The FDA’s new guidance supporting non-animal testing methods is reshaping preclinical drug development, creating unprecedented opportunities for biotech innovation. This session brings together biotech CEOs, translational scientists, and platform leaders using organoids, organ-on-chip systems, and other human-based models to improve predictability, reduce cost, and accelerate development. Panelists will share real-world case studies on how companies have successfully navigated the new FDA framework, particularly in the antibody and biologics space, to cut preclinical timelines and move candidates into the clinic faster. Attendees will gain insights into how next-generation, human-relevant models are transforming R&D strategy, regulatory interactions, and the future of drug discovery beyond animal testing.