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肺部领域技术商业化的挑战与机遇:美国胸科学会官方报告

Challenges and Opportunities for Commercializing Technologies in the Pulmonary Arena: An Official American Thoracic Society Report.

作者信息

Vukmirovic Milica, Benam Kambez H, Rose Jason J, Turner Scott, Magin Chelsea M, Lagares David, Cohen Alan H, Kaminski Naftali, Hirota Jeremy A, Maher Toby M, Konigshoff Melanie, Mallampalli Rama K, Sheppard Dean, Tarran Robert, Gomer Richard H, Kenyon Nicholas J, Morris David, Hobbie Silke, Raju S Vamsee, Petrache Irina, Watkins Timothy, Kumar Rishav, Lam Wilbur A, Sherer Todd, Hecker Louise

出版信息

Ann Am Thorac Soc. 2024 Jan;21(1):1-11. doi: 10.1513/AnnalsATS.202310-872ST.

Abstract

"Translational medicine" has been a buzzword for over two decades. The concept was intended to be lofty, to reflect a new "bench-to-bedside" approach to basic and clinical research that would bridge fields, close gaps, accelerate innovation, and shorten the time and effort it takes to bring novel technologies from basic discovery to clinical application. Has this approach been successful and lived up to its promise? Despite incredible scientific advances and innovations developed within academia, successful clinical translation into real-world solutions has been difficult. This has been particularly challenging within the pulmonary field, because there have been fewer U.S. Food and Drug Administration-approved drugs and higher failure rates for pulmonary therapies than with other common disease areas. The American Thoracic Society convened a working group with the goal of identifying major challenges related to the commercialization of technologies within the pulmonary space and opportunities to enhance this process. A survey was developed and administered to 164 participants within the pulmonary arena. This report provides a summary of these survey results. Importantly, this report identifies a number of poorly recognized challenges that exist in pulmonary academic settings, which likely contribute to diminished efficiency of commercialization efforts, ultimately hindering the rate of successful clinical translation. Because many innovations are initially developed in academic settings, this is a global public health issue that impacts the entire American Thoracic Society community. This report also summarizes key resources and opportunities and provides recommendations to enhance successful commercialization of pulmonary technologies.

摘要

“转化医学”已经流行了二十多年。这个概念旨在立意高远,反映一种基础研究与临床研究的全新“从 bench 到 bedside”的方法,这种方法将跨越不同领域、弥合差距、加速创新,并缩短将新技术从基础发现转化为临床应用所需的时间和精力。这种方法是否成功并兑现了承诺呢?尽管学术界取得了令人难以置信的科学进步和创新,但将其成功转化为实际临床解决方案却很困难。在肺部疾病领域,这一挑战尤为突出,因为与其他常见疾病领域相比,美国食品药品监督管理局批准的肺部治疗药物较少,且肺部治疗的失败率更高。美国胸科学会召集了一个工作组,目标是确定与肺部领域技术商业化相关的主要挑战以及改进这一过程的机会。为此制定了一项调查问卷,并对肺部领域的 164 名参与者进行了调查。本报告总结了这些调查结果。重要的是,本报告指出了肺部学术环境中一些未得到充分认识的挑战,这些挑战可能导致商业化努力的效率降低,最终阻碍成功临床转化的速度。由于许多创新最初是在学术环境中开发的,这是一个影响整个美国胸科学会群体的全球公共卫生问题。本报告还总结了关键资源和机会,并提供了促进肺部技术成功商业化的建议。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/841b/10867911/c4e614f2eff0/AnnalsATS.202310-872STf1.jpg

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