Health Canada (HC) is seeking a method to accurately identify and characterize micro-organisms found in microbial mixtures, and predict their interactions that could mask or enhance adverse effects with a view to determining risks to the environment and human health.
Sponsoring department: Health Canada
Funding mechanism: Contract
Opening date: August 26, 2019
Closing date: October 18, 2019 14:00 Eastern Daylight Time
Please refer to the tender notice for this challenge on Buy and Sell.
Micro-organisms and microbial mixtures have the capacity to perform novel and complex tasks in a diverse array of biotechnology applications, many of which support the goals of sustainability. The testing required under the regulations for assessment can be expensive. When multiple micro-organisms are used together in a mixture, the cost of testing becomes prohibitive to the small-medium enterprises that represent the majority of notifiers. Companies have requested the option to conduct testing on the microbial mixture, but it is unknown how interactions between micro-organisms in the mixture during testing could affect prediction of an adverse effect subsequent to environmental release. Lack of suitable test methodologies and novel approaches to determine the adverse effects of microbial mixtures also puts pressure on the program to provide timely guidance to notifiers to meet the regulatory requirements or to assess the notifications within regulated timelines, which prevents Canadian companies from bringing products to the market. The solution will equip HC with complete information needed to conduct the risk assessment of biotechnology-derived products containing microbial mixtures, and meet its operational and regulatory responsibility. It would enable HC to provide informed guidance to notifiers on cost-effective, reliable test methods required to fulfill the regulatory requirements prior to the manufacture or import of microbial mixtures into Canada.
Desired outcomes and Considerations
The solution must be a cost-effective*, robust and reliable** method to: (i) identify members of microbial mixtures; (ii) characterize their stability and population dynamics; and (iii) predict possible interactions among the micro-organisms in the mixture (e.g. using omic approaches such as genomics, transcriptomics, proteomics, etc.), that may mask or enhance adverse effects (e.g. pathogenicity, toxicity) in humans.
*Cost-effective: Current cost estimate is about $150K per micro-organism for accurate identification and characterization of micro-organisms in microbial mixtures, and conducting pathogenicity/toxicity testing for one micro-organism with Good Laboratory Practices (GLP). The solution must aim to reduce these testing costs significantly and make it affordable for SMEs.
**Robust and reliable: The solution must provide a well-constructed method with demonstrated sensitivity (capable of identifying wide range of target micro-organisms in the mixture with threshold of detection limits defined), specificity (capable of distinguishing different micro-organisms in the mixture at least to species level) and reproducibility (reliable for any microbial mixtures containing different micro-organisms.
Background and Context
There is an increasing demand to enrich natural microbial consortia and formulated microbial mixtures. These complex microbial products often display an enhanced adaptability to complex nutrient substrates and tolerance to environmental stressors. The capacity of microbial mixtures to perform novel and complex tasks has diverse biotechnology applications, many of which support the goals of sustainability (e.g. contaminated site remediation, production of hydrogen fuels, biofuels, biogas or bioplastics, or replacement of harmful substances in products such as cleaners, complete waste recycling for space missions). In order to comply with the New Substances Notifications Regulations (Organisms) [NSNR (Organisms)], notifiers intending to manufacture or import micro-organisms contained in such products are required to submit data from tests supporting the taxonomic identity and characterization of micro-organisms in these mixtures as well as to determine their potential to cause adverse effects (pathogenicity, toxicity, etc.) to humans and the environment. The testing required under the regulations for assessment can be expensive for companies. When multiple micro-organisms are employed together in a mixture, the cost of testing quickly becomes prohibitive to the small-medium enterprises (SMEs) that represent the majority of our notifiers. In addition, there currently exist no tests or models to predict the fate or complex interactions between multiple micro-organisms in various environments, including conditions found in human body. Lack of suitable test methodologies and novel approaches to determine the adverse effects of complex microbial mixtures also place an increasing demand on the Department's capability to provide timely guidance to notifiers to meet the NSNR (Organisms) requirements or to assess the notifications within regulated timelines. The goal of this research is to develop a cost-effective, robust and reliable automated method to identify members of microbial mixtures and consortium, characterize their stability and population dynamics, and predict possible interactions between individual micro-organisms of the mixture (e.g. using OMIC approaches such as genomics, transcriptomics, proteomics, etc.) that may mask or enhance adverse effects (pathogenicity, toxicity, allergenicity, hypersensitivity, etc.) in humans. The outcomes from the challenge will empower the program with cutting-edge science-based methods and tools to assess complex microbial mixtures and consortia, as well, provide informed guidance to biotechnology industry stakeholders on cost-effective, reliable test methods and help them to meet the regulatory requirements of the NSNR (Organisms). This challenge will particularly benefit the small-medium enterprises, as they will have the option of using alternative methods to test microbial mixtures that are less expensive than testing individual microbial constituents present in the mixtures.
