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

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

Program Goal

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.
Business Development and Investment professionals receive complimentary registration for the Pipeline Day, Friday, April 17th

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 Moderator: Marc Dichter, MD, PhD
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 Moderator: Bernd Schmidt, MD, PhD
10:55-11:15	Photosensitivity trials: Should they drive go-no-go decisions?	Dorothee Kasteleijn, MD, PhD
11:15-11:35	Time to “nth” seizure	Jacqueline French, MD
11:35-11:45	Modeling and Simulation: Fundamental concepts	Ronald Reed, PharmD
11:45-12:05	Short proof of principle for intractable epilepsy	Birol Emir, PhD
12:05-12:35	Discussion
12:35-2:00	Lunch
Session III: Monotherapy revisited Moderator: Jacqueline French, MD
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 Moderator: John Pollard, MD
4:10-4:30	Device trials update	Gregory Worrell, MD, PhD
4:30-4:50	Alternative therapies beyond brain stimulation: cooling, direct drug application, etc.	Steven Rothman, 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 Moderator: Emilio Perucca, MD, PhD
	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 Moderator: Gregory Krauss, MD
9:50-10:10	Generics and brand: What goes into making a tablet, and is it important?	Allan Kaplan PhD
10:10-10:30	Generics: Is there a way to compare them to brand drugs?	Michael Privitera, MD
10:30-10:50	Coffee Break
10:50-11:10	How will generics change the marketplace?	Roundtable
11:10-11:30	Ideal trial design for acute seizure therapies: Intranasal benzodiazepines, etc.	Gregory Krauss, MD
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 Moderator: Martin Brodie, MD
2:00-2:20	Recruitment in the US: how do we do better?	Jacqueline French, MD
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?	David Squillacote, MD
3:00-3:30	Roundtable and Discussion: Jacqueline French, Bernd Schmidt and David Squillacote
3:30-3:50	Coffee Break
Session VIII: Regulatory Issues Moderator: Jacqueline French
3:50-4:10	Suicidality and AEDs	Andres Kanner, MD
4:10-4:20	Centralized Ratings in Clinical Trials: Application in Epilepsy	Earl Giller, MD, PhD
4:20-4:40	EMEA Update	Michel Baulac, MD
4:40-5:00	FDA Update	Russell Katz, MD
5:00-5:30	Discussion

Day 3 - Friday, April 17, 2009: PIPELINE DAY

Download Pipeline Schedule (PDF)

Later Stage Pipeline		Moderator: Harvey Kupferberg, PhD
Phase III
8:15-8:30	Responsive Neurostimulation System	Neuropace	Martha Morrell, MD
8:30-8:45	Brivaracetam	UCB Pharma	Philipp von Rosenstiel, MD
8:45-9:00	Carisbamate	Johnson and Johnson PRD	Gerald Novak, MD
9:00-9:15	Eslicarbazepine	Sepracor	Mark Versavel, MD
9:15-9:30	Intranasal Midazolam	Intranasal Inc	Jeff Edelson, MD
9:30-9:45	Modif Release Oxcarbazepine	Supernus	Paolo Baroldi, MD, PhD
9:45-10:00	Retigabine	Valeant Pharmaceuticals	Hank Mansbach, MD
10:00-10:20	BREAK
10:20-10:35	Vigabatrin	Ovation Pharmaceuticals	Stephen Sagar, MD
10:35-10:50	Clobazam	Ovation Pharmaceuticals	Mark Weinberg, MD
Phase II
10:50-11:05	Ganaxalone	Marinus Pharmaceuticals	Julia Tsai, PhD
11:05-11:20	ICA-105665	Icagen	Greg Rigdon, PhD
11:20-11:35	Perampanel (E2007)	Eisai Medical Research, Inc.	David Squillacote, MD
11:35-11:50	T2000: Non sedating barbiturates	Taro	Daniel Moros, MD
11:55-12:10	YKP3089	SK Life Sciences	S. James Lee, PhD
12:10-12:25	VPA: 2nd Generation Drugs	Hebrew Univ. of Jerusalem	Meir Bialer, PhD, MBA
12:25-1:25	Lunch

Early Stage Pipeline		Moderator: Joyce Cramer, Epilepsy Therapy Project
1:25-2:25	Panel:
Public, Private Equity & Industry Perspectives on Financing New Therapies in Epilepsy & CNS: Finding the Money in 2009
	Chair, Frank Fisher: Neuropace Nicole Vitullo: Biotech VC/crossover, Domain Associates Omar Amirana: Device-focus VC, Oxford Bioscience Partners Tim Coan: Institutional investor, Deerfield Management Co Markus Goebel: Pharma VC, Novartis Ventures Nancy Santilli: Commercial development, Endo Pharmaceuticals Michael King: Healthcare banking, Rodman & Renshaw
2:25-2:40	Break
Phase 1
2:40	Huperzine	Harvard	Steven Schachter, MD
2:50	NPY gene transfer	Neurologix	Christine Sapan, Matt During MD
3:00	Neural Plasticity: 2DG	NeuroGenomeX	Thomas Sutula, MD,PhD
3:10	Drug Delivery Pump	Sierra Neuropharmaceuticals	Daniel Abrams, MD
3:20	Drug Delivery System	New York University	Orrin Devinsky, MD
3:30	Seizure detection/prevention	NeuroVista	John Harris, PhD
Pre-Clinical
3:40	New molecular entity	NeuroTherapeutics Pharma	Stephen Collins MD,PhD
3:50	Galanin NTX 5055	Neuroadjuvants	Steve White, PhD
4:00	AMP-X-001, 026	AurimMed Pharma	Manny Balandrin, PhD
4:10	Magnetonanoparticles for MRI	Epinano	Massoud Akhtari, PhD
4:20	Intranasal lorazepam NanoCrystal	Neurelis	Craig Chambliss, PhD
4:30	Convection-enhanced toxin delivery	MedGenesis Therapeutix	Michael Rogawski MD,PhD
4:40	GAERS, MTLE mouse models	Synapcell	Corrine Roucard PhD
Summary
4:50	The role of Epilepsy Therapy Project in supporting the future		Warren Lammert

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