...clinical need, scientific evidence and the technology landscape. That is the approach we have been developing at FRESCI within the EIC Transition Coati-X project. For patients undergoing haemodialysis or long-term cancer treatment, central vascular access devices can be essential to care. At the same time, infection and thrombosis remain important complications, with consequences for patients, treatment continuity and healthcare systems. Our 2025 white paper, Safer Devices

Organoid teams are entering a phase where reviewers ask what the assay can inform, compared with what, and under which uncertainty. The strategic task is to turn model biology into a claim package that survives diligence, funding review, and regulatory-science discussion.

LLMs can speed up evidence work. But if you can’t reproduce and audit what the model changed, your “AI-enabled” pipeline can become a credibility liability.

Qualification of Novel Methodologies ( QoNM ) has moved beyond its old role as a specialist regulatory procedure. It is becoming one of the clearest signals of how Europe intends to judge AI tools, imaging methods, mechanistic models and other next-generation evidence instruments in drug development. For years, the EMA’s Qualification of Novel Methodologies process was easy to leave to specialists. It sat in the part of the regulatory map reserved for biomarkers, technical