Biomedical Catalyst: Developmental Pathway Funding Scheme (DPFS)
The £180 million Biomedical Catalyst is an integrated translational funding programme jointly operated by the Medical Research Council and the Technology Strategy Board providing responsive and effective support for the best life science opportunities arising in the UK.
Support through the Biomedical Catalyst is available to academics and UK SMEs looking to develop innovative solutions to healthcare challenges either individually or in collaboration.
Business-led applications under the Biomedical Catalyst will be administered by the Technology Strategy Board; applications will need to be made via the TSB website.
Three categories of grant are available under the Biomedical Catalyst:
• Feasibility Award (TSB)/Confidence in Concept (MRC)
• Early Stage Award
• Late Stage Award
MRC supports academically-led feasibility research through the Confidence in Concept scheme which is open to institutions but not individual researchers. Academic-led applications for Early and Late Stage awards are primarily administered through the BMC: DPFS scheme. Proposals involving novel regenerative medicine therapies will be administered through the BMC: RMRC scheme.
Biomedical Catalyst: Developmental Pathway Funding Scheme (DPFS)
Therapeutics, Devices and Diagnostics Development
The BMC: DPFS scheme forms part of the MRC’s Translational Research Strategy and supports the translation of fundamental discoveries toward benefits to human health. It funds the pre-clinical development and early clinical testing of novel therapeutics, devices and diagnostics, including “repurposing” of existing therapies.
Where the proposal involves collaboration with one or more industrial partners the applicant will need to submit a MICA form and Heads of Terms, at the full stage, if invited forward.
- Funding available
- Application process
- Intellectual Property
- How to apply and timings
- Ethics and governance
- Additional guidance
- Panel Membership
- Hints and tips
The BMC: DPFS scheme supports projects whose goals are to improve prevention, diagnosis, prognosis, or treatment of significant health needs, or that focus on developing research tools that increase the efficiency of developing interventions.
Projects supported by the scheme have clearly defined milestones, outcomes and future plans. These help to maximise both the chance of success, and the likelihood of the project attracting the downstream funding, from public or private sources, required to meet its clinical and commercial aims. The funding panels assessing the project will, if necessary, help to develop proposals and suggest enhancements.
The following activities are eligible for support:
- Developing candidate therapeutic entities (e.g. drug discovery)
- Pre-clinical testing of novel therapeutic entities
- Early-phase clinical studies of novel therapeutic entities (phases 1 and 2)
- “Repurposing” clinical studies – using existing therapies for new indications
- Developing and testing novel devices
- Developing and testing diagnostics (including biomarker validation where the intent is for diagnostic use)
Individual projects can start and finish at any point along the translational pathway; however, the MRC would not normally expect to support a project from initial development through to phase 2 clinical testing in a single application. Where there is a justified need for continued MRC support, sequential applications are encouraged.
All disease areas (including those relevant to global health) and modalities of intervention are eligible for support from the scheme, including small molecules, peptides, antibodies, vaccines, gene therapy, devices, surgical techniques and psychological approaches.
Projects whose goals are to develop regenerative medicine therapies are funded through the BMC: Regenerative Medicine Research Committee and should be directed to that scheme and not BMC: DPFS.
The following activities are ineligible for support under the BMC: DPFS scheme:
- Fundamental or investigative research not linked to a development plan (supported by the MRC Research Boards)
- Clinical studies where the primary purpose is to investigate disease mechanism (supported by the MRC Research Boards)
- Late-phase clinical trials (supported by the MRC-NIHR Efficacy, Mechanisms and Evaluation scheme and the NIHR Health Technology Assessment scheme)
- Late-phase global health trials (supported by the MRC Global Health Trials Programme and the DfID-Wellcome Trust-MRC Joint Global Health Trials Scheme)
The BMC: DPFS scheme has an annual budget of over £30m per year and incorporates MRC’s contribution to the Biomedical Catalyst. We would normally expect applications to be substantive and therefore seeking a minimum of £250k in costs. There is no formal upper limit on project costs, but applicants will be required to justify costs based on the needs of the individual project. Likewise, duration should be based on the needs of the project. As broad guidance, pre-clinical projects are likely to be around 2 years in duration, with clinical projects frequently requiring support for a longer period.
Awards are subject to up to 4 key milestones (go/no-go decisions). This allows risk to be managed appropriately, and enables projects to be supported when later stages of the work are dependent on the success of earlier stages. Failure to meet a milestone may lead to early termination of funding.
