Who's in and who's out: Leveraging macroscopic preclinical data to simulate trials on truly heterogeneous populations
Developing new drugs requires substantial financial and time investments, with each candidate undergoing rigorous preclinical and clinical trials. Despite these efforts, many promising candidates fail during clinical trials. A key factor contributing to this may be the reliance on genetically identical animals and monoclonal cell lines in preclinical trials, which fail to represent the diversity of real-world populations. Moreover, preclinical data is often reported in aggregate, obscuring individual-level insights that could be critical for predicting clinical success. In this talk, I will present case studies of how our Standing Variations Modeling technique can address these challenges by: (1) deconstructing aggregate data from preclinical studies to recover individual-level insights ('who’s in'); and (2) extrapolating these findings to a more diverse population by conducting a virtual preclinical trial ('who’s out’).