Funding competition Biomedical Catalyst 2021 Round 2: Feasibility & Primer Awards

UK registered businesses can apply for a share of up to £12 million to develop innovative healthcare products, technologies and processes.

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Competition sections

Description

Innovate UK, part of UK Research and Innovation, will invest up to £12 million for businesses to develop innovative healthcare products, technologies and processes.

The aim of this competition is to explore and evaluate the commercial potential of an innovative scientific idea or carry out a technical evaluation through to proof of concept in a model system. Your project must focus on the development of a product or process that is an innovative solution to a health and care challenge

Your project can focus on:

  • disease prevention and proactive management of health and chronic conditions
  • earlier and better detection and diagnosis of disease, leading to better patient outcomes
  • tailored treatments that either change the underlying disease or offer potential cures

This list is not intended to be exhaustive.

This competition combines the feasibility and primer strands of the Biomedical Catalyst.

Feasibility Award

The feasibility award is designed for projects that have developed an innovative concept or carried out experimental proof of concept but have not validated the technology. The aim of the feasibility award is to explore and evaluate the commercial potential of innovative ideas.

Primer Award

The primer award is for conducting a technical evaluation of an idea through to proof of concept in a model system.

In applying to this competition, you are entering into a competitive process. This competition closes at 11am UK time on the deadline stated.

Funding type

Grant

Project size

Your project’s total eligible costs must be between £50,000 and £1million.

Who can apply

Your project

Your project must:

  • have total eligible costs between £50,000 and £1million
  • start on 1 April 2022
  • end by 31 March 2024
  • last between 3 months and 24 months
  • carry out all of its project work in the UK
  • intend to exploit the results from or in the UK

If your project’s total eligible costs or duration falls outside of our eligibility criteria, you must provide justification by email to support@innovateuk.ukri.org at least 10 working days before the competition closes. We will decide whether to approve your request. If you have not requested approval or your application has not been approved by us you will be made ineligible and your application will not be sent for assessment.

Lead organisation

To lead a project or work alone your organisation must be a UK registered micro, small or medium-sized enterprise (SME)

Academic institutions cannot lead or work alone.


Project team

To collaborate with the lead, your organisation must be one of the following UK registered:

Each partner organisation must be invited into the Innovation Funding Service by the lead to collaborate on a project. Once accepted, partners will be asked to login or to create an account and enter their own project costs into the Innovation Funding Service.

In a collaboration, the lead and at least one other organisation must claim funding by entering their costs during the application.

Large companies can be collaborators but will not be able to claim grant funding.

Your project can include partners that do not receive any of this competition’s funding, for example non-UK businesses. Their costs will count towards the total eligible project costs.

Subcontractors

Subcontractors are allowed in this competition.

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 also provide a detailed rationale, evidence of the potential UK contractors you approached and the reasons why they were unable to work with you.

We expect all subcontractor costs to be justified and appropriate to the total eligible project costs. We will not accept a cheaper cost as a sufficient reason to use an overseas subcontractor. You must provide justification by email to support@innovateuk.ukri.org at least 10 working days before the competition closes.

Innovate UK will decide whether to approve your request.

Extenuating circumstances where overseas work may be allowable include, for example; clinical trial in a specific patient population.


Number of applications

An SME can only lead on one application but can be included as a collaborator in a further 2 applications.

If an SME is not leading on any application, it can collaborate in any number of applications.

An RTO, academic institution, not-for-profit, charity or public sector organisation can collaborate on any number of applications.

Previous applications

You can use a previously submitted application to apply for this competition.

We will not award you funding if you have:

Subsidy control (and State aid where applicable)

This competition provides funding in line with the UK's obligations and commitments to Subsidy Control. Further information about the UK Subsidy Control requirements can be found within the EU-UK Trade and Cooperation agreement and the subsequent guidance from the department of Business, Energy and Industrial Strategy (BEIS).

Innovate UK is unable to award organisations that are considered to be in financial difficulty. We will conduct financial viability and eligibility tests to confirm this is not the case following the application stage.

EU State aid rules now only apply in limited circumstances. Please see our general guidance to check if these rules apply to your organisation.


Further Information

If you are unsure about your obligations under the UK Subsidy Control regime or the State aid rules, you should take independent legal advice. We are unable to advise on individual eligibility or legal obligations.

You must make sure at all times that the funding awarded to you is compliant with all current Subsidy Control legislation applicable in the United Kingdom.
This aims to regulate any advantage granted by a public sector body which threatens to or actually distorts competition in the United Kingdom or any other country or countries.

If there are any changes to the above requirements that mean we need to change the terms of this competition, we will tell you as soon as possible.

Funding

Innovate UK have allocated up to £12 million to fund innovation projects in this competition.

