Program Committee
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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 Advisor
VB Insights, LLC, United States -
Greg Ball, PhD Safety Data Scientist
ASAPprocess, United States -
Amy Bertha Executive Director, Regulatory Policy and Innovation
Bayer, United States -
Sanghita Bhattacharya, PhD Associate 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 of Clinical Policy, CDER/OC/OSI/DCCE
FDA, United States -
Courtney Granville, PhD, MPH Chief Scientific Officer
GO2 Foundation 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, Eastern Europe, Middle East & Africa (EEMEA) Global Regulatory Policy
MSD, United Arab Emirates
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