Evidence of meeting #17 for Industry, Science and Technology in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was vaccines.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Eric Costen  Senior Assistant Deputy Minister, Industry Sector, Department of Industry
Maria Aubrey  Vice-President, Strategic Initiatives, National Research Council of Canada
Darryl C. Patterson  Director General, Life Sciences and Biomanufacturing Branch, Department of Industry
Daniel Quinn  Director, Research Infrastructure and Outreach, Science and Research Sector, Department of Industry
Lakshmi Krishnan  Vice-President, Life Sciences, National Research Council of Canada
Rodrigo Arancibia  Senior Director, Life Sciences and Biomanufacturing Branch, Department of Industry
John R. Fulton  President, Spokesperson and Representative for Biolyse Pharma Corporation, BioNiagara
Oliver Technow  Chief Executive Officer, BioVectra Inc.
Volker Gerdts  Director and Chief Executive Officer, Vaccine and Infectious Disease Organization - International Vaccine Centre
Alain Lamarre  Full Professor, Institut national de la recherche scientifique, As an Individual
Andrew Casey  President and Chief Executive Officer, BIOTECanada
Marc Sauer  Vice-President, Process Science and Development Services, BioVectra Inc.

1:50 p.m.

Senior Assistant Deputy Minister, Industry Sector, Department of Industry

Eric Costen

Thank you for the question.

I think maybe there are two dimensions to the answer. One of course would have to do with Canada's donation strategy.

1:50 p.m.

Liberal

Nathaniel Erskine-Smith Liberal Beaches—East York, ON

Let's bracket that off, because donations are vaccines we've procured from elsewhere that we plan to donate. I'm not interested in that at all. I'm interested in what we are producing here at home that we plan to ship elsewhere.

1:50 p.m.

Senior Assistant Deputy Minister, Industry Sector, Department of Industry

Eric Costen

I'll look to maybe Maria, who could probably offer a thought on the time-frame element of your question around getting vaccines when the facility is qualified and when they're rolling off the line. Novavax would probably be the first example of that.

Perhaps Maria, you might be able to offer an answer to the question that's better than what I could offer.

1:50 p.m.

Vice-President, Strategic Initiatives, National Research Council of Canada

Maria Aubrey

Thank you for the question.

The pandemic brought to bear, as it was originally indicated, the importance of being able to produce vaccines in Canada for our own certainty but also to be able to support others as you have highlighted. We are going as fast as we possibly can without actually jeopardizing or putting at risk the importance of producing vaccines in a safe manner in accordance with good manufacturing practices.

The way the biologics manufacturing centre is intended to work is that we don't own the vaccine. We work with people who are vaccine sponsors, and we take that vaccine, such as the case with Novavax, and produce it either for the need in Canada, if we need it obviously, or for other countries in need, which would have to be where the Canadian approval and the vaccine sponsor have the authority to bring it to them.

Therefore, for us right now, we are, as I indicated, in the commissioning, qualification and validation, we have completed the pilot runs with the Novavax vaccine—

1:55 p.m.

Liberal

Nathaniel Erskine-Smith Liberal Beaches—East York, ON

I apologize. I understand there's great detail to this, but I'm more interested in the timeline, the reasonably expected timeline and the number of doses that we expect as well. Surely we have a trajectory here and a plan in place so that we can say it's between x date and y date, and this is our expectation.

What's the date we expect and what are the doses we expect?

1:55 p.m.

Vice-President, Strategic Initiatives, National Research Council of Canada

Maria Aubrey

The actual date has to be determined, in combination, by the vaccine sponsor and Health Canada, because they will generate the approval. Right now our target is to have our engineering runs and our quality batches completed at the end of this fiscal year, assuming everything goes right. Obviously we—

1:55 p.m.

Liberal

Nathaniel Erskine-Smith Liberal Beaches—East York, ON

Can I pause there?

