Abstract:The pathway from discovery of novel candidate drugs, including nanomedicine compounds, to FDA approval is lengthy and may be difficult to navigate. Oftentimes, investigational drugs are appropriately abandoned early in the development pathway due to preclinical failure. Other novel compounds may look quite promising in rodent models and preclinical trials, but prove disappointing when tested in human patients. In fact, only 5% of drugs entering Phase I human cancer clinical trials in the US are ultimately approved. Given the enormous cost, in terms of both financial investment and delay in progress toward improved patient outcome, there is a critical need for a more reliable and efficient process. One solution may be to improve translatability of our preclinical data by including trials in cancer-bearing pet dogs in the drug development pathway.