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FDA is anticipating how AI may advance manufacturing and improve supply chain security.
Editor's Note: This article was previously published in Pharmaceutical Technology’s September 2023 issue.
Hollywood has long presented artificial intelligence (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 Center 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, making decisions, and making predictions” (2). The National Academies of Sciences, Engineering, and Medicine 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).
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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.
Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk eBook