Specialty Pharmacy's Critical Role as Advanced Therapies Move Into the Community: Fran Gregory, PharmD, MBA

The advanced therapy pipeline is no longer a niche concern. Speaking ahead of her presentation at Asembia's AXS26 Summit in Las Vegas from April 26 to 30, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, made clear that the field's rapid expansion—from 61 approved therapies today to a projected tripling of that number by 2030—is fundamentally reshaping who needs to be involved in delivering these treatments and how.

Gregory was direct about the scope: advanced therapies now encompass not only cell and gene therapies but also bispecific therapies, sophisticated monoclonal antibodies, and other innovative treatments moving quickly through the pipeline. Critically, some of those therapies are being developed for high-volume conditions like cardiovascular disease and metabolic disorders—populations that will far outpace what academic medical centers can absorb on their own.

"The capacity to actually ensure patient access to these treatments moving forward really needs to expand," said Gregory in an interview with The American Journal of Managed Care® (AJMC®).

That expansion, in Gregory's view, runs through 2 channels: community providers and specialty pharmacy. For community providers who want to administer these therapies, the clinical and operational lift is significant—nursing coverage, triage protocols, and workflow infrastructure—and many are still building toward readiness. For those who are not yet there or who choose not to take on the buy-and-bill model, specialty pharmacy offers an alternative path to keeping patients in their care.

"I almost feel like the specialty pharmacy component is giving a physician's or provider's site a choice," said Gregory.

It is a choice that covers far more than dispensing—securing reimbursement, managing patient logistics, coordinating clinical follow-up, and collecting the long-term real-world data that the field urgently needs.

"Specialty pharmacies are really stepping into a sophisticated role, helping manage any complexity that they can kind of offload from the physician or the provider,” she continued.

The implications extend to patients directly. The easier and less burdensome these therapies are to access, Gregory argued, the more equitably they will reach the patients who need them most.