Roundtable Discussion: Extending the Lifecycle of Oligonucleotide Therapeutics: Strategic Considerations to Maximize Product Value Beyond Approval

Key questions to be addressed:

• Defining lifecycle management strategies to extend product longevity and delay generic entry while maintaining regulatory compliance
• Leveraging CMC changes and control strategy evolution to support product differentiation and sustain competitive advantage
• Aligning scientific, regulatory, and commercial priorities to maximize product value across late-stage development and commercialization
• Identifying key risks and trade-offs when implementing lifecycle strategies, including comparability, regulatory burden, and market impact

Speakers:

George Bou-Assaf

Associate Director

Biogen