Funding competition SBRI: Dementia Mission Bio-Hermes 2 - phase 3

Organisations can apply for a share of up to £4 million, inclusive of VAT, to enable selected blood-based and digital biomarkers to be evaluated as part of the Bio-Hermes 2 study led by the Global Alzheimer’s Platform Foundation (GAP).

Competition opens: Monday 15 April 2024
Competition closes: Monday 22 April 2024 11:00am

This competition is now closed.

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Description

This is a Small Business Research Initiative (SBRI) competition funded by Innovate UK.

The aim of this competition is to enable organisations with selected blood-based and digital biomarkers, related to Tau and inflammation markers to apply for and be evaluated as part of the Bio-Hermes 2 study. The study will be led by the Global Alzheimer’s Platform Foundation (GAP).

Organisations wishing to have their tests incorporated in the trial protocol must subscribe to the study by 1 May 2024.

Bio-Hermes 2, led by GAP, is investigating digital and blood-based biomarkers related to Tau and inflammation markers and their relationship to the current gold standard diagnosis through Tau and amyloid PET scans.

It will evaluate multiple biomarkers in an ethnically diverse population of 1000 participants across 30 sites in the United States, Canada, and Europe. The data collected in Bio-Hermes 2 will provide a rich dataset on the extent to which digital and blood-based biomarkers can substitute for more labour intensive clinical exams and expensive PET scans.

Participating organisations will gain access to the full dataset and regulatory-standard data for subsequent submissions.

Successful outcome of the study will be to markedly accelerate the adoption and effective use of biomarkers.

This is a single-phase competition.

In applying to this phase 3 competition you are entering into a competitive process. This competition has a funding budget of up to £4 million, so we may not be able to fund all the proposed projects.

It may be the case that your project scores highly and receives positive comments from the assessors but we are still unable to fund it due to the portfolio approach we take.

This phase 3 SBRI is a standalone competition open to any eligible applicants with existing pre-commercial innovations.

The reference to phase 3 indicates that this competition will support the project in progress towards ongoing regulatory approval.

It will not provide funding for initial exploration of ideas or low technology readiness prototypes.

Any adoption and implementation of a solution from this competition would be subject to a separate, possibly competitive, procurement exercise. This competition does not cover the purchase of any solution.

This competition closes at 11am UK time on the deadline stated in this Innovate UK competition brief. We cannot guarantee other government or third party sites will always show the correct competition information.

Funding type

Procurement

Project size

Phase 3 projects can range in size up to total costs of £1.2 million, inclusive of VAT. Your total costs must include the mandated $1 million study membership fee.

Accessibility and Inclusion

We welcome and encourage applications from people of all backgrounds and are committed to making our application process accessible to everyone. This includes making reasonable adjustments, for people who have a disability or a long-term condition and face barriers applying to us.

You can contact us at any time to ask for guidance.

We recommend you contact us as soon as possible before this competition’s closing date to allow us to put the most suitable support in place. The support we can provide may be limited if you contact us close to the competition deadline.

You can contact Innovate UK by email or call 0300 321 4357. Our phone lines are open from 9am to 12pm and 2pm to 5pm UK time, Monday to Friday (excluding bank holidays).

Who can apply

Your project

Projects must:

start on 1 May 2024
end by 31 March 2026
last up to 21 months
have total costs of no more than £1.2 million, inclusive of VAT, which must include the mandated $1 million (approx. £800,000) study membership fee

Applicant

To lead a project, you can:

be an organisation of any size
work alone or with the subcontracted skills and expertise of others from business, research organisations, research and technology organisations, or the third sector (charities, social enterprises and voluntary groups)

This competition will not fund any procurement, commercial, business development or supply chain activity with any Russian or Belarusian entity as lead or subcontractor. This includes any goods or services originating from a Russian or Belarusian source.

Contracts will be awarded to a single legal entity only. The majority of the project work and key deliverables must be completed by the applicant and be carried out in the UK. Subcontractors can be used, but only for specialist skills.

Use of animals in research and innovation

Innovate UK expects and supports the provision and safeguarding of welfare standards for animals used in research and innovation, according to best practice and up to date guidance.

