Frequently Asked Questions – Developing Medicines through Open Science

To assess whether your target disease aligns with market failure criteria, consider the following questions:

1. Are you addressing an unmet medical need with a small or uncertain market?
2. Are there few or no pharmaceutical efforts ongoing in your target disease area?
3. Is the incidence rate of your target disease area low enough to be classified as a rare or orphan disease?
4. Is your focus on infectious diseases or antimicrobial resistance?
5. Are you contributing to pandemic preparedness efforts? 

For your target disease to be considered an area of market failure, you should be able to answer “yes” to at least one of these questions. However, if you would like to discuss your target disease further, please feel free to reach out to us via email, and we would be happy to assist you.

We do not have a preference for any specific modality. Projects of all kinds can be submitted, and modality is not a factor in our selection criteria.

Yes, vaccine development is within the scope of the program, provided that the vaccine targets a disease in an area of market failure.

No, clinical trials are not within the scope of the program.

At least one Canadian SME is required for eligibility. Foreign SMEs can participate as co-investigators or collaborators, but they cannot be the Principal Investigator.

For our program, an SME is an organization registered in Canada with fewer than 499 employees.

Below are the definitions for each role:

• Principal Investigator (PI): The researcher leading the project and receiving funding. If there is more than one PI, please designate one lead PI and refer to the others as Co-Investigators (Co-I).
• Co-Investigator (Co-I): Researcher(s) responsible for project activities and also receiving funding.
• Collaborator: Researcher(s) involved in the project but not receiving funding.

Matching funds can come from any source as long as they are used to cover actual, incurred, and eligible expenses recorded in the recipient’s accounts. For SME applicants, at least 25% of the matching funds must come from non-government sources. This 25% non-government requirement does not apply to academic applicants.

Matching funds must be secured by the full proposal submission deadline. Proof of secured matching funds is a mandatory requirement in the full proposal application, and the funds must be accessible by the start of the grant agreement. Note that Conscience will only cover a maximum of 33% of the project cost. Since the Strategic Innovation Fund, which supports our program, operates as a reimbursement fund, recipients should be prepared to cover costs upfront with their own funds until reimbursement is processed.

Yes, up to 5% of the total budget for each ultimate recipient (grantee) can be allocated to eligible expenses incurred outside of Canada.

a) Yes, each participant must secure their own matching funds, as our program will only fund 10-33% of each participant’s budget.

b) Yes, a participant with sufficient funds can transfer funds to another participant who lacks resources, and the receiving participant can use those funds as matching funds.

No, in-kind contributions cannot be counted as matching funds

You can submit your Letter of Intent (LOI) to either CQDM or Conscience through our online grants management system. Please indicate in your LOI that you are seeking matching funds from CQDM, and we coordinate with them.

After you submit your Letter of Intent (LOI), we will review. If selected, you will receive a notification email, and when you log back into the online grants management system, you will see the full proposal application available to you. Please refer to the program overview for the deadlines relevant to the current funding round.

No, there is no fixed number of projects per TRL that we plan to fund. The total available  funding for this round is $5 million, applicable to all projects across all TRLs. The distribution of funds will depend on the number of and quality of proposals received at each TRL. Since the funding per project varies byTRL (please refer to the table below), if we receive a larger number of proposals at earlier TRLs, we may be able to fund more of those projects.

To determine the Technology Readiness Level (TRL) of your project, refer to the following guidelines regarding the type of work associated with each TRL:

• TRL 2-3:  Projects at this stage should have validated targets and developed cellular assays. The objective should be to identify (TRL2) and enhance (TRL3) the potency, selectivity, and cell permeability of compounds (i.e. “hits”) to produce one or more viable “lead” compounds. For these projects, activities include screening, in vitro assay, structure-activity relationship chemistry, in vitro toxicity analysis.

• TRL 3-4: This stage focuses on lead optimization. Projects should already have potent, cell-permeable, and selective lead compounds. The goal is to improve drug-like properties by modifying the lead compound series. For these projects, activities include medicinal chemistry, testing lead compounds in animal models, conducting Drug Metabolism and Pharmacokinetics (DMPK) studies, performing in vivo toxicity analysis, and selecting a candidate drug for further preclinical studies.

• TRL 4-6: Projects at this stage should have a drug candidate with an established pharmacokinetic/pharmacodynamic (PK/PD) profile. The objective is to generate the preclinical data necessary for regulatory approval of clinical trials. This includes animal pharmacology, toxicology, and efficacy studies, as well as manufacturing data (formulation, stability, and processes) and conducting required toxicity and efficacy studies under Good Laboratory Practice (GLP) protocols, along with chemistry, manufacturing, and control (CMC) studies.

