A Q&A with Zahra Mahmoudjafari on building successful cell and gene therapy programs

Earlier this year, Zahra Mahmoudjafari, Pharm.D., MBA, clinical pharmacy manager for hematologic malignancies and cellular therapeutics at the University of Kansas Cancer Center, and her coauthors published “From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs.” The study looks at the strong infrastructure and scientific innovation that’s critical to the success of cell and gene therapy (CGT) programs.

In an interview with Managed Healthcare Executive, Mahmoudjafari shared her insights on common readiness gaps, pharmacy’s central role, program design, payer engagement and lessons from the University of Kansas Cancer Center.

This first half of our interview has been edited for length and clarity.

MHE: Your study shows that strong infrastructure, not just scientific innovation, determines whether CGT programs succeed. For health system leaders looking to launch these programs, what readiness gaps do you see most often, and which pose the greatest risks to patient safety or financial stability if overlooked?

Zahra: So what I see most often is that we have an overemphasis on the therapy and the clinical innovation of the therapy, which is extremely exciting, and I don’t want to discredit that. It’s often treating potentially rare diseases or more prevalent diseases, but there’s often an underinvestment in the system around it.

Some common readiness gaps include fragmented ownership across departments, immature workflows for referral and prior authorization, and underdeveloped financial modeling that doesn’t account for cash flow timing, denied claims or patient attrition.

The greatest risks to patient safety come from unclear escalation pathways, lack of appropriate outpatient monitoring and limited staff experience with therapies that have unique toxicities. Financially, some organizations treat CGT like traditional oncology reimbursement without understanding the risks for site-of-care product acquisition and maybe even potentially payer carve-outs. Programs fail not because the science doesn’t work, but because the infrastructure can’t absorb that complexity.

MHE: What does it look like in practice to stand up a CGT program? Does it require dedicated space or specialized equipment? How large should the team be? Which roles need to be dedicated, and which can be shared across departments?

Zahra: Launching a program is less about building something entirely new and more about intentionally designing or redesigning what already exists. Dedicated physical space can help, especially for outpatient cell therapy, but it’s not always required at the start. What’s required is access to infusion areas, proper cold chain handling and clearly defined patient flow.

Team size varies by volume. You don’t necessarily need all new staff at the outset, but you do need clear accountability across program leadership, pharmacy, nursing, financial coordination and data and quality oversight. At KU, shared resources worked initially, but success hinged on clarity of ownership, standardized workflows, and leadership alignment. As volume grows, roles naturally become more dedicated.

MHE: Your framework places pharmacy at the center of these programs. Where should pharmacy leaders be involved early, and what do health systems often underestimate about their role?

Zahra: Pharmacy leaders should be involved early on and before a single patient is referred. They should help with site selection, contract reviews, REMS programs and workflow design. Too often, pharmacy is brought in only after therapy approval, through traditional pharmacy and therapeutics processes.

Pharmacy functions as an operational integrator, coordinating product handling, ensuring regulatory compliance, supporting toxicity management and safeguarding financial stewardship. You know, we're not just about dispensing product anymore. We're really quite anchored in safety, continuity and overall sustainability across the program. So again, demonstrating my bias on that end, but I really believe that pharmacy is well positioned to help in all facets of this program.

MHE: Are health systems beginning to separate CAR T-cell therapy from gene therapy?

Zahra: I think many systems are becoming more deliberate about separating them operationally. CAR T is often housed in cancer centers and linked to existing transplant or cell therapy programs. Gene therapy involves different disease states, patient populations and long-term monitoring. Some centers focus only on CAR T because of payer uncertainty or operational intensity. It really boils down to what the system wants to do strategically and focusing that execution more than just trying to do it all. It just really becomes very center-dependent. You have to think, “What is your patient population? Who am I serving? How do I best serve them?”

MHE: Your study emphasizes workflows for prior authorization, billing and appeals, and preparing finance teams for CGT-specific reimbursement. How should health systems work with payers to make programs viable?

Zahra: I think this space in particular requires partnership, partnership with our industry colleagues but then also with our payer colleagues, and really looking to educate health systems responsible for that education piece. Health systems also educate payers who are catching up with innovation. Success comes from defining coverage pathways, site-of-care expectations and appeal strategies before the first case.

It’s also important to look at aligning coding and billing, modeling best- and worst-case scenarios for each payer, and documenting clearly all help reduce delays. Payers remain a challenge, but they’re no longer this black and white box. Early engagement and transparency improve collaboration and help ensure patients receive the outcomes seen in clinical trials.