Blueprint for Breakthroughs is a LinkedIn newsletter published by Adrienne B. Mendoza, MHA, SVP BioBridge Global and Chief Operating Officer (COO), BBG Advanced Therapies
Originally published on LinkedIn on January 26, 2026
The Question That Has to Come First
If we keep today’s delivery architecture and simply add more diseases into it, we will almost certainly treat more people in absolute numbers—and fail a larger share of those who could benefit.
That is not a failure of the science. It is a failure of how we’ve chosen to organize access. How we respond to pressure with imagination.
We’ve built a narrow, high‑performance funnel for a handful of blood cancers. Now we’re trying to pour sickle cell, autoimmune disease, pediatric neurology, and in vivo editing into that same structure—and hoping the “treated fraction” will somehow hold steady. It won’t.
The core questions for this article are:
- Which constraints are truly dictated by biology and safety?
- Which persist because we haven’t yet chosen to design different pathways and infrastructure for these therapies?
The Funnel We Actually Have
Right now, access to approved cell and gene therapies runs through a system that was never designed for the full breadth of what’s coming:
- A small number of hubs. A few hundred large, mostly academic cancer centers carry most of the load. They are optimized for DLBCL, ALL, myeloma—not for sickle cell disease, lupus, MS, or pediatric neurology.
- Geography as a gatekeeper. Just living far from a CAR‑T center measurably lowers the odds a patient will ever receive treatment. Distance alone is a form of triage.
- Community as “next frontier,” not standard practice. Most community oncology practices still don’t administer CAR‑T or other CGTs directly. When they do, it’s usually via carefully controlled referral arrangements and limited local infusions.
Even within that relatively narrow scope, only a minority of eligible patients get through. The funnel is already tight before we add anything else.
Now layer in:
- Solid tumors, with different toxicity profiles, referral patterns, and endpoints.
- Sickle cell and other hematologic conditions, where transplant, pediatrics, and chronic‑disease care intersect.
- Autoimmune and neurologic diseases, where rheumatologists, neurologists, and pediatric subspecialists are the primary clinicians.
If we simply pour all of this into the same funnel, we increase the numerator (more people treated), but the denominator (people who could benefit) explodes. The overall proportion who ever receive a therapy goes down, even as the headlines say “access is expanding.”
What GLP‑1’s Actually Changed
GLP‑1’s are not blueprints for CAR‑T, but they are useful because they showed how quickly access patterns can change when demand and infrastructure align.
Over a few years, we’ve seen:
- Multiple visible routes to treatment. GLP‑1s can be reached via traditional insurance, manufacturer programs, telehealth bundles, and retail‑enabled cash‑pay models. Patients know these routes exist and can compare them.
- Integrated navigation. Many programs combine consultation, benefit checks, prescribing, and pharmacy fulfillment into a single experience, rather than leaving patients to coordinate each step.
- Logistics as a solved problem. Same‑day refrigerated delivery, ongoing titration, and adherence support are now normalized.
Most use is still funded by insurance. But expectations shifted:
- People now know that it is possible to see what they qualify for, what it will cost roughly, and how long it might take.
- Payers and manufacturers have learned that logistics and transparency are not side issues; they are part of the value proposition.
For cell and gene therapy, the lesson is not “make it a subscription.” The lesson is:
- Access patterns are designable. We are not stuck forever with opaque, fragile pathways just because that’s how they started.
- Patients will notice if one part of healthcare offers coherent, navigable experiences while advanced therapies remain trapped in a decades‑old operating model.
What Does Not Translate
There are hard boundaries we should respect:
- Cost. Even with allogeneic and manufacturing efficiencies, per‑patient total costs for many advanced therapies remain in the six‑figure range. Full self‑pay may exist at the margins, but it cannot become a primary access route.
- Risk and setting. These therapies still come with significant acute risks. They require trained teams, monitoring, and the ability to manage serious toxicities. That is fundamentally different from initiating a chronic injectable in retail or purely virtual settings.
- Long‑term safety. We need registries, coordinated pharmacovigilance, and durable follow‑up frameworks that go well beyond typical chronic‑disease models.
So “consumerization” here cannot mean casualizing the medicine. It has to mean bringing the same level of intentionality to access, coordination, and communication that patients already see in other parts of healthcare—within stricter clinical guardrails.
Centralization vs Future Pathways: A More Realistic Picture
If we take GLP‑1 dynamics and global signals seriously, but stay grounded in CGT realities, a more credible future looks like this:
1. From single centers to connected networks
- Keep what must remain centralized:
- Expand where care can safely happen:
Academic centers become coordinating hubs, not the only door through which patients can pass.
2. From “one cell therapy pathway” to disease‑specific access designs
We cannot stretch an oncology‑centric pathway to cover everything new:
- Sickle cell requires coordination between hematology, pediatrics, transplant, and social support structures very different from those for a 70‑year‑old with lymphoma.
- Lupus or MS will demand pathways anchored in rheumatology or neurology, with different risk‑benefit trade‑offs, monitoring, and patient education.
That means designing distinct access architectures for oncology, for sickle cell and other genetic diseases, and for autoimmune indications, even if they share manufacturing and testing infrastructure.
3. From opaque status to shared visibility
Borrowing from GLP‑1 and digital models doesn’t mean copying their economics; it means matching their clarity:
- A shared, up‑to‑date view for patients and clinicians:
We already have the technology and operational know‑how to build this for drugs. Applying it to cell therapy is a choice, not a technical impossibility.
4. From a single financial story to a small portfolio of models
We’re moving toward a mix:
- Autologous oncology therapies likely remain heavily hospital‑centric, with complex episodes funded primarily by payers and subject to outcomes‑based or bundled contracts.
- Allogeneic and CAR‑NK therapies, if they prove durable and safer, can support more sites and more standardized contracting, closer to high‑end biologics.
- Ex vivo therapies for sickle cell and autoimmune disease will demand multi‑payer, Medicaid‑aware approaches and may reuse oncology and transplant infrastructure while needing different benefit designs.
We don’t need one perfect model. We need a coherent set of models, each matched to its clinical and economic reality.
Why This Matters for the Ratio We Don’t Talk About
Underneath all of this is a simple ratio:
- People who could benefit.
- People who actually receive a therapy.
Today, for many indications, we accept that this ratio is poor. We can’t talk about “adoption” and “uptake” as if they were weather patterns rather than direct consequences of how we built the system.
As new indications arrive, we have two options:
- Keep the funnel mostly as it is, celebrate higher absolute numbers treated, and accept that the share of eligible patients served gets worse.
- Or acknowledge that we need to redesign where and how these therapies are delivered—who can initiate them, where collection happens, where infusions occur, how monitoring is done, and how patients and clinicians see and navigate the process.
The first path is familiar. The second is harder, but it’s the only one that keeps our access ratio from deteriorating as the science accelerates.
Where This Leaves Us Going into Part 3
Part 1 posed the question: will the future of cell therapy be built inside existing structures, or around them?
Part 2 refines that:
- We can’t just bolt more indications onto a narrow, oncology‑centric delivery model and expect the same fraction of patients to benefit.
- GLP‑1s and global experience have already shown that access architecture is malleable—and that patients will not un‑see what coordinated, transparent access can look like.
- For cell and gene therapy, the challenge is to blend central expertise with broader access, and to design pathways intentionally rather than by default.
In Part 3, I’ll try to make this tangible: outlining what it could mean for health systems, community clinicians, advanced therapy organizations, payers, and a carefully chosen set of retail and technology partners to sit at the same table as co‑designers of the next generation of access—so that the story of advanced therapies is not just about what we can do in the lab, but who we actually reach.
