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Meet the Program Commitee for 2021!
Program Committee
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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 -
Kristina Bowyer, LPN • Vice President, Patient Centric Drug Development
Ionis Pharmaceuticals, United States -
Philip (P.J.) Brooks, PhD • Program Director, Office of Rare Diseases Research
National Center for Advancing Translational Sciences (NCATS), NIH, United States -
Bill Byrom, PhD • Vice President, Product Intelligence and Positioning
Signant Health , United Kingdom -
Meghana Chalasani, MHA • Lead, Science Strategies, Office of New Drugs, CDER
FDA, United States -
Andrew Chang, PhD • Vice President, Quality and Regulatory Compliance
Novo Nordisk, United States -
Karla Childers, MS • Senior Director, Strategic Projects, Office of the Chief Medical Officer
Johnson & Johnson, United States -
Leah Christl, PhD • Executive Director, Global Regulatory and R&D Policy
Amgen, 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 -
Julie Dietrich, MS • Vice President, Clinical Operations
Genfit Corp, United States -
Sonya Eremenco, MA • Associate Director, PRO Consortium, and Acting Director, ePRO Consortium
Critical Path Institute, United States -
Jennifer Farmer, MS • Executive Director
Friedreich's Ataxia Research Alliance (FARA), 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 -
Alicia Gilsenan, PhD, MS, RPh • Senior Director and Head, Epidemiology
RTI Health Solutions, United States -
Renmeet Grewal, PharmD, MS • Division Director, Project Management Staff, ORO, OND, CDER
FDA, United States -
Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division
European Medicines Agency, Netherlands -
Alan M Hochberg • Principal Scientific Enablement Director
F. Hoffmann- La Roche, Switzerland -
Michelle Hoiseth • Senior Vice President and Chief Data Officer, Scientific Data Organization
Parexel, United States -
Kenneth Hu, PharmD, MBA • Oncology and Immunology Global Regulatory Strategy and Policy Manager
Bristol-Myers Squibb Company, United States -
Jeremy Jokinen, PhD, MS • Vice President, Epidemiology, Safety Science, Capabilities and Innovation
Bristol-Myers Squibb Company, United States -
Darryl Zachary L'Heureux, PhD, MPharm, MSc • Clinical Scientist, Global Strategic and Regulatory Documentation
Bristol-Myers Squibb Company, United States -
Erik Laughner • Project Manager, Business Operations Staff, OD, CBER
FDA, United States -
Cathryn C Lee, MSN • Senior Regulatory Project Manager, OPO,PDIMS, OND, CDER
FDA, United States -
Rebecca Lipsitz, PhD • Director, Regulatory Policy
Janssen, United States -
Sheila Mahoney Jewels, MBA • Independent Workforce Advocate
LifeSciHub , United States -
Ingrid Markovic, PhD • Senior Science Advisor, Office of the Center Director, CBER
FDA, 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 -
Lindsay McNair, MD, MPH, MS • Chief Medical Officer
WIRB-Copernicus Group (WCG), United States -
Ann Meeker-O'Connell, MS • Vice President, Integrated QMS/OMS
Vertex Pharmaceuticals, United States -
Christine M. V. 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 -
Erin Mulrooney, MSc • Director, Discovery Project Management
Merck & Co., Inc., United States -
Nobumasa Nakashima, PhD • Associate Executive Director for International Programs and Asia Training Centre
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
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 -
Sissi Pham, PharmD • Chief Executive Officer
AESARA, United States -
Paul Phillips • Director (Acting), Office of Program Operations, OND, CDER
FDA, 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 -
Earl Seltzer, MBA • Senior Director, Feasibility and Site Selection
Covance, 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 -
Evelyn Soo, PhD • Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFD
Health Canada, Canada -
Mat Soukup, PhD • Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, 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 -
Daniel Urban, PhD • Pharmacology/Toxicology Reviewer, OTAT, CBER
FDA, United States -
Paula Walker, MA • Inspectorate Unit Manager, GCP/GPvP/ GLP and Lead Senior GCP Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom -
Nancy Watanabe, MS, PMP • Senior Director, New Market Development Project Leadership
BeiGene, Inc., United States -
Keith Wenzel • Senior Director, Scientific Data Organization
Parexel International, United States -
Judith Zander, DrMed, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States