Part 31 of our Bridging the Gap Series (Summary of the webinar session held in June 2026)
For much of the past two decades, the cell and gene therapy industry has been defined by scientific possibility.
Researchers demonstrated that engineered cells could eliminate previously untreatable cancers. Gene therapies began addressing diseases once considered incurable. Manufacturing technologies evolved, regulatory pathways matured, and investment flowed into a sector built on the promise of transformative medicine.
Today, however, the conversation is changing.
The scientific proof points exist. Patients are benefiting from approved therapies. New clinical data continues to emerge across oncology, autoimmune disease, rare disease, and beyond.
Yet despite that progress, the industry finds itself confronting a different set of questions. How do we make these therapies scalable? How do we create sustainable business models? How do we ensure patients can actually access treatments that already exist?
These themes formed the basis of a recent Bridging the Gap webinar hosted by Olga Bukatova, Azenta Life Sciences, featuring Dr. Phil Vanek, Chief Commercialization Officer at ISCT, entrepreneur, advisor, and longtime industry leader whose career has spanned technology development, manufacturing, commercialization, investment, and strategic leadership across the cell and gene therapy ecosystem.
Joining the discussion was George Eastwood, Executive Director of the Emily Whitehead Foundation. Together, they explored what may be the defining challenge of the next decade: transforming scientific success into sustainable patient access.
Building an Industry While Flying the Plane
Reflecting on his career, Dr. Vanek described a journey that began not with commercialization, but with science.
Originally trained as a biochemist, he quickly discovered that his interests extended beyond the laboratory bench and toward translating innovation into real-world impact. That path eventually led him through startup environments, manufacturing organizations, technology platforms, and industry leadership roles.
Looking back at the evolution of cell and gene therapy, one theme stood out: Unlike many other therapeutic areas, the field has often been forced to develop infrastructure, manufacturing systems, and supply chains simultaneously with the therapies themselves.
As Dr. Vanek observed, the industry has effectively been “building the plane while flying it.”
Many of the earliest manufacturing approaches were adapted from biologics production. Over time, however, the unique requirements of living therapies demanded entirely new solutions. Closed systems, single-use technologies, chain-of-custody processes, specialized logistics, and novel manufacturing workflows all emerged as the field learned how to translate promising science into reproducible therapies.
The result has been an industry that continuously innovates not only at the therapeutic level, but across every stage of development and delivery.
Scientific Success Has Changed the Conversation
The discussion highlighted just how far the field has progressed. Landmark patient stories such as Emily Whitehead’s CAR-T treatment and more recent individualized gene therapy breakthroughs have fundamentally altered perceptions of what is possible.
These successes have helped move cell and gene therapy from a purely experimental concept to a viable therapeutic modality. But success has also created new expectations. Rather than asking whether these therapies can work, the industry is increasingly being asked whether they can be delivered consistently, affordably, and at scale.
As George Eastwood noted during the discussion, the field now faces an unusual challenge: many of the scientific hurdles have been overcome, yet operational and systemic barriers continue to limit patient access.
In some ways, that represents a positive problem to have.
The challenge is no longer proving that transformative therapies are possible. The challenge is ensuring[2.1] that patients who need them can actually receive them.
Manufacturing Remains Central to the Future
A significant portion of the discussion focused on manufacturing, an area where Dr. Vanek has spent much of his career. While the industry broadly recognizes manufacturing as a critical challenge, he argued that solving it requires a more holistic perspective than simply improving individual technologies.
Successful innovation cannot exist in isolation. A manufacturing technology may offer clear advantages at a single process step, but unless it fits within the broader workflow – from patient collection through manufacturing and delivery – it is unlikely to achieve widespread adoption.
For developers, investors, and technology providers alike, understanding the entire ecosystem has become increasingly important.
Questions around centralized versus distributed manufacturing, supply chain resilience, automation, scalability, and chain of custody all remain active areas of development. At the same time, the economic realities of the market have shifted. As investment environments have become more selective, fewer organizations have the resources to explore and adopt new manufacturing approaches at the pace seen several years ago.
Yet despite these challenges, Dr. Vanek remained optimistic. The industry has already developed many of the technologies needed to improve manufacturing efficiency. The next step is determining how those solutions fit together into scalable and sustainable systems.
What Does Industry Maturity Actually Look Like?
One of the most thought-provoking discussions centered on the idea of industry maturity. Cell and gene therapy now has approved products, commercial infrastructure, and growing clinical adoption. But does that mean the field has reached true commercialization?
For Dr. Vanek, maturity is ultimately about becoming mainstream. That means more than regulatory approvals.
It requires clinicians to be comfortable prescribing these therapies. It requires hospitals to overcome operational and reimbursement barriers. It requires payment systems that support access rather than creating friction. And it requires confidence from investors that the industry can generate sustainable returns while continuing to innovate.
Perhaps most importantly, it requires creating a system where patient eligibility – not financial or operational constraints – determines access.
As Dr. Vanek explained, every stakeholder in the ecosystem must be aligned if advanced therapies are to achieve widespread adoption. The scientific innovation is only one part of the equation.
Collaboration, Communication, and the Race Against Time
While discussions often focus on capital, talent, infrastructure, or technology, he suggested that time is the industry’s most precious resource. Patients cannot wait indefinitely for solutions. As a result, accelerating collaboration and reducing duplication have become increasingly important.
Throughout the discussion, both Vanek and Eastwood emphasized the need for stronger communication across the ecosystem. Whether through industry organizations, collaborative research efforts, data-sharing initiatives, or emerging digital tools, there is growing recognition that progress depends on learning faster together.
Eastwood pointed to recent examples of commercial competitors sharing long-term follow-up data to improve understanding of patient outcomes, demonstrating that collaboration can coexist with innovation.
As therapies become more complex and healthcare systems continue to evolve, the ability to share knowledge efficiently may become one of the industry’s greatest competitive advantages.
Why This Matters
The conversation highlighted a reality that many across the industry are beginning to recognize. Cell and gene therapy is no longer defined solely by scientific breakthroughs. The next chapter will be shaped by commercialization, manufacturing, reimbursement, policy, workforce development, and operational excellence.
In other words, the challenge is no longer proving that these therapies work. The challenge is building systems capable of delivering them to every patient who could benefit. That work is undoubtedly complex. But as the discussion made clear, the opportunity remains enormous.
The science continues to advance. New clinical successes continue to emerge. And the community supporting these therapies – from researchers and manufacturers to clinicians, patients, advocates, investors, and industry organizations – remains committed to solving the challenges that stand in the way.
If the first era of cell and gene therapy was defined by proving what is possible, the next era may be defined by ensuring those possibilities become accessible realities.
Key Takeaways
- Cell and gene therapy has moved beyond scientific proof-of-concept and is now focused on scalability, commercialization, and patient access.
- The industry has effectively been “building the plane while flying it,” developing manufacturing systems and infrastructure alongside the therapies themselves.
- Manufacturing innovation remains critical, but solutions must address the entire workflow rather than individual process steps.
- True industry maturity will require broader clinical adoption, sustainable reimbursement models, and improved operational readiness.
- Collaboration and communication across the ecosystem are increasingly important to accelerate progress and reduce duplication.
- Time may be the industry’s most important resource, making efficiency and collective learning essential.
- The next phase of growth will depend on building systems that make transformative therapies accessible to more patients worldwide.
Stay Updated
Join us for the next Bridging the Gap webinar as leaders across cell and gene therapy continue exploring the science, infrastructure, and collaboration shaping the future of advanced therapies.
Explore more in the Bridging the Gap Series