Commercialization of cell and gene therapy in Canada: Current landscape, challenges and opportunities
Bibliographic record
Abstract
• Canada lags other jurisdictions, such as the USA and EU, in CGT commercialization despite recent approval trends. • Regulatory ambiguity and lack of orphan drug incentives limit CGT development. • Traditional health technology assessment (HTA) approaches in Canada struggle to capture CGTs’ long-term value. • Implementing real-world evidence and decentralized manufacturing could improve domestic commercialization. • Adopting global policy models could improve CGT access, equity, and innovation in Canada. Cell and gene therapies (CGTs) offer transformative treatments for certain genetic diseases and cancers, with a growing number of global approvals. Yet Canadian commercialization lags behind the USA and Europe. This review identifies key barriers and proposes policy solutions informed by international examples. A policy-oriented environmental scan was conducted using regulatory documents, peer-reviewed literature, government reports, and industry publications. Barriers and solutions are organized into four domains: regulation, manufacturing, pricing and reimbursement, and access and equity. Despite recent investment downturns in this therapeutic area, Canada’s approval of its first clustered regularly interspaced short palindromic repeats (CRISPR)-based therapy and chimeric antigen receptor (CAR) T-cell expansion suggest future growth. Strategic reforms could improve domestic CGT innovation, affordability, and equitable access.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".