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 December 2, 2025
I set out this year (2025) to work on something new — to draft, articulate, share, and collaborate on a blueprint for advanced therapies, especially cell and gene therapies. A passion project, yes, but also a deeply personal one: not only to help inspire a future where access to better treatments is possible for more people fighting for a chance to live long, healthy lives, but to honor one life that did not get that chance — my mom’s, cut short by ovarian cancer in 1989. The field has evolved, but not fast enough, and that simple, stubborn fact is what keeps me from accepting “good enough” as the endpoint.
I want to change that. It is why I pour my energy into the work of the nonprofit but savvy BBG Advanced Therapies, and just as importantly, why I show up here with you — readers and subscribers of this bi-weekly Blueprint for Breakthroughs series — as fellow builders in a field that is still drawing its first real floor plans. Together, we are sketching and re-sketching how advanced therapies might reach the people who need them, in time to matter.
2025 Year in Review: The Year the Blueprint Started to Show
Every blueprint begins as lines and notes, sketched in the quiet space between what is and what might be. This year, those lines started to feel less hypothetical and more like framing you can run your hands along — imperfect, unfinished, but undeniably real. Together, we watched the concepts and science soar ahead while the reports, surveys, and hallway conversations all echoed the same refrain: reimbursement, infrastructure, and geography are still the beams that determine who actually gets to live inside what we are building.
There were plot twists — policy curveballs, reimbursement headaches, clinical site delays that reminded us that “breakthrough” is never a straight line. There were setbacks — patients who waited too long, programs that launched before the system was ready to hold them. And there were moments of genuine inspiration: new models of care, new ways of thinking about equity, new voices insisting that advanced therapies must be built for the patients who cannot travel, cannot wait, cannot navigate a maze alone.
A Year Drawn Around Access
When this series began, “access” was already a theme, but over 2025 it became the center of the page. National access and market reports made the picture uncomfortably clear: restrictive payer policies, prior authorization delays, and coverage criteria that stretch beyond label language are keeping eligible patients from ever reaching therapy. Those stories are not numbers to you — they show up as patients you have met, cases you have carried home in your mind long after the workday ended.
In the essays and conversations that followed, we started to redraw the lines. Hub-and-spoke models stopped feeling theoretical and started to sound like lifelines, especially as more stakeholders called for treatment centers beyond a handful of academic hubs. Decentralized collection and regional approaches were no longer just “interesting pilots,” but pieces of a new map — a map where advanced therapies can be offered closer to home through carefully enabled community and regional sites.
Infrastructure as the Bones of the Story
If access was the outline of the house, infrastructure emerged as the bones that keep it standing. Infrastructure and delivery-model analyses reminded us that our current footprint — sites, staff, supply chains — was built for a smaller, earlier chapter of this story. At the same time, pipeline and market forecasts pointed to a future with many more trials, more approvals, and far more patients expecting these therapies to be within reach.
In that context, bottlenecks stopped being abstract and became the lived experience of the field. Manufacturing capacity, scalability, and cost were highlighted again and again as the biggest blockers to meaningful access, alongside the reality that too much of CGT is still anchored to a small number of high-acuity centers. In response, we explored new structural elements together: what it means to separate where you collect cells from where you treat, to lean on regional or mobile capabilities, to standardize and automate the starting material so more sites can participate. These were not just operations diagrams; they were statements of belief — that a patient’s chance at a therapy should not be determined by the number of Apheresis centers within a 50-mile radius.
The Wiring Behind the Walls
This year also pulled us behind the drywall, into the wiring and codes that most people never see: regulation, quality, data. With ICH E6(R3) moving into focus, regulators signaled a shift toward principle-based, risk-proportionate quality management that better fits the complexity and speed of CGT trials. We sat with the idea that quality is not a gate at the end of the process, but the electrical plan that must be drawn before the lights ever come on.
Digitalization showed up as the circuitry that can either connect everything or overload the system. Case examples and manufacturing analyses made it clear that paper and patchwork data flows cannot carry the weight of individualized or small-batch products at scale. Integrated batch records, real-time visibility, and connected quality systems are no longer “nice-to-have” efficiency tools; they are fast becoming the only way to safely deliver complex therapies at the scale the pipeline demands.
Commercial Foundations and Hard Questions
We also spent time this year in the less romantic parts of the blueprint: the budget lines, the financing pipes, the load calculations that decide whether the whole structure stands. Commercial and access reports challenged us to admit that long-term value and near-term affordability are often in tension — and that financial models not designed for CGT can unintentionally shut patients out. Early, honest engagement with payers and health systems emerged as a strategic imperative, not a late-stage box to check.
In these discussions, “launch” began to feel less like a ribbon-cutting and more like the moment when the doors have to stay reliably open for the people who need them. Commercial readiness became a lived question: can a patient in a community setting, with imperfect support and very real constraints, actually receive this therapy on time, safely, and without losing everything else in the process? With hundreds of therapies projected by 2030 and tens of thousands of patients in need, the cost of slow system change is measured not just in dollars, but in years of life.
Through It All…
Through plot twists and setbacks, through hopeful pilots and sobering realities, one thread has run through this year: none of us are drawing this blueprint alone. The comments, messages, and quiet conversations that followed each installment of Blueprint for Breakthroughs have shaped what this series became in 2025. You shared where the walls feel too close, where the hallways are too narrow, and where entirely new doors need to be cut for patients who have been waiting outside for far too long.
This week’s article closes the “year in review” chapter for 2025. Later in December, the next installment of Blueprint for Breakthroughs will turn to the 2026 Year Ahead — an attempt to look forward together and ask: if this is the blueprint we have drawn, what are we brave enough to build next?
My hope is that, as we step into the new year, we carry both the urgency and the tenderness this work demands — the head for systems and the heart for the people those systems must finally serve.
