Defining the Drug/Device Opportunity

Combination therapies represent a multi-billion dollar opportunity, but we have only begun to capitalize on the true potential.  What is that potential?  A group of corporate and strategic investors, from both big and small companies, explain what they're looking for in their next investments.

Moderator:

• Fred Hernandez, Principal, Fish & Richardson

Panelists:

• Gregory R. Stewart, Ph.D.,Director, CNS Drug Therapy R&D, Medtronic Neurological
• Jason Hannon, Vice President of Legal Affairs, NuVasive, Inc.
• Mark Hedrick, MD, President, Cytori Therapeutics Inc.

Combination Products: What’s the Big Deal?

Biotech and device companies are culturally very different.  Their expectations and approach to collaborations differ as well.  In this panel, we look at successful deal models in convergence products.  What makes them work?  What did they have to work through? What are the elements of success?

Moderator:

• J. Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati

Panelists:

• Jeffrey Walker, Vice President, Business Development, Angiotech, Inc.
• Jonathan Rigby, Vice President, Business Development, Zogenix, Inc.
• Peyton Anderson, CEO, Affinergy, Inc.
• Oded Ben-Joseph, CEO, X-Cell Medical, Inc.
• Paul V. Buckley, Senior Director, Licensing, Global Business Development, Wyeth Pharmaceuticals

THE NEXT BIG THING FOR COMBINATION PRODUCTS -
Key Players and Issues at the Intersection of Nanotech, Microelectronics, and Regenerative Medicine  

This plenary session will highlight a panel discussion of the Intellectual Property positions and funding considerations that affect the near-term prospects for medical products combining nanostructured materials with microelectronic or cellular components. In this fashion we look to inform an entrepreneurial, investor-oriented audience on legal and business issues that are just over the horizon for this particular area of combination products.

Moderator:

• Steve Reiter, Partner, Foley & Lardner LLP

Panelists:

• Mike Heller, Ph.D., Professor, Electrical & Computer Engineering, Bioengineering, UC San Diego
• Tim Mills, Ph.D., Managing Director, Sanderling Ventures
• Jeff Newman, Senior Counsel, Foley & Lardner LLP

The FDA and Innovative Products - Regulatory Issues for New In Vitro Diagnostics and Combination Products  

New combination products and in vitro diagnostic tests raise novel regulatory considerations for the FDA.   The Office of Combination Products issued regulations to assist in the determination of the primary mode of action of a combination product; the Office of In Vitro Diagnostic Device Evaluation and Safety issued draft guidance on in vitro diagnostic multivariate index assays and some members of Congress are talking about clarifying FDA's authority over laboratory-produced, or home-brew, tests.  What does this mean for companies developing these kinds of products?
 

Moderator:

• Linda D. Bentley, Member, Health Section and Biotechnology Group, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC

Panelists:

• Mark Kramer, Director, Office of Combination Products, FDA
• Elizabeth Mansfield, Ph.D., Scientific Policy Analyst, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, FDA