidence and Policy Boston Mount Sinai School of Medicine Department of Veterans Affairs

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126 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Robert Giffin Felix Gyi Vice President, Healthcare Policy CEO and Reimbursement Chesapeake IRB Covidien Anthony Hayward Director, Division for Clinical Andrea Giuffrida Health Scientist—AAAS Science Research Resources & Technology Policy Fellow National Center for Research Office of Science Policy Resources National Institutes of Health National Institutes of Health Rashmi Gopal-Srivastava Elina Hemminki Director, Extramural Research Professor Program National Institute for Health and Office of Rare Diseases Research Welfare, Helsinki, Finland National Institutes of Health Janie Hofacker Director of Programs Jennifer Graff Research Director, Methods, Association of American Cancer Evidence & Coverage Institutes National Pharmaceutical Council Jeffrey Humphrey Executive Director Cheryl Grandinetti Health Scientist Policy Analyst Bristol-Myers Squibb Center for Drug Evaluation and Research Ekopimo Ibia U.S. Food and Drug Administration Director Merck & Co., Inc. Candice Griffin Senior Program Manager John Iglehart American Society of Clinical National Correspondent Oncology New England Journal of Medicine Claudia Grossmann Rebecca Jackson Program Officer Professor and Associate Dean for Institute of Medicine Clinical Research Director and Principal Investigator, OSU Center for Kristi Guillory Senior Policy Analyst Clinical and Translational American Cancer Society Science The Ohio State University

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127 APPENDIX C Michael King Jolly Kathy Kopnisky Senior Vice President Senior Policy Analyst, Advisor for Quintiles Innovation Regulatory Science Office of Science Policy National Institutes of Health Rasika Kalamegham Senior Associate Pew Charitable Trusts Ronald Krall Associate Fellow Center for Bioethics Petra Kaufmann Director, Office of Clinical University of Pennsylvania Research National Institute of Neurological Judith Kramer Disorders and Stroke Associate Professor of Medicine, National Institutes of Health Duke University Medical Center Executive Director, Clinical Trials Dominick Kennerson Director Transformation Initiative CryerHealth (CTTI) Steven King Steven Krosnick Assistant Executive Director Program Director American College of Radiology National Cancer Institute National Institutes of Health Timothy King Director Kelly Lai PRA International Director of Science and Regulatory Affairs Biotechnology Industry Roger Klein Medical Director, Molecular Organization Oncology Blood Center of Wisconsin, Michael Lauer Medical College of Wisconsin Director, Division of Cardiovascular Sciences National Heart, Lung, and Blood Charles Knirsch Vice President, Clinical Research Institute Pfizer Inc. National Institutes of Health Hon-Sum Ko David Leventhal Medical Officer Director, Clinical Innovation Center for Drug Evaluation and Pfizer Inc. Research U.S. Food and Drug Administration

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128 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Shao-Lee Lin Marissa Miller Executive Medical Director Chief, Advanced Technologies Amgen Inc. and Surgery Branch National Heart, Lung, and Blood Institute Bryan Luce Senior Vice President, Science National Institutes of Health Policy United BioSource Corporation Carol Mimura Assistant Vice Chancellor for Intellectual Property & Kelsey Mace Program Coordinator Industry Research Alliances American Society of Clinical (IPIRA) Oncology University of California, Berkeley Diane Maloney Briggs Morrison Associate Director for Policy Senior Vice President Center for Biologics Evaluation Worldwide Medical Excellence and Research Pfizer Inc. U.S. Food and Drug Administration Catherine Muha Public Health Advisor Michael Marcarelli Director, Division of Bioresearch National Cancer Institute Monotoring National Institutes of Health Office of Compliance, Center for Devices and Radiological Sharon Murphy Health Scholar-in-Residence U.S. Food and Drug Administration National Cancer Policy Forum Institute of Medicine Karen Margolis Professor of Medicine, University Richard Murray of Minnesota Medical School Vice President, Global Center for Director of Clinical Research Scientific Affairs HealthPartners Research Office of the Chief Medical Foundation Officer Merck & Co., Inc. Paula McKeever Senior Policy Coordinator Elizabeth Ness Center for Drug Evaluation and Nurse Consultant Research National Cancer Institute U.S. Food and Drug Administration National Institutes of Health

