Purpose
The purpose of the Regenerative Medicine Catalyst Grants programme is to provide catalytic funding for translational research projects within the identified thematic research areas (described below), aligned with Novo Nordisk Foundation strategic areas. The proposed programme focuses on catalysing solutions to current challenges in the regenerative medicine (RM) field, thereby advancing the field, strengthening the Nordic RM ecosystem, promoting international collaboration, and lowering time- and cost-barriers to RM therapies.
Thematic Research Areas
Overall, the programme aims to address current challenges within development of regenerative medicine therapies, especially the advance of stem cell-based therapies towards clinical development. Funding will be prioritised for high-impact projects that aim to solve or make significant strides towards solving the listed challenges, as well as projects that can advance the broader regenerative medicine field, for instance through platform potential.
Research projects suitable for funding within the call must:
- Be in scope of at least one of the four thematic research areas outlined below
- Have a translational and applied focus, aiming to progress discovery phase regenerative medicine projects towards clinical development
- Lead to the development of new protocols or methods that can advance the regenerative medicine field
- Have clearly articulated aims or goals with respect to the outcomes that are expected to be catalysed by this project and the potential long-term impact of these outcomes (beyond the project itself)
Themes considered out of scope
Fundamental, discovery phase projects, projects focused on adult immune cell-based therapy, such as CAR-T- and NK-cell therapy, as well as projects with a focus on gene therapy, will not be considered for funding.
Theme 1: Allogeneic cell therapy
Allogeneic therapy represents a major cell therapy paradigm and involves the use of donor-derived cells. A key advantage is the potential to generate scalable off-the-shelf products. However, donor-derived cells face challenges related to immunogenicity and patient immune rejection, while scalable and cost-effective manufacturing requires robust tools to enhance cell differentiation efficiency and functionality.
Areas of translational research could be (but are not limited to):
- Overcoming immunogenicity and patient immune rejection of donor cell-based therapies, including the development of immuno-evasive/hypo-immune cells
- Developing and validating cell engineering methods (including gene editing approaches) with broad platform potential to e.g. enhance cell differentiation, functionality
Theme 2: Analytical methods to validate stem cell-based medicine
Development of stem cell-based therapies requires robust and reliable analytical methods for validation of key parameters such as cell differentiation efficiency, cell population composition and purity, and therapeutic efficacy, among others. With the aim to reduce cost- and time-barriers to therapy development, projects within this theme should focus on solving challenges related to analytical methods for stem cell-based medicine, preferably with broad platform potential, in research as well as chemistry, manufacturing, and controls (CMC) settings.
Areas of translational research could be (but are not limited to):
- Development of analytical methods and technologies, especially for functional assessment and potency testing of stem cell-based medicines
Theme 3: Engineering biomaterials for regenerative medicine therapy
Although the principal component of cell therapy is the cellular product itself, optimal culturing conditions, complex cell organisation, and efficient cell therapy delivery often require the use of specialised biological or synthetic scaffolds and specialised devices. Importantly, these scaffolds must be designed to be compliant with health authority regulation. Within this theme, funding will be allocated to projects that seek to engineer such innovative scaffolds, biomaterials, and devices.
Areas of translational research could be (but are not limited to):
- Engineering of scaffolds and biomaterials to support
- cell culture and disease modelling
- delivery of cell therapies
- controlled tissue regeneration and cell growth in vivo aiming for human use
- Advancing technologies such as bioprinting to allow generation of complex organoids and tissues
- Development of novel devices for cell transplantation or delivery
- Preclinical testing of novel scaffolds, biomaterials, or devices
Theme 4: Clinical development of cell therapies
Transitioning a cell therapy research candidate into clinical trials is currently associated with significant challenges from a manufacturability point-of-view, which is reflected in the highly exploratory nature of the cell therapy field. Collectively, these challenges constitute a substantial risk in the ability to reach human testing and ultimately the patients in need. Efficient translation using scalable technologies and advanced analytics, mindful of health authority expectations and cost effectiveness, will be key to enable further progression of the cell therapy field into clinical development.
