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: info@aedtrials.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. 

Our Top-Sponsors

We are pleased to know that more people and companies are interested in testing antiepileptic drugs and devices. This is a really important topic; millions of people worldwide suffer from epilepsy and its consequences.

We want to help everyone recover or at least alleviate the course of the disease. It's nice to know that other people and companies are just as interested in this issue. We want to especially thank our top sponsors - ASCIN Loans, Indy Medical Supplies, and Audio & Video Solutions.

Indy Medical Supplies

Indy Medical Supplies LLC has been in business since July 2007. It specializes in technologically advanced products such as the Electrostatic Sprayer System or ESS, which uses an environmentally safe solution that kills 99.9995 % of MRSA, Clostridium Difficile or C-Diff, Salmonella, E-Coli, EBOLA, Enterococcus and a number of infectious microorganisms that haven't been listed.

The company also carries Portable Oxygen Concentrators, which produce their own oxygen and improve quality of life.

Audio & Video Solutions

Audio & Video Solutions has provided professional products and installation services to the best homes and commercial venues in South Florida, the Caribbean, and South America since 1989 and is a recognized leader in both commercial and residential sound, video, shades, automation, and lighting.

Well-trained professionals work to maximize your investment's value and ensure your satisfaction. Its customer service follows your project from the beginning design stages through end-user training upon completion and is there to answer all your concerns throughout the process.


 

Registration - Conference & Hotel

Conference Registration & Payment

Registration for the 2023 conference is now open.

General Registration: $600.00 USD
Clinical Coordinator/Nurse : $450.00 USD

Hotel reservations

This year's conference will be held at the:

Turnberry Isle Miami Hotel
19999 West Country Club Drive
Aventura (North Miami Beach), Florida, 33180 USA
Phone: 305.932.3788

The conference rate is $239.00 + tax and resort fee per night.

This is a special rate for this symposium and available only early April 17, 2023. Please make your reservations early as rooms will be limited. This rate will increase significantly after the deadline.

To Reserve your Room

You may call the Reservations Department at the hotel: 305.932.3788

Or you may reserve online via Passkey

 

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, 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

word cloud 1.png
  • Obtain an understanding of the processes by which new drugs are discovered, including discussion new animal models and molecular targets
  • Discuss new translational models in the epilepsy space
  • Discuss new regulatory pathways for epilepsy approval, including orphan indications indications, and extrapolation from adults to children
  • Discuss new ways to assess patient suitability for epilepsy trials, including centralized patient interview
  • Discuss with FDA and EMA representatives new objectives and legislation that have an impact on AED development 
  • Discuss novel trial designs that reduce placebo exposure
  • Discuss new methods and devices for seizure counting 
  • Outline the drugs and devices in preclinical and clinical development for epilepsy