Biosimilars Conference

American Conference Institute (ACI) will be holding a conference on Biosimilars on June 7-8, 2011 in New York, NY.  ACI faculty will help attendees:

• Understand the FDA's current position on the implementation of a biosimilar pathway and strategically position companies to protect or increase market share;
• Determine what level of clinical data biosimilar applicants must provide to prove safety and efficacy;
• Evaluate the impact that the 12-year exclusivity period will have on competition and research and development;
• Assess the financial viability of biosimilars in light of potential regulatory hurdles and forecast potential profit margins; and
• Develop proactive strategies and plans in preparation for the eventuality of biosimilar patent disputes.

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

• Update on current FDA position and initiatives regarding biosimilars;
• Predicting, preparing and positioning for the FDA's implementation of the biosimilar pathway;
• Scrutinizing the financial viability of biosimilars and making the business case for or against follow-on biologics;
• No two biologics are alike: Defining biosimilarity and meeting the heightened standard of interchangeability under the statute -- to be presented in part by Patent Docs author Dr. Kevin Noonan;
• Debating the practical implications of a 12-year exclusivity period: Striking a balance between innovator and biosimilar interests;
• Branding and promotional considerations for biosimilars;
• Learning from the global development of biosimilars: Enforcement and risk management strategies to protect your biologic on the international stage;
• An overview of the statutory dispute resolution mechanisms: Analyzing the practical impact of linking the FDA approval process with the patent resolution process;
• Developing proactive procedures and strategies now for the eventual flood of biosimilar litigation: Early considerations to best position yourself;
• Developing proactive procedures and strategies now for the eventual flood of biosimilar litigation: Prevailing through preparedness;
• Ascertaining the type and volume of clinical data necessary to establish biosimilarity;
• Structuring a patent portfolio strategy to protect IP in light of FOB legislation; and
• Alternative routes to market for biosimilars: Evaluating the benefits of using the abbreviated pathway.

A pre-conference primer, entitled "Biologics Science 101: Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilar," will be offered from 2:00 pm to 5:00 pm on June 6, 2011.  In this in-depth and interactive primer, scientists on the front lines of research and development and the thought-leaders who are guiding the FDA on the relevant scientific considerations will maximize your understanding of the science to put you in the best position to determine actual costs of biosimilar research and development and to prepare for protecting your intellectual property at the patenting and litigation stages.  In addition, a post-conference master class, entitled "In-Depth Breakdown of the Biosimilar Framework in the EU," will be offered from 9:00 am to 12:00 pm on June 9, 2011.

The agenda for the Biosimilars conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and either pre-conference primer or post-conference master class), or $3,495 (conference, pre-conference primer, and post-conference master class).  Those registering by April 15, 2011 will receive a $300 discount and those registering by May 13, 2011 will receive a $200 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of the Biosimilars conference.

Comments

[Jared]

Seems to me that companies are pushing harder than before to compete with competitors without doing the actual work of inventing new things rather just building on the work of others I think as this trend continues so will the cases of patent infringement and patent enforcement increase.