An AI Foundation Toxicology Model and Framework to Support Waiving a Second Species in Drug Safety Studies

Call UE del programma Horizon Europe (HORIZON), bando "Innovative Health Initiative JU Call 13" (HORIZON-JU-IHI-2026-13-two-stage). Tipo di azione: HORIZON JU Research and Innovation Actions. Stato: aperta. Prossima scadenza: 08/10/2026 (two-stage). Testo ufficiale (in inglese): Scope: Regulatory guidelines e.g. ICH M3(R2) for nonclinical safety assessment of new small molecule medicines have historically required toxicity studies in two species, typically one rodent and one non-rodent, to maximise the likelihood of detecting adverse effects, improve the translatability to humans and guide patient dosing and monitoring. This two species approach is increasingly challenged by ethical considerations, long and costly study durations, limited reproducibility, and uncertainty regarding human relevance [1], [2]. In parallel, scientific progress in mechanistic toxicology, advanced in vitro systems (e.g. organoids and micro-physiological systems), multi-omics technologies, and AI based modelling is enabling NAMs to help reduce reliance on animal models without compromising patient safety. Within the context of this topic, the AI Foundation Toxicology Model will be considered a NAM, facilitating NAM-enabled second species waivers. In addition, the policy landscape across global jurisdictions is evolving rapidly. The European Commission is preparing a roadmap towards phasing out animal testing for chemical assessment safety, expected in 2026 [3]; the European Medicines Agency (EMA)…