Why Canada needs more Phase 1 clinical trials to reach its full potential in biotech

By Anne Stevens and Jessica Patterson, AbCellera

IT IS A POINT OF PRIDE FOR ANYONE WORKING IN CANADA’S BIOTECH ECOSYSTEM that our country hosts more than its share of later stage clinical trials. Now, by ramping up our Phase 1 capability, Canada can realize its full potential as a world leader in medical innovation and research.

Phase 1 clinical trials are an essential step in the overall continuum of drug development. Following early discovery and development, Phase 1 trials are the first time a medicine is tested in human patients and are used to determine safety, appropriate dose levels, and preliminary efficacy. They are followed by more extensive trials that ultimately lead to the regulatory approvals needed before a medicine can be made broadly available to patients.

According to the World Health Organization (WHO), Canada was home to 1,875 clinical trials spanning all phases in 2022. On a per capita basis, that outpaces all other G7 nations. Canada’s strong performance stems mainly from our world-leading higher education and public health care systems, both of which entice many domestic and foreign pharmaceutical companies to conduct later-stage trials here.

Canada’s Phase 1 performance tails off dramatically, however, with a mere 85 trials conducted in 2022. The world-leading United States, meanwhile, was home to 1,334 Phase 1 trials last year. Canada’s Phase 1 deficit is a problem for several reasons. For one thing, early stage trials often guide decisions on where to conduct later trials, and when these decisions bypass Canada there is an associated loss of revenue, partnerships, training, and other business opportunities. For another, when innovative medicines discovered and developed in Canada are clinically tested elsewhere, we also miss out on the opportunity to integrate them into our healthcare system early, and Canadian patients fail to benefit from the innovation happening on home soil.

A prime example of these pitfalls emerged during the COVID-19 pandemic. In March of 2020, at the start of the COVID-19 pandemic, AbCellera prioritized speed in getting therapies out to patients. This resulted in the discovery of bamlanivimab, the first COVID-19 antibody treatment to reach patients in Phase 1 clinical trials. It was also the first to be authorized by Health Canada and the U.S. Food and Drug Administration.

Bamlanivimab was discovered by AbCellera, and our partner Lilly, who responded to the urgency of COVID-19 in heroic fashion, was responsible for developing it and advancing it into the clinic. This process of going from screening an initial blood sample to launching a Phase 1 trial usually takes years; together with Lilly, we did it in 90 days. And in 2021, AbCellera and Lilly discovered and brought a second COVID-19 antibody treatment, bebtelovimab, to patients in response to the emergence of new variants. While both antibody treatments were discovered in Canada, the Phase 1 trials were conducted in the United States. Logically, the subsequent later phase trials were also conducted in the United States, which likely streamlined the adoption of the antibody medicines into the U.S. healthcare system. As a result, 2.5 million doses of AbCellera’s COVID-19 antibody treatments were delivered to patients, potentially saving tens of thousands of lives.

So the question is: Why does Canada host so few Phase 1 trials? A rationale for this can be linked to the competition with other countries. Favourable regulatory conditions, larger population bases, and more mature clinical infrastructures in other countries act as driving forces, diverting Phase 1 clinical trial activities away from Canada. To level the playing field, Canada must nurture its distinctive strengths in research centres, hospitals, and academic institutions with the requisite resources and expertise for these early clinical trials that set the stage for Canadian patients to receive highly innovative therapies.

That’s where AbCellera’s $701-million co-investment with the B.C. and federal governments comes in. As a step towards the creation of a biotech hub like those established in Boston and San Francisco, AbCellera’s state-of-the-art biotech campus at the heart of this historic partnership will include extensive wet lab facilities, build on capabilities needed to reach the clinic, and leverage existing early clinical trials networks across the country. This all will foster collaboration among clinical researchers across Canada, allowing them to design and conduct Phase 1 trials that deliver promising new medicines to patients for a broad range of diseases, with an initial focus on cancer and immune diseases.

At the same time, AbCellera is building an internal team of manufacturing and operations specialists, scientists, and engineers responsible for developing the processes to manufacture antibody medicines in Canada. When combined with our world-leading antibody discovery capabilities and anchor-company resources, this will enable us to move rapidly and seamlessly from discovery to Phase 1 trials.

Building a strong early-stage clinical trials ecosystem would strengthen Canada’s position as a leader in medical innovation and research. Having the required infrastructure, proven capabilities, and an efficient regulatory environment will attract international pharmaceutical and biotech companies to conduct their early-stage trials within our borders. This will foster collaboration between researchers, clinicians, and industry experts as novel medicines advance towards the benefit of global health.

There are also significant economic benefits in building a strong clinical trials environment. The life sciences and pharmaceutical sectors are major contributors to the global economy. By becoming a leading destination for clinical trials that span the entire drug development continuum, Canada can attract research investments, partnerships, and collaborations from domestic and international pharmaceutical companies. This influx of funding and expertise will drive economic growth, create a wealth of new highly skilled jobs, reduce our reliance on foreign nations when the next global health crisis strikes, and fuel collaborative innovation in life sciences that will benefit Canadians, and the world, for generations to come.

In order to unlock Canada’s remarkable biotech potential to its fullest, strengthening the continuum of capabilities towards Phase 1 clinical trials stands out as the most strategic starting point.