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Home › Epilepsy Therapy Project › Conferences and Webcasts

Antiepileptic Drug Trials IX / March 2007

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Program Agenda

Day 1 | Day 2 | Day 3

March 21-23, 2007

Sponsored by the University of Pennsylvania Epilepsy Center and the Epilepsy Therapy Project

 

Program Goals

This is the ninth biannual conference focusing on issues related to antiepileptic drug (AED) development from preclinical discoveries through clinical evaluations. In 2005 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. 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 the advantages and disadvantages of monotherapy trial designs and possible alternatives.
  • Explore optimal trial designs for specific well-defined populations within the epilepsy community, including the elderly, infants and children.
  • 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 IX is $450.00 prior to 2/1/07, and $500.00 after 2/1/07. On site registration is $550.00
A reduced fee of $300 is available for clinical coordinators and nurses.

To print the registration form, click here

Organizing Committee

  • Jacqueline French, MD (Symposium Director)
  • Marc A. Dichter, MD, PhD
  • Russell Katz, MD
  • Warren Lammert
  • Mary Ann Brodie (Symposium Administrator)

For more information, contact:

David Fischer - Epilepsy Therapy Project

Kim Macher - Epilepsy Therapy Project

Mary Ann Brodie - University of Pennsylvania
Symposium Administrator

www.aedtrials.com


Day 1 - Wednesday March 21

8:15 Introduction Jacqueline A. French, MD


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

Moderator: Marc A. Dichter, MD, PhD
8:30-8:50 New Animal models for refractory epilepsy: Are they ready for prime time?
 H. Steve White, PhD
8:50-9:10 Models of epileptogenesis available for drug screening Asla Pitkanen, MD
9:10-9:30 Biomarkers in epileptogenesis:
Results from NIH consensus conference 		Marc A. Dichter, MD, PhD
9:30-9:50 Human dose prediction from animal studies Meir Bialer, PhD, MBA
9:50-10:10 Why/when do epilepsy drugs fail during development? Roger J. Porter, MD, LLC
10:10-10:40 Discussion  
10:40-11:00 Coffee Break  


Session II: Proof of Principle
Moderator Jacqueline A. French, MD
11:00-11:20 Proof of Principle I: Relevance of the photosensitivity model Dorothee Kasteleijn-Nolst Trenite, MD, PhD, MPH
11:20-11:40 Proof of Principle II: POP for epileptogenesis Susan T. Herman, MD
11:40-12:00 Proof of Principle III: Time to Nth seizure Jacqueline A. French, MD
12:00-12:30 Discussion  
12:30-2:00 Lunch  


Session III: Monotherapy
Moderator Bernd Schmidt, MD, PhD
2:00-2:20 Options for monotherapy approval: US Jacqueline A. French, MD
2:20-2:40 Options for monotherapy approval: Europe Michel Baulac, MD
2:40-3:00 Active control trials: Details do matter! Martin J. Brodie, MD
3:00-3:10 How to approach monotherapy: In search of a synthesis Bernd Schmidt, MD, PhD
3:10-3:40 Discussion  
3:40-4:00 Coffee Break  


Session IV: Device Trials
Moderator Brian Litt, MD
4:00-4:20 Device trials: Investigator perspective Robert S. Fisher, MD, PhD
4:20-4:40 Device trials: FDA perspective Ann H. Costello, PhD, DMD
4:40-5:00 Difficulties in recruitment for device trials Nina Graves, PharmD
Joan Grebin
5:00-5:30 Discussion  


Day 2 - Thursday March 22

Session V: Special Populations Moderator John Pollard, MD

  • Pediatrics
  
8:00-8:20 Trial designs in infantile spasms Donald W. Shields MD
8:20-8:40

Placebos and equipoise in new-onset pediatric epilepsy: Implications for monotherapy trials

Dennis Dlugos, MD
8:40-9:00 Neonatal/infant trials John M. Pellock, MD
9:00-9:10 Pediatric exclusivity Russell Katz, MD

  • Elderly
  
9:10- 9:30 AED trials in the elderly: Why and how? Ilo E. Leppik, MD
9:30-10:00 Discussion  

  • Women’s Issues
 Moderator Cynthia Harden, MD
10:00-10:20 Pregnancy registries: What do they teach us? Page B. Pennell, MD
10:20-10:40 Coffee Break  
10:40-11:00

AED interactions with oral contraceptive steroids and hormones: How and when to test

Emilio Perucca, MD, PhD
11:00 – 11:20 Results of the NEADs study Kimford J. Meador, MD
11:20-11:50 Discussion  


Session VI: Formulations
Moderator Emilio Perucca, MD, PhD
11:50-12:10 Long-acting formulations: What is the goal? James Cloyd, PharmD
12:10-12:30

Lessons learned in the development of extended-release AEDs: An industry perspective

