Funding competition Biomedical Catalyst 2022 Round 1: Industry-led R&D

UK registered SMEs can apply for a share of up to £15 million to develop innovative solutions to health and healthcare challenges. This funding is from Innovate UK.

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Competition sections

Description

Innovate UK, part of UK Research and Innovation will invest up to £15 million in projects to support UK registered businesses to develop innovative health or healthcare-focussed products, technologies and processes.

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
  • the development of digital health technologies

This list is not intended to be exhaustive.

The Industry-led research and development (R&D) stream of the Biomedical Catalyst programme supports pre-market R&D projects. Applicants must be able to demonstrate existing evidence of commercial and technical feasibility.

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 costs must be between £150,000 and £4 million. The total grant cannot exceed £2 million.

Who can apply

Your project

Your project must:

  • have total project costs between £150,000 and £4 million
  • not exceed a grant request of £2 million
  • have at least 50% of the total project costs shared by the SMEs, if collaborative
  • start by 1 December 2022
  • end by 30 November 2025
  • last between 6 months and 36 months
  • carry out all of its project work in the UK
  • intend to exploit the results from or in the UK

You must only include eligible project costs in your application. If you have requested an overall grant of over £500,000, and your online application is successful at Stage 1, you may be invited to attend an interview

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

Lead organisation

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


Project team

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

  1. business of any size
  2. academic institution
  3. charity
  4. not for profit
  5. public sector organisation
  6. research and technology organisation (RTO)

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.

Partners must accept terms and conditions (T&C’s) and complete the subsidy question in order for the application to be submitted.

For collaborations, the lead and at least one other organisation must claim funding by entering their costs during the application.

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

You must provide justification by email to support@iuk.ukri.org at least 10 working days before the competition closes. Innovate UK will decide whether to approve your request via email.The application assessors will also be asked to judge whether you have sufficiently made a case for the use of overseas subcontractors.


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, a large business, academic institution, charity, not for profit, 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 non 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 at all times make sure 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.

Eligibility overview

Here is a diagram showing a summary of eligibility.

This is a new way of showing you eligibility. Your feedback will help us to improve it.

Funding

Up to £15 million has been allocated to fund innovation projects in this competition. Funding will be in the form of a grant. You must not claim more than £2 million in grant against your total project costs. A minimum of 50% of your total eligible project costs must be incurred by SME(s).

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 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
  • up to 50% if you are a large organisation

For experimental development projects which are nearer to market, you could get funding for your eligible project costs of:

  • up to 45% if you are a micro or small organisation
  • up to 35% if you are a medium sized organisation
  • up to 25% if you are a large 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 project costs if you are an RTO, charity, not-for-profit organisation, public sector organisation or research organisation

Your proposal

The aim of this industry-led R&D competition is to support the development of innovative solutions to health and healthcare challenges.

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.

Your project can include:

  • experimental evaluation (at laboratory scale)
  • use of in vitro and in vivo models to evaluate proof of concept or safety
  • exploring potential production mechanisms
  • prototyping
  • product development planning
  • intellectual property protection
  • a demonstration of clinical utility and effectiveness
  • a demonstration of safety and efficacy (including phase 1 and 2 clinical trials)
  • regulatory planning


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

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.

Specific themes

Your project can focus on any health or healthcare sector or discipline.

The Biomedical Catalyst now incorporates the Digital Health Technology Catalyst and will support digital health projects.

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

  • biosciences
  • advanced therapies (gene and cell therapies)
  • diagnostic, medical technology and devices
  • digital health
  • independent living and wellbeing
  • precision medicine
  • preclinical technologies and drug target discovery
  • therapeutic and medicine development

This list is not intended to be exhaustive.

Research categories

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

Projects we will not fund

We are not funding projects that:

  • are fundamental research or feasibility projects
  • are not related to human life sciences
  • focus on a product that is already on the market
  • focus on laboratory accreditation
  • are conducted to anything less than the highest standards of animal welfare
  • are 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
  • are 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
28 March 2022
Competition opens
5 April 2022
Online briefing event: watch the recording
25 May 2022 11:00am
Competition closes
26 July 2022
Invite to interview
15 August 2022
Interviews start
19 August 2022
Interviews stop
2 September 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.

Interviews

If you have requested an overall grant of over £500,000, and your online application is successful at stage 1, you may be invited to attend an interview with the major investment panel (MIP), where you must give a presentation. Your interview will take place online. The date and time of your interview will be included in your invitation.

