Qiao Juan

Hong Kong Research Institute of Technology, Hong Kong, China
Peking University, Beijing, China
-
Integrating AI into the pharmaceutical product lifecycle: from R&D to manufacturing and safetyLomonosov Public Administration Journal. Series 21 2025. Vol. 22. N 4. p.102-120
-
Artificial Intelligence (AI) is transforming the pharmaceutical lifecycle —from discovery to manufacturing and safety oversight. In discovery, AI accelerates target identification, molecular design, and repurposing (e.g., baricitinib; rentosertib), while the DSP-1181 experience highlights the risk of structural conservatism. In clinical development, AI supports patient stratification, digital-twin-informed design, and automated analysis, improving statistical power and operational speed. In manufacturing, predictive analytics, computer vision, and knowledge-graph-assisted documentation enhance quality and throughput. Pharmacovigilance benefits from natural language processing (NLP) — enabled signal detection and workflow automation. Emerging uses in antibody engineering and personalized therapy broaden its scope, but real-world benefit hinges on data quality, rigorous validation, transparency, and regulatory alignment (including real-world evidence).
Keywords: AI-based pharmacovigilance, AI-driven drug development, AI-enabled personalized therapy, AI-optimized trials, Digital twins, Drug repurposing, Molecular design, Patient stratification.
-

