Building CAR T-Cell Therapy in the Community: The Operational Blueprint for Success

In an interview with Pharmacy Times, Cassandra Perkey, PharmD, BCOP, regional clinical pharmacist at American Oncology Network, discussed the operational groundwork community oncology practices must complete before administering CAR T-cell therapy to their first patient.

Perkey emphasized that the first step is establishing a dedicated, multidisciplinary cellular therapy team. This group should include a physician champion, nursing leadership, a CAR T-cell coordinator, financial personnel, and well-trained pharmacy staff. Each member must have clearly defined responsibilities, particularly because CAR T-cell therapy requires close coordination among the clinic, manufacturers, payers, and hospital partners. Pharmacy staff must also be prepared to manage chain-of-custody requirements, temperature monitoring, product storage, thawing, and preparation before infusion.

She also highlighted the importance of developing comprehensive standard operating procedures that cover the full treatment journey, from patient identification and eligibility assessment through infusion, adverse event management, and long-term follow-up. These SOPs should establish clear protocols for managing cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome, as well as expectations for communication with partner hospitals. Clinics must also determine whether they have staff available around the clock to monitor patients and communicate with caregivers during the high-risk early postinfusion period, including weekends and holidays.

According to Perkey, practices may underestimate how long the onboarding process can take. Developing SOPs, meeting manufacturer requirements, completing approval processes, and preparing staff may require several months. Clinics must also devote substantial time to planning meetings and coordination.

Financial readiness is another major consideration. Because CAR T-cell therapies are highly expensive, practices must work closely with manufacturers and payers to secure authorization, complete contracting requirements, and determine whether offering treatment is financially sustainable. Perkey advised clinics to begin planning well before identifying an immediate patient need, as patients may otherwise require referral to another treatment center while the program is being established.