FDA现代化法案2.0给疾病动物模型发展带来的启示和思考

doi:10.12300/j.issn.1674-5817.2023.083

实验动物与比较医学 ›› 2023, Vol. 43 ›› Issue (5): 472-481.DOI: 10.12300/j.issn.1674-5817.2023.083

FDA现代化法案2.0给疾病动物模型发展带来的启示和思考

万颖寒¹()(), 顾也欣², 袁雨浓²^,³, 汤忞²()(), 鲁立¹()

^1.上海实验动物研究中心, 上海 201203
^2.赛箔(上海)生物科技有限公司, 上海 201312
^3.澳大利亚悉尼大学医学与健康学院, 悉尼 2006

收稿日期:2023-06-20 修回日期:2023-08-28 出版日期:2023-10-25 发布日期:2023-11-01
通讯作者: 鲁立（1979—），女，博士，副研究员，研究方向：细胞分子生物学。E-mail： luli@slarc.org.cn；
汤忞（1992—），女，博士，青年研究员，研究方向：生物3D打印。E-mail: min@cyberiad.cn。ORCID: 0000-0002-6084-1827
作者简介:万颖寒（1984—），女，硕士，助理研究员，研究方向：疾病动物模型表型相关研究。E-mail：wanyinghan@slarc.org.cn；
基金资助:
上海市科学技术委员会科技计划项目“3D打印脑胶质瘤肿瘤免疫类器官”(21140900700)

Implications on the Development of Animal Disease Models from FDA Modernization Act 2.0

Yinghan WAN¹()(), Yexin GU², Yunong YUAN²^,³, Min TANG²()(), Li LU¹()

^1.Shanghai Laboratory Animal Research Center, Shanghai 201203, China
^2.Cyberiad Biotechnology Ltd. , Shanghai 201312, China
^3.Faculty of Medicine and Health, University of Sydney, Sydney, 2006, Australia

Received:2023-06-20 Revised:2023-08-28 Published:2023-10-25 Online:2023-11-01
Contact: TANG Min (ORCID: 0000-0002-6084-1827), E-mail: min@cyberiad.cn
LU Li, E-mail: luli@slarc.org.cn;

摘要/Abstract

摘要：

实验动物是生命科学研究和生物医药产业发展的基础条件，是科学探索和医疗健康事业中不可或缺的技术支撑。科学地开发疾病动物模型对生物医药科研和产业发展意义重大。但鉴于多种新兴体外建模技术在过去十年中的蓬勃发展，2022年美国国会全票通过了FDA Modernization Act 2.0（即《美国食品药品监督管理局现代化法案2.0》，简称FDA现代化法案2.0），取消了自1938年以来实施的FDA批准新药进入人体临床试验前必须经过动物实验的联邦强制要求，并正式提出体外疾病模型也可以被运用在临床前试验中，但并未禁止开展动物实验。本文解读了FDA现代化法案2.0的由来，介绍了细胞培养、类器官、器官芯片、生物3D打印模型和计算机模型这5种体外建模方式在科研、生物化工和制药业中的最新应用及其各自的优缺点，同时概括了实验动物和疾病动物模型发展的新趋势，并关注各种模型之间的交叉应用，旨在为我国今后的疾病动物模型发展提供一些参考。

关键词: 疾病动物模型, 体外疾病模型, 类器官, 器官芯片, 生物3D打印, FDA现代化法案2.0

Abstract:

Laboratory animals are the foundational conditions and indispensable technical support in life science research and biomedical industry development. The scientific development of animal models of diseases is of great significance to biomedical research and industrial development. In light of the booming development of multiple emerging in vitro modelling technologies over the past decade, in 2022, the U.S. Senate unanimously passed the bill FDA Modernization Act 2.0. This bill rescinded the requirement for animal testing in investigating the safety and effectiveness of a drug—a federal mandate since 1938, and highlighted the potential of various invitro disease modeling approaches in future biomedical fields. This paper provides a comprehensive review of the latest advances and applications of in vitro disease modeling approaches in academia and industry followed by an interpretation of the FDA bill, namely cell culture, organoid, organ-on-a-chip, 3D bio-printing model and computer-based model. The paper next introduces the crossed applications of various disease models and discusses the advantages and disadvantages of each system, thereby providing insights into future trends in the use of animal disease models in China.

Key words: Animal disease models, In vitro disease models, Organoid, Organ-on-a-chip, 3D bio-printing, FDA Modernization Act 2.0

中图分类号:

R-332

万颖寒, 顾也欣, 袁雨浓, 汤忞, 鲁立. FDA现代化法案2.0给疾病动物模型发展带来的启示和思考[J]. 实验动物与比较医学, 2023, 43(5): 472-481.

Yinghan WAN, Yexin GU, Yunong YUAN, Min TANG, Li LU. Implications on the Development of Animal Disease Models from FDA Modernization Act 2.0[J]. Laboratory Animal and Comparative Medicine, 2023, 43(5): 472-481.

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FDA现代化法案2.0给疾病动物模型发展带来的启示和思考

Implications on the Development of Animal Disease Models from FDA Modernization Act 2.0

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