Canada needs a comprehensive life sciences strategy that treats the sector as strategic infrastructure and better integrates research outcomes into the health care system, biotech and medical leaders said at Research Money’s 25^th annual conference in Ottawa.

The country also needs broader governance to align strong regional life sciences clusters, a regulatory system that supports commercialization of Canadian innovations, and greater investment in translational research and clinical trials, they said.

“We need to commit that our health system, our life sciences system, is strategic infrastructure for health security, for national security, for productivity, for the wellness of all of us,” said Cate Murray (photo at left), president and CEO of Canada’s Stem Cell Network.

“As part of that, the bold thing we need to do is to take bets on Canadian science, on Canadian companies, and we need to support them,” she said.

“We need to have a regulatory system that does prioritize Canadian health innovations from beginning to end. Not just in expediting their reviews, but in giving them . . . procurement pathways, giving them supports to manufacture, giving them expedited and special routes to be able to conduct their clinical trials.”

Canada needs to double down on Canadian innovations, “and stop with this [attitude of] ‘If it comes from somewhere else, it must be better,’” Murray said. “That's garbage.”

“So it's time to buy Canadian. It's time for a made-in-Canada designation and pathways and procurement routes that support them,” she said.

Dr. Stéphanie Michaud (photo at right), president and CEO of BioCanX, said Canada lacks the systems to effectively measure the performance of the country’s life sciences ecosystem.

“I would say as citizens, it's our collective responsibility to take the research that we have been investing in for decades and turn it into products that are meaningful to patients that can advance their lifespan,” she said.

It’s important for all Canadians, including policymakers and regulators, to have a shared vision of what they want from the life sciences sector and where they want it to go, she added.

“And for me, an integrated, high-performing life science ecosystem in Canada looks like a patient that is accessing care in Canada, [who] knows that there could be a clinical trial available to them,”  Michaud said.

“And that is not the truth right now. This type of thinking does not exist,” she said.

But with a health care system that integrates translational research, Canadian patients who have exhausted the standard of care, “would have the option of a clinical trial and, more importantly, would expect access to a clinical trial,” Michaud said.

Rob Annan, president and CEO of Genome Canada, said what’s required is a national coordinated effort to align governance of life sciences and health, and implement regulatory reforms.

The piece that’s missing “is identification of what we're trying to actually achieve. And planting a flag in the ground that says we are aiming to double the number of clinical trials within the next five years, 10 years, whatever it is,” he said.

“If we put some markers in the ground, then the system can self-organize around those markers. And to me, that's the piece that's really missing, and that requires real leadership,” Annan said.

Canada health care system is so balkanized that within provinces and among different health authorities, they can’t even communicate except by fax, he said. referring to the failure of Canada Health Infoway’s $300-million PrescribeIT program to replace faxed prescriptions with digital alternatives.

“It’s just, it's shameful for a country like ours. So we may not have the level of political sophistication needed to have a constitutional conversation, but we should absolutely be ready to actually have bigger systems conversations,” he said.

“And we, the individuals in Canada, should put the pressure not just on our federal, but our provincial politicians to say we want better. We want this to be working more collectively, because without the pressure from us, it's not going to happen.”

Only a fraction of clinical trials in Canada involve made-in-Canada therapies

Geneviève Lavertu (photo at right), director, government affairs and policy, Johnson & Johnson MedTech, pointed out that France implemented a national life sciences strategy about three years ago. The strategy anticipates that by 2030, at least 60 percent of all medications that will be used in Europe will be biopharmaceuticals.

So France’s life sciences strategy set a goal for France to be the No. 1 manufacturer of biopharmaceuticals in Europe, Lavertu said.

“From there, they started to build the how. So they had a destination, and they started to build the building blocks,” she said.

France also put in place all the different pieces of its life sciences ecosystem, including funding translational research and supporting the pathway to biopharmaceutical products commercialization, she added.

