The Children's Hospital of Philadelphia

Building the Plane While Flying It: Operational Realities of Cell and Gene Therapy Program Development

- A panel of advanced therapeutics leaders discussed strategic planning, operational readiness, and financial sustainability for cell and gene therapy programs at academic medical centers. - Panelists emphasized that governance success depends on identifying institutional champions across pharmacy, managed care, financial clearance, legal, and clinical teams organized into a centralized steering structure. - Payer variability remains the most persistent challenge a decade into CAR-T therapy, with prior authorization approval not guaranteeing payment and reimbursement models varying dramatically across payers. - The panel expressed optimism about allogeneic and in vivo therapies streamlining delivery and expanding community access, while flagging that volume growth may require rethinking the buy-and-bill paradigm.