If the majority of your organisation’s work on the project is commercial or economic, your funding request must not exceed the limits below. These limits apply even if your organisation normally acts non-economically.

For feasibility studies and industrial research projects, you could get funding for your eligible project costs of:

  • up to 70% if you are a micro or small organisation
  • up to 60% if you are a medium-sized organisation

For more information on company sizes, please refer to the company accounts guidance. This is a change from the EU definition unless you are applying under State aid.

If you are applying for an award funded under State aid Regulations, the definitions are set out in the European Commission Recommendation of 6 May 2003.

Research participation

The research organisations undertaking non-economic activity as part of the project can share up to 50% of the total eligible project costs. If your consortium contains more than one research organisation undertaking non-economic activity, this maximum is shared between them.


Of that 50% you could get funding for your eligible project costs of up to:

  • 80% of full economic costs (FEC) if you are a Je-s registered institution such as an academic
  • 100% of your eligible project costs if you are an RTO, charity, non-profit organisation, public sector organisation or research organisation

Your proposal

The aim of this competition is to explore and evaluate the commercial potential of an innovative scientific idea, or to carry out a technical evaluation through to proof of concept in a model system.

Your project must focus on the development of a product or process that is an innovative solution to a defined health or care challenge.

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

Visit the UKRI Good Research Hub and NC3R’s animal welfare guidance for further information.

This competition combines the feasibility and primer strands of the Biomedical Catalyst.

Your project can:

  • review research evidence and identify possible applications
  • assess business opportunities
  • assess or protect intellectual property
  • validate initial concepts and existing pre-clinical work through experimental studies
  • initially demonstrate using in-vitro and in-vivo models, but not human clinical trials
  • develop early-stage prototyping
  • acquire preliminary regulatory advice

Equality, diversity and inclusion (EDI) considerations are highly encouraged where appropriate in the proposal. Applications will continue to be assessed on their innovation merit, where innovation is defined as the potential for commercially successful exploitation of ideas.

We want to fund a portfolio of projects, across a variety of technologies, markets, technological maturities and research categories.

Specific themes

Your project can focus on any health and care sector or discipline.

Innovate UK particularly welcomes applications that support innovation in the following areas:

  • child health technologies
  • innovations that support clinical trials in the UK
  • biomedical innovations that combat the threat of antimicrobial resistance

Your project can align with one or more of the following:

  • medical technologies and devices
  • stratified healthcare
  • advanced therapies such as gene and cell therapies
  • digital health
  • drug discovery
  • diagnostics

This list is not intended to be exhaustive.

Research categories

We will fund feasibility projects and industrial research projects, as defined in the guidance on categories of research.

Projects we will not fund

We are not funding projects that are:

  • in scope for the Biomedical Catalyst early-stage or late-stage awards
  • not related to human life sciences
  • already on the market
  • laboratory accreditation
  • conducted to anything less than the highest standards of animal welfare
  • dependent on export performance – for example giving a subsidy to a baker on the condition that it exports a certain quantity of bread to another country
  • dependent on domestic inputs usage- for example giving a subsidy to a baker on the condition that it uses 50% UK flour in their product
18 October 2021
Competition opens
22 October 2021
Online briefing event - join at 10am
1 December 2021 11:00am
Competition closes
24 January 2022
Applicants notified

Before you start

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

What we ask you

The application is split into 3 sections:

  1. Project details.
  2. Application questions.
  3. Finances.

1. Project details

This section provides background for the assessors and is not scored.

Application team

Decide which organisations will work with you on the project. Invite people from those organisations to help complete the application.

Application details

The lead applicant must complete this section. Give your project’s title, start date and duration.

Subsidy Basis

Will the project, including any related activities, you want Innovate UK to fund, affect trade between Northern Ireland and the EU?

All participants must complete this section.

Research category

Select the type of research you will undertake.

Equality, diversity and inclusion

We collect and report on equality, diversity and inclusion (EDI) data to address under-representation in business innovation and ensure equality, diversity and inclusion across all our activities.

All participants must complete this EDI survey and the lead applicant must then select yes in the application question. The survey will ask you questions on your gender, age, ethnicity and disability status. You will always have the option to ‘prefer not to say’ if you do not feel comfortable sharing this information.

Project summary

Describe your project briefly and be clear about what makes it innovative. We use this section to assign experts to assess your application.

Your answer can be up to 400 words long.

Public description

Describe your project in detail, and in a way that you are happy to see published. Do not include any commercially sensitive information. If we award your project funding, we will publish this description. This could happen before you start your project.

Your answer can be up to 400 words long.

Scope

Describe how your project fits the scope of the competition. If your project is not in scope it will not be eligible for funding.

Your answer can be up to 400 words long.

2. Application questions

The assessors will score your answers to questions 2 to 11, question 1 is not scored. You will receive feedback for each scored question.