Ronald C. Reed, BS, RPh, PharmD
12:30-12:50 Alternate Routes for AED administration James Cloyd, PharmD
12:50-1:00 FDA perspective Russell Katz, MD
1:00-2:30 Lunch  
2:30-2:50 Discussion  


Session VII: Secondary Endpoints
Moderator Joyce Cramer
2:50-3:10 Positive affects of new AEDs on cognition and memory Frank G. Gilliam, MD, MPH
3:10-3:30 Assessment of the positive psychiatric impact of AEDs Andres M. Kanner, MD
3:30-3:50 Fixed vs. flexible dosing Virinder Nohria, MD, PhD

3:50-4:10

FDA Update Russell Katz, MD
4:10-4:40 Discussion  


Day 3 – Friday March 23

Session VIII: CNS/Epilepsy Company Forum: Drugs in the Pipeline Moderator Harvey Kupferberg,PhD
8:00-8:15 Brivaracetam / UCB Pharma Philipp von Rosenstiel, MD

8:15-8:30

Carisbamate / Johnson and Johnson PRD Gerald Novak, MD
8:30-8:45 Eslicarbazepine / Bial Antonio Gil-Nagel, MD
8:45-9:00 Fluorofelbamate / MedPointe Bryan Roecklein,PhD
9:00-9:15 Ganaxalone / Marinus Pharmaceuticals Earl Giller, MD, PhD
9:15-9:30 Huperzine Steve Schachter, MD
9:30-9:45 JZP-4 / Jazz Pharmaceuticals Mark Foreman, PhD
9:45-10:00 Lacosamide / Schwarz Biosciences Timothy Sullivan, MD
10:00-10:15 Retigabine / Valeant Pharmaceuticals INTL Hank Mansbach, MD
10:15-10:30 Coffee Break  
10:30-10:45 Rufinamide / Eisai Medical Research, Inc. Santiago Arroyo, MD, PhD
10:45-11:00 Seletracetam / UCB Pharma Barbara Bennett, PhD
11:00-11:20

Selecting novel AEDs among SV2A ligands / UCB Pharma

Henrik Klitgaard, PhD
11:20-11:35

T2000: Uses of Non-sedating barbiturates

Taro Daniel Moros, MD
11:35-11:50 Valproate Derivatives / Hebrew University of Jerusalem Meir Bialer, PhD, MBA
11:50-12:10 Vigabatrin / Clobazam Ovation Pharmaceuticals Stephen Collins, MD, PhD
12:10-1:30 Lunch (Panel Discussion 12:45-1:30 - see below)  
12:45-1:30

Panel Discussion: Partnership & Financing Opportunities in Epilepsy and CNS: Corporate and VC Perspectives

Participants:
Dan O’Connell / NeuroVentures
Nicola Campbell, PhD / Sofinnova Ventures
Jason Levin / Jazz Pharmaceuticals
Richard Masterson / Valeant Pharmaceuticals
Lauren Silverman, PhD / Novartis Option Fund
Christine De Los Reyes, PharmD / Pfizer, Inc.
Thomas Woiwode, PhD / Synosis Therapeutics, Inc.

Moderator Garry Menzel, PhD

1:30-5:30		 Emerging Compounds and Company Forum

Moderator Warren Lammert

1:30-1:45 NINDS Mark Scheideler, PhD
1:45-2:00 Epilepsy Study Consortium Jacqueline A. French, MD
2:00-2:30

Panel Discussion: The Role of the CRO in the Clinical Development of Epilepsy/CNS Drugs

Participants:
Wendy L. Martin, MD / PRA International
Michael Cioffi / INC Research
Tomislav Babic, MD, PhD / i3 Research

Moderator Stephen Collins, PhD
2:30-2:45 NeuroInsights / Epilepsy and CNS Market Dynamics Zach Lynch
2:45-3:00 Coffee Break  
3:00-3:15 NeuroPace, Inc. Frank M. Fischer
3:15-3:30 NeuroAdjuvants / Galanine H. Steve White, PhD
3:30-3:45 Cambria Biosciences /In Vivo Anticonvulsant / HTS Leo Liu, MD
3:45-4:00 EPINANO / Magnetonanoparticles Massoud Akhtari, PhD
4:00-4:15 Icagen Greg Rigdon, PhD
4:15-4:30 Neurologix, Inc. Christine V. Sapan, PhD
4:30-4:45 Intranasal Franz F. Hefti, PhD

4:45-5:00

SK Bio-Pharmaceuticals / YKP3089 and SK S. James Lee, PhD
5:00-5:15 VistaGen Therapeutics H. Ralph Snodgrass, PhD

5:15-5:30

NeuroGenomics Thomas Sutula, MD, PhD
5:30-7:30 Cocktail Reception - Trump International Sonesta Beach Resort

Trump International Sonesta Beach Resort
18001 Collins Avenue
Sunny Isles Beach, FL 33160
United States of America
P: (305) 692-5600
P2: 800-SONESTA
F: (305) 692-5601

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