The Bill & Melinda Gates Foundation, Seattle, WA, USA.
PricewaterhouseCoopers, Los Angeles, CA, USA.
Lancet Infect Dis. 2020 May;20(5):e108-e115. doi: 10.1016/S1473-3099(20)30123-7. Epub 2020 Mar 17.
WHO has listed several priority diseases with epidemic potential for which there are no, or insufficient, medical countermeasures. In response, the Bill & Melinda Gates Foundation (with support from PricewaterhouseCoopers) coordinated subject matter experts to create a preparedness plan for Disease X. Disease X is caused by Pathogen X, an infectious agent that is not currently known to cause human disease, but an aetiologic agent of a future outbreak with epidemic or pandemic potential. We have identified crucial areas for acceleration in medical countermeasure product development and international coordination. We have also reviewed novel platforms and process improvements related to manufacturing, which could revolutionise the response to the next pandemic. Finally, we created several coordination and engagement guides. These guides range from the rational design of an intervention target product profile, to the key facets of vaccine and therapeutic development, to accelerated manufacturing and regulatory mechanisms. In this Personal View, we provide a high-level summary of the outcomes of the medical countermeasure development workstream, intended for a broad audience including academia, medical countermeasure developers, and multilateral coordinating bodies. We hope that they might find this piece useful in prioritising strategic investments and efforts to accelerate medical countermeasure development. We observed that in-depth analyses of clinical trial design, chemistry, manufacturing and control activities, and accelerated regulatory pathways are necessary for shortening the timelines for the product development of medical countermeasures. We intend to cover these topics in future publications.
世界卫生组织（WHO）列出了几种具有潜在流行可能性但目前尚无或现有医疗对策不足的优先疾病。为此，比尔及梅琳达·盖茨基金会（在普华永道的支持下）协调了专题专家，为“X 疾病”创建了一项防范计划。“X 疾病”由病原体 X 引起，病原体 X 是一种目前尚未已知会导致人类疾病的传染性病原体，但它是未来具有流行或大流行潜力的疫情的病因病原体。我们已经确定了医疗对策产品开发和国际协调方面需要加速的关键领域。我们还审查了与制造相关的新型平台和流程改进，这可能会彻底改变对下一次大流行的应对方式。最后，我们创建了几个协调和参与指南。这些指南涵盖了干预目标产品概况的合理设计，疫苗和治疗开发的关键方面，以及加速制造和监管机制。在这篇个人观点中，我们提供了医疗对策开发工作流程的结果的高级别总结，旨在为包括学术界、医疗对策开发者和多边协调机构在内的广泛受众提供参考。我们希望他们会发现这篇文章有助于优先考虑战略投资并加快医疗对策的开发。我们观察到，需要对临床试验设计、化学、制造和控制活动以及加速监管途径进行深入分析，以缩短医疗对策产品开发的时间线。我们打算在未来的出版物中涵盖这些主题。
