Topic: New approach methodologies

New approach methodologies can support drug safety and efficacy evaluation while improving the mechanistic understanding of human disease and therapeutic response. This workshop addresses two barriers to their wider use: awareness of available applications and confidence that their results are biologically relevant, reproducible and translatable. Pharmaceutical developers, regulators and biomedical researchers will discuss validation, standardisation and integration of NAM-based evidence into research and development. Sessions consider human-based models, organoids, tissue microenvironments, o

NIH investigators will examine gaps in human-based models for basic biomedical research, disease mechanisms and translation. The programme covers human development and evolutionary specializations, transformative experimental models, integration of laboratory and computational methods including AI, and disease applications. Talks address stem cells, organoids, tissue architecture, vascularized models, mechanistic digital twins and reproducible disease platforms. Session discussions conclude with research priorities and next steps; medical phantom demonstrations illustrate imaging validation.