HEALTH INNOVATION CHALLENGE FUND

Preliminary ApplicationGuidance

1Introduction

1.1Purpose

1.2Essential Requirements

1.3Eligibility

2Funding Conditions

2.1Project duration and amount

2.2Project Financials

3Application Process

3.1Preliminary applications

3.2Shortlisting

3.3Full applications and interviews

3.4Post-award process

4Assessment Criteria

5Important Information

6Programme Management

7Call Timetable

8Submission Process

9Completing the Preliminary Application Form

9.1General

9.2The sections of the form

10Contact Details & Further Information

1Introduction

1.1Purpose

The Health Innovation Challenge Fund is positioned as a translational funding schemeto accelerate the clinical application of projects that are well advanced along the development pathway.

Its objective is to:

  • Stimulate the development and uptake of innovative products, technologies and interventions for the benefit of patients in the NHS and other healthcare systems;
  • Support UK-led projects, which target unmet, or poorly met, healthcare needs;
  • Provide translational funding for projects that have demonstrated ‘proof-of-principle’ and have the potential for early clinical use or adoption;
  • Take the product, technology or intervention to the stage at which it is sufficiently validated and developed to be attractive to follow-on funders or investors;
  • Encourage the collaboration of companies, academia and clinicians to better confront today’s healthcare challenges.

1.2Essential Requirements

Projects must have already demonstrated ‘proof-of-principle’ supported by experimental and, where feasible, in vivo data. Evidence from the applicant’s team must clearly illustrate the technical feasibility of the project and demonstrate the potential for development from its current state to a final product. Early stage research or discovery science is not fundable.

Proposals must include first testing in man during the concluding stages of the project and must have the potential to benefit patients within the following 3-5 years, having demonstrated efficacy and received regulatory approvals.

Applications must articulate a plan to progress the technology or intervention to the stage at which it is sufficiently, validated, de-risked or developed to be attractive to:

  • Commercial organisations (e.g. venture capital funds and corporate bodies) for follow-on development and completing the path to market;
  • Not-for-profit organisations (e.g. the National Institute of Health Research) that can offer expertise and resources to assist with the evaluation and development of products;
  • Healthcare providers (e.g. the NHS), if the product is ready for procurement and adoption.

Proposals must set out a commercial strategy that takes into account the regulatory pathway, IP management, commercial barriers, health economics and routes to market.

Proposals must present a plan for the adoption of the technology into the NHS and other healthcare systems, whilst addressing the requirements of patients and health professionals.

Projects must offer solutions that can be:

  • Seamlessly integrated with the current hardware and software infrastructures, care pathways and resources currently deployed within the NHS and by other healthcare providers;
  • Scaled up from local to national level and not, for example, reliant on specialised centres or expertise which can hinder widespread adoption.

Project teams must contain strong clinical representation and be clinically driven..

1.3Eligibility

Project eligibility

All proposals must meet the Essential Requirements of the HICF scheme and address at least one of its specific themes (a project may address either a single theme within the current call or may span several themes). Applications falling outside of the current themes will be declined.

The HICF will not fund:

  • Early stage or basic research;
  • Proposals to conduct stand-alone clinical trials that are not preceded by a programme of R&D or technology development (except for re-purposing of approved medicines);
  • Health delivery research by the NHS where the focus is on the broad adoption, dissemination and uptake of products, technologies and interventions within the NHS;
  • Delivery or provision of health services by or within the NHS;
  • Projects that are already at a stage of development where funding from industry or venture capital could reasonably be secured.
  • Drug development (except for re-purposing of approved medicines)
  • Programs where the time to benefit patients exceeds those specified in the HICF scheme’s Essential Requirements.

Applicant eligibility

The lead organisation must be UK-based and carry out R&D in the UK. Overseas collaborators are permitted.

The following types of organisation are eligible for funding:

  • Publicly listed or privately owned companies;
  • SMEs (including start-up or ‘spin-out’ companies);
  • NHS organisations (including NHS Trusts and NHS Foundation Trusts), and equivalent UK authorities;
  • Universities, research institutes and not-for-profit organisations.

A collaboration between two or more of the above is eligible and is actively encouraged where it strengthens the overall proposal. Wherever there is a commercial partner in such a collaboration that will ultimately be responsible for the development and sale of the end product then that party should assume the role of lead applicant.

The Wellcome Trust is able to use charitable monies to fund commercial companies to meet its charitable objectives through programme-related investment (PRI). For further details, please see our policy on PRI at (

2Funding Conditions

2.1Project duration and amount

Projects are typically awarded for a period of approximately 3 years.

There is no upper or lower set limit for the size of these awards. Applicants should request a budget appropriate for developing their innovative solutionto the point at which it is either attractive to follow-on developers/investors or is ready for deployment.

Preliminary Application Forms should indicate a reasonably accurate estimate of the total funds required. Short-listed applicants must declare an actual amount and a detailed cost breakdown in their Full Application Form. It is accepted that this final figure may differ slightly from the initial estimate given in the preliminary round.