You said you want to do everything as quickly as you can but not jeopardize safety. We're in a global pandemic. Other countries need vaccines. We have the vaccines we need, and thankfully we do and I'm glad that we do, but other countries desperately need vaccines.

We're going to hear later this afternoon from BioNiagara. They were pushing for amendments to the Patent Act. They were pushing for us, using the Canadian access to medicines regime, to add COVID-19, in addition to tuberculosis, malaria and HIV/AIDS. Wouldn't it have made sense, as we ramp up domestic manufacturing capacity, as we get closer to Novavax being completed, as we get closer to a place where we can produce vaccines with IP in a Canadian context, to say on an interim basis we're going to have BioNiagara produce vaccines, amend the Patent Act and ship vaccines to developing countries that are in desperate need?

Mr. Costen.

1:55 p.m.

Liberal

The Chair Liberal Joël Lightbound

The answer will have to be very brief, Madam Aubrey or Mr. Costen.

1:55 p.m.

Liberal

Nathaniel Erskine-Smith Liberal Beaches—East York, ON

It would be for Mr. Costen.

1:55 p.m.

Senior Assistant Deputy Minister, Industry Sector, Department of Industry

Eric Costen

There are a couple of quick things. I think it's an unavoidable reality that the manufacturing of these vaccines and the fitting up of these facilities takes years. If you look at a typical or even an aggressive schedule for building and qualifying, these are extraordinarily technical and finicky processes that do span years.

The reality is that in Canada, after these investments, the facility that Maria's describing will be the first one rolling vaccines off the line. It has been done, by any reasonable comparison, at light speed compared to what you might have seen 10 years ago. For other facilities where we have made investments—I think of Sanofi as an example—we will be waiting several years before this facility is ready and we see vaccines. That's not because of needless delays. It's just because of the nature of this manufacturing.

On your point about the global demand, you're absolutely—

1:55 p.m.

Liberal

The Chair Liberal Joël Lightbound

Mr. Costen, I'm afraid I'm going to have to stop you. I'm sorry. I have a terrible role here.

We need to move to Mr. Lemire for two and a half minutes.

1:55 p.m.

Bloc

Sébastien Lemire Bloc Abitibi—Témiscamingue, QC

Thanks to the witnesses for their presentations today and for all their work, particularly over the past two years. I remember there was considerable criticism, particularly in this committee, of the fact that Canada was unable to produce Canadian vaccines in response to the pandemic and that it didn't have a strategy.

Mr. Costen, if memory serves me, you confirmed that earlier when you said that we didn't know what to do in October 2020 after staking everything on the Chinese vaccine CanSino.

We had a first phase of $900 million and a second of $1.3 billion, for a total of $2.2 billion, $1.6 billion of which has been spent. If I'm not mistaken, that leaves us with $600 million to spend.

Thus far, how has that government spending tangibly increased Canada's biomanufacturing capacity in the short and medium terms? What will we do with the remaining $600 million?

2 p.m.

Senior Assistant Deputy Minister, Industry Sector, Department of Industry

Eric Costen

Thank you very much for the question. There are maybe just a couple of quick things. I will try to be very brief.

In my reference to October 2020, the strategy was to identify, following expert scientific advice, which candidate vaccines had the greatest promise to come to market safely and effectively. Canada made a series of investments across a diversity of platforms including Moderna, Pfizer, Medicago and Novavax. Canada invested in a portfolio of vaccines and we're seeing the results of those investments play out today.

In terms of your question about investment priorities going forward, many of those are articulated directly in the strategy. We will continue to see investments made upstream in R and D and in talent. We will see investments made to continue to build out our industrial capacity across protein-based vaccines, mRNA vaccines and viral vector vaccines. You will see investment in development of therapeutics and antibody therapies as well as supply chain investments.

We still have quite a bit of work to do to continue down this path to rebuild the sector, guided by the strategy, and to strategically build out the ecosystem that is described in the document that was published last summer.

