A panel of advanced therapeutics leaders—Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, Jenny L. Craven, PharmD, BCPS, Elias Pittos, PharmD, BCOP, CSP, and Mark Duckworth, BS—explored the operational, financial, and governance realities of standing up cell and gene therapy programs. The conversation moved through three areas: strategic planning, operational readiness, and financial sustainability.
Meet the Speakers
Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, is the director of pharmacy in advanced therapeutics at the University of Kansas City Health Center in Kansas City.
Jenny Craven, PharmD, BCPS, is the senior clinical pharmacist and pharmacy lead for emerging therapies at University of California (UC) Davis Health.
Ellias Pittos, PharmD, BCOP, CSP, is the medical director of Cell, Gene, and Advanced Therapies at McKesson in Chicago.
Mark J. Duckworth, BS, is the rlinical Research program manager in the Division of Oncology at The Children's Hospital of Philadelphia
On governance, panelists emphasized that success depends less on clinical readiness than on identifying institutional champions across every stakeholder lane — pharmacy, managed care, financial clearance, legal, and clinical teams — and organizing them into a centralized steering structure with clear accountability. Ethicists and contracting teams were flagged as groups that frequently get left out early on.
On operations, the group addressed SOP development and sustainability, stressing that effective procedures are written by the people who actually follow them, revisited frequently, and supported by dedicated pharmacist leads. The pipeline volume problem — potentially requiring a unique SOP per drug — was raised as a systemic threat to scalability.
On reimbursement, the panel was candid: a decade into CAR-T, payer variability remains the field's most persistent and underestimated challenge. PA approval does not guarantee payment, reimbursement models vary dramatically across payers, and community centers face additional structural barriers that academic medical centers largely do not.
Looking ahead, the group expressed optimism about allogeneic and in vivo therapies streamlining delivery and expanding community access, while flagging that volume growth and evolving reimbursement models may require rethinking the buy-and-bill paradigm entirely.
