Fedele Bonifazi, president of Fondazione Gianni Benzi, spoke about the upcoming revision of both the Paediatric and Orphan Regulations during the workshop “L’intelligenza artificiale a tutela della salute in età pediatrica. Implementazione di una piattaforma digitale per il design di farmaci pediatrici sicuri” held on 30 March in Bari, Italy.

The outcomes of the two Regulations, in terms of paediatric and orphan medicinal products approved by the European Medicines Agency until 2020, as well as the challenges encountered in the implementation of the Regulations, were widely discussed.

The event was organised by the working group of Università degli Studi di Bari Aldo Moro within a research project funded by the Horizon Europe Seeds call. The workshop provided multidisciplinary contributions aimed to encourage the discussion on how the artificial intelligence contributes to the identification and development of safer paediatric medicines.

The project aimed to develop machine learning models to predict the toxicological profile of medicines currently in use and to provide a priority scale of toxicological profiles to be validated experimentally. The study was mainly focused on paediatric oncological medicines for rare and ultra-rare diseases, affecting exclusively paediatric patients.

As part of the project, a digital platform, Tiresia, accessible free of charge via web, was developed and implemented to facilitate, with the help of artificial intelligence models with a high predictive capacity, the design of medicines for children, optimising their risk/benefit ratio.

Istituto Superiore di Sanità, IRCCS - Istituto di ricerche farmacologiche Mario Negri, the European Paediatric Translational Research Infrastructure (EPTRI) and Exprivia contributed to this project.

Stay tuned for further updates on this relevant project!