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129 APPENDIX C Martha Nolan Richard Platt Vice President, Public Policy Professor, Harvard Medical Society for Women’s Health School Research Co-Chair, Clinical Effectiveness Research Innovation Collaboration Ann O’Mara Program Director IOM Roundtable on Value and National Cancer Institute Science-Driven Health Care National Institutes of Health Laura Povlich AAAS Congressional Fellow Keiko Ono Senior Program Associate Representative Sandy Levin National Research Council Mary Purucker National Center for Research John Orloff Chief Medical Officer and Resources Senior Vice President, Global National Institutes of Health Development, US Medical & Drug Regulatory Affairs Elizabeth Rach Novartis Pharmaceuticals Scientist Corporation Cato Research Ltd. Maggie Owner Ihor Rak Government Affiars Consultant Vice President, Clinical Lewis-Burke Associates LLC Neuroscience AstraZeneca Rose Mary Padberg Public Health Advisor Domenic Reda National Cancer Institute Director National Institutes of Health VA Cooperative Studies Program Coordinating Center Linda Parreco Public Health Advisor Stephanie Reffey National Cancer Institute Research Science Manager National Institutes of Health Susan G. Komen for the Cure Gary Persinger Theodore Reiss Consultant Research Professor of Medicine National Pharmaceutical Council Vanderbilt

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130 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE John Reppas Deborah Runkle Director of Public Policy Senior Program Associate Neurotechnology Industry American Association for the Organization Advancement of Science Gloria Romanelli Jody Sachs Senior Director Program Officer American College of Radiology National Center for Research Resources National Institutes of Health Patrick Rooney Co-Founder Bionymity, Inc. Chas Scammell Director, New York Pharmaceutical Practice Jean Rouleau Scientific Director, Institute of Milliman Circulatory and Respiratory Health Amber Hartman Scholz Canadian Institutes of Health Assistant Executive Director Research President’s Council of Advisors on Science and Technology & Office of Science and Arthur Rubenstein Professor, Department of Technology Policy Medicine, Division of Endocrinology Jeff Schomisch Raymond and Ruth Perelman Senior Managing Editor School of Medicine Guide to Good Clinical Practice University of Pennsylvania Kevin Schulman Professor of Medicine and Emily Rubinstein Manager, Data Analytics Gregory Mario and Jeremy Context Matters Mario Professor of Business Administration Duke University School of Richard Rudick Hazel Prior Hostetler Chair of Medicine and the Fuqua School Neurology, Cleveland Clinic of Business Professor of Medicine, Cleveland Clinic Lerner College of Talisha Searcy Medicine Program Analyst Case Western Reserve University Office of Inspector General, Office of Evaluation and Inspections U.S. Department of Health and Human Services

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131 APPENDIX C Joe Selby Kathleen Stratton Executive Director Project Director Patient-Centered Outcomes Pew Charitable Trusts Research Institute Tibor Szentendrei Senior Clinical Research Scientist Lisa Shapiro Associate Director, Clinical KAI Research, Inc. Program Management Astellas Pharma Global Carmen Tamayo Development R&D Consultant HeteroGeneity, LLC Rachel Sherman Associate Director for Medical Jacob Tenai Policy Director Center for Drug Evaluation and Orphan Child Africa Research Organization U.S. Food and Drug Administration Umesh Thakkar Senior General Engineer Mark Smith Policy Counsel U.S. Government Accountability National Coalition for Cancer Office Research Douglas Throckmorton Deputy Director, Center for Drug Phillip Smith Director, Planning, Evaluation Evaluation & Research and Research U.S. Food and Drug Administration Indian Health Service Janet Tobias President Sierra/Tango Heather Snyder Senior Associate Director, Productions Scientific Grants Ikana Media Alzheimer’s Association Sean Tunis President & CEO Anil Srivastava Director Center for Medical Technology Open Health Systems Laboratory Policy Scott Steele Kathleen Uhl Director, Research Alliances Deputy Director, Office of University of Rochester Medical Policy Center for Drug Evaluation and Research U.S. Food and Drug Administration

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132 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Clyde Yancy Jill Wechsler Magerstadt Professor of Washington Editor Medicine, Chief, Division of Pharmaceutical Executive magazine Cardiology Feinberg School of Medicine, Neil Weisfeld Northwestern University New Associates, LLC Tara Yazinski Neil Weissman Advocate President National Fibromyalgia and MedStar Health Research Chronic Pain Association Institute John Yeh Clarissa Wittenberg Professor Consultant Massachusetts General Hospital, European Organization for Harvard Research and Treatment of Cancer Peter Yu Oncologist, Palo Alto Medical Hui-Hsing Wong Foundation Medical Officer Chair, Electronic Health Record Assistant Secretary for Planning Working Group and Evaluation American Society of Clinical U.S. Department of Health and Oncology Human Services Deborah Zarin Alastair Wood Director, ClinicalTrials.gov Partner & Managing Director National Library of Medicine Symphony Capital LLC Paul Zimmet Janet Woodcock Research Advocate Director Parkinson’s Disease Foundation Center for Drug Evaluation and Research Bram Zuckerman U.S. Food and Drug Administration Director Division of Cardiovascular Devices U.S. Food and Drug Administration