FDA Officials to Discuss Regulatory Issues Regarding Combination and In
Vitro Products
WASHINGTON, Nov. 28 /PRNewswire/ -- 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. http://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
SOURCE Biotechnology Industry Organization
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Related links:
http://www.bio.org
CONTACT:
Stephanie Fischer of Biotechnology Industry
Organization, +1-202-312-9263
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