CALL FOR PROPOSALS JOINT TRANSNATIONAL (2027) for Cell and Gene Therapy for Personalised Medicine (CGT4PM2027), ZonMw

(EP PerMed Grant 101137129)

CALL TEXT

Important Deadlines

Submission of pre-proposals: 20 January 2027 at 14:00 (CET)

Submission of invited full proposals: 25 May 2027 at 14:00 (CEST)

Link to the electronic proposal submission tool: https://ptoutline.eu/app/eppermed2027

For further information, please visit our website: www.eppermed.eu or contact the EP PerMed Joint Call Secretariat (JCS):

French National Research Agency (ANR)

86 rue Regnault, 75013 Paris, FRANCE

Mylène Vaillancourt, Dr. Mérick Machouri

Phone: +33 1 78 09 80 36, +33 1 72 73 06 72

Email: EPPerMed@anr.fr

Table of contents

1	Introduction and aims of EP PerMed
2	Participating regions, countries and funding organisations
3	Timeline of the call
4	Rationale of the call
5	Aim of the call
6	Expected Results, Outcome and Impacts
7	Application
8	Formal check and evaluation of proposals
9	Ethical clearance – Ethics and RRI evaluation
10	Final decision on funding
11	Redress procedure
12	Project Start, Consortium Agreement and Data Management Plan
13	Reporting requirements and Open Access to publications
14	Annex I. Regional/National Contact Details
15	Annex II. Indicative funding commitments of the participating organisations of the EP PerMed JTC2027
16	Annex III. Definition of early career researcher/scientist

1 Introduction and aims of EP PerMed

Personalised Medicine (PM) represents a paradigm shift from a “one size fits all” approach to an optimised strategy for the prevention, diagnosis and treatment of disease for each individual, based on their unique characteristics, including biological features (e.g. phenotype, genotype), as well as lifestyle and other environmental factors. Accordingly, PM puts the patient at the very centre of healthcare, aiming for optimised health promotion, treatments and management of disease or predisposition to disease. Today, the field of PM has been advancing rapidly and the range of technologies, methods and information utilised has become much broader, supporting improved healthcare, diagnostics and tailormade treatments, including rehabilitation, and prevention strategies.

Definition of Personalised Medicine:

EP PerMed adheres to the definition stated in the PerMed SRIA: ‘Shaping Europe’s Vision for Personalised Medicine’ (2015)[1], adopted from the Horizon2020 Advisory Group[2]:

“Personalised Medicine refers to a medical model using characterisation of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention.”

Some additional information can be found in the 2018–2020 Advice of the Horizon 2020 Advisory Group for Societal Challenge 1, “Health, Demographic Change and Well-being”.

“Different synonymous terms have been used alongside ‘personalised medicine’, most commonly ‘precision medicine’ and ‘stratified medicine’. While there may be subtle differences in the literal meanings of these terms, they usually refer to the same concept when applied in practice. Stratified medicine (mainly used in the UK) is more treatment-dependent, while precision medicine (mostly used in US) has a relatively broad meaning as it refers to 4P (predictive, preventive, personalised and participatory) medicine. We use the term personalised medicine because this term best reflects the ultimate goal of effectively tailoring treatment based on an individual’s ‘personal profile’, as determined by the individual’s genotype and phenotype data. Based on individuals’ profiles, PM aims to identify the optimal treatment regime by avoiding the treatment failure approach commonly used in current evidence-based medicine.”

1 https://www.eppermed.eu/wp-content/uploads/2023/09/EPPerMed-SRIA.pdf

2 European Commission. Advice for 2016/2017 of the Horizon 2020 Advisory Group for Social Challenge 1, “Health, Demographic Change and Wellbeing”, July 2014:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AC%3A2015%3A421%3AFULL

The European Partnership for Personalised Medicine, EP PerMed, is a platform for joint programming of national and European regional research and innovation (R&I) programmes putting into action “The Strategic Research & Innovation Agenda (SRIA) for Personalised Medicine (2023)”, SRIA for PM (2023), through dedicated research, development and innovation funding. The funding of transnational collaborative research is a joint activity to further enhance the cooperation between stakeholders across Europe and beyond to maximise the benefits of PM approaches and thus pooling resources and achieving investments of scale in this field. Furthermore, to ensure efficient utilisation and accessibility of new and improved PM approaches, project consortia are required to be multidisciplinary and intersectoral in EP PerMed calls for proposals, by including academia (universities, research performing organisations both public and private not for profit), clinical settings and public health organisations, the private sector (spin-offs, start-ups, SMEs, the European biotechnology and health/pharma industries), and also participatory research e.g. with patients, citizens, clinicians and healthcare providers.

