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灵活创新——公共抗生素试验的网络化模式

NIMble innovation-a networked model for public antibiotic trials.

作者信息

Glover Rebecca E, Singer Andrew C, Roberts Adam P, Kirchhelle Claas

机构信息

Department of Health Services Research and Policy, Faculty of Public Health Policy, London School of Hygiene & Tropical Medicine, London, UK.

UK Centre for Ecology & Hydrology, Wallingford, UK.

出版信息

Lancet Microbe. 2021 Nov;2(11):e637-e644. doi: 10.1016/S2666-5247(21)00182-8. Epub 2021 Oct 7.

DOI:10.1016/S2666-5247(21)00182-8
PMID:35544083
Abstract

Antibiotic research and development is at an inflection point. Faced with ongoing problems with commercial innovation, we argue for a networked public approach to support and coordinate existing research and development initiatives by sustainably moving promising compounds through clinical trials. We propose a global public infrastructure of institutes tasked with (1) conducting all trial stages up to market authorisation, including small-scale compound production; (2) negotiating licensing agreements for global production and distribution by industry partners; and (3) using public purchasing agreements or subscription models to ensure commercially viable drug production at equitable prices. We invite stakeholders to consider our Networked Institute Model's benefits for unblocking the public and private antibiotic pipeline.

摘要

抗生素研发正处于一个转折点。面对商业创新方面持续存在的问题,我们主张采用一种网络化的公共方法,通过将有前景的化合物可持续地推进临床试验,来支持和协调现有的研发计划。我们提议建立一个全球性的公共机构基础设施,其任务包括:(1)开展直至市场授权的所有试验阶段,包括小规模化合物生产;(2)就行业合作伙伴进行全球生产和分销的许可协议进行谈判;(3)利用公共采购协议或订阅模式,以确保以公平价格实现商业上可行的药品生产。我们邀请利益相关者考虑我们的网络化机构模式对于打通公共和私人抗生素研发渠道的益处。

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