Menu
Meet the Program Commitee for 2023!
Program Committee
-
Venkatraman Balasubramanian, PhD, MBA
•
Healthcare and Life Sciences Strategic Advisor
VB Insights, LLC, United States -
Greg Ball, PhD
•
Safety Data Scientist
ASAPprocess, United States -
Amy Bertha
•
Executive Director, Regulatory Policy and Science
Bayer, United States -
Claire Blanchette, PMP
•
Executive Drug Development Program Leader
Consultant, 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 -
Leah Christl, PhD
•
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Mary Ellen Cosenza, PhD, MS, RAC
•
President
MEC Regulatory & Toxicology Consulting, LLC, United States -
Stephanie Y. Crawford, PhD, MPH, MS
•
Professor, Pharmacy Systems, Outcomes and Policy
University of Illinois at Chicago, United States -
Alysha Croker, PhD
•
Director, Centre for Policy, Pediatrics and International Collaboration, BRDD
Health Canada, Canada -
Ebony Dashiell-Aje, PhD
•
Executive Director and Head, Patient Centered Outcomes Science
BioMarin, United States -
Julie Dietrich, MS
•
Vice President, Clinical Development
GENFIT, United States -
Andrew Emmett, MPH
•
FDA Liaison | US Regulatory Policy and Global Intelligence
Pfizer 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 -
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 -
Cheryl Grandinetti, PharmD
•
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
FDA, 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 -
Cammilla Horta Gomes, MA, MPharm
•
Latam Regulatory Policy Lead
Roche, Brazil -
Emily (Xianghong) Jing, PhD
•
Associate Director for Scientific Coordination, OBP, OPQ, CDER
FDA, United States -
Jeremy Jokinen, PhD, MS
•
Vice President and Head, Safety Evidence and Sciences
Bristol-Myers Squibb Company, United States -
Cathryn C Lee, MSN
•
Director, Office of Program Operations, PDIMS, OND, CDER
FDA, United States -
Demetra Macheras, MBA
•
Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, United States -
Nicole Mahoney, PhD
•
Executive Director US Regulatory Policy & Intelligence
Novartis Pharmaceuticals Corporation, 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 -
Lindsay McNair, MD, MPH, MS
•
Principal Consultant
Equipoise Consulting, United States -
Melodi J McNeil, MS, RPh
•
Director, Regulatory Policy and Intelligence
AbbVie, United States -
David Meats
•
Director, Regulatory Services Management
Certara, 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 -
Erin Mulrooney, MSc, PMP
•
Director, Portfolio Management
Daiichi Sankyo, Inc, United States -
Sissi Pham, PharmD
•
Chief Executive Officer
AESARA, United States -
Margaret Richards, PhD, MPH
•
Executive Director, Solutions
Panalgo, United States -
Cynthia Rothblum-Oviatt
•
Science Policy Analyst, Rare Disease Team, OND, CDER
FDA, United States -
Leslie Sam
•
President
Leslie Sam and Associates, LLC, 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 -
Elizabeth Somers, MS
•
Executive Director, Global Project and Alliance Management
Merck Sharp & Dohme LLC, United States -
Mat Soukup, PhD
•
Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, United States -
Shannon Sparklin, MS
•
Project Manager, OPPD, OMP, CDER
FDA, 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 -
Phil Tregunno
•
Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom -
Pujita Vaidya, MPH
•
North America Lead, Regulatory Science and Policy
Sanofi, 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 -
Jennifer Whiteley, PhD, MSc
•
Executive Director, Head OMNI Evidence for Access
Genentech, A Member of the Roche Group, 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