Funding competition Biomedical Catalyst 2018 round 1: early stage award

SMEs can apply for a share of up to £8 million to continue a project's early stage development and technical evaluation, up to readiness for clinical testing.

Competition opens: Monday 26 March 2018
Competition closes: Wednesday 6 June 2018 12:00pm

This competition is now closed.

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Description

The aim of the Biomedical Catalyst is to support the development of innovative healthcare products, technologies and processes. These can include (but are not limited to):

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 is a competition for an early stage award in the Biomedical Catalyst.

We are also running a feasibility award competition. You should make sure that you are applying for the correct competition.

If you submit for the wrong award your application will be immediately rejected and you will not be able to reapply into this round. You can only submit the same application twice to Innovate UK.

We welcome applications from any sector or discipline.

Funding type

Grant

Project size

We expect the total project costs to range in size from £250,000 to £4 million. Projects should last between 12 and 36 months. Successful applicants will be notified of their start date by Innovate UK.

Who can apply

To lead a project you must:

be a UK-based small or medium-sized enterprise (SME)
work on your own or with other UK SMEs or research organisations
carry out your project work in the UK

If your project is academic-led you should apply to the Medical Research Council instead.

If we offer you an award we will contact you soon after to agree the start date.

For all research organisations, the maximum level of project participation is 50% of total eligible project costs. If your consortium contains more than one research organisation, they must share this allocation. Refer to the Innovate UK definition of research organisations.

If you are a business, you can:

take part in up to 3 applications in this competition round, although you may only be the lead partner in one application in this round
lead only one active project in any one Biomedical Catalyst category at any time

There is an exception to the rule on leading only one active project. This is when a new project will be a direct progression from one award to the next category of awards. For example, you may already hold both a primer stage and an early stage award. When the primer stage project finishes, you can apply in this round for an early stage award to continue that specific programme of work while still holding your original early stage award. We will ask you to provide evidence that you have enough resources to run 2 projects at the same time.

Innovate UK has the right to decline or withdraw funding from any project where the company has previously been awarded Innovate UK funding and not fully exploited this.

Resubmissions

If Innovate UK judges that your proposal is not materially different from your previous proposal, it will be classed as a resubmission.

If your application is unsuccessful, you may reapply with the same proposal once more, taking into account the feedback received from the assessors. This can be into another round of this competition or another competition. In other words, you can make a maximum of 2 applications in total with any proposal.

Funding

We have allocated up to £8 million to fund early stage projects in this competition.

You could get funding for your eligible project costs of:

up to 70% if you are a small business
up to 60% if you are a medium-sized business

Find out if your business fits the EU definition of a micro enterprise or an SME.

Your proposal

Biomedical Catalyst has 4 types of funding award to support progression from initial concept through to late stage development:

Feasibility
Primer
Early stage
Late stage

They are designed to help SMEs develop a product or process to provide an innovative solution to a health and care challenge.

The aim of the early stage award is to create a data package that is sufficient to support the subsequent testing of your products or process in a clinical setting or other relevant environment. It 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
early stage prototyping
product development planning
intellectual property protection

We expect projects to start from a point where their technology has been validated in a laboratory or relevant setting and finish at a point where the technology has been demonstrated in a relevant environment (but excluding any human clinical trials).

Support is available for any sector or discipline, including (but not limited to):

stratified healthcare
advanced therapies (gene and cell therapies)
diagnostics
medical technologies and devices

If you choose the innovation area ‘Diagnostics, medical technology and devices’, indicate in the initial project summary whether your project falls within ‘Diagnostics’ or ‘Medical technology and devices’.

Projects we won't fund

Projects including human clinical trials of safety or efficacy.

Projects that are too early stage, for example:

basic research
generation of pure scientific and technological knowledge
development of research ideas, hypotheses and experimental designs without application

Projects that are too close to market or are already at market, for example:

evaluations to inform labelling
laboratory accreditation
distribution or marketing activity
post-marketing studies and post-marketing surveillance
those that include large organisations as partners

26 March 2018: Competition opens
4 April 2018: Briefing event recording.
6 June 2018 12:00pm: Competition closes
7 September 2018: Invitation to interview notification.
1 October 2018: to 2 Oct 2018: interview at Major Awards Committee.
31 October 2018: Notification of outcome of interviews.
2 November 2018 11:03am: Applicants notified

Before you start

Make sure you are applying to the right competition. Would the feasibility award be more appropriate for your stage of development?

Please read the general guidance for applicants. It will help your chances of submitting a quality application.

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. You will need an account to track the progress of your application.

Only the lead organisation can create an application. Contributors or collaborators will need to be invited to participate by the lead organisation.

