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AIFA Flags Rapid AI Shift in Drug R&D as Regulators Rework Oversight

A new dossier positions AI as a strategic lever for faster, more precise therapies, highlighting gaps in transparency, liability, privacy.

Overview

  • AIFA reports 62% of pharma firms already deploy AI in R&D, with adoption projected to rise about 45% over five years and the market growing at over 40% annually to 2030.
  • Deep-learning systems scan vast chemical, genetic and clinical datasets to identify targets and generate candidate molecules in hours; several AI-assisted drugs have reached advanced human trials, including rentosertib and Rec-994.
  • Trial operations are being streamlined through tools such as TrialGPT for rapid patient matching and through virtual patient cohorts that simulate therapeutic scenarios to cut cost and failure risk.
  • Efficiency gains cited by Capgemini include up to a 30% faster time-to-market, roughly 40% higher research productivity and about 25% lower engineering costs.
  • Regulators are adjusting processes, with EMA launching an AI program, FDA testing algorithmic tools and AIFA piloting predictive analytics, even as concerns persist over black-box explainability, liability and data protection raised by AIFA president Robert Nisticò.