BIO’s Drug|Device Summit to Highlight Trends in Healthcare Convergence
FDA Officials to Discuss Regulatory Issues Regarding Combination and In Vitro Products
WASHINGTON, D.C. (November 28, 2006) – Key stakeholders in biotechnology, pharmaceuticals and diagnostic and medical devices will explore the latest trends in healthcare convergence at the annual Drug|Device Summit to be held December 4-5 at the Hyatt Regency La Jolla at Aventine in San Diego, CA. The conference, hosted by the Biotechnology Industry Organization (BIO), BIOCOM, Windhover Information, Inc., and the Advanced Medical Technology Association (AdvaMed), will bring together top companies working to develop combination products and therapies, as well as leading industry investors.
Tuesday’s lunch plenary, entitled “The FDA and Innovative Products – Regulatory Issues for New In Vitro Diagnostics and Combination Products,” will examine the novel regulatory considerations raised by new combination products and in vitro diagnostic tests for the Food and Drug Administration (FDA). Moderator Linda D. Bentley, Member, Health Section and Biotechnology Group, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC, will be joined by Mark Kramer, Director, Office of Combination Products, FDA; and Elizabeth Mansfield, Ph.D., Scientific Policy Analyst, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, FDA.
The breakfast plenary on Tuesday, December 5, brings together a panel discussion on “The Next Big Thing for Combination Products – Key Players and Issues at the Intersection of Nanotech, Microelectronics, and Regenerative Medicine.” Moderated by Steve Reiter, Partner, Foley & Lardner LLP, the panel will focus on intellectual property and funding considerations for medical products combining nanostructured materials with microelectronic or cellular components. Panelists include Mike Heller, Ph.D., Professor, Electrical and Computer Engineering, Bioengineering, UC San Diego; Tim Mills, Ph.D., Managing Director, Sanderling Ventures; and Jeff Newman, Senior Counsel, Foley & Lardner LLP.
The varying expectations and approach to collaborations by biotech and device companies reflect the cultural differences between the industries. Monday’s evening plenary entitled, “Combination Products: What’s the Big Deal?” will explore successful deal models in convergence products, including current successes and challenges. Moderator J. Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati will be joined by panelists Jeffrey Walker, Vice President, Business Development, Angiotech, Inc.; Jonathon Rigby, Vice President, Business Development, Zogenix, Inc.; Peyton Anderson, CEO, Affinergy, Inc.; Oded Ben-Joseph, CEO, X-Cell Medical, Inc.; and Paul V. Buckley, Senior Director, Licensing, Global Business Development, Wyeth Pharmaceuticals.
The opening plenary on Monday, December 4, entitled “Defining the Drug/Device Opportunity,” will address the true potential of combination therapies. Corporate and strategic investors from small and large companies will share what they look for in future investments. Moderated by Fred Hernandez, Principal, Fish & Richardson, the panel includes Gregory R. Stewart, Ph.D., Director, CNS Drug Therapy R&D, Medtronic Neurological; Jason Hannon, Vice President of Legal Affairs, NuVasive, Inc.; and Mark Hedrick, MD, President, Cytori Therapeutics, Inc.
Information on the program as well as presenting companies can be accessed at http://drugdevice.bio.org/opencms/summit/2006/index.jsp .
Advance media registration for Drug|Device Summit 2006 is available online through 5 p.m. EST on Friday, December 1. Registration is complimentary for credentialed members of the news media. Only reporters and editors working full-time for print or broadcast news organizations may register onsite with valid media credentials. To register, please visit: http://drugdevice.bio.org/opencms/summit/2006/registration/mediareg.html.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. www.bio.org
Upcoming Events
· BIO Drug, Device & Diagnostic Summit
December 4-5, 2006, San Diego, CA
· BIO CEO & Investor Conference
Feb. 12-14, 2007, New York City
· 2007 World Congress on Industrial Biotechnology and Bioprocessing
March 21-24, 2007, Orlando, FL
· BIO International Convention
May 6-9, 2007, Boston, MA
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