American Conference Institute (ACI) will be holding a conference on Biosimilars on June 1-2, 2015 in New York, NY. ACI faculty will help attendees:
• FDA's approval of Sandoz's Zarxio biosimilar: Analysis of FDA standards for labeling, biosimilarity, interchangeability, and clinical studies;
• Reviewing the biosimilars litigation cases to date including Sandoz v. Amgen and Celltrion v. Janssen and detailing strategies for declaratory judgment actions, preliminary injunctions, and using new USPTO inter partes review procedures;
• US Federal Trade Commission and state law updates: Understanding the controversy surrounding competition, substitution, and naming in the biosimilars arena; and
• Cost-benefit analysis: determining the potential value of biosimilars revenue based on relevant pricing, IP, regulatory, and commercial factor.
In particular, ACI's faculty will offer presentations on the following topics:
• FDA Keynote Address: Insights into FDA's Current Position and Initiatives Regarding Biosimilars
• The Road Ahead: Minimizing the Uncertainty Surrounding FDA Standards for Interchangeability and Biosimilarity
• Protecting Both Innovation and Competition: Finding Compromise Within Federal and State Biosimilars Substitution Laws
• Biosimilars Around the World: Leveraging Regulatory, IP, Pricing, and Safety Lessons Learned So Far
• Judges’ Spotlight: Lessons from the Hatch-Waxman Experience for Biosimilars Litigation
• Declining to Dance? Lessons Learned from Early BPCIA Cases on Whether the Pathway is Mandatory
• What’s at Stake: Commercial Opportunity, Risk, and Pricing Considerations for the Emerging U.S. Biosimilars Landscape
• Incorporating Inter Partes Review and New USPTO Procedures Into Branded and Biosimilar Litigation Strategies
• Following the Rules of the BPCIA: A Cheat Sheet for Managing the Complicated Timing and Logistics of the Statutory IP Exchange Process
• The Next Battle Ground: Strategies for Obtaining or Challenging Preliminary Injunctions
• Obtaining Adequate Patent Protection While Operating in an "Anti-Patent" Climate: Factoring Key Cases into Your Biosimilars Patent Strategy
• Open Floor Session Benchmarking Session: Putting It All Together: Is the Biosimilars Abbreviated Pathway Worth It?
In addition, a post-conference workshop, entitled "Workshop: Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space," will be offered from 9:00 am to 12:00 pm on June 3, 2015. The post-conference workshop will be presented in part by Patent Docs author Dr. Kevin Noonan.
The agenda for the Biosimilars conference can be found here and an agenda for the post-conference workshop 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 $2,195 (conference alone) or $2,695 (conference and post-conference workshop). 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 the Biosimilars conference.
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