About Neuro-AI

Neuroimaging can play a role in drug development at all stages of the process, pre-clinical to phase IV. In pre-clinical it can be used for validating animal models. In phase I, it can be used to better establish dose response curves, aid in the shifting the proof of concept (POC) from late to early phase, and identifying additional/alternative targets for late stage study. In phases II & III, it can aid and/or serve, thanks to the recent passage of passage of the 21st Century Cures ActI, as proof of efficacy. In phase IV, it can be used to provide differentiation between available treatments.

Focusing here just on POC, the CNS drug pipeline has stymied, with CNS drugs 45% less likely to proceed to regulatory filling than non-CNS drugsII. Failures in CNS drugs are due in large part to failures to demonstrate efficacy in Phase III, with rates significantly higher than non-CNS drugsII. While phase III attrition rates are significantly higher for CNS drugs, it is not the case for phase II. Putting it in other words CNS drugs fail late in trials predominately for efficacy when compared to other drugs. These late stage failures are costly both in time and in dollars.