
Launching a Rare Disease Company in Canada
​Client: Leading Global Specialty Pharma
(Hematology & Oncology)
Services:
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Full Go-to-Market Strategy
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Relaunch Execution
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Canadian Market Infrastructure
The Challenge
A global rare disease pharma leader needed to revive an approved but dormant treatment for Acute Lymphoblastic Leukemia (ALL) in Canada. Though reimbursed nationally (except Quebec), the product had never been launched, and Canada was managed remotely from the U.S. The company aimed to establish a fully independent Canadian operation to unlock market potential and improve patient access.
Key Challenges
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No local medical or commercial team
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Limited awareness among clinicians and KOLs
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Quebec access pending
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No patient support infrastructure
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Stalled market perception
Our Approach
1. Medical Affairs Infrastructure
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Conducted national audits and mapped KOLs
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Launched pan-Canadian advisory boards and expert working groups
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Engaged pediatric hospitals to support diagnostic innovation
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Supported trial participation to boost scientific engagement
2. Patient-Centric Support
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Launched nurse-staffed hotline for access and treatment inquiries
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Shifted pharmacovigilance operations to Canada
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Built systems to ensure patients received uninterrupted medication
3. Canadian Commercial Strategy
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Built and trained an in-market marketing team
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Tailored global messaging for Canadian providers
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Fast-tracked approvals through collaboration with PAAB
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Ran market research to develop local standards of care
4. Market Access & Reimbursement
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Secured provincial agreements across all provinces (excluding Quebec) within one year
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Devised pricing strategy aligned with rare disease policy and PMPRB flexibility
Results
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Top Market Performance: Canada became the company’s highest-performing affiliate
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Local Independence: Full medical and commercial teams operated with minimal global reliance
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Strategic Acquisition: Success in Canada contributed to a major acquisition
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Research Leadership: Positioned Canada as a Hematology research and clinical trial hub
Why It Matters
This case demonstrates how the right strategy, execution, and local presence can turn a dormant product into a national success. It also highlighted the critical role of Medical Affairs, patient-first thinking, and reimbursement expertise in rare disease commercialization.​
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