The Center for Business Intelligence (CBI) will be holding its 5th Summit on Biosimilars and Follow-on Biologics on October 18-19, 2010 in Washington, DC. At the Summit, CBI's faculty will offer presentations on the following topics:
• FDA's implementation of the biosimilar approval pathway -- What to anticipate and how to be prepared (keynote panel discussion);
• Analysis of exclusivities and pre-launch patent dispute mechanisms created by the PPACA;
• FTC address -- Follow-on biologics -- FTC perspective on market competition;
• Follow the money -- How capital will shape the challenges and opportunities for the U.S. biosimilars market (panel discussion);
• Biosimilar innovation -- Differentiated biosimilars and biobetters;
• Evolution of the global biosimilar competitive landscape;
• Operational lessons learned from the approved biosimilars in the EU;
• Differences in clinical trial requirements for biosimilars;
• Fc enhanced antibody biosuperiors versus true biosimilars; and
• Informing the payer and prescriber -- How to assure clinical safety and efficacy to overcome challenges to market penetration.
A pre-conference workshop entitled "Develop a Manufacturing, Preclinical and Clinical Plan for Protein Therapeutic Biosimilars" will be offered on October 18, 2010. The workshop will address the following questions:
• What are the biggest challenges with biosimilar development?
• How to develop an adequate manufacturing, preclinical and clinical plan?
• What strategies can be implemented to ensure target safety and efficacy qualities are achieved?
A complete agenda for the Summit on Biosimilars and Follow-on Biologics can be found here (Day One) and here (Day Two). A brochure for this conference can be requested here.
The standard registration rate for the conference is $1,695 (conference alone) or $1,995 (conference plus workshop), and the academic/government/non-profit rate is $995 (conference alone) or $1,195 (conference plus workshop). Attendees (standard rate only) registering by August 20, 2010 will receive a $300 discount off the registration fee, and attendees registering a group of three individuals will receive a fourth registration for free. Those interested in registering for the conference can do so here, by calling 1-800-817-8601, or by e-mail at [email protected].
Patent Docs is a media partner of CBI's Summit on Biosimilars and Follow-on Biologics.
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