When most people think of Canadian medical innovation, the first thing that typically comes to mind is insulin. And while Banting and Best’s discovery was a breakthrough in the treatment of diabetes, it also took place almost a century ago.
“We always go there, don’t we?” says Pamela Fralick, president of Ottawa-based Innovative Medicines Canada, an association representing the Canadian pharmaceutical industry. But we should also recognize the accomplishments of James Till and Ernest McCulloch, who discovered stem cells; Dr. Lap-Chee Tsui, who identified the gene responsible for cystic fibrosis; Dr. Chil-Yong Kang, whose HIV prevention vaccine is currently in clinical trials. And many, many more.
From the first whispers last year about the emergence of a deadly respiratory coronavirus in China, Canadian scientists have been researching and developing possible treatments, cures and vaccines for SARS-CoV-2, or COVID-19.
Already, a promising discovery has come out of Vancouver-based biotech company AbCellera Biologics Inc. – a potential treatment for the virus developed in record time. In partnership with U.S. drug maker Eli Lilly and Co. and with $175-million in funding from the Canadian government, the lab-produced treatment that mimics antibodies isolated from a recovered patient has already entered into human testing.
There are many other promising treatments in the works as well, but some researchers are expressing concern that regulatory hurdles and a relative lack of funding may prevent Canada from becoming the international drug development and innovation powerhouse it could be.
“Canada does very good research, and, particularly in the academic and government sector, some very good early-stage research,” says Dr. Don Stewart, chief executive officer of PlantForm Corp., a Toronto-based biopharmaceutical company that is developing a COVID-19 test and treatment. initiatives. “The problem is translating that research into the private sector for development.”
While Prime Minister Justin Trudeau announced $275-million in funding for COVID-related medical research in March, some researchers worry that the process is not moving forward quickly enough and that Canada may miss an opportunity to make history.
University of Toronto molecular engineer Dr. Sachdev Sidhu and his team are designing synthetic therapeutic antibodies.
Already there are good results in trials in which antibodies collected from someone who has recovered are transferred to someone who is sick, Dr. Sidhu says. For many, this could be a successful treatment, he explains, keeping sicker patients off ventilators and, in less dire cases, alleviating symptoms and kickstarting patients’ own immune systems.
Dr. Sidhu says his engineered antibodies work in a similar way – except that they are more potent and targeted than naturally occurring antibodies and, because they are engineered, can be produced in massive quantities.
The treatment can also rapidly be altered if mutations occur or as new pathogens emerge. “We shouldn’t be treating every viral emergence as an emergency,” Dr. Sidhu says. “We’d like to be in a position with a synthetic that we’re in a predictive mode and we can rapidly develop drugs. Because we all know the best way to treat a viral outbreak is before it reaches pandemic or even epidemic levels.”
Dr. Sidhu says his treatment is ready to scale up, but after an initial $500,000 research grant from the federal government, no further funds have been advanced for clinical trials. Fortunately, he says, a $7.6-million commitment from Italy means his team will be doing clinical trials there. There is also interest from the Indian government to do the same.
“That’s good news for us; our drug will advance,” Dr. Sidhu says. But without additional funding from the Canadian government, he adds, it will be made and tested elsewhere and then brought back to Canada eventually as an approved treatment.
“Eventually we have to do a gut check, and what better time than COVID-19 to say not only will we support our scientists, but we will support them all the way [from innovation through to manufacturing]?” Dr. Sidhu adds. “Nothing of this scale can be done without a partnership between the governments of Canada and the innovators of Canada.”
PlantForm’s Dr. Stewart also notes a hesitation to be bold on the part of the funding agencies. “I think that’s one of the problems of translating research out of the academic environments and into product development: It’s expensive and risky, but you can only move these things forward if you provide money and are prepared to take risks.”
PlantForm is working with Canadian and international partners and using its plant-based manufacturing system to develop one of Canada’s first antibody tests for COVID-19, as well as producing therapeutic antibodies to treat infected patients and as a preventative for health care professionals and first responders.
“It’s encouraging to see that out of the pandemic there is a better understanding of lack of [manufacturing] capacity,” Dr. Stewart says. “But it’s going to take some time and a lot of investment to move that forward. And there will have to be partnerships in the public and private sectors.”
There is also concern in the pharmaceutical industry that proposed regulations governing drug prices in Canada may only strain the relationship between industry and government, whose health care dollars must be spread in many directions. When the new rules, which establish price ceilings for patented drugs, come into effect Jan. 1, Ms. Fralick explains, there could be a dramatic impact on the bottom line of the companies that produce such innovations.
“Our companies spend a good part of their time … fighting to bring investment dollars into Canada,” she says. “And it’s almost impossible to tell global decision makers why they should come to Canada and invest now because of the long-term uncertainty of where this regulatory process is going.”
“We’re a very attractive place to invest,” says Marissa Poole, Sanofi Canada country lead and general manager for Sanofi Genzyme, which has two therapies in clinical trials, and that is working globally to develop two vaccines for COVID-19, as well as a home-testing solution. “We have world-class researchers and scientists and a diverse population base,” both of which have in the past encouraged investment and a predictable market.
But the competition for global investment is significant and has rapidly increased. Pharmaceutical companies base their investment decisions on a number of factors, one of which is whether there is a predictable government approval process – something that Ms. Fralick says is more uncertain in Canada now with the new regulations.
“Companies are not going to bring their latest, greatest, newest innovative drugs into a clinical trial in Canada if they have a good sense that that drug is not going to be available in Canada after the trial,” explains Ms. Fralick. “This means the patients, you and I, our families, friends and colleagues, are not necessarily going to have the drugs we need and should have.”
But if there’s such a thing as a silver lining to a pandemic, she adds, it’s that companies are working together toward the same goal.
“I have never seen the collaboration that’s happening around this pandemic between governments and academics, philanthropists and industry,” she notes.
Her hope is that this way of working together will outlast the pandemic. “I think COVID-19 has given us a once-in-a-century opportunity to see the benefit in collaboration and get over some of the pieces that have held us back. Everyone is a stakeholder, is a player and has something to contribute and something to gain.”