Registration and Continental Breakfast, Seacliff Foyer

Welcome & Overview

Joyce Cramer, President, Epilepsy Therapy Project

Keynote Lecture: How Open Innovation Advances Medical Breakthroughs: Business Models for 2010

Henry Chesbrough PhD, Center for Innovation, Haas Business School, UC Berkeley
He coined the term open innovation and is the author of Open Innovation: The New Imperative for Creating and Profiting from Technology (Harvard Business School Press, 2003),Open Business Models: How to Thrive in the New Innovation Landscape (HBS Press, 2006), and Open Innovation: Researching a New Paradigm (Oxford, 2006).

The Science of Epilepsy: Detecting and Aborting Seizures

Robert Fisher MD, PhD, Stanford University
Discussion of technologies including external & intracranial stimulation, seizure detection algorithms, intracranial drug delivery, and hybrids.
Pros and Cons: Will these new devices fill the gap between drug therapy and surgery?
Ivan Osorio MD (University of Kansas)

Pipeline Review: Early Stage & Marketed Devices, Hybrids

What device will solve the seizure detection problem? This session will provide highlights of a series of novel emerging detection/stimulation devices and drug-device hybrids. Presenters will briefly answer a series of questions describing their concepts and plans, followed by questions from the audience.

Moderator: Frank Fischer (Neuropace)

"5 Slides in 5 Minutes"

• How does the device/hybrid work?
• What is the IP status?
• What are the development challenges?
• What are the timelines, milestones and financial needs?
• What does it bring to the marketplace?

The Science of Epilepsy: Mechanisms of Action of Drugs and Biologics

Mechanisms of Action of Drugs and Biologics
Michael Rogawski MD, PhD, University of California, Davis
Pros and Cons: Do Mechanisms of Action Matter?
Roger Porter MD (Formerly Wyeth & NINDA, Consultant)

Screening models: Now and future efficiencies in drug development

Pipeline Review: Early Stage Drugs, Biologics

Where will the next epilepsy blockbuster come from? This session will provide highlights of a series of novel emerging drugs & biologics. Presenters will briefly answer a series of questions describing their concepts and plans, followed by questions from the audience.

Moderator: Dan O'Connell (NeuroVentures)

"5 Slides in 5 Minutes"

• How does the drug/biologic work?
• What is the IP status?
• What are the development challenges?
• What are the timelines, milestones and financial needs?
• What does it bring to the marketplace?

Panel: The Impact of Changes in Financing: How to Get Started & Keeping Going

What is the new Venture Capital Model?
Moderator: Heath Lukatch PhD (Novo Ventures)
Panelists: Thomas Beck MD (Fidelity Biosciences), Manuel Lopez-Figueroa PhD (Bay City Capital), Anand Mehra MD (Sofinnova), Roger Quy PhD (Technology Partners)

Panel: Market Dynamics: The Value Proposition in Epilepsy and Beyond (Drugs & Devices)

Moderator: Nancy Santilli (Endo)
Panelists: Charles Cho MD (Palo Alto Investors), Stephen Collins MD, PhD (Neurotherapeutics), Sherrie Perkins (Cyberonics), Suzanne Giordano PhD (Pfizer), Matthew Simonian (UCB)

Business Model for Partnering With a NonProfit Organization: Non-Dilutive Funding & Match-Making

Joyce Cramer, President, Epilepsy Therapy Project

Networking Reception and Dinner

Ondine Restaurant in Sausalito. Transportation will be provided, to and from the Hyatt. Please meet in the Hyatt Regency Lobby at 5:45 p.m.

Continental Breakfast, Seacliff Foyer

The Science of Epilepsy: New Approaches

Orphan Indications and Novel Formulations

Overview of technology and formulation choices among extended release, intranasal, intra-muscular formulations, and special populations.
C. James Cloyd PhD, University of Minnesota
Pros and Cons: Do Orphan Indications and Novel Formulations move us forward?
Jacqueline French MD (New York University)

Pipeline Review: Phase 3 and Marketed Drugs

How useful is an indication for special populations? What strategies are useful for product life-extensions? What makes an epilepsy blockbuster? This session will provide highlights of a series of devices and drugs in late-stages of development and post-marketing. Presenters will briefly answer a series of questions describing their strategic planning, followed by questions from the audience.

Moderator: Jacqueline French MD (New York University)

"5 Slides in 5 Minutes"

1. How does the drug/device work?
2. What are its efficacy and tolerability characteristics?
3. What is the differentiation from other epilepsy treatments?
4. What additional indications are being evaluated or considered?
5. What are the challenges in product life-extension (value-added for payors after patent expiration)?

Planning for Reimbursement CMS, Part D, PBMs and other formulary access

Panel: Reimbursement and Regulatory Issues

Novel & Modified Drugs, Stimulators & Drug Delivery systems

Moderator: Cynthia Rask MD (formerly FDA, Consultant)
Panelists: Rich Denness (Director, Managed Care Director, UCB), Elizabeth Spurgin (B&D Consulting)

The Science of Epilepsy: Bio-Markers

Panel: The Search For Markers for Localization-related (Partial Onset) Epilepsy

Genetics, Genomics, Genotypes, Phenotypes, Gene-By-Environment Interactions

Moderator: Dan Lowenstein MD, PhD (UCSF)

Panelists: David Agus (USC), Anatol Bragin PhD (NeuroIndx), Richard Finnell PhD (Texas Institute for Genomic Medicine), Jeffrey Noebels MD, PhD (Baylor), Geoffrey Pitt MD, PhD (Duke)

Markers: Path to the Pot of Gold

Vigabatrin/Sabril
Clobazam

IV Carbamazepine