Biomedical Catalyst: Regenerative Medicine Research Committee: Mar 2017
- Who can apply?
- Industrial partners
- Case for support
- Ethics and governance
- NHS* costs
- Terms and conditions of RMRC research awards
- Regenerative Medicine Research Committee
- Contacts and guidance
Supports translation of fundamental discoveries toward benefits to human health.
The translation of the burgeoning knowledge in regenerative medicine into new treatment strategies is a key objective of the MRC’s strategic plan. The Biomedical Catalyst: Regenerative Medicine Research Committee (RMRC) provides support for high quality proposals that may underpin or progress the development of regenerative medicine therapies to improve human health. The RMRC:
- Supports confidence in concept studies that if successful will promote the translation of fundamental discoveries toward benefits to human health, thereby accelerating the transition from discovery research to mature translational development projects
- Funds preliminary work or feasibility studies to establish the viability of an approach, through addressing focussed research questions needed to unlock progress in pre-clinical development and/or early clinical testing of novel regenerative medicine therapies
- Forms part of the MRC’s Translational Research Strategy and forms part of the Biomedical Catalyst funding stream, operating in conjunction with the Developmental Pathway Funding Scheme
The translation of the burgeoning knowledge in regenerative medicine into new treatment strategies is a key objective of the MRC’s strategic plan.
The Biomedical Catalyst: Regenerative Medicine Research Committee (RMRC) will provide support for high quality proposals aiming to provide sufficient preliminary data to establish the viability of further progressing a regenerative medicine approach before seeking more substantive funding through the Developmental Pathway Funding Scheme. It is intended to de-risk and/or accelerate the transition from discovery research through to mature translational development projects.
The RMRC will fund confidence in concept projects that go beyond the understanding of basic endogenous repair mechanisms or stem cell biology or which use stem cells to probe the mechanisms of disease (which are funded through our boards). The intention is to support the translation of such research to a stage where further funding can be found to continue development towards human application. To deliver against this objective and to help scale your proposal, successful applications are expected to be in the order of 1-2 years duration, with RMRC committing up to £2m per year across ~10 awards.
The RMRC scheme will consider applications whose goals will provide key underpinning data and/or evidence of the viability of regenerative medicine approaches needed to unlock further support for the pre-clinical and/or early clinical development of regenerative medicine therapies including:
- Cellular regenerative therapies spanning stem, progenitor and differentiated cells
- Tissue repair strategies, including small molecule, gene therapy and biologics, where these directly target and enhance endogenous repair
- Biomaterial interventions which actively engage repair and regeneration processes.
The Biomedical Catalyst: Developmental Pathway Funding Scheme (DPFS) is the RMRC’s sister programme, and will take the lead on mature regenerative medicine proposals where more substantive funding is required to deliver a project with a clear pathway to product or clinical development.
The MRC/EPSRC/BBSRC UK Regenerative Medicine Platform (UKRMP) complements the RMRC and DPFS focus on therapy development. The UKRMP supports the development of generic tools and approaches addressing key early translational challenges including controlled differentiation and manufacture, engineering the stem cell niche, therapeutic delivery, immunity and safety. Applicants should consider whether added value can be achieved through cooperation with the UKRMP and/or other relevant strategic investments in their area of interest.
The following activities are ineligible for support under the RMRC scheme:
- Fundamental or investigative research not linked to a development plan (best supported by our response mode grants through the MRC research boards)
- Mature regenerative medicine development pipeline proposals (supported by the Biomedical Catalyst: Developmental Pathway Funding Scheme).
- Clinical studies where the primary purpose is to investigate disease mechanism (best supported by our response mode grants through the MRC research boards)
- Late-phase (phases 3 and 4) clinical trials (supported by the MRC-NIHR Efficacy, Mechanisms and Evaluation scheme and the NIHR Health Technology Assessment scheme)
- Those eligible for standard MRC research grants as described in the guidance for applicants and the Research Councils UK website
- MRC unit/institute staff
- Investigators from international institutions can apply as co-applicants. However, the research should be carried out for the main part within the UK and be clearly led by a UK principle investigator within a UK institution
Applicants with an industrial partner(s) will need to:
- Include “MICA:” as a prefix to your project title
- Complete the Project Partner section in Je-S
- Submit an MRC Industry Collaboration Application (MICA) Form and Heads of Terms as part of your Je-S application
If you are considering establishing a collaboration with an industrial partner(s), you and your potential collaborator(s) should refer to the guidance on MRC Industry Collaboration Applications (MICAs).
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 and freedom to operate, reporting, and access to data and samples.
Applicants with an industrial partner(s) will need to submit an MRC Industry Collaboration Award (MICA) Form and Heads of Terms as part of their Je-S application.
Please refer to the guidance on MICAs.
Je-S selections for full applications:
- Council: MRC.
- Document Type: Standard Proposal.
- Scheme: Research Grant.
