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Biomedical Catalyst: Regenerative Medicine Research Committee

The Biomedical Catalyst: Regenerative Medicine Research Committee (RMRC), formally the Translational Stem Cell Committee (TSCRC), supports the translation of fundamental discoveries toward benefits to human health. It funds the pre-clinical development and early clinical testing of novel regenerative medicine therapies.

This scheme forms part of the MRC’s Translational Research Strategy and will help deliver the joint MRC/Technology Strategy Board Biomedical Catalyst in the short term.

Background
Remit
Who can apply?
Guidance to applicants
Deadline dates for applications to RMRC
Case for support
Ethics and governance
Costs
Terms and conditions of RMRC research awards
Publishing results
Regenerative Medicine Research Committee
Contacts and guidance

Background

The translation of the burgeoning knowledge in regenerative medicine into new treatment strategies is a key objective of the MRC Strategic Plan.

Drawing on the experience and expertise of the MRC’s Translational Stem Cell Research Committee (TSCRC), the MRC has recently established the Regenerative Medicine Research Committee to provide support for high quality proposals aiming to develop regenerative medicine therapies to improve human health.

Remit

The RMRC will consider applications whose goals will advance 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 and biologics for the enhancement of endogenous repair
Biomaterial interventions which actively engage repair and regeneration processes

The RMRC’s sister programme, the Biomedical Catalyst: Developmental Pathways Funding Scheme/Developmental Clinical Studies (BMC: DPFS/DCS) will take the lead on proposals developing:

Organ transplantation strategies
Interventions targeting cancer stem cells
Gene therapies
Drug screening programmes using stem-cell derived assays to identify interventions that do not stimulate repair/regeneration processes
Use of cells to deliver drugs, antibodies, etc

The RMRC focus on therapy development will be complemented by the MRC/EPSRC/BBSRC UK Regenerative Medicine Platform (UKRMP), whose goal is to support the development of generic tools and approaches addressing key early translational challenges, such as controlled differentiation, manufacture and safety.

The RMRC will fund 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 will be funded through the MRC boards), with the intention of supporting the application of such research to a stage where further funding can be found to continue development towards the latter stages of therapeutic development.

The following activities are ineligible for support under the RMRC scheme:

Fundamental or investigative research not linked to a development plan (best supported by the Research Boards)
Clinical studies where the primary purpose is to investigate disease mechanism (best supported by the 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)

Who can apply?

Eligibility criteria are the same as for standard MRC research grants as described in the applicant’s handbook and the Research Councils UK website. In addition, proposals are also welcomed from MRC unit staff.

Commercial organisations and applicants from international institutions are welcome to apply as co-applicants; however the research should be carried out for the main part within the UK, and be lead by a UK institution.

If invited forward to the full stage, applicants with an industrial partner(s) will need to include MICA: as a prefix to their project title, complete the Project Partner section in Je-S and submit a MRC Industry Collaboration Agreement (MICA) Form and Heads of Terms as part of their Je-S application. 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 Agreement (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, reporting, and access to data and samples.

Guidance to applicants

Outlines

Outline applications will be received by the MRC around twelve weeks before the RMRC meeting, and will be reviewed by external expert referees. There will be no opportunity to respond to reviewers comments at this stage.

The RMRC will then consider the outline applications and either decline the application or invite a full application. Proposals declined at the outline stage because they are viewed as being outside the remit of the RMRC may be eligible to apply to MRC for funding through appropriate MRC programmes. Proposals invited to the full stage will be advised to submit their full application to either the RMRC for review or, depending on the proposals aims, to the Biomedical Catalyst’s Major Awards Committee.

The case for support for your project should be no more than four pages in length (including references). See case for support for further details.

Specific guidance also includes:

When making an outline application, applicants should Select Council MRC; Document Type Outline Proposal; Scheme Standard Outline; Call/Type/Mode Regenerative Medicine Research Committee Outline <Relevant Deadline>

Invited full applications

The RMRC will give feedback on applications that are invited to submit full proposals. Such applications will often be milestone-based, with the potential for the committee to impose stop/start conditions as appropriate.

