Federal investment required to build a cell and gene therapy ecosystem in Canada, says Innovation Economy Council

The federal government needs to co-invest with the private sector in building facilities to manufacture cell and gene therapies or risk losing Canada’s advantage in this fast-growing global market, according to a new report by the Innovation Economy Council (IEC).

Although Canadian science helped pioneer stem-cell biology in the 1960s, “the challenge now is to build a complete Canadian ecosystem, from discovery and venture capital to talent and commercial-scale manufacturing,” says the IEC’s report.

Ottawa’s focus during the COVID-19 pandemic has been on announcing funding to build domestic biomanufacturing plants to make vaccines, says Dr. Michael May, PhD, president and CEO of the Centre for Commercialization of Regenerative Medicine (CCRM).

“But there’s much more to our biomanufacturing opportunity outside of crisis, pandemic-driven investing,” he told Research Money.

Canada has the potential to create a multibillion-dollar industry built around cell and gene therapies, May argued. “If we want Canadians to have access to these life-saving medicines, then we need to be in the game.”

But to do so, he added, the federal government needs to ensure its biomanufacturing strategy integrates and incorporates the “future of medicine”, such as cell and gene therapies, biologics, and other technologies.

Federal spending drives development

CCRM, a public-private partnership based in Toronto, is Canada’s largest and most advanced biotech contract manufacturer. The IEC is a coalition of tech-sector leaders.

Federal Budget 2021, as part of Ottawa’s Biomanufacturing and Life Sciences Strategy, provided a total of $2.2 billion over seven years for companies, researchers, universities, and hospitals to grow the life sciences sector and secure pandemic preparedness.

According to the IEC’s report, the federal government is also spending another $1.2 billion on new vaccine manufacturing plants, along with the development of COVID-19 vaccines and associated therapeutics.

Beyond vaccines, however, the report noted that many of the large global drug makers are either building or acquiring new biomanufacturing capacity to produce cell and gene therapies. None of these facilities is located in Canada.

Biomanufacturing more than vaccines

The IEC report concluded Canada has no contract manufacturing firms with large-scale plants capable of producing cell and gene therapies at the scale required to meet expected future demand, according to the IEC’s report. These so-called “living medicines” are designed to directly attack a range of deadly and debilitating diseases, including cancer, rheumatoid arthritis, diabetes, liver disease, Alzheimer’s and many rare conditions.

The global market for cell and gene therapies has been growing by more than 25 per cent per year, reaching a value of US$4.4 billion in 2020, according to a report by the Business Research Company. By 2030, the value of that market is projected to reach more than US$34 billion.

Canada needs a domestic manufacturing base and supply chain for cell and gene therapies, May insisted, so that the country is not wholly reliant on the economics of global drug multinationals. Along with co-investing in new manufacturing facilities and related infrastructure, the federal government needs to also invest in developing talent and initiatives to attract venture capital.

Canada doesn’t lack for federal support of foreign-driven biomanufacturing opportunities, he said. This includes a new vaccine manufacturing plant in Quebec, to be built by U.S.-based Moderna, and another vaccine manufacturing facility in Ontario, to be built by France-based Sanofi Pasteur.

Ottawa also has provided funding to Canadian manufacturers of vaccines and related therapeutics, such as AbCellera in Vancouver, Medicago in Quebec, and the Vaccine and Infectious Disease Organization in Saskatoon.

However, no federal funding has been forthcoming for Canadian cell and gene therapy manufacturing “that’s being advanced by Canadian innovation and which is in Canadian control and Canadian interests,” May said.

Build manufacturing facilities in major urban innovation centres

May said if Canada wants a share of that market, then it needs to build as soon as possible large-scale cell and gene therapy manufacturing facilities and training centres in major urban innovation ecosystems, including Toronto, Montreal and Vancouver.

He pointed to the fact that these sites have access to patients and concentration of health care delivery, with access to financing and capital, intellectual property, and universities and other institutions. “You have to take the gamble around each ecosystem.”

The CCRM, through its subsidiary OmniaBio Inc., is leading efforts to build a new 250,000-square-foot (first of two phases that will total 400,000 sq ft) biomanufacturing plant at McMaster Innovation Park in Hamilton, Ont. Construction of phase one is expected to start this year and will take 18 months.

The $580-million plant will be the largest contract development and manufacturing facility in Canada for regenerative medicine-based technologies, including homegrown and international cell and gene therapies.

OmniaBio, as the anchor tenant in the envisioned biomanufacturing centre of excellence, will create approximately 2,300 direct and indirect jobs in Ontario and add $4 billion a year to the province’s GDP by 2032 by building a strong industry cluster, according to an economic analysis commissioned by CCRM.

In March, the Ontario government announced it will provide a loan, through the Invest Ontario Fund, to OmniaBio for up to $40 million.

“Our hope is that the federal biomanufacturing strategy and government will invest alongside Ontario and the private sector and CCRM in this jewel of Canadian innovation,” May said.

Sector employment needs to double

Canada’s biotech industry will require an additional 36,000 workers by 2029 —  more than doubling the current industry workforce, according to Ottawa-based BioTalent Canada.

May said the key to the industry’s future success is to build a strong, end-to-end drug production pipeline, including cell and gene therapies.

“If all that we do is generate ideas and intellectual property, and license those around the world without participating in the value-added components — commercialization, manufacturing, product development and clinical trials — then we lose,” May said.

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