• Complying with
the FDA standards on the abbreviated biosimilars pathway requirements;
• Meeting the heightened standard of interchangeability and outlining the parameters of similarity in the context of large complex biological compounds;
• Analyzing the complex patent resolution mechanisms outlined in the statute and proactively preparing for the intricate exchange process;
• Ascertaining the volume and level of safety data that will be required to prove patient safety and efficacy to facilitate approval;
• Determining the financial viability of biosimilars and exploring alternative pathways to approval including biobetters;
• The debate over naming and the new bills introduced restricting the ability of pharmacists to substitute generic versions of biological drugs for brand name products; and
• Investigating the impact of citizen’s petitions on the biosimilars market.
• The biosimilars pipeline: Evaluating the
commercial opportunity and viability of follow-on products;
• Overcoming the complicated challenges to establishing biosimilarity;
• The next frontier of biosimilars challenges: Naming and substitution at the pharmacy level;
• Two roads diverged in a wood: Evaluating whether to go down the biosimilars or BLA pathway;
• In-house keynote: Interchange or "out of change" -- The changing world of biosimilars;
• In-house round table debate: Companies weigh in on the abbreviated pathway;
• The reality of the market: Lessons learned so far from global biosimilars development and litigation;
• Preparing for the impending reality of biosimilars patent litigation: Immediate action plans for the first wave;
• The post-AIA world: Revolutionizing biosimilars litigation strategies in light of validity assessment at the PTO;
• Practical claim drafting and patent prosecution strategies for biosimilars and innovators;
• Exploring opportunities to strengthen your patent portfolio through licensing;
• The use of citizen's petitions in the biosimilars context: A case study of AbbVie's petition;
• Evaluating the benefit of trade secret protection versus patent protection: Alternative ways to protect biologic and biosimilar technology; and
• Navigating tricky confidentiality and conflicts issues in the new biosimilars exchange process -- to be presented in part by Patent Docs author Dr. Kevin Noonan.
Two pre-conference workshops will be held on June 5, 2013. The first, entitled "Translating the underlying science into a strong biosimilars patent portfolio strategy," will be offered from 9:00 am to 12:00 pm. The second, entitled "Monoclonal antibodies: Successful and practical strategies for developing and commercializing antibody therapies," will be offered from 1:30 pm to 4:30 pm.
The agenda for the Biosimilars conference can be found here, and additional information about the pre-conference workshops 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 one workhop), or $3,495 (conference and both workshops). Those registering by April 26, 2013 will receive a $300 discount and those registering by May 17, 2013 will receive a $200 discount. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, 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.