Notice

Competition guidance: vaccines for global epidemics - preclinical

Updated 21 December 2016

This notice was withdrawn on 21 September 2017

This competition is no longer open. Search current funding opportunities.

1. Dates and deadlines

Competition opens	17 October 2016
Competition briefing event	31 October 2016
Final date for registration	Midday (12.00pm) 21 December 2016
Submission of the full application (including appendices) deadline	Midday 4 January 2017
Decision to applicants	24 February 2017
Contracts awarded	24 March 2017
Feedback provided	24 March 2017

These Guidance Notes complement the Invitation to Tender (Document SBRI_DH_344_001) and are designed to help with completing the Application Form (Document SBRI_DH_344_004).

Please read the full competition scope before you make your application.

2. Funding

The Department of Health is to invest up to £25 million in projects to develop new vaccines against infectious diseases as described in the brief for this competition.

The competition has two stages:

• stage 1: we have allocated up to £10 million for stage 1 of the competition. Applicants should explore the scientific, technical and commercial feasibility of their concept. This should focus on the development of vaccines and vaccine technology. Individual contracts will be worth up to £500,000, but we will consider making larger awards on a case by case basis. We expect projects to last for up to 12 months. Only projects that we support in stage 1 will be eligible to apply for stage 2 funding.

• stage 2: we have allocated up to £15 million for stage 2 of the competition, to take forward successful projects from stage 1. Individual contracts will be worth up to £2 million, but we will consider making larger awards on a case by case basis. We expect projects to last up to 24 months.

3. How to apply

Before you apply to this Department of Health (DH) funded SBRI competition, it is important to understand the whole application process. The information below is specific to this competition.

All applications will be treated in confidence.

The application process for the SBRI competition requires the completion of the Application Form.

The form should be completed and submitted as directed. We strongly advise that the accompanying guidance notes are read prior to submission.

The competition closes at 12.00pm midday on 4 January 2017. All entries must be submitted in accordance with the directions in the guidance notes.

Do not send completed applications by post or by any other means than as directed.

Assessment: Once the competition submission deadline is reached, your application is sent for assessment.

Notification: We will notify you of the outcome of your application on the date stated in the timeline.

Feedback: We will give feedback to successful and unsuccessful applicants approximately 4 weeks after you have been notified of the decision. You can access the feedback by signing into the secure website where you uploaded your application documents. No additional feedback can be provided and there will be no further discussion on the application.

4. The application form

This section explains the structure of the application form and offers guidance on what to answer in each question.

The structure is as follows:

• application details (mandatory)
• title and abstract for publication
• competition questions (mandatory)
• technical team and expertise
• application finances
• additional questions
• declarations

Please make sure that you upload the final version of your application by the deadline. It is your responsibility to ensure that you do not upload a blank or incomplete application form.

These notes should be read together with the application form. They are designed to help you provide the information required. Where text limits are indicated, please do not exceed these, as this will result in your application being rejected.

Applications will be given a reference number. It should be noted that you will need this number for all subsequent enquiries. If your application is successful in progressing to stage 2, you will be given the same application number.

A reference number will be assigned to the applicant once you have registered for the competition. You will be notified of this number by email. You will need to register separately for each application that you intend to submit.

The application form should be completed using a font size no smaller than 10 (Arial). Keep the use of acronyms to a minimum and be sure to define them. Only use acronyms where a term is mentioned frequently throughout the proposal. Bear in mind that individual sections of the application may be read separately during the selection process.

In order for your application to be accepted, you must submit all the required information. This includes all mandatory fields from the application form. Failure to complete these fields will result in your application being rejected on the grounds that it is incomplete.

5. Competition questions

5.1 Application

Project title (mandatory)

Please provide the title for the project. This should be both clearly descriptive and concise. It should contain keywords relevant to the project.

Contract duration (months) (mandatory)

Projects are expected to start 1 April 2017 and the work must be completed and delivered by the end of March 2018.

Total contract cost (£s) (mandatory)

Proposed projects can request a maximum total cost of £500,000 for stage 1.

Proposed start date (mandatory)

What is the best way to describe your Innovation? (select from options) (mandatory)

5.2 Applicant details (mandatory)

Please submit all the details requested in the application form.

5.3 Contact details (mandatory)

Please submit the lead applicant’s name, post held, institution/company, position etc.

In addition, please provide details of where you heard about the competition.

5.4 Title and abstract for publication

Please provide a brief, public facing description of the project. Should your project be successful, this information will be made public once the award is confirmed. We reserve the right to amend the description before publication if necessary, but will consult you about any changes.

5.5 Description of proposed idea/technology (mandatory)

Avoiding the use of unnecessary technical jargon, describe clearly how the proposed project will deliver the outcomes as described in the competition documentation. Describe the immunisation agent (in development or marketed) the technology is linked to. This is an application for stage 1, available for exploring scientific and technical feasibility of the proposed project. Document the current state of development or readiness of the project. Consider including a target product profile to concisely capture how the vaccine to be developed will fulfil the clinical need.

