Centre for Anti-Infective Agents, Vienna, Austria.
Clin Microbiol Infect. 2017 Oct;23(10):713-717. doi: 10.1016/j.cmi.2017.06.020. Epub 2017 Jun 24.
The public health threat of antibiotic resistance has gained attention at the highest political levels globally, and recommendations on how to respond are being considered for implementation. Among the recommended responses being explored for their feasibility is the introduction of economic incentives to promote research and development of new antibiotics. There is broad agreement that public investment should stimulate innovation and be linked to policies promoting sustainable and equitable access to antibiotics. Though commonly used, the term 'innovation' is not based on a common understanding.
This article aims to initiate discussion on the meaning of 'innovation' in this context.
Literature and expert opinion.
As the definition of a novel class (novel scaffold, novel pharmacophore), a novel target (novel binding site) and a novel mode of action-the three traditional criteria for 'innovation' in this context-may be confounded by the complexities of antibacterial drug discovery, a biological and outcome-oriented definition of innovation is presented to initiate discussion. Such an expanded definition of innovation in this specific context is based on the overarching requirement that a drug not be affected by cross-resistance to existing drugs in the organisms and indications for which it is intended to be used, and that it have low potential for high-frequency, high-level single-step resistance if intended as a single drug therapy.
Policy makers, public health authorities and funders could use such a comprehensive definition of innovation to prioritize where publicly funded incentives should be applied.
抗生素耐药性对公共卫生的威胁已引起全球最高政治层面的关注,正在考虑实施应对建议。正在探索的应对措施之一是引入经济激励措施,以促进新抗生素的研究和开发。人们普遍认为,公共投资应刺激创新,并与促进可持续和公平获得抗生素的政策挂钩。尽管“创新”一词被广泛使用,但它并不是基于共同的理解。
本文旨在讨论这一背景下“创新”的含义。
文献和专家意见。
由于新型类别(新型支架、新型药效团)、新型靶标(新型结合部位)和新型作用模式——这是该背景下“创新”的三个传统标准——可能会受到抗菌药物发现的复杂性的影响,因此提出了一种基于生物学和结果的创新定义,以引发讨论。在这种特殊情况下,对创新的这种扩展定义是基于一个总体要求,即药物不应受到其预期用于的生物体和适应症中现有药物交叉耐药性的影响,并且如果作为单一药物疗法使用,它具有低水平高频单步耐药的潜力。
政策制定者、公共卫生当局和资助者可以使用这种创新的全面定义来确定公共资助激励措施应优先应用的领域。