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Meet the Program Commitee for 2025!
项目委员会
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Linda Akunne, MPH • Chief, Project Management Staff, ORO, OND, CDER
FDA, United States -
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 -
Sanghita Bhattacharya, PhD • Director Data Science , Feasibility and Analytics, Clinical Operations
Johnson & Johnson Innovative Medicine, United States -
Asia Blackwell • Consumer Safety Officer
FDA, United States -
Claire Blanchette, PMP • Executive Drug Development Program Leader
Consultant, United States -
Tywnia Brewton • Executive Director, Human Resources
Astellas , United States -
James Buchanan, PharmD • President
Covilance LLC, United States -
Mandy Kaur Budwal-Jagait, MSc • Head of GCP and Lead Senior GCP Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom -
Meghana Chalasani, MHA • Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
FDA, United States -
Joan Chambers • Senior Consultant
Tufts CSDD, United States -
Rachel Chasse, MS • Associate Director, Digital Science Strategy
AbbVie, United States -
Christine Colvis, PhD • Director, Drug Development Partnership Programs
National Center for Advancing Translational Sciences (NCATS), United States -
Karen Correa, PhD • Vice President, Head of Global Clinical Operations
Takeda, United States -
Solange Corriol-Rohou, DrMed, MD, PhD • Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
AstraZeneca , France -
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 -
Victoria DiBiaso, BSN, MPH, RN • Global Head, Patient Informed Development and Health Value Translation
Sanofi, France -
Megan Doyle, JD, MPH • Associate Vice President, Assistant General Counsel - Diagnostics
Eli Lilly & Company, United States -
Nancy A Dreyer, PhD, MPH, FISPE • Founder
Dreyer Strategies LLC, United States -
Joseph Dustin • Founder and Managing Partner
eClinical Consulting, United States -
Jennifer Emerson, PhD, MPH, RN, PMP • Head Quality Analytics & Risk Management
Boehringer Ingelheim, Germany -
Andrew Emmett, MPH • FDA Liaison | US Regulatory Policy and Global Intelligence
Pfizer Inc, United States -
Ron Fitzmartin, PhD, MBA • Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Celeste Frankenfeld Lamm, PhD • Senior Director, Global Regulatory Affairs – CMC
Merck Sharp & Dohme LLC , United States -
Danielle Friend Economo, PhD • Senior Director, US Head Regulatory Policy and Intelligence
Johnson & Johnson Innovative Medicine, United States -
David Fryrear, MS • Executive Vice President and Head of Quality Assurance
Astellas, United States -
Cheryl Grandinetti, PharmD • Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
FDA, United States -
Courtney Granville, PhD, MPH • Chief Scientific Officer
GO2 For Lung Cancer, United States -
Lani Hashimoto • Associate Director, Patient Engagement
Novartis Pharmaceuticals Corporation, United States -
Sabine Haubenreisser, PhD, MSc • Principal Scientific Administrator, Stakeholders and Communication Division
European Medicines Agency, Netherlands -
Cammilla Horta Gomes, MA, MPharm • Latam Regulatory Policy Lead
Roche, Brazil -
Stacy Hurt, MBA, MHA • Chief Patient Officer
Parexel , United States -
Huong Huynh, PhD • Director of Regulatory Science
Critical Path Institute, United States -
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 -
Dominique Lagrave, PharmD • Senior Vice President of Regulatory Innovation
Accumulus Synergy, United States -
Cathryn C Lee, MSN • Director, Office of Program Operations, PDIMS, OND, CDER
FDA, United States -
Jingyu (Julia) Luan, PhD • Executive Regulatory Science Director, BioPharmaceuticals R&D
AstraZeneca, 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 -
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 -
Timothe Menard, PharmD, MSc • Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics)
F. Hoffmann-La Roche Ltd, Switzerland -
Pallavi Mishra-Kalyani, PhD, MS • Deputy Division Director, DBV, OB, CDER
FDA, United States -
May F Mo, MBA, MS • Executive Director, Biostatistics
Amgen, United States -
Monica Munoz, PharmD, PhD • Division Director, Division of Pharmacovigilance-I, OSE, CDER
FDA, United States -
Lauren Oliva, PharmD, RPh • US Lead, Global Regulatory Policy
Biogen, United States -
Y. Veronica Pei, MD, MEd, MPH • Acting Associate Director, Biomedical Informatics and Regulatory Review Science
FDA, United States -
Vada A. Perkins, DrSc, MSc • Vice President, Global Head of Regulatory Intelligence & Policy
Boehringer Ingelheim, United States -
Ranjini Prithviraj, PhD, PMP • Director, Global Medical Affairs, Publication Management
Regeneron, United States -
Kim Ribeiro, MS •
United States -
Margaret Richards, PhD, MPH • Executive Director, Solutions
Panalgo, United States -
Elizabeth Rosenkrands-Lange, MPH, MS • Senior Director/ Head of US Regulatory Scientific Policy
EMD Serono, Part of Merck KGaA, Darmstadt, Germany, 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 -
Nancy Pire Smerkanich, DrSc, MS • Assistant Professor Regulatory & Quality Sciences
University of Southern California School of Pharmacy, United States -
Elizabeth Somers, MS • Executive Director, Global Project and Alliance Management
Merck Sharp & Dohme LLC, United States -
Benjamin Stevens, PhD, MPH • Director CMC Policy and Advocacy
GlaxoSmithKline, United States -
Nancy Linda Styple • Project Management Leader
Bayer AG, United States -
Ling Su, PhD • Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China -
Alec Thompson, PharmD, MS • Senior Product Manager, Oncology
Gilead Sciences, United States -
Michael Torok, PhD • Vice President, Global Head of Quality Assurance Programs
Genentech, A Member of the Roche Group, United States -
Phil Tregunno • Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom -
Yoshiaki Uyama, PhD, RPh • Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
James Valentine, JD, MHS • Director
Hyman, Phelps & McNamara, PC, United States -
James Wabby, MHS • Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States -
Paula Walker, MA • Global Head of Risk Based Quality Management
Roche Products Ltd., United Kingdom -
Robin Whitsell • President
Whitsell Innovations, Inc., United States -
Amira Younes • Director, Global Regulatory Policy EEMEA
MSD, United Arab Emirates
