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Day 1 – Wednesday, March 21, 2007
Development of new drugs to prevent epilepsy and treat epilepsy, and how to test drugs and devices |
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Introduction
Jacqueline A. French, MD |
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Session I: Preclinical-development of new AEDs and new drugs to prevent epilepsy
Moderator – Marc A. Dichter, MD, PhD
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New Animal models for refractory epilepsy: Are they ready for prime time?
H. Steve White PhD |
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Biomarkers in epilepetogenesis:
Results from NIH consensus conference
Marc A. Dichter, MD, PhD |
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Human Dose prediction from animal studies
Meir Bialer, PhD, MBA |
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Why/When do epilepsy drugs fail during development?
Roger J. Porter, MD, LLC |
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Panel Discussion |
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Session II: Proof of Principle
Moderator – Jacqueline A. French, MD
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Proof of Principle I: What does activity in photosensitivity
mean?
Dorothee Kasteleijn-Nolst Trenite, MD, PhD, MPH |
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Proof of Principle II: POP for eleptogenesis
Susan T. Herman, MD |
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Session III: Monotherapy
Moderator – Bernd Schmidt, MD, PhD
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Options for monotherapy approval: US
Jacqueline A. French, MD |
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Options for monotherapy approval: Europe
Michel Baulac, MD |
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Active control trials: Details do matter!
Martin J. Brodie, MD |
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Panel Discussion |
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Session IV: Device Trials
Moderator – Brian Litt, MD
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Device Trials: Investigator perspective
Robert S. Fisher, MD, PhD |
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Panel Discussion |
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Day 2 – Thursday, March 22, 2007
Special Populations, formulations, and secondary endpoints
Session V: Special Populations
Moderator – John Pollard, MD
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Pediatrics
Placebos and equipoise in new-onset pediatric epilepsy:
Implications for monotherapy trials
Dennis Dlugos, MD |
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Neonatal/infant trials
John M. Pellock, MD |
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Pediatric exclusivity
Russell Katz, MD |
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| Elderly |
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Panel Discussion |
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Women’s Issues |
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Pregnancy registries: What do they teach us?
Page B. Pennell, MD |
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AED interactions with oral contraceptive steroids and
Hormones: How and when to test
Emilio Perucca, MD, PhD |
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Results of the NEADs study
Kimford Meador, MD |
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Panel Discussion |
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Session VI: Formulations |
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Long-acting formulations: What is the goal?
James Cloyd, PharmD |
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Lessons learned in the development of extended-release
AEDs: An industry perspective
Ronald c. Reed, BS, RPh, PharmD |
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Alternate routes for AED administration
James Cloyd, PharmD |
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FDA Perspective
Russell Katz, MD |
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Panel Discussion |
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Session VII: Secondary Endpoints
Moderator – Joyce Cramer
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Assesment of the positive psychiatric impacts of AEDS
Andres M. Kanner, MD |
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Fixed vs. flexible dosing
Vinder Nohria, MD, PhD |
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FDA Update
Russell Katz, MD |
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Panel Discussion |
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Day 3 – Friday, March 23, 2007
Drugs in the Pipeline and the CNS Epilepsy Company Forum
Session VIII: Drugs in the Pipeline
Moderator – Harvey Kupferberg, PhD
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Eslicarbazepine
Antonio Gil-Nagel Rein, MD |
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Huperzine
Steve Schachter, MD |
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Selecting novel AEDs among SV2A ligands
Hentrik Klitgaard, PhD |
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T2000: Uses of Non-sedating barbiturates
Daniel Moros, MD |
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Valproate Derivitives
Meir Bialer, PhD, MBA |
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Session IX
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Panel Discussion: Partnership and Financing Opportunities in Epilepsy and CNS:
Corporate and VC Perspectives
Nicola Campbell, PhD
Christine De Los Reyes, PharmD
Jason Levin
Richard Masterson
Garry Menzel, PhD
Dan O’Connell
Lauren Silverman, PhD
Thomas Woiwode, PhD |
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The Epilepsy Study Consortium
Jacqueline French, MD |
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Panel Discussion: The Role of the CRO in the Clinical Development of Epilepsy/CNS Drugs
Moderator – Stephen Collins, PhD
Tomislav Babic, MD, PhD
Michael Cioffi
Wendy L. Martin, MD
Moderator – Warren Lammert |
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Epilepsy and CNS Dynamics
Zach Lynch |
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Neuropace, Inc
Frank Fischer |
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NeuroAdjuvants: Galanin
H. Steve White, PhD |
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In Vivo Anticonvulsant HTS
Leo Liu, MD |
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Intranasal
Franz F. Hefti, PhD |
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YKP3089 and SK
S. James Lee, PhD |
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