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Steering Committee Representatives

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NAME (in alphabetical order) REPRESENTING

John Alexander, MD
Associate Professor of Medicine

Duke University

Leslie Ball, MD
Director, Division of Scientific Investigations

U.S. Food and Drug Administration/Center for Drug Evaluation and Research

Kelly Blackburn, MHA, MEd
Vice President, Clinical Development Operations

Vertex Pharmaceuticals Inc.

Frederick Bloom, PhD
Associate Director of Science, Division of STD Prevention

Centers for Disease Control and Prevention (Liaison)

Sally Bolmer, PhD, RAC
Senior Vice President, Development and Regulatory Affairs

Human Genome Sciences Inc.

Jackie Bosch, MSc
Project Manager

Population Health Research Institute, McMaster University

Barbara Buch, MD
Associate Director for Medicine

U.S. Food and Drug Administration/Center for Biologics Evaluation and Research

Mark Carlson, MD, MA
Chief Medical Officer and Senior Vice President, Clinical Affairs

St. Jude Medical

David Ciavarella, MD
Staff Vice President, Corporate Clinical Affairs

C.R. Bard Inc.

Sabrina Comic-Savic, MD, MPH
Senior Director, GCP Compliance

The Medicines Company

Roger DeRaad, MN, CNP
Director of Research

Black Hills Clinical Research Center

Susan Ellenberg, PhD
Associate Dean for Clinical Research

University of Pennsylvania School of Medicine

Daniel Ford, MD, MPH
Vice Dean for Clinical Investigation

Johns Hopkins University

Curt Furberg, MD, PhD
Professor, Division of Public Health Sciences
Wake Forest University Health Sciences

Society for Clinical Trials

Cami Gearhart, JD
Chief Executive Officer

Quorum Review Inc.

Coleen Glessner
VP, Development Operations, Head of Clinical Trial Process Quality

Pfizer Inc.

Gerry Gray, PhD
Associate Director, Division of Biostatistics

U.S. Food and Drug Administration/Center for Devices and Radiological Health

Felix Khin-Maung-Gyi, PharmD, MBA, CIP, RAC
Chief Executive Officer

Chesapeake Research Review Inc.

Wendy Hague, MD
Clinical Trials Programme Director

University of Sydney NHMRC Clinical Trials Centre

Cynthia Hahn

Feinstein Institute for Medical Research

Carla Helaszek
Executive Director

Daiichi Sankyo Inc.

Gregory Hockel, PhD
Executive Vice President, Regulatory Affairs

PharmaNet Development Group Inc.

Grant Huang, MPH, PhD
Deputy Director of the Cooperative Studies Program

U.S. Department of Veterans Affairs

John Isidor, JD
Chairman, Schulman Associates  IRB

Consortium of Independent Review Boards

Clay Johnston, MD
Associate Vice Chancellor of Research and CTSI Director

University of California, San Francisco CTSI

Michael Jones
Senior Director, Regional Clinical Operations

Eli Lilly and Company

Mairead Kehoe-Whistance
Vice President, Global Clinical Operations

Celgene Corporation

Michele Kennett, JD, MSN, LLM
Compliance Officer, Health Science IRB

University of Missouri

Amy Kissam
Senior Director of Clinical Operational Quality Management


Preston Klassen, MD
Senior Vice President/Head, Global Development

Orexigen Therapeutics Inc.

Andreas Koester, MD, PhD
Global Head, External Alliances and Business Models

Johnson & Johnson Pharmaceutical Research and Development

Susan Kornstein, MD
Director of Clinical Research, Department of Psychiatry
Executive Director, VCU Mood Disorders Institute and VCU Institute for Women's Health
Medical Director, VCU Clinical Trials Office

Virginia Commonwealth University

Rebecca Kush, PhD
President and Chief Executive Officer

Clinical Data Interchange Standards Consortium

Kelly Lai
Director, Science and Regulatory Affairs

Biotechnology Industry Organization

Martin Landray, PhD, FRCP
Reader in Epidemiology and Honorary Consultant Physician, Clinical Trial Service Unit and Epidemiological Studies Unit

University of Oxford, Clinical Trial Service Unit

Trudie Lang, MD
Head of Global Health Clinical Trials Research Programme

University of Oxford, Centre for Tropical Medicine

Patrick Lee, MD

Palo Alto Investors Inc.

