Archived - This content has been developed for the transition binder for the NRC Acting President, September 2020
| Status: | Protected B |
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| Effective date: | 22 September 2020 |
This is a weekly update report on selected NRC COVID-19 initiatives.
Latest updates
- Biomanufacturing Vaccine Facility (BVF): Completed work at the existing Royalmount facility on the temporary location for the Vanrx fill and finish. It will likely take approximately four months to have the unit validated and fully operational. Completing workflow modifications recommended by Health Canada (HC) to enable GMP production of clinical trial material in the facility, initial engagement with HC has been successful. QA/QC team is on schedule for finalization of required documentation.
- NRC Operations: As of Sept 17th, 69% of the NRC is working remotely. Of the total number of NRC employees, 11% are working onsite full time and 20% are coming in intermittently to perform essential tasks.
- [REDACTED]
For more information: Additional information on programs in this report can be obtained upon request from the NRC Policy, Strategy and Performance Branch c/o John Burnett (John.Burnett@nrc-cnrc.gc.ca).
Industrial Research Assistance Program
NRC IRAP Innovation Assistance Program ($250M)
- All funds have now been committed. [REDACTED]
NRC IRAP SME Support for COVID-19 Response
- NRC IRAP has a number of projects underway focused on short and medium term responses to COVID-19 and aligned with priority areas (PPE, Sanitization, Diagnostics, etc.). For a full list of projects please contact NRC.
| Challenge | Date Closed | Proposals Received | Firms Supported | Status |
|---|---|---|---|---|
| Intelligent Data Clearing House | June 2 | [REDACTED] | 4 | All phase 1 agreements signed (11983393 Canada Inc., Bulky Inc., Cole Webber Productions, Optima Analytics). Not yet announced. |
| Magnetic reagents for detection of COVID-19 | June 16 | [REDACTED] | 2 | Phase 1 grant agreement signed with Galenvs Sciences. Project plan being finalized with Microstar Biotech, following which an agreement will be provided to them for signature. |
| Low-Cost Sensor Challenge | April 21 | [REDACTED] | 2 | Signed grant agreements received from 2 firms (Cloud Diagnostics Canada and Braebon Medical Corporation). Announced Aug 25. |
| Diagnostic Kit Challenge | April 21 | [REDACTED] | 4 | Four Phase 1 winners (Deep Biologics, Fourien Inc., Metabolic Insights, Nicoya Lifesciences). Announced June 2. |
| Made in Canada Filtration Material for the Manufacture of N95 Respirators and Surgical Masks | April 17 | [REDACTED] | [REDACTED] | Phase 2 agreements with Stedfast Inc. and Rosewell Downhole Technologies signed. Announced Aug 25. Projects starting Aug 17 and Aug 31 for 4 weeks. |
| ISC Testing Stream Challenge | [REDACTED] | [REDACTED] evaluations completed. [REDACTED] | ||
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| Program Stream | Projects | Status |
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33 | Projects on-boarded. An additional 16 are pending (i.e. project plan has been submitted for consideration). |
| Open "Moonshot" Challenge - Chewable saliva based diagnostic test. | 3 | One of the four selected collaborators declined; three funding agreements have been signed with two separate principal investigators at the University of Toronto; and with [REDACTED] |
| Clinically-relevant Interactive Content for Mental Health Support Project | 1 | Project with Douglas Hospital on the development of digital health tools and technologies to support front line workers with issues such as sleep disorders, fatigue and stress is in development with PHAC. |
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Impacts and Outcomes
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Vaccine development and production
Upgrades to Royalmount Facility ($126 + $15M, GMP; $29M Fill & Finish)
- On August 31, the Prime Minister and Minister Bains announced that the Government of Canada is investing $126 million over two years to build a new Biomanufacturing Vaccine Facility (BVF) adjacent to the existing Royalmount building. An additional investment of $20 million will be made annually to offset the operating costs of the new facility. This investment will expand the domestic vaccine production capacity by up to two million doses a month by this time next year and ensure Canada is prepared to safely manufacture large quantities of vaccines using Good Manufacturing Practices (GMP).
- NRC is advancing a TB submission targeting Sept 24.
- Have separated out upgrades into two separate components: Modification of the existing NRC Royalmount facility and the design and build of the new Biomanufacturing Vaccine Facility (BVF). Combined, the upgrade of Royalmount and the BVF will position the NRC to support the biomanufacturing of various vaccine candidates at different stages of development simultaneously.
- Completed work at the existing Royalmount facility on the temporary location for the Vanrx fill and finish unit which is to be delivered the week of September 14th. It will likely take approximately four months to have the unit validated and fully operational. Completing workflow modifications recommended by Health Canada to enable GMP production of clinical trial material in the facility. QA/QC team is on schedule for finalization of required documentation.