Applicants must ensure that all of the proposed work within projects, both that in the UK and internationally, will comply with the UKRI guidance on the use of animals in research and innovation.

Any projects selected for funding which involve animals will be asked to provide additional information on welfare and ethical considerations, as well as compliance with any relevant legislation as part of the project start-up process. This information will be reviewed before an award is made.

Funding

A total of up to £4 million, inclusive of VAT, is allocated to this competition.

This phase 3 SBRI is a standalone competition open to any eligible applicants with existing pre-commercial innovations.

The total funding available for the competition can change. The funders have the right to apply a ‘portfolio’ approach.

The contract is completed at the end of the competition, and the successful organisation is expected to pursue commercialisation of their solution.

Value Added Tax (VAT)

You must select whether you are VAT registered before entering your project costs.

VAT is the responsibility of the invoicing business. We will not provide any further advice and suggest you seek independent advice from HMRC.

VAT registered

If you select you are VAT registered, you must enter your project costs exclusive of VAT. As part of the application process VAT will be automatically calculated and added to your project cost total. Your total project costs inclusive of VAT must not exceed £1.2 million, which must include the mandated $1 million (approx. £800,000) study membership fee.

Not VAT registered

If you select you are not VAT registered, you must enter your project costs exclusive of VAT and no VAT will be added. You will not be able to increase total project costs to cover VAT later should you become VAT registered. Your total project costs must not exceed £1.2 million, which must include the mandated $1 million (approx. £800,000) study membership fee.

Research and development (R&D)

Your application must have at least 50% of the contract value attributed directly and exclusively to R&D services, including solution exploration and design. R&D can also include prototyping and field-testing the product or service. This lets you incorporate the results of your exploration and design and demonstrate that you can produce in quantity to acceptable quality standards.

R&D does not include:

commercial development activities such as quantity production
supply to establish commercial viability or to recover R&D costs
integration, customisation or incremental adaptations and improvements to existing products or processes

Subsidy control

SBRI competitions involve procurement of R&D services at a fair market value and are not subject to subsidy control criteria that typically apply to grant funding.

Your project

The aim of this competition is to enable organisations with selected blood-based and digital biomarkers related to Tau and inflammation markers to apply for and be evaluated as part of the Bio-Hermes 2 study. The study will be led by the Global Alzheimer’s Platform Foundation (GAP).

Organisations wishing to have their tests incorporated in the trial protocol must subscribe to the study by 1 May 2024. If invited you will be required to purchase the mandatory membership to participate in the GAP Bio-Hermes 2 study.

Participating organisations will gain access to the full dataset and regulatory-standard data for subsequent submissions.

Successful outcome of the study will be to markedly accelerate the adoption and effective use of biomarkers.

In this competition you must:

complete a mandatory first milestone, working with Innovate UK, to secure and evidence a membership to participate in the Bio-Hermes 2 study
evidence your capacity and preparedness to participate
evidence the readiness and suitability of your product or technology to be included within the Bio-Hermes 2 study
submit a detailed plan of the trial activity you will undertake as a participant of the Bio-Hermes 2 study
explain how the data sets will support ongoing regulatory approval for your product or technology
detail any further objectives for participating in the Bio-Hermes 2 study
provide a detailed commercialisation plan
detail any relevant approvals required to participate in the Bio-Hermes 2 study

Contracts will be given to successful applicants.

You must demonstrate a credible and practical route to market, so your application must include a plan to commercialise your results.

Portfolio approach

We want to fund a variety of projects across different themes, products, technologies and technological maturities. We call this a portfolio approach.

Specific themes

Your project can focus on one or more of the following, for Alzheimers disease:

blood-based biomarkers
digital biomarkers, including speech, electroencephalogram (EEG), mood

Research categories

Phase 3: real world implementation and testing

The primary objective is to make further technical improvements on products, processes or services that are not substantially set.

This can include further prototyping, demonstrating, testing and validation of existing pre-commercial products, processes or services in environments representative of real-life operating conditions.

