Abstract
Italy's nanomedicine expertise has long developed in fragmented manner, with limited coordination across academia, clinical institutions, industry and regulatory bodies. The Italian Nanomedicine Platform (INP) was established to integrate discovery, preclinical validation, regulatory science and industrial translation within a single ecosystem aligned with Horizon Europe Cluster 1. We report the proceedings of the First INP Meeting (Rome, 16-18 Feb 2026), encompassing keynote contributions from European and international leaders, a national pitch session mapping institutional capabilities, and results from a structured inaugural survey. The meeting gathered ~140 principal investigators from nearly 100 institutions and formalized eight thematic Working Groups. A subsequent registration round reached 170 participants from 109 institutions. Over 60% of declared activity concerns nanomedicine products, physicochemical characterization, cell-based models and imaging, whereas regulatory science, AI and Health Technology Assessment remain under-represented (10-25%). The Technology Readiness Level distribution is markedly skewed toward early stages (~80% at TRL 1-4). Keynote speakers identified translational bottlenecks in GMP scalability, regulatory harmonization, mRNA-LNP technologies and clinical validation, concluding with a 24-month implementation roadmap. INP represents a strategic national node that converts distributed excellence into coordinated translational impact, explicitly addressing persistent bottlenecks in manufacturing, regulation and clinical validation.