Research council units and institutes (including MRC units) can apply to this scheme.
In addition, the following conditions apply to this scheme:
- Individuals may be the principal investigator (the named, lead applicant) on one application per round. Individuals can act as co-applicants or collaborators on any number of applications per 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.
Applications including partnerships with charities or industry are encouraged where these add value to the project – for example, in terms of access to expertise, technologies, reagents or funding. The MRC does not generally broker arrangements on individual grant applications.
Applications involving collaboration with industry should adhere to the MRC Industry Collaboration Agreement guidance. The lead applicant must be the academic partner, and the MRC will meet the academic costs of the project only.
The terms of collaboration, particularly in relation to industry, should be determined early in the study development and the 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.
Proposals are funded on the basis of 80% of the full economic cost (except for “exceptional costs”, which are funded at 100% - see the applicants’ handbook). The MRC will meet the academic costs of the project only.
Applications including a clinical trial should include the cost of the International Standard Randomised Controlled Trial Number (ISRCTN) registration. Costs relating to patenting are not eligible for support.
Applicants should refer to the AcoRD guidance to ensure that research costs, NHS treatment costs and NHS support costs are correctly attributed. In particular, applicants should note that drug costs in “repurposing” clinical studies are generally considered to be NHS treatment costs; drug costs for unlicensed therapies are more likely to be research costs. Applications involving NHS costs are required to include a completed “Additional Costs Proforma: NHS Support and Treatment costs”.
*This guidance is applicable to England, Wales, Scotland and Northern Ireland.
Proposals are assessed in a two-step process. The first step involves review of an outline proposal by the BMC: DPFS Panel. Successful outline applicants are then invited to submit a full application, which undergoes external peer review before a further, more detailed, review by an expert panel. The total assessment time for an application submitted to MRC, from outline submission to full decision, is approximately 26 weeks.
At the full application stage, projects that focus on demonstration of efficacy in a relevant environment (e.g. human clinical human proof of concept studies) and that have significant commercial potential or impact will be assessed by the Biomedical Catalyst Major Awards Committee (MAC); all other applications will be assessed by the BMC: DPFS Panel. The office will confirm the appropriate route with the applicants prior to the full submission deadline.
The application process for full applications assessed by the MAC incorporates two additional steps:
- Applicants have the opportunity to provide a written response to referee comments.
- An interview stage wherein applicants are invited to give a short presentation and are invited to respond to questions directed to them by the MAC.
The BMC: DPFS panel and MAC contain members with expertise in fundamental and clinical research, therapeutic and diagnostic product development, commercialisation and intellectual property. The panels meet three times a year.
The purpose of the outline application is to ascertain whether the project’s aims, rationale, and deliverability are appropriate for consideration through the BMC: DPFS scheme. The outline application should be completed in partnership with the lead academic research organisation’s Technology Transfer Office (TTO), or equivalent, and failure to do so may prejudice the application.
The outline project plan should include up to 4 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:
- Clinical/medical need: Is the need significant and does the proposal have an advantage over competing solutions?
- Rationale: What is the strength of the rationale and supporting evidence for why the proposed solution will meet the targeted need?
- Deliverability: Is the proposed development plan realistic? Will it answer the question or address the need identified? Does it offer good value for money? Does the team have access to the necessary assets and expertise to deliver the planned work?
- Intellectual Property: Is there an appropriate intellectual property strategy in place to facilitate potential downstream exploitation (funding, partnering, commercialisation, etc)? Note that projects that will not generate patentable materials but that will nevertheless be able to provide health benefits are accepted on an equal basis by the DPFS scheme.
Further guidance is provided in the guidance for outline stage applicants. Successful outline applicants will be invited to submit a full application using a full case for support form which will be provided directly by the MRC.
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 to deliver the project goals.
As for the outline, the full application should be completed in partnership with the lead academic research organisation’s institution’s Technology Transfer Office (TTO), or equivalent, and additional external experts as required. Failure to do so may prejudice the application.
The criteria by which the full applications will be assessed are:
- The significance of the need the proposal is seeking to address and competitive advantage.
- Potential impact of the research
- The quality of the proposal’s rationale and approach
- Robustness of the design, methodology and analysis plans to address the research questions
- The feasibility and appropriateness of the project plan: Project start points; Project objectives; Costs, tasks, deliverables, and schedule; Value for money, Adequacy of the risk management plan
- 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), Suitability of the exploitation strategy
- For clinical studies, the ability of the team to design and deliver a methodologically robust study will be a key assessment criterion.
