Posted on: Thu 13-08-2020

Description

The Healthcare Sector Research and Development (R&D) Intervention (Grant) Scheme is an initiative of the Central Bank of Nigeria (CBN) aimed at triggering intense national R&D activities to develop vaccines, drugs and herbal medicine/medical devices in Nigeria against the spread of COVID-19 and any other communicable or non-communicable diseases through the provision of grants. The current call priotises research and development of drugs, herbal medicines, medical devices and vaccine for control, prevention and treatment of infectious diseases. 

The Scheme forms part of the Bank's commitment to supporting the domestic manufacturing of critical drugs, medical devices and vaccines to ensure their sustainable domestic supply and exports. 

For this purpose, a Body of Experts (BoE) has been constituted from the academia and industry. The BoE shall be responsible for the evaluation of submitted research proposals, and recommendations for financing R&D projects with high potentials tc contribute to the development of vaccines, drugs, and herbal medicines and medical devises for infectious diseases in Nigeria. 

This call builds on the provisions contained therein the guidelines for the implementation of the Healthcare Sector Research and Development (R&D) Intervention (Grant) Scheme to facilitate a coordinated research approach. Restrictions apply, please refer to the guidelines for full information.

Scope

The call specification is based on the Scheme Body of Experts' priorities identified through a consultative process that involved experts constituted from the academia and industry. Eligible projects under the Scheme snail include R&D into drugs, herbal medicines, medical devices and vaccines for COVID-19 and other infectious diseases. Priority w II be given to projects on infectious diseases. 

Eligibility

Applications are particularly encouraged from biotechnological and pharmaceutical companies, universities, polytechnics, research institutes and other established researchers based in Nigeria. Applicants must have relevant qualifications or licenses and permits from relevant government health agencies and authorities. 

Where the application is submitted by an organisation, the primary headquarters of that organisation must be based in Nigeria, legally registered and the Principal Investigator must be employed by the organisation hosting the research. 

It is not permitted for same person to be a Principal Investigator on more than one proposal at any one time. He/she may support others as co-investigator, as long as he/she has the capacity to do so without detriment to the project he/she leads.

Female applicants are encouraged to apply. 

Grants Categories 

1. Proposals of up to N50 mil ion will be considered for academia, Institute or research-based regulatory establishment. 

2. Proposals of up to N500 million will be considered for established pharmaceutical and biotechnology companies who have demonstrated competency through product lines and or manufacturing track records. The environment of such companies must be conducive enough for measurable outcomes. The company must belong to a Trade Association. 

NOTE:

The size of grants will vary according to the needs of each research project and will need to provide a robust case for value for money. Funded projects will be required to submit periodic reports to the CBN which shall be reviewed by the BoE. 

Inventions arising from HSRDIS financed research and development projects must be reported to CBN that funded the grants. Individual researchers and pharmaceutical manufacturers are to retain substantial (80%) ownership of the drugs, medical devices, herbal medicines and vaccines made under HSRDIS funded research. Inventors are expected to file for patent protection and to ensure commercialization upon licensing for the benefit of public health.

Duration

Grants period will not be more than 24 months and applicants should be ready to start the research within 4 weeks of being notified of the award. 

All proposals will need to show a GANTT Chart with milestones to track progress. There must also be a clear description of how the project will contribute to the development of drugs, herbal medicine/medical devices or vaccines in Nigeria.

SEE THE DOCUMENTATION REQUIREMENTS BELOW: 

Grant Application 

The Grant Application must include the following components highlighted in tie Award Criteria listed below. These requirements must be clearly written. Repetition. 

1. Executive Summary: This should include hypothesis, goals, objectives, innovations, duration with milestones, expected outcomes and impact. The project must meet up with the set objectives of the HSRDIS scheme. 

2. Introduction: Background of the project, emphasizing the problem statement and the hypothesis

3. Significance: This will include the goal in relation to the objective of the HSRDIS scheme, innovations and expected outcomes and impact of project 

4. Research Approach: Scope, methods, anticipated problems and solutions, preliminary data if available, timelines (Gantt Chart) with milestones, progress monitoring plan and detailed budget with justification. 

