BIOMEDICAL CATALYST 2021: EARLY AND LATE STAGE AWARDS- FUNDING

1. Title: BIOMEDICAL CATALYST 2021: EARLY AND LATE STAGE AWARDS- FUNDING2. Awarding Authority: Innovate UK, GB Tel: 0300 321 4357. Email: support@innovateuk.ukri.org.3. Contract type: Service contract4. Description: UK registered organisations can apply for a share of up to £18 million to develop innovative healthcare products, technologies, and processes.UK registered businesses can apply for a share of up to £18 million to develop innovative healthcare products, technologies and processes. This funding is from Innovate UK, part of UK Research and Innovation.Your project can address:disease prevention and proactive management of health and chronic conditionsearlier and better detection and diagnosis of disease, leading to better patient outcomestailored treatments that either change the underlying disease or offer potential curesThis list is not intended to be exhaustive.This competition combines the early and late-stage strands of the Biomedical Catalyst.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.In applying to this competition, you are entering into a competitive process This competition closes at 11am UK time on the date of the deadline.5. CPV Code(s): 73110000, 73210000, 731000006. NUTS code(s): UKK, UKK1, UKK147. Main site or location of works, main place of delivery or main place of performance: South West (England), Gloucestershire, Wiltshire And Bristol/Bath Area, Swindon.8. Reference attributed by awarding authority: Not provided.9. Estimated value of requirement: Project size: Your project’s total eligible costs must be between £250,000 and £4 million.FundingWe have allocated up to £18 million to fund innovation projects in this competition.If your organisation’s work on the project is mostly 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 organisationup to 60% if you are a medium-sized organisationFor 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 organisationup to 35% if you are a medium-sized organisationThe 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.10. Competition closes: 26.8.2021 (11:00:00).11. Address to which they must be sent: For further information regarding the above contract notice please visit: 12. Other information: Funding type GrantWho can applyYour projectYour project must:have total eligible costs between £250,000 and £4 millionstart from 1 April 2022last between 12 months and 36 monthsIf your project’s 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.Lead organisationTo lead a project or work alone your organisation must:be a UK registered micro, small or medium-sized enterprise (SME)carry out its project work in the UKintend to exploit the results from or in the UKFor 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.Academic institutions or research organisations cannot lead or work alone.Project teamTo collaborate with the lead, your organisation must:be a UK registered business of any size, academic institution, charity, not-for-profit, public sector organisation, or research technology organisation (RTO)carry out your project work in the UKintend to exploit the results from or in the UKbe invited by the lead organisationLarge companies can be collaborators but will not be able to claim grant funding.Each partner organisation must be invited into the Innovation Funding Service by the lead to collaborate on a project. Partners must enter their own project costs.If your project requires work to be undertaken overseas, you must provide justification by email to support@innovateuk.ukri.org at least 10 working days before the competition closes.Extenuating circumstances where overseas work may be allowable include, for example:clinical trial in a specific patient populationaccess to skills or expertise not in UKThis list is not intended to be exhaustive. We will decide whether to approve your request.Partners with no fundingYour project can include partners that do not receive any of this competition’s funding, for example non-UK businesses or large businesses. Their costs will count towards the total eligible project costs.SubcontractorsSubcontractors 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 question 9 for 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.Multiple applicationsWhen a business leads on an application it can collaborate in a further 2 applications.If a business is not leading any applications, it can collaborate in up to 3 applications.Research organisations, academic institutions, charities, not-for-profit and public sector organisations can collaborate on any number of applications.Previous applicationsYou can use a previously submitted application to apply for this competition.We will not award you funding if you have:failed to exploit a previously funded projectan overdue independent accountant’s reportfailed to comply with grant terms and conditionsSubsidy 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.European Commission State aidYou must apply under European Commission State aid rules if you are an applicant who is conducting activities that will affect trade of goods and electricity between Northern Ireland and the EU as envisaged by Article 10 of the Protocol on Ireland/Northern Ireland in the EU Withdrawal Agreement.In certain limited circumstances, the European Commission State aid rules may also apply if you are an organisation located in England, Wales, or Scotland and conduct activities that affect the trade of goods and electricity between Northern Ireland and the EU. For further information, please see section 7 of the BEIS technical guidance.For further information see our general guidance on state aid and BEIS guidance on the Northern Ireland Protocol.For applicants subject to the European Commission State aid rules, applicants will be required to prove that they were not an “Undertaking in Difficulty” on the date of 31 December 2019 but became a UID between 1 January 2020 and 30 June 2021. We will ask for evidence of this.Further InformationIf you are unsure about your obligations under the UK Subsidy Control regime or the State aid rules, please take independent legal advice.