Cell and gene therapies are advancing rapidly, with 33 FDA approvals to date and 2,000+ global trials in progress. Success depends on navigating complex regulations, managing long-term safety follow-up, and leveraging expedited pathways like fast-track and orphan drug designations. Platforms include cell therapies, gene therapies, CAR-T, gene editing, and RNA therapies, each with unique clinical and operational demands. Challenges span patient identification, complex manufacturing, trial execution, and long-term monitoring up to 15 years. IQVIA Biotech’s integrated teams align regulatory, clinical, and operational strategies to accelerate development, ensure compliance, and optimize delivery.

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