Evolving With The Patient: Optimizing CAGT Post-Trial Long-Term Follow-Up

By Barbara AroneBarbara Arone, VP of global medical affairs, Real World Solutions division, IQVIA; and Erin FinotErin Finot, MSc, MBA, VP of Immuno-Oncology & CAGT, IQVIA Biotech

The exponential growth of cell and gene therapy (CAGT) in the pharma industry is evident, with nearly a thousand next-generation biotherapeutics in development as of 2022. However, monitoring methods for potential adverse events and secondary malignancies continue to evolve.

As more CAGTs gain approval, sponsors and researchers have the opportunity to gather scientific insights and adjust clinical approaches accordingly. Regulatory agencies like the FDA and EMA have issued guidelines for long-term follow-up (LTFU) studies, lasting from five to 15 years, to address safety concerns. Navigating these longer study durations presents unique challenges, necessitating efficient data collection methods and flexibility to adapt to evolving patient journeys and regulatory landscapes.