2 p.m.

Bloc

Sébastien Lemire Bloc Abitibi—Témiscamingue, QC

Thank you, and keep up the good work.

2 p.m.

Liberal

The Chair Liberal Joël Lightbound

Thank you, Mr. Costen.

I now give the floor to Mr. Masse for two and a half minutes.

It seems he's not with us. So that concludes our last round for the first hour.

2 p.m.

Conservative

Bernard Généreux Conservative Montmagny—L'Islet—Kamouraska—Rivière-du-Loup, QC

Mr. Chair, Ms. Zarillo is here replacing Mr. Masse.

2 p.m.

Liberal

The Chair Liberal Joël Lightbound

Ms. Zarillo, would you like to use Mr. Masse's two and a half minutes?

2 p.m.

NDP

Bonita Zarrillo NDP Port Moody—Coquitlam, BC

I'm going to pass, if you don't mind.

Thank you.

2 p.m.

Liberal

The Chair Liberal Joël Lightbound

That's actually a blessing because we're really short on time and we have a second panel coming in.

Thank you very much to our witnesses for this first hour. It is much appreciated. Thanks for all the hard work you're doing on behalf of Canadians.

We will now suspend briefly until all our witnesses are in place.

Thank you. Have a good day and have a good weekend.

April 8th, 2022 / 2:05 p.m.

Conservative

The Vice-Chair Conservative Michael Kram

Thank you very much to the witnesses for joining us this afternoon to share their expertise in this field.

Every witness will have a six-minute presentation, and then we'll move to questions. We are starting with John Fulton from BioNiagara.

Mr. Fulton, you have six minutes. Take it away.

2:05 p.m.

John R. Fulton President, Spokesperson and Representative for Biolyse Pharma Corporation, BioNiagara

I'd like to start by thanking the Standing Committee on Industry and Technology for inviting me today. I am the president of BioNiagara in St. Catharines.

I'd like to make a little clarification. In the last meeting, they referred to BioNiagara as the company that wishes to produce a COVID-19 vaccine. It's actually Biolyse Pharma, a GMP and GLP industrial-level sterile fill injectable drug manufacturer based in St. Catharines.

In October 2005, during the bird flu H5N1 pandemic, there was a worldwide shortage of the patented antiviral drug oseltamivir, known as Tamiflu, which at the time was considered the only therapeutic with any effect on this killer virus. Biolyse quickly reverse-engineered Tamiflu and secured access to millions of Christmas trees, which contain the main ingredient necessary to fabricate this drug.

At the time, Roche's Tamiflu was under patent, and for Biolyse to scale production to meet the needs of this global crisis, a compulsory licence would have had to be issued by Industry Canada, now ISED, to protect Biolyse from litigation. After I contacted the director of patent policy in Ottawa, I discovered that there was legislation on the books that allowed generic manufacturers to produce patented medicines for global emergencies. This is currently known as Canada's access to medicines regime, or CAMR.

As of 2005, Biolyse would have been the first company in the world to attempt to have a drug manufactured using this emergency legislation. In 2003, under Prime Minister Jean Chrétien, Canada was the first country in the world to proudly adopt this legislation from the World Trade Organization's TRIPS agreement. In October 2006, seven months after applying to have oseltamivir added to schedule 1 of the Patent Act, which is the necessary first step in applying for a compulsory licence, it was successfully listed, and we were the first to achieve that.

By then, Canada and other countries had sent billions to Roche for their Tamiflu. Fortunately, by then, seven months later, after applying to have us added, the bird flu had ceased to be an immediate threat to Canadians and to the world's population. Unfortunately, now without a country in need, there was no market for our generic version of Tamiflu, and we abandoned the project.

Let's fast forward to March 1, 2021. When the COVID-19 pandemic hit in early 2020, the supply of the essential medicines and personal protective equipment became critical. The lack of domestic production capacity was a reality check for the Canadian government and its provinces. In response to the insecurity of global supply, a federal government COVID-19 vaccine task force was formed to seek out high-potential Canadian candidates for the manufacturing of vaccines.

