Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: Cooperation toward extracellular vesicle‐based products

Fukaya-Shiba, Ai; Shimokawa, Masafumi; Sasaki, Hajime; Wakao, Rika

doi:10.1111/bcp.15065

Cited by 6 publications

(8 citation statements)

References 8 publications

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“…However, it is highly sensitive to certain terms; when text mining is used with other methods, the problem of terminological distortion will be unignorable. Therefore, we propose an objective methodology for horizon scanning that identifies cutting edge technology to be applied to medical products, which are AI-based medical devices, drugs related to T cell immune responses, and extracellular vesicle-based products from all research papers in the target field using both citation network analysis methods and text mining ( 16 – 19 ).…”

Section: Introductionmentioning

confidence: 99%

Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

et al. 2022

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BackgroundThe need for a new style of clinical trials, called decentralized clinical trials (DCTs), has been increasing as they do not depend on physical visits to clinical sites. DCTs are expected to provide a new opportunity to patients who cannot participate in a clinical trial due to geographical and time limitations. For the adoption of DCTs, it is essential that medical devices with Internet of Medical Things (IoMT) and Internet of Health Things (IoHT) based technologies are developed and commercially adopted. In this study, we aimed to identify the regulatory considerations when IoMT/IoHT-based technologies are used in DCTs or products developed using DCTs.MethodTo understand the study and development field of IoMT/IoHT comprehensively and panoramically, relevant papers published in Web of Science were searched online. Subsequently, a citation network was obtained and characterized as a cluster using a text mining method to identify IoMT/IoHT-based technologies expected to be utilized in DCTs or products developed using DCTs.Result and DiscussionUpon analysis of the top 15 clusters and subsequent 51 sub-clusters, we identified the therapeutic areas (psychology, neurology) and IoMT/IoHT-based technologies (telemedicine, remote monitoring, and virtual reality) that are expected to be used in DCTs. We also identified several considerations based on the current regulatory guidance.ConclusionIoMT/IoHT-based technologies that are expected to be used or products developed using DCTs and key considerations made when they are used in DCTs were identified. The considerations could encourage conducting DCTs using IoMT/IoHT-based technologies.

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Section: Introductionmentioning

confidence: 99%

Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

et al. 2022

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“…The immuno-modulatory activity of MSC-derived exosomes was compared with that of parental MSCs ( 85 ). Respiratory diseases were the most common indication in clinical trials registered for MSC-derived EVs therapeutics ( 90 ). Clinical studies of exosomes carrying siRNA ( 87 ) have also been reported.…”

Section: Resultsmentioning

confidence: 99%

“…Developing guidance for EVs is the top priority among the identified modalities, since there is no guidance available. The PMDA Science Board, a high-level consultative body that discuss the scientific aspects of medical product review, will develop points to consider (PTC) for EV-based products in a year ( 90 ). Although EVs, including exosomes, have drawn attention as potential therapeutics, their quality requirements are yet to be addressed by regulatory bodies.…”

Section: Discussionmentioning

confidence: 99%

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity

et al. 2021

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Background: The mission of medicines regulatory agencies is to ensure the timely access of innovative products for patients to improve public health. Thus, regulators should foresee evolving technologies and build expertise prior to reviewing innovative products. Novel modalities and new classes of therapeutics in biological or cell-based products represent a regulatory challenge because of knowledge gaps, as exemplified by the unexpected cytokine release syndrome in the first-in-human clinical trial of the CD28 super-agonist. Meanwhile, recent treatments harnessing T cell co-signaling pathways provide an opportunity for investigation. Therefore, this study aimed to systematically identify and evaluate novel modalities for T cell immunity to assess the need for regulatory guidance.Methods: A PubMed search was carried out using the query, “immun* AND t lymph*” to select publications. Subsequently, a citation network was created, followed by clustering and text mining to identify the modalities and classes of therapeutics under development.Results and Discussion: Analysis of the top 20 clusters revealed research domains characterized by keywords such as immune checkpoint antibody, chimeric antigen receptor (CAR)-T cells, microbiota, exosome, regulatory T cells, unconventional T cells, and vaccines. After reviewing the pharmacological concepts, clinical trial information, and available guidance, we presented a perspective on the future development of guidance for these domains.Conclusion: Bibliometric analyses identified a set of innovative modalities targeted for drug development with which regulatory guidance is going to catch up. This strategy could help in the successful development of upcoming modalities to ensure readiness for clinical application as part of horizon scanning.

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“…Despite the growing interest in exosome or extracellular vesicle-based therapies, the technologies are still in their infancy, and regulatory requirements for these products need to be clarified by regulators worldwide. The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, in collaboration with the International Coalition of Medicines Regulatory Authorities (ICMRA), is developing a “regulatory points to consider” document to address the open questions in the field ( 39 ).…”

Section: Discussionmentioning

confidence: 99%

Enabling technologies driving drug research and development

Vass

Akdag²,

Broholm³

et al. 2023

Front. Med.

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One of the strategic goals of the European Medicines Agency (EMA) and the European Medicines Regulatory Network is to support the research and uptake of innovative methods and technologies in the development of medicines. To promote this goal, EMA drew up a list of enabling technologies (ETs), which are novel and fast-growing technologies that have the potential to enable innovation and therefore exert considerable impact on drug development. In this work, enabling technologies identified by the EMA are analysed to measure their impact on drug development by following their journey from publications through early regulatory interactions to clinical trials between 2019 and 2022. This work also reviews the current list of EMA-identified ETs by scrutinising previously unseen innovative technologies identified in EMA submissions data. The analysis shows large variations in the appearance of the various innovative technologies in the different studied data sources, which provided valuable insights into the “Journey of Innovation” that innovative technologies undergo. Several emerging technologies were identified and endorsed for inclusion in the enabling technologies list, whereas some others already on the list were proposed to be excluded due to their low appearance in regulatory interactions as well as clinical trials and publications. Overall, this analysis highlights the relevance and value of continuously scanning and monitoring enabling technologies, supporting Europe’s goal to remain a leader in research and development of innovative technologies, methods, and methodologies relevant to drug development.

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Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: Cooperation toward extracellular vesicle‐based products

Cited by 6 publications

References 8 publications

Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity

Enabling technologies driving drug research and development

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