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.Your proposalThe aim of this early and late-stage competition is to enable businesses to create a data package that can support the further development of their products.The project can include:experimental evaluation (at laboratory scale)use of in vitro and in vivo models to evaluate proof of concept or safetyexploring potential production mechanismsprototypingproduct development planningintellectual property protectiondemonstrating of clinical utility and effectivenessdemonstrating of safety and efficacy (including phase 1 and 2 clinical trials)regulatory planningYour 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 early and late-stage strands of the Biomedical Catalyst.Early-stageThe aim of an early-stage award is to create a data package that is sufficient to support the testing of your product or process in a clinical setting or other relevant environment.Late-stageThe late-stage award is designed to test a well-developed concept and show its effectiveness in a clinical setting or other relevant environment.Your project must build on prior credible research on a product prototype or process. This is likely to have included a demonstration or validation in an appropriate model systemHow your proposal will be assessedThis competition has 2 stages.Stage 1: assessed written application.Stage 2: interview with our Major Awards Committee (MAC).We want to fund a portfolio of projects, to ensure that opportunities are provided to companies across the whole spectrum of life sciences. The MAC 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. They will provide short written feedback to all applicants who attend the interview panel.Specific themesYour project can focus on any health and care sector or discipline. We particularly welcome applications that support innovation in the following areas:child health technologiesinnovations that support clinical trials in the UKbiomedical innovations that combat the threat of antimicrobial resistanceYour project can align with one or more of the following:medical technologies and devicesstratified healthcareadvanced therapies (gene and cell therapies)digital healthdrug discoverydiagnosticsThis list is not intended to be exhaustive.Research categoriesWe will fund industrial research projects and experimental development projects, as defined in the guidance on categories of research.Projects we will not fundWe will not fund projects as part of this competition that are:in scope for the Biomedical Catalyst feasibility or primer awards.not related to human life sciencesalready on the marketlaboratory accreditationdistribution or marketing activity, post-marketing studies and post-marketing surveillancedependent on export performance – for example giving a subsidy to a baker on the condition that they export a certain quantity of bread to another country.dependent on domestic inputs usage- for example if they insisted that a baker use 50% UK flour in their productWe will not support innovation projects conducted to anything less than the highest standards of animal welfare.Dates7 June 2021: Competition opens15 June 2021: Online briefing event: join at 10:3026 August 2021 11:00am : Competition closes2 October 2021: Invite to interview19 October 2021: Interview panel week commencing30 October 2021: Applicants notifiedBefore you startYou must read the guidance on applying for a competition on the Innovation Funding Service before you start.What we ask youThe application is split into 3 sections:Project details.Application questions.Finances.InterviewsThe purpose of stage 1 is to identify applications that will pitch their project to the Major Awards Committee (MAC).If your online application is successful at stage 1, you will be invited to attend an interview with the major awards committee (MAC), where you must give a presentation. Your interview will take place either online or at a designated location.The major awards committee 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. They will provide short written feedback to all applicants who attend the interview panel.Funding decisions are solely made based on the recommendations of the MAC.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, by the deadline stated in the invitation email, you:must send a list of who will attend the interviewmust send your interview presentation slidescan send a written response to the assessors’ feedbackList of attendeesAgree 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 slidesYour interview presentation must:use Microsoft PowerPointbe no longer than 20 minutesnot include any video or embedded web linksYou cannot change the presentation after you submit it or bring any additional materials to the interview.InterviewAfter your presentation the panel will spend 30 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.1. Project detailsThis section provides background for the assessors and is not scored.Application teamDecide which organisations will work with you on the project. Invite people from those organisations to help complete the application.Application detailsThe lead applicant must complete this section. Give your project’s title, start date and duration.Subsidy BasisIs your company based in Northern Ireland and are you planning to undertake any work for which you are seeking Innovate UK funding in Northern Ireland?Research categorySelect the type of research you will undertake.Equality, diversity and inclusionWe 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.You must complete this EDI survey and 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 summaryDescribe 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 descriptionDescribe your project in detail, and in a way that you are happy to see published for the public. Do not include any commercially sensitive information or jargon. 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.ScopeDescribe 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.Your answer can be up to 400 words long.Application questionsThe Innovate UK assessors will score your answers for questions 2 to 11, question 1 is not scored. You will receive feedback from them for each scored question.Your answer to each question can be up to 600 words long. Do not include any website links (URLs) in your answers unless we have explicitly requested a link to a video.Question 1. Project partners location (not scored)Please state the name of each organisation along with its full registered address. If you are working with an academic institution this doesn’t need to be included.Question 2. Healthcare need and impact (Minimum expected score: 7/10)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 (Minimum expected score: 7/10)What is the underpinning scientific evidence to support your solution?