The MIP will score each project in line with scoring matrices. They will recommend a ranked list of applications for Innovate UK and its affinity partners to fund. Funding decisions are solely made based on the recommendations of the MIP and not on the scores from the original written assessment.

We aim to build a portfolio that is consistent with the spend profile of available funding. Innovate UK reserves the right to maximise the funding available across high-quality projects. This means that the portfolio of projects funded may not follow a strict ranked sequence of the assessors’ scores, but they will all meet or exceed the agreed quality line throughout our independent external assessment process.

Before the interview and by the deadline stated in the invitation email, you:

  • must send a list of who will attend the interview
  • must send your interview presentation slides
  • can send a written response to the assessors’ feedback

List of attendees

Agree the list with your consortium. Up to 3 people from your project can attend, ideally one person from each organisation. They must all be available on all published interview dates. We are unable to reschedule slots once allocated.

Presentation slides

Your interview presentation must:

  • use Microsoft PowerPoint
  • be no longer than 10 minutes
  • have no more than 10 slides
  • not include any video or embedded web links

You cannot change the presentation after you submit it or bring any additional materials to the interview.

Written response to assessor feedback

This is optional and is an opportunity to answer the assessors’ concerns. It can:

  • be up to 10 A4 pages in a single PDF or Word document
  • include charts or diagrams

Interview

After your presentation the panel will spend 20 minutes asking questions. You will be expected to answer based on the information you provided in your application form, presentation and the response to feedback.

After your interview

The panellists will individually score your performance at your interview. The scores will be averaged and will supercede the one you received from initial assessment. We will notify you of the outcome by email and you will receive feedback on your interview within a week of notification.

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?

You and all your project partners must respond and mark this question as complete, before you can submit your application.

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 the right 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 be immediately rejected and will not be sent for assessment. We will tell you the reason why.

Your answer can be up to 400 words long.

2. Application questions

The assessors will score all your answers apart from question 1 and 2. You will receive feedback for each scored question.

You must answer all questions. Your answer to each question can be up to 600 words long. Do not include any website addresses (URLs) in your answers.

Question 1. Applicant location (not scored)

You must state the name and full registered address of your organisation and any partners working on the project. We are collecting this information to understand the geographical location of all applicants.

Question 2. Project category (not scored)

Digital Health Technology Catalyst has been integrated into the Biomedical Catalyst. Is your project a digital health project?

Select:

  • Yes
  • No

Question 3. Health or Healthcare Need or Challenge

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

You must:

  • describe the health or healthcare challenge this project addresses and the impacts your solution will have
  • provide evidence that the health or healthcare challenge is real and define the market that will generate demand for your proposed solution
  • outline any socio-economic benefits of your solution
  • provide any input you have received from healthcare professionals, patients, potential partners or representatives of the onward supply chain

If your project addresses a specific health or healthcare need, how does your solution compare to the current gold standard?

Question 4. Scientific evidence

What is the underpinning scientific evidence to support your solution?

Detail all relevant prior experimental or technical evidence and explain how this links to the proposed study. Include any preclinical or clinical work conducted to date and the outcomes.

You must 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 and no larger than 10mb in size. The font must be legible at 100% zoom.

Question 5. Innovation

What is innovative about your idea from a commercial, scientific and technical perspective?

You can for example:

  • refer to existing products, current gold standards and practices that are currently in use, and how your innovation compares
  • comment on how this innovation will fit into the current standard of care
  • explain both the technical and commercial benefits and shortcomings of your approach
  • outline the target product profile for your innovation in terms of safety and performance characteristics

This could include the results of competitor analyses and literature surveys. This list is not exhaustive.

Question 6. Technical approach

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

Please provide an overview of the technical approach including the main objectives of the work with enough detail for the assessors to understand tasks involved and resources required.

You must describe:

  • the current status of your innovation and where you expect to be at the end of the project
  • the stages of the project (the work packages) and link the main areas of work together with their resource and management requirements
  • key milestones and any stage gates
  • how the method and technical approach is appropriate to the needs of the project and the timescale
  • how any study design is robust and that key milestone timings are realistic
  • your resources and capability to undertake the project
  • clear management reporting lines

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

You must 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 and no larger than 10mb in size. The font must be legible at 100% zoom.

Question 7. Freedom to operate

Do you have freedom to operate?

