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评估病毒病原体的框架:生物医学高级研究与发展局新兴传染病战略的关键要素

A Framework for Assessing Viral Pathogens: A Key Element of the BARDA Emerging Infectious Diseases Strategy.

作者信息

White Richard C, Kovacs Gerald, Chandran Suchismita, Adams Peter L, Britson Kyla A, Cao Huyen, Dale Christopher, Eisnor Derek L, Erlandson Karl J, Fredericksen Brenda L, Fritch Ethan J, Killens-Cade Rushyannah, Lee John S, Link Malen A, Little James, Michalik Mark, Natarajan Ramya, Robertson George, Rowe Michael, Sciarretta Kimberley L, Skiadopoulos Mario H, Tong Xiaomi, Villanueva Julie M, Wolfe Daniel N, Johnson Robert A

机构信息

Richard C. White, PhD, is an Interdisciplinary Scientist, Medical Countermeasures Program; Peter L. Adams, PhD, and Karl J. Erlandson, PhD, are Interdisciplinary Scientists, and Ramya Natarajan, PhD, is a Health Scientist, Influenza and Emerging Infectious Diseases Division; Kyla A. Britson, PhD, Rushyannah Killens-Cade, PhD, and Malen A. Link, PhD, are Interdisciplinary Scientists, and Daniel N. Wolfe, PhD, is Deputy Director, Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Countermeasures; Derek L. Eisnor, MD, is a Medical Officer, Division of Clinical Development; Brenda L. Fredericksen, PhD, is Program Director, Nonclinical Research Program, and James Little, MS, is a Senior Scientific Advisor, Division of Nonclinical Development; John S. Lee, PhD, is Program Director, Molecular Diagnostics Program, and Julie M. Villanueva, PhD, is a Scientific Advisor, Detection, Diagnostics, and Devices Infrastructure Division; Kimberly L. Sciarretta, PhD, is Program Director, Launch Office, Division of Research, Innovation, and Ventures; and Robert A. Johnson, PhD, is Director, Medical Countermeasures Program; all at the Biomedical Advanced Research and Development Authority, Washington, DC. Gerald R. Kovacs, PhD, is a Senior Advisor; Huyen Cao, MD, is a Senior Clinical Studies Analyst; Christopher Dale, PhD, and Mark Michalik, MBA, are Senior Subject Matter Experts; Mario H. Skiadopoulos, PhD, is a Preclinical Drug Development Subject Matter Expert; and Xiaomi Tong, PhD, is a Senior Regulatory Affairs Subject Matter Expert; all at Tunnell Government Services, Berwyn, PA. Suchismita Chandran, PhD, is a Lead Associate, and Michael Rowe, MS, is a Senior Consultant; both at Booz Allen Hamilton, McLean, VA. Ethan J. Fritch, PhD, is an ORISE Fellow, Oak Ridge Institute for Science and Education, Oak Ridge, TN. George Robertson, PhD, is Chief Scientific Officer, Cambra Consulting, Inc., Woodbridge, VA.

出版信息

Health Secur. 2025 Jan-Feb;23(1):47-54. doi: 10.1089/hs.2024.0076. Epub 2025 Jan 30.

Abstract

The COVID-19 pandemic has revealed the need for nations to prepare more effectively for emerging infectious diseases. Preparing for these threats requires a multifaceted approach that includes assessing pathogen threat, building flexible capabilities for rapid medical countermeasure (MCM) development, and exercising, maintaining, and improving those response capabilities. The Biomedical Advanced Research and Development Authority (BARDA) promotes the advanced development of MCMs in response to natural and manmade threats. In this article, the authors describe a BARDA threat assessment tool that, in conjunction with other factors, facilitates portfolio management and decisionmaking related to the advanced development of MCMs for emerging infectious diseases. The tool was designed to use readily accessible public data and information related to the threat posed by pathogens. It can be adjusted to modify the specific areas of interest (eg, removal/addition of parameters) to facilitate cross-pathogen analysis and can be updated to reflect changes (eg, new outbreak) that may impact the overall threat assessment. Finally, assessment of certain pathogens is included.

摘要

新冠疫情已表明各国需要更有效地为新发传染病做好准备。应对这些威胁需要采取多方面的方法,包括评估病原体威胁、建立灵活的快速医学应对措施(MCM)开发能力,以及演练、维持和提升这些应对能力。生物医学高级研究与发展管理局(BARDA)推动针对自然和人为威胁的MCM的先进开发。在本文中,作者描述了一种BARDA威胁评估工具,该工具与其他因素相结合,有助于进行与新发传染病MCM先进开发相关的项目组合管理和决策。该工具旨在使用与病原体构成的威胁相关的易于获取的公共数据和信息。它可以进行调整以修改特定关注领域(例如,去除/添加参数),以促进跨病原体分析,并且可以更新以反映可能影响总体威胁评估的变化(例如,新的疫情爆发)。最后,还包括对某些病原体的评估。

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