Feasibility High Impact Medium Time horizon Short (0–24 months) Barriers Reliance on manual processes for data compilation, review and formatting. Submission requirements that differ by regulatory body. Biggest unlock Collaboration between regulators and industry to develop frameworks and guidelines supporting the use of Gen AI in regulatory submission. Regulatory submission today The increasing complexity of clinical trials produces inefficiency, with the number of procedures per trial growing by 60%18 over the past decade and the length of trial submission also growing. Many companies still rely on manual processes for regulatory submission, leading to frequent filing errors. Moreover, submission teams often work in silos, leading to inconsistencies and frequent duplication of effort. Regulatory submission enhanced by Gen AI In the future, Gen AI will automate many aspects of regulatory submission and review, including generating, organizing and validating submission filings. Gen AI will be used to compile and structure trials data and findings into the required formats and then flag omissions, cross-reference as appropriate and ensure regulatory compliance – reducing the need for costly requests for more information. Gen AI can also feed predictive algorithms to predict the probability of regulatory success.Low-hanging fruit: Regulatory submission and review 5 Moderna has launched RegBot, a solution that uses large-language models to streamline interactions with health authorities, reducing the administrative burden on regulatory affairs teams. RegBot features two main components: an automated system for the intake and archiving of health authority enquiries and an advanced chatbot that assists users in navigating internal documents to draft accurate and timely responses, further speeding up regulatory correspondence.USE CASE Moderna Intelligent Clinical Trials: Using Generative AI to Fast-Track Therapeutic Innovations 11

Intelligent Clinical Trials 2024