Department of Pharmaceutical Sciences, The Skaggs School of Pharmacy and Pharmaceutical Sciences, the University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045, United States.
Brigham and Woman's Hospital, Department of Medicine, Division of Engineering in Medicine, Harvard Medical School, Boston, Massachusetts 02215, United States.
ACS Nano. 2024 Jun 4;18(22):13983-13999. doi: 10.1021/acsnano.4c00182. Epub 2024 May 20.
In recent years, steady progress has been made in synthesizing and characterizing engineered nanoparticles, resulting in several approved drugs and multiple promising candidates in clinical trials. Regulatory agencies such as the Food and Drug Administration and the European Medicines Agency released important guidance documents facilitating nanoparticle-based drug product development, particularly in the context of liposomes and lipid-based carriers. Even with the progress achieved, it is clear that many barriers must still be overcome to accelerate translation into the clinic. At the recent conference workshop "Mechanisms and Barriers in Nanomedicine" in May 2023 in Colorado, U.S.A., leading experts discussed the formulation, physiological, immunological, regulatory, clinical, and educational barriers. This position paper invites open, unrestricted, nonproprietary discussion among senior faculty, young investigators, and students to trigger ideas and concepts to move the field forward.
近年来，在合成和表征工程纳米粒子方面取得了稳步进展，已有几种已批准的药物和多个有前途的候选药物进入临床试验。食品和药物管理局和欧洲药品管理局等监管机构发布了重要的指导文件，促进了基于纳米粒子的药物产品的开发，特别是在脂质体和脂质载体方面。即使取得了这些进展，显然仍有许多障碍需要克服，以加速向临床应用的转化。在美国科罗拉多州 2023 年 5 月举行的“纳米医学中的机制和障碍”会议研讨会上，领先的专家们讨论了制剂、生理、免疫、监管、临床和教育方面的障碍。这份立场文件邀请资深教师、年轻研究人员和学生进行公开、无限制和非专有性的讨论，以激发推动该领域前进的想法和概念。
