The Institute for International Research (IIR) will be holding its 3rd Annual Business of Biosimilars & Biobetters conference from September 19-21, 2011 in Boston, MA.  The conference will allow attendees to:

• Understand the regulatory and legal implications that may affect your biosimilar profitability;
• Create strategies to ensure commercialization success;
• Leverage new manufacturing processes to increase profit; and
• Delve into scientific considerations including establishing similarity, defining bioequalivance and interchangeability and assess immunogenicity to preserve biosimilar integrity.

In particular, IIR's faculty will offer presentations on the following topics:

Full Day Symposium — September 19:

• Improve higher-order structure comparability studies;
• Regulate immunogenicity to decrease unwanted responses and ensure patient safety;
• Improve cell line development;
• Streamline testing during the early stages of biosimilar development;
• Determine clinical trials necessary for biosimilar development;
• Case study;
• Identify new tools that aid in biosimilar development; and
• Guided discussion: If technological advances in manufacturing create a better version of the originator, is the product still a biosimilar?

Pre-Conference Workshops — September 19:

• Create or re-assess your emerging market strategy;
• Biosimilar ip protection and patent litigation strategies for development in the us and abroad; and
• Biosimilar commercialization primer from compliant market to consumer acceptance.

Day One of Conference — September 20:

• Main Street outlook: Current trends and outlook of the biosimilar market around the world;
• Wall Street outlook: Analyze biosimilars' financial status;
• Investor outlook: Examine biosimilar development from investors' points of view to better position your biosimilar;
• Regulatory update of FDA considerations on biosimilars;
• Implementation of single use technologies in the manufacture of biosimilars;
• Regional spotlight: Biosimilar development in India;
• The U.S. abbreviated pathway: The good, the bad and the undefined;
• Understand the biological, chemical and clinical considerations when establishing similarity;
• Define bioequivalence and interchangeability;
• Immunogenicity assessment while preserving desired structural and functional aspects of the biosimilar;
• Anticipate sales and marketing costs associated with biosimilar product launch;
• Identify obstacles and opportunities biosimilar manufactures must consider to successfully launch in the future managed care landscape; and
• Prepare for potential traceability and labeling problems in biosimilar commercialization.

Day Two of Conference — September 21:

• Roundtable discussions: Does a global biosimilar opportunity even exist?
• Increase profitability by considering new biosimilar manufacturing processes;
• Regional spotlight: Lessons learned from biosimilar development in the established European marketplace;
• Overcome IP barriers to biosimilar development and commercialization;
• Regional spotlight: Biosimilar opportunities within the U.S.; and
• 90-minute intensive: Delve into oncology money-making opportunities.

The agenda for the Business of Biosimilars & Biobetters conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, descriptions of the scheduled presentations, and registration information can be downloaded link.

The registration fee for this conference is $2,195 (conference only), $2,595 (conference and one pre-conference workshop), $2,895 (conference and two pre-conference workshops or symposium).  Those registering before July 29, 2011 will receive a $400 discount, and those registering before August 26, 2011 will receive a $300 discount.  Those interested in registering for the conference can do so here, by calling 1-888-670-8200, or by sending an e-mail to register@iirusa.com.

Patent Docs is a media partner of the Business of Biosimilars & Biobetters conference.