2.2Project Financials

DH and WT have different allowable cost policies. Consequently, the sums received by a successful applicant will reflect the combination of these different funding rules. Applicants should note the following:

  • The HIC Fundprovidesonly project funding, not core support or working capital.
  • Higher Education Institutions(HEIs)should calculate the Full Economic Cost (FEC)of their bids and request an award at 100% FEC.
  • DH will fund its share of the project costs at up to 100% of FEC. From its share of the project costs the WT will fund onlydirectly incurred costs and other allowable costs.
  • Project budgets should not include NHS Treatments Costs or NHS Support Costs. If shortlisted, applicants must identify and quantify all NHS costs on their Full Application Form but these are not eligible for HIC Fund support.
  • For projects that involve patientstudied please applicants are refered to the guidance concerning NHS Treatment and Support costs at;
  • NHS organisations may include in their budgetanycosts relating to management, patent searching, market assessments and economic viability of the ultimate product.
  • All awards will be divided into funding tranches paid at the start of each project milestone period. With the exception of the initial payment, all tranches are contingent on the continuing attainment of pre-agreedproject milestones.

3Application Process

3.1Preliminary applications

Refer to the HICF Grant Conditions and the terms and conditions of the relevant HICF funding agreement before making an application.

Download and complete the Preliminary Application Form, which is available from the HIC Fund websites mirrored at and

Preliminary application forms should be emailed to before 1pm on the advertised closing date. The Joint Secretariat will acknowledge receipt within 2 days. If you do not receive an acknowledgment please contact the team – details can be found at

3.2Shortlisting

Assessment of preliminary applications is made by an expert committee (the Joint Funding Panel (JFP)) that includes representatives of the Wellcome Trust and the Department of Health but is independent of both and its role is advisory only.

Preliminary applications will be reduced to a shortlist and successful applicants will be invited to prepare and submit a full application. Details of the full application process will be provided at that time.The HIC Fund Secretariat will notify all applicants of the JFP’s decision within 7 days of the shortlisting meeting.

3.3Full applications and interviews

All invited full applications undergo independent peer review. During this review process the Wellcome Trust and the Department of Health will exchange information contained in each application and peer review. Applicants will see the peer reviewers’ comments and will have the opportunity to respond in writing. The application form, peer reviews and the applicant’s rebuttals are all taken into consideration by the JFP in reaching their funding decision.

All shortlisted applicants must present their project proposal in person to the JFP at a funding committee meeting held at the London office of the Wellcome Trust. The interview takes the form of a short presentation followed by a question and answer session. Applicants will be notified of the JFP’s funding decision within 7 days of the committee meeting.

3.4Post-award process

Successful applicants are expected to enter promptly into a Funding Agreement that governs matters such as:

  • Scope of project and usage of funds
  • Project management, oversight and reporting requirements
  • Development milestones
  • Confidentiality
  • Intellectual property
  • Dissemination of results
  • Revenue and equity sharing

Funding Agreement templates may be downloaded from the HIC Fund websites. The core terms and conditions of HICF funding are non-negotiable.

4Assessment Criteria

All proposals will be assessed against the following criteria:

The evidence of clinical need and healthcare relevance of the proposed technology/solution

  • What is the clinical need for the proposed technology/solution within the NHS and globally?
  • How will the proposed technology address healthcare priorities within the NHS and beyond?
  • What benefits does the proposed technology provide to both the NHS and patients, e.g. healthcare improvements and/or cost savings?
  • How will clinical practice be affected by using the technology and will this lead to constraints in adoption?

The strength of the project team

  • Does the project team have a strong track record in relevant areas?
  • Does the project team have the right skills and experience to deliver the identifiable benefits?

The strength of the project plan

  • Are the aims and objectives realistic within the timeframe and within the resources proposed?
  • Does the project plan adequately address the aims and objectives?
  • Have the main technical and regulatory barriers and key risks to successful completion of the project been identified and will the appropriate steps be taken to mitigate these?
  • Are the arrangements for managing the project adequate?
  • Are the arrangements for involving patient/user representatives appropriate?

The innovative nature of the technology/solution

  • What is innovative about the proposed technology/solution and what advance is there over current science and technology?
  • Will any new intellectual property arise from this project?
  • What are the competitor clinical practices and technologies and how strong is the market competition?
  • Is there freedom to operate in this area?
  • What are the market opportunities, both domestic and global, and the expected impact of the proposed technology/solution?
  • What are the key stages and challenges on the route to market? Is the commercial strategy for the technology appropriate?

The value for money provided by the proposal

  • Are the requested resources, including staffing, clearly justified? Are they essential for the work proposed?
  • Taking into account the expected benefits of the work proposed and the level of resources requested, do the proposals promise good value for money?

5Important Information

5.1An invitation from the WT and DH to submit a HIC Fund full application does not necessarily mean that an award will be made.

5.2Projects must fit within the defined scope and aims of the HIC Fundand comply with the requirements of the:

  • DH Research Governance Framework
    (
  • WT policies and position statements
    (

5.3Applicants must provide clear development and post-funding commercialisation plans and are obligated to follow these plans under the Funding Agreement. To ensure that non-commercialised, and/or unsuccessfully commercialised IP, is utilised to achieve maximum healthcare benefits allHIC FundFunding Agreements include intellectual property reversion clauses that allow WT and DH to take the lead in exploitation in the event that the award recipient does not do so within an agreed timeframe.

