Foley Hoag partners Lance Shea and Brendan Jones will speak at MassBio’s 2025 General Counsel invite only Roundtable, “Exclusivity Explained: Regulatory Protections for Life Science Companies” on September 15th. In today’s competitive life sciences landscape, understanding the nuances of regulatory exclusivity is critical for protecting innovation and maximizing commercial opportunities. This roundtable will provide an in-depth overview of the various forms of regulatory exclusivity available to life science companies, including:
Data exclusivity
Orphan drug exclusivity
Pediatric exclusivity
The discussion will also cover:
How innovator companies at different stages of development can prepare to safeguard their drugs from inappropriately approved generics
The role of ANDA Standards Advocacy (ASA) as an evidence-driven approach to help ensure that generics are truly equivalent to the innovator drug, including when more robust bioequivalence evidence may be required for generics of complex innovator drugs
This comprehensive session is essential for anyone involved in the development, regulation, or market protection of innovative therapies. Attendees will gain practical strategies to ensure robust regulatory protections and maintain the integrity and value of complex pharmaceutical products throughout their lifecycle.
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