The New Bottleneck: Systems, Not Science 

The barriers are well known and increasingly shared across countries. Manufacturing remains a critical constraint. Many regenerative medicine therapies rely on living cells or complex biological materials, making them inherently difficult to standardize, scale, and deliver cost-effectively. 

But the more profound challenge is structural. Regulatory, health technology assessment, and reimbursement systems, designed for earlier generations of medicines, are struggling to adapt to therapies that are personalized, complex, and potentially curative. Processes remain fragmented, sequential, and resource-constrained. 

The outcome is delay. In a globally competitive environment, delays shape where therapies are launched, where investment flows, and ultimately, which patients gain access first. As system leaders are increasingly acknowledging, companies are already reconsidering whether to launch in jurisdictions that are slower, less predictable, or misaligned.  

In this context, access is not just a health issue. It is a competitiveness issue. 

A Global Coordination Problem 

What makes this challenge more acute is that it is not unique to any one country. Across jurisdictions, similar barriers are being addressed, but often independently. 

Regulators are adapting frameworks. Health systems are experimenting with new reimbursement models. Developers are rethinking manufacturing strategies. Yet without purposeful coordination these efforts create duplication, inefficiency, and inconsistent pathways for therapies that are inherently global. 

This fragmentation is a constraint on progress. The question is no longer whether systems can evolve, but whether they can evolve in a coordinated way, and at the pace required. There are encouraging signals. Health systems are beginning to move from sequential decision-making toward more parallel, coordinated approaches, demonstrating that speed and rigour can coexist. But these changes remain uneven, and insufficient relative to the pace of scientific advancement. 

Reframing the Problem: From Discovery to Delivery 

If regenerative medicine is to deliver on its promise, the focus must expand beyond discovery and development to include the full pathway to patient access. 

This requires three interconnected shifts: 

Greater alignment across systems. 
Improved coordination between regulators, HTA bodies, and payers, along with more consistent approaches to evidence generation and evaluation. The goal is not harmonization for its own sake, but reducing avoidable friction. 

Faster, more integrated pathways. 
Moving beyond siloed, step-by-step processes toward parallel and coordinated models that reflect how therapies are actually developed, and how they need to be delivered. 

A deliberate focus on adoption. 
Ensuring therapies are not only clinically successful, but also manufacturable, affordable, and implementable within real-world health systems, including for delivery outside of major population centers or developed countries. 

Taken together, these shifts represent a fundamental reframing: In regenerative medicine, success is not just a breakthrough in the lab but must also be ensuring therapies reach patients. 

From Insight to Action: A Collective Effort 

Recognizing this shift, progress will depend not only on policy change, but on deliberate coordination across the ecosystem. 

The Stem Cell Network (SCN), as a national convenor spanning research, industry, and health systems, is bringing together leaders from across the innovation landscape -including regulators, health technology assessment bodies, payers, clinicians, industry, and patients – in workshops designed to confront these challenges directly. The focus is clear: identify barriers and move toward shared, actionable solutions. 

This kind of convening reflects an important evolution in the field. The barriers to access are no longer owned by any single part of the system and they cannot be solved in isolation. Progress will depend on collective agreement, shared accountability, and a willingness to move forward together. 

For Canada, this represents an opportunity to not only strengthen its own system, but to demonstrate how coordinated, system-level approaches can accelerate access while supporting innovation. 

Canada as a Case Study in Both Risk and Opportunity 

Canada illustrates both the opportunity, and the consequences of inaction. 

With globally recognized science and sustained public investment, Canada is well positioned to lead in regenerative medicine. Yet like many jurisdictions, it has struggled to translate this leadership into timely domestic access and economic return – too often, therapies rooted in Canadian science are developed and commercialized elsewhere, while Canadian patients wait for access. This reflects a broader structural issue: systems that are not fully aligned to support the end-to-end pathway from discovery to delivery. 

One approach SCN is hoping to advance is the development of a Made-in-Canada designation and prioritized pathway for advanced therapeutics which is designed to integrate regulatory review, health technology assessment, and reimbursement into a more coordinated, predictable process. By enabling earlier engagement across these functions and supporting priority review, such a pathway aims to accelerate patient access while strengthening the conditions that attract investment and clinical development.  

While specific to Canada, this reflects a broader principle: systems must evolve to support both health outcomes and innovation, ensuring that therapies reach patients efficiently while maintaining rigorous standards of safety and evidence. 

The Missing Piece: Talent for Translation 

Even with better coordination, another constraint remains: talent. 

The workforce required to deliver regenerative medicine extends far beyond discovery science. It includes expertise in regulatory science, biomanufacturing, clinical development, and health system implementation, and these capabilities remain underdeveloped globally. 

Recognizing this, the SCN and the International Society for Stem Cell Research (ISSCR) have launched a joint global workforce development initiative, including an international Working Group focused on identifying skills gaps, understanding evolving career pathways, and advancing strategies to better prepare the next generation of talent across the field. As therapies become more complex, the need for individuals who can operate across these domains is becoming more urgent. Addressing this gap will be essential to ensuring that system improvements translate into real-world impact.  

A Call for Coordinated Progress 

Regenerative medicine is moving faster than the systems built to evaluate, fund, manufacture, and deliver it. The next phase of progress will not depend on science alone. It will depend on whether regulators, HTA bodies, payers, manufacturers, clinicians, developers, patients, and funders can work in more coordinated ways across the full pathway to access. 

This does not require uniformity. But it does require greater alignment, earlier engagement, more parallel decision-making, and sustained investment in the talent needed to translate complex therapies into real-world care. 

No single organization, sector, or country can solve this alone. But coordinated action can reduce avoidable delay, strengthen innovation ecosystems, and ensure that regenerative medicine reaches patients more efficiently, equitably, and at scale. 

The field is closer than ever to therapies that can transform how disease is treated. The task now is to ensure the systems are in place that allow those therapies to reach the patients who need them.