You must answer all questions. Your answer to each question can be up to 400 words long. Do not include any website addresses (URLs) in your answers.

Question 1. Applicant location (not scored)

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

If you are working in collaboration you must also state the name and full registered address of all your partners.

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

Question 2. Need or challenge

What is the healthcare challenge that this project addresses and what impacts will your solution have?

If your project addresses a specific healthcare need, what is the current 'gold standard'?

Give evidence that the healthcare challenge is real and sizeable. Explain how your project will address it. Define the market, both nationally and internationally, that will generate demand for your proposed solution.

How will the project outputs or the solution lead to a commercial opportunity for your organisation?

How will the outputs of the project meet the healthcare challenge?

Give any input you have from healthcare professionals, patients, potential partners or representatives of the onward supply chain.

Measure the potential positive impact on socio-economic factors and healthcare at a patient and community level. Detail the number of anticipated users and the benefits your solution will provide, with estimated timescales.

Question 3. Scientific Evidence

What is the underpinning scientific evidence to support your solution?

Detail all relevant prior experimental or technical evidence and explain how the previous results link to the proposed study.

Outline any preclinical or clinical work conducted to date and the outcomes.

You can submit one appendix to support your answer. It can include diagrams and charts. It must be a PDF and can be up to 4 A4 pages long. The font must be legible at 100% zoom.

Question 4. Innovation

What is innovative about your idea?

Identify the extent to which the project is innovative, from a commercial, scientific and technical perspective. Refer to existing products, current gold standards and practices that are currently in use and those known to be under development both in the UK and internationally. Comment on how this innovation will fit into the current standard of care.

If relevant outline the target product profile for your innovation in terms of safety & performance characteristics.

Describe both the technical and commercial benefits and shortcomings of your approach. This could include the results of competitor analyses and literature surveys.

Highlight the timeliness and novelty of your innovation and explain it in an industrial context.

Question 5. Technical approach

What technical approach will be adopted and how will the project be managed?

Provide an overview of the technical approach including the main objectives of the work.

Describe where you are now and where you want to be at the end of the project in terms of the deliverables. Describe the stages of the project (the work packages) and link the main areas of work together with their resource and management requirements.

Identify milestones and go or no-go points.

You must:

  • describe how the method and technical approach is appropriate to the needs of the project
  • ensure there is enough detail in your project plan for the assessors to understand tasks involved and resources required
  • ensure any study design is robust, and the key milestone timings are realistic
  • have committed enough resource and have the capability to undertake the project
  • ensure clear management reporting lines have been identified

If relevant, compare and contrast alternative research and development (R&D) strategies and describe why your proposed approach will offer the best outcome.

Provide justification for the use of animal or human subjects and the numbers of animals and samples to be tested.

You must submit a project plan or Gantt chart as an appendix to support your answer. You can also include a study design, protocol or approach. It must be a single PDF and can be up to 4 A4 pages long. The font must be legible at 100% zoom.

Question 6. Freedom to Operate

Do you have the freedom to operate?

Detail any existing intellectual property (IP) which may affect or which is relevant to project delivery and exploitation?

State the ownership of IP and, where necessary, how rights have been assigned.

Provide evidence that you have freedom to operate (FTO), who conducted the FTO, and that you can work without infringing other patents, for example by summarising the results of patent searches.

Detail any IP that you expect to be generated as a result of your project, and who will own it.

Describe your strategy for protecting the knowledge resulting from the project. If it is a collaborative project, how will you assign IP rights to project partners?

Question 7. Exploit the opportunity

How do you intend to exploit the opportunity?

How will the outputs of this project take you nearer to your objectives, and what will the steps be in this journey?

Describe how these outputs will be exploited including, where applicable:

  • the route to market, channel, geographies
  • reconfiguration of the value system, such as who will benefit or pay
  • changes to business models and business processes for the payor, provider or patient

Provide evidence that the proposed solution would be commercially viable for the target market. For example; cost of manufacturing at launch and at scale, and pricing.

Describe the size of the market opportunities that this project would create, including details of:

  • the current nature of the specific markets at which the project is targeted
  • the dynamics of this market including measuring its current size then actual and predicted growth rates, providing references to sources
  • the projected or target market share gains over time for the project outcome taking account of possible restrictions on market access and penetration, including any potential competitors
  • the longer term potential economic benefits to the UK in terms of increasing revenue, profitability, job creation

Outline the regulatory pathway for the innovation you are developing and how this project fits into your regulatory strategy.

For example:

  • define what regulatory requirements apply to your innovation
  • outline the evidence requirements & strategy to demonstrate conformity

You can submit an appendix to support your answer. It must be a single PDF and can be up to 4 A4 pages long. The font must be legible at 100% zoom.

