By Ignacio Urdaneta, Consultant and Shannon McElroy, Senior Consultant
Cell and gene therapy has long been framed as a scientific frontier problem: improve durability, manage toxicity, expand into earlier lines, and eventually move beyond hematologic malignancies. But the most commercially relevant messages emerging around ASCO 2026 suggest the field is entering a new phase.
The science is still advancing, but the more immediate bottlenecks are increasingly structural: where patients can be treated, which sites are allowed to participate, how product gets distributed, and how regulators enable developers to build on prior knowledge rather than repeat work. In that sense, this year’s signals point toward a new reality: the next major differentiator in cell therapy will be access architecture, not just molecule design.
FACT Accreditation: When Equivalent Outcomes Meet Unequal Access
One of the most provocative access signals came from the real-world analysis comparing CAR-T treatment at FACT-accredited and non-FACT centers in large B-cell lymphoma. In a cohort of 6,857 patients, investigators found generally comparable clinical characteristics, early safety outcomes (including CRS and ICANS), time to next treatment, and post-infusion healthcare resource utilization across site types. If outcomes remain comparable, FACT accreditation may increasingly be scrutinized as an access filter and a quality signal.
The ASCO analysis does not eliminate the need for rigorous standards, but it does challenge existing standards. Put differently, if patients are traveling farther for equivalent outcomes, the debate shifts from “can community sites do this safely?” toward “what is the rationale for requiring patient travel?”
340B: The Economics May Be Shifting Too
Site-of-care discussions between FACT and non-FACT centers become even more important when paired with ASCO’s updated 340B position, which proposes a new Indigent Care Ratio to allow certain non-hospital-affiliated practices, including independent oncology practices, to qualify for 340B participation if they meet specified criteria.
In cell therapy, the economics angle is critical. One of the biggest constraints on broader community participation has been a combination of operational complexity and difficult economics, including high acquisition cost and working capital pressure, as well as limitations in the business case to support program investment, which steep discounts could support.
While 340B expansion could theoretically support broadening patient access to cell therapy, it doesn’t address the growing concerns about the program: 340B has grown far beyond its original intent, there is limited transparency and accountability on how savings are used, and it is unclear whether savings reach low-income or uninsured patients. The near-term feasibility of the proposal remains uncertain, and there will be meaningful debate before any implementation, making this a point for further monitoring.
FDA: Regulators Are Moving Toward Scalability
Outside ASCO, the FDA’s June 2, 2026 draft guidance adds another important piece to the story of cell therapy ecosystem evolution. The agency said the guidance is intended to help sponsors accelerate cell and gene therapy development by making greater use of existing public and platform knowledge, including chemistry, manufacturing and controls data, nonclinical studies, and clinical information to support regulatory submissions for human gene therapy products using genome editing in somatic cells.
This is strategically meaningful because it suggests regulators are increasingly willing to treat cell and gene therapy not as a set of wholly bespoke one-off programs, but as a field where accumulated knowledge can be leveraged more systematically. The ecosystem is slowly shifting from exceptionalism to scalability.
Distribution: Manufacturers Are Already Rewiring the Channel
Recent distribution partnerships across the cell therapy ecosystem suggest that manufacturers are already preparing for a more distributed treatment landscape. Distribution models that were once relatively exclusive and centered on a limited number of specialized treatment sites are increasingly evolving to support broader provider site participation, including community-based oncology settings.
The significance of this shift is that the site-of-care debate is no longer hypothetical. If community-based participation continues to grow, competitive advantage may increasingly depend not only on manufacturing performance, but also on making complex therapies easier for provider sites to adopt, integrate, and deliver at scale.
In vivo CAR-T: The Science Reinforces the Same Logic
There were also additional ASCO scientific signals worth noting because they reinforce the long-term logic for this access expansion. ASCO coverage highlighted continued momentum in in vivo CAR-T, off-the-shelf/allogeneic platforms, and early attempts to push engineered cell therapies into solid tumors.
Next-generation off-the-shelf approaches emphasized the industry’s ambition to solve the scale limitations of autologous manufacturing. These programs remain early, but they matter strategically because they point toward a future in which the field is trying to reduce the logistical burden of cell therapies.
Why This Matters Now
Taken together, these developments suggest a common conclusion: cell therapy is entering an “access architecture” era.
ASCO 2026 did not just highlight new efficacy and safety data; it surfaced a broader shift in how the field is thinking about:
- where cell therapy can be delivered
- who should be allowed to deliver cell therapy
- how economics could change for cell therapy
- what infrastructure is needed to support cell therapy scale
The FDA’s guidance then extends that same logic upstream into development, while announcements of expanding distribution networks bring it downstream into real-world commercialization. In vivo CAR-T’s off-the-shelf platform may further support scalability.
The conversation is finally shifting toward addressing the operational and economic challenges that have significantly impacted access to innovative therapies for nearly a decade, making them a core priority, instead of a downstream consideration.
Find out how The Dedham Group’s expertise can enhance your cell and gene therapy strategies in the access architecture era. Contact us.