This call is now closed for applications and is available for reference purposes only.
The Biotechnology and Biological Sciences Research Council (BBSRC), Engineering and Physical Science Research Council (EPSRC) and Medical Research Council (MRC) are establishing a £25M UK Regenerative Medicine Platform (UKRMP) to address the technical and scientific challenges associated with translating promising scientific discoveries in this area towards clinical impact.
At its core, the first stage of funding supports interdisciplinary and complementary research hubs that together will provide a world-leading programme to promote the development of regenerative therapies by addressing key translational gaps. With the successful establishment of this Platform, up to £6.5M is now available to support second stage funding for the UKRMP to build on this initial investment in order to address specific human health needs.
The RC sponsors, in partnership with Arthritis Research UK and the Multiple Sclerosis Society are therefore inviting proposals to establish high quality, collaborative research groupings to address key challenges in translational regenerative medicine focussed into particular diseases or physiological systems with therapeutic potential.
Applications across all health areas are welcome, with the exception of cardiovascular disease. Proposals addressing arthritis and related musculoskeletal conditions/rheumatology and multiple sclerosis are particularly encouraged, reflecting the key partnership with Arthritis Research UK and the MS Society in this call.
Regenerative medicine is an interdisciplinary approach spanning tissue engineering, developmental and stem cell biology, gene therapy, cellular therapeutics, biomaterials (scaffolds and matrices), nanoscience, bioengineering and chemical biology. It may involve:
- transplantation of stem cells, progenitors or tissue
- stimulation of dormant repair processes
- using cells as delivery vehicles for therapeutic agents
- engineered cells / synthetic biology
Regenerative medicine has already provided significant medical advances in areas such as skin regeneration for burns patients and diabetic ulcers and the treatment of anaemia, and has the potential to go much further with next-generation products offering treatments with long term benefits or cures. The underpinning science is progressing rapidly, yet there are a number of developmental challenges which need to be overcome if we are to successfully translate promising discoveries for the benefit of patients as well as the UK economy. These are elaborated upon in the Research Council/TSB Strategy for UK Regenerative Medicine, published in March 2012.
As a response to these translational requirements, and to ensure that research addressing regenerative medicine connects seamlessly from discovery science through to clinical and commercial application, the RC sponsors have established a UK Regenerative Medicine Platform (UKRMP) with the goals of:
- establishing interdisciplinary research hubs with the critical mass and expertise to address key knowledge-gaps in the translation of stem cell and regenerative biology towards application;
- providing the novel tools, platform technologies and engineering solutions needed for therapeutic development;
- creating a world-leading and fully connected national programme to pull through excellent discovery science in support of the commercial development and clinical delivery of regenerative medicine products.
The first stage in the development of the UKRMP has focussed on approaches with broad applicability. Under this stage, three Research Hubs have been created:
- Engineering and exploiting the stem cell niche
Director: Professor Stuart Forbes, University of Edinburgh
- Safety and efficacy, focussing on imaging technologies
Director: Professor Kevin Park, University of Liverpool
- Acellular (smart material) approaches for therapeutic delivery
Director: Professor Kevin Shakesheff, University of Nottingham
Further details on these Hubs can be found here.
A further Hub addressing pluripotent stem cell characterisation, differentiation & manufacturing challenges will be operational by the end of 2013 (with detail to be released on the UKRMP website early autumn).
The remaining constituent hub in the UKRMP, addressing immune challenges in regenerative medicine, will be established alongside this call’s timeline.
Further updates on progress of the first stage of the UKRMP will be posted on the UKRMP website and applicants to this call are advised to keep abreast of these further investments as they develop their own bids.
Aim of the UKRMP II Call
Stage II of the UK Regenerative Medicine Platform (UKRMP II) will fund a small number of cutting-edge research consortia to undertake multidisciplinary translational programmes in regenerative medicine in target areas amenable to clinical intervention.
The UKRMP II call will support research based around disease or physiological/organ systems, positioned within the continuum from preclinical to early stage clinical studies (Phase 0/I/II). It is anticipated that the awards will bring together research teams with the necessary expertise to drive current progress towards application of regenerative medicine approaches in the clinic. However, it should be noted that in-human studies are NOT a requirement under this call, although bids should clearly identify the translational pathway towards clinical application.
