April 27-29, 2011
Turnberry Isle Resort
Aventura (North Miami Beach), Florida

Sponsored by The Epilepsy Study Consortium in collaboration with the University of Pennsylvania Epilepsy Center and the Epilepsy Therapy Project.

Program Agenda

Day 1 | Day 2 | Day 3 (Day 3 is Pipeline Day)

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.

REGISTRATION FEE
Prior to February 1, 2011: $500
After February 1, 2011: $550
Clinical Coordinators and Nurses
Prior to February 1, 2011: $350
After February 1, 2011: $400
On Site Registration for All: $600

Registration and hotel information can be found on the AED Trials XI Website

Draft Agenda

Day 1 - Wednesday, April 27, 2011

8:00	Introduction and Welcome	Jacqueline French, MD
Session I: Preclinical drug development and early clinical development Moderator: Thomas Sutula, MD, PhD
8:15-8:35	Animal models of drug resistant epilepsy redux	Steve White, PhD
8:35-8:55	Modeling neocortical epilepsy	Peter Crino, MD, PhD
8:55-9:15	Canine Epilepsy: A translational platform	Ilo Leppik, MD
9:15-9:25	Recording and processing continuous intracranial EEG in ambulatory epilepsy dogs	Brian Litt, MD
9:25-9:45	Antiepileptogenesis models - summary of NIH workshop	Frances Jensen, MD
9:45-10:15	The good, the bad, and the ugly of trials to prevent epilepsy	Marc Dichter, MD, PhD
10:15-10:35	Disease modification in epilepsy	Asla Pitkänen, PhD
10:35-10:55	Coffee Break
10:55-11:15	Regulatory perspective on antiepileptogenesis trials	Russell Katz, MD
11:15-11:35	Discussion
Session II: Genetics Moderator: Marc Dichter, MD, PhD
11:35-11:55	Using genetics to develop targeted therapies for epilepsy	Jeffrey Noebels, MD, PhD
11:55-12:15	Are we ready for individualized therapies?	Tracy Glauser, MD
12:15-12:30	Pro/Con: Epilepsy prevention trials in PGE – the time is right	Drs. Noebels, Dichter, and Glauser
12:30-12:40	Discussion
12:40-2:00	Lunch
Session III: Pediatrics Moderator: Tracy Glauser, MD
2:00-2:20	Pediatric requirements from FDA	Russell Katz, MD
2:20-2:40	Pediatric recruitment - are the rules changing?	Alexis Arzimanoglou, MD
2:40-3:00	Development of AEDs for the immature brain	Frances Jensen, MD
3:00-3:30	Discussion
3:30-3:50	Coffee Break
Session IV: Monotherapy revisited Moderator: Anthony Marson, MD
3:50-4:10	Historical control studies for monotherapy: Now we have results: what do they mean?	Michel Baulac, MD
4:10-4:30	Active control trials: Now we have more results: What do they mean?	Martin Brodie, MD
4:30-5:00	Discussion
5:30-7:30	Cocktail Reception	Magnolia Courtyard, Turnberry Isle Resort

Day 2 - Thursday, April 28, 2011

Session V: Generics Moderator: Scott Mintzer, MD
8:25-8:40	Generics in epilpesy: time to be concerned	Michael Privitera, MD
8:40-8:55	Generics in epilepsy: time to be reassured	Meir Bialer, PhD, MBA
8:55-9:10	Debate: Generics: acceptable or unacceptable	Drs. Meir Bialer and Michael Privitera
9:10-9:30	Discussion
Session VI: Trial Methodology Moderator: Jacqueline French, MD
9:30-9:50	Novel Adjunctive Trial designs-It's time!	Emilia Bagiella, PhD
9:50-10:10	Placebo effect in epilepsy, and who can you still treat?	Philippe Ryvlin, MD, PhD
10:10-10:30	Status Epilepticus	Simon Shorvon, MD
10:30-10:50	Adaptive designs for dose-finding: Background and Case Study	Michael Krams, MD and Gerald Novak, MD
10:50-11:10	Coffee Break
11:10-11:30	Discussion
Session VII: Why are epilepsy trials failing? Moderator: Gregory Bergey, MD
11:30-11:50	Carisbamate: Review of its development as an adjunctive treatment of partial onset seizures	Gerald Novak, MD
11:50-12:10	Global site selection: How is it impacting trials	Bernd Schmidt, MD, PhD
12:10-12:30	The Placebo effect in epilepsy trials: Where does it come from?	Emilio Perucca, MD, PhD
12:30-12:40	Perampanel Phase 3: Regional Variations in Placebo Rate	David Squillacote, MD
12:40-2:00	Lunch
2:00-2:20	Assessment of patients for suitability for enrollment: Who, when, how and will it matter?	Jacqueline French, MD
2:20-2:40	Why are epilepsy trials failing?	Roundtable: Drs. Novak, Schmidt, Perucca and French
2:40-3:10	Discussion
Session VIII: Drugs and Devices Moderator: Joyce Cramer
3:10-3:30	Device Trial Update	Robert Fisher, MD, PhD
3:30-3:50	Alternative therapies beyond brain stimulation: cooling, direct drug application, etc	Steven Schachter, MD
3:50-4:00	An overview of wearable seizure detectors	Ruben Kuzniecky, MD
4:00-4:10	Vagus nerve stimulation: new developments	Shaun Comfort, MD
4:10-4:20	Subdural hybrid neural prosthesis	Ruben Kuzniecky, MD
4:20-4:30	Seizure Advisory System	Brian Litt, MD
4:30-4:40	Trigeminal Stimulation	Christopher DeGiorgio,MD
4:40-5:00	FDA perspective	Ann Costello, PhD, DMD
5:00-5:45	Panel: Investor and Business Development Views of Devices & Hybrids	Frank Fischer, Neuropace Daniel Le Maitre, White Pine Medical Sherrie Perkins, Cyberonics Roger Quy, Technology Partners Nicole Vitullo, Domain