- Call/Type/Mode: Regenerative Medicine Research Committee <Relevant Deadline>
Proposals will be sent out for external peer review. Applicants will be able to respond to reviewers comments prior to the final funding decisions made by the RMRC. Please note that the decisions of the committee will not be open to appeal and that the MRC reserves the right to amend the application process.
There should be no inclusion of additional annexes to those identified in the guidance without prior agreement from the MRC office scientific contacts:
Dr David Pan, Programme Manager:
The main body of the case for support may be up to four A4 pages in length, including references, using Arial 11pt with 2cm margins and a minimum of single line spacing. You are allowed to include a further two page Annex to this case for support containing preliminary data only (such as graphs, images or data tables, but not descriptive text which should be in the main body). In keeping with MRC’s revised guidance on demonstrating excellent and robust experimental methodology, you are also allowed to include an additional one page annex as set out in Section 126.96.36.199 of the MRC’s Applicants’ Handbook. Please note these are not opportunities to extend the other information needed within the case for support beyond the four page limit and any applications where this is deemed to have occurred will not be accepted. In addition to this case for support, you should provide a Gantt chart setting out the key developmental work, milestones, and points of regulatory/ethical engagement needed to bring your proposal to human application, i.e. to include those expected steps beyond the term of the immediate grant request.
The case for support is your opportunity to convince the committee that you have:
- a clear vision of where you are going, based on an appropriately developed start point
- an understanding of the key science needed to provide proof of concept and unlock future translational potential
- given appropriate consideration to providing mechanistic insights into the effects of the intervention and which may be used as success measures in future translational development
- a logical and well managed experimental plan for achieving next steps towards your goal(s).
You should set out your case for support under the following headings, using the description under each heading as guidance to identify the key information needed by the committee in their assessment of your proposal and referring to the Annexes as appropriate.
- Describe the nature and scale of clinical need you are targeting and your proposed solution to meeting this need
- Describe competing solutions and the advantages of your proposed approach over these
- Describe the mechanistic basis of your approach, what learning opportunities arise and the benefits that these could bring to future development
- Give sufficient details of past and current research to show that your proposal is scientifically justified
- Clearly set out the proposal’s objectives
- Give key details of the general experimental approaches, study designs, and techniques that will be used to achieve these objectives:
- It is not necessary to describe each experiment, but enough detail must be given to show why the proposed plan is logical and likely to achieve its goals
- Explain in greater detail how new techniques, or particularly difficult or risky studies, will be tackled and alternative approaches should these fail
- Provide a clear end-point(s) with criteria that could be used to critically assess project success
- The requested duration and cost of your submission should be driven by the nature of the evidence needed to provide confidence in your concept and the time and resources required to deliver this, rather than by, for instance, standard employment periods. As a guide, RMRC will expect to commit up to £2m per year, seeking to fund in the order of 10 applications, with an expected duration of 1-2years
- Briefly demonstrate your team has the necessary skills, expertise and access to resources to successfully deliver the proposed work, being clear how each member will specifically contribute.
- Provide an overview of the ethical and research governance challenges in the current proposal and what measures/approvals have been put in place to address these or need to be obtained.
- Briefly describe how your proposed intervention will be classified (e.g. non medicinal product, medicinal product, ATMP, medical device, etc.) and the regulatory/ethical/governance path that your intervention will need to traverse to enter clinical evaluation, using the proposed developmental pipeline’s Gantt chart as a reference and to provide greater detail of the proposed pipeline to human application.
- Briefly describe your exploitation strategy, including required downstream work through reference to the proposal’s Gantt chart, and reference possible sources of support.
- Briefly describe your intellectual property strategy, including whether you have freedom to operate for the proposed work.
We do not require ethics permissions and regulatory approvals to be in place when you submit an application.
However, given that research requiring the use of human tissue/organs may raise various ethical and regulatory issues, applicants will need to demonstrate that they have adequately considered these matters. Points of contact through the proposed development pipeline to human application should be indicated in the Gantt chart to be included with the proposal. Early discussions with regulatory bodies may be needed to ensure that all requirements can be met in a timely manner. Once an application is successful, it is the responsibility of your 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. If your work involves human stem cells, you should consider how the UK Code of Practice for the Use of Human Stem Cell Lines applies to your proposal.
Proposals are funded on the basis of 80% of the full economic cost (except for exceptional costs, which are funded at 100% - see the guidance for applicants). The MRC will meet the academic costs of the project only. 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.
In addition to the standard MRC and RCUK terms and conditions, applicants undertaking research involving human stem cell lines must adhere to MRC supplementary terms and conditions for MRC grants introduced in the context of stem cell research - see MRC additional terms and conditions: section AC18.
General contact for pre-award enquiries, please contact:
MRC pre-awards administration team: firstname.lastname@example.org
Queries relating to Je-S should be directed to the Je-S Helpdesk
If you have a query about scientific aspects of your research proposals, please contact:
Dr David Pan, Programme Manager: