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Meet the Program Commitee for 2022!
Program Committee
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Amy Bertha • Executive Director, Regulatory Policy and Science
Bayer, United States -
David Bowers, PharmD • Senior Director, Operations
PPD, United States -
Kristina Bowyer • Vice President, Patient Advocacy & Engagement
Ionis Pharmaceuticals, Inc., United States -
Susan Callery-D'Amico, BSN • Retired, Vice President, R&D Quality Assurance, AbbVie
United States -
Brooke Casselberry, MS, RAC • Vice President, Advisory and Delivery
Epista Life Sciences, United States -
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 -
Wendy Charles, PhD • Chief Ethics and Compliance Officer; Adjunct Faculty
Equideum Health, United States -
Ethan Chen, MBA, MS, PMP • Director, Division of Data Management
FDA CDER, 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 -
Ebony Dashiell-Aje, PhD • Executive Director and Head, Patient Centered Outcomes Science
BioMarin, United States -
Sameen Desai, MBA, MS • Executive Director, IT Worldwide Patient Safety
Bristol-Myers Squibb Company, United States -
Julie Dietrich, MS • Vice President, Clinical Development
GENFIT, United States -
Hetal Doshi, MBA • Director, Business Operations and Strategy
AbbVie, Inc., United States -
Jennifer Farmer, MS • Chief Executive Officer
Friedreich's Ataxia Research Alliance (FARA), United States -
Maureen Feeney, PharmD, MBA, RPh • Vice President Scientific Communications and Strategic Alliances
Takeda, 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 -
Annie Kennedy • Chief of Policy, Advocacy, and Patient Engagement
EveryLife Foundation for Rare Diseases, 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
United States -
Lindsay McNair, MD, MPH, MS • Principal Consultant
Equipoise Consulting, United States -
Munish Mehra, PhD, MS, MSc • Managing Director and Sr. Principal Biostatistician
Quantum Biopharma, United States -
Timothe Menard, PharmD, MSc • Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics)
F. Hoffmann-La Roche Ltd, Switzerland -
Alexis Miller, JD • Acting Global Lead, Global Regulatory Policy and Intelligence
Merck & Co., Inc., United States -
Martha Monser • Consumer Safety Officer, Office of Regulatory Operations, CBER
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 -
Lisa Palladino-Kim, MS • Program Director / Lecturer
Rutgers School of Health Professions Clin Research Mgmt, 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 -
Earl Seltzer, MBA • Senior Director, Partnerships and Innovation
CTI, United States -
Anjali Shah, PharmD • Executive Director, Business Capabilities and Innovation, WWPS
Bristol-Myers Squibb Company, 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 -
Linda B Sullivan, MBA • Senior Fellow
Tufts Center For the Study of Drug Development, United States -
Melek Sunay, PhD • Pharmacology and Toxicology Reviewer, DCEPT, OTAT, CBER
FDA, United States -
Ashley Trieu, PharmD • Manager, Pharmacovigilance Scientist
Kyowa Kirin, Inc, United States -
Rachel Turow, JD, MPH • Managing Counsel, FDA Regulatory
Walmart, Inc., United States -
Pujita Vaidya, MPH • North America Lead, Regulatory Science and Policy
Sanofi, United States -
Casey Walker, PharmD • Pharmacist
Jushi Holdings, Inc, United States -
Paula Walker, MA • Global Head of Risk Based Quality Management
Roche Products Ltd., United Kingdom -
Susan Wang, PhD • Global Head of Biostatistics and Data Sciences Inflammation
Boehringer Ingelheim, United States -
Nancy Watanabe, MS, PMP • Independent Consultant
Independent Consultant, United States -
Keith Wenzel • Volunteer
DIA Study Endpoints Community, United States -
Robin Whitsell • President
Whitsell Innovations, Inc., United States -
Judith Zander, MD • Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States -
Martine Zimmermann, PharmD • Senior Vice President, Head of Global Regulatory Affairs
Ipsen , France