Navigating the Shift from Animal Testing to NAMs in Drug Development

Understand emerging FDA expectations, evaluate the role of New Approach Methodologies, and prepare your drug development programs for a more modern regulatory landscape.

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Session Overview

Animal testing has long been a standard component of drug development, but advances in science and evolving regulatory expectations are reshaping that paradigm. Recent milestones, including the FDA Modernization Act 2.0, the FDA’s 2025 roadmap for reducing animal testing in preclinical safety studies, and the 2026 draft guidance on the use of New Approach Methodologies (NAMs), signal a significant shift toward more modern, human-relevant approaches.

In this on-demand webinar, experts explore how these developments may affect biotech and pharmaceutical companies developing innovative therapies. They review key FDA guidances, examine the benefits and challenges of reducing animal testing, and discuss the near and long-term implications for drug development programs.

The session also explores examples of reduced animal testing paradigms and how sponsors can integrate NAMs and Model-Informed Drug Development (MIDD) approaches into their development strategies.

For organizations planning their pipelines, understanding these emerging expectations is critical to designing efficient development strategies and preparing for a changing regulatory environment.

What You’ll Learn:

• Recent FDA guidances and regulatory developments driving the shift away from animal testing
• Implications of evolving expectations for ongoing and planned drug development programs
• How New Approach Methodologies (NAMs) can support more human-relevant approaches to drug development
• Strategies for integrating NAMs and Model-Informed Drug Development (MIDD) into sponsor development programs

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