AI-Accelerated R&D, Trial Design & Portfolio Decisions
Background: Drug discovery and development timelines and costs are becoming unsustainable, while success rates in late-stage trials remain low and competitors are already using AI to prioritize targets, indications, and trial designs. Traditional, largely manual decision-making in discovery, pre-clinical, and early clinical stages cannot keep pace with the explosion of biological data and competitive pipelines. Objective: Use AI and advanced analytics to accelerate target identification, molecule design, biomarker discovery, trial design, and portfolio decisions, improving probability of technical and regulatory success while reducing time-to-clinic and time-to-market. Scope: • AI/ML for target identification, hit-to-lead and lead optimization, including structure- and data-driven design • In-silico prediction of ADME/Tox and safety signals to de-risk molecules earlier • AI-assisted trial design (endpoints, inclusion/exclusion, sample size, site selection, enrichment strategies) • Portfolio optimization across indications, assets, and stages based on value, risk, and capacity constraints • Integrated decision-support platforms for asset teams, governance committees, and senior R&D leadership • Feedback loops from clinical outcomes, post-marketing data, and competitor moves into R&D and portfolio models