AXS2026: How Specialty Pharmacies Support Advanced Therapy Access in Community Settings

In an interview with Pharmacy Times at Asembia’s AXS26 Summit, Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discussed the rapid expansion of the advanced therapy pipeline, including cell and gene therapies, bispecifics, and individualized neoantigen treatments. She emphasized the critical need to transition these complex therapies from academic medical centers into community-based settings to improve patient access. Gregory highlighted how specialty pharmacies are evolving to provide the essential clinical, operational, and financial support that community providers require to manage high-cost, high-complexity products. The conversation underscored the importance of collaboration between manufacturers, providers, and specialty pharmacies to bridge gaps in the care continuum and streamline the delivery of lifesaving treatments.

Pharmacy Times: Can you introduce yourself and explain your current role?

Fran Gregory, PharmD: Hi, everyone. My name is Fran Gregory. I am the vice president of emerging therapies at Cardinal Health. What that means is that I oversee our advanced therapy solutions team, which focuses on high-cost, complex therapies like cell and gene therapies, and I also cover our biosimilars team.

Pharmacy Times: Your session covers a lot of ground—what is the one insight you most want attendees to walk away with?

Gregory: I think the main insight that I'd like attendees to walk away with—although you're right, we are covering a broad range of topics—is really the need to improve patient access with advanced therapies. I'll be talking about the advanced therapy pipeline, some of the challenges to adoption, and, most importantly, steps toward solutions. I'll also discuss the future of advanced therapy. I have a lot of data-heavy slides for the audience, which they typically love, and I really want the audience to take away how the pipeline of advanced therapies is growing exponentially over time.

This pipeline does not only include gene and cell therapies, but we're also focused on innovative therapies like bispecifics, TIL [tumor-infiltrating lymphocyte] therapies, oncolytic vaccines, or individualized neoantigen therapies—the broad spectrum of what we consider advanced therapies—and how those will impact not only the market, but providers who want to administer these products and, ultimately, patients. Joining me will be Leigh Denny, [PharmD,] the senior director of value and evidence at Johnson & Johnson, and also Philip Marjon, [MD,] a physician from the California Cancer Associates for Research and Excellence. They're going to pull in those pieces of how the manufacturer views the landscape of advanced therapies and how important it is for us all to work together with providers and patients to improve access across more than just those academic medical center channels. We're really excited to share with the audience the importance of improving patient access to the treatments that these patients need.

Pharmacy Times: How are specialty pharmacies evolving their role as advanced therapies move into community settings?

Gregory: This is really the crux of our presentation. We are helping the audience understand why specialty pharmacy involvement is so important and why this is a critical time in the evolution of advanced therapies and specialty pharmacies. If we think about advanced therapies—cell therapies, gene therapies, and many other highly complex biologic treatments—these treatments expand beyond academic medical centers. We really want to see them move into outpatient and community-based settings because we know we will see this movement, and we're already beginning to see it.

These providers need support. They need clinical support, they need operational support, and they need financial support. Some of these providers in the community setting will be very comfortable buying and billing these high-cost products, but there may be some providers who do not have the operational components in place or who may not have the financial confidence to have an accounts receivable on their books for $400,000 to multiple millions of dollars. That's where specialty pharmacies are really coming into play and stepping up to help community providers manage some of those complexities associated with the operational, financial, and clinical components of managing these patients in various settings.

Pharmacy Times: Where do you see the biggest gaps in how manufacturers, providers, and specialty pharmacies are currently collaborating?

Gregory: When we think about these extremely complex treatments, there are fragmentations and gaps across the care continuum. Unfortunately, when we look at the manufacturing process, some of these products are made for one patient from one patient's cells, and that process can take from days to weeks—sometimes even months—for that manufacturing to be completed. That time lapse can be challenging for the patient's well-being. Some of these patients are at their last line of treatment, kind of their last hope. We want to get that manufacturing process as efficient as possible, minimizing the number of days from where the provider is diagnosing and prescribing the advanced therapy to when the patient actually receives it.

Manufacturers are hyper-focused on solving some of those challenges. We'll hear from a lot of manufacturers at assembly and elsewhere, where they're focused on making those processes more efficient and even evolving their science so that these treatments aren't necessarily one patient to one treatment. For example, allogeneic therapies could allow many patients to be treated with the cells from one donor. We're looking at how we get the treatment to the patient more quickly when it comes to those extremely advanced cell and gene therapies.

When we look at some of the less complex but still sophisticated types of treatments—like your bispecifics, your BiTE [bispecific T-cell engager] therapies, or your individualized neoantigen therapy—these treatments may require a dosing regimen where the patient is required to continue to receive infusions on a very specific schedule. This is where that provider component really comes in. Most providers are very capable and competent clinically, but we need to help those who are newer to administering these complex therapies bridge that gap between their clinical desire to treat patients and the question of, “How do I make that happen in my practice?"

Those are some of the gaps that we are addressing currently—helping those providers fill in gaps that may be operational, financial, or clinical in nature. That's really where the specialty pharmacy piece comes in as well. Specialty pharmacies have provided wonderful clinical support and fulfillment programs for years, but we're seeing a much more sophisticated model here. This includes Cardinal Health specialty pharmacy, which will fill a gap in these extremely niche therapeutic categories and products that require a very sophisticated clinical team, financial diligence, and operational expertise to help these providers get those patients access as quickly and efficiently as possible.