Notice

Competition guidance: vaccines for global epidemics, preclinical stage 2 development

Published 4 June 2018

This notice was withdrawn on 31 July 2018

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

1. Dates and deadlines

Competition opens	11 June 2018
Final date for registration	midday 20 June 2018
Submission of the full application (including appendices)	deadline: midday 27 June 2018
Interviews	24 and 25 July 2018
Decision to applicants	31 July 2018
Contracts awarded	1 September 2018 at latest
Feedback provided	3 September 2018
Project start date	1 September 2018 at latest

These guidance notes complement the invitation to tender (Document SBRI_DH_344_001), which can be found on the FTP site, and are designed to help with completing the application form.

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

2. Funding

The Department of Health and Social Care (DHSC) will invest up to £15 million to support the further development of vaccine:

• candidates
• platform technology
• manufacturing technologies

You can apply only if you were awarded funding in the first ‘Vaccines for global epidemics, preclinical’ competition, which opened 17 October 2016.

3. How to apply

Before you apply into this DHSC funded SBRI competition, it is important you understand the whole application process. The information below is specific to this competition.

All applications will be treated in confidence.

To apply you must complete the application form.

You must follow the directions in the guidance when submitting your application. Do not send by post or any other means than as directed in the guidance.

Assessment: Once the competition submission deadline is reached, your application is sent for assessment. Please note that your reports from the first competition will form part of the assessment process for this competition.

Interview: Successful applications at the written stage will be invited to attend an interview. Further details about the interview process will be provided to successful applicants.

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 the decision notification. 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 guidance on what to answer in each question. The structure is as follows:

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

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 to provide the information required. Where text limits are indicated, do not exceed these, as this will result in your application being rejected.

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.

Failure to complete the whole application form will result in your application being rejected.

For projects involving clinical trials please note the following: The funders require that all funded trials are run according to the EU Clinical Trials Directive (2001/20/EC) and the subsequent UK Clinical Trials Regulations 2004.

5. Competition questions

The following are all mandatory fields.

Field	Guidance
1. Application
Project title	Enter the full title of the project including trial acronym if applicable. This should be descriptive and concise. It should contain keywords relevant to the project.
Contract duration (months)	Projects are expected to start by 1 September 2018 and the work must be completed and delivered by the end of Aug 2020.
Total contract cost (£)	Proposed projects can request a maximum total cost of £2 million.
Proposed start date	Enter the estimated start date.
What is the best way to describe your innovation?	Select from the options.
2. Application details	Please submit all the details requested in the application form.
3. Contact details	Please submit the lead applicant’s name, post held, institution or company, and position. Tell us where you heard about the competition.

4. Title and abstract for publication

Please provide a brief, public facing description of the project. If your project is 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. Description of proposed idea or technology

Avoiding the use of unnecessary technical jargon, describe clearly how the proposed project will meet the competition scope.

Describe:

1. The immunisation agent (in development or marketed) the technology is linked to. This is an application for a single stage SBRI and funding is available to projects at a more advanced stage of development. This competition is aimed at candidate vaccines that are now, or will soon be, ready for phase I or II human trials and manufacturing technology that could potentially be commercially viable in the near future.
2. The current state of development or readiness of the project. Please include any pilot data and information to support the feasibility of your proposed approach.

You can submit data as evidence of the rationale for the project in an appendix. This can be a maximum of 2 A4 pages and must be in PDF format.

6. Scientific or technical project summary

Provide a structured summary of the technical basis of the project, including trial design and proposed methodology. Explain and justify all statistical aspects of any trial and the assumptions they are based on (for example power calculations, sample sizes and effect sizes).

Other considerations should include:

• which centres will be involved and planned recruitment rates
• any risks to the patients in the proposed trial

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.

Data which provides evidence to support the rationale for the project should be uploaded in a supplementary document. This should be a maximum of 2 A4 pages and should be submitted in PDF format.

7. Technical background, current state of the art and intellectual property (IP)

Please provide details of any competing technologies or market alternatives and the relative benefits of the proposed technology. Describe how the proposed study or trial differs from or complements any relevant planned, ongoing or recently completed studies internationally. Include details of any existing IP and its significance to your freedom to operate, both in the current project and the future commercialisation.

8. Project plan and methodology

The project plan should identify the major work packages within the project with well-defined milestones and deliverables. Include go/no-go decision points. Your plan must be comprehensive and emphasise practicality. We are seeking evidence that the technology works, can be made into a viable product and can achieve the proposed benefits.

Appropriate record-keeping and reporting are essential but reports are not in themselves the main goal of the project.

You must include:

• a Gantt chart (maximum 2 A4 pages, in PDF format)
• an indication of how you would handle any IP which might arise during the project. After the award, how will the project continue so it can meet its aims (for instance, what is the exit strategy?)

Project management

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.

For projects including trials, please detail trial management including:

• who will be the trial sponsors
• the ethical review and research governance arrangements that would apply to the proposed study
• the Trial Steering Committee (if appropriate)

9. Technical team and expertise

Provide a detailed description of the skills, expertise and track record of the team, including the relevant knowledge and skills of each member and the amount of their time that will be spent on the project. Include relevant commercial, scientific, clinical and management expertise.

10. Application finances

Summarise and justify all costs. All costs must include VAT. If there is significant use of subcontractors, please explain how these will be used and the costs of each. Your costs must reflect actual costs at a ’fair market value’ and not include profit.

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

Please provide:

• quarterly spend profiles for the duration of the project
• a payment schedule

The costs should cover the following, as applicable.

Directly incurred costs

These are costs that are specific to the project. They will be charged to the project as the amount actually spent. They should be 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 (including 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. Calculate them using your own cost rates. They may include:

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

You may be asked for an itemisation of costs and methods of calculation at a later date.

11. Commercialisation

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 thought 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 or an epidemic situation.

Consider how the product is likely to be used, by whom, how it will be paid for and distributed.

12. Use of proposed technology in low-income settings

Detail how the proposed product will be able to speed up containment of developing epidemics in resource-poor settings.

13. Declarations

You should discuss your proposals with your own organisation as well as those who will be required to co-operate in the project. Do this before you submit your application.

By submitting this application you are confirming that:

• the information given is complete
• you are actively engaged in this project and responsible for its overall management
• you agree to administer the award if made
• you have read and understand the relevant explanatory materials: the invitation to tender, the guidance notes and the guide for participants
• 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.