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MRC-AMED Regenerative Medicine and Stem Cell Research Initiative

Please note this opportunity is now CLOSED.
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The MRC and the Japan Agency for Medical Research and Development (AMED) are pleased to invite proposals to the UK-Japan Regenerative Medicine and Stem Cell Research Initiative.

This initiative will provide funding for approximately eight collaborative research projects that build upon fundamental insights and initial early-stage discoveries, to advance regenerative approaches towards clinical use in the future and to utilise stem cells as medical research tools.

In total MRC will make up to £5 million available in support of the UK components; with matched equivalent resource provided by AMED in support of the Japanese components.

Background

The UK and Japan are world leaders in stem cell and regenerative medicine research. Past pioneering work in our countries has had a transformative impact and has revolutionised the potential for innovative approaches to medicine.

In order to advance towards patient benefit in Japan, the UK and internationally, it is timely for our research leaders to work together to further understand critical regenerative processes in human health and disease, develop tools and technologies, obtain further proof of concept data, and ultimately be moving towards translation into the clinic. Both countries are working towards the same therapeutic goals, and it is clear that significant momentum could be achieved by linking research teams in the area of preclinical development such that learnings and technologies can be shared for mutual benefit. Given that the UK and Japan have aligned regulatory environments that are strict but permissive, our countries are well positioned to attract future commercial interest and progress well designed and tested novel therapies.

Regenerative medicine is an interdisciplinary research field that seeks to develop the science and tools to help repair or replace damaged or diseased human tissue. As a form of ‘advanced therapy’ regenerative medicine has the potential to address a number of currently incurable degenerative conditions and is poised to revolutionise medical treatment in the 21st century.

All regenerative medicine strategies depend upon harnessing, stimulating or guiding our naturally occurring developmental or repair processes, and could involve transplantation of cells, stimulation of the body’s own repair processes, or the use of cells as delivery vehicles for therapeutic agents. Stem cells have various potential in medical applications such as pathological elucidation and novel drug development, etc, thus it is important to utilise stem cells broadly in medical research.

MRC

MRC will support this activity under the umbrella of the Fund for International Collaboration (FIC). FIC aims to enhance the UK’s excellence in research and innovation through global engagement. It focuses on bilateral and multilateral partnerships with global research and development (R&D) leaders and is administered by UK Research and Innovation (UKRI).

AMED

AMED will support the Japanese components of the collaborative projects through “The Program for Technological Innovation of Regenerative Medicine”. This program implements objective-achievement-type basic research, based on original ideas that advance the development of the field of stem cells and regenerative medicine. The main purpose of this program is to develop seeds of next-generation innovative medicine; therefore, emphasis is on research that will be of high international competitiveness, research based on innovative and creative ideas, and research that contributes to technological innovation.

Aim

Through the UK-Japan Regenerative Medicine and Stem Cell Research Initiative, MRC and AMED aim to:

  • Support world-leading collaborative research teams focused on building upon fundamental insights and initial early-stage discoveries, to advance regenerative approaches towards clinical use in the future and to utilise stem cells as medical research tools.
  • enhance existing partnerships and develop new partnerships between the UK and Japan in the area of Regenerative Medicine and Stem Cell Research.
  • strengthen the strategic relationship between the UK and Japan.

Objectives and scope

The objective is to deliver research funding for internationally competitive and innovative collaborations between researchers from Japan and the UK in the fields of stem cell research and regenerative medicine.

This initiative will support research projects that build upon fundamental insights and initial early-stage discoveries, to advance regenerative approaches towards clinical use in the future and to utilize stem cells as medical research tools.

Support will be available for research that underpins the development of regenerative medicine therapeutic strategies, including by developing scientific knowledge, tools and technologies with the overall goal of progressing regenerative medicine therapies further along the development pipeline.

Applications are particularly welcome for projects focusing on:

  • Human cell engineering, gene editing and cellular reprogramming approaches where a clear future therapeutic goal has been identified
  • Investigations into modulation of the human tissue niche, or improving understanding of the niche; this may include for example establishing mechanisms for differentiation in transplanted stem cells or understanding immunological barriers  
  • Improving efficacy of engraftment and regeneration of transplanted cells
  • Developing tools, technologies and methods to enable translational regenerative medicine research including, but not limited to, in-vivo cell imaging approaches or high throughput screening techniques
  • Creating novel in-vitro models utilising stem cells which could be used for robust predictive safety testing or as drug screening models

Alternative project outcomes such as therapeutic candidates, medical devices and diagnostic agents may also be supported by this call.

The funders encourage the participation of early career researchers within the collaborative research teams in order to stimulate a future generation of UK-Japanese collaborations in this important area.

