Inspiration and Reflection on the Development of Disease Animal Models from the FDA Modernization Act 2.0

  Experimental animals are the fundamental conditions for life science research and the development of the biopharmaceutical industry, and are an indispensable technological support for scientific exploration and healthcare. The scientific development of disease animal models is of great significance for biopharmaceutical research and industrial development. However, given the flourishing development of various emerging in vitro modeling technologies over the past decade, the US Congress unanimously passed the FDA Modernization Act 2.0 (also known as the FDA Modernization Act 2.0) in 2022, which abolished the federal mandatory requirement since 1938 that new drugs must undergo animal testing before entering human clinical trials, And it is officially proposed that in vitro disease models can also be used in preclinical trials, but animal experiments are not prohibited.

  This article interprets the origin of FDA Modernization Act 2.0, introduces the latest applications and advantages and disadvantages of five in vitro modeling methods, including cell culture, organoids, organ chips, biological 3D printing models, and computer models, in scientific research, biochemistry, and pharmaceutical industries. At the same time, it summarizes the new trends in the development of experimental animal and disease animal models, and focuses on the cross application of various models, Intended to provide some reference for the development of disease animal models in China in the future.