HHS secretary mandates NIH and FDA federal agencies to implement immediately the FDA Modernization Act which aims to establish a new roadmap to reduce animal testing in preclinical safety studies. Such recent legislative changes endorsed by Congress, and combined with some public sentiment support, encourage the use of alternative testing methods, or so-called New Approach Methodologies (NAMs), which encompass AI/ML computer modeling, organoids, and human organ-on-a-chip technologies. Although pharma and biotech companies are increasingly exploring and adopting NAMs in drug development, including for clinical studies, their readiness and widespread adoption are still evolving. To overcome these challenges, the panel of experts will discuss how to build a national framework leveraging current investment in NAMs with domains of expertise and infrastructure from academic and clinical institutions, and their industry partners, to ramp up technological scale-up access and quality manufacturing, while establishing robust validation protocols and standardized approaches across product platforms.