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Antiepileptic Drug Trials X Conference / April 2009
April 15-17, 2009
Biltmore Hotel
1200 Anastasia Avenue
Coral Gables, Florida 33134
USA
Phone: 800-915-1926
305-445-8066 Ext. 4306
Fax: 305-913-3158
Sponsored by the New York University Medical Center and The Epilepsy Study Consortium as well as the University of Pennsylvania Epilepsy Center and The Epilepsy Therapy Project.
Program Agenda
Program Goals
This is the tenth conference focusing on issues related to antiepileptic drug (AED) development from preclinical discoveries through clinical evaluations. In 2008 as many antiepileptic drugs are in the pipeline as at any time in the past. There is a 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.
- goalDiscuss the potential for clinical trials of epilepsy prevention (antiepileptogenesis).
- Discuss the advantages and disadvantages of monotherapy trial designs and possible alternatives.
- Discuss options for novel phase II and III trial designs.
- Discuss with FDA representatives new objectives and legislation that have an impact on AED development.
- Explore methods for obtaining proof of principle for new AEDs, including time to Nth seizure.
- Discuss novel methods of drug delivery.
- Discuss the impact of generic AEDs on clinical trials in epilepsy, and on the epilepsy marketplace.
- Discuss trial designs for devices.
Registration
The registration fee for AED Trials X is:
prior to 2/1/09 = $500
after 2/1/09 = $550
On site = $600
A reduced fee of $350 is available for clinical coordinators and nurses.
To register, please send a check in the appropriate amount, plus your name, affiliation, address, phone and mail to:
Mary Ann Brodie
Symposium Administrator
Epilepsy Study Consortium
P.O. Box 596
Woodbury, New Jersey 08096
Please make checks payable to Epilepsy Study Consortium
Download the registration form here.
Additional information available on the AED Trials X website.
Day 1 - Wednesday, April 15, 2009
| 8:00 | Introduction and Welcome | Jacqueline French, MD |
| Session I: Preclinical drug development and early clinical development | ||
| 8:15-8:35 | Animal models of drug resistant epilepsy pros and cons | Helen Scharfman, PhD |
| 8:35-8:55 | Generalized epilepsy rat models | Henrik Klitgaard, PhD |
| 8:55-9:15 | Preclinical development of synergistic AED regimens | Steve White, PhD |
| 9:15-9:35 | Discussion | |
| 9:35-9:55 | New mechanisms vs. old models: Is it time for out of the box thinking? | Michael Rogawski, MD, PhD |
| 9:55-10:15 | Blocking epileptogenesis – from animal models to clinical trials | Marc Dichter, MD, PhD |
| 10:15-10:35 | Discussion | |
| 10:35-10:55 | Coffee Break | |
| Session II: Proof of principle trials | ||
| 10:55-11:15 | Photosensitivity trials: Should they drive go-no-go decisions? | |
| 11:15-11:35 | Time to “nth” seizure | Jacqueline French, MD |
| 11:35-11:55 | Short proof of principle for intractable epilepsy | |
| 11:55-12:15 | Modeling better trials using old data | Ronald Reed, PharmD |
| 12:45-2:00 | Lunch | |
| Session III: Monotherapy revisited | ||
| 2:00-2:20 | Historical control studies for monotherapy: Recruitment and methodology | Philipp vonRosenstiel, MD |
| 2:20-2:40 | Active control trials-optimal design | Michel Baulac, MD |
| 2:40-3:00 | Monotherapy: The European perspective | Martin Brodie, MD |
| 3:00-3:20 | The case for combined monotherapy/add-on indication | Joyce Cramer |
| 3:20-3:50 | Do we need a separate monotherapy indication? | Roundtable |
| Philipp von Rosenstiel, Michel Baulac, Marc Dichter, Joyce Cramer and Russell Katz | ||
| 3:50-4:10 | Coffee Break | |
| Session IV: Device trials | ||
| 4:10-4:30 | Device trials update | |
| 4:30-4:50 | Alternative therapies beyond brain stimulation: cooling, direct drug application, etc. | Ruben Kuzniecky, MD |
| 4:50-5:10 | FDA perspective | Ann Costello, PhD, DMD |
| 5:10-5:30 | Discussion | |
Day 2 - Thursday, April 16, 2009
| Session V: Special populations | ||
| Pediatrics | ||
| 8:00-8:20 | What pediatric syndromes should we study? | Dennis Dlugos, MD |
| 8:20-8:40 | Orphan Indications –are they worth it? | Stephen Collins, MD, PhD |
| Other | ||
| 8:40-9:00 | What is the relation between "mood stabilization" and antiepileptic drugs, especially in the aging population? | Ilo Leppik, MD |
| 9:00-9:20 | Who can you still treat with placebo; under what circumstances, and for how long? | Emilio Perucca, MD, PhD |
| 9:20-9:50 | Discussion | |
| Session VI: Formulations and delivery systems | ||
| 9:50-10:10 | Generics: Is there a way to compare them to brand drugs? | Michael Privitera, MD |
| 10:10-10:30 | How will generics change the marketplace? | Roundtable |
| 10:30-10:50 | Coffee Break | |
| 10:50-11:10 | Understanding intranasal formulations | James Cloyd, PharmD |
| 11:10-11:30 | Ideal trial design for acute seizure therapies: Intranasal benzodiazepines, etc. | |
| 11:30-11:50 | Sustained release formulations; when they are useful and when they are not. | Meir Bialer, PhD, MBA |
| 11:50-12:10 | Sustained release and acute therapies: Regulatory issues | Russell Katz, MD |
| 12:10-12:40 | Discussion | |
| 12:40-2:00 | Lunch | |
| Session VII: Recruitment | ||
| 2:00-2:20 | Recruitment in the US: how do we do better? | |
| 2:20-2:40 | Recruitment abroad: Site selection | Bernd Schmidt, MD, PhD |
| 2:40-3:00 | How do sites outside the US differ from US sites, and does it matter? | |
| 3:00-3:30 | Discussion | |
| 3:30-3:50 | Coffee Break | |
| Session VIII: Regulatory Issues | ||
| 3:50-4:10 | Suicidality and AEDs | Andres Kanner, MD |
| 4:10-4:30 | EMEA Update | Michel Baulac, MD |
| 4:30-4:50 | FDA Update | Russell Katz, MD |
| 4:50-5:30 | Discussion | |
Day 3 - Friday, April 17, 2009
Session IX:
Review of drugs in the pipeline – early and late stage development
Session X:
CNS/Epilepsy emerging company forum – partnership and financing opportunities Pathways to commercialization