Describe:

  • any existing intellectual property (IP) which may affect, or which is relevant to, project delivery and exploitation
  • the current state of IP ownership and, where necessary, how rights have been assigned
  • if completed, who conducted any FTO analysis
  • 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
  • any IP that you expect to be generated as a result of your project, and who will own it

You must provide evidence that you have freedom to operate and that you can work without infringing other patents, for example by summarising the results of patent searches.

Question 8. Exploit the opportunity

Describe the size of the market you have identified and how you intend to exploit it.

Explain:

  • the dynamics of this market including its current size, actual and predicted growth rates and provide 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 long-term potential economic benefits to the UK in terms of increasing revenue, profitability, job creation
  • the regulatory requirements for the innovation you are developing and the strategies to demonstrate conformity
  • how the outputs of your project take you nearer to your organisation’s objectives, and what will the steps be to achieve this

Describe where applicable:

  • your route to market, channel, geographies
  • who will benefit and how
  • any 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. Consider cost of manufacturing at launch and at scale.

These examples are not exhaustive.

You must submit an exploitation plan to support your answer. It must be a single PDF and can be up to 4 A4 pages long and no larger than 10mb in size. The font must be legible at 100% zoom.

Question 9. Technical, commercial and environmental risks

Innovate UK recognises that projects of this type are risky, we expect that your project has adequate arrangements for managing these risks. What are the technical, commercial and environmental risks to project success?

Explain:

  • your project’s risk management strategy
  • the main risks and uncertainties of the project and provide a detailed risk analysis for the project content and approach
  • the technical (including regulatory), commercial, managerial and environmental risks as well as other uncertainties, such as ethical issues associated with the project
  • the potential impact of these risks, stating how the project would mitigate them
  • the project management tools and mechanisms that will be used to minimise operational risk

You must submit a risk register as an appendix using an international standard such as ISO 14971 where possible to support your answer. It must be a PDF and can be up to 2 A4 pages long and up to 10mb in size. The font must be legible at 100% zoom.

Question 10. Skills and experience

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

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

Demonstrate:

  • how the project supports or builds on the existing UK supply chain and addresses end user needs
  • how the work is being conducted internally where possible and, if subcontractors are being used, there is adequate justification for the choice made
  • how the project has access to the appropriate facilities, resources, tools, equipment and human capability

All subcontractor costs must be justified and appropriate to the total project costs. Extenuating circumstances where overseas work may be allowable include, but are not limited to; clinical trials in a specific patient population.

You must provide justification by email to support@iuk.ukri.org at least 10 working days before the competition closes. Innovate UK will decide whether to approve your request via email. The application assessors will also be asked to judge whether you have sufficiently made a case for the use of overseas subcontractors.

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

Question 11. Resources required

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

You must:

  • provide justification of the breakdown of your costs, for example any quotations you have received
  • include all internal and external costs for your project. Costs must be consistent with the category of R&D being undertaken
  • describe how funding will be available to cover cash flow pending quarterly reimbursement of costs from Innovate UK
  • explain your eligible project costs, from each of the project partners and the level of funding required
  • explain the resources required to carry out your project including materials, capital equipment and people

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

Question 12. Financial support and added value

How does financial support from Innovate UK and its funding collaborators add value to your project?

Explain:

  • what advantages would public funding offer your project, for example; appeal to investors, more partners, reduced risk or a faster route to market (this list is not exhaustive)
  • the likely impact of the project outcomes on the organisations involved
  • what your project would look like without public funding
  • why you are not able to wholly fund the project from your own resources or other forms of private-sector funding
  • the avenues of alternate funding you have explored and the responses
  • how failure to secure public funding for your project would affect the R&D activity undertaken by the project partners (and related spend profile)
  • your 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.

Further information can be found in the Biomedical Catalyst guidance.

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 R&D

Data sharing

With your permission, your submitted application, and any other information you provide at the application stage can be submitted to each agency on an individual basis for its storage, processing and use. Any relevant information produced during the application process concerning your application can be shared by one agency with the other, for its individual storage, processing and use.

This means that any information given to or generated by Innovate UK in respect of your application may be passed on to our partner organisations, the Innovate UK KTN, Innovate UK EDGE and the Catapult network and vice versa.

Innovate UK is directly accountable to you for its holding and processing of your information, including any personal data and confidential information. It is held in accordance with its Information Management Policy.

Innovate UK and our partner organisations are directly accountable to you for their holding and processing of your information, including any personal data and confidential.

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.

Find a project partner

If you want help to find a project partner, contact the Innovate UK 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 Innovate UK 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@iuk.ukri.org or call 0300 321 4357. Our phone lines are open from 9am to 5pm, 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