Funding competition SBRI: Clinical biomarker tools and technologies for dementia

Organisations can apply for a share of £6 million, inclusive of VAT, to develop or repurpose platform technologies. These technologies can be used as clinical tools to enable the bio-marker guided development of transformative dementia therapies.

Competition opens: Monday 24 July 2023
Competition closes: Monday 4 September 2023 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 the competition is to accelerate innovations in dementia biomarker detection to transform clinical trials and precision therapies.

This will be achieved by the development of or repurposing of technologies that will enable the robust detection of emerging dementia clinical biomarkers. The application of innovations in wet biomarkers, data, and tools and services, will feed into and support the aims of the UK government’s Dame Barbara Windsor dementia mission.

This is a single-phase competition.

In applying to this competition you are entering into a competitive process.

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 date of the deadline.

Funding type

Procurement

Project size

Projects total costs must be between £100,000 to £1 million, inclusive of VAT.

Who can apply

Your project

Projects must:

start on 1 December 2023
end by 30 November 2024
last between 6 months and 12 months
have a dedicated project manager

Applicant

To lead a project, you can:

be an organisation of any size
work alone or with others from business, research organisations, research and technology organisations or the third sector as subcontractors

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.

You are responsible for entering your project costs and completing your Project Impact questions in the application.

Contracts will be awarded to a single legal entity only. However, if you can justify subcontracting components of the work, you can engage specialists or advisers. This work will still be the responsibility of the main contractor.

Subcontractors can be from anywhere in the UK and you must select them through your usual procurement process.

You can use subcontractors from overseas but must make the case in your application as to why you could not use suppliers from the UK.

You must provide a detailed rationale, evidence of the potential UK contractors you approached and the reasons why they were unable to work with you. We will not accept a cheaper cost as a sufficient reason to use an overseas subcontractor.

All subcontractor costs must be justified and appropriate to the total project costs.

Funding

A total of up to £6 million, inclusive of VAT, is allocated to this competition.

The feasibility study R&D contracts will range from £100,000 up to £1 million, inclusive of VAT, for each project for up to 12 months. We expect to fund up to 10 projects.

The total funding available for the competition can change. The funders have the right to:

adjust the provisional funding allocations
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 million.

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 million.

Research and development

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 the competition is to accelerate innovations in dementia biomarker detection to transform the clinical development of precision therapies. These technologies will enable the discovery, validation and implementation of a suite of decision-enabling biomarkers. Your project can involve exemplar biomarkers that can be adapted towards a broader range of clinically actionable dementia markers.

This will be achieved by the development of or repurposing of technologies that will enable the robust detection of emerging dementia clinical biomarkers.

The application of innovations in wet biomarkers, data, and tools and services, will feed into and support the aims of the UK government’s Dame Barbara Windsor dementia mission.

Your project must:

improve the sensitive detection of neurodegeneration, inflammation or vascular biomarkers associated with dementia
advance the development of a novel biomarker platform or repurposed technology towards dementia indications
describe how the technological solution would be implemented, including consideration of dementia patients, their carers and infrastructure and healthcare requirements
consider diversity of patients to provide an accessible, equitable solution
describe a credible and practical route to market, including manufacturing, health economic and regulatory considerations
have a dedicated project manager

We are especially interested in technologies that enable detection during early stage of the disease.

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, technologies, technological maturities and platform technologies for dementia. We call this a portfolio approach.

Specific themes

Your project can focus on one or more of the following:

technologies to subtype and stratify dementia patient cohorts
technologies to measure early-stage trial endpoints in dementia clinical trials
technologies to predict efficacy of emerging therapies currently in the drug discovery and clinical pipeline
technologies for longitudinal monitoring of treatment outcomes in dementia
repurposing of technologies that will enable the robust detection of emerging dementia clinical biomarkers

We are particularly looking for minimally invasive wet biomarker solutions including, but not limited to, blood, saliva, urine or breath sampling.

Technologies applying cerebrospinal fluid, neuroimaging or digital tools that augment, integrate and support clinical biomarker decision support can be included as part of your project.

