Tuesday, July 16, 2013

Save the date for IIR’s 14th Annual Biosimilars Event!

No other event provides the business know-how of getting biosimilars to market quickly and efficiently.Through a multidisciplinary approach of competitive intelligence, regulatory strategy, bioanalytical comparability, clinical development and more, IIR’s industry-leading 14th Business of Biosimilars provides insight from market leaders on choosing the best pathway for a Biosimilar product.

Why you should attend:

 • NEW! Pre-conference workshop—Understanding the Nuts and Bolts of Biosimilar Regulatory Requirements
• NEW! Point-counterpoint talks deliver both the Biosimilar and Brand perspectives on hot policy topics
• Navigate the EMEA approval pathway for monoclonal antibodies
• Conduct structural and PK/PD comparability assessments
• Overcome the science and complexity of indication extrapolation
• Define the role of higher order structure in fingerprinting
• Analyze current biosimilar market trends and future challenges
• And more!

Hear executive-level expert insight on critical Biosimilar success factors from:

• Mark McCamish MD, PhD, Head Global Biopharm. Development, SANDOZ INTERNATIONAL GMBH
• Michael Malecki,Director, Regulatory Policy, AMGEN
• Bruce A. Leicher,Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS
• Dr. Michel Mikhail, Chief Regulatory Officer & Executive Vice President Global Regulatory - Governmental Relations,FRESENIUS KABI
• Dr. Duncan A. Emerton, Biosimilars Practice Lead, DATAMONITOR HEALTHCARE CONSULTING
• Naomi Pearce,VP, IP Counsel and Director, Global Biologics COE, MYLAN
• Erika Lietzan, Partner, COVINGTON & BURLING LLP
• Paul Greenland,Vice President—Biologics, HOSPIRA UK LIMITED
• Magdalena Leszczyniecka PhD MBA, President and CEO, STC BIOLOGICS, INC.
• Bob Ward, VP, Head of Strategy & Alliances, New Opportunities,ASTRAZENECA
• Elizabeth Jex, Attorney Advisor, Office of Policy Planning, FEDERAL TRADE COMMISSION
• Wenyan (David) Shen,VP, Global Head of Biologics Development, TEVA

Stay Tuned! We are currently in the process of finalizing the speaking faculty as well as the event website. Be sure to check out our website for more information.
Best,
The Biosimilars Team

Biosimilars Homepage
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