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Meet the Program Commitee for 2021!
プログラム委員会
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Matt Baldwin, MS • Biomedical Data Stewardship Senior Manager
Amgen, United States -
Amy Bertha • Executive Director, Regulatory Policy and Science
Bayer, United States -
Poonam Bordoloi, PharmD • Executive Director, Head of Global Medical Affairs Capabilities
Organon & Co., United States -
David Bowers, PharmD • Senior Director, Operations
PPD, United States -
Kristina Bowyer • Vice President, Patient Advocacy & Engagement
Ionis Pharmaceuticals, Inc., 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 -
Bill Byrom, PhD • Vice President, Product Intelligence and Positioning; Principal, eCOA Science
Signant Health , United Kingdom -
Meghana Chalasani, MHA • Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
FDA, United States -
Andrew Chang, PhD • Vice President, Quality and Regulatory Compliance
Novo Nordisk, United States -
Karla Childers, MS • Head, Bioethics-Based Science and Technology Policy
Johnson & Johnson, United States -
Leah Christl, PhD • Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Freda Cooner, PhD • Senior Director - Statistics
Eli Lilly and Company, 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 Development
GENFIT, United States -
Sonya Eremenco, MA • Executive Director, PRO Consortium
Critical Path Institute, United States -
Jennifer Farmer, MS • Chief Executive Officer
Friedreich's Ataxia Research Alliance (FARA), United States -
Ron Fitzmartin, PhD, MBA • Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States -
David Fryrear, MS • Executive Vice President and Head of Quality Assurance
Astellas, United States -
M. Scott Furness, PhD • Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, United States -
Alicia Gilsenan, PhD, MS, RPh, FISPE • Vice President, Epidemiology
RTI Health Solutions, United States -
Renmeet Grewal, PharmD, MS • Division Director, Office of Regulatory Operations (DRO-II), OND, CDER
FDA, United States -
Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division
European Medicines Agency, Netherlands -
Alan Hochberg • Principal Scientific Enablement Director, Scientific Enablement and Processes
Genentech, A Member of the Roche Group, United States -
Michelle Hoiseth • General Manager, Project-Based Services
Cytel, United States -
Kenneth Hu, PharmD, MBA • Senior Manager (US Reg Lead), Global Regulatory Strategy & Policy, Oncology
Bristol Myers Squibb, United States -
Jeremy Jokinen, PhD, MS • Vice President and Head, Safety Evidence and Sciences
Bristol-Myers Squibb Company, United States -
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 -
Cathryn C Lee, MSN • Director, Office of Program Operations, PDIMS, OND, CDER
FDA, United States -
Rebecca Lipsitz, PhD • Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
AstraZeneca, United States -
Sheila Mahoney Jewels, MBA • Drug Development Multi-Functionalist
LifeSciHub , United States -
Ingrid Markovic, PhD • Senior Science Advisor for CMC, Office of the Center Director, CBER
FDA, United States -
Christopher Marrone, PharmD, RPh • Outcomes Liaison Advisor – National Accounts, Value, Evidence and Outcomes (VEO)
Eli Lilly and Company, United States -
Chris Matheus, MBA • Chief Commercial and Networking Officer
Global Life Sciences Alliance (GLSA), United States -
K. Kimberly McCleary • Founder and Chief Executive Officer
The Kith Collective, LLC, United States -
Lindsay McNair, MD, MPH, MS • Principal Consultant
Equipoise Consulting, United States -
Ann Meeker-O'Connell, MS • Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, 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 -
Erin Mulrooney, MSc, PMP • Director, Portfolio Management
Daiichi Sankyo, Inc, United States -
Nobumasa Nakashima • Health Policy Director, National Healthcare Policy Secretariat
Cabinet Office, Japan -
Anita Nelsen • Executive 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, Office of Program Operations, OND, CDER
FDA, United States -
Margaret Richards, PhD, MPH • Executive Director, Solutions
Panalgo, United States -
Steven L. Roberds, PhD • Chief Scientific Officer
Tuberous Sclerosis Alliance, United States -
Earl Seltzer, MBA • Senior Director, Partnerships and Innovation
CTI, 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, PhD, MPA, FISPE • Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States -
Evelyn Soo, PhD, MS • Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFB
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 Sharp & Dohme LLC , United States -
Ling Su, PhD • Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China -
Rachel Turow, JD, MPH • Managing Counsel, FDA Regulatory
Walmart, Inc., United States -
Daniel Urban, PhD • Pharmacology/Toxicology Reviewer, OTAT, CBER
FDA, United States -
Paula Walker, MA • Global Head of Risk Based Quality Management
Roche Products Ltd., United Kingdom -
Nancy Watanabe, MS, PMP • Independent Consultant
Independent Consultant, United States -
Keith Wenzel • Volunteer
DIA Study Endpoints Community, United States -
Judith Zander, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States