- Following GMP approval by Health Canada, NRC will have 500L/month production capacity within in its existing facility for clinical trial material, as early as this fall.
- [REDACTED]. Construction is progressing with excavation to be completed by 23 September. Design layout for the facility has been completed and will be presented to Health Canada for approval on 18 September. Work is proceeding on the operational requirements of the facility, including costing of operations and identifying all necessary positions, equipment, and materials. Two procurement experts from DND joined NRC 14 September to aid in procurement of necessary equipment and materials. Will soon be releasing a RFP to assist with recruiting of key positions to get the facility operationally ready by July 2021 (e.g. Manufacturing and Operations; QA/QC Manager; Supply Chain/ Inventory Logistics Lead; and Engineering and Maintenance Lead).
- [REDACTED].
Vaccine / Therapeutics Collaborations
- [REDACTED].
- The NRC is currently working with two partners developing COVID 19 vaccine candidates: VBI Vaccines Inc. (Massachusetts; signed on March 30, 2020) and VIDO (Saskatchewan; signed May 6, 2020).
- VBI's eVLP candidates have been selected and work is underway to improve the manufacturing process. This week had technical discussions on the purification process. Pre-clinical data are promising. [REDACTED].
- Initial scope of the VIDO collaborative agreement has expanded for NRC to provide additional support to accelerate scale-up production and characterize its vaccine candidate. [REDACTED]. NRC will be available for further collaboration that would be needed for later stages of clinical testing, should the VIDO candidate vaccine show promise in early clinical trials.
- The third Virtual Vaccine Clinical Trial Forum for stakeholders (organized by NRC, working with PHAC, HC, CIHR, and CAIRE) was held on September 16th. It was an invitation event bringing together government, universities and industry, and will focus on Canada's vaccine pipeline and biomanufacturing. Roger Scott Douglas from the Vaccine Task Force will introduce the session, followed by speakers from SMEs; large pharma; and regulatory agencies who discussed manufacturing capacity; scale; fill and finish; regulatory aspects; and related topics. A fourth session, to be held later in the fall, will focus on, among other topics, the process for emergency authorizations and the National Advisory Committee on Immunization's recommendations for target populations. These events bring together by invite government, universities and industry.
- NRC is working with Nexelis, a Contract Research Organization, which may be contributing to global COVID-19 clinical trials by providing assays to measure the level of neutralizing antibodies generated by vaccines.
- [REDACTED].
- [REDACTED].
| Program | Details | Status |
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| NRC Student Employment and Research Associate Programs ($7.5M) |
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| IRAP Youth Employment Program ($15M) |
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| Parliamentary Budget Office (PBO) Monthly Updates (Transmitted to PBO through ISED) |
Next Update to ISED |
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| Number of work opportunities and associated dollar amounts for graduate students and post-doctoral fellows | Week Oct. 5 |
| Amounts transferred to the HHT facility for scale up and future production of a COVID-19 vaccine and details | Week Oct. 5 |
| Support to innovators and start-ups through the NRC-IRAP IAP | Week Oct. 5 |
| Number of challenges / challenge teams associated with NRC's Pandemic Response Challenge Program (Request received August 11, with first reply to PBO by September 15. PBO confirmed it will be consolidated with other PBO requests) |
Week Oct. 5 |
| Reporting to House of Commons Committees | Last Update |
| NRC appearance at Finance Committee (FINA) | June 4 |
| Government Operations and Estimates (OGGO) | July 14 |
| Human Resources, Skills and Social Development and the Status of Persons with Disability (HUMA) | July 7 |
NRC operations
- As of Sept 17th, 69% of the NRC is working remotely. Of the total number of NRC employees, 11% are working onsite full time and 20% are coming in intermittently to perform essential tasks.
- NRC has developed guidelines and protocols to manage the onsite presence of essential staff working on COVID-related programs, supporting firms and clients in critical sectors, and performing critical tasks such as ensuring buildings are secure, monitoring equipment and facilities, keeping systems running safely, and receiving essential shipments at the loading dock.
- With the easing of provincial and municipal restrictions across the country, the NRC is increasing its efforts to resume work with its clients on key projects. With this in mind, the NRC onsite presence is now no more than 30 percent of employees in its research buildings, effective September 1, 2020. The NRC will continue to develop and apply its guidelines and protocols within its buildings to ensure the health and safety of onsite staff.
- NRC continues to provide support to Canadians and organizations seeking technical COVID-19 advice via the Community Support Initiative and associated teams with expertise in sterilization, physical testing of PPE, diagnostic and testing, manufacturing. These teams continue to address challenges and streamline activities across the NRC in order to improve efficiency of communications within NRC and with external partners and clients, including PHAC and Health Canada.
Contributions: IRAP, LS, HHT, DT, PSP, CB, FPS, BPS, SG