In May 2020, Deloitte, the contractor, contacted Biolyse Pharma on behalf of the COVID-19 vaccine task force. Deloitte was ecstatic to have discovered one of the few remaining domestic manufacturers of sterile injectables in Canada, which was several years into the construction of a biologics manufacturing centre designed to produce monoclonal antibodies. As a result of Deloitte's inquiry, Biolyse pivoted to repurposing the facility for vaccine production.

Biolyse already had the available expertise and equipment to produce millions of doses of adenovirus vector or mRNA vaccines. At that time, Biolyse was also busy supplying Canadian hospitals and international health ministries with its sterile injectable medicines, while undergoing the major expansion of its 125,000-square-foot, seven-acre, St. Catharines-based manufacturing plant.

At the bequest of Deloitte, Biolyse put forth all the requested information to support its fill and finish capacity for specific vaccine platforms—more specifically, volume capacity at each stage of the production process, formulation, API production, filtration, filling, sealing, labelling, packaging and all types of specialized equipment readily available and on site for vaccine production.

The main advantage of Biolyse's response to the task force was that all the equipment and expertise necessary to fabricate biologics as well as the Health Canada licences to produce vaccines were immediately available and on site. For example, Biolyse has bioreactors up to 2,500 litres, numerous large industrial chromatography systems, multiple high-speed fill lines—it takes three years to get a fill line now if you want to purchase or fabricate it—and all the necessary GLP laboratories, water purification and air filtration systems required.

It's worth noting that such specialized equipment would generally take years to acquire, especially since ordering such equipment was nearly impossible during the pandemic due to global demand and supply chain chaos.

Considering the readiness of Biolyse with the potential of producing a minimum of 20 million and up to 80 million vaccine doses per year, supported by the existing equipment and its level two biosecurity, GMP-GLP facility, Biolyse and Deloitte determined that, with an investment from the federal government of as little as $4 million, which at the time would have been equivalent to a small PPE order, Biolyse could hire the necessary contractors and staff to accelerate the repurposing for vaccine production and, within four to six months, be in a position to attract one of the vaccine candidates that Biolyse had open dialogues with and were seeking to expand their production capacity.

After spending nearly a year trying to get support—

2:15 p.m.

Conservative

The Vice-Chair Conservative Michael Kram

As much as I hate to cut you off, you are out of time.

Maybe those comments can come forward during the question and answer period.

2:15 p.m.

President, Spokesperson and Representative for Biolyse Pharma Corporation, BioNiagara

John R. Fulton

Sure.

I just have a lot to say. It's quite the story.

2:15 p.m.

Conservative

The Vice-Chair Conservative Michael Kram

Our next witnesses are from BioVectra. We have Mr. Technow and Dr. Sauer.

Feel free to begin your presentation.

2:15 p.m.

Oliver Technow Chief Executive Officer, BioVectra Inc.

Good afternoon, Mr. Chair and members of the committee.

My name is Oliver Technow. I am the CEO of BioVectra, a contract development and manufacturing organization headquartered here in Charlottetown, Prince Edward Island. Thank you for the opportunity to speak with you today. Also joining me is Dr. Sauer, BioVectra’s chief science officer and a 20-year veteran of the sector, who is leading the charge on our mRNA vaccine and biomanufacturing expansion. I have 30-plus years of global pharmaceutical industry leadership experience, having lived and worked in Europe, the United States and Canada.

My company is a leading Canadian CDMO, with 17 of our clients being among the world’s top 20 pharmaceutical companies. Overall, we serve more than 100 clients. We produce active pharmaceutical ingredients, and as a full service CDMO, we support our clients globally to develop and produce pharmaceuticals and therapies, making a huge difference in the lives of patients. We have a 50-year track record, with beginnings as a start-up company that was the brainchild of Dr. Regis Duffy, former dean of science here at UPEI. Today we have 600 employees and five state-of-the-art facilities in both Charlottetown and Windsor, Nova Scotia, certified by Health Canada, U.S. FDA and the Japanese PMDA.

