American Conference Institute (ACI) will be holding is 9th Annual Summit on Biosimilars on June 25-27, 2018 in New York, NY. Patent Docs author Kevin Noonan is a co-chair of this conference. ACI faculty will help attendees:
• Explore the current initiatives to foster innovation and lower healthcare costs from the current administration;
• Review current case law that will impact the biologics marketplace, such as Amgen v. Hospira and Amgen v. Sanofi;
• Compare various strategies for biosimilar manufactures and reference product sponsors in view of the Supreme Court's Sandoz v. Amgen case;
• Consider strategic decisions related to the use of IPRs in the biosimilars context;
• Examine the status of interchangeability and a review of state legislation for pharmacy-level substitution;
• Review the impact of the FDA's naming guidance; and
• Analyze the ethical concerns facing the biologics and biosimilars marketplace.
In particular, ACI faculty will offer presentations on the following topics:
• Biosimilars on the Hill: Policy and Legislative Updates
• Regulatory Year in Review and Predictions for the Future
• Update on Hot-Button Litigation Issues and the Impact on the Biologics Market and Strategies
• NOW . . . You Can Dance If You Want to
• Navigating through Biosimilars IPRs
• Perfecting Your Biologics Prosecution Strategies
• Interchangeability for Biosimilars: Envisioning the Future
• Naming and Labeling Considerations for Biosimilar Products
• Market Access, Pricing, and Reimbursement
• Evaluating Ethical Concerns for the Biologics Industry
In addition, two post-conference workshops will be offered on June 27, 2018, from 9:00 am to 12:00 noon and 1:30 to 4:30 pm, respectively. The first workshop is entitled "Untangling the Inner Workings of IPRs for Biosimilars," and the second workshop is entitled "Gaining a Global Perspective: Tips and Strategies for Establishing and Maintaining an International Biosimilars Portfolio."
An agenda for the conference and additional information regarding the 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 early-bird registration fee if paid before April 20, 2018 is $1,995 (conference alone), $2,595 (conference and one workshop), and $2,995 (conference and both workshops). Special rates are available for in-house counsel (see brochure). Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD18. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's 9th Annual Summit on Biosimilars.