Needs Assessment

 

In an era where we have brought over 15 new antiepileptic drugs (AEDs) to the marketplace...

We need to be mindful of the remaining unmet needs, which should drive continued therapeutic innovation. Second and third generation AEDs have consistently produced statistically significant improvement when added on to background drugs in patients with refractory epilepsy. Yet, the number of patients who become seizure free is small, and even fewer remain so over the long term. In addition, many patients are still plagued by drug-related side effects and co-morbidities. Finally, all of our existing drugs are for symptomatic relief (i.e. reduction in seizures). We have not even begun to approach the problem of epilepsy prevention, nor of a true “cure”, which would eliminate the ongoing need for chronic therapy. Despite how far we have come, we still have a long way to go. New therapeutic strategies are urgently needed. 

To this end, for more than two decades a group of individuals have been meeting on a biennial basis to discuss ways in which the process of bringing innovative therapies to patients can be expedited. Participants include individuals from academia, from interested government agencies such as the Food and Drug Administration/EMEA and the National Institutes of Health, as well as representatives from the pharmaceutical and device industries. The purpose of these meetings has been the exchange of ideas, discussion of roadblocks to therapeutic development, dialogue about regulatory strategies, and sharing of successful approaches. Over the years, discussions at this symposium have led to implementation of new trial designs, as well as new important analyses of trials that have already been performed. In addition, new regulatory pathways have been identified, particularly as related to approval of new antiepileptic drugs for monotherapy use. In addition, each meeting presents a pipeline of drugs and devices currently in development, and includes a Shark Tank competition, where novel innovations to improve the lives of people with epilepsy are presented.