Cell and gene therapies (CAGT) are shifting from oncology into autoimmune disease, bringing new opportunities but also unique challenges. Success requires a clear playbook covering regulatory engagement, complex trial design, site readiness, patient recruitment, and logistics management. Autoimmune trials often involve multidisciplinary coordination and patient-centric approaches, as chronic disease patients weigh risks differently than cancer patients. Sponsors must also plan early for commercialization, addressing payer concerns and market competition. With robust strategies, CAGT can deliver transformative treatments and improve quality of life for patients with unmet needs.

Join for free to read