Question 8. Technical, commercial, and environmental risks

What are the technical, commercial and environmental risks to project success? What is the project’s risk management strategy?

Innovate UK recognises that projects of this type are risky, and organisations that succeed focus on key risks, but we ask that the project has adequate arrangements for managing these risks.

Focus on:

  • the main risks and uncertainties of the project and provide a detailed risk analysis for the project content and approach
  • including the technical, regulatory, commercial, managerial and environmental risks as well as other uncertainties, such as ethical issues associated with the project
  • creating the risk register defining the severity and likelihood of specific risks along with measures taken to reduce risk, using an international standard such as ISO 14971 where possible
  • the potential impact of these scenarios, stating how the project would mitigate all significant and relevant risks

Identify project management tools and mechanisms that will be used to minimise operational risk. This should include the arrangements for managing the consortium where applicable. Identify ownership of each of the risks.

You must submit a risk register as an appendix to support your answer. It must be a PDF and can be up to 2 A4 pages long. The font must be legible at 100% zoom.

Question 9. Skills and experience

Does your team have the right skills and experience and access to facilities to deliver the project and exploit it?

Detail the expertise and track record of the project team, including collaborators and subcontractors. Explain if you have worked with them before and on what basis. Show your capability to deliver the project and exploit the output.

You must consider:

  • how the project builds the UK supply chain and addresses end-user needs
  • if collaborative, are the consortium’s formation objectives clear
  • if collaborative, is extra benefit gained from the collaboration
  • if subcontractors are being used, is there adequate justification
  • whether the project has access to the appropriate facilities, resources, tools, equipment and human capability

If you are planning to use subcontractors from outside the UK then you must provide evidence that no UK alternative exists or strong justification to support your choice of non-UK contractor.

Question 10. Resources Required

What are the resources required to deliver the project and how much will they cost?

You must indicate the anticipated eligible project costs, making clear the level of contribution from any project partners and the level of funding required.

This information must complement the financial summary table in the application form.

Detail the resources required to carry out the project for example; materials, capital equipment and people. Fully break down the costs and justify them for example; quotations to prove value for money. This must include all internal and external costs.

Costs must be consistent with the category of R&D being undertaken.

You must consider:

  • the robustness and justification of budget breakdown for the scale and complexity of the project
  • clarity of cost allocation
  • whether financial support required is within the limits set by the competition
  • value for public money
  • financial commitments to the project from non-grant claiming partners
  • whether funding will be available to cover cash flow pending quarterly reimbursement of costs from Innovate UK

Question 11. Financial Support and Added Value

How does financial support from Innovate UK add value?

What difference would public funding make? For example; a faster route to market, more partners or reduced risk?

Describe the likely impact of the project on the wider businesses of the partners involved.

Tell us why you are not able to wholly fund the project from your own resources or other forms of private-sector funding.

Tell us what avenues of alternate funding you have explored and the responses.

Tell us your alternate plan should public funding not meet any or all of your request.

3. Finances

Each organisation in your project must complete their own project costs, organisation details and funding details in the application. Academic institutions must complete and upload a Je-S form.

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

Background and further information

The Biomedical Catalyst (BMC) was established in 2012, and identified a market failure in terms of access to funding for early stage UK life sciences companies.

Life Sciences industry is a core pillar of the UK economy and is specifically referenced in the Build Back Better document published by HM Treasury in March 2021. The market failure identified in 2012 is still present.

The Biomedical Catalyst (BMC) has 3 key objectives:

  • deliver growth to the UK life sciences sector
  • deliver innovative life sciences products and services into healthcare more quickly and effectively
  • provide support to academically and commercially led research and development

Find a project partner

If you want help to find a project partner, contact the KTN.

Support for SMEs from Innovate UK EDGE

If you receive an award, you will be contacted about working with an innovation and growth specialist at Innovate UK EDGE. This service forms part of our funded offer to you.

These specialists focus on growing innovative businesses and ensuring that projects contribute to their growth. Working one-to-one, they can help you to identify your best strategy and harness world-class resources to grow and achieve scale.

We encourage you to engage with EDGE, delivered by a knowledgeable and objective specialist near you.

Contact us

If you need more information about how to apply or you want to submit your application in Welsh, email support@innovateuk.ukri.org or call 0300 321 4357. Our phone lines are open from 9am to 11:30am and 2pm to 4:30pm, Monday to Friday (excluding bank holidays).

Innovate UK is committed to making support for applicants accessible to everyone.

We can provide help for applicants who face barriers when making an application. This might be as a result of a disability, neurodiversity or anything else that makes it difficult to use our services. We can also give help and make other reasonable adjustments for you if your application is successful.

If you think you need more support, it is important that you contact our Customer Support Service as early as possible during your application process. You should aim to contact us no later than 10 working days before the competition closing date.

Need help with this service? Contact us