Developmental Pathway Funding Scheme
The Developmental Pathway Funding Scheme (DPFS) is a new, rigorously-assessed, funding scheme set up by the MRC to help strengthen the translation of fundamental research towards patient benefit. It does not fund discoveries of new causes or risk factors of disease, biomarkers, drug targets, biomaterials or research tools, but takes these as starting points and supports their application to improve healthcare and benefits for patients. The DPFS forms a key part of the MRC’s Translational Research Strategy.
- Introduction
- Objective
- Scope
- Funding available
- Eligibility
- Application process
- Oversight
- Underpinning support
- How to apply and timings
- Frequently Asked Questions
- Panel Membership
- Contact
Introduction
As part of its Translational Research Strategy, which aims to turn fundamental research discoveries into patient benefits, the Medical Research Council is launching a major new funding stream – the Developmental Pathway Funding Scheme (DPFS). The scheme – which will not fund basic discoveries – will support the development of novel therapies, interventions and diagnostics, and the research tools used in the development of therapies, interventions or diagnostics. Projects should target significant and unmet health needs. Projects supported by the DPFS must have clearly defined milestones, outcomes and future value. These will help maximise success and enable the project to attract required downstream funding, whether from public or private sources, along the path to meet its clinical aims. The DPFS panels will, if necessary, actively develop proposals, introducing enhancements and emphasising coordination of projects and research resources within and across centres and funding schemes.
Objective
The objective of the Developmental Pathway Funding Scheme is to support the translation of fundamental basic and clinical research findings towards the clinic.
Scope
The DPFS will support the development of novel therapies, interventions and diagnostics, and the research tools used in the development of therapies, interventions or diagnostics. Projects supported by the DPFS will be milestone-driven with clearly defined outcomes and future value – this will influence the potential for projects to attract required downstream funding, whether from public or private sources, along the path to meet its clinical aims.
The DPFS will support projects targeting significant and unmet health needs by improving prevention, diagnosis, prognosis, or treatment of patients, or by the development of research tools that increase the efficiency of the development of such interventions. The DPFS will support a significant proportion of high-risk high-payoff projects, especially in fields not being actively pursued in the private sector at present. The DPFS panels will, if necessary, actively develop proposals, introducing enhancements and emphasising coordination of projects and research resources within and across centres.
A project need not begin with a fundamental discovery. Later start points along the development path are also acceptable. The endpoints of the project, if successfully attained, should reasonably enable the project to attract further support, if required, to allow the project to meet its clinical aim.
DPFS proposals will need to show a clear understanding of the evidence needed to advance a treatment into medical use and use this to define two to three clear milestones, depending on project complexity, in their project plans. Negative results, or poor progress, at these milestones will result in funding being redirected.
Examples of proposals likely to be supported:
- Validating an association between a fundamental discovery and a preventive, diagnostic or disease process (target validation).
- Developing candidate therapeutic entities - from drug discovery up to early evaluation in humans.
- Developing candidate diagnostics or medical devices - from prototype design up to early evaluation in humans.
- Developing a new research tool that might overcome a significant bottleneck in the development of therapies or diagnostics.
The DPFS is not designed to support the discovery of new causes or risk factors of disease, biomarkers, drug targets, biomaterials or research tools. Instead it takes such discoveries as its starting point.
Examples of proposals not likely to be supported through DPFS:
- Fundamental research that is not linked to a development plan.
- Clinical development of therapies or diagnostics.
Such studies will be supported by other MRC schemes or, for later stage clinical evaluation, by the Efficacy and Mechanisms Evaluation or Health Technology Assessment programmes managed by our partner the National Institute for Health Research (NIHR).
Please note that the DPFS will not support applications whose goals will advance stem cell research towards clinical use or application, including enabling technological development or preclinical stem cell research. Such proposals should be submitted to the MRC’s Translational Stem Cell Research Programme.
Funding available
The MRC plans to spend £25 million over the next three years on this initiative. It is envisaged that projects would normally seek initial funding in the range of £250k-750k. Depending on the nature of the research, this might be sufficient for one or two years work, or occasionally longer. Larger development programmes will normally be supported in stages, but higher awards can be justified by the work needed and endpoints sought.