Relevant data providing evidence to support the rationale for the project should be provided in a supplementary document (PDF format). This should be a maximum of 2 A4 pages.

5.6 Scientific/technical project summary (mandatory)

Please provide a structured summary of the technical basis of the project including data to provide confidence in the likely successful delivery of an effective vaccine. This should outline the background to the technology, including what the innovation is, and the main deliverables. This would typically involve highlighting the research and development that will prove the scientific and commercial merit of the project. Also describe what might be achieved by deploying the innovation to address the technical challenges.

Relevant data providing evidence to support the rationale for the project should be provided in a supplementary document (PDF format). This should be a maximum of 2 A4 pages.

5.7 Technical background, current state of the art and intellectual property (IP) (mandatory)

Please provide details of any competing technologies; what are the competing solutions and what is their developmental status? What are the shortcomings of competing solutions and what is the advantage of your proposed solution? Include details of any existing IP and its significance to your freedom to operate, both within the current project and the onward commercialisation.

5.8 Project plan and methodology (mandatory)

The project plan should identify the major packages of work within the project, with well-defined milestones and deliverables. Highlight what resources will be required to address the technical challenges and what the main success criteria would be. The plan should be comprehensive and the emphasis throughout should be on practicality; we are seeking evidence that the technology works, can be made into a viable product and can achieve the proposed benefits. Where animal studies are proposed the number of animals must be clearly justified including statistics. Where a future clinical study is planned an explanation should be provided for how this study will inform the future clinical study design, dosing, administration regime etc. Appropriate record-keeping and reporting are essential but reports are not in themselves the main goal of the project.

• a Gantt chart should be supplied (in PDF format)
• please provide an indication of how any IP issues which might arise during the project would be handled

Project management (mandatory)

Identify the project management processes that you will use to make sure that milestones are achieved in a timely manner. In addition, provide details of identified risks (technical, commercial and environmental) and mitigation actions.

5.9 Technical team and expertise (mandatory)

A detailed description of the skills and expertise and track record of the team, including the relevant knowledge and skills of each member and the proportion of their time that will be spent on the project. Relevant commercial, scientific, clinical and management expertise should also be included.

5.10 Application finances (mandatory)

Please provide a summary of costs for stage 1. All costs should include VAT. In addition, please provide a justification of the costs. If there is significant use of subcontractors, please explain how these will be used and the costs of each. Applicants are instructed that the costs quoted must reflect actual costs at a ‘fair market value’ and profit should not be included.

Please note the assessors are required to judge the application finances, in terms of value for money, for instance, does the proposed cost for effort and deliverables reflect a fair market price.

Please provide quarterly spend profiles for the duration of the stage 1 project. Please also provide a payment schedule for the first stage of this project.

The costs should cover the following, as applicable.

Directly incurred costs:

These are costs that are specific to the project that will be charged to the project as the amount actually spent, fully supported by an audit record in justification of a claim. They comprise:

• labour costs for all those contributing to the project broken down by individual
• material costs (inc consumables specific to the project)
• capital equipment costs
• sub-contract costs
• travel and subsistence
• indirect costs
• other costs specifically attributed to the project

Indirect costs

Indirect costs should be charged in proportion to the amount of effort deployed on the project. Applicants should calculate them, using their own cost rates.They may include:

• general office and basic laboratory consumables
• library services/learning resources
• typing/secretarial
• finance, personnel, public relations and departmental services
• central and distributed computing
• cost of capital employed
• overheads

Itemisation of costs and methods of calculation may be requested to support the application at a later date.

5.11 Commercialisation

Please describe how you would realise the potential commercial solution and the relevant timescales. Give an overview of your commercialisation and business plans, from feasibility to market launch, including an estimate of the resources needed to get there. What is the anticipated cost of your proposed solution both at launch and at scale? How does this compare with competing solutions? If the cost is anticipated to be greater than competing solutions, why will your solution be favoured or be more appropriate for deployment in a low or middle-income country/epidemic situation. Consider how the product is likely to be used, by whom, how it will be paid for and distributed.

5.12 Use of proposed technology in low-income settings

Please detail how the proposed product will be able to accelerate containment of developing epidemics in resource-poor settings.

5.13 Declarations (mandatory)

Lead applicants are expected before submitting applications, to have discussed their proposals with their own company/institution or any other body whose co-operation will be required in the conduct of the project. By submitting the application you are confirming that the information given in this application is complete. You also confirm that you are actively engaged in this project and responsible for its overall management. You agree to administer the award if made.

You are also confirming that you have read and understood the relevant explanatory materials, such as the Invitation to Tender, the Guidance Notes and the Guide for Participants.

By submitting this application you acknowledge that you have read the statement above and agree that your contact details can be passed to other government agencies and Affinity Partners. For further information please see our personal information charter.