Across the panels at the recent Meeting on the Mesa in Phoenix, AZ, one pattern stood out. It wasn’t a failing of any one company. Rather, it was a habit of the whole field. We make our fastest progress on problems we know how to engineer: clinical design, manufacturing, automation, and new modalities. Harder problems get less attention because no single player owns them. These include referral, reimbursement, care coordination, and site readiness, and that lack of ownership is exactly why they persist. During our time at the conference, we noticed four themes that make that case.
Referral is the bottleneck, and ownership is the open question. Leaders named the barriers clearly. Community physicians often judge eligibility by their own sense of what a patient can handle rather than by the label. Treatment center experts are too stretched to build those relationships alone. Fixing referral pathways and physician education requires shared investment, and manufacturers are among the best placed to lead it.
Autoimmune developers need a commercialization plan, not just a manufacturing plan. Progress on manufacturing and supply is real. But consider oncology: in lymphoma and myeloma, where relapsed disease is often fatal, only about 2 in 10 eligible patients receive CAR-T therapy. Autoimmune outcomes are more often debilitating than fatal. If urgency is what moves patients through today’s process, what will move autoimmune patients? That question needs an answer well before launch.
Autoimmune CAR-T requires a care team that doesn’t exist yet. In oncology, the doctors who diagnose and the doctors who treat share a specialty. In autoimmune disease, patients are managed by rheumatologists, nephrologists, neurologists, and dermatologists. CAR-T expertise, meanwhile, sits with hematology-oncology and cellular therapy teams, and these groups rarely work together. Treatment centers will likely require external support to bridge that gap.
In vivo is promising, but it doesn’t change how care is delivered. Removing apheresis addresses a real barrier to community adoption. But broad use may be years away, and tens of thousands of patients are eligible today. Reimbursement, patient financial burden, care coordination, and site readiness remain whether the therapy is made ex vivo or in vivo.
None of these barriers is new. Blue Matter and InspiroGene by McKesson laid them out in our e-book, 10 Critical Success Factors for Launching & Commercializing Cell and Gene Therapies. What Mesa showed is where the field still has the most work to do. That includes shaping referral pathways and preparing treatment centers, educating on the disease as well as the technology, and starting commercial planning two to three years before launch. It also means building referral pathways across specialties that have never shared patients.
The common thread is where the eBook ends: CGT commercialization is a systems problem, and it needs a system-level approach. The next leap in patients treated won’t come from a better product alone. It will come from shared investment in the system around it.
In the coming weeks, we’ll share more on how we’re putting that system-level approach into practice.
