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Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation
Session Chair(s)
Alen Agaronov, DRSC
Independent, United States
Multi-stakeholder research reveals why long-term follow-up fails in gene therapy despite new FDA requirements. Patient advocates, clinical researchers, industry leaders, and ethicists examine practical solutions for sustainable evidence generation.
Learning Objective : Identify factors driving growing significance of long-term follow-up (LTFU) in gene therapy; Compare stakeholder challenges and solutions in sustaining LTFU for gene therapy programs; Evaluate strategies to build accountability and align incentives for sustained LTFU participation.
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