This white paper summarises the current use of AI in ATMP preclinical assessment, outlining key challenges and limitations, and explores potential future directions to enable the meaningful integration of in silico and AI-based approaches into ATMP preclinical development.
This white paper also captures the key discussions, perspectives, and insights generated during the symposium “AI Applications in Preclinical Assessment of ATMPs”, organised by Cell and Gene Therapy Catapult on behalf of the Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT).
