Canada has the science and expertise to develop breakthrough therapies, but needs a fit-for-purpose pathway to move them from discovery to patient access

OTTAWA, September 15, 2026 – Promising Canadian-developed advanced therapies risk stalling before reaching patients because Canada’s development and access pathways often do not fit therapies serving small populations, according to a new report released today by the Stem Cell Network (SCN).

Rare diseases affect millions of Canadians, yet most still lack effective treatments. Advanced therapies – including cell and gene therapies, tissue-engineered products and other emerging approaches – offer new possibilities for patients with rare and other conditions affecting small populations.

However, Canada’s existing pathways were largely built around therapies developed for larger patient populations and backed by conventional commercial sponsors. For therapies that may serve dozens or even a handful of patients, traditional approaches to development, manufacturing, evidence generation, commercialization, and reimbursement can be difficult or unsustainable.

“Canada has the science, talent, and infrastructure to develop advanced therapies that could transform the lives of patients with rare diseases and conditions. What we don’t yet have is a coordinated pathway designed to move these therapies from Canadian labs to Canadian patients,” said Cate Murray, President and CEO, Stem Cell Network. “The good news is we don’t need to build a new system. We need to better connect and activate the capabilities Canada already has.”

As part of SCN’s national initiative focused on the accessibility, affordability, and adoption of advanced therapies, SCN, in partnership with the Azrieli Foundation, convened a workshop in June 2026 that brought together leaders from across Canada’s regenerative medicine ecosystem. Nearly 50 leaders participated, bringing perspectives representing researchers and clinicians; patient partners and health charities; industry, manufacturers and non-profit organizations; regulators; health technology assessment (HTA) and reimbursement bodies; and policy leaders.

The resulting report identifies six actionable recommendations to create a more coordinated pathway from Canadian discovery to patient access:

• Create a prioritized Made-in-Canada innovation pathway connecting promising Canadian therapies with early regulatory, manufacturing, clinical, funding, and commercialization support.
• Establish an orphan and ultra-rare designation that enables proportionate development and evidence approaches while maintaining rigorous safety and efficacy standards.
• Pilot Canada’s Advanced Therapeutic Products framework using real Canadian therapies to establish clear processes, timelines, and precedents.
• Treat low-volume manufacturing as national infrastructure and strengthen the Canadian capacity needed to manufacture therapies for small patient populations.
• Create a neutral navigation function to help academic innovators and emerging companies navigate regulatory, manufacturing, reimbursement, financing and commercialization requirements.
• Develop sustainable evidence, funding, and access models that account for the full cost and complexity of bringing advanced therapies to patients.

Taken together, the recommendations propose a coordinated Canadian pathway that would identify promising therapies earlier, reduce avoidable delays and duplication, and create a clearer route from discovery through development, regulatory review, reimbursement and patient access.

“Better coordination would not only help Canadian-developed therapies reach patients more predictably, it would also strengthen Canada’s ability to capture the benefits of discoveries made here,” added Murray. “That means retaining more intellectual property, clinical trials, manufacturing, companies, highly skilled talent, and investment in Canada.”

To read the full report, visit: https://stemcellnetwork.ca/about/2026-advanced-therapies-workshop-report/ 

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About the Stem Cell Network
The Stem Cell Network (SCN) is a Canadian not-for-profit that supports stem cell and regenerative medicine research; training the next generation of highly qualified personnel; enabling knowledge mobilization of research; and enhancing the commercialization readiness of stem cell and RM innovations. From the lab to the clinic, SCN’s goal is to power life-saving therapies and technologies through regenerative medicine research for the benefit of all. Created in 2001, with support from the Government of Canada, the Network has funded over 280 research projects and 30 clinical trials, cumulatively driven by experts from 350 research groups across Canada. Since its inception, over 28 biotech companies have been catalyzed or enhanced and more than 7,900 highly qualified personnel have been trained. In 2023, the Government of Canada announced additional funding for SCN through the Strategic Science Fund that will support SCN activities and research through to the end of the decade.

Media Contact
Brooke Anderson
Manager, Communications & Marketing
Stem Cell Network
broanderson@stemcellnetwork.ca