2026 Advanced Therapies Workshop & Report

2026 Advanced Therapies Workshop & Report

2026 Advanced Therapies Workshop & Report

Building a Made-in-Canada pathway for advanced therapies

Canada has world-class regenerative medicine science, clinical expertise, infrastructure and talent. But promising advanced therapies — including those developed in Canada or being advanced through Canadian clinical expertise and infrastructure — can struggle to move from discovery or clinical development to patient access.

On June 18–19, 2026, the Stem Cell Network (SCN), in partnership with the Azrieli Foundation, convened nearly 50 leaders from across Canada’s regenerative medicine ecosystem to identify practical ways to address these challenges.

The resulting report identifies six priorities for building a more coordinated Made-in-Canada pathway for advanced therapies.

Status: 1

Create a prioritized Made-in-Canada innovation pathway

Identify high-potential Canadian-developed advanced therapies and connect them early to regulatory advice, manufacturing expertise, translational funding, clinical trial support, evidence and HTA planning, financing, commercialization assistance and adoption supports.

Status: 2

Establish an orphan / ultra-rare designation

Define eligibility for therapies where prevalence, disease severity, unmet need and the feasibility of conventional development require proportionate evidence and access approaches. The designation should support early coordination, lifecycle evidence planning and tailored regulatory advice while preserving rigorous standards.

Status: 3

Operationalize ATP through Canadian pilot therapies

Use real Canadian driver projects to clarify ATP eligibility, timelines, evidence expectations, authorization responsibilities, post-access data collection and lifecycle commitments — and to establish precedents that future Canadian therapies can use.

Status: 4

Support low-volume manufacturing as infrastructure

Treat low-volume advanced-therapy manufacturing as national health and innovation infrastructure. Use national asset mapping, readiness funding, CMC support, technology-transfer assistance and proportionate GMP/QA-QC approaches to stabilize Canadian capacity between sporadic projects and keep Canadian innovations manufacturing here.

Status: 5

Provide neutral navigation and sponsor-like support (Not for Profit Concierge)

Academic innovators and early-stage Canadian biotechs need help navigating regulatory strategy, CMC, GMP, HTA, payer expectations, financing, commercialization and adoption. A neutral function should help innovators engage the right bodies early, design with the end in mind and reduce repeated reinvention.

Status: 6

Build sustainable evidence, funding and access mechanisms

Approval alone does not equal access. Canada needs lifecycle evidence, managed access, risk-sharing, procurement, stewardship and full care-pathway funding models that account for diagnostics, delivery, hospital readiness, monitoring, travel, long-term follow-up and therapies without conventional commercial sponsors.

A coordinated pathway from Canadian discovery to patient access

Taken together, these priorities would help identify promising therapies earlier, reduce avoidable delays and duplication, and create a clearer route through development, manufacturing, regulatory review, reimbursement, adoption, and patient access.

The goal is not to build this system from the ground up. It is to better align, activate and scale the capabilities Canada already has to help more Canadian-developed therapies reach patients while retaining intellectual property, clinical trials, manufacturing, companies, talent and investment in Canada.

Read the full report

Interested in how the discussion evolved? Read the initial key takeaways from the June 2026 workshop.