2 Participating regions, countries and funding organisations

The funding organisations listed below are jointly launching the EP PerMed Joint Transnational Call 2027 (JTC2027), co-funded by the European Union (EU). The JTC2027 is managed by the EP PerMed Joint Call Secretariat (JCS).

The call is opened and simultaneously supported by the following (39) funding organisations in their respective regions or countries:

Country/Region	Funding Organisation	Acronym
Austria	Austrian Science Fund	FWF
Belgium (Flanders)	The Research Foundation – Flanders	FWO
Belgium (Flanders)	Vlaams Gewest – VLAIO Flanders Innovation & Entrepreneurship	FIO/VLAIO
Belgium (Wallonia-Brussels Federation)	Fund for Scientific Research – FNRS	F.R.S.-FNRS
Belgium (Wallonia)	Service Public de Wallonie	SPW EER
Canada	Canadian Institutes of Health Research	CIHR
Czech Republic	The Ministry of Health of the Czech Republic	MZCR
Estonia	Estonia Enterprise	EIS
Estonia	Sihtasutus Eesti Teadusagentuur	ETAG
Finland	Business Finland	BFRK
France	The French National Research Agency	ANR
Germany	Federal Ministry of Research, Technology and Space, (BMFTR) / German Aerospace Center e.V. Project Management Agency	BMFTR/DLR
Germany	Federal Ministry of Health, (BMG) / German Aerospace Center e.V. – Project Management Agency	BMG/DLR
Germany (Saxony)	Saxon State Ministry for Science, Culture and Tourism	SMWK
Greece	General Secretariat for Research & innovation	GSRI
Hungary	National Research, Development and Innovation Office	NKFIH
Ireland	Taighde Éireann-Research Ireland	TE-RI
Israel	Ministry of Health, The Chief Scientist Office	CSO-MOH
Israel	National Technological Innovation Authority	IIA
Italy	Italian Ministry of Health	IT-MoH
Italy (Friuli- Venezia Giulia)	Regione Autonoma Friuli Venezia Giulia	FVG
Italy (Lombardy)	Fondazione Regionale per la Ricerca Biomedica	FRRB
Italy (Tuscany)	Tuscany Region	RT
Latvia	Latvian Council of Science	LZP
Lithuania	Research Council of Lithuania	LMT
Luxembourg	National Research Fund	FNR
Norway	Research Council of Norway	RCN
Poland	National Centre for Research and Development	NCBR
Portugal	Fundação para a Ciência e a Tecnologia	FCT
Portugal (Azores)	VicePresidency of Azores Regional Government	VP-GRA
Romania	Executive Agency for Higher Education, Research, Development and Innovation Funding	UEFISCDI
Slovak Republic	Centrum vedecko-technických informácií Slovenskej republiky	CVTI SR
Spain	National Institute of Health Carlos III	ISCIII
Spain (Andalusia)	Consejería de Presidencia, Sanidad y Emergencias de la Junta de Andalucía	CPSEJA
Spain (Catalonia)	Health Department – Generalitat de Catalunya	DS-CAT
Sweden	Swedish Research Council	SRC
Sweden	VINNOVA Sweden´s Innovation Agency	VINNOVA
The Netherlands	The Netherlands Organisation for Health Research and Development	ZonMw
Türkiye	The Scientific and Technological Research Council of Türkiye	TÜBİTAK

3 Timeline of the call

04 November, 2026	Publication of the call
20 January, 2027 (14:00, CET)	Deadline for pre-proposal submission
Expected around 9 April, 2027	Communication of the results of the pre-proposal as-sessment and invitation to the full proposal stage
25 May, 2027 (14:00, CEST)	Deadline for full proposal submission
Beginning of August 2027	Rebuttal stage
Expected for October 2027	Communication of the funding decisions to the applicants
End of 2027, beginning of 2028	Expected project start (according to regional/national funding regulations)

4 Rationale of the call

Cell and Gene Therapies (CGT) are advanced, transformative treatments with the potential not only to outperform conventional therapies in terms of efficacy, but also to address unmet clinical needs in diseases for which no curative treatment currently exists.Unlike conventional pharmacological therapies, which primarily target symptoms, CGT address the underlying causes of disease. Strategies include the ex vivo engineering of stem cells and immune cell populations, as well as in vivo delivery of cells, genes or gene-editing reagents.

