Canada’s mark on the world of stem cell research goes back 60 years to James Till and Ernest McCulloch, two scientists who discovered these miraculous cells. Stem cells are capable of dividing into a multitude of different cell types — a boon for medical science.
Unfortunately, life science companies in Canada have found it difficult to capitalize on the country’s research into cell and gene therapies. Clinical trials are risky and expensive. So is biomanufacturing, hiring good talent, and ensuring the basic science underpinning a revolutionary new therapy checks out.
Enter the Center for Commercialization of Regenerative Medicine (CCRM), a network of researchers and leading companies trying to put Canada firmly on the life sciences and biomanufacturing map.
Michael May, the CCRM’s president and CEO, has been interested in the dilemma of moving scientific discoveries beyond the ivory tower for a long time.
After co-founding Rimon Therapeutics, a Toronto-based regenerative medical company, May moved on to MaRS Innovation, and took his place at CCRM in 2011. He spoke to the Star about fighting cancer, spurring life sciences innovation, and his love of public -private partnerships:
A lot of our readers might not necessarily know what the Center for Commercialization of Regenerative Medicine does. Can you walk us through it?
The CCRM is in the area of cell and gene therapy. These really therapies represent the future of medicine, where engineered cells become the backbone of cures for disease rather than just treating symptoms. If you can replace damaged or diseased tissue, you start to think about being able to cure diseases.
What kind of diseases are we talking about? It could be heart disease, it could be Alzheimer’s or Parkinson’s disease, blindness. Where the industry has really advanced aggressively in the last few years has been around cancer treatment. One of the best examples is with blood cancers like leukemias. We can take the white blood cells from a patient with cancer, remove them, and engineer them outside the body to become these soldiers that march around the body seeking out the patient’s tumor cells.
That has really attracted a lot of funding into the cell and gene therapy space, but there is a diversity of products and a diversity of diseases. At the highest level, this is the future of medicine.
Are you working on anything related to regeneration from the damage COVID causes to the body?
Our partners are not working, as far as we know, on treatments for the impact of COVID directly, but I would bet that the impact that COVID has on different tissues in the body could ultimately be treated by regenerative medicines and cell and gene therapies.
One of the cell therapies that has been in development for many years has been using mesenchymal stromal cells, which are anti-inflammatory cells to treat pneumonia or lung-related inflammatory diseases. At the Ottawa Hospital Research Institute, and around the world, these MSCs are being used to treat the lung outcomes of COVID. That is an example.
A lot of medical research was put on pause or delayed during COVID. Was that the experience of you and your clients as well?
For a while, clinical trials were put on hold, but CCRM itself and the industry as a whole grew incredibly during the COVID pandemic. We almost doubled the size of the CCRM team. The companies we work with experienced record levels of investment during COVID. In some respects, some research and clinical trials slowed down for a period, but I think COVID put a spotlight on life sciences and health care and showed everyone that investing in innovation in health care is actually important.
There was a lot of criticism of Canada’s lack of biomanufacturing in the first year of the pandemic. Do you think the momentum you mentioned is going to continue five or 10 years on?
I hope so. We at CCRM have been talking about biomanufacturing for 10 years. COVID helped back up that position. But I hope people understand that we need to continue to innovate in life sciences. This is important, not just for patients, but it’s also an incredible economic driver.
Canada needs to be in the mix. It needs to take a leadership position in life sciences and health care if it wants to be a partner when pandemics or crises happen, but also because it is just good business.
Why do so many life science companies not manufacture their own products? You’d think that would be an easy way to ensure a great life cycle, from development to sending a treatment out the door.
It’s very expensive to invest in that infrastructure and the talent to do that manufacturing, particularly before you have demonstrated those products in clinical trials, which are also very expensive. Typically, you raise money to do a novel new therapy and you have to take it through preclinical and then clinical studies. The manufacturing support that you need to do those clinical studies is often done through contract manufacturing organizations. CCRM has created a contract manufacturing organization to support that work in the Canadian or, really, the North American context.
Once those products are approved, then it makes sense for a company to either enhance its relationship with a contract manufacturer, but then also consider raising money and investing in its own manufacturing. It’s really just about managing risk and managing investments.
Do you see any signs of life around that in Canada, pardon the pun?
What I see, initially, is a need for strong contract manufacturing organizations in Canada. CCRM, as part of its mission for more than a decade, has been focused on manufacturing capability—not only developing the technologies for manufacturing, but then putting those technologies together in a contract manufacturing organization (CMO) to support clinical trial manufacturing.
In the MaRS building in Toronto, we have partnerships that do both the technology development with Cytiva, and then we also have a facility with the University Health Network as a partner to make products for companies for clinical trials. Just last week, we announced investment in a spinoff of CCRM that will be a commercial-scale CMO. About a month ago, there was an announcement that the Ontario government is supporting the spinoff of this company with $40 million in support.
What we’re doing now is catalyzing the establishment of a large-scale commercial CMO. The next step would be companies investing in their own manufacturing. This has been an important milestone for building manufacturing capacity and capability in Canada.
When do you think that next milestone will come — when organizations don’t need multi million-dollar grants from the government and the support of an organization like yours to actually get their products to market?
That’ll be happening in Canada. It’s happening globally in cell and gene therapy as we speak. As these products come to market, you get economies of scale, and you are addressing large markets as opposed to rare disorders. This is a five-to-10-year process.
But I just have to remind you that big companies like pharmaceutical company Sanofi got support from governments over the last several years to enhance their capacity in Canada as well. Large, established multinationals still depend on the government to help them take risks to build and grow their ecosystems. The automotive industry in Canada still gets government support and it’s an ecosystem that’s been around for decades.
CCRM is a public-private partnership. I think the future of business is actually embedded in savvy, creative public private partnerships. Gone are the days where you have pure for-profits trying to maximize shareholder value and forget about employees and their customers.
During the pandemic, there’s been a lot of conversation around commercializing medical developments. What would you say to people who might look at the research you do and insist you’re trying to commercialize something that should be available to everyone?
I think, ultimately, by providing access to cost-effective products for patients around the world, you are sharing it and providing access. I think part of that pandemic discussion around vaccines was in the context of it being a crisis, one that was affecting everybody in the world. What’s more important, getting one out and helping people, or driving both an economic and health care mandate?
If you’re going to think about sustainability in any business or in health care, you have to think of economics in addition to helping people. The pandemic skewed it towards crisis considerations, and rightly so. But, ultimately, you have to create an ecosystem that is sustainable. With investors putting money in and governments investing and businesses taking risks, you can’t just give it away for free.
This interview has been edited for length and clarity
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