Pharmacy leadership is key to building safe and sustainable cell and gene therapy programs

Starting a cell or gene therapy program is about much more than offering a new treatment. Behind each therapy is a complex system of contracts, safety rules, payer agreements and detailed workflows that all have to work together. In the study, “From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs,” Zahra Mahmoudjafari, Pharm.D., MBA, and her coauthors shared what health systems need to build safe and sustainable programs. In an interview with Managed Healthcare Executive, Mahmoudjafari said that strong planning and early pharmacy involvement are essential to making these programs succeed.

Mahmoudjafari, clinical pharmacy manager for hematologic malignancies and cellular therapeutics at the University of Kansas Cancer Center, said she believes pharmacy leaders should be involved before a single patient is referred. She added that pharmacy is typically brought in too late, after a therapy has already been approved and key decisions have been made.

Mahmoudjafari suggested pharmacies should help guide site selection, contract review and workflow design from the start.

“We’re not just about dispensing product anymore,” Mahmoudjafari said. “We’re really quite anchored in safety, continuity and then overall sustainability across the program.”

She said that pharmacists play a much larger role in these programs than many people realize. They help coordinate how products are handled, make sure the center meets regulatory requirements and support the management of serious side effects. Pharmacy teams also educate staff and help oversee the financial side of these high-cost treatments. Because cell and gene therapies are complex and expensive, missing these steps can put both patients and the program at risk.

Related: Strong systems are key to making cell and gene therapy programs work

Mahmoudjafari also discussed how health systems are organizing these services. Cell and gene therapies are often talked about together, but many systems are now separating them in practice.

CAR T-cell therapy is usually offered within cancer centers and often builds on existing transplant programs. Gene therapy, however, may involve different diseases, patient groups and long-term follow-up needs. Some hospitals may choose to focus only on CAR T-cell therapy if they do not treat certain rare diseases or pediatric patients.

She noted that gene therapies can require more long-term monitoring and come with ongoing payer uncertainty. For some centers, it may not make sense to build a full gene therapy program if only a few patients would qualify each year.

Mahmoudjafari concluded by saying that health systems should focus on who they serve and what they can do well. As these therapies continue to grow, she stressed that strong infrastructure and early pharmacy involvement are key to turning medical breakthroughs into real patient care.