CGT are not necessarily personalised per se, but they form the basis of modern PM and are often highly individualised. They have demonstrated unprecedented efficacy, namely in the treatment of inherited haematological and immunodeficiency disorders, refractory lymphoid malignancies, and melanoma. With only 22 CGT currently authorised by the European Medicines Agency¹, there is a critical need to develop innovative and novel CGT for PM for a broader range of diseases with unmet medical needs, and to accelerate their translation into clinical implementation.

Cell therapy: treatment in which living cells are administered to a patient to treat, cure or pre-vent a disease.

Gene therapy: treatment that works by modifying a patient’s genetic material to treat or cure a disease. This includes gene addition or replacement, gene editing, and gene silencing or suppression.

Combined CGT: is a treatment in which cells are genetically modified to achieve a therapeutic effect before being administered to a patient.

Despite many promising clinical successes, CGT face a range of biological, manufacturing and commercial challenges. Ensuring precise targeting of the appropriate cells and tissues is critical to optimising therapeutic efficacy while minimising off-target effects and associated risks. In parallel, monitoring of outcomes is essential to ensure treatment efficacy and patient safety. Therefore, the development of diagnostics approaches to enable early patient stratification or predict treatment response, potential adverse effects, biodistribution and toxicity is needed to improve both the safety and effectiveness of CGT.

Some of the most limiting barriers to CGT translation to clinical implementation are related to the manufacturing complexity and cost. Unlike classical pharmacotherapies, CGT are highly individualised and often involve living cells, viral vectors or gene-editing systems, which are sensitive to environmental conditions. Therefore, researchers should consider the manufacturing process from the earliest stages of CGT development and testing. For example, for autologous therapies, this would include establishing a “vein-to-vein” process: cell collection, transport, modification, and administration, within a limited timeframe. Each step carries risks, including delays, contamination, potential failure, and batch-to-batch variability that may affect the potency and consistency of the final product. Considering the manufacturing process can also influence the therapy strategy. For example, while autologous cell therapies are attractive for their immune compatibility, allogeneic approaches offer the potential for faster, more scalable and accessible treatments, with an improved cost-effectiveness.

Addressing these challenges requires better product, patient and disease understanding alongside improved manufacturing and delivering processes, and better characterisation of the CGT functional and preclinical attributes, leading to a stronger Chemistry, Manufacturing, and Controls (CMC) preparedness. Such advances are essential to facilitate the efficient translation of promising research findings into clinical trials and, ultimately, routine clinical implementation.

5 Aim of the call

With this JTC, EP PerMed will fund research projects in human health on CGT for PM approaches. Proposals must focus on the development and validation of an innovative and novel CGT² for PM.

For this call, CGT are considered innovative and novel when they offer clear therapeutic advantages over the standard of care, such as improved efficacy, enhanced safety, longer-lasting effects, or the ability to address previously untreatable conditions.

At least one of the following approaches must be employed:

• Somatic cell therapeutics (e.g., in the form of stem cells, organoids, or cells of the immune system);

• Gene therapeutics in the form of gene substitution, addition or suppression therapies using viral and non-viral vectors or genome editing;

• Combined cell- and gene therapeutics in the form of genetically modified cells;

• Novel biological products such as mRNA, other nucleic acid-based methods, and extracellular vesicles as vehicle for gene-based therapeutic procedure.

The research projects have to use physiologically relevant preclinical models (e.g., human cell cultures, organoids, organs-on-chips, animal models). Furthermore, they have to show solid preliminary data (e.g., defined vector or cell system, existing preclinical model) and have to describe a credible pathway towards clinical application.

Accompanying the above research fields, proposals may include:

• Diagnostic approaches provided there is a clear link to personalised CGT to enable patient stratification or to predict response, efficacy, dosage optimisation, adverse effects or toxicity.

• Development of novel manufacturing or delivery methods provided they incorporate a personalised CGT backbone.

