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Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
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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

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
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Steven Brotman

Senior Vice President, Payment and Health Care Delivery Policy

AdvaMed

Suanna Bruinooge

Director, Research Policy

American Society of Clinical Oncology

Barbara Buch

U.S. Food and Drug Administration

Liza Bundesen

Acting Chief, Science Policy and Evaluation Branch

Office of Science Policy, Planning, and Communications

National Institute of Mental Health

Robert Califf

Director, Duke Translational Medicine Institute

Vice Chancellor for Clinical and Translational Research

Professor of Medicine

Duke University Medical Center

Scott Campbell

Executive Director & CEO

Foundation for the National Institutes of Health

Tanisha Carino

Senior Vice President

Avalere Health

Kelli Carrington

Lead, Public Affairs

National Institutes of Health Clinical Center

Christine Carter

Vice President, Scientific Affairs

Society for Women’s Health Research

Dorothy Castille

National Institute on Minority Health and Health Disparities

National Institutes of Health

Carroll Child

Clinical Research Risk Manager

University of California, San Francisco

Charles Clayton

Director of Training

American Society of Hematology

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
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Elaine Collier

Senior Advisor to Director

National Center for Research Resources

National Institutes of Health

Doug Cropper

President and Chief Executive Officer

Genesis Health System

Dennis Cryer

Chief Medical Officer CryerHealth

Donna Cryer

CEO

Cryer Health

Ulyana Desiderio

Senior Manager for Scientific Affairs

American Society of Hematology

Dinora Dominguez

Chief, Patient Recruitment and Public Liasion

National Institutes of Health Clinical Center

James Doroshow

Director, Division of Cancer Treatment and Diagnosis

National Cancer Institute

National Institutes of Health

Jeffrey Drazen

Editor-in-Chief

New England Journal of Medicine

Peggy Eastman

Oncology Times

Paul Eisenberg

Senior Vice President, Global Regulatory Affairs and Safety

Amgen Inc.

Lynn Etheredge

Consultant, Rapid Learning Project

George Washington University

Gary Filerman

President

Atlas Health Foundation

Louis Fiore

Principal Investigator, VA Cooperative Studies Program

Director, VA Cooperative Studies Program Coordinating Center, Boston

Department of Veterans Affairs

J. Michael Fitzmaurice

Senior Science Advisor for Information Technology

Agency for Healthcare Research and Quality

Mark Fleury

Associate Director, Science Policy

American Association for Cancer Research

Sherine Gabriel

William J. and Charles H. Mayo Professor of Medicine & Epidemiology, Mayo Medical School

Co-Principal Investigator and Director of Education, Mayo Clinical Center for Translational Scientific Activities (CTSA)

Jenny Gaffney

Senior Manager

Avalere Health

Elaine Gallin

Principal

QE Philanthropic Advisors

John Gallin

Director, Clinical Center

National Institutes of Health

Annetine Gelijns

Professor of Health Policy

Co-Chair, Department of Health Evidence and Policy

Mount Sinai School of Medicine

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Robert Giffin

Vice President, Healthcare Policy and Reimbursement

Covidien

Andrea Giuffrida

Health Scientist—AAAS Science & Technology Policy Fellow

Office of Science Policy

National Institutes of Health

Rashmi Gopal-Srivastava

Director, Extramural Research Program

Office of Rare Diseases Research

National Institutes of Health

Jennifer Graff

Research Director, Methods, Evidence & Coverage

National Pharmaceutical Council

Cheryl Grandinetti

Health Scientist Policy Analyst

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Candice Griffin

Senior Program Manager

American Society of Clinical Oncology

Claudia Grossmann

Program Officer

Institute of Medicine

Kristi Guillory

Senior Policy Analyst

American Cancer Society

Felix Gyi

CEO

Chesapeake IRB

Anthony Hayward

Director, Division for Clinical Research Resources

National Center for Research Resources

National Institutes of Health

Elina Hemminki

Professor

National Institute for Health and Welfare, Helsinki, Finland

Janie Hofacker

Director of Programs

Association of American Cancer Institutes

Jeffrey Humphrey

Executive Director

Bristol-Myers Squibb

Ekopimo Ibia

Director

Merck & Co., Inc.

