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Meet the Program Commitee for 2026!
Comité del programa
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Representative Invited • FDA, United States

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Sanghita Bhattacharya, PhD • Director Data Science Global Function

Johnson & Johnson Innovative Medicine, United States -
Asia Blackwell • Consumer Safety Officer, CBER

FDA, 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

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 • Independent Senior Consultant

Tufts Center For the Study of Drug Development, United States -
Rachel Chasse, MS • Associate Director, Digital Science Strategy

AbbVie, United States -
Monica Chiaramonte, PhD • Director, Clinical Regulatory Writing

AstraZeneca Pharmaceuticals LP, United States -
Christine Colvis, PhD • Director, Drug Development Partnership Programs

National Center for Advancing Translational Sciences (NCATS), United States -
Karen Correa, PhD • Vice President, Clinical Development Operations

Boehringer Ingelheim, United States -
Solange Corriol-Rohou, DrMed, MD, PhD •

SCR Consulting, France -
Stephanie Y. Crawford, PhD, MPH, MS • Professor, Pharmacy Systems, Outcomes and Policy

University of Illinois at Chicago, United States -
Alysha Croker, PhD • Director, Strategic and Horizontal Policy

Health Canada, Canada -
Matthew Curin, PharmD • Sr. Dir, Head of Program Management, Therapeutic Dermatology

Galderma, United States -
Representative Invited • FDA, United States

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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 Dreyer, PhD, MPH, FISPE • Founder

Dreyer Strategies LLC, United States -
Joseph Dustin • Founder and Principal

Dauntless Eclinical Strategies, United States -
Jennifer Emerson, PhD, MPH, RN, PMP • Head Quality Analytics & Risk Management

Boehringer Ingelheim, Germany -
Andrew Emmett, MPH • VP, Global Regulatory Policy and Global Intelligence

Pfizer Inc, United States -
Celeste Frankenfeld Lamm • 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 • Chief Quality Officer

Astellas, United States -
Cheryl Grandinetti, PharmD • Associate Director for Clinical Policy, CDER/OC/OSI/DCCE

FDA, United States -
Courtney Granville, PhD, MPH •

United States -
Lani Hashimoto • Consultant, Patient Experience

Hashimoto Consulting Services, 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 -
Yatika Kohli, PhD, MBA • Chief Compliance and Strategy Officer

NoNO Inc, Canada -
Dominique Lagrave, PharmD • Chief Regulatory Officer

Accumulus Technologies, United States -
Elizabeth Lange, MPH, MS • Executive Director/ Head of Regulatory Scientific Policy

EMD Serono, 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 -
David Meats • Director, Regulatory Services & Medical Affairs Management

Certara, United States -
Timothe Menard, PharmD, MSc • Global Head, Quality Excellence Digital | Bioethics Ambassador

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 Regulatory Policy Lead

Biogen, United States -
Representative Invited • FDA, United States

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Vada Perkins, DrSc, MSc • Vice President, Global Head of Regulatory Intelligence & Policy

Boehringer Ingelheim, United States -
Regina Lynn Preciado • VP, Content Strategy Solutions

Content Rules, Inc., United States -
Ranjini Prithviraj, PhD, PMP • Director, Global Medical Affairs, Publication Management

Regeneron, United States -
Kim Ribeiro, MS • Director Patient Experience & Engagement

Boehringer Ingelheim, 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 -
Cary Smithson, MBA • Managing Partner

LeapAhead Solutions, Inc., 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

Yeehong Business School, China -
John Z. Sun, PhD, MBA, PMP • Program Lead, Global Clinical Operation, Development

Novartis Pharmaceuticals Corporation, 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 -
Representative Invited • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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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 Deia Younes • Director-Eastern Europe, Middle East & Africa (EEMEA) Global Regulatory Policy

MSD, United Arab Emirates
