Bridging the gap in cell and gene therapy: addressing operational and financial barriers to achieve sustainable access.

Cell and gene therapies (CGTs) represent a major transformation in modern medicine, offering the potential for cure in patients with serious and treatment-refractory diseases. However, despite this promise, real-world delivery remains highly constrained. This white paper synthesizes insights from a multidisciplinary advisory council of 21 healthcare professionals involved in CGT delivery, together with the authors' collective experience, to examine operational and financial barriers from a provider perspective and to identify strategies to support sustainable expansion of CGT programs across diverse care settings. While clinical management of CGTs has become increasingly standardized, operational and financial barriers continue to impede broader implementation. Product onboarding can often be a complex process, as treatment sites must navigate manufacturer-specific site qualification processes, quality standards, and compliance requirements that can result in significant administrative burden. At the same time, reimbursement processes remain complex and variable across payers, with high upfront costs and inconsistent coverage and reimbursement models that can contribute to institutional financial risk and treatment delays. Drawing on provider experiences and advisory council discussions, this white paper identifies opportunities to improve the sustainability and scalability of CGT delivery. Key priorities include greater standardization of manufacturer onboarding and contracting processes, improved reimbursement predictability, and enhanced alignment among manufacturers, providers, and payers. Addressing these challenges may help reduce administrative burden, mitigate financial risk, and support streamlined implementation of CGTs across both academic and community settings.