As the lead applicant you will be 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 to contribute to the application
other organisations to participate in the project as partners if your application is successful

Partner organisations can be other businesses, research organisations, public sector organisations or charities.

What we will ask you

The application is split into 3 sections:

Project details
Application questions
Finances

1. Project details

Explain your project. This section is not scored, but we will use it to decide whether the project fits with the scope of the competition. If it doesn’t, it will be immediately rejected.

Application details

The lead applicant must complete this section. Give your project’s title, start date and length. List any partner organisations you have named as collaborators.

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. It should cover the technical subject matter of work packages planned and the deliverables for this project.

Public description

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

Project 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 give you feedback on why.

2. Application questions

In this section, answers to these questions are scored by the assessors. Following assessment, you will receive feedback from the assessors for each question.

Please ensure that your answer to each question does not exceed 600 words. Do not include any URLs in your answers unless we have explicitly requested a link to a video.

Question 1: What is the healthcare need that this project addresses and what impacts will your solution have? (Minimum expected score: 7)

Describe the healthcare challenge or issue that your project addresses. Give evidence that the healthcare need is real and explain how your project will address it. Define the market that will generate demand for your proposed solution. How will the project outputs and/or the innovation lead to a commercial opportunity for your business?

You should describe or explain the nearest current state-of-the-art technology, including those near market or in development, and its limitations.

How will the outputs of the project meet the healthcare need? Give any input you have from healthcare professionals, patients 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. Our Horizons tool can help with this.

Question 2: What is the underpinning scientific evidence to support your solution? (Minimum expected score: 7)

Detail all relevant experimental and technical evidence linked to the proposed study.

Outline any preclinical or clinical work conducted to date and the outcomes. You may provide an appendix to present relevant figures such as chemical structures, graphs or schematics, with relevant descriptions. This appendix should be a PDF no more than 2 pages long and 1MB in size. This should not be used as an overflow for answers to the application form questions.

Question 3: What is innovative about your idea? (Minimum expected score: 6)

Identify the extent to which the project is innovative, from a commercial, scientific and/or technical perspective. Refer to existing products and practices that are currently in use and those known to be under development both in the UK and internationally. Discuss the benefits and shortcomings of these (both technical and commercial) compared with your solution. This could include the results of competitor analyses, literature surveys and so on.

In evaluating this section assessors will also consider whether:

you have provided evidence that it will push boundaries over and beyond current leading-edge world science and technology
it is looking to apply existing technologies in new areas and, if so, what the challenges are in doing so
it could be innovative in the area of application

The timeliness and novelty of your research and/or proposed innovation should be highlighted and explained in an industrial and/or academic context.

Question 4: What technical approach will be adopted and how will the project be managed? (Minimum expected score: 6)

Please 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 (‘deliverables’). Describe the stages of the project (‘work packages’) and link the main areas of work together with their resource and management requirements.

Identify milestones and go or no-go points.

Note: projects may be approved subject to interim review at key decision points.

The assessors will also consider whether:

the technical and methodological approach is appropriate to the needs of the project
the innovative steps are achievable through your proposed approach
the project plan is sufficient in comparison to the complexity of the project. For example, have you provided enough detail to allow assessors to understand the tasks involved and the resources required?
any study design is robust
the timing of the main milestones is realistic
you have committed enough resource commitment and the ability to undertake the project
clear management reporting lines have been identified

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

Please provide justification for the use of animals or human subjects and the numbers of animals, samples and so on tested.

You can submit one appendix with a detailed Gantt chart and information on your study design, protocol and approach, such as experimental detail. This should be a PDF no more than 2 pages long and 1MB in size.

Question 5: Do you have freedom to operate? (Minimum expected score: 6)

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 without infringing other patents by summarising the results of patent searches and so on.

Detail the intellectual property that you expect to be generated as a result of your project.

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 6: How do you intend to exploit the opportunity? (Minimum expected score: 6)

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
reconfiguration of the value system
changes to business models and business processes
other methods of exploitation and protection

Provide evidence that the proposed solution would be commercially viable for the target market (consider cost of manufacturing at launch and at scale, pricing and so on). You should describe the size of the market opportunities that this project would create, including details of:

the current nature of the targeted markets, such as whether they are characterised by price competition among commoditised suppliers or dominated by a single leading firm, and what the channels to market are
the dynamics of this market, including measuring its current size then actual and predicted growth rates
the projected market share for the project outcome, taking into account possible restrictions on market access and entry, including any potential competitors
what the biggest obstacles will be to the exploitation and commercialisation of your innovation
what impact the project outputs will have on the business’s and non-academic partners’ forecasts for annual turnover, profit, exports and R&D spend (as a percentage of turnover if appropriate) and employment (in FTEs) for 1, 3 and more than 5 years after project completion

