CGT Panel: Building an Advanced Therapeutics Program Takes More Than Clinical Readiness

Building an advanced cell and gene therapy (CGT) program takes far more than clinical readiness, according to panelists who tackled the operational, financial, and governance challenges of chimeric antigen receptor (CAR) T-cell, tumor-infiltrating lymphocyte (TIL), and gene therapy delivery in a recent panel discussion.

Moderator Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, the director of pharmacy in advanced therapeutics at the University of Kansas City Health Center, opened by noting that despite the clinical promise of these therapies, most institutions' infrastructure to deliver them remains immature. Panelists Elias Pittos, PharmD, BCOP, CSP, medical director of cell, gene, and advanced therapies at McKesson; Jenny Craven, PharmD, BCPS, senior clinical pharmacist and pharmacy lead for emerging therapies at University of California Davis Health; and Mark J. Duckworth, senior director of cellular and gene therapy operations at The Children's Hospital of Philadelphia, shared perspectives shaped by pharmacy, payer strategy, and enterprise operations.

A recurring theme was that institutions often underestimate complexity, assuming these products can be ordered like conventional drugs. Duckworth stressed identifying internal experts across clinical, operational, and financial pillars and building a centralized governance structure, including overlooked voices like ethicists and legal teams. Craven emphasized starting small and leaning into institutional strengths rather than waiting for a fully built-out program, while Pittos highlighted that community hospitals face steeper readiness gaps than academic medical centers due to limited infrastructure for apheresis, toxicity management, and accreditation.

On sustainability, panelists agreed that standard operating procedures must be built collaboratively with frontline teams and revisited regularly, with single accountable owners preventing breakdowns during staff turnover. Reimbursement emerged as the greatest challenge: Pittos cited research showing roughly 60% of physicians flag financial constraints as access barriers, while Craven noted treatment delays caused by missing permanent billing codes for newly approved therapies.

Looking ahead, panelists anticipate allogeneic and in vivo therapies will simplify delivery but warned that current "buy and bill" reimbursement models may need fundamental change. Their closing advice emphasized dedicating staff to CGT programs, understanding payer coverage vs payment realities early, and treating CGT as an enterprise initiative rather than a single service line.