ArticleFrontiers in medicine2023
Search, identification, and curation of cell and gene therapy product regulations using augmented intelligent systems.
Article in Frontiers in medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.Biotech (Basel (Switzerland)) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Manually keeping up-to-date with regulations such as directives, guidance, laws, and ordinances related to cell and gene therapy is a labor-intensive process. We used machine learning (ML) algorithms to create an augmented intelligent system to optimize systematic screening of global regulations to improve efficiency and reduce overall labor and missed regulations. Methods: Combining Boolean logic and artificial intelligence (i.e., augmented intelligence) for the search process, ML algorithms were used to identify and suggest relevant cell and gene therapy regulations. Suggested regulations were delivered to a landing page for further subject matter expert (SME) tagging of words/phrases to provide system relevance on functional words. Ongoing learning from the repository regulations continued to increase system reliability and performance. The automated ability to train and retrain the system allows for continued refinement and improvement of system accuracy. Automated daily searches for applicable regulations in global databases provide ongoing opportunities to update the repository. Results: Compared to manual searching, which required 3-4 SMEs to review ~115 regulations, the current system performance, with continuous system learning, requires 1 full-time equivalent to process approximately 9,000 regulations/day. Currently, system performance has 86% overall accuracy, a recommend recall of 87%, and a reject recall of 84%. A conservative search strategy is intentionally used to permit SMEs to assess low-recommended regulations in order to prevent missing any applicable regulations. Conclusion: Compared to manual searches, our custom automated search system greatly improves the management of cell and gene therapy regulations and is efficient, cost effective, and accurate.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.