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

investigación innovación I+D+i desarrollo tecnológico europeo. HORIZON JU Research and Innovation Actions Expected Impact: The action under this topic is expected to achieve the following impacts: Faster and more informed decision-making through the use of an AI-driven NAM (AI Foundation Toxicology Model) and increased efficiency through rapid processing of vast amounts of data [1] . Increased consistency and standardisation in a NAM-based approach, specifically an AI model, used by industry in the efficient development, testing and production of safe and effective innovative health technologies, improving industrial competitiveness. Regulatory adoption of a NAM-enabled second species waiver model (AI Foundation Toxicology Model) and weight-of-evidence framework, in line with recommendations and more consistent global decision-making on waiving second species testing. Reduction in animal use, accelerated timelines and lower costs, enhancing the competitiveness of the European health industry through economical and ethical benefits. Improved public health as patients will benefit from safe and effective medicines developed faster using validated NAMs. The action is expected to contribute to the EU Directive (2010/63/EU) [2] on the protection of animals used for scientific purposes and t