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 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 (Minimum expected score: 6/10)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.Consider outlining the target product profile for your innovation in terms of safety & performance characteristics.Discuss 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 (Minimum expected score: 6/10)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.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.The assessors will also consider whether:the method and technical approach is appropriate to the needs of the project, the innovative steps achievable, in the timescalethere is enough detail in your project plan for the assessors to understand tasks involved and resources requiredany study design is robust, are the key milestone timings realisticyou have committed enough resource and have the capability to undertake the projectclear management reporting lines have been identifiedIf 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 can 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 (Minimum expected score: 6/10)Do you have 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 (Minimum expected score: 6/10)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, geographiesreconfiguration of the value system, such as who will benefit or paychanges to business models and business processes for the payor, provider or patientProvide 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.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 targetedthe dynamics of this market including measuring its current size then actual and predicted growth rates, providing references to sourcesthe 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 competitorsthe longer term potential economic benefits to the UK in terms of increasing revenue, profitability, job creationOutline the regulatory pathway(s) for the innovation you are developing and how this project fits into your regulatory strategy.For example:define what regulatory requirements apply to your innovationoutline the evidence requirements & strategy to demonstrate conformityYou can submit 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 8. Technical, commercial, and environmental risks (Minimum expected score: 6/10)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:identifying the main risks and uncertainties of the project and provide a detailed risk analysis for the project content and approachincluding 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 projectcreating a 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 possiblediscussing the potential impact of these scenarios, stating how the project would mitigate all significant and relevant risksIdentify 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 (Minimum expected score: 6/10)Does the 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 participants, including collaborators and subcontractors, to show your capability to deliver the project and exploit the output. Explain whether you have worked with them before and on what basis.In evaluating this, the assessors will also consider whether:the project builds the UK supply chain and addresses end-user needsif collaborative, are the consortium’s formation objectives clear, is extra benefit gained from the collaboration, for example, increased knowledge transfer, and is the consortium greater than the sum of its partsthe work is being conducted internally where possible and, if subcontractors are being used, there is adequate justification for the choice madethe project has access to the appropriate facilities, resources, tools, equipment and human capability.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 10. Resources required (Minimum expected score 6/10)What are the resources required to deliver the project and how much will they cost?Indicate the anticipated eligible project costs, making clear the level of contribution from any project partners and the level of funding required.This information should complement the financial summary table in the application form.Detail the resources required to carry out the project (e.g. materials, capital equipment and 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.In evaluating the costs, assessors will consider:robustness and justification of budget breakdown for the scale and complexity of the projectclarity of cost allocationwhether financial support required is within the limits set by the competitionvalue for public moneyfinancial commitments to the project from non-grant claiming partnerswhether funding will be available to cover cash flow pending quarterly reimbursement of costs from Innovate UKQuestion 11. Financial support and added value (Minimum expected score: 6/10)How does financial support from Innovate UK and its funding collaborators add value?What difference would public funding make? 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.Explain how failure to secure public funding for this project would affect which R&D activity the collaborating partners would undertake (and related spend profile). Tell us your alternate plan should public funding not meet any or all of your request.FinancesEach 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 informationThe 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 sectordeliver innovative life sciences products and services into healthcare more quickly and effectivelyprovide support to academically and commercially led research and developmentContact usIf you need more information about how to apply 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.Finding a project partnerIf you want help to find a project partner, contact the Knowledge Transfer Network.Support for SMEs from Innovate UK EDGEIf you receive an award, you will be contacted about working with an innovation and growth specialist at InnovateUK 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.TKR-2021518-EX-1614839# funding opportunity