Applicants invited to submit a full proposal to the RMRC will have a choice of either:

(i) Submitting to the next RMRC meeting, which will mean they will only have c. one month to develop the full submission. This is likely to be in exceptional circumstances, where there are few criticisms to address and there is a particular issue of timeliness;

(ii) Submitting to the following RMRC meeting. This would be the normal route, and would allow applicants to address criticisms or refine more complex applications over a four to five month period, and support proactive development where advised by the committee.

Applicants invited to submit a full proposal to the RMRC should follow the normal application process for MRC research grants. General guidance on how to complete a research grant and the case for support can be found in the applicant’s handbook.

Applicants with an industrial partner(s) will need to submit a MRC Industry Collaboration Award (MICA) Form and Heads of Terms as part of their J-eS application. Please refer to the MRC web site for further guidance on MICAs.

Specific guidance also includes:

When making a full application, applicants should Select Council MRC; Document Type Standard Proposal; Scheme Research Grant; Call/Type/Mode Regenerative Medicine Research Committee Full <Relevant Deadline>
Applicants must include details on the project timetable and milestones (within section 3.3 Research Plans of the case for support).

Assessment process

Proposals will be reviewed and assessed following the standard process for MRC grants.

Full proposals submitted to the RMRC will be sent out for external peer review, as in common practice with MRC standard research grants. Applicants will be able to respond to the 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.

Deadline dates for applications to RMRC

Application deadlines are usually in March, July and November. All proposals are assessed by external experts before they are considered by the MRC research boards at their meetings in June, October and February.

Your proposal must be submitted through the MRC Je-S system by 4pm on the relevant deadline date.

Case for support

In addition to completing the specific fields requested in the J-eS, you will need to submit a case for support which must be attached as a PDF to the J-eS application. The case for support may be up to four A4 pages in length, including references, using Verdana 10pt typeface with margins of 2cms on the left hand side and 1.5cms on other edges. No annexes are allowed.

In your case for support should address each of the following headings using the description under each heading as guidance.

Structural Guideline for the case for support:

Title
Importance of the research - what is the translational outcome within the project time-frame?
Scientific potential
People and track record
Environment
Research plans
Milestones
Consideration of ethical, governance and IP issues around the project

There should be no addition of annexes without prior agreement from MRC office scientific contact:

Dr Jonathan Pearce

Programme Manager

Email: jonathan.pearce@headoffice.mrc.ac.uk

Ethics and governance

The MRC does 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 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 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.

Costs

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.

NHS* costs

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.

Terms and conditions of RMRC research awards

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 Medical Research Council - MRC Terms and Conditions , section AC24. Projects funded by the RMRC may be asked to provide regular progress reports against the milestones set out in the proposal.

Publishing results

Results of MRC-funded clinical studies (whether positive or negative) must be published within a reasonable period* following the conclusion of the study. Results should be reported in accordance with the recommendations in the CONSORT statement [Schulz et al. BMJ 2010;340:c332]. Data should be made available in line with the MRC Data Sharing Policy.

*Generally within a year of completion

Regenerative Medicine Research Committee

Professor Ian Greer (Chair), Pro-Vice-Chancellor (Health and Life Sciences), University of Liverpool
Professor Peter Andrews, Department of Biomedical Sciences, University of Sheffield
Dr Raj Chopra, Vice President of Translational and Early Drug Development, Celgene Corporation
Professor Robin Ali, Professor of Human Molecular Genetics, University College London
Professor Stuart Forbes, Professor of Transplantation and Regenerative Medicine, University of Edinburgh/MRC Centre for Inflammation Research
Professor Sian Harding, National Heart & Lung Institute, Imperial College London
Professor Doug Higgs, Director MRC Molecular Haematology Unit, Oxford
Professor Anthony Hollander, ARC Professor of Rheumatology & Tissue Engineering, Dept. of Cellular & Molecular Medicine School of Medical Sciences, Bristol
Dr Paul Kemp, Intercytex Ltd
Professor Sheila MacNeil, The Kroto Research Institute, University of Sheffield
Professor Martin Wilkins, Professor of Clinical Pharmacology, Imperial Collage London
Professor Paul Whiting, Pfizer Neusentis