John Iglehart

National Correspondent

New England Journal of Medicine

Rebecca Jackson

Professor and Associate Dean for Clinical Research

Director and Principal Investigator, OSU Center for Clinical and Translational Science

The Ohio State University

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Michael King Jolly

Senior Vice President

Quintiles Innovation

Rasika Kalamegham

Senior Associate

Pew Charitable Trusts

Petra Kaufmann

Director, Office of Clinical Research

National Institute of Neurological Disorders and Stroke

National Institutes of Health

Dominick Kennerson

Director

CryerHealth

Steven King

Assistant Executive Director

American College of Radiology

Timothy King

Director

PRA International

Roger Klein

Medical Director, Molecular Oncology

Blood Center of Wisconsin, Medical College of Wisconsin

Charles Knirsch

Vice President, Clinical Research

Pfizer Inc.

Hon-Sum Ko

Medical Officer

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Kathy Kopnisky

Senior Policy Analyst, Advisor for Regulatory Science

Office of Science Policy

National Institutes of Health

Ronald Krall

Associate Fellow

Center for Bioethics

University of Pennsylvania

Judith Kramer

Associate Professor of Medicine, Duke University Medical Center

Executive Director, Clinical Trials Transformation Initiative (CTTI)

Steven Krosnick

Program Director

National Cancer Institute

National Institutes of Health

Kelly Lai

Director of Science and Regulatory Affairs

Biotechnology Industry Organization

Michael Lauer

Director, Division of Cardiovascular Sciences

National Heart, Lung, and Blood Institute

National Institutes of Health

David Leventhal

Director, Clinical Innovation

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Pfizer Inc.

Shao-Lee Lin

Executive Medical Director

Amgen Inc.

Bryan Luce

Senior Vice President, Science Policy

United BioSource Corporation

Kelsey Mace

Program Coordinator

American Society of Clinical Oncology

Diane Maloney

Associate Director for Policy

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

Michael Marcarelli

Director, Division of Bioresearch Monotoring

Office of Compliance, Center for Devices and Radiological Health

U.S. Food and Drug Administration

Karen Margolis

Professor of Medicine, University of Minnesota Medical School

Director of Clinical Research

HealthPartners Research Foundation

Paula McKeever

Senior Policy Coordinator

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Marissa Miller

Chief, Advanced Technologies and Surgery Branch

National Heart, Lung, and Blood Institute

National Institutes of Health

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Carol Mimura

Assistant Vice Chancellor for Intellectual Property & Industry Research Alliances (IPIRA)

University of California, Berkeley

Briggs Morrison

Senior Vice President

Worldwide Medical Excellence

Pfizer Inc.

Catherine Muha

Public Health Advisor National Cancer Institute

National Institutes of Health

Sharon Murphy

Scholar-in-Residence

National Cancer Policy Forum

Institute of Medicine

Richard Murray

Vice President, Global Center for Scientific Affairs

Office of the Chief Medical Officer

Merck & Co., Inc.

Elizabeth Ness

Nurse Consultant

National Cancer Institute

National Institutes of Health

Martha Nolan

Vice President, Public Policy

Society for Women’s Health Research

Ann O’Mara

Program Director

National Cancer Institute

National Institutes of Health

Keiko Ono

Senior Program Associate

National Research Council

John Orloff

Chief Medical Officer and Senior Vice President, Global Development, US Medical & Drug Regulatory Affairs

Novartis Pharmaceuticals Corporation

Maggie Owner

Government Affiars Consultant

Lewis-Burke Associates LLC

Rose Mary Padberg

Public Health Advisor

National Cancer Institute

National Institutes of Health

Linda Parreco

Public Health Advisor

National Cancer Institute

National Institutes of Health

Gary Persinger

Consultant

National Pharmaceutical Council

Richard Platt

Professor, Harvard Medical School

Co-Chair, Clinical Effectiveness Research Innovation Collaboration

IOM Roundtable on Value and Science-Driven Health Care

Laura Povlich

AAAS Congressional Fellow

Representative Sandy Levin

Mary Purucker

National Center for Research Resources

National Institutes of Health

Elizabeth Rach

Scientist

Cato Research Ltd.

Ihor Rak

Vice President, Clinical Neuroscience

AstraZeneca

Domenic Reda

Director

VA Cooperative Studies Program Coordinating Center

Stephanie Reffey

Research Science Manager

Susan G. Komen for the Cure

Theodore Reiss

Research Professor of Medicine

Vanderbilt

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

John Reppas

Director of Public Policy

Neurotechnology Industry Organization

Gloria Romanelli

Senior Director

American College of Radiology

Patrick Rooney

Co-Founder

Bionymity, Inc.

