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Funding competition Biomedical Catalyst round 4: late stage award

Small or medium-sized UK companies can apply for a share of up to £8 million to work on solving healthcare challenges in a clinical setting or a relevant late stage environment.

This competition is now closed.

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Summary

Description

This is a competition for a late stage award in the Biomedical Catalyst.

The aim of the Biomedical Catalyst is to support the development of innovative healthcare products, technologies and processes. These can include:

  • 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 Biomedical Catalyst has 4 types of funding award. These are: feasibility, primer, early stage and late stage. They are designed to help SMEs developing a product or process to provide an innovative solution to a health and care challenge. The scheme supports progression from initial concept through to late stage development.

In Biomedical Catalyst round 4 we have 2 competitions, one focusing on the primer stage award and this one, which is focused on the late stage award. You must submit your project to the competition for the correct award. 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.

You should have prior credible research on your proposal, including a demonstration of validation in a relevant model system. We welcome applications from any sector or discipline.

Funding type

Grant

Project size

We expect projects to range in size from £200,000 to £4 million (total project costs). Projects should last 12 to 36 months.

Eligibility

Find out whether you are eligible to apply

To lead a project you must:

  • be a UK-based 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 Resarch Council instead.

If we offer you an award we will contact you soon after that 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 award at any time

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

If you applied to a previous competition as the lead or sole company and were awarded funding by Innovate UK, but did not make a substantial effort to exploit that award, we will award no more funding to you, in this or any other competition. We will:

  • assess your efforts in the previous competition against your exploitation plan for that project
  • review the monitoring officers’ reports and any other relevant sources for evidence
  • document our decision, which will be made by 3 team members
  • communicate our decision to you in writing

You will not be able to contest our decision.

Resubmissions

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

If an application is unsuccessful you may use the feedback received to reapply for the same project once more. In other words you may only apply twice with one proposal. This can be into another round of this competition or another competition.

Projects that we won’t fund

In this competition we won’t fund projects that:

  • we think are too early stage, for example basic research, generation of pure scientific and technological knowledge, or the development of research ideas, hypotheses and experimental designs that have no practical commercial application
  • are not supported by sufficiently validated prior research on your technology, product prototype or process, including demonstration in an appropriate model system
  • are too close to market or are already at market, such as evaluations to inform labelling, laboratory accreditation, distribution or marketing activity, post-marketing studies, or post-marketing surveillance
  • include large organisations as partners

Funding and project details

Your project is expected to focus on industrial research. For this you could get:

  • up to 70% of your eligible project costs if you are a small business
  • up to 60% if you are a medium-sized business

For any work packages considered to be experimental development projects (nearer to market), you could get:

  • up to 45% of your eligible project costs if you are a small business
  • up to 35% if you are a medium-sized business

Find out if your business fits the EU definition of an SME.

Scope

Competition scope

This is a competition for a late stage award. The aim of this award is to support projects which test a well-developed concept and show its effectiveness in an environment that is relevant to the use of the product or process. A late stage project can include:

  • initial human proof-of-concept studies
  • demonstration of clinical utility and effectiveness
  • demonstration of safety and efficacy (including phase I and II clinical trials)
  • developing production mechanisms
  • prototyping
  • market testing
  • intellectual property protection

These solutions should be innovative healthcare technologies, products or processes that will help provide at least one of the following:

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

We will support projects from any sector or discipline, including (but not limited to):

  • advanced therapies (cell and gene therapy)
  • precision medicine (both therapy and diagnostic components)
  • diagnostics
  • digital health
  • medical technologies and devices

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

The work required will depend on the maturity and intended application of the technology you are developing in your project. Your late stage project must build on prior credible research on your technology, product prototype or process. This prior research should include a demonstration or validation in an appropriate model system.

Dates

27 November 2017
Competition opens
28 November 2017
Weblink to the briefing recording.
7 February 2018 12:00pm
Competition closes
11 May 2018
Applicants invited to interview.
5 June 2018
Major awards committee.
6 June 2018
Major awards committee.
21 June 2018 11:38am
Applicants notified

How to apply

Before you start

Make sure you are applying to the right competition. Would the primer 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:

  1. Project details
  2. Application questions
  3. Finances

Interviews

Following the written stage, successful applicants will be invited to give a presentation and interview to the major awards committee.

If you are invited to give a presentation, we will provide you with written feedback on your application and guidance to help you prepare. The guidance will describe the process and give you specific areas to prepare answers for.

Before the interview you will have the opportunity to provide a 3 page document with your response to the feedback.

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 your project is successful and awarded 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 and/or it falls within the description of projects that we won’t fund, it will be immediately rejected and will not be sent for assessment. We will give you feedback if we decide that your project is not in scope.

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.

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 this. 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?

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.

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

Detail all relevant prior experimental or technical evidence which can explain how the previous results link 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 are the challenges 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/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. Are the innovative steps 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. Is the timing of key milestones realistic?
  • you have committed enough resource and have the capability 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 may 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 4 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 (for example by summarising the results of patent searches).

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 specific markets at which the project is targeted (for example is it characterised by price competition amongst commoditised suppliers? Is it dominated by a single leading firm? What are the channels to market?)
  • 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 account of possible restrictions on market access and penetration, 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 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 5+ years after project completion?
Question 7: what are the risks (technical, commercial and environmental) 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 provide 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/low (H/M/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 and 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 capability 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: are the consortium’s formation objectives clear? Is extra benefit gained from the collaboration, for example, increased knowledge transfer? Is the consortium is greater than the sum of its parts?
  • the work is being conducted internally where possible and, if subcontractors are being used, whether 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 strong justification to support your choice of non-UK contractor.

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 required to carry out the project (materials, capital equipment, infrastructure, people). Fully break down the costs and justify them (for example 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 the following questions:

  • is the budget breakdown realistic and justified for the scale and complexity of the project?
  • is it clear how costs are being allocated?
  • does the financial support required fit within the limits set by the specific competition?
  • does the funding request provide value for public money?
  • is a financial commitment from other sources demonstrated for the balance of the project costs?
  • will funding 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: where individuals have roles in 2 or more participating collaborative organisations, cost 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, 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 (what would happen if the application is unsuccessful).

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

3. Finances

The finances section asks each organisation to complete project costs, organisational details and funding details for each organisation in your project. 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.

Supporting information

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’; the stage of development of an innovation where it is difficult to get private sector funding

An independent evaluation in 2015 has 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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