Open Letter – A €1 Billion European Moonshot for New Approach Methodologies

This Open Letter, endorsed by 125 scientists, researchers and innovators across Europe, calls on the European Union to establish a dedicated €1 billion “Moonshot” programme for New Approach Methodologies (NAMs) within the next Horizon Europe Framework Programme (2028–2034). NAMs, including human cell-based systems, organoids, microphysiological systems and advanced computational approaches, offer more human-relevant and innovative tools to study disease, develop medicines and improve safety assessment while supporting the transition away from animal testing. Although Europe hosts world-leading expertise in these technologies, progress remains fragmented and underfunded. A coordinated European initiative is needed to accelerate infrastructure development, regulatory acceptance, interdisciplinary collaboration and workforce training. Strategic investment in NAMs would strengthen public health, enhance Europe’s global competitiveness in life sciences and support a more predictive, efficient and sustainable biomedical research ecosystem.