Applications may be submitted across the health spectrum where regenerative medicine will have an impact, with the exception of cardiovascular disease which has seen significant investment in this space, aligned with the UKRMP, through the British Heart Foundation’s “Mending Broken Hearts” Appeal.
The UKRMP II call will build upon the stage 1 UKRMP investments in the established Research Hubs (see above). Connectivity to the UKRMP Hubs is expected in successful applications, in order to provide the funded teams with access to technological support, expertise and advice to advance their goals which will drive towards therapeutic development and clinical testing.
To achieve the ambitious aims of this call, proposed consortia are strongly encouraged to:
a) bring together new partnerships/expertise;
b) effectively link basic and clinical groups;
c) engage and/or partner with industry & end-users.
It should be noted that the UKRMP Hubs have specific support to encourage and develop engagement with other stakeholders. Early conversation with the Hub Directors (where presently identified) may therefore be useful in shaping proposals.
To encourage industry engagement, particularly where opportunities for collaboration and to catalyse progress are not immediately apparent, the UKRMP II call includes a compulsory “Intention to Apply” stage. These submissions will be made available on the UKRMP website. In addition, this opportunity and the Intention to Apply submissions will be drawn to the attention of pharma and SMEs operating in this arena.
Partnership with Arthritis Research UK and Multiple Sclerosis Society
Applications to the UKRMP II call are particularly encouraged in the areas of arthritis and related musculoskeletal conditions/rheumatology and multiple sclerosis, acknowledging partnership with Arthritis Research UK and the MS Society that will enable joint awards to be made with the RC sponsors, subject to internationally competitive standards being achieved.
Brief details of each Charity’s strategic priorities under this call can be found below. Applicants seeking support in these areas of potential joint-funding are encouraged to contact the Charities to discuss their plans further.
Arthritis Research UK
A central focus of the research supported by Arthritis Research UK is bringing forward novel approaches to therapy in patients and to be at the forefront of international efforts to develop new treatments that promote regenerative repair and those that harness the potential of stem cells. As well as already supporting a Centre of Excellence in the field of tissue engineering and a broad portfolio of world class research in the area, Arthritis Research UK have a particular interest in supporting new studies aimed at translating the outputs of experimental regenerative medicine research into patient benefit.
Following bi-lateral meetings and discussions, Arthritis Research UK and the Dutch Arthritis Foundation ‘Reumafonds’, are aware of the overlapping and synergistic interests between UK and Dutch research groups in regenerative medicine and osteoarthritis. Thus, collaborative applications that demonstrate meaningful added value from joint working between UK and Dutch partners will be welcomed and would be considered for joint funding as part of this overall initiative. Such applications would need to demonstrate how the partners would work and how they will represent more than ‘the sum of the individual parts’. Such Applications would be expected to meet the criteria set out under Support Available.
Multiple Sclerosis Society
The MS Society recognises the current unmet need for treatments that can slow, stop or reverse the damage caused by MS. The Society’s new Research Strategy (2013-17) has outlined a more targeted approach to funding research that will aim to bring benefits to people with MS as quickly as possible. This approach includes, but is not limited to, improving our understanding of; neurobiology, myelin biology and remyelination, and immunological mechanisms relevant to neurodegeneration and progressive MS.
Applications that complement the MS Society’s Research Strategy will be considered a priority.
- Approximately £6.5M will be available under this call for the second stage of the UKRMP.
- Awards will be for 3 years; it is anticipated each award will in the region of £1m-£1.5m.
- Awards jointly-funded with Charity partners will be administered by the MRC. Supplementary terms will apply to these jointly funded awards to address partnership needs. This will include specific terms covering acknowledgement of funders, reporting requirements, public engagement and intellectual property/commercial exploitation. Further details are available on request (see Contacts and guidance)
- Applications may include costs of preclinical research up to and including costs associated with early stage (Phase I/II) clinical trials (Note: in-human studies are not a requirement if inappropriate to the current development stage of the proposed translational programme and considered not feasible to be delivered within the funding and 3 year term of any award).
- Applications may address developmental pathways or challenges associated with the pursuit of a specific therapeutic goal, or the broader agenda of developing novel approaches of broader applicability to the development of therapies within a particular physiological or organ system.