5.4Applicants are expected to provide all information necessary for their proposal to be properly assessed. In some instances it will be necessary to disclose proprietary or unpublished information in order for the Joint Funding Panel to arrive at a fully informed decision.Please see the confidentiality statement below.

5.5Applicants should be aware that all applications (together with any supplementary information) are available to selected staff of the WT, DH and to external advisors for the purpose of short-listing.

5.6The day-to-day business of the funders involves the receipt and review of many applications and consequently it is only under highly exceptional circumstances that they will enter into a confidentiality or non-disclosure agreement with applicants.

5.7Under some circumstances applicants may receive feedback on their project proposal. This feedback is meant to inform and guide applicants but is not meant to be definitive. Applicants should seek their own independent advice on feedback and its validity.

CONFIDENTIALITY STATEMENT

5.8 WT and DH will each treat the technical, scientific and commercial information you supply to them during the application process ("Confidential Information") as confidential for so long as the Confidential Information is not in the public domain, or for a period of ten years, whichever is the shorter.

5.9WT and DH will each: a) take reasonable care to keep the Confidential Information secret and secure; b) use the Confidential Information only for the purposes set out on the front of the grant application form, and; c) only disclose it to third parties under conditions of confidentiality and only as necessary to fulfil such purposes.

5.10Neither WT nor DH will be under any obligation to keep the Confidential Information confidential to the extent that: a) The Confidential Information was already lawfully known to WT or DH at the date it was disclosed to them; b) The Confidential Information becomes public through no fault of WT or DH; c) The Confidential Information is lawfully disclosed by a third party to either of WT or DH without any obligations of confidentiality being placed on them, or; d) The Confidential Information is developed independently by employees of WT or DH without reference to your information.

5.11WT or DH shall each be entitled to disclose any Confidential Information to any court, administrative or regulatory body, or to answer any request under the Freedom of Information Act 2000 to the extent required by law but will endeavour to inform you of any required disclosure as soon as possible.

5.12Although WT and DH put in place appropriate confidentiality provisions with their external advisers, consultants and contractors to whom they may disclose Confidential Information, neither of them accepts any liability for breaches of confidentiality by third parties.

6Programme Management

6.1The WT and DH take an active role in the ongoing management and monitoring of funded projects, including the measurement of progress against the milestones which trigger the release of funds.

6.2Tranches of funding will be released to award holders on the achievement of pre-determined and agreed project milestones.

6.3Progress reports and site visits may be used to evaluate the attainment of defined objectives and milestones.

6.4Applicants who are short-listed for submission of a full proposal may be required to engage with independent advisor(s) during the detailed planning of the project, and beyond if the project is funded. For applicants in academic, non-profit and SME settings, the WT may allocate funds costs incurred in developing their full application.

6.5The Lead Applicant/Principal Investigator, or alternate, may be required to establish a Research Steering Group to monitor project progress.

6.6The funders may require that Intellectual property and translation strategy is managed through an Intellectual Property Management Group that will meet on an ‘as-needed’ basis.

6.7Funded projects may be subject to periodic review by a WT and DH convened Project Advisory Group.

6.8All funded projects must appoint a Project Manager to coordinate and oversee project activities.

7Call Timetable

The timetable for Round 11is shown below:

Preliminary Application Closing Date
(deadline for applications is 1pm on the day) / 5thMay 2015
Short-listing of Preliminary Applications / 12th June 2015
Full Application Closing Date
(deadline for applications is 1pm on the day) / 7th September 2015
Funding decisions / 23/24th November 2015

8Submission Process

Completed application forms should be sent by email to , to arrive no later than 1:00pm on the advertised closing date.

9Completing the Preliminary Application Form

These notes are for guidance in completing the ‘HIC Fund Preliminary Application Form’. Please refer also to the project assessment criteriain Section 6.

9.1General

  • Important: The shaded form field text boxes will extend automatically as you type. All word limits must be adhered to.
  • All abbreviations and acronyms must be defined where they are first used.
  • Only text can be typed into the fields. Images, diagrams or charts cannot be pasted directly into the application form but may be submitted on a single Supplementary Sheet, which is available as separate download.
  • For your application to be accepted you must complete all of the fields in the application form. Failure to do so will result in your application being rejected.
  • Applications which exceed the word or supplementary sheet limits may be returned to the applicant.

9.2The sections of the form

FRONT PAGE - Summary Table

Enter the following information:

  • HICF theme - enter the name of the theme that you are applying under.
  • Project title -this should be concise and descriptive. It should contain keywords relevant to the project.
  • Total funding requested - provide an estimate of the total funding needed. HEIs, should enter the 100% FEC figure. (see Funding Conditions, Section 2).
  • Project duration - indicate the expected length of the project (in months).
  • Name/Address of Lead Institution – this can only be a UK organisation
  • Collaborating Organisations– please listall other organisations with co-applicants or collaborators on the project

SECTION A: PROPOSAL OUTLINE