Shionogi Canada is the Canadian affiliate of Shionogi & Co., a Japan-based, research-driven pharmaceutical company focused on developing and commercializing innovative medicines for unmet medical needs. The company established its presence in Canada following the acquisition of Tanabe Pharma Canada’s local operations, including its amyotrophic lateral sclerosis (ALS) therapy Radicava.
Could you outline your career journey and what led you to enter the pharmaceutical industry?
I have worked in the Canadian pharmaceutical space for over 25 years, much of that time with global biopharmaceutical companies. I was drawn to the industry because I enjoy the business world, but equally value the connection between commercial objectives and improving patient outcomes. I’ve really enjoyed being part of new product launches and overcoming obstacles—[the latter of which] is a theme in Canadian business.
Bringing innovation through to commercialization in Canada is not straightforward, but it is achievable and highly impactful when done well. About eight years ago, I had the opportunity to become the first Canadian employee for Mitsubishi Tanabe Pharma Canada, a 150-year-old Japanese company expanding into the market through the launch of Radicava, a treatment for ALS. It offered a unique chance to build a company from the ground up and define its values. [That experience of building from scratch] has been very rewarding, and with the transition to Shionogi Canada Inc., we now have the opportunity to do it again.
Could you talk us through your experience of doing business in Canada and bringing Radicava to fruition in the Canadian market?
Radicava is a product that was desperately desired by the ALS community. Its success shows the role that strong patient advocacy can play in Canada. The company responded by establishing a footprint and filing with Health Canada, who worked collaboratively to review the product and provide approval.
That sounds like the hard part, but often the hard part starts after approval. The key challenge is navigating the various bodies involved in commercialization: Patented Medicines Pricing Review Board, the Canada’s Drug Agency for health technology assessment evaluations, the Pan-Canadian Pricing Alliance for negotiations, and then individual provinces and private plans. This process is not coordinated and often leads to long timelines. The most recent data shows about a 600-day average from approval to reimbursement in Canada, which is a long time for patients in high unmet need areas.
Why has commercialization in Canada been so challenging, and what needs to change to improve timelines for patient access?
Commercialization in Canada has been challenging largely due to fragmentation and a lack of coordination across the system, particularly when it comes to government budgets. Hospital budgets are separate from pharmaceutical budgets, and payers are often focused on one area without seeing the broader impact. In contrast, in the U.S., the same payer often covers hospitalization, physician services, and pharmaceuticals, which makes it easier to demonstrate how one investment can offset costs elsewhere. Those connections are not always as visible in Canada, and, in constrained funding environments, innovations may not receive the attention they deserve.
That said, there are a number of encouraging developments aimed at improving timelines for patient access. A recently established federal pharmaceutical task force is bringing together these fragmented stakeholders at the same table, which is a significant step forward. Additionally, initiatives such as Canada’s Drug Agency’s time-limited recommendation program allow promising therapies in Phase II clinical trials to reach patients while further evidence is generated. Similarly, Ontario’s FAST (Funding Accelerated for Specific Treatments) program has already demonstrated that reimbursement timelines can be shortened by several months. Up until now, these initiatives have focused mainly on oncology, but there is an opportunity to expand them into other high unmet need areas.
What is driving Shionogi’s focus on rare diseases and high unmet need areas, and where are you seeing the most promising developments in your pipeline?
The company aims to be a global leader in infectious diseases by not just treating infections, but by providing comprehensive solutions covering prevention, diagnosis, and treatment (including HIV, influenza, and antimicrobial resistance). At the same time, there is a clear recognition that the greatest unmet needs often lie in rare diseases. Shionogi has identified rare disease as a key platform within its 2030 strategic vision, using Radicava as a foundation to build from.
In terms of the pipeline, we are seeing continued progress in infectious disease, particularly in addressing antimicrobial resistance for infections such as complex UTIs, as well as expansion into areas beyond ALS, including Pompe Disease. We are also placing a strong emphasis on clinical development in Canada, ensuring that patients have access to innovation not only at the point of commercialization but earlier through clinical trials. This creates a more complete, end-to-end pathway for Canadians to benefit from new technologies, both before and after approval.
How would you describe the clinical development environment in Canada compared to the U.S.?
Clinical development is one of Canada’s strengths. Canada has the highest proportion of clinical trials in the G7, with more than 3,000 ongoing trials in 2025, representing over 5% of global trials. In 2024, 30% of those trials were in rare diseases.
This is driven by world-class institutions, strong collaboration, and a diverse population. There is also a strong public-private partnership and patient advocacy that helps attract trials. The quality of research in Canada is globally recognized and can be used by regulatory bodies like the FDA and EU authorities.
How do pricing frameworks and market access challenges influence decisions to launch new therapies in Canada?
Canada is recognized for its commercialization capabilities, though market access and pricing are not always as predictable. It has benefited from early-stage launches, but we cannot take that for granted as the global market shifts.
We need to address time to reimbursement, speed, and predictability. These are key factors global companies consider when deciding where to launch. If we can work with stakeholders and deliver solutions, we can maintain Canada’s position as an early-stage launch market.
Where does Canada risk falling behind relative to peers like the U.S. or Europe?
The key metric is the number of new launches relative to other markets. Falling behind means products either don’t launch or launch significantly later than elsewhere.
There is also a link to clinical trial investment. Companies are more likely to invest early if they are confident that their products will be successfully commercialized later. All these elements are connected, and maintaining strength in early-stage research depends on success at the back end.