5. Investigators' contributions to the project 

6. Research/Manufacturing Environment and how it will contribute to project success 

7. Institutional Ethics Committee (IEC) or Review Board (IRB), NAFDAC protocol approval or NHREC approval (for clinical trials involving human subjects) 

8. References

Grant Criteria 

Evaluation of proposal will be based on the following criteria: 

1. Executive Summary: This should include hypothesis, goals, objectives, innovations, duration with milestones, expected outcomes and impact. The project must meet up with the set objectives of the HSRDIS scheme. (It should not be more than one and half pages) 
2. Introduction: Background of the project, problem statement and hypothesis 
3. Significance of research: 
4. Research will contribute to an innovation in at least one of the following areas that could impact the health sector: 

• Translational science research methodology with positive outcomes in drug, herbal medicines, medical devices and vaccine development with potential for commercialization and incorporation into primary healthcare delivery 
• Improvement in drug delivery and manufacturing that could lead to regional or continental harmonization approval 
• WHO prequalification or approval by other stringent regulatory authority 
• Clinical trial efficacy that could result in use of the product for treatment or cure of an infections disease 
• Overall contribution to public health and medication safety 
• Demonstration of benefit of collaboration to achieve any of the above positive outcomes 
• Comprehensive and updated literature review of the subject matter

Preliminary Results or Published Report (not compulsory) 

• To demonstrate the feasibility of the research 
• Unpublished or published data, or products launched to support at least 25% of the proposed studies 

Research Scope 

Research methodology or design is rational based on the following criteria: 

• Appropriate and sound methods 
• Preliminary results if available, proof of concept 
• Possibility of completion within the two year timeline 
• Justification of the amount of money that is requested 
• Collaboration logistics of the multidisciplinary parties well stated and understood o Anticipated results 
• Pitfalls and solutions o Alternative plan included if the proposed method(s) do not work 

Investigators and Environment

• Investigators' experience or industry outputs will contribute positively to the outcomes 
• Collaboration with researchers who have relevant experience (Letters of support or teaming agreements are required). 
• Environment (academia or industry) is conducive for successful completion of the project 
• Availability of basic equipment and core facilities or central laboratories 

Data Interpretation 

• Well-stated methods of evaluation 
• Input variables aligned well with the expected outcomes 
• Statistical data interpretation will yield a conclusive outcome 

Power analysis where humans and animals are involved 

Budget 

• A detailed budget is provided that justifies the proposed expenses 
• Projected expenses are reasonable for the scope of the project

Institutional Ethics Committee (IEC) or Institutional Review Board IRS) approval letter, NAFDAC protocol registration and approval or/and NHREC Approval 

• Copy of completed IRB application for approval (for clinical trial) 
• Copy of IEC or IRB, NAFDAC, NHREC approval if available (This can be sent within a month after close of application submission deadline) If the clinical trial sites are not more than three sites, and the drug or herbal medicine/medical devices is not new, only NAFDAC protocol registration/ approval and institutional IRB approval are needed. Otherwise, NHREC approval must be obtained. 

Page Limit 

Grant application should not exceed 15 typed pages (11 or 12-point font, 1.5 spaced) excluding the executive summary of one and half pages. 

• Introduction and Significance of Research — 3 pages 
• Preliminary Results-2 pages 
• Research Approach — 6 pages 
• Investigators' Contributions to the project-1 page 
• Environment — 1 page 
• Institutional Ethics Committee or NAFDAC protocol registration and approval, and NHREC approval — 2 pages.

Summarized Curriculum Vitae of Applicant 

A two-page biosketch of applicant showing the following: 

1. Education 

2. Educational experience/industrial accomplishments of applicant or company 

3. Past recognition or honours 

4. Contribution to science, industrial pharmacy, pharmaceutical or biopharmaceutical technology development 

5. Past research support or industry support from any national or international source 

6. Five (5) research outputs or industrial milestones where at least one (1) must be relevant to the goals of the HSRDIS. 

Due Date: October 30, 2020 

Submission of full application 

Applications must follow the headings listed under Award Criteria. Applications must be submitted electronically to: [email protected], copy to [email protected] on or before the due date, October 30, 2020 Late applications will NOT be considered. Applications that are not responsive to the stated required components will NOT be considered. 

Note: All applications submitted before this publication are by this notice expected to reapply following these documentation requirements. 

Only shortlisted applicants will be contacted.

Announcement of Grants 

Successful beneficiaries of the grant would be contacted via the submitted address in the submitted applications. 

The central bank of Nigeria reserves the right to final approval of the grants. 

Signed:

Yusuf, Yila Philip 

Director, Development Finance Department 

Central Bank of Nigeria.

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