In contrast, in Canada “there is a massive productivity gap in the health sector and one that I think is not so difficult to overcome,” Lavertu said.

There are examples of where Johnson & Johnson MedTech has worked with the workflows in some health centres in Canada to increase productivity so they were able double the number of cases that they were able to do in one day with the same staff and the same equipment, she said.

“So here are easy fruits to gain here in order to make our health care system more sustainable and to be able to continue to finance our health care system, quite frankly, on a sustainable footing,” she said.

Michaud said that when it comes clinical trials, BioCanX has been able to attract more than 1,500 clinical trials to Canada over the past 24 years, providing investment and access for patients to novel therapeutics.

However, only 47 of those clinical trials, or 3.4 percent, involved Canadian-made innovations – and BioCanX was responsible for attracting half of those clinical trials even though the organization started only in 2015.

“That's an abysmal performance, but shows that by connecting and coordinating some dots, which we've done by linking by manufacturing, by really investing in the gaps that exist in the ecosystem, we're able to change that narrative, even though it's still really small,” Michaud said.

“We're able to harness and deliver therapeutics that are very sophisticated, that are at the cutting edge, and this is what our patients want,” she said.

“We need real investments in translational research. We need support for clinical trials. We need that goalpost to be very clearly defined,” Michaud said.

Murray said Canada needs a life sciences infrastructure “that will hold us in good stead in times of crisis. It will support us as we build a new economy, a thriving economy. It will support our families who need to be able to be at work.”

“We need new sectors, different sectors, to be supporting and growing our economy. And the life sciences is clearly that,” she said.

“We're seeing the United States cede its responsibilities and its leadership in research and in health. That's an opportunity for Canada. We need to move,” Murray said.

Global projections are that the value of the regenerative medicine sector will reach upwards of $150 billion in the next 10 to 15 years, and Canada’s current share is $500 million.

“There’s a huge opportunity for us,” she said. “Let's just, you know, be Canadian and go after five percent or seven percent. That would be huge for this country.”

Lack of investment to move potential products through to manufacturing centres

Murray said Canada has made significant financial investments in building out the infrastructure for biomanufacturing.

But what’s missing is adequate support for Canadian innovations to actually get to the biomanufacturing stage, she said. The financing to be able to do that “doesn't really exist, not at appropriate levels.”

“So we've got a gap there to be able to support bringing products through to those manufacturing centres. We also have challenges in making sure that we're bringing properly designed products to biomanufacturing,” Murray said.

Canada’s research community needs to be thinking of biomanufacturing as the end in mind and designing for something that can be translated from research purposes into clinical purposes and then can be scaled for a commercial purpose, she said.

A lot of Canada’s small very early-stage or pre-seed companies coming out of the stem cell network have got great intellectual property or a promising therapeutic, “but they can't attract the external investment to move it forward, because you need now in our investment environment human data before investors will come in,” Michaud said.

That human data means you have to have a manufactured product and investors are not going to put their money down on chemical biomanufacturing facilities, she said.

“VCs used to invest in very early-stage research. They don't anymore. They are looking for first-in-human data before making their investment,” she added.

“So this is where there's a real gap and we need to make sure that we are supporting publicly de-risking so we can bring these types of products through to manufacturing,” Michaud said. “So there's an education piece, there's a cost piece, there's a de-risking piece that all needs to be done.”

“And if we can do that and we can get the clinical trials, we have more clinical trials going, then we bring in more investment, that's great, then all of this infrastructure that we've paid for can actually get used.”

When it comes to regulatory reform, there is little to no funding to help companies – especially SMEs – prepare an application for a clinical trial for Health Canada, Michaud noted.

To meet those requirements requires a 1,000-page regulatory dossier that is very expensive and requires testing assays, a detailed description of what the biomanufacting looks like and how it will operate.

For example, BioCanX has spent about $1 million so far on applying for a drug substance – a regent to make another product.

Early-stage innovative life sciences and biotech companies don’t have the financial resources to afford to enter Canada’s regulatory system, Michaud said.

