Community oncology wants CAR-T and bispecifics — here’s the infrastructure it takes to deliver them safely | HSES 2026

According to the National Cancer Institute, 2.1 million people in the United States receive a cancer diagnosis annually, while an estimated 626,140 people will die of cancer. While it sadly isn’t a cure-all, the use of CAR-T cell therapies, which are immune cells that are genetically engineered to target cancer cells have made a significant difference in outcomes, particularly in blood cancers. Furthermore, a study published in the Journal of Clinical Oncology confirmed one of the first Food and Drug Administration-approved CAR-T cell therapies offered long-term survival and remission in patients who battled relapsed or refractory large B-cell lymphoma— years after treatment.

The biggest issue facing CAR-T cell therapy is one that plagues many other areas of innovative healthcare: accessibility and affordability. There is currently 74 NCI-Designated Cancer Centers, located in 37 states and the District of Columbia as well as over 150 medical centers that offer CAR-T. A simple math equation immediately can highlight just how big of a disparity that is.

Expanding into community hospitals and health systems is the logical next step, but how should they handle the practical side of delivering this high-complexity treatment? CAR-T in particular requires specialized staff training to manage severe side effects (cytokine release syndrome, neurotoxicity), careful patient monitoring, and coordination with the academic centers that manufacture the modified cells — which not every hospital is equipped to do safely.

In a panel discussion at the Health System Executive Summit, moderator Melody Chang, RPh, BCOP, MBA, vice president of pharmacy operations at American Oncology Network, was joined by panelists Wafa Samara, PharmD, vice president and chief pharmacy officer at City of Hope, and Timothy Tyler, PharmD, to discuss the operational realities of delivering bispecific antibody and CAR-T cell therapy in community oncology settings.

“The true north is making sure that we deliver the right medication to the right patient, at the right location and the right time,” said Wafa Samara, PharmD, vice president and chief pharmacy officer at City of Hope. “We know that there’s a lot of complication that comes with bispecifics and CAR-T. So the foundation is making sure that you have the framework for delivering safe care.”

Building CAR-T capacity

City of Hope’s approach has centered on building infrastructure before expanding access. Samara said standardization is what makes it possible to deliver the same quality of care “regardless of where you live” — whether that’s 100 miles from an academic medical center or in an underserved zip code. Defined eligibility criteria, staff training and an escalation process worked out in advance of treating a patient, not improvised afterward, is what will make a difference. Pharmacy sits at the center of that framework. At City of Hope, Samara said 90% of pharmacists are oncology-certified — the highest rate in the nation — and work under collaborative practice agreements that give them prescribing authority.

Community practices without that scale are building toward similar capacity differently. Chang said American Oncology Network, a network of 144 independent, outpatient clinics across 20 states, launched its outpatient bispecific program in April 2025. Eighty-seven percent of its practices now offer bispecifics, and 70% of those administer them, including step-up dosing and observation, entirely outpatient — roughly 5,000 doses delivered so far. The network started its CAR-T program three months before the panel, with one patient already treated outpatient and a second scheduled.

What community oncology needs

Both panelists pointed to the same structural requirement: a community program needs a hospital partner before it can safely administer CAR-T or bispecifics outpatient, and that relationship has to be built in advance, not discovered during a crisis.

Tyler, whose program has held prescriptive authority since 2007 and has managed infusion reactions in-house ever since, said his team has spent years educating emergency room staff on recognizing and escalating cytokine release syndrome and neurotoxicity, since oncology patients’ needs don’t stop when the ER’s regular rhythms do.

Samara noted the escalation pathway — who to call, which hospital to use, how the patient gets handed back once stabilized — has to be defined before a program goes live. Formal agreements that patients return to their referring practice once stable, she said, are what let community programs refer out without fear of losing the relationship for good.

Chang’s network built a wristband with a QR code linking to grading and management protocols for treatment-related toxicities, giving patients, caregivers, and outside hospital staff a shared reference in an emergency. She said AON spent six months preparing before its 2025 launch and has revised its standard operating procedure through roughly a dozen versions since, including after an FDA label update changed monitoring requirements for one agent.

All three speakers agreed that expanding access doesn’t mean treating every patient in the community — patient selection, caregiver support, and social determinants of health all factor into candidacy.

“Cancer is the competition — we’re not competing with each other,” Samara said, framing collaboration between academic and community sites, rather than competition for patients, as what will ultimately get bispecific and CAR-T therapy to more people.