Research categories

Initial technical development

This means planned research or critical investigation to gain new knowledge and skills for developing new technologies, tools, processes or services.

You must:

deliver distinct packages of work to further develop your platform technologies
complete a technical plan, methodology and justification for utilising re-purposed technologies

Projects we will not fund

We are specifically looking to advance the platform tools that can be used in the clinical validation of biomarkers being developed within the dementia mission.

We will not fund projects that:

are for medicines discovery
are biomarker discovery or validation
do not show that you have the required expertise to complete work packages to the appropriate time, cost and GxP standards
do not have appropriate industrial expertise and commercial insight in project design
focus on disease families outside of dementia
cannot be undertaken within the working restrictions of any pandemics such as coronavirus (COVID 19)
duplicate other UK government work you have already been funded to deliver
duplicate existing innovation, or work in progress by others
have total eligible project costs over the amount allowed
have not considered ethical and regulatory implications and requirements
do not have a dedicated project manager

24 July 2023: Competition opens
25 July 2023: Online briefing event: watch the recording
4 September 2023 11:00am: Competition closes
9 October 2023: Feedback
10 October 2023 7:49am: Applicants notified
1 December 2023: 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. 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 4 sections:

Project details.
Application questions.
Finances.
Project impact

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

We welcome and encourage applications from people of all backgrounds and are committed to making our application process accessible to everyone. This includes providing support, in the form of reasonable adjustments, for people who have a disability or a long-term condition and face barriers applying to us. Watch the video on how we are making our application process more accessible and inclusive for everyone.

You must contact us as early as possible in the application process. We recommend contacting us at least 15 working days before the competition closing date to ensure we can provide you with the most suitable support possible.

You can contact us by emailing support@iuk.ukri.org or calling 0300 321 4357. Our phone lines are open from 9am to 5pm, 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 question 1 which is 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)

State which of the following themes you will address:

technologies to subtype and stratify dementia patient cohorts
technologies to measure early-stage trial endpoints in dementia clinical trials
technologies to predict efficacy of emerging therapies currently in the drug discovery and clinical pipeline
technologies for longitudinal monitoring of treatment outcomes in dementia
repurposing of technologies that will enable the robust detection of emerging dementia clinical biomarkers

Question 2. Proposed idea or technology

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

Provide a description of your proposed idea or technology.

Include a description of the current state of development or readiness of the idea.

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 3. Technical and societal 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 or societal 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
why and how your idea for repurposing any existing technology would apply to dementia

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

Question 4. 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 5. Project plan and methodology

Describe your project plan and identify the main milestones.

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
describe what the main success criteria will be
identify the project management processes that will ensure you achieve the milestones
provide a clear 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 clear plan for development of a working prototype

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

Include details of how you will maintain freedom to operate and fulfil the IP requirements detailed in the contract if you are working with subcontractors.

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:

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:

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 be effectively managed
are the milestones and evaluation procedures appropriate

Please 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 6. 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
the project management role

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

Question 7. 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.

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.

Please note that all payments are made quarterly in arrears for milestones reached in that quarter, 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?

Please 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 8. Commercial potential

What is the commercial potential of your project? You must focus on how your proposed solution supports activity in the Neurodegenerative Initiative and how it will support the aims of the wider Dame Barbara Windsor Dementia Mission.

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.

Where the technology being developed is repurposed, describe how this expands commercial opportunity.

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 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 £1,000,000.

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.

Project Impact

This section is not scored but will provide background to your project.

You must complete the Project Impact questions before being able to submit the application.

More information can be found in our Project Impact guidance and by viewing our Impact Management Framework video.

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 their ideas
bridges the seed funding gap experienced by many early-stage companies

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). The SBRI scheme is particularly suited to small and medium-sized businesses, as the contracts are of relatively small value and operate on short timescales. Developments are 100% funded and focused on specific identified needs, increasing the chance of exploitation.

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 applications are expected to list total costs inclusive of VAT.

