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Program Committee
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Jonathan Raymond Andrus, MS • Chief Business Officer
Clinical Ink, United States -
Matt Baldwin, MS • Senior Biostatistician
Advance Research Associates, Inc (ARA), United States -
David Bowers, PharmD • Director, Medical Communications
PPD, United States -
Philip (P.J.) Brooks, PhD • Program Director, Office of Rare Diseases Research
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
Signant Health , United Kingdom -
Susan Callery-D'Amico, BSN • Vice President, R&D Quality Assurance
AbbVie, Inc., United States -
Dannis Chang, PharmD • Senior Director, Medical Communications & Operations
Myovant Sciences, United States -
Yeh-Fong Chen, PhD • Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
FDA, United States -
Karla Childers, MS • Senior Director, Strategic Projects, Office of the Chief Medical Officer
Johnson & Johnson, United States -
Deborah E. Collyar • President
Patient Advocates In Research (PAIR), United States -
Sonya Eremenco, MA • Associate Director, PRO Consortium, and Acting Director, ePRO Consortium
Critical Path Institute, United States -
Ron Fitzmartin, PhD, MBA • Senior Informatics Advisor, Office of the Director, CBER
FDA, United States -
David Fryrear, MS • Executive Vice President and Head of Quality Assurance
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 • Chief Executive Officer
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 • Patient Advocacy
bluebird bio, Inc., United States -
Nita Ichhpurani, PMP • Consultant
Phase One Forward, Canada -
Jeremy Jokinen, PhD, MS • Vice President, Epidemiology, Safety Science, Capabilities and Innovation
Bristol-Myers Squibb Company, 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 Y. 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 Victoria 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 • Director, Regulatory Policy
Janssen, United States -
Chris Matheus, MBA • President
Matheus BD Connections LLC, United States -
K. Kimberly McCleary • Founder and Chief Executive Officer
The Kith Collective, LLC, United States -
Ann Meeker-O'Connell, MS • Vice President, Integrated QMS/OMS
Vertex Pharmaceuticals, United States -
Christine Moore, PhD • Executive Director and Global Head, CMC Policy
Merck & Co., Inc., United States -
Jean M. Mulinde, MD • Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI
FDA, United States -
Nobumasa Nakashima, PhD • Associate Executive Director for International Programs and Asia Training Centre
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Michael Neidl, MBA, MS, MSc • Senior Clinical Research Executive
Clinical Research Consultant, LLC, 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 •
Bayer U.S. LLC, United States -
Giuseppe Randazzo, MS • Director, Global Regulatory and Development Policy
Novartis Pharmaceuticals Corporation, United States -
Margaret Richards, PhD, MPH • Senior Research Leader, Real World Evidence
Evidera, United States -
Amanda Marie Roache, MS • Senior Director, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (PhRMA), United States -
Steven L. Roberds, PhD • Chief Scientific Officer
Tuberous Sclerosis Alliance, United States -
Khyati Roberts, RPh • Head US/Canada, Regulatory Policy and Intelligence
AbbVie, Inc., United States -
Khushboo Sharma, MBA • Deputy Director for Operations, Office of New Drugs, CDER
FDA, United States -
Leigh Shultz, PhD, PMP • Associate Vice President, Global Project and Alliance Management
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 -
Meredith Smith, DrPH, PhD, MPA • Director, Risk Management, Global Drug Safety, Research and Development
Alexion Pharmaceuticals, United States -
Elizabeth Somers, MS • Executive Director of Infectious Disease, Global Project and Alliance Management
Merck & Co., Inc., United States -
Jeffrey N. Stuart, PhD • Associate Vice President, Global Regulatory Affairs
Merck & Co., Inc., United States -
Ling Su, PhD • Professor
Shenyang Pharmaceutical University, China -
Rachel Turow, JD, MPH • Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy
Teva Pharmaceutical Industries Ltd., United States -
Kristin Voorhees, MA • Senior Manager, Patient Advocacy
Ultragenyx Pharmaceutical, United States -
Robin Whitsell • President
Whitsell Innovations, Inc., United States -
Amy Xia, PhD • Vice President, Center for Design and Analysis
Amgen Inc., United States -
Judith Zander, DrMed, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States