In comparison, she said, in 2015 China decided to support a made-in-China strategy, overhauled the country’s regulatory system, and doubled down on ensuring Chinese companies were able to develop and commercialize drugs not only for their own citizens but for the world.

Within 10 years, 30 percent of the drugs imported by pharmaceutical companies are now coming out of China, Michaud said. “It’s because they . . . have innovated, they have made sure that their system works really well. This is the kind of incredible competition that Canada is facing.”

Broader governance structure needed to align regulation and commercialization

Panel moderator Dominique Bérubé (photo at right), vice-president, research and innovation, and professor in the Faculty of Engineering at McGill University, said “the question is not really whether Canada has excellent science – that has been established. The question is rather ‘How we can convert that science, that excellence, into better health outcomes, stronger domestic capacity and trusted data systems?’”

Michaud said there’s need for Canada to bridge the divides between the mandate of Health Canada in regulation and managing risk, and Innovation, Science and Economic Development Canada when it comes to commercializing health products.

“There’s really a need for us to have a broader governance infrastructure to really align the activities of what I see are very disparate activities and investments that are taking place in the ecosystem, get everybody rowing in the same direction so that we can all achieve what it is that we want to achieve, which is, of course, sovereignty, which is health and safety of Canadians and then also commercial benefit,” she said.

But Canada’s health regulatory system and its regulators haven’t had any pressure on them to support domestic innovation, Michaud said. “They haven't had to evolve. And so that to me is a huge friction point for us to bring domestic innovation forward here in Canada and really achieve the goal of keeping our innovations here in Canada.”

For example, BioCanX asked Health Canada for a very common end-of-phase 2 meeting to go over the data from a clinical trial. It took three months to get a response and Health Canada said no, BioCanX would have to file a pre-new drug submission – a lot of complicated work.

Nevertheless, BioCanX submitted the pre-new drug submission to Health Canada. Between the initial email requesting the meeting and finally being able to have a discussion about the data took nine months, Michaud said.

In contrast, in Europe and with the U.S. Food and Drug Administration there are mechanisms to encourage having such discussions, she said.

Updating the regulatory system hasn’t been a political priority, “and the way that medicine is advancing, we're working with an old paradigm. So we're setting ourselves up to lose,” Michaud said.

For example, Murray pointed out that the product developed by Montreal-based biotech firm ExCellThera is now available in Germany and other European countries.

The company tried to introduce its product in Canada, but the regulators said that wasn’t possible without launching a Phase 3 clinical trial and producing data in Canada, she said.

“Small biotechs don’t have those kinds of [financial] resources. We’ve tailored a system that’s creating barriers,” Murray said. “We need our regulatory and access systems designed with safety and advocacy in mind, but also viewed as a tool for economic growth. 

Lavertu said if Canada wants to be able to continue to keep up with Horizon Europe projects that are being supported by “this massive infrastructure” in the European health data space, “we need to be able to keep up with our data assets and to be able to create these types of projects, now that Canada is an associate of Horizon Europe.”

However, Annan noted that Canada has policy challenges about jurisdictional issues, especially among provinces, when it comes to health data.

“The biggest issue has to do with the culture of sharing. There is a risk aversion in this country when it comes to actually sharing data. It's one manifestation of, I guess, a regionalism,” he said.

“So I think we maybe overcorrect towards the technical end of how do you build federated data systems. And we underappreciate the human and cultural side when it comes to the lack of incentives, in many cases, disincentives to data sharing,” he added.

Canada needs to invest time and resources now into building effective governance systems for health data, Annan said.

Annan said Canada has huge regional strengths in health and life sciences across the country, including a large and thriving life sciences sector in B.C., government support for the growing sectors Ontario and Quebec, and a strong life sciences cluster in Prince Edward Island.

Despite the challenges, he said, “I've never seen the type of collaborative spirit I'm seeing right now in the life sciences space.”

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