Joanne Less, PhD
Director, Good Clinical Practice Program, Office of the Commissioner

U.S. Food and Drug Administration/Good Clinical Practice Program

Elliott Levy, MD, Co-chairperson
Senior Vice President, Global Pharmacovigilance and Epidemiology

Bristol-Myers Squibb Co.

Michael Lincoff, MD
Director, Center for Clinical Research and Vice Chairman for Clinical Research, Lerner Research Institute
Director, Cleveland Clinic Coordinating Center for Clinical Research (C5Research)
Vice Chairman, Department of Cardiovascular Medicine
Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
The Cleveland Clinic Foundation

American College of Cardiology

Mary Long
Senior Vice President, Project Quality Compliance

ICON Clinical Research

Beverly Lorell, MD, FACC, Co-chairperson
Senior Medical and Policy Advisor

King & Spalding LLP

Kate Marusina, PhD, MBA
Manager, Clinical Trials
Clinical and Translational Science Center

University of California, Davis

Yvonne McCracken, MPH
President and Chief Executive Officer

Carolinas Research Associates

Jerry Menikoff, MD, JD

Office for Human Research Protections (Liaison)

Jules Mitchel, MBA, PhD

Target Health Inc.

Steve Nissen, MD, MACC
Chairman, Department of Cardiovascular Medicine

Cleveland Clinic Coordinating Center for Clinical Research

John Orloff, MD
Chief Medical Officer and Senior Vice President, Global Development

Novartis Pharmaceuticals

Bray Patrick-Lake

Patient representative

Amy Patterson, MD
Associate Director, Office of Science Policy

National Institutes of Health (Liaison)

Doug Peddicord, PhD
Executive Director

Association of Clinical Research Organizations

Vlado Perkovic, MBBS, PhD, FRACP, FASN
Executive Director
Associate Professor, University of Sydney
Physician in Nephrology and Hypertension, Royal North Shore Hospital

The George Institute

Jane Perlmutter, PhD

Patient representative

Kenneth Pienta, MD
Director, Michigan Institute for Clinical and Health Research
Associate Dean for Clinical and Translational Research
Director, Experimental Therapeutics, Michigan Center for Translational Pathology

University of Michigan School of Medicine

Christine Pierre, RN

Rx Trials Inc.

James Rollins, MD
Director of the Division of Items and Devices, Coverage and Analysis Group, Office of Clinical Standards and Quality

Centers for Medicare and Medicaid Services

Corsee Sanders, PhD
Senior Vice President and Global Head, Biometrics

Genentech–a member of the Roche Group

Jonathan Seltzer, MD, MBA
President, Applied Clinical Intelligence LLC

Academy of Physicians in Clinical Research

Jeffrey Sherman, MD, FACP
Chief Medical Officer and Executive Vice President, Development and Regulatory Affairs
Horizon Pharma Inc.

Drug Information Association

Christine Sorkness, PharmD
Senior Associate Director, Institute for Clinical and Translational Research

University of Wisconsin

Barbara Tardiff, MD, MBA
Corporate Vice President, Data Sciences, Clinical Research Services

PAREXEL International

Alice Till, PhD
Vice President, Science Policy and Technical Affairs

Pharmaceutical Research and Manufacturers of America

Bruce Tomason, MBA
Chief Executive Officer

Copernicus Group IRB

Anne Trontell, MD, MPH
Program Director, Centers for Education and Research on Therapeutics
Center for Outcomes and Evidence

Agency for Healthcare Research and Quality (Liaison)

Janet Vargo, PhD
Executive Director, Clinical Design

Johnson & Johnson Devices and Diagnostics

José Vega, MD
Vice President, Global Safety

Amgen Inc.

Neil Weissman, MD

MedStar Health Research Institute

Craig Wozniak
Vice President, CCSE NA and Global Monitoring Practice


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