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

The Life Sciences Vision was published in July 2021 and included a commitment to deliver a healthcare mission in neurodegeneration and dementia. This is a response to the soaring global burden of dementia with approximately 50 million people currently living with dementia, a number that is expected to triple to more than 150 million by 2050.

In the UK, dementia is already the leading cause of death with an economic cost of over £34.7 billion per annum. However, despite over $42 billion being spent on dementia drug development over the past 30 years, only six drugs have been approved by the FDA and these are mostly for treating symptoms rather than offering the potential to modify disease progression.

Life Sciences Vision

The government and the life science sector’s plan to create a thriving sector and tackle the major causes of death and disease.

The challenges in dementia are:

The global burden of dementia and other neurodegenerative conditions is soaring. Approximately 50 million people are currently living with dementia worldwide, a number expected to triple to more than 150 million by 2050.
In the UK, dementia and Alzheimer’s disease are already the leading cause of death, with an economic cost of over £34.7 billion per annum
Over the past 30 years over $42.5 billion has been spent on dementia drug development, yet only six drugs, four of which are symptom relieving and one which is no longer being sold, have been currently approved by the FDA.

For the purposes of this competition dementia refers to the syndrome associated with an ongoing decline of brain functioning as a result of one or more diseases, including:

Alzheimer’s disease
vascular dementia
Lewy body dementia
frontotemporal dementia
other diseases including mixed dementia

The UK Government’s Dame Barbara Windsor Dementia Mission is looking to realise a new generation of dementia precision therapies for the UK. This will be achieved by accelerating innovations in biomarkers and clinical trials. As part of the mission, this competition aims to support the development of or repurposing of technologies that will enable the robust detection of emerging dementia clinical biomarkers.

The application of these innovations will support the foundations of the overall dementia mission in:

translational biomarkers and experimental medicine
data and digital sciences
clinical trial innovation
end to end implementation

Dementia is a complex, highly heterogenous disease with substantial variability in how patients respond to approved treatments. Currently there is only a very limited biomarker-guided approach and a lack of ultra-sensitive, minimally invasive biomarker platforms.

There is an urgent need for precision medicine tools that subtype disease and provide sensitive endpoints for clinical trials. This is a once-in-a-generation opportunity to apply precision approaches pioneered in more advanced disciplines such as oncology to deliver transformative medicines for dementia patients.

The Office for Life Sciences (a joint unit of the Department for Science, Innovation and Technology (DSIT) and the Department of Health and Social Care (DHSC)) has been leading work to develop the Dame Barbara Windsor Dementia Mission, together with DHSC, the National Institute for Health Research, the Medical Research Council, and Innovate UK. Together we have carried out early engagement with industry, academia, philanthropy (in the UK and globally), colleagues from across Government, as well as conducting our own market analysis, to design the Mission.

We are proposing delivering the Mission through three elements:

The Neurodegeneration Initiative (NI): a globally unique entity that will work in partnership with industry, academics, the NHS and the third sector to develop and apply innovations in biomarkers, data, and digital sciences to realise a new era for precision neuroscience, addressing identified gaps contributing to high failure rates in drug development.
The National Institute for Health and Care Research D-TRC Trials Network: a significant expansion of the existing NIHR D-TRC (D-TRC = Dementia Translational Research Collaboration), bringing early phase sites together in a centrally coordinated way to promote rapid trial readiness, increased site capability and capacity and upskilling and retention of staff. The overall aim is to attract and offer support to industry to conduct a greater volume of dementia clinical trials in the UK.
And this Innovate UK Small Business Research Initiative (SBRI) Competition - to develop and apply innovations in wet biomarkers, data, and tools and services, to feed into and support the work of the Neurodegeneration Initiative.

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 is accessible here.

Innovate UK complies with the requirements of GDPR, and is committed to upholding the data protection principles, and protecting your information. The Information Commissioner’s Office also has a useful guide for organisations, which outlines the data protection principles.

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 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 5 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, and this must be completed within 5 working days of being notified your application was successful.

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 KTN.

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 5pm, Monday to Friday (excluding bank holidays).

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