Projects we will not fund

We will not fund projects that:

are not original in scope and duplicates someone else’s work
cannot evidence capacity and preparedness to participate
do not have a detailed plan to utilise the data resources in the Bio-Hermes 2 study
do not have appropriate regulatory approvals in place
do not have the required membership in place by 1 May 2024
do not have a robust plan to commercialise

15 April 2024: Applicant briefing: watch the recording
15 April 2024: Competition opens
22 April 2024 11:00am: Competition closes
26 April 2024: Applicants notified
29 April 2024: Phase 3 contracts awarded

Before you start

By submitting an application, you agree to the terms of the draft contract which is available once you start your application. The terms of the contract are non-negotiable and are included in the draft contract. We reserve the right to change the terms and conditions if necessary.

The final contract will include any milestones you have agreed with the funding authority and will be sent to you if your application is successful. The contract is binding once it is returned by you and signed by both parties.

When you start an application, you will be prompted to create an account as the lead applicant or sign in as a representative of your organisation. Using your account, you will be able to track your applications progress.

As the applicant you are responsible for:

collecting the information for your application
representing your organisation in leading the project if your application is successful

You will be able to invite colleagues from your organisation to contribute to the application.

What happens next

A selected panel of assessors will review and score your application. The portfolio review of applications will include an independent expert.

You will be notified of the outcome and feedback will be provided. Contracts for this competition will then be issued to all successful applicants.

What we will ask you

The application is split into three sections:

Project details.
Application questions.
Finances.

You must read the guidance on applying for a competition on the Innovation Funding Service before you start.

Before submitting, it is the lead applicant’s responsibility to make sure:

that all the information provided in the application is correct
your proposal meets the eligibility and scope criteria
all sections of the application are marked as complete

You can reopen your application once submitted, up until the competition deadline. You must resubmit the application before the competition deadline.

Accessibility and Inclusion

You can contact us at any time to ask for guidance.

You can contact Innovate UK by email or call 0300 321 4357. Our phone lines are open from 9am to 12pm and 2pm to 5pm UK time, Monday to Friday (excluding bank holidays).

1. Project details

This section provides background for your application and is not scored.

Application details

Give your project’s title, start date and duration.

Who made you aware of the competition?

Select a category to state who made you aware of the competition. You cannot choose more than one.

How long has your organisation been established for?

Select a category to state how long has your organisation been established for. You cannot choose more than one.

What is your organisation’s primary area focus?

Select a category to state your organisation’s primary focus area. You cannot choose more than one.

Project and scope summary

Please provide a short summary of your project.

Describe your project briefly. Be clear about what makes it innovative and how it relates to the scope of the competition. How does it tackle different aspects of the challenge and how will it provide an integrated solution?

Give details of the lead organisation. Before you submit, we expect you to have discussed your application within your organisation.

Your answer for this section can be up to 800 words long.

This section is not scored, but we will use it to decide whether the project fits the scope of the competition. If it does not, it may be rejected.

Public description

Please provide a brief description of your project. If your application is successful, we will publish this description. This could happen before you start your project. This question is mandatory, but we will not assess this content as part of your application.

Describe your project in a way that you are happy to see published. Do not include any commercially sensitive information. We have the right to amend the description before publication if necessary but will consult you about any changes.

Your answer can be up to 400 words long.

Applicant location

You must state the name of your organisation along with your full registered address.

You must also state the name and full registered address of any potential or confirmed subcontractors.

We are collecting this information to understand the geographical location of all participants of a project.

Your answer can be up to 400 words long.

2. Application questions

The assessors will score all of your questions except questions 1, 2 and 3 which are not scored. You will receive feedback for each scored question. Find out more about how our assessors assess and how we select applications for funding.

Your answer to each question can be up to 400 words long. Do not include any URLs in your answers unless we have explicitly requested a link to a video.

Question 1. Themes (not scored)

Select one main theme from the specific themes list in the ‘Scope’ section of this competition. You cannot choose more than one.

You must select one of the following options:

blood-based biomarkers
digital biomarkers

Question 2. Animal testing (not scored)

Will your project involve any trials with animals or animal testing?

You must select one option:

We will only support innovation projects conducted to the highest standards of animal welfare.

Further information for proposals involving animal testing is available at the UKRI Good Research Hub and NC3R’s animal welfare guidance.

Question 3. Permits and licences (not scored)

Will you have the correct permits and licences in place to carry out your project?

We are unable to fund projects who do not have the correct permits or licences in place by your project start date.

