Cell and gene therapies hold immense promise in revolutionizing patient care for life-threatening conditions; however, their journey from development to market is multifaceted and intricate. A critical aspect is the long-term follow-up (LTFU) required post-treatment, often spanning up to 15 years. In this paper, we delve into essential clinical, data and operational considerations specific to gene therapy LTFU. Read the Insight Brief that explores innovative approaches to ensure patient-centered outcomes and address the challenges inherent in monitoring these transformative therapies over extended periods.