Steering Committee

Maria Ali, MBBS, MBA

Chief Medical Officer

The George Institute for Global Health

Jeff Allen, PhD

Executive Director

Friends of Cancer Research

Jaime Arango, EdD, CIP

Director, CITI Educational Initiatives

CITI Program, a Division of BRANY

Rupa Balasubramanian

Senior Advisor

Women’s Heart Alliance

Richard Barohn, MD

Vice Chancellor for Research

University of Kansas Medical Center

Jimmy Bechtel

Senior Project Manager

Society for Clinical Research Sites

Lisa Berdan, PA, MHS

Director, Global Megatrials

Duke University

Elise Berliner, PhD

Director of Technology Assessment Program, Center for Evidence and Practice Improvement

Agency for Healthcare Research and Quality

David Borasky, MPH, CIP

Vice President, Quality Management

WIRB-Copernicus Group

Angie Botto-van Bemden, PhD, ATC, CSCS

Director, OA Programs, Science

Arthritis Foundation

Angela Britton

Head of Clinical Operations

Lupus Research Alliance

Marianne Chase

Director of Research Operations

Neurological Clinical Research Institute of Massachusetts General Hospital

David Ciavarella, MD

Vice President, Global Clinical Development

Becton Dickinson

Linda Coleman

Director, Human Research Protection Program

Yale University

Sabrina Comic-Savic, MD, MPH

Vice President, GCP Quality and Compliance

The Medicines Company

Dan Cooper

Associate Vice Chancellor for Clinical and Translational Science

UC Irvine, Institute for Clinical and Translational Science (ICTS)

Valentina Dilda

Director Experimental Medicine

CHDI Foundation, Inc

Kristin Dolinski

Director, Science and Regulatory Advocacy

PhRMA

Emily Eldh, CIP

Interim Director, Office for Human Research Studies

Dana-Farber Cancer Institute

William Erhardt, MD

Vice President, Clinical Operations

Pfizer Inc.

Karen Erickson

Chief Operating Officer

The Alpha-1 Project

Scott Evans, PhD, MS

Harvard University, Senior Research Scientist

Representing Society for Clinical Trials (SCT)

Gary Fanjiang, MD, MBA, MS

Executive Medical Director

Amgen

Ari Feldman

Vice President, Global Compliance & Strategy

Medidata Solutions

Pat Furlong

President

Parent Project Muscular Dystrophy (PPMD)

Rodrigo Garcia, MD, MS

Head, Global Clinical Applications and Innovation, Biopharma | Global Clinical Operations

EMD Serono Inc.

Cynthia Geoghegan

Patient/Caregiver Representative

Hernando Giraldo

US Regional Lead Digital Development, Global Clinical Operations

Boehringer Ingelheim

Judith Hochman, MD

Co-Director, NYU-HHC, CTSI

New York University Langone Medical Center

Christopher Houchens, PhD

Biomedical Advanced Research and Development Authority

Grant Huang, MPH, PhD

Deputy Director, Cooperative Studies Program, Office of Research and Development

U.S. Department of Veterans Affairs

Brenda Huneycutt

Director, Regulatory Innovation

FasterCures, a Center of the Milken Institute

Patricia Hurley, MSc

Director, Research and Analysis, Center for Research & Analytics (CENTRA)

American Society of Clinical Oncology (ASCO)

Telba Irony, PhD

Deputy Director, Office of Biostatistics and Epidemiology

Food and Drug Administration/Center for Biologics Evaluation and Research (CBER)

Cheryl Jernigan, CPA, FACHE

Volunteer Advocate/AIS Steering Committee Member

Susan G Komen

Michael Kaplan

President and Chief Executive Officer

Melanoma Research Alliance

Hallie Kassan, MS, CIP

Director, Office of the HRPP

N orthwell Health

Nicholas Kenny, PhD

Chief Scientific Officer

Syneos Health

Joseph Kim

Senior Advisor, Patient Experience and Design Innovation

Eli Lilly and Company

Jim Kremidas

Executive Director

Association of Clinical Research Professionals

Michael Kurilla, MD-PhD

Director, Division of Clinical Innovation, NCATS

National Institutes of Health

Martin Landray, PhD, FRCP

Professor of Medicine & Epidemiology; Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford

University of Oxford

Patrick Lee, MD

Partner

Palo Alto Investors Inc.

