• Minimizing the Uncertainty Surrounding the Pathway: Insights Into USFDA’s Current Initiatives Regarding the First Wave of Biosimilars Applications
• Evaluating the Risk and Commercial Opportunity in the Emerging U.S. Biosimilars Landscape
• In-House Keynote Address
• Timing is Everything: A Cheat Sheet for Managing the Logistics of the BPCIA Exchange Process
• Biosimilars Litigation Spotlight: Immediate Action Plans for Innovators and Biosimilars to Prepare For the Battles to Come
• Incorporating Inter-Partes Review and New USPTO Procedures Into Branded and Biosimilar Litigation Strategies
• Open Floor Session: Lessons Learned so Far: Comparing and Contrasting the US and EU Biosimilars Experience
A pre-conference boot camp, entitled "Biosimilars 101: Essential Training for EU Pharmaceutical Lawyers on the Relevant US Regulatory and Legal Landscape," will be held on April 20, 2015. The boot camp will offer presentations on the following topics:
• Diving Into the Science of Biologics and Biosimilars: What Counsel Needs to Know to Formulate a Regulatory and Patent Strategy
• Understanding the Structure of the USFDA and Its Role in Approving and Regulating Biosimilars
• Delving into the Mechanics of the USFDA Biosimilars Approval Process and Section 351(k) Applications Under the Pathway
• Mastering the Essentials of New USPTO Post-Grant Proceedings For Effective Use in the Biosimilars Space -- to be presented in part by Patent Docs author Kevin Noonan
• Obtaining Adequate Patent Protection in the US: Factoring Key Cases into Your Biosimilars Patent Strategy
• US Federal Trade Commission and State Law Updates: Understanding the Controversy Surrounding Competition, Substitution, and Naming in the Biosimilars Arena
The agenda for the U.S. Biosimilars conference can be found here, and additional information about the pre-conference boot camp 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 €1195. Those interested in registering for the conference can do so here.