In this interview, Joe DePinto, head of cell, gene, and advanced therapies at McKesson, discusses the evolving frameworks, policy advancements, and early commercialization strategies necessary to expand patient access to cell and gene therapies, highlighting the role of specialty pharmacies in reducing care deserts and supporting equitable delivery.

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Joe DePinto: Hi, good afternoon. My name is Joe DePinto. I'm the head of cell, gene, and advanced therapies at McKesson.

How do payer frameworks need to evolve to better support cell and gene therapy access and affordability?

DePinto: The value chain and the science of cell and gene therapy are a bit complex, but getting manageable. Patients, payers, providers, and manufacturers are all working together to navigate these unique frameworks. What we've seen is a variety of different mechanisms and frameworks to better support cell, gene, and advanced therapy access and affordability.

Actually, just two weeks ago, the Center for Medicare & Medicaid Innovation (CMMI) demonstration project was in the news again, with Secretary Kennedy showing that demonstration project in sickle cell as a great example of innovation through the CMMI demonstration project and the Centers for Medicare and Medicaid Services (CMS). Approximately, 35 or so states have already signed up, and [Kennedy expressed] hope that more states would sign up, looking at this demonstration project as an opportunity to take the learnings here in sickle cell and [determine if this could] be expanded to other cell and gene therapy areas that could benefit. That's from the government side.

From the payer side, I think commercial payers are looking at frameworks that look at outcomes, value, and even, perhaps, warranties or unique payment mechanisms that would allow for more patients to get access and for a bit of risk sharing to occur. Those are the exciting frameworks that are being explored in a space that, quite frankly, is really starting to take off.

What role do manufacturers need to play in ensuring seamless integration of cell and gene therapies into existing clinical pathways?

DePinto: The cell and gene therapy space continues to evolve, with our manufacturer partners showing unbelievably strong clinical data in the space. The clinical progress is significant in areas of rare diseases, late-stage hematologic malignancies, and non-malignant hematology.

But we're starting to see an expansion into larger therapeutic areas like autoimmune disease, cardiovascular disease, and neurology. As these larger disease areas come into scope, manufacturers need to understand how that plays out with the product journey, the patient journey, and the payer journey in the transition from clinical to commercial. These larger patient populations will have different challenges and opportunities than perhaps in rare disease and smaller therapeutic areas, more late-stage patients.

It's continuing to evolve. Manufacturers are digging in deep and getting a lot of strong insights from the different journeys that the patient has, the product has, and also the reimbursement journey.

What infrastructure or policy advancements are needed over the next 3–5 years to support sustainable growth in CGT?

DePinto: The cell and gene therapy market is nascent. It's still in the early days of the commercial evolution. The Alliance for Regenerative Medicine has predicted that by 2030, we'll see an additional 10 blockbusters in the cell and gene therapy space, and they define blockbuster as $1 billion in revenue.

The prognostication that's occurring is that we will see 10 to 20 approvals every year from now through 2030. Obviously, when you have all those approvals and all that upside opportunity, it's a lot different than when you have 4 to 10 to 15 approvals. Currently, this year, we're looking at more than 40 approvals in cell and gene therapy, so the infrastructure, policy, operational flows, clinical flows, and financial flows all have to evolve.

Like any evolving space, this is a market that's really starting to move from clinical to commercial. In doing so, the infrastructure and policies all have to be shaped to support the patient access for those products.

How can early collaboration with stakeholders—like specialty pharmacies or providers—help de-risk commercialization efforts?

DePinto: I'm asked often about cell and gene therapy commercialization and some of the best practices. The first one I always go to is starting your market access and commercialization planning early, at pivotal trial time, when you feel like the product is tracking well. It's never too early, simply because this isn't a small molecule, this isn't a biologic.

Typically, there is some complexity of delivery of these products, so the earlier you get started, the better off [you are] in understanding not only the current space in the disease area but what the future state upon launch will be, and how you optimize the position of the product in the space so that the appropriate patient gets access to the product at the right time and in the right fashion.

One of the biggest variables I can say here that will assure the best chance for success is not starting late in your planning process and ensuring it's interdisciplinary. What I mean by that is make sure you have multiple stakeholders inside the manufacturer company working on this: clinical, technical operations, commercial market access, and the payer groups. They all need to work in a coordinated fashion as you think about the market access and commercialization planning process.

What key takeaways from your panel do you hope resonated most with the audience?

DePinto: I was really pleased with the panel that we had on Tuesday afternoon at Asembia 2025. It was great to have Dan Kirby from Iovance and Rocky Billups from HCA and Sarah Cannon talking about the commercialization progress that we're seeing in the space. What came away as a key takeaway for me is the critical role specialty pharmacy plays in allowing for sites to have access to cell and gene therapy products.

If you look at the US, many of the cell and gene therapies are being delivered at academic centers, and geographically, they tend to be spread out. We know that patients don't particularly like to travel extended distances, and there are some care deserts. The ability to use specialty pharmacy came out clearly in the panel as a great opportunity to reduce those care deserts and to help centers deliver these products closer to home so patients have the choice to get a cell and gene therapy rather than another therapy that they may be able to use closer to home.

The ability for cell and gene therapy products to be delivered through specialty pharmacy was a common theme that many believe will expand access for patients geographically, that will be better for them and the caregivers that often are involved in the treatment of these patients. All in all, that was a key takeaway that was clear and compelling at the panel.