This paper explores the transformative shift in drug discovery from traditional animal-based modeling toward human-centric New Approach Methodologies (NAMs). This evolution is driven by high clinical failure rates and is supported by updated regulatory frameworks from the FDA and NIH that no longer mandate animal testing. The review categorizes these innovations into stem cell-based, organoid-based, and in silico (AI) platforms, detailing how they replicate complex human physiology more accurately than animal models. These technologies span the entire drug development continuum, facilitating disease modeling, toxicity forecasting, and precision medicine. Ultimately, the sources highlight successful bench-to-bedside transitions where NAM-derived candidates have entered human clinical trials, signaling a new era of safer and more efficient therapeutic development.

References:

• Liu W, Pang P D, Wu C A, et al. New approach methodologies for drug discovery[J]. Cell, 2026, 189(7): 1877-1903.