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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