- Applications for in-human studies must encompass activity to inform mechanistic understanding. Such applications must also include details of the methodological approaches employed and oversight arrangements in sufficient detail to enable appropriate review of the trial arrangements.
- User and public engagement, coordination and collaboration costs to bring the research closer to application and patients may be included.
- Exceptionally, support for international partnership is available where it can be demonstrated that this will bring specific advantage and significant added value to the proposal in addressing the aims of this call. It is anticipated that such partnerships will be underpinned with evidence of existing collaborative working with the UK consortium members.
Support not available
- Funds cannot be requested for infrastructure and core administrative services (secretarial, finance, personnel, computing support, estates and building maintenance) covered by the indirect cost component of FEC from RC funds.
- For awards jointly funded with Arthritis Research UK or the Multiple Sclerosis Society, indirect and estates costs will be calculated in agreement with the principles of funding agreed between RCUK and the Association of Medical Research Charities. This upholds the principle that whilst RCUK will provide support under the full economic costing model, charity funds within the joint award may only be used to support direct science costs. Applications should be therefore be costed as usual practice for MRC’s standard awards.
- Funds cannot be requested for training awards, including studentships and fellowships.
Prior submission of an “Intention to Apply” is an eligibility requirement – please see “Application and assessment procedure” below for further details.
For administrative purposes, applications will be led by a single UK academic institution or independent research organisation approved by the Research Councils. Applications from throughout the UK are eligible.
Partnerships with industry are encouraged. Applicants considering establishing collaboration with an industrial partner(s), are advised to refer to the guidance on MRC Industry Collaboration Awards (MICAs).
Application and assessment procedure
Intention to Apply
ALL applicants are required to submit an “Intention to Apply” by e-mail to Dr David Pan, UKRMP Science Manager by 4pm 18th September 2013.
The Intention to Apply will allow the funders to ensure that proposals are aligned with the remit of the call and their strategic interests. No feedback will be given other than confirmation that the proposed bid is within scope and can be submitted.
Please note that Intentions to Apply will be made publicly visible on the UKRMP website to facilitate engagement with other stakeholders/end users such as biopharma/small-medium enterprises who might wish to explore opportunities to engage collaboratively with one or more of the proposals ahead of the final submission.
The Intention to Apply should be top level and a maximum of 2 sides of A4 (Arial 11pt, 2cm margins, no less than single line spacing). This should briefly address the key strategic needs and challenges, setting out the proposal’s aims and objectives (using the information required for the full submission as a guide to critical issues) and identify the lead and key partners of the proposed consortium. It is recognized that final proposals are likely to continue to evolve right up to the application deadline, so they need not be restricted to the precise description provided within the abstract, although the full proposal must fully reflect its core elements. An overall budget should be provided (identifying total estimated staff/investigator costs, non-staff costs and indirect and estates costs only). A more detailed breakdown is not required, nor is there a need to provide specific justification for the resources requested at this stage.
Applicants who do not submit an intention to apply will be ruled ineligible to submit a full application.
Submissions to the full call
The deadline for full applications will be 4pm 7th November 2013.
Proposals will be externally peer reviewed following MRC’s standard review processes before being considered by an expert review panel in February 2014. Final funding decisions will be made by the contributing funding partners and announced in March 2014.
Please follow the general guidance for completing an application in the applicants’ handbook. This will guide applicants through the standard processes for preparing a proposal, costing proposals and how to address any ethical and regulatory requirements that may apply to the research. The case for support must not exceed 8 sides of A4 (Ariel 11 point), including references and governance. Applications exceeding the page limit will be rejected.
Applicants considering establishing collaboration with an industrial partner(s), are advised to refer to the guidance on MRC Industry Collaboration Awards (MICAs). A MICA form and Heads of Terms may be required as supporting documents in this case.
Case for Support
Proposals should describe:
- the critical translational challenges to be tackled by the proposal;
- the gaps in knowledge, and how the proposal will address these in driving progress towards the therapeutic goal;
- how what is being proposed is innovative and will transform current progress towards human health benefit;
- the positioning of the proposal relative to other (academic or commercial) therapeutic approaches being pursued in the area;
- the PIs / groups and/or industrial partners involved;
- end-user groups that need to be engaged; for example, linkage to clinicians /surgeons, manufacturing capabilities, the TSB Cell Therapy Catapult etc.
