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创新药物倡议组织的“应对耐药菌的新药”项目:欧洲公私合作开发应对抗生素耐药性的新策略。

The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance.

作者信息

Kostyanev T, Bonten M J M, O'Brien S, Steel H, Ross S, François B, Tacconelli E, Winterhalter M, Stavenger R A, Karlén A, Harbarth S, Hackett J, Jafri H S, Vuong C, MacGowan A, Witschi A, Angyalosi G, Elborn J S, deWinter R, Goossens H

机构信息

Department of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.

Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.

出版信息

J Antimicrob Chemother. 2016 Feb;71(2):290-5. doi: 10.1093/jac/dkv339. Epub 2015 Nov 15.

DOI:10.1093/jac/dkv339
PMID:26568581
Abstract

Antibiotic resistance (ABR) is a global public health threat. Despite the emergence of highly resistant organisms and the huge medical need for new drugs, the development of antibacterials has slowed to an unacceptable level worldwide. Numerous government and non-government agencies have called for public-private partnerships and innovative funding mechanisms to address this problem. To respond to this public health crisis, the Innovative Medicines Initiative Joint Undertaking programme has invested more than €660 million, with a goal of matched contributions from the European Commission and the European Federation of Pharmaceutical Industries and Associations, in the development of new antibacterial strategies. The New Drugs for Bad Bugs (ND4BB) programme, an Innovative Medicines Initiative, has the ultimate goal to boost the fight against ABR at every level from basic science and drug discovery, through clinical development to new business models and responsible use of antibiotics. Seven projects have been launched within the ND4BB programme to achieve this goal. Four of them will include clinical trials of new anti-infective compounds, as well as epidemiological studies on an unprecedented scale, which will increase our knowledge of ABR and specific pathogens, and improve the designs of the clinical trials with new investigational drugs. The need for rapid concerted action has driven the funding of seven topics, each of which should add significantly to progress in the fight against ABR. ND4BB unites expertise and provides a platform where the commitment and resources required by all parties are streamlined into a joint public-private partnership initiative of unprecedented scale.

摘要

抗生素耐药性是全球公共卫生威胁。尽管出现了高度耐药的生物体,且对新药有巨大的医疗需求,但全球范围内抗菌药物的研发已放缓至不可接受的水平。众多政府和非政府机构呼吁建立公私合作伙伴关系并采用创新的融资机制来解决这一问题。为应对这一公共卫生危机,创新药物倡议联合事业计划已投资超过6.6亿欧元,目标是欧盟委员会、欧洲制药工业协会联合会提供等额资金,用于开发新的抗菌策略。“治疗耐药菌的新药”(ND4BB)计划是一项创新药物倡议,其最终目标是在从基础科学和药物发现到临床开发,再到新商业模式和抗生素合理使用的各个层面加强对抗生素耐药性的斗争。ND4BB计划内已启动了七个项目以实现这一目标。其中四个项目将包括新抗感染化合物的临床试验以及前所未有的大规模流行病学研究,这将增加我们对抗生素耐药性和特定病原体的了解,并改进使用新研究药物的临床试验设计。迅速采取一致行动的必要性推动了七个主题的资金投入,每个主题都应为对抗生素耐药性的斗争取得重大进展做出贡献。ND4BB整合了专业知识,并提供了一个平台,将各方所需的承诺和资源整合到一个规模空前的公私联合倡议中。

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