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Combination Drug and Device Products - Is the Pathway Towards Success?
Program Code:
80
Date:
Thursday, June 19, 2008
Time:
2:00 PM to 3:30 PM
EST
CHAIR
(S):
Paul Buckley, Senior Director, Licensing , Wyeth Pharmaceuticals, Inc
David L. Rosen, Esq, Chair, Regultory Practice and Co-chair, Life Sciences Industry Team , Foley & Lardner LLP
SPEAKER
(S):
Paul Buckley, Senior Director, Licensing , Wyeth Pharmaceuticals, Inc
David L. Rosen, Esq, Chair, Regultory Practice and Co-chair, Life Sciences Industry Team , Foley & Lardner LLP
Description
"As the drug, device and biologics industries continue to advance and medical products become more sophisticated and personalized, the classical distinctions between what the FDA considers a "drug" or "device" begin to blend together.
This session will look to inform an audience on this particular area of combination products and how companies can navigate the regulatory, business and legal process for converging technologies including:"
Objective1:Successful business development case studies for drug device combination products.
Objective2:Legal barriers/issues for navigating FDA approval pathways and techniques that are being implemented by companies to move their products through FDA.
Objective3:"What's the best strategy for structuring business agreements
between patent holders, financiers, suppliers and distributors?"