American Conference Institute is holding their 5th annual "Biosimilars" conference in New York on June 5-6. Speakers include in-house counsel from Eli Lilly, Mylan, Sandoz, Amgen, AbbVie, Momenta, J&J, and Actavis. Also speaking will be representatives of the Federal Trade Commission, GPhA, and PhRMA.
The agenda includes the following presentations:
- 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
- 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
- The Importance of Biologic Manufacturer Accountability: Key Policies for Biologic Substitution and Nonproprietary Names
- 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 v. Amgen: 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 Reveiw 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
- 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
ACI is also offering a pre-conference primer on June 4 that includes two sessions: "Biosimilars 101: Comprehensive Deep Dive Into the Relevant Legal, Regulatory, and Scientific Factors Companies Must Now" in the morning and "Biosimilars Around the World: A Regulatory and Patent Cheat Sheet to Maximize Global Biosimilars Market Share and Minimize Risk" in the afternoon.
For more information or to register, please visit the conference website.