Eligibility
The normal MRC eligibility rules apply; please see the applicants’ handbook and the Research Council UK website.
In addition, the following apply to this scheme:
- Individuals may be the principal investigator (the named, lead applicant) on one application per DPFS application round. However, individuals can act as co-applicants or collaborators on any number of applications per DPFS application round. However, please note that the assessment will consider the level of engagement of co-applicants and collaborators with the research and their capacity to meet these requirements.
- There is no limit to the number of applications per higher education institution (HEI) or research institution, but capacity to conduct the study will be considered during assessment.
- Research council units and institutes can apply.
- Applications involving industrial collaboration are encouraged. However, the lead applicant must be the academic partner. Further details of support available for academic-industry partnerships can be found in the Guidance for DPFS Applicants.
Collaborations
Applications including partnerships with charities or industry are strongly encouraged where these add value to the project for example in terms of access to expertise, technologies, reagents or funding. The MRC does not have the capacity to broker these arrangements.
The terms of collaboration, particularly in relation to industry, should be determined early in the study development and relevant agreements must be in place by the outset of the project. Partnership arrangements should ensure transparency in the project design and in the analysis and publication of results (including if these are negative). Consideration should also be given to issues such as: relative responsibilities, governance arrangements, regulatory approvals, indemnity, intellectual property rights, reporting, and access to data and samples.
If you are considering establishing a collaboration with an industrial partner(s), you and your potential collaborator(s) are advised to refer to the guidance on MRC Industry Collaboration Awards (MICAs), MICAs are the mechanism by which academic-industrial collaborations can apply to the DPFS.
For advice on collaborative projects contact by email: jonathan.pearce@headoffice.mrc.ac.uk
Application process
Proposals will be assessed by a two-step process. A brief outline proposal will be reviewed by an expert panel. Successful outline applicants will be invited to submit a full application, which will undergo a further round of more detailed review.
Outline applications
The purpose of the outline application is to ascertain whether the project’s aims, rationale, and deliverability are appropriate for consideration through the DPFS.
The outline application is expected to be completed in partnership with your institution’s Technology Transfer Office (TTO), or equivalent, and failure to do so may prejudice your application.
The outline project plan should include two to three milestones, depending on project complexity. The criteria used to assess the project at each milestone should be chosen so that they address reasons for progressing or discontinuing the project, ensuring that the plan progresses along the critical developmental path.
The criteria by which the outline applications will be assessed are:
- Need: What is the need the proposal aims to help address. Is the need significant and does the proposal have a competitive advantage over competing solutions?
- Rationale: What is the rationale and supporting evidence for why the proposed solution will meet the targeted need? Is the rationale and level of qualification reasonable?
- Deliverability: Is the proposed development plan realistic? Does it offer good value-for-money? Does the team have access to the necessary assets to deliver the plan?
- Intellectual Property: Is there an appropriate intellectual property strategy in place to optimise the chances of downstream funding/partnering?
Guidelines on the questions that will be expected to be addressed under each criterion are provided in the Guidance for DPFS Applicants.
Outline applications will be considered by the DFPS panel. These panels meet three times a year, six weeks after the outline application deadline.
The DPFS panel is made up of members with expertise in fundamental and clinical research, therapeutic and diagnostic product development, commercialisation and intellectual property.
Successful outline applicants will be invited to submit a full application using a DPFS Full Application Form, which will be provided by the DPFS programme manager.
Full applications
The purpose of the full application is to assess, in greater depth, the need being targeted and the proposal’s rationale and to establish whether there is a robust development plan in place that is capable of delivering on the project goals.
The full application is expected to be completed in partnership with your institution’s Technology Transfer Office (TTO), or equivalent, and additional external experts as required, and failure to do so may prejudice your application.
The criteria by which the full applications will be assessed are:
- The significance of the need the proposal is seeking to address and the proposal’s competitive advantage.
- The quality of the proposal’s rationale and approach.
- The feasibility and appropriateness of the project plan:
- Project start points.
- Target product profile at each milestone.
- Project objectives.
- Costs, tasks, deliverables, and schedule.
- The value for money.
- The adequacy of the risk management plan.
- The appropriateness of the project management plan:
- Project management group membership and experience.
