The Institute for
International Research (IIR) will be holding its 2nd Annual Business of
Biosimilars conference from September 20-22, 2010 in Boston, MA.  The conference will allow attendees to:

• Navigate
worldwide regulatory and legislative issues;
• Build strategic
partnerships with emerging markets;
• Adopt effective
IP and patent protection strategies for biosimilars;
• Evaluate
scientific implications of biosimilars to ensure safety, quality, and efficacy;
• Manage risk and
make investment decisions to ensure ROI;
• Obtain branding
strategies to differentiate a product on the market;
• Negotiate pricing
and reimbursement strategies with government and payers;
• Profit from
practical lessons in Canada and Europe's regulatory policies and market
experience; and
• Discuss evolving
consumer and physician perspectives on biosimilars.

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

Full Day Symposium
— September 20:

• Understand
comparability criteria for biosimilar development;
• Minimize unwanted
immunogenicity issues for biosimilars to avoid adverse clinical consequences;
• Implement best
practices in immunogenicity testing for clinical safety and product
comparability; and
• Assembling the
Biologics License Application (BLA) for your biologic, biosimilar and
biobetter.

Day One of
Conference — September 21:

• Industry
landscape overview — Adapt to a changing marketplace;
• Government
perspective on current and pending legislation and the Administration's impact
on the biopharmaceutical industry;
• FDA perspective
on regulation in the U.S. and compliance abroad:  Bioequivalence, safety and efficacy considerations;
• Lessons learned
from European regulatory policies and market experience;
• Canada's
regulatory perspective on biosimilars;
• Stakeholders
debate biosimilar regulations in the U.S. versus the global market;
• Competitive
economic landscape — Develop techniques to optimize your business model;
• Strategic
alliances in an era of globalization — How to find the right partner strategic
alliances in an era of globalization — How to find the right partner; and
• Worldwide
experience with biosimilar development.

IP Protection and
Patent Litigation Strategies for Biosimilars — Dinner Workshop — September
21:

• Prepare your
patent portfolio — to be presented by Patent
Docs author Donald Zuhn;
• Develop offensive
and defensive strategies to prepare your company for patent disputes; and
• Assess the impact
of past and current cases on the biopharmaceutical industry.

Day Two of
Conference — September 22:

• Wall street
address:  Making biosimilar
investment decisions;
• Meet payer needs
— Formulary placement and pricing and reimbursement strategies;
• Evolving
physician and consumer perspectives on biosimilars;
• Develop a
strategy to ensure a successful biosimilar product launch;
• Industry insights
of the EPO market; and
• The future of
biosimilars and the biopharmaceutical industry.

A complete brochure
for this conference, including an agenda, list of speakers, descriptions of the
scheduled presentations, and registration information can be downloaded here.

The registration
fee for this conference is $2,195 (conference only), $2,595 (conference and
dinner workshop), $2,895 (conference and symposium), or $3,095 (conference,
dinner workshop, and symposium). 
Those registering before July 30, 2010 will receive a $400 discount, and
those registering before August 27, 2010 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.