Canada has long been a global leader in regenerative medicine. From the discovery of stem cells to decades of sustained investment through organizations like the Stem Cell Network (SCN), the country has built a strong foundation in cell and gene therapies.

But as discussions at the 2026 CDA-AMC Symposium made clear, leadership in science does not automatically translate into leadership in patient access or economic impact.

Across two panels—one launching the 2026 Watch List on Regenerative Medicine and another focused on accelerating cell and gene therapy adoption—a consistent message emerged. Canada is at a critical inflection point. The opportunity is enormous, but so is the risk of falling behind.

A Transformative Moment in Medicine

The 2026 Watch List highlighted regenerative medicine as a field poised to reshape healthcare. These therapies, ranging from cell and gene therapies to bioengineered tissues, have the potential to move beyond symptom management and toward restoring function or even curing disease.

For patients, this represents a profound shift. Conditions once treated over a lifetime could be addressed through a single intervention.

Yet while the science is advancing rapidly, the systems responsible for assessing, funding, and delivering these therapies are struggling to keep pace.

The Gap Between Discovery and Access

One of the clearest challenges discussed was the persistent gap between innovation and implementation. In Canada, patients often wait three to five years longer than those in other countries to access regenerative therapies.

This delay is not due to a lack of scientific capability. Instead, it reflects systemic barriers across the innovation pathway, from early-stage development through to clinical adoption.

Panelists discussed the “valley of death” between discovery and commercialization, where promising therapies stall due to limited translational funding, fragmented coordination, and insufficient alignment across the ecosystem.

This challenge is particularly relevant to the SCN community. Canada continues to generate world-leading discoveries, but too often these innovations are developed or commercialized elsewhere.

Why This Matters Now for the SCN Community

Many therapies supported through SCN are now approaching the point where system barriers become critical.

In Quebec, researchers have developed the self-assembled skin substitute (SASS), a tissue-engineered graft designed to permanently replace skin in patients with severe burns. In Ottawa, teams are advancing a lung-targeted gene therapy for premature infants with serious lung disease. These therapies are moving closer to clinical use and will depend on coordinated regulatory pathways, manufacturing capacity, and system readiness to reach patients.

At the same time, there are clear examples of what happens when those systems are not in place.

A Canadian-developed stem cell expansion platform, UM171, has already reached patients abroad. The therapy, commercialized as Zemcelpro, received conditional marketing authorization in the European Union for patients with blood cancers who lack a suitable donor. Despite being discovered and developed in Canada, it is not yet approved for use here.
Similarly, Canadian companies are increasingly turning to other jurisdictions to advance clinical trials. Satellos Bioscience, which is developing a regenerative therapy for Duchenne muscular dystrophy, initiated its early clinical studies through Australia’s regulatory system, with further trials planned globally.

This approach reflects a broader reality: companies often go where pathways are faster, more predictable, and better aligned with development timelines.

Together, these examples illustrate a critical point. SCN has long supported research across the full translational continuum, including clinical trials. What is changing now is the scale, maturity, and urgency of the therapies moving through Canada’s regenerative medicine pipeline. Many are reaching the point where system performance, not scientific potential, will determine whether they succeed. Without changes to how therapies are evaluated, funded, manufactured, and adopted, Canada risks continuing to export its breakthroughs and importing them back later at higher cost.

Systems Designed for a Different Era

A central tension is that current health system structures were built for traditional pharmaceuticals, not for personalized, low-volume, high-impact therapies.

Health technology assessment (HTA), regulatory pathways, and reimbursement models are still largely oriented toward population-based approaches. This creates challenges when evaluating therapies designed for small patient populations or even individual patients.

At the same time, the complexity of delivering these therapies, including biomanufacturing, supply chains, and specialized clinical infrastructure, places new demands on the healthcare system.

As one panelist noted, the issue is not that existing systems don’t work. It is that they do not work well enough for what is coming next.

The Need for Earlier Alignment

A recurring theme across both sessions was the importance of earlier and deeper system alignment.

While progress has been made in coordinating regulatory, HTA, and reimbursement processes, these efforts tend to occur late in the development lifecycle. By that stage, key decisions about product design, evidence generation, and commercialization have already been made.

To accelerate adoption, alignment must begin much earlier. Developers need to engage with regulators, HTA bodies, and payers from the outset to ensure that:

• Evidence generation aligns with decision-making needs
• Value propositions are clearly articulated
• Investment cases are credible

Without this early coordination, even scientifically promising therapies face significant downstream barriers.

Competing in a Global Landscape

The urgency of these challenges is amplified by a rapidly evolving global environment.

Other jurisdictions are moving aggressively to attract investment, streamline regulatory pathways, and scale biomanufacturing capacity. Countries like the United States, Japan, and China are aligning policy, funding, and industrial strategy to position regenerative medicine as a driver of both health and economic growth.

Canada, by contrast, risks losing ground. The issue is not weak science, but system fragmentation and limited competitiveness.

The stakes are high. The global regenerative medicine market is projected to grow from approximately $50 billion today to $150 billion within the next decade. Capturing even a fraction of that growth will require a system that supports both innovation and adoption.

Building a Future-Ready System

What would a future-ready system look like?

Across both panels, several priorities emerged:

• Strengthening translational funding, particularly for biomanufacturing and clinical trial readiness
• Modernizing regulatory and HTA frameworks to better accommodate personalized therapies
• Investing in health system capacity, including specialized treatment centres and workforce training
• Enhancing coordination across the ecosystem, from researchers and clinicians to regulators and payers
• Exploring new funding and reimbursement models, including outcomes-based approaches

Equally important is a shift in mindset. This is not just about fixing bottlenecks. It is about designing pathways that are fit for purpose in a new era of medicine.

For the SCN community, these priorities are not abstract. They directly affect whether Canadian discoveries can reach Canadian patients.

A Call to Action

Canada has the science, talent, and infrastructure needed to lead in regenerative medicine.

What is needed now is alignment, ambition, and action.

The therapies emerging from SCN-supported research are moving closer to the clinic. Ensuring their success will require systems that are ready to receive them.

The science is ready. The question is whether Canada is prepared to deliver on its promise.