• Preclinical in vitro/in vivo characterisation assays for novel and personalised CGT, to assess key aspects such as batch-to-batch consistency, biodistribution, potency, stability, safety and tolerability, ideally according to Good Laboratory Practice (GLP) standards, where required from a regulatory perspective for further development and translation to patients.

Research projects in all disease areas are encouraged.

The following approaches are excluded: • Any standalone approach (e.g. immune therapy, delivery platforms, development of preclinical models, etc.) if the approach does not incorporate a CGT backbone in the proposal; • Identification and validation of new targets; • Tissue engineering4 (e.g., production of tissue for surgical use, such as tissue replacement or reconstruction); • Approaches based exclusively on small-molecule substances, recombinant proteins, or therapeutic antibodies; • Approaches developed for objectives other than CGT (e.g. tumour vaccination, mRNA vaccination against infectious diseases, microbiome-based therapeutics); • Clinical trials (phases I-IV), defined as prospective interventional clinical studies involving the administration of an investigational medicinal product in human subjects.

Proposals that align with any of these excluded approaches will be deemed “out of scope” during the evaluation.

Thorough knowledge of regulatory requirements, including preclinical guidelines (e.g. GLP standards) and CMC is critical to de-risk the therapy’s transition to clinical trials. While proposals funded under this call are not expected to deliver fully regulatory-ready innovations, they are required to include a dedicated work package addressing preclinical development and early CMC proportionate to the maturity and objectives of the proposed CGT (see also the “Guidelines for Applicants”, section 8). This could outline a preclinical development strategy covering pharmacology, biodistribution, and toxicology studies. It could also include designing a robust and scalable manufacturing process, defining a control strategy linked to a credible pathway toward GMP-compliant manufacture, etc. Where applicable, CMC and preclinical development should include an early assessment of the feasibility of GMP-compliant manufacture and a prospective manufacturing strategy. Activities under this work package should aim to anticipate and support the preparation of the quality and nonclinical sections of an Investigational Medicinal Product Dossier in accordance with the requirements of the European Medicines Agency³. Broad consultation with stakeholders such as regulatory authorities, clinical investigators, and patient/citizen representatives, early in the project conception and during the course of the project is recommended to ensure a successful clinical translation.

Aspects to consider during the preparation of proposals

The EP PerMed overall aims to (see also “Guidelines for Applicants”):

• Foster interdisciplinary collaborations, i.e. multi-actor research, by engaging a range of relevant disciplines such as preclinical and clinical research, bioinformatics/health informatics/data research, ethics, social sciences, law makers, etc.;

• Encourage cross-sectorial collaborations between academic researchers and the private sector (e.g. small and medium enterprises (SMEs), large enterprises), healthcare providers, patient/citizen organisations, etc.

Proposals must be interdisciplinary and clearly demonstrate the potential impact on disease outcome or healthcare delivery through PM, as well as the added value of the transnational collaboration in sharing resources (e.g. registries, biobanks, databases, electronic health records, etc.), platforms/infrastructures, and specific knowledge important for the project and the PM field. The individual project partners within a joint application should complement each other. The proposed work should contain novel and ambitious ideas and promote innovative PM solutions moving from scientific value to patient benefits and ensure an adequate analysis of the emerging ethical and the legal aspects related to the research, e.g. data sharing and protection of privacy.

A growing body of evidence demonstrates system-wide (cardiovascular, immune, neurological, etc.) sex and gender differences in clinical disorders and therapeutic interventions, including differences in severity, mechanisms, and treatment response, even when the prevalence is similar between males and females. Therefore, and unless robustly justified, proposals must integrate the sex and gender dimension into their research (see also the “Guidelines for Applicants”, section 7).

Applicants are also strongly encouraged to consider underrepresented populations (e.g. ethnic minorities), or underrepresented patient sub-groups, e.g. children or elderly, in proposals submitted to the EP PerMed call (see also the “Guidelines for Applicants”, section 7).

EP PerMed strongly encourages the active involvement of patients, citizens, healthcare providers, pharmacists and health and social care service users to raise awareness, share knowledge, improve dialogue and facilitate implementation. These entities can be involved as collaborators or integrated as partners in the consortium, and their coherent integration will be part of the proposal evaluation (see section 8: Formal check and evaluation of proposals). Applicants should employ patient engagement and co-creation methods appropriate to the research objectives and target population, which may include patient advisory boards, interviews, focus groups, co-design workshops, patient journey mapping, patient preference studies, etc. Applicants should demonstrate how patient-centred research principles will be systematically applied throughout the project. EP PerMed is financially supporting the involvement of patient/citizen organisations as full consortium partners (please read carefully also the “Guidelines for Applicants”, section 6 and Annex II).

