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1、White PaperFuture-Proofing Long-Term Follow-Up in Cell&Gene Therapy A patient-centered,data-driven approachDIEGO CORREA,VP and Global Head,CAGT Center of Excellence,IQVIAIAN BONZANI,PhD,Senior Principal Real World Technology Solutions,IQVIABARBARA ARONE,MSc,VP Medical Affairs,Real World Solutions,IQ

2、VIAJIP KLERKS,MSc,Product Strategy Lead Medical Affairs,Real World Solutions,IQVIAB|Future-Proofing Long-Term Follow-Up in Cell&Gene Therapy:A Patient-Centered,Data-Driven ApproachTable of contentsIntroduction 3Challenges in executing CAGT long-term follow-up studies 3How to overcome LTFU challenges

3、 6Patient-centered,journey-driven design 6Enriched data collection using real-world sources and registries 8Digital and decentralized tools to reduce burden 10Designing for adaptability and longevity 12Future vision:Toward more efficient and scalable LTFU 13Industry collaboration and shared registri

4、es 13Seamless integration with routine care 14Smarter analytics and AI 14Lifecycle-based LTFU models 14Regulatory leadership and advocacy 15References 16 |3As cell and gene therapies(CAGTs)advance toward curative potential,long-term follow-up(LTFU)has become a regulatory cornerstone for ensuring sus

5、tained efficacy and safety.CAGTs carry uncertainties that only years of observation can resolve.1 When a patient receives cell or gene therapy,the treatment marks the beginning of a long-term journey.Regulators worldwide mandate that patients treated with gene therapies are monitored for 5 to 15 yea

6、rs to track delayed side effects and sustained efficacy.2,3 Tracking patients over extended periods can become costly and lead to operational challenges if not managed efficiently.With over 3,000 cell and gene therapies in development globally and dozens of new launches expected each year4,the stake