- how the research programme will be developed and managed, in accordance with the nature of the proposal (cross-site working, work-package relationships etc.),to provide evidence of the programme’s likelihood of achieving a successful outcome;
- consideration of the “next steps” towards human application that are required if all aims and objectives of the proposal are completed, including regulatory aspects where relevant
Applications involving human subjects
For applications involving in-human studies, an additional annex (of not more than four A4 sides) must be included, setting out the study plans in sufficient detail to enable robust review of any proposed clinical study/trial. 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
- Experimental Medicine Toolkit
- EMEA guidance on high risk, first-in-man clinical trials
- There should be sufficient clinical need and background proof of concept to justify the proposed trial.
- Study design, including oversight and governance arrangements, should be appropriate and be informed by relevant expertise.
- Dose and anticipated effect sizes (and why)
- Analysis plans (especially if using adaptive design) and powering calculations/information on powering should be included for all proposed clinical studies.
- Study participants; Inclusion/exclusion criteria should be specified and recruitment plans realistic and evidenced where possible.
- Endpoints should be relevant, appropriate and measurable.
- 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.
The assessment will take account of the scientific opportunities and capabilities presented. Consideration will be given to the:
- significance of the therapeutic challenges to be addressed;
- novelty, importance and timeliness of the research;
- ability of the investigators to deliver the translational research proposed;
- strength and clarity of collaborations and end-user engagement;
- appropriateness and quality of the project management structure proposed;
- quality and suitability of the research environment and of the facilities;
- value for money;
- ethical considerations and governance arrangements.
Applicants are directed to the supplementary terms and conditions for RC grants introduced in the context of stem cell research, see for example Medical Research Council – MRC Terms and Conditions, section AC24. All awardees will be required to annually submit reports to MRC’s Electronic Valuation System (Researchfish; previously MRC e-Val). For those applications which are jointly funded with Arthritis Research UK and Multiple Sclerosis Society, additional reporting requirements may apply.
Further details are available from Dr David Pan.
How to apply? The Joint electronic-Submission System (Je-S)
Completed proposals must be submitted through the Research Council’s Joint Electronic System (Je-S) and be received by the deadline date. This is done by the lead host institution’s administrative department, after they have completed their section of the Je-S application form. To ensure that applications reach Je-S in time, please give the administrative department advance notice of potential applications and the deadline date. Applications received after the deadline will not be considered.
For the purposes of this call, when filling in the Je-S application details, applicants should ensure that they select:
Select Council: MRC
Select document type: Standard
Select Scheme: Research Grants
Select call: UKRMP II Systems-focussed programme Oct 2013
Please note: All mandatory sections on the application need to be completed.
Call Launch – 30th July 2013
Call open on Je-S – 23rd August 2013
Submission Deadline ‘Intention to Apply’ – 4.00pm 18th September 2013
Submission Deadline ‘Full Applications’ – 4.00pm 7th November 2013
Funding Decisions – March 2014
Contacts and guidance
Dr David Pan
Programme Manager, UKRMP (on behalf of the BBSRC, EPSRC & MRC)
Telephone: 01793 416430
Dr Caroline Aylott, Arthritis Research UK
Telephone: 01246 541172
Dr Susan Kohlhaas, MS Society
Telephone: 0208 438 0822
Guidance can also be sought from:
- Dr Paul Colville-Nash (MRC Head Office) E-mail: firstname.lastname@example.org Telephone: 0207 395 2261
- Dr Jef Grainger (BBSRC) E-mail: Jef.Grainger@bbsrc.ac.uk
- Dr Nicola Goldberg (EPSRC) E-mail: Nicola.Goldberg@epsrc.ac.uk; Telephone: 01793 444475
Guidance and support for using the Je-S is provided by the Je-S helpdesk. Contact details for this service are as follows:
Phone: 01793 44 4164 *Staffed Monday to Friday 9am – 5pm (excluding bank holidays and other holidays)
Out of hours: leave a Voice Mail message
*Phone calls that cannot be answered during working hours will be redirected after 30 seconds to Voice Mail. The helpdesk will normally return your call within 3 hours.
Detailed online guidance for the Je-S is also provided on the Je-S website, together with a series of frequently asked questions. There are also help pages on the Je-S system itself to accompany each section of the application form.