Start Date and Duration

On the UK side, projects must start on 1 October 2020. Projects must be three years in duration and have completed by 30 September 2023.

On the Japanese side, projects must start by 15 September 2020 and complete in March 2023. The Japanese component of the projects will therefore be shorter than three years.

UK applicants should refer to the standard MRC Guidance for Applicants  for information on what the starting procedure entails; please inform the relevant support staff in your organisation of this requirement to ensure the project starts on time.

Japanese based applicants should refer to MRC-AMED Call Specific Guidance for Applicants as well as the ‘2020 AMED Call Guideline’ for “The Program for Technological Innovation of Regenerative Medicine *(written in Japanese) for application development.

How to Apply

  • Intention to Submit (ItS)

UK based researchers planning to submit to this scheme should submit a short Intention to Submit (ItS) by 23:00 UK time on 20 January 2020. Please note, this step does not form part of the review process and the MRC will not undertake eligibility checks at this point; applicants should not await a response from the MRC following ItS submission, but simply continue with the development of the full proposal to be submitted by the deadline of 20 February 2020. The MRC will use the ItS to help prepare for the review process.

Applicants are not expected to submit an ItS to AMED too, however, all details submitted to the MRC will be shared with AMED.

  • Full applications

UK and Japanese applicants must apply separately to their respective funding agencies by 20 Feb 2020 for the funding component requested within each country, but this must be based around a common research plan and vision. The application must be JOINTLY prepared by both UK and Japanese applicants.

Both partners must therefore submit an identical joint Case for Support (including if applicable a one-page methodology annex) and separate optional one-page Gantt chart written in English to the MRC and AMED.

As there will be a single Case for Support, it is vital that it provides full details of the work proposed for both the UK and Japanese components.

An identical version (in English) of the call-specific Justification of Resources template should also be submitted to both MRC and AMED.

The submission to AMED (by the Japanese PI) must be via the online submission system, e-rad: https://www.e-rad.go.jp/. The AMED submissions must be received by 18:00 (Japanese time) on 20 Feb 2020. Japanese based applicants must complete all forms announced on the AMED website. Further guidance can be found in the ‘2020 AMED Call Guideline’ for “The Program for Technological Innovation of Regenerative Medicine”.

The submission to MRC (by the UK PI) must be via the UKRI Joint electronic Submission (Je-S) System. The Je-S submissions must be received by 16:00 UK time on the day of the deadline. UK applicants must complete all sections required for a standard research council grant proposal. Further guidance can be found in the general MRC Guidance for Applicants, and the MRC-AMED Call Specific Guidance for Applicants.

Failure to submit a valid application to both the MRC and AMED by the deadline will invalidate both submissions. The MRC and AMED will conduct a remit check/relevance review to ensure applications are aligned with the scope of the call. Applications that are deemed not eligible or are not relevant to the call will be withdrawn from the competition.

UK and Japanese researchers should discuss ethics and intellectual property before fully developing their proposal. For more details, see the collaboration agreement, ethics and intellectual property section of this call document and the MRC-AMED Call Specific Guidance for Applicants.

Additional guidance for 'Case for Support'

A jointly-prepared Case for Support should be submitted by the applicants to both funders’ application systems, attached as a PDF.

Briefly, the case for support may be up to 8 A4 pages in length (including illustrations and references) plus an optional additional one-page methodology annex, using Arial 11pt typeface with margins of 2cm on all sides. The Case for Support should address each of the following headings:

  1. title
  2. importance of the research (including synergistic effects of the collaboration)
  3. scientific potential
    1. people and track record (including plans for the participation of early career researchers)
    2. research environment
    3. research plans and deliverables
  4. ethics and research governance
  5. exploitation and dissemination
  6. project partners.

Generic guidance on content under each of these headings can be found in section 2.2.3.3 of MRC’s standard Guidance for Applicants document and call-specific guidance can be found in the MRC-AMED call-specific Guidance for Applicants.

Funding available

In total, up to approximately £7m will be made available for this initiative. The funding agencies intend to use these available funds to support approximately 8 collaborative projects, subject to quality.

Each grant will require a UK PI and a Japanese PI who will equally share leadership and project management for each project. Each PI will apply for funding to support the specific component of the grant from their respective funding agency.

UK: MRC will make up to £5m available to cover the UK components of the collaborative research projects selected for funding under this call. UK based applicants may therefore request up to a maximum of £625k at 80% fEC to cover the UK component of the research project. The MRC will provide funding under standard arrangements and at 80% of the full Economic Cost (fEC). The UK element of funding will not cover UK PhD studentships or requests for capital items.

