American Conference Institute (ACI) will be holding is 13th Annual Summit on Biosimilars & Innovator Biologics: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace on June 28-29, 2022 at the Hyatt Regency Boston. ACI faculty will offer presentations on the following topics:
• Regulatory and Legislative Developments Impacting the Biopharmaceutical Industry
• Satisfying Section 112 Requirements and the Future of Genus Claims
• The "Skinny Label" Post-GSK v Tevaregarding Biosimilar Carve-Outs
• Litigation Strategies for Challenging Reference Drug Patents in IPRs
• The Role of ITC in Biotech Litigation
• The Future of Patent Thicket on the Balance of Innovation and Competition in the Biologic Ecosystem
• Global Strategies from patent protection to cost and market access Naming, Labeling, Interchangeability, and Promotion: Regulatory Considerations
• Naming, Labeling, Interchangeability, and Promotion: Regulatory Considerations
• The Economics of Biosimilars regarding Market Access, Sustainable Prices, and Reimbursement
• Forward-Thinking Portfolio Strategies
Keynote talks include the FDA's insights on implementing interchangeability for biosimilar products. Other talks include FTC perspectives on antitrust considerations involving innovator biologic companies and biosimilar competitors and PTAB Live! with the Hon Michelle Ankenbrand. There will also be an interactive ethics drill, and a panel on advocating for diversity in IP. Time for interactive networking is included each day.
The conference includes two pre-conference workshops on Monday June 27th. The first, "Patenting mRNA, CRISPR, and Emerging Biotechnological Inventions" will be presented by Kevin E. Noonan and Bart Newland; and a "Biosimilar Patent Litigation Settlement Master Class," presented by Rob Cerwinski.
An agenda for the 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 is $1,895 for in-house counsel and $2,395 otherwise. The in-person workshops are $600 apiece. There is also a livestream option, costing $1,595 for in-house counsel and $2,095 for others. Patent Docs readers are entitled to a 10% discount off registration using discount code D10-658-658EX08. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's 13th Annual Summit on Biosimilars.
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