Madam Chair, members of the committee, it's an honour to appear before you today.
I'm speaking in French to emphasize what's already at the heart of my approach, namely that pharmaceutical sovereignty is also a country's ability to tell its own scientific story and to write its next chapter.
I'll continue my remarks in English.
My name is Stéphanie Michaud, and I'm the president and CEO of BioCanRx, Canada's immunotherapy network, a federally funded organization that has spent the past decade doing something that Canada does not do nearly enough: taking world-class Canadian cancer research and turning it into actual therapies for actual patients.
I want to use my five minutes to challenge one assumption embedded in how the study is framed. I say this with respect, because I believe it matters enormously for the recommendations this committee will make.
Pharmaceutical sovereignty is most often discussed as a supply chain problem: How do we ensure Canadians can access medicines when global supply is disrupted? That framing accepts as a starting condition that Canada will continue to depend on therapies created elsewhere. The deeper question, the one this committee has an opportunity to address, is this: Why isn't Canada creating more of those therapies itself?
Between 2002 and March 2026, only 3.4% of cancer immunotherapy clinical trials conducted in Canada were based on made-in-Canada innovations. Canada is the only G7 country without a domestic pharmaceutical company producing novel medicines. It's not because our science is weak—it is world-class—but because we have built a federal funding and governance system that is very good at funding the first chapter of a discovery, and then stops.
In December 2025, BioCanRx commissioned the Institute on Governance to benchmark Canada's translational ecosystem against that of six peer countries. The finding was unambiguous: Canada's underperformance is not a science gap; it's a governance gap.
Advanced therapies—the cell and gene therapies that represent the next generation of cancer treatment and, increasingly, treatment for metabolic and other diseases—fall structurally between federal mandates. The work required to move a Canadian discovery to a clinical trial—the GMP value manufacturing, the toxicology studies, the regulatory dossier—is too applied for federal health research funding and too risky for private capital. It falls into a gap, and nothing catches it.
We lived this problem directly. In 2023 and 2024 federal clinical trial competitions, three BioCanRx projects were selected for funding and could not proceed. They could not file a clinical trial application to Health Canada because the regulatory preparation work had never been funded. These projects sat idle for more than a year, and there was no federal mechanism designed to bridge the gap.
We stepped in as an organization due to our funding in the strategic science fund. One of those projects has now opened a clinical trial offering a CAR T therapy to both pediatric and adult blood cancer patients, a therapy that has not existed in Canada before.
About two weeks ago, the Government of Canada announced a $280-million commitment to support Aspect Biosystems, a Vancouver company developing bioengineered cellular medicines targeting diseases, including type 1 diabetes. That is exactly the model Canada should be building. It's Canadian science and Canadian manufacturing integrated with global expertise, but it is remarkable precisely because it is rare.
BioCanRx is asking this committee for three things.
First, redesign the scope of the study. Pharmaceutical sovereignty must mean the capacity to create novel therapies, not only to secure supply of existing ones.
Second, fill the structural gap. Canada needs a permanent milestone-driven translational health research program that funds the work currently falling between mandates, including the regulatory preparation that federal clinical trial funding currently leaves unfunded. CIHR should not fund a trial that cannot proceed. The IOG has made this recommendation, and we are here to reinforce it.
Third, publish a strategy with real accountability: a framework with milestones aligned across Health Canada, ISED and federal research bodies, and a coordination mechanism so that Canadian innovators are not navigating this alone. The committee's task is to make success the system, not the exception.
Canada discovered insulin. Researchers trained at the University of Alberta pioneered the science behind CAR T-cell therapy. Canadian science is not the problem. The problem is that we continue to invest heavily in the first chapters and leave the rest unfunded. The result is that Canadians with cancer are accessing therapies created from Canadian science in other countries' clinical trials and manufactured in other countries' facilities. That is not sovereignty.
I'm asking this committee to help us build this.
Thank you. I welcome your questions.