You must select one option:

Yes
No
In process of being applied for

Question 4. Proposed idea or technology

How does the project meet the challenge described in the competition scope?

Provide a description of your product or technology.

Include evidence of the readiness and suitability of your product or technology.

You can submit a single appendix as a PDF containing images and diagrams to support your answer. It can be no larger than 10MB and up to 2 A4 pages long. The font must be legible at 100% zoom.

This question will be scored against this assessment criterion: ‘How well does the proposal meet the challenge?’

Question 5. Technical project summary

What are the main technical challenges you are addressing?

Explain:

how you will address the challenge
what the innovation is
the main technical deliverables
the research and development that will prove the scientific, environmental and commercial merit of the project
what might be achieved by deploying the innovation to address the selected challenge

This question will be scored against this assessment criterion: ‘How valid is the technical approach?’

Question 6. Current state of the art and intellectual property

Are similar products currently available in the market?

How is your proposed project differentiated from them?

You must include details of:

any existing intellectual property (IP)
its significance to your freedom to operate
novel concepts you develop or employ
new approaches or technologies you use
new tools or technologies

This question will be scored against these assessment criteria: ‘How innovative is this project? How much does the project develop or employ novel concepts, approaches, methodologies, tools or technologies for this area?’

Question 7. Project plan and methodology

Describe your project plan and identify the main milestones.

The plan must be comprehensive. The emphasis throughout should be on practicality.

Provide evidence that the technology works, can be made into a viable product and can achieve the proposed benefits.

You must:

describe resources that will be needed to deliver the project with particular emphasis on your preparedness to participate in the Bio-Hermes 2 study
describe what the main success criteria will be
identify the project management processes that will ensure you achieve the milestones
provide a detailed plan for establishing technical and commercial feasibility
describe the main technical, commercial and environmental risks and what you will do to mitigate them
provide a detailed plan of the trial activity you will undertake as a participant of Bio-Hermes 2 study

You must explain how you would handle any intellectual property (IP) issues which might arise during the project.

If you are working with subcontractors (specialist skills only), include details of how you will maintain freedom to operate and fulfil the IP requirements detailed in the contract.

You must upload a project plan or Gantt chart as an appendix in PDF format no larger than 10MB and up to 2 A4 pages. The font must be legible at 100% zoom.

Your milestones must:

complete a mandatory first milestone, working with Innovate UK, to secure and evidence a membership to participate in the Bio-Hermes 2 study by 1 May 2024
be clear
be defined using SMART (specific, measurable, achievable, realistic and time-bound) criteria
be associated with the appropriate deliverables and payments
indicate your payment schedule by month

This question will be assessed against these assessment criteria:

has the mandatory milestone been included and is it achievable
does the project demonstrate technical and resource preparedness to participate in the Bio-Hermes 2 study
does the proposal show a clear plan for establishing technical and commercial feasibility and the development of a working prototype
is there a clear management plan
what are the main technical, commercial, and environmental risks to the project’s success
how will these risks be effectively managed
are the milestones and evaluation procedures appropriate

Note: information from the finances section will be used to support the assessment of this question. Proposed milestones and associated payments stated in this section must match those entered in the finance summary on your application.

Question 8. Technical team and expertise

Who is in the technical team? What expertise do they offer?

Provide a brief description of your technical team, including any subcontractors.

Describe:

how each organisation has the skills, capabilities, and experience to deliver the intended benefits
how much of their time will be spent on the project

This question will be scored against this assessment criterion: Does the applicant have the skills, capabilities and experience to deliver the intended benefits?

Question 9. Costs and value for money

How much will the project cost? How does it represent value for money for the team and the taxpayer?

Describe:

the total costs inclusive of VAT (If applicable) you are requesting in terms of the project goals
how this project represents value for money for you and the taxpayer

Proposed costs stated in this section must match those entered in the finance summary and must include the mandated $1 million (approx. £800,000) study membership fee.

All costs quoted must reflect actual costs at a ‘fair market value’ and not include profit.

You can submit a single appendix as a spreadsheet in PDF format, no larger than 10MB and up to 2 A4 pages long to support your answer. The font must be legible at 100% zoom.