Question 7: What are the technical, commercial and environmental risks to project success? What is the project’s risk management strategy? (Minimum expected score: 6)

Innovate UK recognises that projects of this type are risky, but we ask that the project has adequate arrangements for managing this risk. Please focus on:

identifying the main risks and uncertainties of the project and providing a detailed risk analysis for the project content and approach. Include the technical (including regulatory), commercial, managerial (such as managing stakeholders) and environmental risks, as well as other uncertainties, such as ethical issues, associated with the project
developing a risk register, identifying the main risks as high, medium or low (H, M or L)
discussing the potential impact of these scenarios

State 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.

Question 8: Does the team have the right skills, experience and access to facilities to deliver the project and exploit it? (Minimum expected score: 6)

Please detail the expertise and track record of the project participants, including collaborators and subcontractors, to show your ability to deliver the project and exploit the output.

In evaluating this, the assessors will also consider whether:

the project builds the UK supply chain and addresses end-user needs
for collaborations: the consortium’s formation objectives are clear, extra benefit such as increased knowledge transfer is gained from the collaboration, and the consortium is greater than the sum of its parts
the work is being conducted internally where possible and, if subcontractors are being used, there is adequate justification for the choice made
the project has access to the appropriate facilities

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

You can upload a risk register as an appendix in PDF format no larger than 1MB and up to 2 pages long.

Question 9: What are the resources required to deliver the project and their cost? (Minimum expected score 6)

Indicate the anticipated project cost, making clear the level of contribution from any project participants and the level of funding required.

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

Please use this section to detail the resources needed to carry out the project, including materials, capital equipment, infrastructure and people. Fully break down the costs and justify them, for example by giving quotations to prove value for money. This should include all internal and external costs.

Costs must be consistent with the category of R&D being undertaken. Please see our funding rules guidance for more information on the rules for the various categories.

In evaluating the costs, assessors will consider whether:

the budget breakdown is realistic and justified for the scale and complexity of the project
it is clear how costs are being allocated
the financial support required fits within the limits set by the specific competition
the funding request provides value for public money
a financial commitment from other sources is demonstrated for the balance of the project costs
funding will be available to cover cash flow pending quarterly reimbursement of costs from Innovate UK

Read detailed guidance on eligible and ineligible project costs in our project costs guidance.

Note that where individuals have roles in 2 or more participating collaborative organisations, costs will be closely scrutinised.

Question 10: How does financial support from Innovate UK and its funding collaborators add value? (Minimum expected score: 6)

Could this project go ahead in any form without public funding? What difference would public funding make, such as a faster route to market, more partners or reduced risk? Describe the likely impact of the project on the 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. In other words, what would happen if the application is unsuccessful?

Explain how failure to secure public funding for this project would change the nature of the R&D activity the collaborating partners would undertake, and the related spend profile.

3. Finances

The finances section asks each organisation in your project to complete their own project costs, organisational details and funding details. Academics will need to complete and upload a Je-S form. For full details on what costs you can claim please see our project costs guidance.

Background and further information

The Biomedical Catalyst is a unique partnership between Innovate UK and the Medical Research Council. It provides responsive and effective support to the most innovative life sciences opportunities, regardless of scientific approach.

The Catalyst evolved from the 2011 Life Sciences Industrial Strategy. It aims to de-risk innovative scientific ideas coming out of academia and industry. In this way it helps UK SMEs to develop into competitive and sustainable organisations which:

speeds up the progress of novel products to market
supports onward investment
bridges ‘the valley of death’, which is the stage of development of an innovation where it is difficult to get private sector funding

An independent evaluation in 2015 confirmed that the Biomedical Catalyst is already achieving its goals of:

providing support to both academically and commercially led research and development in a seamless, effective and efficient way. For example, at least 40% of supported companies have originated in UK academia and many others have in-licensed academic intellectual property
encouraging UK economic growth and leveraging investment into the healthcare and life sciences sectors. For example, supported projects leveraged over £120 million of private funding against grant funding over the first 8 competition rounds
delivering innovative life sciences products and services more quickly and effectively into healthcare. For example, the Biomedical Catalyst has supported more than 60 first-in-human studies

In autumn 2016, the government allocated £100 million to continue funding the Catalyst for a further 4 years.

Innovate UK, the Medical Research Council and Scottish Enterprise fund Biomedical Catalyst awards.

If you want help to find a project partner, contact the Knowledge Transfer Network.

If you need more information, contact the competition helpline on 0300 321 4357 or email us at support@innovateuk.gov.uk.

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