NAMs Live Talk Session 4: Europe in Transition: Scaling Human-Relevant Research Through NAMs

The fourth NAMs Live Talks session explored how breakthroughs in New Approach Methodologies (NAMs) can move from research to real-world adoption, with a focus on organoid technology and implementation frameworks. Prof Daniela Salvatori presented Ombion, a €125 million Dutch initiative supporting animal-free biomedical translation. Prof Hans Clevers, a pioneer in the field of organoid models, presented his research through immersive videos and highlighted applications of organoids in drug development, disease modeling, and personalized medicine. Key challenges discussed included the lack of standardized organoid protocols, regulatory readiness, industry trust, and education. A centralized, living repository of validated organoid protocols accessible to academia and industry was proposed as a practical step toward regulatory acceptance. Participants also emphasized that validation frameworks must be co-developed with regulators and industry to ensure relevance and adoption. Europe has strong scientific leadership in organoid technology but risks losing momentum due to fragmented funding, regulatory burden, and limited coordinated infrastructure investment, while China and the US accelerate large-scale implementation efforts. Models such as Ombion — public-private partnerships designed to bridge innovation and application — were highlighted by Prof Clevers as important frameworks to replicate across Europe.