Emily Lemons

Associate Director of Quality Assurance

PMG Research, Inc.

Joanne Less, PhD

Director, Good Clinical Practice Program

Food and Drug Administration/Office of the Commissioner (FDA)

Barbara LeStage

Patient/Caregiver Representative

Michael Lincoff, MD

Director, Center for Clinical Research; Director, Cleveland Clinic Coordinating Center for Clinical Research (C5 Research)

Cleveland Clinic Coordinating Center for Clinical Research

Beverly Lorell, MD, FACC

Senior Medical & Policy Advisor

King & Spalding LLP

Theodore Lystig, PhD

Distinguished Statistician

Medtronic, Inc

Jerry Menikoff, MD, JD

Director

Office for Human Research Protections (Liaison)

Lynn Meyer, CCRP

President, Integ Review IRB

representing Consortium of Independent Review Boards

Kristen Miller, PharmD

Health Science Policy Analyst, OMP

Food and Drug Administration/Center for Drug Evaluation and Research (CDER)

Jules Mitchel, MBA, PhD

President

Target Health Inc.

Virginia Nido

Head, Industry Collaborations Management, Product Development, Global External Collaborations

Genentech – A member of the Roche Group

Kathryn O'Callaghan

Acting Associate Director for Science and Strategic Partnerships

Food and Drug Administration/Center for Devices and Radiological Health (CDRH)

Kelley O'Donoghue, MPH, CIP

Executive Director, Research Subjects Review Board

University of Rochester

Janette Panhuis, BScN, MBA

Chief Executive Officer

Population Health Research Institute, McMaster University

Lynne Quittell, MD

Vice Chair Data Safety Monitoring Board

Cystic Fibrosis Foundation

Sesquile Ramon, PhD

Director, Science and Regulatory Affairs

Biotechnology Innovation Organization

James Riddle, MCSE, CIP, CPIA

Vice President of Client Services, Kenetiq

Quorum Review IRB

Lindsey Riley

Associate Director, Research Partnerships

The Michael J. Fox Foundation for Parkinson's Research

James Rollins, MD

Director of the Division of Items and Devices; Coverage and Analysis Group

Centers for Medicare and Medicaid Services

Daniel Rose, MD

Senior Advisor

Pulmonary Fibrosis Foundations

Joshua Rose

Vice President, Head R&D Solutions Strategy

IQVIA

Ronenn Roubenoff, MD, MHS

Global Head, Musculoskeletal Translational Medicine

Novartis Institutes for Biomedical Research

Michele Russell-Einhorn, JD

Chief Compliance Officer and Institutional Official

A dvarra

Norman Scherzer

Executive Director

The Life Raft Group

Karlin Schroeder, MA

Director, Community Engagement

Parkinson's Foundation

Jeffrey Sherman, MD, FACP

Horizon Pharma, Inc., Chief Medical Officer; Executive VP, Development, Manufacturing, and Regulatory Affairs

Representing Drug Information Association (DIA)

Theresa Strong, PhD

Director of Research Programs

Foundation for Prader-Willi Research (FPWR)

Janet Trunzo

Senior Executive Vice President

Advanced Medical Technology Association (AdvaMed)

Kristin Van Goor, PhD

Senior Director, Global Regulatory Policy

Biogen

Tracy Vanderslice

Vice President of Global Clinical Sciences & Delivery

GlaxoSmithKline

Jose Vega

Vice President, Chief Safety Officer

Merck & Co., Inc.

Neil Weissman, MD

President

MedStar Health

Kristi Whiteside

Senior Director, Clinical Trial Data Sharing and Disclosure

Celgene Corporation