The root cause of this is a lack of human-relevant models. Preclinical studies are conducted in 2D cell culture and animal models, however they are insufficient to account for and disentangle the complex, multicomponent molecular processes that underlie the onset and progression of most diseases. As a result, the vast majority (~92%) of drugs that pass in vitro and animal preclinical tests fail to pass human clinical trials and make it to market. Further, the genetic and environmental variation between humans means that adverse drug reactions still occur even after drugs have passed clinical trials – killing at least hundreds of thousands of people every year.
Starting at the tissue level, we seed human cells on to scaffolds and coax them to grow to mimic particular tissues by providing the right conditions, including a sterile environment with temperature and pH control, as well as adequate supply of nutrients and removal of waste by a perfusion system that also provides appropriate shear stress specific to that tissue. This technology is made possible by recent developments in sensor technology and smart control algorithms.
As well as having the potential to replace many 2D cell culture and animal experiments, our technology will also enable novel experiments and data capture not previously possible, and help usher in the Biology 2.0 revolution, where the power of big data coupled with machine learning algorithms promises to bring much progress to humanity.