Notice

Competition guidance: vaccines for global epidemics; clinical

Updated 12 April 2017

This notice was withdrawn on 21 September 2017

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

1. Dates and deadlines

Competition opens	23 January 2017
Final date for registration	Midday 12 April 2017
Submission of the full application (including appendices)	Midday 19 April 2017
Interviews	1 and 2 June 2017
Decision to applicants	16 June 2017
Contracts awarded	14 July 2017
Feedback provided	14 July 2017

These guidance notes complement the invitation to tender (Document SBRI_DH_345_001) which can be found on the FTP site. They are designed to help with completing the application form.

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

2. Funding

The Department of Health is to invest up to £35 million in projects to develop new vaccines against infectious diseases as described in the brief for this competition.

The competition is a single stage. It covers carrying out clinical development of vaccines up to and including phase IIb trials. We expect that individual contracts will be valued up to £3 million. Projects should last between 24 and 36 months.

3. How to apply

Before you apply into this 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 before you submit.

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.

Interview: Successful applications at the written stage will be invited to attend an interview. Further detail 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 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 to provide the information required. Where text limits are indicated, please do not exceed these, as this will result in your application being rejected.

A reference number will be given to you 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 want 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.

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
Question 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 1 September 2017 and the work must be completed and delivered by the end of August 2019 or 2020.
Total contract cost (£)	Proposed projects can request a maximum total cost of £3 million.
Proposed start date	Enter the estimated start date.
What is the best way to describe your innovation?	Select from the options.
Question 2. Application details	Please submit all the details requested in the application form.
Question 3. Contact details	Please submit the lead applicant’s name, post held, institution/company, position, etc. In addition provide details of where you heard about the competition.

5.1 Question 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.

5.2 Question 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. You should:

• describe the immunisation agent (in development or marketed) that 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 1 or 2 human trials and manufacturing technology that could potentially be commercially viable in the near future
• document the current state of development or readiness of the project. Please include any relevant pilot data and information to support the feasibility of the proposed approach.

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

5.3 Question 6. Scientific/technical project summary (mandatory)

Please provide a structured summary of the technical basis of the project, including trial design and proposed methodology. You should make sure that all statistical aspects of any trial included and the assumptions on which these are based (for example power calculations, sample sizes and effect sizes) are clearly explained and well justified.

Other considerations should include:

• which centres will be involved, 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.

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

5.4 Question 7. Technical Background, Current State of the Art and Intellectual Property (IP) (Mandatory)

Please provide details of any competing technologies/market alternatives and the relative benefits of the proposed technology. Please describe how the proposed study/trial will differ from or complement 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.

5.5 Question 8. Project Plan and Methodology (Mandatory)

The project plan should identify the major work packages within the project with well-defined milestones and deliverables. Clear go and no-go decision points should be included. 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.

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 (maximum 2 A4 pages, in PDF format)
• please provide an indication of how any IP which might arise during the project would be handled. Following the end of the award, how will the project be taken forward to enable it to meet its ultimate aims (for instance, what is the exit strategy)

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.

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)

5.6 Question 9. Technical Team and Expertise (Mandatory)

Provide a detailed description of the skills, expertise and track record of the team. Include 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.

5.7 Question 10. Application finances

Please provide a summary of costs and justification of them. All costs should include VAT. 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 project. Please also provide a payment schedule for this project.

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 include:

• 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. 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.

5.8 Question 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.

5.9 Question 12. Use of proposed technology in low-income settings

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

5.10 Question 13. Declarations (mandatory)

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

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; 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.