The Institute for
International Research (IIR) will be holding its 14th Annual Business of
Biosimilars conference from October 15-17, 2013 in Boston, MA. The conference will allow attendees to:
• 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
In particular, IIR's faculty will offer presentations on the following topics:
Workshop Day --
October 15:
• Understanding the
Nuts and Bolts of Biosimilar Regulatory Requirements
Main Conference Day
One -- October 16:
• Competition and
the Biosimilar Landscape
• Biosimilar Market
Reality Check Panel -- Analyzing the Current Market Trends and Future
Challenges for Biosimilar Success
• The Importance of
Analytical and Biologic Characterization to Tailor Clinical Development
• Examining The
Approval Path For A Biosimilar Monoclonal Antibody and Lessons of Liaising with
the EMEA
• Biosimilar
Commercial Strategies and What We Have Learned from the EU Experience
• Current
Requirements for Biosimilar Approval in Emerging Markets and Defined Regulatory
Pathways
•
Point-Counterpoint Talks: Biosimilar Policy-Making: Is it Based in Science, Law
or the Profit Motive?
Main Conference Day
Two -- October 17:
• Developing a
Stepwise Approach for Biosimilars to Lower the Risk of Clinical Differences
• Defining the Role
of Higher Order Structure in Fingerprinting in Biosimilar Development and
Benefits for Matching a Reference Products Fingerprint
• Considerations
for Biosimilar Clinical Development Plans that Meet Agency Expectations
• Gaining Access to
a Reference Biologic Products to Begin Clinical Trials
• Tailoring a
Manufacturing Process Based Upon Comparability to an Originator Product
• The Landscape of
Biosimilar Strategic Partnerships
• Examining the
Lessons Learned, Opportunities and Models of Biosimilar Partnerships
The agenda for the 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 here.
The registration
fee for this conference is $2,295 (conference only) or $2,695 (conference and half
day workshop). Those registering before September
13, 2013 will receive a $300 discount.
Those interested in registering for the conference can do so here.
Patent Docs is a media partner of the Business of Biosimilars conference.
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