CAR-T has a geography problem

When Sam Neill announced he had received CAR-T cell therapy and was in remission, the coverage was celebratory and rightly so. A beloved actor. A remarkable outcome. A story about what modern medicine can do.

But buried in that story was a detail worth sitting with: Neill accessed treatment through a clinical trial. He didn't pay the privately listed price of over $400,000. He was connected to a programme. He was in the right place, at the right time, with the right referral.

Most patients aren't.

That gap, between what CAR-T can do and who can actually get it, is the defining challenge of this field right now. And it's not a scientific problem. The science is working. The access model isn't.

Approved is not the same as accessible

Several CAR-T therapies have received regulatory approval in major markets. On paper, they exist. In practice, for a significant portion of eligible patients, they remain out of reach.

Research published in Blood Advances has consistently shown that geographic distance from a qualified treatment centre is one of the strongest predictors of whether an eligible patient receives CAR-T therapy at all. It's not biology. It's not clinical ineligibility. It's location. It's whether the oncologist knew the programme existed. It's whether the hospital had a referral relationship. It's whether the manufacturing slot was available in time.

CAR-T is not like filling a prescription. It requires a coordinated system: cell collection, vector supply, cell engineering, quality control, cold-chain logistics, clinical delivery, and intensive patient monitoring. Each one of those steps is a potential point of failure. And the current infrastructure was built to serve a relatively small number of patients at a relatively small number of highly specialised centres.

That was the right model to get the first generation of therapies approved. It is insufficient to get them to the broader patient population that would benefit.

Manufacturing is a patient access issue

The industry tends to treat manufacturing as a back-end operational concern. For advanced therapies, it isn't. In cell and gene therapy, manufacturing determines access. It shapes cost, turnaround time, which sites can participate, and ultimately which patients can be reached.

Lentiviral vectors are a useful lens here. They are critical raw materials for a large proportion of CAR-T and other cell therapy programmes. When vector supply is constrained, expensive, or difficult to customise, it creates a bottleneck that stalls development long before a therapy ever reaches a patient. For academic medical centres or smaller developers working outside major pharma infrastructure, that bottleneck can end a programme entirely.

Workflow design has the same effect. A manufacturing process engineered exclusively for a high-complexity industrial facility cannot easily be transferred to a hospital-adjacent site or a regional centre. That limits the number of places therapy can realistically be delivered. And if access is concentrated around a handful of institutions, patients who don't live near them are, functionally, excluded.

The field needs to shift from industrialisation to operationalisation. That means building systems that are not just scientifically rigorous, but practically transferable, i.e., standardised, reproducible, and deployable closer to where patients are. It means treating technology transfer as an early design requirement, not something in-process and later. And it means taking point-of-care and near-patient manufacturing seriously as a path toward broader reach, not just a theoretical future state.

The information gap compounds the access gap

There is a second problem layered on top of the manufacturing one, and it is less discussed: the people who most need to act on information about this field are often the last to receive it.

The most consequential conversations in cell and gene therapy, about manufacturing advances, lower-cost vector supply, new trial designs, and emerging access pathways, are largely happening in closed industry settings. Little to no press; no patients (sometimes and rarely, patient advocates); no clinicians. The developers, manufacturers (i.e., solution providers), investors, and those connected with regulatory bodies in the room understand what is changing. The oncologist treating an eligible patient three states away does not.

That information asymmetry has direct clinical consequences. If a physician doesn't know a trial is open, the patient never gets referred. If an academic medical centre doesn't know that lower-cost manufacturing infrastructure now exists, a programme that could launch doesn't. With over 3,200 cell and gene therapy trials currently underway worldwide, and the FDA having introduced a new bespoke gene therapy approval pathway earlier this year, the pace of change is accelerating faster than the information is spreading.

Patient advocacy organisations are doing essential work to bridge this gap, fielding calls from families trying to understand whether a therapy might apply, which centres are enrolling, and what the referral process looks like. But they are carrying a burden that the broader industry should be sharing.

What closing the gap actually requires

None of this requires abandoning what has worked. Centralised manufacturing has a role. Specialised centres have a role. Clinical trials remain essential. But the field cannot treat those as the limit of what's possible, or assume that the current model, in total, is the right one to move the field forward.

Closing the access gap requires a deliberate effort on several fronts simultaneously: lower-cost vector supply that doesn't require large-pharma infrastructure to access; manufacturing workflows designed from the start for technology transfer; clinical and regulatory education that reaches community oncologists, not just academic specialists; reimbursement models built for the actual cost structure of advanced therapies; and connectivity between developers, clinicians, payers, patient advocates, and health systems that do not currently exist at scale.

As CAR-T expands into autoimmune disease, infectious disease, and rare disease, some of which carry larger and more geographically distributed patient populations than the haematologic cancers that established the field, the pressure on the access model will intensify. A system designed for a few thousand patients a year at elite academic centres will not serve what this field is becoming.

The progress being made in vector accessibility, manufacturing flexibility, bioprocessing, and near-patient deployment is real. But progress inside the industry is not the same as access across the healthcare system. If the next phase of cell and gene therapy is going to reach broader patient populations, the conversation must expand beyond scientific feasibility and include manufacturability, transferability, and geographic accessibility as core design priorities, not downstream considerations.

About the author

Michael Kadan, PhD, MBA, is chief operating officer at Vector BioMed. He received his PhD in Biology from The Johns Hopkins University and later obtained an MBA from Frostburg State University. Kadan began his biotech industry career in 1989 with one of the founding companies in gene therapy, Genetic Therapy Inc. In his current role, Kadan brings over 30 years of experience in the development and manufacturing of biologics. He has acquired an in-depth understanding of the CMC related issues important for biologics product development and has contributed to numerous INDs, enabling the clinical evaluation of products ranging from retrovirus, adenovirus, monoclonal antibodies, and lentiviral vectors. Prior to launching Vector BioMed, Kadan’s recent experience includes five years specialising in Lentiviral vector scale-up and manufacturing technology. As director of manufacturing at Lentigen Technology Inc. (a Miltenyi company) he led the implementation of a state-of-the-art platform process for lentivirus production and oversaw the successful completion of hundreds of GMP batches of lentiviral vector destined for human clinical trials.