Navigating the Shift from Animal Testing to NAMs in Drug Development

August 27th, 2026
11 a.m. EDT

Animal testing has long been a standard component of drug development, but advances in science and regulations are reshaping that paradigm. Recent milestones, including the 2022 FDA Modernization Act 2.0, the Agency’s 2025 Road to Reducing Animal Testing in Preclinical Safety Studies, and the 2026 draft guidance on the use of New Approach Methodologies (NAMs) in drug development, among others, signal a significant shift toward modern, human-relevant methods¹.

This webinar will explore how these changes may affect biotech and pharmaceutical companies developing innovative therapies. Speakers will review the relevant regulatory guidances, examine the key benefits and challenges of replacing animal testing, and discuss near- and long-term implications for drug development programs. The session will conclude with examples of reduced animal testing paradigms and the integration of NAMs and Model-Informed Drug Development (MIDD) approaches into sponsor drug development programs.

For organizations planning their pipelines, understanding these emerging expectations is critical to designing efficient development strategies and preparing for a more modern regulatory environment. Attendees will leave with a clearer view of where the FDA is heading and what steps sponsors can take now to adapt.

Attendees will gain insights into:

• Recent FDA guidances attributing to the shift away from animal testing
• Implications for ongoing and planned drug development programs
• New Approach Methodologies (NAMs) replacing animal testing
• Strategic integration of Model-Informed Drug Development (MIDD) approaches

Source:

Høeg TB, Kozlowski S, Saber H, Makary MA. Eliminating Unnecessary Animal Testing. JAMA. 2026;335(23):2011–2014. doi:10.1001/jama.2026.7074 

Speakers:

William Salminen, Ph.D., DABT, RAC – Vice President, Toxicology and Clinical Pharmacology 

Angelean Hendrix, Ph.D. – Vice President, Pharmacometrics and MIDD