American Conference Institute (ACI) will be holding is 8th Annual Summit on Biosimilars on June 12-14, 2017 in New York, NY. Patent Docs author Dr. Kevin Noonan is a co-chair of this conference. ACI faculty will help attendees:
• Explore the changes in place and potential changes to come for biosimilars as a result of the new U.S. administration;
• Compare and contrast the various pathways taken by the currently approved biosimilars;
• Compile a robust package of evidence supporting interchangeability;
• Review the Supreme Court Sandoz v. Amgen case, including the arguments presented, predictions for or analysis of the decision, and the potential impact on the industry;
• Examine the institution and denial of IPR petitions for biosimilars;
• Consider strategies for choosing the best suffixes for naming biosimilars;
• Analyze the FDA's draft guidance for labeling biosimilars; and
• Ascertain how payors will deal with biosimilars.
In particular, ACI's faculty will offer presentations on the following topics:
• Policy and Politics of Biosimilars under the New Administration
• Case Study: Reviewing the First 18 Months of Biosimilars and a Look Ahead
• Demystifying the Demonstration of Interchangeability in View of FDA's Draft Guidance
• Amgen v. Sandoz: Where are we Now?
• Patent Portfolio Management in Light of Life Techs. Corp. and Extraterritorial Reach of U.S. Patents
• Untangling the Inner Workings of IPRs for Biosimilars
• Shall we Dance: Mastering the "Steps" of the BPCIA While Avoiding Common Pitfalls
• A Biosimilar by Any Other Name. . . Has a Distinguishing Suffix
• Ensuring Labeling Compliance and Assessing Impact of Labeling on Product Liability Litigation
• The Judges Speak: Inside Perspectives on Biosimilar Litigation
• The Price is Right: Or is it? Dissecting Pricing and Reimbursement Issues for Biosimilars
• Examining the Ethics and Professional Responsibility Concerns for the Biosimilars Industry
In addition, two post-conference workshops will be offered on June 14, 2017, from 9:00 am to 12:00 noon and 2:00 to 5:00 pm, respectively. The first workshop is entitled "Product Patentability Workshop: Navigating through § 101 and § 112 Challenges for Biologics," and the second workshop is entitled "Biosimilars around the World: Examining Challenges and Strategies for Creating an International Biosimilar Portfolio."
An agenda for the conference can be found here, 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 May 19, 2017 is $2,095 (conference alone), $2,695 (conference and one workshop), and $3,295 (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-PTD17. Those interested in registering for the conference can do so here, by e-mailing [email protected], by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of ACI's 8th Annual Summit on Biosimilars.
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