- Assignment of responsibility within the project team.
- Key performance indicators (for example, time, cost).
- The suitability of the exploitation strategy.
Full applications should be submitted no later than six months from the outcome of the outline application. Full applications will be considered by a DFPS panel. These panels meet three times a year, eight weeks after the full application deadline. The total review time by the MRC for an outline and full application is expected to be approximately 14 weeks (Fig. 1). All full applicants will receive feedback from the assessment process.
Please note that the decisions of the DPFS panels will not be open to appeal and that the MRC reserves the right to amend the application process.
Oversight
To ensure effective delivery of the proposal’s objectives, successful proposals will be required to establish an appropriate project management group and reporting system.
Guidance on expected membership and responsibilities of a DPFS project management group can be found in the Guidance for DPFS Applicants
During the period of DPFS support, the project management group will be required to submit to MRC Project Quarterly, Milestone and End Reports. If a milestone is not met, the project management group should submit a remedial plan to the MRC as part of its Milestone Report. Project Milestone and End Reports will be reviewed by the MRC. Projects which show negative results at milestones, or which fail to meet milestones, will be terminated, unless there is a strong remedial plan, and the concept has a high priority.
Details of Project Quarterly, Milestone and End reporting can be found in the Guidance for DPFS Applicants.
Intellectual property generated in the course of a DPFS project will be owned by the host institution, which will have the right to manage and exploit the DPFS project generated intellectual property.
The MRC wishes to assure itself that host institutions are able to manage and exploit effectively the intellectual property generated from MRC-funded research. This is particularly important in the case of the DPFS, as projects supported by the DPFS will likely require further development in order to meet their clinical aims.
To understand the effectiveness of intellectual property management, the project management group will be asked to submit, as part of their Project Milestone and End Reports, details of the intellectual property generated during the course of the project and of the management and exploitation of this intellectual property. The MRC will also require the host institution to submit an annual follow up report on downstream outcomes of DPFS generated intellectual property for up to three years after the project end date.
Details of the requested intellectual property reporting can be found in the Guidance for DPFS applicants.
Underpinning support
The general role of the DPFS is in supporting individual translational projects. The MRC recognises, however, that it may be best to provide underpinning support for DPFS projects, such as experienced project management, centrally by a host university across its portfolio of DPFS projects.
The MRC is open to proposals for underpinning support, where these can be justified by: a large and high quality medical research base; a substantial number of DPFS translational projects; and strong university support for developing new ways of working in applied medical research.
Such proposals must be discussed in advance with the DPFS programme manager, Jonathan Pearce (jonathan.pearce@headoffice.mrc.ac.uk). Applications should then be submitted via EAA using the DPFS Underpinning Support Application Form with reference to the Guidance for DPFS Underpinning Support Applicants.
A research organisation may make only one Underpinning Support application per DPFS application round and is expected only to hold one award at any given time.
How to apply and timings
Outline applications must be submitted via the Electronic Application and Assessment (EAA) system using the DPFS outline application form in conjunction with the guidance for DPFS applicants.
Please bear in mind that all proposals have to be submitted via your research organisation’s administrative department. Please ensure sufficient time to complete their parts of the proposal before the MRC deadline dates.
Standard MRC terms and conditions will apply to this scheme.
The key dates of the assessment process are:
Deadline for full applications |
Deadline for outline applications |
DPFS Panel Meeting |
Wednesday 28 October 2009 |
Wednesday 4 November 2009 |
13 – 14 January 2010 |
Thursday 4 March 2010 |
Thursday 18 March 2010 |
10 – 11 May 2010 |
Tuesday 6 July 2010 |
Wednesday 14 July 2010 |
15 – 16 September 2010 |
Thursday 4 November 2010 |
Thursday 18 November 2010 |
19 – 20 January 2011 |
Applicants must submit their proposals via EAA by 4pm on the deadline date
Frequently Asked Questions
Questions and answers on this funding scheme regarding eligibility, funding, preparing an application, assessment, ethics and governance can be found under Frequently Asked Questions.
Panel Membership
Developmental Pathway Funding Scheme – Panel Membership.
Contact
If you have any queries on this funding scheme, please contact
Email: jonathan.pearce@headoffice.mrc.ac.uk
