Part 26 of our Bridging the Gap Series (Summary of the webinar session held in January 2026)
Cell and gene therapy is changing what’s possible for patients, particularly through CAR-T therapies for certain cancers. But access isn’t equal. Who receive treatment—and when—often comes down to geography, manufacturing capacity, cost, and infrastructure.
Recently, leaders from Canada’s cell therapy community came together to discuss a different approach. Rather than relying solely on commercial models, the conversation explored how academic institutions, clinicians, and nonprofit organizations are building a “made-in-Canada” CAR-T ecosystem grounded in collaboration, shared responsibility, and patient need.
Moderated by Dr. Patrick Hanley, Professor and Director of the Cellular Therapy Program at Children’s National Hospital, the discussion featured Dr. Stéphanie Michaud, President and CEO of BioCanRx, and Dr. Natasha Kekre, a hematologist in the Transplant and Cellular Therapy Program at the Ottawa Hospital and Clinical Lead of the Canadian-Led Immunotherapies Collaborative (CLIC). Together, they shared lessons learned from building national capacity for CAR-T and what it takes to translate promising science into sustainable patient access.
The Work Starts Long Before the First Patient
One theme emerged clearly: successful CAR-T programs are built long before the first patient is treated. Early decisions around manufacturing, regulatory strategy, and long-term feasibility can either accelerate progress – or quietly stall it later.
For academic and nonprofit groups operating with limited resources, decisions around chemistry, manufacturing, and controls (CMC) are especially important. Clear documentation, careful material selection, and realistic planning for scale help teams move forward without having to rebuild foundational work later.
The panelists emphasized that early-stage processes are often manual and limited in scope, and that this is not a failure. What matters is choosing workflows that can evolve over time, rather than locking teams into approaches that become barriers as programs grow. This mindset has enabled Canadian groups transition from research settings into GMP manufacturing without losing momentum.
Regulatory engagement is another critical part of the foundation. Open, early communication helps clarify expectations around quality, safety, and risk early in development. In Canada, ongoing collaboration with Health Canada has supported academic-led manufacturing models and decentralized production models, allowing programs to adapt as therapies evolve without compromising consistency in patient care.
Bringing Manufacturing Closer to Patients
Canada’s CAR-T strategy emphasizes local and distributed manufacturing to reduce delays and logistical barriers – particularly in a geographically vast country.
This model depends on robust quality systems, reliable analytical methods, and consistency across sites. Panelists highlighted the importance of standardized reference materials and well-defined processes to ensure patients receive the same therapy, regardless of where treatment occurs
In this model, CMC is not simply a technical requirement—it is a direct driver of access.
No One Can Do This Alone
One message is clear: building and sustaining CAR-T programs requires coordination across many groups.
Progress in Canada has depended on collaboration among clinicians, academic researchers, hospitals, nonprofit organizations, industry partners, and government stakeholders. Each plays a different role, and success depends on alignment rather than ownership.
This collaborative structure also supports workforce development. Training is embedded within active CAR-T programs, giving scientists, engineers, and clinicians hands-on experience in manufacturing, quality, and clinical translation- skills essential to long-term sustainability.
While the discussion focused on Canada, many of the challenges described – scale, cost, regulatory complexity, and access – are shared globally. Canada’s experience shows that progress does not require a single model, but it does require early CMC planning, clear regulatory communication, and shared responsibility that can help programs move forward even with limited resources.
Throughout the webinar, speakers returned to one measure of success: how many patients ultimately receive treatment.
Looking Ahead
As CAR-T and other cell therapies continue to develop, Canada’s approach offers a compelling case study in how collaboration can improve access.
By aligning academic research, clinical care, and nonprofit leadership around a shared mission, these programs demonstrate that access and quality can advance together when planning, partnerships, and purpose are in place from the start.
Key Takeaways
- Academic and nonprofit groups can play a central role in expanding access to advanced therapies through collaboration and shared infrastructure.
- Early CMC planning supports smoother transitions from research to GMP manufacturing and lays the groundwork for scalability and long-term program viability.
- Ongoing regulatory engagement helps maintain quality and patient safety while allowing programs to evolve.
- Distributed manufacturing models can improve access when paired with standardized quality systems and reproducible processes.
- Cross-sector collaboration among clinicians, researchers, nonprofits, and industry partners is essential for building sustainable, patient-centered cell therapy programs.
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About the Guests
Dr. Natasha Kekre
Hematologist, Transplant and Cellular Therapy Program, The Ottawa Hospital
Scientist, Cancer Research, Ottawa Hospital Research Institute
Associate Professor, Faculty of Medicine, University of Ottawa
Clinical Lead, Canadian-Led Immunotherapies Collaborative (CLIC)
Dr. Natasha Kekre is a Transplant Physician/Hematologist within the Transplant and Cellular Therapy Program at The Ottawa Hospital (TOH), a Scientist within the Ottawa Hospital Research Institute (OHRI), and an Associate Professor of Medicine at the University of Ottawa, Canada. She is also the Acting Associate Program Director of OHRI’s Cancer Research Program and holds the Research Chair in Advanced Stem Cell Therapy at TOH. She obtained her medical degree from the University of Ottawa, where she also trained in Internal Medicine and Hematology. She went on to do a fellowship in stem cell transplantation at Dana Farber Cancer Institute in Boston with a Masters in Public Health from Harvard University.
Dr. Kekre’s research focuses on translating home-grown therapeutic strategies into early phase clinical trials for patients with hematologic malignancies. She collaborated with scientists and physicians across Canada to build the internationally recognized Canadian-Led Immunotherapies Collaborative (CLIC) program and initiate the first clinical trial of a made-in-Canada CAR-T therapy. Building on these transformational achievements, she is now working to expand this platform to other made-in-Canada CAR-T products. Other research interests include clinical research focused on blood and marrow transplant and CAR-T therapy recipients, and projects with an epidemiologic focus.
Dr. Stéphanie Michaud
President and CEO, BioCanRx
Dr. Stéphanie Michaud is the President and CEO of BioCanRx, a not-for-profit in Canada that seeks to accelerate the delivery of innovative immunotherapies from the bench to the bedside. In this position, Dr. Michaud is responsible for running all facets of the organization. She brings more than 20 years of public, government and private sector experience in research and Science & Technology innovation policy. She strives to create partnerships between government, not-for-profits, academia and industry to maximize the impact of research funded by the BioCanRx network on the lives of those affected by cancer.
Prior to joining BioCanRx, Dr. Michaud was Deputy Director of the flagship Government of Canada Networks Centres of Excellence (NCE) program. In addition to responsibility for its performance, management and delivery, she led the implementation of high profile bilateral international initiatives and provided strategic advice to government and stakeholders. She is a strong contributor to S&T policy, most notably in intellectual property. Dr. Michaud earned a PhD in Organic Chemistry from McGill University. She is involved with a number of not-for-profit organizations and is a member of the Board of Directors of Research Canada and CQDM and also, the Advisory Board of the Canadian Cancer Research Alliance.