Finding a Place for New Approach Methodologies (NAMs) in Biomedical Research

New Approach Methodologies (NAMs) can greatly contribute to the Replacement and Reduction of animal experiments in biomedical science. However, while NAMs have seen considerable investment and adoption in toxicology, this growth has not found a parallel in basic and translational biomedical research. Here, we examine the opportunities and the challenges of systematic implementation of NAMs in biomedical research. We demonstrate that NAMs offer significant scientific value by enabling tailored investigations into biological mechanisms and disease processes, enhancing human relevance, and harnessing cutting-edge technological innovations. We highlight key areas—neuroscience, cardiovascular research, and oncology—where NAMs have a distinct advantage and the potential to drive major advancements. However, realizing their full potential requires overcoming critical barriers, including technological limitations, gaps in education and training, and insufficient funding. To facilitate broader adoption of NAMs in biomedical research, we propose the use of Clinical Outcome Pathways (COPs) as a guiding framework. COPs provide a structured approach to mapping knowledge of biological events from molecular initiating events to clinical outcomes, integrating diverse NAM-generated data into experimental workflows. Finally, we outline a stepwise strategy to accelerate the adoption of NAMs, emphasizing interdisciplinary collaboration, parallel studies alongside existing animal models, and sustained investment in infrastructure and education.