UKRI: Clinical biomarker tools and technologies for dementia

Overview

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.

Funding Notes

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

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.

VAT Notes

You must select whether you are VAT registered before entering your project costs. VAT is the responsibility of the invoicing business.

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.

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

Eligibility

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

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.

Scope of 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

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

They 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.