Yes, an organization or applicant can submit several LOIs.

While we currently do not have a dedicated system for matchmaking, we recognize its importance and are actively working on it. In the meantime, applicants are encouraged to submit their applications and indicate their collaboration needs. We will do our best to help connect you with potential SME partners.

Yes, under our Open Science Policy,project molecules and data must be free from patent or trade secret restrictions. Public disclosure of the project molecules will prevent anyone from obtaining a patent on them. However, you or others can still patent improvements made using publicly available data (including your own data) or alterations to the project molecules. Whether such advances qualify for patent protection, or whether such protection is advisable, is a business decision you must make. Obtaining such a patent may, however, prevent you from obtaining further funds for those molecules through the DMOS program. 

We do permit intellectual property in the form of regulatory exclusivity, which involves specific delays and restrictions on the approval of competing drugs. A holder of a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) may be eligible for exclusivity, provided they meet the statutory requirements.

The value proposition for SMEs can vary significantly based on their business model, assets, and target indications. For SMEs successfully securing risk capital from investors, the current patent system effectively supports their endeavors, indicating a well-functioning market.However, for SMEs facing challenges in securing investment, our collaborative program offers significant advantages. SMEs with specialized expertise or technological platforms can receive funding for specific projects, while sharing data through the program can increase their visibility and potentially open doors for further funding opportunities.

For SMEs with project molecules deemed less attractive by  investors (e.g. due to lower expected returns), our program provides an alternative path to drug development, for example by leveraging regulatory exclusivities, which can still lead to commercialization.

Absolutely! At Conscience, we take a collaborative approach to grants management and work closely with our grantees throughout the project. We help our grantees adhere to our Open Science Policy by assisting them in finding suitable repositories and developing a comprehensive data-sharing plan and timeline.

We encourage you to review our Open Science Policy If you still have questions, please contact our Program Manager for Drug Discovery and Development, Dr. Resham Chhabra, at [email protected].

You can still apply, though keep in mind that the project as a whole must comply with this policy. This requirement means that the Project Molecule – which may or may not be related to the originally patented molecule – must be useable by others without restriction. If using the Project Molecule is likely to infringe the initial patent, you will be required to license the patent openly, world-wide, and without cost.

Yes. The public sharing and IP-free requirements of this policy only extend to the Project Molecules, Project Data, and any methods or materials created for the purpose of completing a DMOS project. If you develop new materials or methods for a purpose other than the completion of a DMOS project you may protect them as you wish. However, complying with this policy means that if those new methods or materials are used in the DMOS project and are needed to replicate results, full descriptions must be shared publicly in accordance with the reporting schedule, which may have implications on efforts to obtain or enforce intellectual property rights.

DMOS projects are supported by funds from Innovation, Science, and Economic Development (Canada). Under Conscience’s agreement with ISED, there are restrictions concerning how IP can be sold and licenced, including a requirement to obtain approval before selling it outside of Canada for 5 years and around granting exclusive licenses. Any IP created to complete a project that is outside the scope of this policy will be subject to those restrictions. Failure to comply with this policy may result in a requirement to return all project funding to Conscience. Finally, the secrecy required to obtain a patent may prevent you from sharing information that could lead to useful outside input and hinder collaboration.

Yes. Complying with this policy means that the Project Molecules and Project Data must be free from patent or other IP restrictions, and the requirement for public disclosure of the Project Molecules will prevent anyone from getting a patent on it. However, you or anyone else is fully free to patent later advances or alterations to Project Molecules. Whether such advances qualify for patent protection, or whether such protection is advisable, is a business decision you must make. Obtaining such a patent may, however, prevent you from obtaining further funds under the DMOS program.

Health regulatory agencies (e.g., Health Canada in Canada, the FDA in the USA, EMA in Europe) are responsible for approving new medicines based on evidence submitted to them about safety and efficacy. These agencies often have rules about when later applicants can rely on this data. For example, in both Canada and the USA, there is a period after a new medicine has been approved where others cannot use the safety and efficacy data from clinical trials to prove equivalence in order to gain approval on a competing product. This is called Data Exclusivity, which is a type of “regulatory exclusivity”. Market Exclusivity is another important type of regulatory exclusivity. This policy is written so as to preserve those regulatory exclusivities, which can be thought of as a more targeted and tailored, and consistent with open sharing, form of IP when compared to a patent.