New York City Bar Association
New York, NY
Venable is sponsoring ACI's 15th Summit on Biosimilars and Innovator Biologics, to be held at the New York City Bar Association, New York City, on June 20-21, 2024. Partner Alicia Russo will be speaking on the panel "Implications for Product Launch and Market Exclusivity: Decoding In Re Cellect, USPTO Guidance on Patent Term Adjustments and OTDP," and partner Jeremiah Kelly will be speaking on the panel "Adapting to Regulatory Shifts in Approval Pathways, Labelling, and Staying Ahead of Induced Infringement.”
Jeremiah and his fellow presenter will discuss the following:
- Crafting successful BLAs; reviewing the FDA’s draft guidance on diversity in clinical trials
- Proactively assessing manufacturing for compliance with applicable laws and regulations, with the goal of passing the FDA’s pre-approval inspection; approaches for effective manufacturing monitoring and compliance outside of the U.S.
- Navigating the FDA’s attempts to streamline data requirements for biosimilarity and interchangeable status; identifying the data required by FDA to approve biosimilars for use in specific indications or populations without direct clinical trials and considering the role switching studies currently play in the approval process and evaluating their necessity
- Evaluating the impact that interchangeable status has on market uptake; comparing conflicting state laws on interchangeability
- Unpacking the updated FDA labeling recommendations; understanding when information can put you at risk for infringement claims regardless of labeling revisions have been approved by FDA as part of a skinny label
- Analyzing the evolving jurisprudence for induced infringement of follow-on biologics
The agenda can be found here.
Interested in attending? Register here.