American Conference Institute (ACI) will be holding a conference on Biosimilars on June 4-6, 2014 in New York, NY. ACI faculty will help attendees:
• Understand the battles over naming and substitution on the federal and state levels and exploring the implications on competition including the FTC's current perspective;
• Analyzing the arguments in the first BPCIA case, Sandoz Inc. v. Amgen Inc., and preparing now for the strict litigation timelines once the first applications are filed;
• Integrating the monumental changes under the AIA including inter partes review and post-grant review into your biosimilars prosecution and litigation strategies;
• Meeting FDA's requirements for biosimilarity and the heightened standard of interchangeability and communicating with the FDA regarding the open questions from the guidance;
• Determining the potential value of biosimilars revenue and costs of development based on relevant IP, regulatory, and commercial factors;
• Predicting the first biosimilar challenges based on the current biologics pipeline; and
• Ethics: Navigating confidentiality and conflicts issues in the new biosimilars patent exchange process.
In particular, ACI's faculty will offer presentations on the following topics:
• Minimizing the Uncertainty Surrounding the Untested Pathway: Insight into FDA's Current Position and Initiatives Regarding Biosimilars
• Predicting Follow-On Entry and Evaluating the Risk and Commercial Opportunity in the Emerging Biosimilar Landscape
• In-house Keynote: New Kid No More: Evolution in Biosimilars Science and Regulations
• The Holy Grail for Biosimilars: Meeting FDA's Requirements for Biosimilarity and the Heightened Standard of Interchangeability
• FTC Keynote: Revisiting Competition Issues in the Follow-on Biologics Arena: Substitution and Naming Conventions
• Framing the State Law Issues: Attributing Adverse Events and Applying Interchangeability on the Pharmacy Level
• Industry Round Table: Weighing in on the Emerging Controversy on Biosimilars Naming and State Substitution Laws
• The EU Experience: Regulatory and IP Lessons Learned So Far from the First Biosimilar Antibody Approval in Europe
• Analyzing the Arguments in the First BPCIA Case, Sandoz Inc. v. Amgen Inc.: Immediate Action Plans for Innovators and Biosimilars to Prepare Before the First Application is Public
• The Most Powerful Tool in Your Arsenal: Using Inter-Partes Review at the PTO to Revamp Branded and Biosimilar Litigation Strategies
• Going Beyond the Hatch Waxman Comparisons: Delving into Pre-Suit Due Diligence and Pre-Litigation Tactics for Evaluating Patent Strength and Assertion Strategies
• Platform Patents and Antibodies: Specific Action Plans to Protect or Defend Patents Most Ripe for a Biosimilars First Wave Challenge
• Key IP Case Law Through the Biosimilars Lens: Top 5 Patent Battles to Consider When Updating Your Biosimilars Prosecution and Litigation Strategies
• Case Spotlight: Momenta v. Amphastar and Bioequivalence: Understanding the Implications for the Future of Biosimilars -- to be presented in part by Patent Docs author Kevin Noonan
• Timing is Everything: Managing the Logistics of the BPCIA Exchange Process and Preparing for "Early" and "Late" Phase Litigation
• Ethics in the Biosimilars Realm: Avoiding Conflicts and Maintaining Confidentiality in the Brave New World
Two pre-conference primers will be held on June 4, 2014. The first, entitled "Biosimilars 101: Comprehensive Deep Dive Into the Relevant Legal, Regulatory and Scientific Factors Companies Must Know," will be offered from 9:00 am to 12:00 pm, and the second, entitled " Biosimilars Around the World: A Regulatory and Patent Cheat Sheet to Maximize Global Biosimilars Market Share and Minimize Risk," will be offered from 1:30 pm to 4:30 pm.
The agenda for the Biosimilars conference can be found here (Day 1) and here (Day 2), and additional information about the pre-conference primers 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 pre-conference primer), or $3,295 (conference and both pre-conference primers). Those registering by May 16, 2014 will receive a $200 discount. Those interested in registering for the conference can do so here, 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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