Tumor Growth Modelling for Drug Development

The development of a drug is a long and increasingly expensive process. Mathematical models have become fundamental tools for the most efficient use of resources in pharmaceutical research, driving the design of more informative studies and therefore reducing the number of animals or patients evaluated. Models provided with some mechanistic ground allow discriminating drug-related parameters from system-related parameters, which is a fundamental requirement for predicting the effect of a new treatment in different studies and settings. A tumor growth inhibition model of this kind, which describes the effect of oncology agents in xenograft mice, has been developed. The model returns a measure of drug potency and allows the calculation of the minimal concentration needed to stop the tumor growth. The model has been extended to different scenarios, like combination therapy. Even more importantly, it has been possible to determine a relationship between the drug potency parameters estimated in animals and efficacious clinical exposures in oncology patients, further supporting the robustness of the model in guiding the decision making during the drug development process.