AEDD Trials XIV

Welcome to the website for the 14th conference on Antiepileptic Drug and Device Trials, held every two years and sponsored by The Epilepsy Study Consortium in collaboration with the University of Pennsylvania and the Epilepsy Foundation. 

If you have any questions about the conference, please contact Mary Ann Brodie at the Epilepsy Study Consortium at: brodie.tesc@gmail.com.

Program

This is the fourteenth conference focusing on issues related to antiepileptic drug and device (AEDD) development from preclinical discoveries through clinical evaluations. We are still in need of novel therapies for patients with epilepsy.  Specifically, there is a need for therapies that impact the underlying disease rather than treating symptoms (disease modifying or antiepileptogenic), and that benefit treatment-resistant patients. Increasingly, new therapies are focused on orphan populations, where the regulatory path has not been previously identified. New innovations in therapy may face roadblocks such as complex regulatory requirements, increased payer expectations, and issues in data quality, but progress has been made. At each AEDD conference, we re-evaluate strategies to ensure continued advancement. There is always the opportunity to learn from the past as we move into the future. This symposium will bring together representatives from academia, industry, the NIH, and the FDA to review what has been learned and to discuss strategies to enhance AEDD development. 

Registration - Conference & Hotel

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. 

Objectives