AI integration accelerates drug development and regulatory processes

Artificial intelligence is increasingly being integrated into the entire lifecycle of drug development, from initial drug discovery and clinical trials to manufacturing and post-approval safety monitoring. A survey of 273 stakeholders conducted by the Network Data Steering Group (NDSG), involving the European Medicines Agency (EMA) and BfArM, highlights that while the use of AI is no longer debated, its reliability remains a key concern. The report notes that manufacturers are already using generative AI to autonomously draft regulatory documents, and authorities have identified 61 specific use cases for AI in their own operations.

In the field of metabolic diseases, biotechnology company Insilico Medicine has utilized AI-driven approaches to nominate ISM1354, a new preclinical drug candidate. Designed as a small-molecule GIPR antagonist, ISM1354 targets obesity and its associated complications, with potential future applications for type 2 diabetes and cardiovascular diseases. Preclinical studies across multiple species, including mice, rats, dogs, and monkeys, demonstrated high oral bioavailability and a favorable safety margin compared to existing clinical comparators.