New regulatory thinking is needed for AI-based personalised drug and cell therapies in precision oncology

Until recently the application of artificial intelligence (AI) in precision oncology was confined to activities in drug development and had limited impact on the personalisation of therapy. Now, a number of approaches have been proposed for the personalisation of drug and cell therapies with AI appl...

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Bibliographic Details
Published in:NPJ precision oncology 2024-01, Vol.8 (1), p.23-11, Article 23
Main Authors: Derraz, Bouchra, Breda, Gabriele, Kaempf, Christoph, Baenke, Franziska, Cotte, Fabienne, Reiche, Kristin, Köhl, Ulrike, Kather, Jakob Nikolas, Eskenazy, Deborah, Gilbert, Stephen
Format: Article
Language:English
Subjects:
692/700/1538
692/700/155
692/700/565/2319
Adaptation
Artificial intelligence
Cancer Research
Cancer therapies
Customization
Decision making
Drug development
Drug dosages
Drug therapy
Gene Therapy
Human Genetics
Immunology
Internal Medicine
Medical equipment
Medicine
Medicine & Public Health
Oncology
Patients
Perspective
Precision medicine
Regulatory approval
Targeted cancer therapy
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Summary:Until recently the application of artificial intelligence (AI) in precision oncology was confined to activities in drug development and had limited impact on the personalisation of therapy. Now, a number of approaches have been proposed for the personalisation of drug and cell therapies with AI applied to therapy design, planning and delivery at the patient’s bedside. Some drug and cell-based therapies are already tuneable to the individual to optimise efficacy, to reduce toxicity, to adapt the dosing regime, to design combination therapy approaches and, preclinically, even to personalise the receptor design of cell therapies. Developments in AI-based healthcare are accelerating through the adoption of foundation models, and generalist medical AI models have been proposed. The application of these approaches in therapy design is already being explored and realistic short-term advances include the application to the personalised design and delivery of drugs and cell therapies. With this pace of development, the limiting step to adoption will likely be the capacity and appropriateness of regulatory frameworks. This article explores emerging concepts and new ideas for the regulation of AI-enabled personalised cancer therapies in the context of existing and in development governance frameworks.
ISSN:2397-768X
2397-768X
DOI:10.1038/s41698-024-00517-w