Vass Panna, Akdag Dara Sevkan, Broholm Gabriel Enemark, Kjaer Jesper, Humphreys Anthony J, Ehmann Falk
Regulatory Science and Innovation Task Force, European Medicines Agency, Amsterdam, Netherlands.
Data Analytics Centre, Danish Medicines Agency, Copenhagen, Denmark.
Front Med (Lausanne). 2023 Mar 9;10:1122405. doi: 10.3389/fmed.2023.1122405. eCollection 2023.
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.
欧洲药品管理局(EMA)和欧洲药品监管网络的战略目标之一是支持在药物研发中采用创新方法和技术。为推动这一目标,EMA制定了一份使能技术(ETs)清单,这些技术新颖且发展迅速,有可能推动创新,从而对药物研发产生重大影响。在这项工作中,对EMA确定的使能技术进行了分析,通过追踪它们在2019年至2022年期间从出版物到早期监管互动再到临床试验的历程,来衡量其对药物研发的影响。这项工作还通过审查EMA提交数据中发现的前所未见的创新技术,对EMA确定的ETs当前清单进行了评估。分析表明,不同研究数据源中各种创新技术的出现情况差异很大,这为创新技术所经历的“创新之旅”提供了宝贵见解。确定了几种新兴技术并认可将其列入使能技术清单,而清单上的其他一些技术则因在监管互动以及临床试验和出版物中出现频率较低而被提议排除。总体而言,该分析突出了持续扫描和监测使能技术的相关性和价值,支持欧洲在与药物研发相关的创新技术、方法和方法论的研发方面保持领先地位的目标。