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Antiepileptic Drug Trials IX Webcast - March 2007

The ninth biannual conference sponsored by the University of Pennsylvania Medical Center and the Epilepsy Therapy Project was held in Sunny Isles, Florida, March 21 – 23, 2007. The focus was on issues related to antiepileptic drug (AED) development from preclinical discoveries through clinical evaluations. In 2007, as many antiepileptic drugs are in the pipeline as at any time in the past. With nine new AEDs already approved, there is a unique opportunity to learn from the past as we move into the future. The 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.

  • Day One – Development of new drugs to prevent epilepsy and treat epilepsy, and how to test drugs and devices
  • Day Two – Special Populations, formulations, and secondary endpoints
  • Day Three – Drugs in the Pipeline and the CNS Epilepsy Company Forum

Day 1 – Wednesday, March 21, 2007

Development of new drugs to prevent epilepsy and treat epilepsy, and how to test drugs and devices

  Introduction
Jacqueline A. French, MD
  go

Session I: Preclinical-development of new AEDs and new drugs to prevent epilepsy

Moderator – Marc A. Dichter, MD, PhD

  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
 

  Human Dose prediction from animal studies
Meir Bialer, PhD, MBA
 

  Why/When do epilepsy drugs fail during development?
Roger J. Porter, MD, LLC
 

  Panel Discussion   go

Session II: Proof of Principle

Moderator – Jacqueline A. French, MD

  Proof of Principle I: What does activity in photosensitivity mean?
Dorothee Kasteleijn-Nolst Trenite, MD, PhD, MPH
 

  Proof of Principle II: POP for eleptogenesis
Susan T. Herman, MD
 

Session III: Monotherapy

Moderator – Bernd Schmidt, MD, PhD

  Options for monotherapy approval: US
Jacqueline A. French, MD
 

  Options for monotherapy approval: Europe
Michel Baulac, MD
 

  Active control trials: Details do matter!
Martin J. Brodie, MD
 

  Panel Discussion   go

Session IV: Device Trials

Moderator – Brian Litt, MD

  Device Trials: Investigator perspective
Robert S. Fisher, MD, PhD
 

  Panel Discussion  

Day 2 – Thursday, March 22, 2007

Special Populations, formulations, and secondary endpoints

Session V: Special Populations

Moderator – John Pollard, MD

  Pediatrics Placebos and equipoise in new-onset pediatric epilepsy: Implications for monotherapy trials
Dennis Dlugos, MD
 

  Neonatal/infant trials
John M. Pellock, MD
 

  Pediatric exclusivity
Russell Katz, MD
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Elderly
  Panel Discussion   go

Women’s Issues
  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   go

Session VI: Formulations


  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   go

Session VII: Secondary Endpoints

Moderator – Joyce Cramer

  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   go

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

  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

  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
  go

  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
  go

  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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