#649: Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation

Wednesday, June 17, 2026 4:00 PM to 5:00 PM · 1 hr. (America/New_York)
119AB
05: PersonalizedMed-ComboProd-Diagnostics

Information

Multi-stakeholder research reveals why long-term follow-up fails in gene therapy despite new FDA requirements. Speakers across patient advocacy, clinical research, and medical ethics examine the social conception of long-term follow-up, its challenges, and practical solutions for sustainable participation and evidence generation.
CE
ACPECMERN
Session Level
Basic
Featured Topics
Evidence InnovationTherapeutic Pathways
Learning Objectives
Identify scientific, operational and regulatory factors driving the growing significance of long-term follow-up (LTFU) in gene therapy; Compare stakeholder challenges and solutions in sustaining LTFU participation and data quality for gene therapy programs; Evaluate strategies to strengthen accountability and align incentives to ensure sustained LTFU participation.

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