Maximum value and travel
Maximum funding available in Phase 1: $150,000Maximum funding available in Phase 2: $1,000,000
For Phase 1, it is anticipated that up to five meetings will require the successful bidder(s) to travel to the locations identified below:
- Kick-off meeting Ottawa, Ontario
- Progress Review Meetings: one to three design/progress review meetings by teleconference/videoconference
- Final Review Meeting Ottawa, Ontario
Solution proposals can only be submitted by a small business that meets all of the following criteria:
- for profit
- incorporated in Canada (federally or provincially)
- 499 or fewer full-time equivalent (FTE) employeesFootnote *
- research and development activities that take place in Canada
- 50% or more of its annual wages, salaries and fees are currently paid to employees and contractors who spend the majority of their time working in CanadaFootnote *
- 50% or more of its FTE employees have Canada as their ordinary place of workFootnote *
- 50% or more of its senior executives (Vice President and above) have Canada as their principal residenceFootnote *
The official source of the Evaluation Criteria for this challenge is the Government Electronic Tendering System (Buy and Sell) (https://buyandsell.gc.ca/procurement-data/tender-notice/PW-18-00846769)
In the event of a discrepancy between the information below and the information published on Buy and Sell, Buy and Sell will take precedence.
Part 1: Mandatory and Minimum Pass Mark Criteria
Proposals must meet all mandatory criteria (Questions 1a and 2) and achieve the minimum pass mark for Question 3 in order to be deemed responsive and proceed to Part 2.
1 a. Scope
Describe your proposed solution and how it responds to the challenge. Include in your description the scientific and technological basis upon which your solution is proposed and clearly identify how your solution meets all of the Essential Outcomes (if identified) in the Desired Outcomes and Considerations section in the Challenge Notice.
Mandatory — Pass/Fail
2. Current Technology Readiness Level (TRL)
Mandatory — Pass/Fail
Pass: The Applicant/Bidder has demonstrated that the proposed solution is currently between TRLs 1 and 4 (inclusive), and provided justification by explaining the research and development (R&D) that has taken place to bring the solution to the stated TRL.
Fail: The Applicant/Bidder has not provided sufficient evidence to demonstrate that the current TRL is between 1 to 4 (inclusive) including:
Describe the novelty of your solution and how it advances the state-of-the-art over existing technologies, including competing solutions.
Point Rated with Minimum Pass Mark
The minimum pass mark for this criteria is 4 points.
0 points/Fail: The Applicant/Bidder has not demonstrated that the proposed solution advances the state-of-the-art over existing technologies, including available competing solutions; OR
The stated advancements are described in general terms but are not substantiated with specific, measurable evidence.
Part 2: Point-Rated Criteria
Proposals that do not achieve the overall minimum score of at least 55 points out of a possible 110 points (50%) will be declared non-responsive and given no further consideration.
The overall minimum score is determined by adding the Applicant/Bidder's scores from the following questions together (1b, 3, 4-13).
Describe how your proposed solution addresses the Additional Outcomes (if identified) in the Desired Outcomes and Considerations section in the Challenge Notice. If no Additional Outcomes are identified in the Challenge Notice, text entered in this section will not be considered.
If no Additional Outcomes are identified in the Challenge Notice, Bidders/Applicants will receive 10 points
4. Phase 1 Science and Technology Risks
Identify potential scientific and/or technological risks to the successful development of the proof of concept and how they will be mitigated in Phase 1?
5. Benefits to Canada
Describe the benefits that could result from the successful development of your solution. Applicants/Bidders should consider the potential benefits using the following three categories:
6. Phase 1 Project Plan
Demonstrate a feasible Phase 1 project plan by completing the table.
Note: Phase 1 cannot exceed 6 months and TRL 4.
7. Phase 1 Project Risks
Identify potential project risks (eg. Human resources, financial, project management, etc) to the successful development of the proof of concept and how they will be mitigated?
8. Phase 1 Implementation Team
Demonstrate how your project implementation team has the required management and technological skill sets and experience to deliver the project plan for Phase 1 by completing the table. A member of the implementation team can have more than one role.
Include the labour rates and level of effort for each member. A day is defined as 7.5 hours of work, exclusive of meal breaks. The labour rates and level of effort will be reviewed as part of the evaluation for Question 10.
If your business were to receive funding from Innovative Solutions Canada, describe what actions (e.g., recruitment strategy, internships, co-op placements, etc.) might be taken in Phase 1 to support the participation of under-represented groups (e.g., women, youth, persons with disabilities, Indigenous people, visible minorities) in the research and development of the proposed solution.
Each bidder/applicant in their response to this question must focus only on describing relevant programs, policies, or initiatives that it currently has in place or would put in place to support the R&D effort in Phase 1. Do not provide any personal information of individuals employed by your company or that of your subcontractors in the response below.
10. Phase 1 Financial Proposal
Demonstrate a realistic financial proposal for the Phase 1 project plan by completing the table.
11. Phase 1 Financial Controls, Tracking and Oversight
Describe the financial controls, tracking and oversight that will be used to manage the public funds throughout Phase 1.
12. Phase 2 Strategy
Describe a realistic strategy for the prototype development if selected to participate in Phase 2.
Responses should include:
13. Commercialization Approach
Describe your overall commercialization approach for the proposed solution.
Responses should include:
Questions and answers
Please refer to the tender notice for this challenge on Buy and Sell.
All incoming questions regarding this specific challenge should be addressed to SIC-ISC@pwgsc.gc.ca
You can also consult the Frequently asked questions about the Innovative Solutions Canada Program.
A glossary is also available.