American Conference Institute (ACI) will be holding a conference on Biosimilars on May 22-23, 2012 in New York, NY. ACI faculty will help attendees:
• Understand and comply with the FDA's current position on defining biosimilarity and demonstrating interchangeability under the abbreviated pathway;
• Determine the financial viability of biosimilars and explore new strategic alliances and alternative pathways to approval including biobetters;
• Adapt a practical approach to incorporate biosimilars into a patent portfolio strategy to protect intellectual property and maximize the biologics life cycle;
• Prepare for the intricate patent dispute resolution process and brace for the deluge of patent challenges to come;
• Increase expertise into the already-established biosimilar regime in the EU and learn from successful global commercial launches; and
• Ascertain the level of clinical trials data that will be required to prove safety and efficacy.
In particular, ACI's faculty will offer presentations on the following topics:
• Keynote address: Implementing the biosimilar pathway: FDA guidance and planning for the U.S. biosimilars regime -- presented by Denise Esposito, Deputy Associate Director for Policy, Office of Regulatory Policy (ORP), CDER, U.S. Food and Drug Administration (FDA);
• Answering the $100 million dollar question: Evaluating the commercial viability and opportunity of biosimilars;
• Defining biosimilarity and meeting the additional statutory standards for interchangeability;
• Practical implications of a 12-year exclusivity period: Strategically defining and calculating exclusivity;
• In-house keynote: The biosimilars experience: Providing an optimal patient encounter;
• Overcoming biosimilars regulatory, marketing, and commercialization challenges;
• In-depth breakdown of the biosimilar framework in the EU: Risk management strategies to protect your biologic on the international stage;
• The first wave of litigation: Proactive procedures and early considerations for innovators and biosimilar companies;
• Timing is everything: A checklist to ensure preparedness for litigation;
• The post-AIA world: Factoring the impact of patent reform into biosimilars prosecution and litigation strategies;
• Understanding FDA's requirements for biosimilars clinical trials;
• Safeguarding intellectual property and maximizing biologic patent life through a robust biosimilars patent portfolio strategy -- to be presented in part by Patent Docs author Dr. Kevin Noonan; and
• BLAs, biobetters and beyond: Evaluating the benefits and risks of alternative routes to market.
A pre-conference primer, entitled "Biologics 101: Formulating a Biosimilars Patent Portfolio Development Plan Grounded in Complex Scientific Properties," will be offered from 2:00 pm to 5:00 pm on May 21, 2012. In addition, a post-conference master class, entitled "Maximizing Market Share in a Global Economy: Exploring Opportunities for Biosimilars Growth into Emerging Markets," will be offered from 9:00 am to 12:00 pm on May 24, 2012.
The agenda for the Biosimilars conference can be found here, and additional information about the pre-conference primer and post-conference master class 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 March 23, 2012 will receive a $300 discount and those registering by April 20, 2012 will receive a $200 discount. Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. 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.
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