17th ACI Summit on Biosimilars & Innovator Biologics

Axinn partners Rebecca Clegg and Matt Murphy will speak at American Conference Institute’s Summit on Biosimilars & Innovator Biologics, being held June 2-3 in New York.

Rebecca will speak on the "The Future of Biosimilars and Recent Developments Concerning the Interchangeability Designation: Policy Shifts, Market Incentives & Regulatory Uncertainty" panel. Panelists will discuss:

• Assessing the IRA’s future and its impact on pricing and competition
• Evaluating whether FDA will adopt a less-stringent review process under new leadership
• Examining recent changes in the FDA’s approach to interchangeable Biosimilars and the impact thereof
• Unpacking recent developments and current trends relating to interchangeable biosimilars and implications for the future

Matt will speak on the "Manufacturing Patents as the New Battleground: Protecting Biologics Manufacturing" panel. Panelists will discuss:

• Antibody production technology overview
• Drafting durable manufacturing claims to avoid design arounds and/or overbreadth while preserving enforceability
• Factors to consider for trade secret protection of manufacturing patents
• Coordinating protection strategies with regulatory submissions
• Utilizing litigation over process patents

Click here for more information, including how to register.