Areas of translational research could be (but are not limited to):
- Addressing challenges related to scalability and transition into closed culture systems
- Translating cell therapy candidates to be GMP (good manufacturing practice) compliant
- Optimisation of culturing processes to ensure consistent quality of product and reduce batch variation
- Establishment of robust processes for (cryo)preservation of cell therapies and intermediates
- Advancing cell therapy development into preclinical testing in vivo
Eligibility
- The main applicant must be anchored and have their primary employment and research group at a university, hospital, or other non-profit research institution in a Nordic country (Denmark, Sweden, Norway, Finland, Iceland, Greenland, Faroe Islands).
- The main applicant must be an established investigator with their own line of research.
- It is possible to apply for a ‘collaborative project’ which includes at least one international co-applicant who is anchored and has their primary employment and research group at a university, hospital, or other non-profit research organisation outside of the country of the main applicant. If an international co-applicant is included, they must significantly contribute to the scientific advancement of the project and receive a significant part of the funding (to be detailed in the application). Further, it must be clear from the application how the project collaboration is ensured, and the work and budget are distributed. Co-applicants from a different Nordic country than the main applicant are considered international collaborators.
- Projects that only involve international co-applicants from within the same research centre as the main applicant are not eligible as collaborative projects.
- The main applicant and, if included, the co-applicant must be employed at the institution they are applying from and must be guaranteed their own salaries for the entire project period.
- A named co-applicant can only be included in a maximum of two applications.
- Current Regenerative Medicine Catalyst Grant holders are not eligible as main applicant but can apply as co-applicant provided that there is no overlap in project scope with the funded application.
- Collaboration with for-profit research partners (biotech, industry etc.) is possible, but funding cannot be awarded to for-profit research partner(s), unless they act as sub-contractors (e.g., consultants, service providers, vendors, etc.). The nature of such collaborations must be disclosed (e.g. CRO/subcontractor vs in-kind contributions vs commercial interest etc.)
- Applying for this call will not affect your eligibility to apply for other Novo Nordisk Foundation calls and vice versa (e.g., Project Grants in Bioscience and Basic Biomedicine or Clinical and Translational Medicine). However, you cannot apply to other Novo Nordisk Foundation calls with a project that is overlapping in scope while the assessment of your application to this call is ongoing.
Funding
The total grant budget is DKK 100 million, which can be awarded over two years (2026-2027).
The individual grants awarded can have one of two different granting frameworks:
Standard projects:
- One main applicant based in a Nordic country (Denmark, Sweden, Norway, Finland, Iceland, Greenland, Faroe Islands)
- Co-applicants (optional) from the same Nordic country as the main applicant
- Up to DKK 5 million can be awarded, with a grant period of up to three years
Collaborative projects:
- One main applicant based in a Nordic country (Denmark, Sweden, Norway, Finland, Iceland, Greenland, Faroe Islands)
- At least one international co-applicant based in a country different from that of the main applicant (including another Nordic country)
- Up to DKK 10 million can be awarded, with a grant period of up to three years
- The budget does not have to be split evenly between the main and co-applicant institutions but if one institution will receive significantly more funding, a clear justification must be provided
Application process
About the grants
The application process is divided into two phases.
Phase I:
Applicants submit a brief concept note which is evaluated and triaged internally in the Novo Nordisk Foundation (including employees from the Novo Nordisk Foundation Cellerator and the BioInnovation Institute). Selected applications will be invited to phase II. The Foundation will not provide feedback in case an application is declined in phase I.
Phase II:
Applicants submit a full application which will be evaluated by external peer review.
The peer review will be conducted by international experts within the four thematic research areas, and the anonymous peer review feedback will, in writing, be shared with the applicants post granting decision, regardless of the outcome of that decision. The peer review is meant as valuable feedback regarding the projects. It will not be possible to submit objections to the funding decision nor the peer review.
Please read “Guidelines for Applicants” carefully before initiating the application process. Additional and essential information is found in these guidelines
Important: If the current application is a resubmission of an application to an earlier Regenerative Medicine Catalyst Grants call, there must be a section in the project description that succinctly explains how concerns/suggestions from the peer reviewers have been addressed/incorporated into the project.
