Challenges with expansion of cell and gene therapy: A call for system-level action.
Cellular and gene therapy (CGT) has fundamentally reshaped the treatment landscape for a growing range of malignant and non-malignant diseases. Yet the rapid expansion of CGT has also exposed critical institutional and system-level pressures, including constraints in infrastructure and workforce capacity, product manufacturing, patient access, regulatory and data reporting compliance, and long-term healthcare affordability and sustainability. These opportunities and challenges framed the joint plenary session sponsored by the American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), and the European Society for Blood and Marrow Transplantation (EBMT) at the 2026 ASTCT-CIBMTR Tandem Meetings. This proceedings manuscript summarizes the key challenges inherent to CGT expansion, identifies priority areas for coordinated action, and issues a call to the field to address these needs with urgency and shared commitment.