SBRI: Dementia Mission Bio-Hermes 2 – phase 3

Key Features

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).

Programme:     Innovate UK

Award:     Share of up to £4 million

Opens: 15th Apr 2024

Closes: 22nd Apr 2024

! This scheme is now closed

Overview

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

Scope

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.

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.

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.

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.

Eligibility

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.

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.

Exclusions

Innovate UK 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

Funding Costs

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

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.

Interested in applying for this competition?

Book an appointment to speak to one of our advisors to discuss your eligibility to apply for this Grant Funding opportunity.