Day 3 - Friday, April 29, 2011: PIPELINE DAY

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Session IX: Regulatory Issues Moderator: Roger Porter, MD
8:30-8:50	Measuring suicidality in AED trials		Andres Kanner, MD
8:50-9:10	EMA Update		Michel Baulac, MD
9:10-9:30	FDA Update		Russell Katz, MD
9:30-10:00	Discussion
10:00-10:20	Break
Session X: Phase II and Phase III Moderator: Harvey Kupferberg, PhD
10:20	Brivaracetam	UCB Pharma, Inc.	Zhihong Sarah Lu, MD, PhD
10:30	Eslicarbazepine	Sunovion Pharmaceuticals, Inc.	David Blum, MD
10:40	Perampanel Phase 3 Update	Eisai, Inc.	David Squillacote, MD
10:50	Extended Release Topiramate	Upsher-Smith Laboratories, Inc.	Meir Bialer, PhD
11:00	Clobazam	Lundbeck Pharmaceuticals	Randy Owen, MD
11:10	Vigabatrin	Lundbeck Pharmaceuticals	David Wesche, MD, PhD
11:20	Ganaxolone	Marinus Pharmaceuticals	Gail Farfel, PhD
11:30	ICA-105665	Icagen, Inc.	Greg Rigdon, PhD
11:40	Effect of single oral doses of BGG492 in the photosensitivity model	Novartis International AG	Dorothee Kasteleijn-Nolst Trenite, MD, PhD
11:50	Discussion
12:00	Lunch
1:30-2:15	Panel: The Investment/business development view of the value of epilepsy indications: Do preclinical models and mechanisms of action matter?	Stephen Collins, MD, PhD, Neurotherapeutics, Inc. Brandon Kashfian, Lundbeck Business Development Nancy Santilli, MSN, Endo Pharmaceuticals Mark Simon, Biotech Investor Edward Teitel, MD, JD, MBA, Biotech Entrepreneur
Session XI: Early Stage Pipeline Moderator: Joyce Cramer
2:15	Valproate Analogs	The Hebrew University of Jerusalem	Meir Bialer, PhD
2:25	2DG	NeuroGenomeX	Thomas Sutula, MD, PhD
2:35	Pulmonary propofol	Medkura, Inc.	Michael Rogawski, MD, PhD
2:40	NTP-2014	Neuro Therapeutics Pharma, Inc.	Stephen Collins, MD, PhD
2:55	Vigabatrin Analog, CPP-115	Catalyst Pharmaceuticals Partners, Inc.	Steven Miller, PhD
3:05	NPY gene transfer	Neurologix, Inc.	Matthew During, MD, DSc
3:15	Tonabersat	Upsher-Smith Laboratories, Inc.	TBD
3:25	YKP-3089	SK Life Science, Inc.	S. James Lee, PhD
3:35	IV Topiramate		Joyce Cramer
3:45	Sigma-1 Agonists	Concert Pharmaceuticals, Inc. SynapCell	Philip Graham, PhD
3:55	Preclinical models	SynapCell	Corinne Roucard, PhD
4:05	Concluding Remarks		Jacqueline French, MD
4:30-6:00	Networking & Cocktail Reception	Magnolia Courtyard	Turnberry Isle Resort

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Antiepileptic Drug Trials XI Conference / April 2011