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Antibiotic development - economic, regulatory and societal challenges.
Nature Reviews Microbiology ( IF 88.1 ) Pub Date : 2019-11-19 , DOI: 10.1038/s41579-019-0293-3
Christine Årdal 1 , Manica Balasegaram 2 , Ramanan Laxminarayan 3 , David McAdams 4 , Kevin Outterson 5 , John H Rex 6 , Nithima Sumpradit 7
Affiliation  

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the economic feasibility of antibiotic development. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the international and national initiatives aimed at incentivizing research and the development of new antibiotics to improve the economic feasibility of antibiotic development. Christine Årdal co-leads research and innovation in the European Union Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections. Previously she was the co-lead on incentives to stimulate antibacterial innovation for the European Union’s DRIVE-AB project. She is a senior adviser at the Norwegian Institute of Public Health, where her research and policy work focuses on medicine innovation, access and stewardship. Manica Balasegaram trained as a medical doctor at the University of Nottingham, United Kingdom, and from 2001 onwards worked as a doctor and researcher in several countries in sub-Saharan Africa and southern Asia with Médecins Sans Frontières. In 2007, he joined the Drugs for Neglected Diseases initiative as Head of the Leishmaniasis Clinical Program before returning to Médecins Sans Frontières as Executive Director of the Access Campaign. He joined the Global Antibiotic Research and Development Partnership in June 2016, and is a board member of the Medicines Patent Pool as well as FIND’s Scientific Advisory Committee. He is also the executive director of GARDP. Ramanan Laxminarayan is the founder and Director of the Center for Disease Dynamics, Economics & Policy in Washington, DC, United States, and a senior research scholar at Princeton University. He is a voting member of the US Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. David McAdams is a game theorist and professor of economics in the Fuqua School of Business and Economics Department at Duke University, United States. His current research focuses on the economic epidemiology of information, with applications from antibiotic resistance to ‘fake news’. Kevin Outterson is a professor of law and N. Neal Pike Scholar in Health and Disability Law at Boston University, United States, and Executive Director of CARB-X. He has grappled for a dozen years with issues peculiar to antibiotic research and development, especially relating to intellectual property, reimbursement and business models. He now leads the world’s largest push incentive for antibacterial research and development, CARB-X, with a 5-year budget exceeding US$500 million. The views expressed herein are personal, and do not necessarily represent the views of CARB-X or any CARB-X funder. John H. Rex is a physician and drug developer with more than 30 years of development and policy experience focused on antimicrobial agents. He is currently Chief Medical Officer of F2G Ltd (an antifungal biotechnology company), an expert-in-residence for the Wellcome Trust and an operating partner with a venture capital group (Advent Life Sciences) and was (2015–2019) a voting member of the US Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. He blogs regularly at http://amr.solutions/blog.html. Nithima Sumpradit is a pharmacist and lead coordinator for development and implementation of Thailand’s National Strategic Plan on Antimicrobial Resistance 2017–2021. She is also a programme manager of the Royal Thai Government–WHO Country Cooperation Strategy Programme on Antimicrobial Resistance.

中文翻译:

抗生素开发-经济,法规和社会挑战。

毫无疑问,抗生素耐药性是全球健康面临的最大挑战之一,耐药性的出现已经超过了新抗生素的开发。但是,制药业和生物技术公司用于研究和开发新抗生素的投资正在减少。决策者,监管机构和许多公司都认可了干燥的抗生素管道对公共健康的影响。在这篇观点文章中,七位专家讨论了导致抗生素药物发现和开发下降的挑战,以及旨在激励新抗生素研究和开发以改善抗生素开发的经济可行性的国家和国际计划。在此观点文章中,七位专家讨论了导致抗生素药物发现和开发下降的挑战,以及旨在激励新抗生素研究和开发以改善抗生素开发的经济可行性的国际和国家倡议。克里斯汀·欧达尔(ChristineÅrdal)共同领导欧盟抗微生物药物耐药性和医疗保健相关感染联合行动的研究与创新。此前,她是欧盟DRIVE-AB项目激励抗菌创新激励措施的联合负责人。她是挪威公共卫生学院的高级顾问,在那里她的研究和政策工作专注于药物创新,获取和管理。Manica Balasegaram在英国诺丁汉大学接受过医学博士学位的培训,从2001年开始,他在无国界医生组织中担任撒哈拉以南非洲和南亚多个国家的医生和研究员。2007年,他以利什曼病临床项目负责人的身份加入了被忽视疾病药物计划,然后回到无国界医生担任获取运动的执行主任。他于2016年6月加入了全球抗生素研究与开发合作伙伴关系,并且是药品专利池以及FIND科学咨询委员会的董事会成员。他还是GARDP的执行董事。Ramanan Laxminarayan是美国华盛顿特区疾病动力学,经济与政策中心的创始人兼主任,也是普林斯顿大学的高级研究学者。他是美国总统抗药性细菌咨询委员会的有表决权的成员。大卫·麦克亚当斯(David McAdams)是美国杜克大学Fuqua商学院和经济系的博弈论家和经济学教授。他目前的研究重点是信息的经济流行病学,其应用范围从抗生素耐药性到“假新闻”。凯文·奥特森(Kevin Outterson)是美国波士顿大学法学教授和健康与残疾法N. Neal Pike学者,也是CARB-X的执行董事。他从事抗生素研发所特有的问题已经有十几年的历史了,尤其是与知识产权,费用报销和商业模式有关的问题。现在,他领导着全球最大的抗菌研究和开发激励措施CARB-X,五年预算超过5亿美元。本文表达的观点是个人观点,不一定代表CARB-X或任何CARB-X资助者的观点。John H. Rex是一名医师和药物开发人员,在抗菌剂领域拥有30多年的开发和政策经验。他目前是F2G Ltd(一家抗真菌生物技术公司)的首席医学官,Wellcome Trust的驻地专家,以及一家风险投资集团(Advent Life Sciences)的运营合伙人,并且(2015-2019年)是一名有投票权的成员美国总统抗药性细菌咨询委员会。他定期在http://amr.solutions/blog.html上发表博客。Nithima Sumpradit是制定和实施泰国《 2017-2021年国家抗菌素耐药性国家战略计划》的药剂师和首席协调员。
更新日期:2019-11-20
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