Bringing new therapies to patients remains a challenging, time-consuming, and resource-intensive process. New Approach Methodologies (NAMs) are emerging as powerful tools to transform preclinical research. These approaches, including artificial intelligence, advanced computational modelling, and innovative experimental systems such as organ-on-a-chip technologies, offer opportunities to enhance predictivity, reduce reliance on animal studies, and streamline decision-making. This session will examine the evolving role of NAMs from multiple vantage points, including start-ups, academic research, regulatory authorities, and funding bodies. By connecting these perspectives, we aim to explore how scientific innovation, regulatory frameworks, and financial support mechanisms can align to facilitate the adoption of these methodologies. Through illustrative examples and expert discussion, the session will address current challenges, validation strategies, and implementation pathways, ultimately providing insight into how NAMs can contribute to a more robust, efficient, and future-proof drug development landscape.