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Revolutionizing Drug Development: Harnessing New Approach Methodologies (NAMs) for a Safer Future in Medicine

June 18, 2025
Breakout Session
Translational Research
204AB
New Approach Methodologies (NAMs) are at the forefront of transforming how biomedical research translates into real-world treatments, enabling faster and more precise drug development by, in some cases, bypassing traditional animal models. This session will explore the pivotal role NAMs play in advancing translational research, effectively bridging the gap between laboratory discoveries and clinical applications. Participants will gain a comprehensive understanding of how NAMs are reshaping the journey from basic research to regulatory testing, offering a more ethical, efficient, and scientifically robust pathway to safer and more effective therapies.
Moderator
Carmen Laplaza-Santos, MA
Head of Unit Health Innovations and Ecosystems in Directorate General on Research and Innovation
European Commission
Speakers
Stacey Adam
Vice President of Science Partnerships
FNIH
Karissa Adkins
Head of Global Investigative Toxicology
Sanofi
Falk Ehmann, MD, PhD
Head of Innovation and Development Accelerator
European Medicines Agency
Tracy Beth Høeg, MD, PhD
Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration
Gerd A. Kullak-Ublick, MD
Global Head, Mechanistic Safety and Safety Signal Management Patient Safety & Pharmacovigilance
Novartis
Kylie Sproston
Chief Executive Officer
Bellberry Limited
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