The April 2025 Food and Drug Administration Roadmap to Reducing Animal Testing in Preclinical Safety Studies is a signature effort to shift the prevailing drug development paradigm. Aiming to reduce costs, time, and ethical burdens associated with animal studies and thereby streamline drug development pathways, the FDA Roadmap outlines a stepwise approach to reduce and replace animals via human-centered new approach methodologies (NAMs). It began with a three-year effort to explore existing data availability, develop an open-access data repository, encourage sponsors to submit NAMs data, and reduce the length of toxicology testing for mAbs. Many experts believe this paradigm shift is possible with the right investment, incentives, and clear guidance. Session attendees will hear updates from government panelists on progress and early successes, and discuss the kind of guidance, regulation, funding, and other incentives industry can expect. Panelists will discuss how academia and other critical research assets are being leveraged to help advance NAMs and offer insights on how feasible the shift is proving for industry in terms of advancing candidates into and through the FDA process.