Note that all payments are aggregated and made quarterly in arrears on submission of an invoice. The invoice must be submitted within 30 days of the end of each monitoring period for all completed milestones.

Full Economic Cost (FEC) calculations are not relevant for SBRI competitions. SBRI is a competitive process and applications will come from a variety of organisations. Whatever calculation you use to arrive at your total eligible project costs your application will be assessed against applications from other organisations. Bear this in mind when calculating your total eligible project costs. You can include overheads but remember that this is a competitive process.

The assessors are required to judge the application finances in terms of value for money. They will score your finances against this assessment criterion: ‘Are the budget and costs realistic, justified and appropriate for the aims and methods?

Note: information from the finances section will be used to support the assessment of this question. Proposed costs stated in this section must match those entered in the finance summary on your application.

Question 10. Commercial potential

What is the commercial potential of your project? You must focus on your proposed customer’s needs.

Describe your:

timescales
projects commercial potential for a marketable product, process or service
delivery plan
expected route to market

Describe the competitive advantage that your project has over existing or alternative technologies that meet market needs.

Describe any existing commercial relationships relevant to the project.

With the focus on your proposed customer’s needs, you can also mention the future commercial potential across the public or private sector and international markets.

This question will be scored against these assessment criteria:

is there a clear commercial potential for a marketable product, process or service
is there a clear plan to deliver that and a clear route to market

how significant is the competitive advantage of this technology over existing technologies that meet the market’s needs

3. Finances

Enter your project costs, organisation details and funding details.

You must include under ‘other costs’ the equivalent of US $1 million (approximately £800,000), labelled as the cost of membership to the Bio-Hermes 2 study.

You must select whether you are VAT registered before entering your project costs. We advise you answer the VAT registered question first before entering your costs. Your total project costs must not exceed £1.2 million.

If you select you are VAT registered, you must enter your project costs exclusive of VAT. As part of the application process VAT will be automatically calculated and added to your project cost total.

VAT is the responsibility of the invoicing business. We will not provide any further advice and advise you to seek independent advice from HMRC.

For full information on what costs you can claim, see our project costs guidance.

Background and further information

About Small Business Research Initiative competitions

SBRI provides innovative solutions to challenges faced by the public sector. This can lead to better public services and improved efficiency and effectiveness.

The SBRI programme:

supports economic growth and enables the development of innovative products and services through the public procurement of R&D
generates new business opportunities for companies
provides a route to market for new ideas
creates opportunities to work directly with the public sector

SBRI competitions are open to all eligible organisations that can demonstrate a route to market for their solution. Under current regulations, SBRI contracts are open to applications from organisations registered in the UK, European Union (EU) and the European Economic Area (EEA). Developments are 100% funded and focused on specific identified needs, increasing the chance of exploitation.

SBRI encourages the creation and protection of new (intellectual property) IP. Applicants retain all the rights to both foreground and background IP but will be expected to grant certain royalty-free licences to the funder for use of the foreground IP.

SBRI is a procurement of R&D services. If successful, you will receive a contract to deliver the proposed activity. Costs quoted must reflect actual costs at a ‘fair market value’ and not include profit.

You must submit an invoice for the work undertaken. All payments are made in arrears on submission of an invoice. Invoices must be submitted within 30 days of the end of each monitoring period for all completed milestones.

If you are VAT registered, your total costs are expected to include VAT that you would charge as a service provider. VAT is the responsibility of the invoicing business and applicants should ensure that VAT has been calculated correctly as part of their application. You will need to confirm your VAT status as part of the application process

Note – we are seeing a rise in double counting of VAT during the application process, making some applicants ineligible. To avoid this, it is important you input your costs minus VAT. VAT is added on by us in the Innovation Funding Service (IFS).

Suppliers for each project will be selected by an open competition process and retain the intellectual property generated from the project, with certain rights of use retained by the contracting authority. This is an excellent opportunity to establish an early customer for a new technology and to fund its development.

Broader Information

Dementia is an umbrella term for a diverse range of diseases, including Alzheimer’s disease, which represent one of the biggest health and economic challenges of our time, with estimated annual costs to the UK of £25 billion. With ageing populations, cases globally are predicted to triple by 2050.

