AI-Driven Microfluidic 3D In Vitro Platform for Multi-Tissue Crosstalk in Drug Testing

Current biomedical research and regulatory testing still largely depend on animal models, which are costly, raise ethical concerns, and often fail to predict human responses with sufficient accuracy. Horizon Europe’s HORIZON-HLTH-2026-01-TOOL-03 call emphasises the integration of New Approach Methodologies (NAMs) to shift towards human-relevant tools. Understanding the crosstalk between tissues is crucial for tackling complex diseases involving bone, metabolic, immune and intestinal systems, where systemic interactions often determine therapeutic success or failure.

Università Politecnica delle Marche (UNIVPM) brings strong expertise in advanced 3D in vitro bone models that reproduce healthy and diseased microenvironments, including osteoporotic conditions and dynamic mechanical loading. Building on this foundation, the project will assemble a multidisciplinary consortium to co-develop a next-generation platform that combines microfluidics, multi-tissue 3D models, integrated nano(bio)sensors, AI-driven data analytics and metabolomics/multi-omics profiling for predictive, human-relevant drug testing. Scientifically, the project will deliver a fully validated NAM platform capable of modelling complex multi-tissue interactions—specifically gut–bone–immune crosstalk—under both normal and disease conditions. This will open new avenues to decipher disease mechanisms, identify novel biomarkers and evaluate therapeutic responses in a human-relevant context. On the regulatory side, the platform will generate robust, standardised and reproducible datasets closely reflecting human biology, supporting safety and efficacy assessments for new drugs and combination therapies. This will contribute to the modernisation of regulatory frameworks and the practical adoption of NAMs in line with European and international guidelines. Societally, the initiative will significantly reduce the use of animals in preclinical research, directly supporting the 3Rs principles (Replacement, Reduction, Refinement). By speeding up the development of safer, more effective medicines and improving translational accuracy, the project has the potential to deliver better therapeutic options, enhanced patient outcomes and increased public trust in biomedical innovation.