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Comité del programa
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Jonathan Andrus, MS • CEO

CRIO, United States -
Matt Baldwin, MS • Biomedical Data Stewardship Senior Manager

Amgen, United States -
David Bowers, PharmD • Senior Director, Operations

PPD, United States -
Philip (P.J.) Brooks, PhD • Deputy Director, Division of Rare Diseases Research Innovation

National Center for Advancing Translational Sciences (NCATS), NIH, United States -
Jennifer Burgess, MBA, MPH • Vice President, Global Engagement and Communications

TransCelerate Biopharma Inc., United States -
Bill Byrom, PhD • Vice President, Product Intelligence and Positioning; Principal, eCOA Science

Signant Health , United Kingdom -
Susan Callery-D'Amico, BSN • Retired, Vice President, R&D Quality Assurance, AbbVie

United States -
Dannis Chang, PharmD • Director, Hematology Medical Information Team Lead

Genentech, Inc., United States -
Yeh-Fong Chen, PhD • Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER

Food and Drug Administration, United States -
Karla Childers, MS • Vice President, Bioethics, Policy & Partnerships

Johnson & Johnson, United States -
Deborah Collyar • President

Patient Advocates In Research (PAIR), United States -
Sonya Eremenco, MA • Executive Director, PRO Consortium

Critical Path Institute, United States -
Ron Fitzmartin, PhD, MBA • Principal Consultant

Decision Analytics, United States -
David Fryrear, MS • Chief Quality Officer

Astellas, United States -
Barbara Gladson, PhD, MS • Director of Biopharma Initiative; Interim Chair, Health Informatics

Rutgers School of Health Professions, United States -
Richard Gliklich, MD • Founder

OM1, United States -
William Gregory, PhD • Senior Director, Safety and Risk Management

Pfizer Inc, United States -
Marianne Hamilton Lopez, PhD, MPA • Research Director, Value-Based Payment Reform

Duke-Margolis Center For Health Policy, United States -
Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division

European Medicines Agency, Netherlands -
Jennifer Helfer, PhD • Senior Director, Patient Advocacy and Engagement, Corporate Affairs

Viridian Therapeutics, Inc., United States -
Nita Ichhpurani, PMP • Consultant To Daiichi Sankyo, Inc.

Phase One Forward, Consultant, Canada -
Jeremy Jokinen, PhD, MS • Vice President and Head Global Patient Safety

Argenx, United States -
Nadina Jose, MD • Assistant Professor, School of Health Professions, MS Clinical Research Program

Rutgers, The State University of New Jersey, United States -
Sean Kassim, PhD • Director, Office of Study Integrity and Surveillance, OTS, CDER

FDA, United States -
Sean D. Kennedy, MPH • Global Head, Real World Evidence

ICON plc, United States -
Agnes Klein, MD • Senior Medical Advisor

Health Canada, Canada -
Darryl L'Heureux, PhD, MPharm, MSc • Director, Clinical Science, Medical Writing, and Publications

Ambrx, Inc, United States -
Erik Laughner • Project Manager, Business Operations Staff, OD, CBER

FDA, United States -
Rebecca Lipsitz, PhD • Sr. Director, Regulatory Policy & Intelligence

AstraZeneca, United States -
Chris Matheus, MBA • Chief Commercial and Networking Officer

United States -
K. Kimberly McCleary • Founder and Chief Executive Officer

The Kith Collective, LLC, United States -
Ann Meeker-O'Connell, MS • Executive Director, Monitoring Excellence Head

Novartis, United States -
Christine Moore, PhD • Executive Director, Global External Advocacy and Standards

Organon & Co., United States -
Jean M. Mulinde, MD • Associate Director, Division of Clinical Compliance Evaluation, OSI

FDA, United States -
Nobumasa Nakashima • Professor

Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan -
Michael Neidl, MBA, MS, MSc • Senior Consultant

Clinical Research Quality Consultant, United States -
David O Olaleye, PhD, MSc • Senior Manager and Principal Research Statistician

SAS Institute Inc., United States -
David J Pepperl, PhD • Senior Consultant and Nonclinical Group Leader

Biologics Consulting, United States -
Sissi Pham, PharmD • Chief Executive Officer

AESARA, United States -
Kim Quaintance-Lunn • Vice President, Head of Regulatory Science and Execution

Alexion, United States -
Giuseppe Randazzo, MS • Vice President, Sciences and Regulatory Affairs

Association for Accessible Medicines, United States -
Margaret Richards, PhD, MPH • Open to Work

Pharmacoepidemiology / RWE, United States -
Amanda Roache, MS • Deputy Vice President, Science and Regulatory Advocacy

PhRMA, United States -
Steven L. Roberds, PhD • Chief Scientific Officer

Tuberous Sclerosis Alliance, United States -
Khyati Roberts, RPh • Retired

Retired, United States -
Khushboo Sharma, MBA • Chief Executive Officer

Accumulus Synergy, United States -
Leigh Shultz, PhD, PMP • Executive Director, Human Health Commercial Operations

Merck & Co., Inc., United States -
Nancy Slater, MBA, PMP • Senior Director, Portfolio Program Management Therapeutic Area Head

AbbVie, Inc., United States -
Nancy Pire Smerkanich, DrSc, MS • Assistant Professor Regulatory & Quality Sciences

University of Southern California School of Pharmacy, United States -
Elizabeth Somers, MS • Associate Vice President, Global Project and Alliance Management

Merck Sharp & Dohme LLC, United States -
Jeffrey N. Stuart, PhD • Associate Vice President, Global Regulatory Affairs

Merck Sharp & Dohme LLC , United States -
Ling Su, PhD • Research Fellow

Yeehong Business School, China -
Rachel Turow, JD, MPH • Of Counsel, FDA Regulatory

Skadden, United States -
Kristin Voorhees, MA • Director, Patient Advocacy

Ultragenyx, United States -
Robin Whitsell • President

Whitsell Innovations, Inc., United States -
Amy Xia, PhD • Vice President, Center for Design and Analysis

Amgen Inc., United States -
Meredith Yearsley Smith, PhD, MPA, FISPE • Fellow and faculty member

USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States -
Judith Zander, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER

FDA , United States