IP Power: Understanding, Leveraging and Monetizing Your Intellectual Property
9:45am – 11:00am

The strength of a company’s IP and technology relative to its market value translates into its ability to raise capital, negotiate more favorable funding terms, enter into strategic joint venture out and in-licensing agreements, and intellectual property rights are the collateral against which many transactions are financed. The panel will discuss real-world tools and strategies to maximize the value of an IP portfolio. The panel will explore topics ranging from the valuation of IP, IP rights protection, 1st Party IP insurance risk financing and recent monetization case studies as they relate to various IP-focused business situations.

Panel Moderator:

Linda Judge
Partner , DLA Piper Rudnick Gray Cary US LLP

Panel Speakers:

David Earp
Chief Patent Counsel and Senior Vice President, Business Development, Geron Corporation

Christian Tregillis
Managing Director, Kroll Financial Advisory Services

The Road to FDA Approval: Key Legal, Regulatory and Corporate Organizational Challenges
11:15am – 12:30pm

FDA approval of a drug, biologic or device is the prize at the end of the quest for biotech firms. Getting there requires surmounting an array of obstacles arising from the legal and regulatory framework in which BayBio firms operate. And, to navigate the approval maze, a biotech firm must organize its efforts in a manner that secures approval both as quickly as possible and using financial resources that are often strained to the point of depletion. This session will feature legal, regulatory and industry experts that will highlight key challenges a firm faces during the approval process from a legal, regulatory and organizational perspective and offer solutions on how to overcome those hurdles. Topics to be explored include the future of generic biologics and the use of 505(b)(2) NDAs, especially in the wake of FDA's approval of Omnitrope®; how Vioxx® and safety issues are impacting FDA; how to use regulatory mechanisms to speed approval such as Fast Track and Accelerated Approvals; and optimizing corporate resources to maximize success in the approval pursuit.

Panel Moderator:

Jeffrey Miller
Vice President, Regulatory Affairs and Quality Assurance, Depomed, Inc.

Panel Speakers:

Nathan A. Beaver, Esq.
Senior Counsel, FDA Practice Group, Foley & Lardner LLP

Joel I. Falk
Executive Vice President, The Weinberg Group, Inc.

Annemarie Moseley
Chairman, Repair Technologies, Inc.
Acting Chief Executive Officer, Aggregate Therapeutics, Inc.

Growing Your Business in Europe: Strategic Options and Lessons Learned
2:00pm – 3:15pm

Europe is the single biggest market in population size but is often seen as complex to enter. This session is intended as a forum of best practices and lessons learned on how to develop and commercialize products in Europe. Key alternatives for market entry (should you partner or out-license?) and EU selling strategy will be discussed. Our speakers come from Bay Area biotech firms of different sizes but who all currently work with or in Europe. In a second phase, this session will discuss recent measures put in place by European governments to stimulate the growth of their biotech industries (new tax credits & exemptions, early market access for orphan drugs, new bioclusters) and how Bay Area companies can take advantage of these opportunities.

Panel Moderator:

Michael R. Schuppenhauer
Senior Vice President, CoActive PR

Panel Speakers:

Stephen Aselage
Senior Vice President, Global Commercial Operations, BioMarin

Christophe Degois
Senior Director, Commercial Development, PDL BioPharma

Andrew Hindman
Senior Director, Public Health and Policy, Gilead Sciences, Inc.

Maximizing IP Protection While Managing IP Costs
3:30pm – 4:45pm

The global marketplace, rise of generics, and a growing emphasis on products rather than platform technology has increased the need for comprehensive and coordinated intellectual property protection. To be competitive in the world environment, companies need defensive and offensive IP enforcement policies that go beyond the U.S. borders. Filing patents in multiple countries—each with unique application requirements, timelines, and cost structures—has become critically necessary.

This session brings together a panel of private and corporate patent lawyers with first-hand experience in IP portfolio management. The panel will discuss how to maximize intellectual property protection while effectively managing the associated costs. Particular focus will be placed on U.S. and international strategies related to pharmaceutical products.

Panel Moderator:

Jean B. Fordis
Partner, Finnegan Henderson Farabow Garrett & Dunner L.L.P.

Panel Speakers:

Cameron Marshall
Partner, Carpmaels & Ransford (London, UK)

James Monroe
Partner, Finnegan Henderson Farabow Garrett & Dunner L.L.P.

Dr. Bill Pickering
Blake Dawson Waldron (Melbourne, Australia)

Bart W. Wise
Senior Intellectual Property Counsel, Geron Corporation