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12 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Production Perig - stock.adobe.com H ollywood has long presented artificial intel- ligence (AI) as a futuristic concept far from reality, but technology has now eliminated the gap between science fiction and science fact. AI is here and here to stay; 50% of global healthcare companies plan to implement AI strategies by 2025 (1). For pharmaceutical manufacturers, AI has the potential to revolutionize process design and control, and thus bring benefits to patients and challenges to regulators. Owing to its fictionalized past, the term AI can mean wildly different things to different people. FDA's Cen- ter for Drug Evaluation and Research (CDER) describes AI rather inclusively as "a branch of computer science, statistics, and engineering that uses algorithms or models that exhibit behaviors such as learning, mak- ing decisions, and making predictions" (2). The Na- tional Academies of Sciences, Engineering, and Medi- cine issued a report on innovations in pharmaceutical manufacturing that highlighted AI's potential role in the measurement, modeling, and control used for pharmaceutical manufacturing (3). AI offers potential benefits to pharmaceutical man- ufacturers in the form of optimized process design and control, and smart monitoring and maintenance, to drive continuous improvement. AI in concert with other innovative technologies might advance pharma- ceutical quality, build more resilient supply chains, and improve the availability of medicine for patients (4). In The Future is the Present: Artificial Intelligence in Pharmaceutical Manufacturing Adam Fisher, PhD is Director of Science Staff and Immediate Office within the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research at FDA. FDA is anticipating how AI may advance manufacturing and improve supply chain security.