A key to the global competitiveness of our businesses is that we are continuously investing in expanding our capabilities in terms of offering end-to-end services, from clinical development all the way to commercial manufacturing. We announced in November a $79.6-million expansion of our business to produce mRNA vaccines and therapeutics, with the Government of Canada contributing $39.8 million through the strategic innovation fund and a $10-million investment from the Province of Prince Edward Island. This is a natural next step for our company, as we have decades of experience in making very closely related molecules.

Our expansion includes constructing a cutting-edge biomanufacturing facility here in Charlottetown, creating a single-use clinical scale suite in Windsor, Nova Scotia, and opening an R and D facility in Halifax. We just broke ground, and when completed in 2023, BioVectra will be able to produce up to 160 million doses of mRNA vaccine per year, with the capability to commercially package, or fill and finish, 70 million doses. Through this expansion, we will add at least 125 new jobs in the sector, generate research partnerships and development opportunities for life sciences and biomanufacturing professionals, and create 225 co-op terms for students.

CDMOs like ours are ideally positioned to offer the flexibility needed to respond to the next pandemic, because we have developed platforms that can produce many types of products for many biopharmaceutical companies. We have specialized talent in research and development, engineering, business development, quality and manufacturing, which are needed to support the end-to-end life cycle of drug production and manufacturing.

Over the last several years, Canada has made significant investments in the infrastructure and S and T capabilities needed to reinvigorate the country’s domestic biomanufacturing. I believe that to truly reinstate Canada as a biomanufacturing leader, we need to be nurturing an ecosystem that can sustain it over the long term, such as staying on par with other countries' investments into new technologies, which will remain crucial in attracting more global pharmaceutical companies to come to Canada. Also, I believe the focus now needs to shift from bricks-and-mortar investments towards building a more robust bioscience talent pipeline. Talent truly is the catalyst for a robust and globally competitive Canadian biomanufacturing sector, and we should be aiming really high to make Canada a prime talent destination.

The economic growth potential for this sector is enormous, and our ability to succeed or fail is contingent upon building, attracting and retaining our human capital. The first step that I see needed is to grow and retain top talent in the country. We need engineers, scientists and technicians who can see an attractive career path in the bioscience sector in Canada. We need to be targeting graduates from all academic levels and make the sector attractive by taking approaches such as offering transition-to-work opportunities and establishing more co-op student placements. This can be best solved through close collaboration and partnership between the private and public sector.

One good example of this is CASTL, the Canadian Alliance for Skills and Training in Life Sciences, headquartered here in Prince Edward Island. CASTL is the result of close collaboration between different levels of government, industry and academia, and it brings a world-class technical training curriculum to Canada as the exclusive partner of Ireland’s globally recognized National Institute for Bioprocessing Research and Training. BioVectra was involved in the development and is an early adopter of CASTL, which is a one-stop shop for our industry’s training and academic requirements.

I urge our decision-makers to create better conditions to attract talent from around the world so that they choose Canada as the destination to make their careers. I believe governments could play a leading role in adopting policies that streamline and speed up the immigration process to tackle the domestic talent gaps that we know are coming. They can create other options too, as other countries do, with, for example, personal income tax incentives, which have proven to be quite successful.

Our experience has been that to attract international talent, you need to offer an attractive place to live. I would like to see our leaders continue to work swiftly to create conditions that make Canada that place—conditions such as improving immediate access to health care, child care and middle-income home ownership.

A lesson from the pandemic that we need to keep at the forefront is to nurture and sustain Canada's domestic biomanufacturing capability, which will help prepare Canada to pivot and respond quickly to the next global crisis.

Thank you.