There is a great urgency to deal with this global health challenge, which also presents an opportunity for the UK to build on existing investments and a world-class research ecosystem to deliver life-changing innovations for dementia patients.

The UK Government’s Life Sciences Vision 2021 highlighted ’improving translational capabilities in neurodegeneration and dementia’ as one of its flagship healthcare mission challenges. In response to this, in August 2022 the Prime Minister launched the Dame Barbara Windsor Dementia Mission, along with £95 million funding and a commitment to double the annual dementia research funding by 2024.

Bio-Hermes 2, led by the Global Alzheimer’s Platform Foundation (GAP) is investigating digital and blood-based biomarkers related to Tau and inflammation markers and their relationship to the current gold standard diagnosis through Tau and amyloid PET scans. It will evaluate multiple biomarkers in an ethnically diverse population of 1000 participants across 30 sites in the United States, Canada, and Europe.

GAP have already secured an impressive consortium. Funding is through subscription of participating companies in which those with under $1 billion market capitalization are required to subscribe US $1 million (approximately £0.8 million) and in return have their tests included in the study, gain access to the full dataset and through that have access to regulatory-standard data for subsequent submissions.

Data sharing

This competition is operated by Innovate UK.

Innovate UK is directly accountable to you for its holding and processing of your information, including any personal data and confidential information. Data is held in accordance with our own policies. Accordingly, Innovate UK will be data controllers for personal data submitted during the application.

Innovate UK’s Privacy Policy

Innovate UK complies with the requirements of UK GDPR and the Data Protection Act 2018, and is committed to upholding data protection legislation, and protecting your information in accordance with data protection principles.

The Information Commissioner’s Office also has a useful guide for organisations, which outlines the data protection principles.

Assessment

Your application will be reviewed by three independent assessors based on the content of your application and their skills or expertise relevant to your project. All of the scores awarded will count towards the total score used to make the funding decision unless you are notified otherwise.

You can find out more about our assessment process in the General Guidance.

SBRI Dementia Missions Bio-Hermes 2 phase 3 assessor guidance for applicants.pdf (opens in a new window)

Next steps

If you are successful with this application, you will be asked to set up your project.

You must follow the unique link embedded in your email notification. This takes you to your Innovation Funding Service (IFS) Set Up portal, the tool that Innovate UK uses to gather necessary information before we can allow your project to begin.

You will need to provide:

the name and contact details of your project manager and project finance lead
a redacted copy of your bank details

You must complete the initial setup process within 7 days of receiving notification that you have been successful.

In order to process your claims, we need to make sure that the bank details you give to us relate to a UK high street bank that is regulated by the Prudential Regulation Authority (PRA). The account must have a BACS clearing facility and be in the same company name as your application.

If you have any doubts that your bank account will not meet Innovate UK's funding criteria, you can use the sort code checker. If you input the sort code and find a tick next to the ‘BACS Direct Credit payments can be sent to this sort code’, this will give you an indication that the bank account you hold is acceptable.

Finance checks

We will carry out checks to make sure you are an established company with access to the funds necessary to complete the project.

You must check your IFS portal regularly and respond to any requests we have sent for additional information to avoid any delays. We will also review your milestones, which, if not suitable, will need to be amended during project setup.

Failure to complete project setup may result in your contract being withdrawn.

Your Contract

Once you have successfully completed project setup, we will issue your contract.

The contract will be made available on your IFS portal. You will need to sign and upload this before you start your project on 1 May 2024.

Your contract will show the start date for your project, do not start your project before this date. Any costs incurred before your start date cannot be claimed as part of your contract.

If your application is unsuccessful

If you are unsuccessful with your application this time, you can view feedback from the assessors. This will be available to you on your IFS portal following notification.

Sometimes your application will have scored well, and you will receive positive comments from the assessors. You may be unsuccessful as your average score was not above the funding threshold or your project has not been selected under the portfolio approach if this is applied for this competition.

Further help and guidance

If you want help to find an organisation to work with, contact the Innovate UK Business Connect.

If you need more information about how to apply or you want to submit your application in Welsh, email support@iuk.ukri.org or call 0300 321 4357.

Our phone lines are open from 9am to 12pm and 2pm to 5pm UK time, Monday to Friday (excluding bank holidays).

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