- Applications must demonstrate a strong understanding of the regulatory environment and the requirements for good clinical practice and research governance.
- Ethical issues must be addressed appropriately.
Further guidance will be provided to all applicants invited forward from outline.
All outline and full stage applicants will receive feedback from the assessment process. Please note that the decisions of the panel will not be open to appeal and that the MRC reserves the right to amend the application process.
To ensure effective delivery of the proposal’s objectives, successful proposals will be required to establish an appropriate project management group and reporting system.
During the period of support, the project management group will be required to submit Project Milestone and End Reports to the MRC. If a milestone is at risk of not being met, the project management group may submit a request for change, proposing a resolution to the issues they face. Project Milestone Reports, End Reports and requests for change are reviewed by the MRC. Projects which fail to meet milestones may be terminated.
Selected studies may be deemed to require additional oversight by the MRC. For a small proportion of awards, on a case-by-case basis, the MRC will establish an oversight group to monitor progress against milestones.
Note that the generation of intellectual property is not an essential requirement for this scheme; projects that will not generate patentable materials but that will nevertheless be capable of providing health benefits are accepted on an equal basis.
Intellectual property generated in the course of a project will be owned by the generating organisation(s), which will have the right to manage and exploit this intellectual property. The costs of managing, protecting and exploiting the intellectual property are borne by the generating institution(s) and are not eligible costs for MRC support.
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 scheme, as projects will likely require further development in order to meet their ultimate clinical aims.
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 Principal Investigator to submit an annual follow up report on downstream outcomes of intellectual property for up to three years after the project end date.
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 apply to this scheme.
Application deadlines are usually in March, July and November for consideration by the Panels at meetings in May/June, September/October and January/February respectively.
Your proposal must be submitted through the MRC Je-S system by 4pm on the relevant deadline date.
Information on the full application process will be directly provided to successful outline applicants by the MRC.
The MRC does not require ethics permissions and regulatory approvals to be in place when an application is submitted. However, given that research requiring the use of human tissue/organs may raise various ethical and regulatory issues, applicants will be required to demonstrate that they have adequately considered these matters. Early discussions with regulatory bodies may be required to ensure that all requirements can be met in a timely manner. Once an application is successful, it is the responsibility of the host institution to ensure that the appropriate ethics approval(s) has been obtained and that no research requiring such approval is initiated before it has been granted. Please read the MRC terms and conditions for further details.
Applicants proposing a clinical study are referred to the following literature on experimental medicine methodology and governance in developing their research plans:
- Royal Statistical Society’s Working Party on Statistical Issues in First-in-Man Studies
- EM Toolkit
- EMEA guidance on high risk, first-in-man clinical trials
BMC: Developmental Pathway Funding Scheme
BMC: Major Awards Committee
If you have any queries about this funding scheme, please contact:
Dr Tom Foulkes (firstname.lastname@example.org):
Proteins, peptides, antibodies, siRNA, imaging, surgery
Dr Alex Pemberton (email@example.com):
Small molecules, psychotherapeutics, physical interventions
Dr Catriona Crombie (firstname.lastname@example.org):
Gene therapy, non-imaging diagnostics, vaccines, devices, nutrition
For questions regarding the Je-S application process, please contact the Je-S Helpdesk:
Telephone: +44 (0) 1793 44 4164 (lines open 9-5, Monday-Friday)
- Evidence and/or rationale for the proposed study/target/intervention will generally be required.
- It is strongly advised that as much preliminary data be included as is possible. 2 pages of supplementary data can be uploaded at outline and 5 pages of supplementary data at full stage.
- Project milestones should be specific, quantifiable and measurable.
- Costings should be realistic and appropriate.
Work plans and timescales should be realistic, factoring deliverability of the proposed work and taking into consideration any subsequent developmental or clinical work.
- For projects developing a novel therapeutic, it is advised that a target product profile (TPP) be included.
- It is strongly suggested that for small molecule drug discovery projects, (lead) chemical structures and DMPK/ADMET data should be provided where available.
- Work plans should factor in requirements for progression to clinic.
- There should be sufficient clinical need to justify the proposed trial.
- Trial design should be appropriate and be informed by relevant expertise.
- Powering calculations/information on powering should be included for all proposed clinical studies.
- Inclusion/exclusion criteria should be specified and recruitment plans realistic.
- Endpoints should be relevant, appropriate and measurable.
Outline assessment criteria:
- 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?