Click HERE for the most current version of the 2011 program. (August 2010)
Program Goals
This is the eleventh conference focusing on issues related to antiepileptic drug (AED) development from preclinical discoveries through clinical evaluations. In 2010 the antiepileptic drug pipeline has many interesting compounds. Yet, the path to development of a new antiepileptic drug has become riskier and more difficult. At this juncture, it is important that we reevaluate development strategies, to ensure that it is optimized for the current environment. There is always 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 AED development.
Objectives
During the course of the meeting, participants will:
- Obtain an understanding of the processes by which new drugs are discovered, including discussion of new animal models and molecular targets.
- Discuss the potential for clinical trials of epilepsy prevention (antiepileptogenesis).
- Discuss opportunities to use new genetic studies to develop targeted, individualized therapies for epilepsy.
- Discuss the advantages and disadvantages of monotherapy trial designs and possible alternatives.
- Discuss reasons for recent failed AED trials including placebo effect and impact of globalization of multicenter trials.
- Discuss with FDA and EMA representatives new objectives and legislation that have an impact on AED development.
- Discuss the opportunity for novel trial designs and methodology, including adaptive design.
- Discuss the impact of generic AEDs on clinical trials in epilepsy, and on the epilepsy marketplace.
- Discuss trial designs for devices.
- Discuss the impact of new suicidality concerns on AED trials.
Needs Assessment
In the past decade and a half, there have been many new antiepileptic drugs approved for use by patients with epilepsy. These new drugs have provided major advantages to patients; yet, despite the tremendous advances, the problem of epilepsy is far from solved. Even though each new AED produced statistically significant improvement when added on to background drugs in patients with refractory epilepsy, the number of patients who become seizure free is small, and even fewer remain so over the long term (French, 2004). In addition, many patients are still plagued by drug-related side effects. Finally, 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 almost two decades a group of individuals have been meeting on a biannual basis to discuss ways in which the process of bringing new 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. The proceedings have led to two books and one monograph (French, 1993, 1998, Epilepsy Research 2006).