Japan: AMED will make up to 10,000,000 yen (plus 30% overheads) available per annum per project for 3 Japanese fiscal years.

UK spending obligations

Due to the tight time scales of this call, successful UK research organisations will need to adhere to strict spending requirements. For this call, the end date of the proposed research should be no later than 30 September 2023.

Eligibility

This call will fund partnerships between UK and Japan based researchers working in the area of regenerative medicine and stem cell research.

For support under this call, applicants must be eligible to apply for funding from their respective country’s funding agency:

MRC

For the UK-based participants, standard UKRI eligibility criteria as described on the UKRI website will apply. Research organisations that are eligible to apply to the MRC, for example MRC units and institutes may apply to this call. Further information on eligibility is available in section 1 of the MRC Guidance for Applicants.

AMED

The Japan-based PI must be affiliated with a domestic university or research institution in Japan where the proposed project will be carried out.

For further details, please refer to the ‘2020 AMED Call Guideline’ for “The Program for Technological Innovation of Regenerative Medicine”  (written in Japanese).

Principal investigators/applicants may only submit one application to this scheme as principal investigator but may be involved in more applications if listed as a co-investigator.

Principal investigators/applicants will apply for funding to support their specific component from their respective funding agency. Applications submitted to only one side/funding agency will not be accepted. Please note the deadline for submission to MRC is 20 February at 16:00 UK time and the deadline for submission to AMED is 20 February 18:00 Japanese time.

The funders are not seeking to support partners outside of the UK and Japan through this initiative. Please contact international@mrc.ukri.org (for UK based PI’s) and rminnov”AT”amed.go.jp (replace “AT” with “@”) (for Japan based PI’s) if you are planning to involve co-investigators from a third country in your proposal.

Assessment criteria and decision-making process

To be funded, proposals must be internationally competitive and at a standard equivalent to that normally expected to be supported by each funding organisation.

Key assessment criteria and perspectives for the submissions will be:

  • compatibility with the objectives and scope of the call
  • significance and impact of the research
  • scientific rationale: novelty, innovativeness, importance and timeliness of the research
  • design and feasibility of the project plan
  • partnership: including strength and clarity of collaborations and opportunities provided, and quality of the project management structure proposed; the added value of the UK-Japanese collaboration; engagement of early career researchers
  • quality and suitability of the research environment and of the facilities
  • value for money for Japanese and UK science
  • ethical considerations and governance arrangements.

Eligible applications will be externally peer reviewed. Applicants will be offered the opportunity to provide a written response to these reviews. Following this process, applications will be assessed by a joint MRC-AMED evaluation committee. Applications will be given one overall score. The proposals with the highest scores will be funded in rank order subject to them meeting the minimum quality threshold.

It is envisaged that all applications deemed relevant will go through the full peer review process described above. However, the MRC and AMED reserve the right to adjust the process and introduce a shortlisting/streamlining step if a high number of proposals are submitted to the call.

Funding decisions will be made through a joint process.

Collaboration agreement, ethics and intellectual property

As the research projects will be carried out by multiple research organisations and project partners, the basis of collaboration between the organisations and project partners, including ownership of intellectual property (IP) generated during the project and rights to exploitation, and costs of IP management (this is not an eligible (direct) cost to MRC UKRI or AMED), is expected to be set out in a formal collaboration agreement between the research organisations involved. It is the responsibility of the research organisations to put such an agreement in place within 6 months of the start of the UK component of the project. The terms of collaboration shall not conflict with MRC and AMED terms and conditions. When collaborating, researchers must conform to their respective, applicable requirements on research involving humans, animals or stem cells.

Further details are provided in the MRC-AMED Call Specific Guidance for Applicants for this call and 2020 AMED Call Guideline for “The Program for Technological Innovation of Regenerative Medicine” *1.

Reporting

It will be necessary for each funded group to submit reports to AMED and MRC in accordance with the respective regulations.

Key dates

Stage

Date

Pre-announcement

5 November 2019

Launch date   

9 December 2019

Deadline for compulsory Intention to Submit (to be submitted to MRC only)

20 January 2020

Deadline for applicants to submit proposal (in both countries)

20 February 2020

External/remote peer review

March-June 2020

PI response to peer reviews

June 2020

Joint Panel Meeting

July 2020

Notice of decision date

July/August 2020

Funding start date

15 September on Japan side; 1 October 2020 on UK side

Contacts and guidance

Please read the:

An identical version (in English) of the call-specific Justification of Resources template should be submitted to both MRC and AMED.

For further information, UK applicants should contact: international@mrc.ukri.org

For further information, Japanese applicants should contact rminnov”AT”amed.go.jp (replace “AT” with “@”).