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Wed, 2/22/2012
Take control of your epilepsy and seizures. Seizure management has never been easier.
TAKE CONTROL TODAYAntiepileptic Drug Trials XI Conference Webcasts
This is the eleventh conference focusing on issues related to antiepileptic drug (AED) development from preclinical discoveries through clinical evaluations. This symposium brought together representatives from academia, industry, the NIH, and the FDA to review what has been learned and to discuss strategies to enhance AED development.
Sponsored by The Epilepsy Study Consortium in collaboration with the University of Pennsylvania Epilepsy Center and the Epilepsy Therapy Project.
- Day One – Preclinical drug development and early clinical development, genetics, pediatrics, and monotherapy
- Day Two – Generics, trial methodology, why are trials failing, and drugs and devices
- Day Three – Regulatory issues, Stages II and III, and early stage pipeline
Day 1 - Wednesday, April 27, 2011
Introduction & Welcome
| Jacqueline French, MD |
Preclinical Drug Development and Early Clinical Development
Moderator: Thomas Sutula, MD, PhD
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Animal models of drug resistant epilepsy redux H. Steve White, PhD, University of Utah Canine Epilepsy: A translational platform Ilo Leppik, MD, University of Minnesota Recording and processing continuous intracranial EEG in ambulatory epilepsy dogs Brian Litt, MD, University of Pennsylvania Antiepileptogenesis models - summary of NIH workshop Frances Jensen, MD, Children's Hospital Boston The good, the bad, and the ugly of trials to prevent epilepsy Marc Dichter, MD, PhD Disease modification in epilepsy Asla Pitkänen, PhD, University of Eastern Finland Regulatory perspective on antiepileptogenesis trials Russell Katz, MD Discussion Presentation Not Yet Available |
Genetics
Moderator: Marc Dichter, MD, PhD
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Using genetics to develop targeted therapies for epilepsy Jeffrey Noebels, MD, PhD Presentation Not Available Are we ready for individualized therapies? Tracy Glauser, MD, Cincinnati Children's Hospital Medical Center Pro/Con: Epilepsy prevention trials in PGE – the time is right Drs. Noebels, Dichter, and Glauser Presentation Not Available Discussion Presentation Not Yet Available |
Pediatrics
Moderator: Tracy Glauser, MD
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Pediatric requirements from FDA Russell Katz, MD Pediatric recruitment - are the rules changing? Alexis Arzimanoglou, MD, Lyon Neuroscience Research Center Development of AEDs for the immature brain Frances Jensen, MD Presentation Not Available Discussion Presentation Not Yet Available |
Monotherapy Revisited
Moderator: Anthony Marson, MD
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Historical control studies for monotherapy: Now we have results: what do they mean? Michel Baulac, MD, Paris Institute of Translational Neurosciences Active control trials: Now we have more results: What do they mean? Martin Brodie, MD Presentation Not Available Discussion Presentation Not Yet Available |
Day 2 - Thursday, April 28, 2011
Generics
Moderator: Scott Mintzer, MD
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Generics in epilpesy: time to be concerned Michael Privitera, MD Generics in epilepsy: time to be reassured Meir Bialer, PhD, MBA Presentation Not Available Debate: Generics: acceptable or unacceptable Drs. Meir Bialer and Michael Privitera Presentation Not Available Discussion Presentation Not Yet Available |
Trial Methodology
Moderator: Jacqueline French, MD
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Novel Adjunctive Trial designs-It's time! Emilia Bagiella, PhD, Columbia University Placebo effect in epilepsy, and who can you still treat? Philippe Ryvlin, MD, PhD Status Epilepticus Simon Shorvon, MD Adaptive designs for dose-finding: Background and Case Study Michael Krams, MD and Gerald Novak, MD Presentation Not Available Discussion Presentation Not Yet Available |
Why Are Epilepsy Trials Failing?
