Advanced tissue engineering for in vitro drug safety testing

The FDA modernization act 2.0, signed into law by President Biden in December 2022 encourages the use of alternatives to animal testing for drug discovery. Cell-based assays are one important alternative, however they are currently not fit for purpose. The use of 3D, tissue engineered models represents a key development opportunity, to enable development of models of human tissues and organs. However, much remains to be done in terms of understanding the materials, both bioderived and synthetic that can be incorporated into the models, to provide structural support and also functional readouts. This perspective provides an overview on the history of drug safety testing, with a brief history on the origins of the Food and Drug Administration (FDA). It then goes on to discuss the current status of drug testing, outlining some of the limitations of animal models. In vitro, cell-based models are discussed as an alternative for some parts of the drug discovery process, with a brief foray into the beginnings of tissue culture and a comparison of 2D vs 3D cell culture. Finally, this perspective lays out the argument for implementing tissue engineering methods into in vitro models for drug discovery and safety testing.