Bringing a new brain related drug to the market is the longest and costliest of all therapeutic endeavors. From human testing and on to drug approval it takes on average 8.8 years with direct costs of about $850 million. Finally, only 8.2% of the cases eventually get approved. These statistics have prompted major pharmaceutical companies to significantly cut back their CNS drug development activities in recent years.
The most important financial decision facing CNS drug developers is: how to reduce the risk of failed clinical trials. One of the major challenges in CNS drug development has been translating laboratory findings into clinically meaningful treatments, mainly due to the lack of objective and reliable research tools necessary to test drug candidates.
The current standard for measuring drug effect on cognitive processes in clinical trials, neuropsychological assessment, does not isolate specific cognitive processes that are associated with discrete neural systems, and therefore does not provide direct information about the drug-induced changes in brain function. In addition, these tests cannot be performed in most non-human species used in the screening of pharmacological agents. Available techniques for identifying cognitive processes such as fMRI and PET do not directly measure neural activity, and suffer from low temporal resolution, while common electrophysiological methods (EEG and MEG) and analysis technologies such as QEEG and ERP provide high temporal resolution information relating to direct neural activity, but suffer from low sensitivity and specificity and low spatial resolution.
To reduce failure rates in CNS drug development, there is a need for objective measures based on neuro-physiological activity that can automatically detect neural response and quantify drug-induced changes in cognitive function. Such techniques and methodologies can also be used for diagnosis and for the assessment of disease progression.
BNA™ serves as a valuable tool in CNS drug development, providing the means to quantify drug-induced neuro-physiological changes in brain network activity. elminda’s BNA™ platform has been at the center of several collaborations with major pharmaceutical companies involved in CNS drug development.
 Miller G. Is Pharma Running Out of Brainy Ideas?Science 30 July 2010: Vol. 329 no. 5991 pp. 502-504