Bisimilars and Biobetters

Venue: Copthorne Tara Hotel

Location: London, United Kingdom

Event Date/Time: Sep 24, 2012 End Date/Time: Sep 25, 2012
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Join SMi at their third Biosimilars and Biobetters conference that will discuss the impact of these new regulatory guidelines and their effects on approval of follow on biologics at this exciting event. There will also be discussions on the rising development cost of biosimilars and marketing and pricing strategies, with a focus on case studies from those who are both developing and distributing follow on biologics. You cannot afford to miss this event.

Key Benefits of Attending:

• Be informed of the latest news in biosimilar pipelines
• Evaluate current and future developments in intellectual property and patent protection
• Discuss the impact of recent guidelines issued by regulatory bodies such as the FDA and EMEA
• Asses commercial and financial strategies
• Consider market access pathways and strategies
• Develop plans and methods for biosimilar and biobetter drug design and clinical testing

Hear key presentations from experts in the field:

• Sreedhar Sagi, Risk Management Compliance Officer Biopharmaceuticals Development, Sandoz
• Ezogelin Oflazoglu, Senior Director and Senior Project Leader, MBV Biologics PPM, Merck Bioventures
• Laura McKinley, Director Worldwide Regulatory Strategy, Pfizer
• Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc
• Anne Dollard, Chief Patent Counsel, Deputy General Counsel, Takeda Pharmaceuticals
• Sandy Eisen, Chief Medical Officer, former CMO, Frontline Pharma Consulting, Teva Pharmaceuticals
• David Szymkowski, Senior Director, Research, Biotherapeutics, Xencor, Inc
• Heinz Hänel, Director, Diabetes Division R&D Projects, Sanofi
• Andrew Rankin, Head of Clinical Development, Teva Pharmaceuticals


Additional Information

Plus an interactive half-day post-conference workshop Wednesday 26th September 2012, Copthorne Tara Hotel, London A critical review of US and EU legal framework for biosimilars products including practical examples for strategic development 9.00am – 12.30pm In association with Arnold and Porter LLP