Jean Rouleau

Scientific Director, Institute of Circulatory and Respiratory Health

Canadian Institutes of Health Research

Arthur Rubenstein

Professor, Department of Medicine, Division of Endocrinology

Raymond and Ruth Perelman School of Medicine

University of Pennsylvania

Emily Rubinstein

Manager, Data Analytics

Context Matters

Richard Rudick

Hazel Prior Hostetler Chair of Neurology, Cleveland Clinic

Professor of Medicine, Cleveland Clinic Lerner College of Medicine

Case Western Reserve University

Deborah Runkle

Senior Program Associate

American Association for the Advancement of Science

Jody Sachs

Program Officer

National Center for Research Resources

National Institutes of Health

Chas Scammell

Director, New York Pharmaceutical Practice

Milliman

Amber Hartman Scholz

Assistant Executive Director

President’s Council of Advisors on Science and Technology & Office of Science and Technology Policy

Jeff Schomisch

Senior Managing Editor

Guide to Good Clinical Practice

Kevin Schulman

Professor of Medicine and Gregory Mario and Jeremy Mario Professor of Business Administration

Duke University School of Medicine and the Fuqua School of Business

Talisha Searcy

Program Analyst

Office of Inspector General, Office of Evaluation and Inspections

U.S. Department of Health and Human Services

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Joe Selby

Executive Director

Patient-Centered Outcomes Research Institute

Lisa Shapiro

Associate Director, Clinical Program Management

Astellas Pharma Global Development

Rachel Sherman

Associate Director for Medical Policy

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Mark Smith

Policy Counsel

National Coalition for Cancer Research

Phillip Smith

Director, Planning, Evaluation and Research

Indian Health Service

Heather Snyder

Senior Associate Director, Scientific Grants

Alzheimer’s Association

Anil Srivastava

Director

Open Health Systems Laboratory

Scott Steele

Director, Research Alliances

University of Rochester

Kathleen Stratton

Project Director

Pew Charitable Trusts

Tibor Szentendrei

Senior Clinical Research Scientist

KAI Research, Inc.

Carmen Tamayo

R&D Consultant

HeteroGeneity, LLC

Jacob Tenai

Director

Orphan Child Africa Organization

Umesh Thakkar

Senior General Engineer

U.S. Government Accountability Office

Douglas Throckmorton

Deputy Director, Center for Drug Evaluation & Research

U.S. Food and Drug Administration

Janet Tobias

President Sierra/Tango Productions

Ikana Media

Sean Tunis

President & CEO

Center for Medical Technology Policy

Kathleen Uhl

Deputy Director, Office of Medical Policy

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Jill Wechsler

Washington Editor

Pharmaceutical Executive magazine

Neil Weisfeld

New Associates, LLC

Neil Weissman

President

MedStar Health Research Institute

Clarissa Wittenberg

Consultant

European Organization for Research and Treatment of Cancer

Hui-Hsing Wong

Medical Officer

Assistant Secretary for Planning and Evaluation

U.S. Department of Health and Human Services

Alastair Wood

Partner & Managing Director

Symphony Capital LLC

Janet Woodcock

Director

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Clyde Yancy

Magerstadt Professor of Medicine, Chief, Division of Cardiology

Feinberg School of Medicine, Northwestern University

Tara Yazinski

Advocate

National Fibromyalgia and Chronic Pain Association

John Yeh

Professor

Massachusetts General Hospital, Harvard

Peter Yu

Oncologist, Palo Alto Medical Foundation

Chair, Electronic Health Record Working Group

American Society of Clinical Oncology

Deborah Zarin

Director, ClinicalTrials.gov

National Library of Medicine

Paul Zimmet

Research Advocate

Parkinson’s Disease Foundation

Bram Zuckerman

Director

Division of Cardiovascular Devices

U.S. Food and Drug Administration

Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
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Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 124
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 125
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 126
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 127
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 128
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 129
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 130
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 131
Suggested Citation:"Appendix C: Registered Workshop Attendees." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 132
Next: Appendix D: Discussion Paper: The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation »
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There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions.


With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

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