Pharmaceutical development is undergoing a technical transition as the FDA pushes for a reduction in animal-based preclinical safety studies. This shift, underscored by the agency's 2025 roadmap and recent guidance on New Approach Methodologies (NAMs), forces companies to recalibrate their research strategies. The primary goal is to prioritize human-relevant data, utilizing Model-Informed Drug Development (MIDD) to maintain safety while increasing overall efficiency.

To address these regulatory updates, Xtalks is hosting a webinar on August 27, 2026, featuring Premier Research experts William Salminen and Angelean Hendrix. The session will break down the practical implications of current guidelines, offering a roadmap for sponsors to navigate the transition. Participants will examine specific paradigms for reducing animal reliance and learn how to incorporate predictive modeling into active development programs to ensure compliance in a tightening regulatory environment.