Menu
Program Committee
-
Jonathan Raymond Andrus, MS • Chief Business Officer
Clinical Ink, United States -
Matt Baldwin, MS • Senior Biostatistician
Advance Research Associates, Inc (ARA), United States -
Amy Bertha • Senior Director, Regulatory Policy
Bayer, United States -
Poonam A. Bordoloi, PharmD • Executive Director, Head of Global Medical Affairs Capabilities
Organon & Co., 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 -
Meghana Chalasani, MHA • Lead, Science Strategies, Office of New Drugs, CDER
FDA, 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 -
Freda W. Cooner, PhD • Director, Statistical Innovation
Amgen, United States -
Stephanie Y. Crawford, PhD, MPH, MS • Professor, Pharmacy Systems, Outcomes and Policy
University of Illinois at Chicago, 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 William Fryrear, MS • Senior Vice President and Head of Clinical and Research QA, Medical and Dev
Astellas, United States -
M. Scott Furness, PhD • Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, 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 -
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 D. Kennedy, MPH • Global Head, Real World Evidence
ICON plc, United States -
Agnes Victoria Klein, MD • Senior Medical Advisor
Health Canada, Canada -
Darryl Zachary L'Heureux, PhD, MPharm, MSc • Clinical Scientist, Global Strategic and Regulatory Documentation
United States -
Erik Laughner • Project Manager, Business Operations Staff, OD, CBER
FDA, United States -
Rebecca Lipsitz, PhD • Director, Regulatory Policy
Janssen, United States -
Christopher Marrone, PharmD, RPh • Outcomes Liaison
Eli Lilly and Company, United States -
Chris Matheus, MBA • President
Matheus BD Connections LLC, United States -
K. Kimberly McCleary •
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 • Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER
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 -
Anita Nelsen • Senior Vice President, Translational Medicine
Parexel, 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 -
Paul Phillips • Director (Acting), Office of Program Operations, OND, CDER
FDA, United States -
James E. Polli, PhD • Prof, Ralph F Shangraw/Noxell Endowed Chair in Industrial Pharmacy/Pharmaceutic
University of Maryland School of Pharmacy, United States -
Margaret Richards, PhD, MPH • Senior Research Leader, Real World Evidence
Evidera, 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 -
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 -
Evelyn Soo, PhD • Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFD
Health Canada, Canada -
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 -
Nancy Watanabe, MS, PMP • Senior Director, New Market Development Project Leadership
BeiGene, Inc., United States -
Judith Zander, DrMed, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States