Please note:

Funded Technology Readiness Levels (TRL)^# differ between participating funding organisations. Please check the regional/national regulations (“Guidelines for Applicants”).

Regional/national eligibility rules apply for the funding of the applicant category, research stage/s, as well as for the funding of clinical studies (see also Annex III of the “Guidelines for Applicants”). There-fore, applicants are strongly advised to contact their relevant funding organisation (see also Annex I of the Call Text) and to carefully read the regional/national eligibility rules (“Guidelines for Applicants”, Annex III) prior to submission.

^# Horizon 2020 scale for TRL: https://ec.europa.eu/research/participants/data/ref/h2020/other/wp/2016_2017/annexes/h2020-wp1617-annex-g-trl en.pdf

Responsible Research and Innovation (RRI) and ethical compliance

Proposals should follow the principles of Responsible Research and Innovation (RRI). Consortia submitting a proposal to this call should demonstrate a commitment to investigating and addressing social, ethical, political, environmental or cultural dimensions of the proposed research.

Furthermore, proposed research must respect fundamental ethical principles. Applicants have to describe any potential ethical aspects of the work to be carried out, and how the project will fulfil applicable requirements in institutional, regional/national and European Union legislation (including the ethical standards and guidelines of Horizon 2020/Horizon Europe⁴).

Further information is available in the “Guidelines for Applicants” document, and consortia are requested to elaborate on both aspects, RRI and ethical dimensions, in the proposal application forms.

6 Expected Results, Outcome and Impacts

Research conducted in this call should result in one or more of the following aspects:

• Development/validation of innovative and novel personalised Cell and Gene-based Therapeutic approaches for clinical application;

• Diagnostic approaches for patient stratification for CGT or prediction of potential outcomes of CGT treatments;

• A better characterisation of novel, personalised CGT in terms of pharmacokinetics, biodistribution, pharmacodynamics, potency, safety, tolerability, effective therapy dosage and delivery optimisation;

• A “proof of principle” (POP) to demonstrate the feasibility of the therapeutic approach (e.g., via scientific publication, patent application);

• Collection of necessary in vitro and in vivo data for a scientific advice from a regulatory authority to plan the next steps for clinical research in order to reach clinical trial readiness for Phase I.

• For more mature projects, progression towards GMP-compliant clinical manufacturing and generation of the quality and nonclinical documentation required to support an Investigational Medicinal Product Dossier.

Furthermore, the funded research will lead to:

• Scientific publications or patent applications and creation of knowledge on personalised CGT for patients;

• Transnational and multidisciplinary collaboration or networks across sectors and in teams.

On a mid-term perspective the funded research will have the following outcomes:

• Accelerated translation of innovative Cell and Gene-based Therapies for PM into clinical practice;

• Innovative personalised CGT with improved safety and reduced adverse reactions;

• Optimisation of advanced treatment choices and evidence-based rationalisation of therapies used in healthcare;

• Strengthening of national/regional communities for translational research, including improved collaboration between clinical, manufacturing and academic settings and the development of sustainable innovation networks.

The call aims at supporting research projects that contribute to the EP PerMed (operational, specific and global) objectives and therewith contribute to the following expected impacts:

• The transnational, multidisciplinary, intersectoral and public-private collaborations will support the ‘Personalised Medicine System of Health’¹ in that the research, innovation and implementation fields and the involved actors are interconnected. This includes national/ regional networks where integrated care, open data policies, and institutional commitment to PM are already in place. This will contribute to a comprehensive and faster uptake of PM approaches from preclinical to clinical research, innovation and implementation in a circular and bidirectional manner and support the development of innovative tools, technologies and digital solutions for health and care.

• EP PerMed aims to enhance the understanding of diseases and translate research achievements (diagnostic tools, biomarkers, clinical strategies, advanced therapies, digital solutions, big data, health economics, ELSI) within PM and towards personalised care.

Overall, PM research funded in this call is expected to support Europe’s and Associated Countries’ strategy to stay in the forefront of research and innovation and simultaneously foster synergies between regions and countries. Outcomes of the research projects are meant to impact the European biotechnology and health/pharma industry. PM approaches will lead to reduced adverse effects, more efficient diagnostics and (follow-up of) treatments as well as new drug and technology production, faster adoption of innovation and an increase in market competitiveness.

