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Europe’s next evidence gatekeeper: why EMA’s Qualification of Novel Methodologies now deserves board-level attention
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
FRESCI TEAM
Mar 317 min read


Biotech competitiveness will be decided less by scientific excellence than by how fast science can clear capital and regulation.
A new OECD comparison of the European Union and the United States makes one point impossible to ignore: the next phase of biotechnology leadership will not be won in the lab alone. It will be won in the operating system that moves discoveries into markets. Both jurisdictions have world-class research ecosystems. But they do not convert science into commercial scale in the same way. The United States still leads on the classic translation metrics. It files roughly twice as man
FRESCI TEAM
Mar 253 min read


3D Modeling Life 2026: Strong Demand, High Scientific Value, and Clear Momentum for 3D Human-Based Technologies
More than a successful symposium, 3D Modeling Life 2026 sent a clear signal: the biomedical ecosystem is actively seeking more predictive, human-relevant models and more strategic dialogue on how to translate them into research and innovation practice. Held on 18–19 February 2026 at Sapienza University of Rome , Modeling Life 2026 – 3D Human-Based Technologies in Modern Biology brought together academic, industrial, and public-sector stakeholders around one central question
FRESCI TEAM
Mar 185 min read


FRESCI launches VISI-ON-BRAIN, a €4.5M Horizon Europe doctoral network advancing human-relevant neuroscience tools beyond animal models
Terrassa (Barcelona), 25 February 2026 — FRESCI by SCIENCE&STRATEGY SL today announced the launch of VISI-ON-BRAIN (Cutting-edge Human In Vitro and In Silico Biomedical Tools on Brain Disorders), a Horizon Europe project funded with over €4.5 million under the Marie Skłodowska-Curie Actions – Doctoral Networks (MSCA-DN). Over 48 months (2026–2029) , the consortium will train 15 doctoral researchers to develop and apply next-generation human in vitro and in silico approaches
FRESCI TEAM
Feb 253 min read
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