Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective
Artificial Intelligence (AI) has the disruptive potential to transform patients’ lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies. AI’s rapid a...
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| Format: | Article |
| Language: | English |
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MDPI AG
2025-01-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/18/1/47 |
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| author | Fahimeh Mirakhori Sarfaraz K. Niazi |
| author_facet | Fahimeh Mirakhori Sarfaraz K. Niazi |
| author_sort | Fahimeh Mirakhori |
| collection | DOAJ |
| description | Artificial Intelligence (AI) has the disruptive potential to transform patients’ lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies. AI’s rapid advancement has revealed regulatory gaps as existing public policies struggle to keep pace with the challenges posed by these emerging technologies. The term AI itself has become commonplace to argue that greater “human oversight” for “machine intelligence” is needed to harness the power of this revolutionary technology for both potential and risk management, and hence to call for more practical regulatory guidelines, harmonized frameworks, and effective policies to ensure safety, scalability, data privacy, and governance, transparency, and equitable treatment. In this review paper, we employ a holistic multidisciplinary lens to survey the current regulatory landscape with a synopsis of the FDA workshop perspectives on the use of AI in drug and biological product development. We discuss the promises of responsible data-driven AI, challenges and related practices adopted to overcome limitations, and our practical reflections on regulatory oversight. Finally, the paper outlines a path forward and future opportunities for lawful ethical AI. This review highlights the importance of risk-based regulatory oversight, including diverging regulatory views in the field, in reaching a consensus. |
| format | Article |
| id | doaj-art-12c97a83cd304ecd98cd271c6e52f777 |
| institution | Kabale University |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj-art-12c97a83cd304ecd98cd271c6e52f7772025-01-24T13:45:10ZengMDPI AGPharmaceuticals1424-82472025-01-011814710.3390/ph18010047Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory PerspectiveFahimeh Mirakhori0Sarfaraz K. Niazi1College of Natural and Mathematics Sciences, University of Maryland, Baltimore County (UMBC), USG, Rockville, MD 20850, USACollege of Pharmacy, University of Illinois, Chicago, IL 60612, USAArtificial Intelligence (AI) has the disruptive potential to transform patients’ lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies. AI’s rapid advancement has revealed regulatory gaps as existing public policies struggle to keep pace with the challenges posed by these emerging technologies. The term AI itself has become commonplace to argue that greater “human oversight” for “machine intelligence” is needed to harness the power of this revolutionary technology for both potential and risk management, and hence to call for more practical regulatory guidelines, harmonized frameworks, and effective policies to ensure safety, scalability, data privacy, and governance, transparency, and equitable treatment. In this review paper, we employ a holistic multidisciplinary lens to survey the current regulatory landscape with a synopsis of the FDA workshop perspectives on the use of AI in drug and biological product development. We discuss the promises of responsible data-driven AI, challenges and related practices adopted to overcome limitations, and our practical reflections on regulatory oversight. Finally, the paper outlines a path forward and future opportunities for lawful ethical AI. This review highlights the importance of risk-based regulatory oversight, including diverging regulatory views in the field, in reaching a consensus.https://www.mdpi.com/1424-8247/18/1/47artificial intelligence (AI)drug product developmentregulatory frameworksethical considerationbiologicscell and gene therapy (CGT) |
| spellingShingle | Fahimeh Mirakhori Sarfaraz K. Niazi Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective Pharmaceuticals artificial intelligence (AI) drug product development regulatory frameworks ethical consideration biologics cell and gene therapy (CGT) |
| title | Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective |
| title_full | Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective |
| title_fullStr | Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective |
| title_full_unstemmed | Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective |
| title_short | Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective |
| title_sort | harnessing the ai ml in drug and biological products discovery and development the regulatory perspective |
| topic | artificial intelligence (AI) drug product development regulatory frameworks ethical consideration biologics cell and gene therapy (CGT) |
| url | https://www.mdpi.com/1424-8247/18/1/47 |
| work_keys_str_mv | AT fahimehmirakhori harnessingtheaimlindrugandbiologicalproductsdiscoveryanddevelopmenttheregulatoryperspective AT sarfarazkniazi harnessingtheaimlindrugandbiologicalproductsdiscoveryanddevelopmenttheregulatoryperspective |