Moderator: Gregory Bergey, MD
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Carisbamate: Review of its development as an adjunctive treatment of partial onset seizures Gerald Novak, MD, Johnson & Johnson Research and Development Global site selection: How is it impacting trials Bernd Schmidt, MD, PhD Presentation Not Available The Placebo effect in epilepsy trials: Where does it come from? Emilio Perucca, MD, PhD, University of Pavia Perampanel Phase 3: Regional Variations in Placebo Rate David Squillacote, MD Presentation Not Available Assessment of patients for suitability for enrollment: Who, when, how and will it matter? Jacqueline French, MD, New York University Roundtable: Why are epilepsy trials failing? Drs. Novak, Schmidt, Perucca and French Presentation Not Available Discussion Presentation Not Yet Available |
Drugs and Devices
Moderator: Joyce Cramer
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Device Trial Update Robert Fisher, MD, PhD Alternative therapies beyond brain stimulation: cooling, direct drug application, etc Steven Schachter, MD An overview of wearable seizure detectors Ruben Kuzniecky, MD, New York University Vagus nerve stimulation: new developments Shaun Comfort, MD
Session Webcast Subdural hybrid neural prosthesis Ruben Kuzniecky, MD, New York University Seizure Advisory System John Harris, MD, University of Pennsylvania
View Abstract Trigeminal Stimulation Christopher DeGiorgio, MD, UCLA
View Abstract Panel: Investor and Business Development Views of Devices & Hybrids Frank Fischer, Neuropace Daniel Le Maitre, White Pine Medical Sherrie Perkins, Cyberonics Business Development Roger Quy, Technology Partners Nicole Vitullo, Domain Associates, LLC |
Day 3 - Friday, April 29, 2011: Pipeline Day
Regulatory Issues
Moderator: Roger Porter, MD
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Measuring suicidality in AED trials Andres Kanner, MD, Rush Medical College EMA Update Michel Baulac, MD Presentation Not Available FDA Update Russell Katz, MD Discussion Presentation Not Yet Available |
Phase II and Phase III
Moderator: Harvey Kupferberg, PhD
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Brivaracetam O'Neill D'Cruz, MD, MBA, UCB Pharma, Inc.
Session Webcast Eslicarbazepine David Blum, MD, Sunovion Pharmaceuticals, Inc.
Session Webcast Perampanel Phase 3 Update David Squillacote, MD, Eisai, Inc. Presentation Not Available Extended Release Topiramate Meir Bialer, PhD, Upsher-Smith Laboratories, Inc. Presentation Not Available Clobazam Randy Owen, MD, Lundbeck Pharmaceuticals
Session Webcast Vigabatrin David Wesche, MD, PhD, Lundbeck Pharmaceuticals
View Abstract Ganaxolone Gail Farfel, PhD, Marinus Pharmaceuticals
Session Webcast ICA-105665 Greg Rigdon, PhD, Icagen, Inc.
View Abstract Effect of single oral doses of BGG492 in the photosensitivity model Dorothee Kasteleijn-Nolst Trenite, MD, PhD, Novartis International AG
View Abstract Discussion Presentation Not Yet Available 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 Presentation Not Available |
Early Stage Pipeline
Moderator: Joyce Cramer
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Valproate Analogs Meir Bialer, PhD , The Hebrew University of Jerusalem Presentation Not Available 2DG Thomas Sutula, MD, PhD, NeuroGenomeX
Session Webcast Pulmonary propofol Michael Rogawski, MD, PhD, Medkura, Inc.
View Abstract NTP-2014 Stephen Collins, MD, PhD, Neuro Therapeutics Pharma, Inc.
Session Webcast Vigabatrin Analog, CPP-115 Steven Miller, PhD, Catalyst Pharmaceuticals Partners, Inc.
Session Webcast NPY gene transfer Matthew During, MD, DSc , Neurologix, Inc. Tonabersat H. Steve White, PhD, University of Utah, Upsher-Smith Laboratories, Inc.
View Abstract
YKP-3089
Session Webcast IV Topiramate Joyce Cramer
Session Webcast Sigma-1 Agonists Philip Graham, PhD, Concert Pharmaceuticals, Inc. SynapCell
Session Webcast VX765 James Paskavitz, MD, Vertex Pharmaceuticals, Inc.
Session Webcast SPN538, a topiramate extended release formulation: conversion study in epileptic patients Paolo Baroldi, MD, PhD, Supernus Pharmaceuticals Presentation Not Available Preclinical models Corinne Roucard, PhD, SynapCell
Session Webcast |
Concluding Remarks
| Jacqueline French, MD |