7 Application

A. Eligibility criteria

• Only transnational projects will be funded.

• Each consortium must involve at least three partners from three different EU Member States or Associated Countries⁵ whose funding organisations participate in the call (see list above)⁶. Each of these partners must be eligible and request funding from the respective funding organisation. All three legal entities must be independent of each other.

• The project coordinator (i.e. the principal investigator and the applicant’s organisation) must be eligible to be funded by his/her regional/national participating funding organisation. The project coordinator (i.e. principal investigator and organisation) cannot be changed between the first and second stage.

Consortium composition:

• Max. 2 project partners per consortium can request funding from the same funding organisation. For some funding organisations, the maximum number of eligible partners who can be funded in one project is limited to one (see also the “Guidelines for Applicants” for individual funding rules).

• It is mandatory to integrate at least one early-career researcher (ECR) as principal investigator in a consortium. For the EP PerMed definition of ECR, please consult section 16 (Annex III).

• Pre-proposal stage:

• Maximum number of partners is 6 (no more than 2 partners from the same country, including partners on own funds),

• Maximum number of partners can be 7 if the consortium includes a 3^rd partner of the same country (condition: funding requested from at least 2 different funders of the respective country; applies to only one country per consortium, including partners on own funds).

• Widening concept⁷: In the full proposal phase, consortia are allowed to include an additional project partner that is eligible to receive funding from a funding organisation that is underrepresented in the second stage of the call and that agrees to participate in the widening option (a list of underrepresented regions/countries will be provided to coordinators invited to submit full proposals). The rules for the consortium composition need to be respected, i.e. the final number of partners can only sum up to 7 or 8 if there are 3 partners of the same country in a consortium (condition: funding requested from at least 2 different funders of the respective country; applies to only one country per consortium, including partners on own funds).

• No more than one partner on own funds is allowed in the consortia with at least three partners eligible for funding (more indications in “B. Funding recipients” of this section 7).

• Exception: To facilitate the integration of organisations representing patients or citizens into consortia, they can be added as additional partners at the pre-proposal stage or full proposal stage. Organisations representing patients or citizens can be added as additional partner(s) either on own funds or by applying for funding, if eligible, from EP PerMed (see also the “Guidelines for Applicants”: section 6 and Annex II) or the respective funding organisations. The consortia must follow all of the above-mentioned rules regarding the consortia composition without counting the patient/citizen representing organisations, except for the following rule: within one consortium, no more than 2 partners can request funding from the same funding organisation, including patient/citizen organisations. For some funding organisations, the maximum number of eligible partners who can be funded in one project is one.

B. Funding recipients

Joint research proposals may be submitted by applicants belonging to an entity according to the following categories (subject to regional/national funding regulations; see the “Guidelines for Applicants”):

• A. Academia (research teams working in universities, other higher education institutions) or research institutes;

• B. Clinical/public health sector (research teams working in hospitals/public health and/or other healthcare settings and health organisations). Participation of clinicians (e.g. medical doctors, nurses), pharmacists and general practitioners in the research teams is encouraged;

• C. Private for-profit (enterprise) partners, e.g. SME ⁸ (small and medium enterprises) and private non-profit partners, e.g. foundations, associations or non-governmental organisations.

Consortia submitting applications to this call are strongly encouraged to include partners from different categories (A, B and C) in line with the crosscutting/multidisciplinary nature of the call, where the aim is to include partners at different levels in the value chain. The number of participants, the category of partner organisations and their research contribution should be appropriate for the aims of the call (section 5), the aims of the research project and should be reasonably balanced in terms of international participation (the different points are reflected in the three evaluation criteria). Each collaborative project should represent the critical mass necessary to achieve the ambitious scientific goals and should clearly demonstrate the added value for the cooperation. The coherent integration of interdisciplinary and intersectoral partners and collaborators to the consortium will be part of the proposal evaluation (see section 8: Formal check and evaluation of proposals).

Research groups, SMEs and industrial partners (non-SMEs) or not-for-profit organisations not eligible for funding by one of the organisations participating in this joint transnational call (e.g. from non-funding countries or not fundable according to regional/national regulations of the participating funding organisations) may participate if they are able to secure their own funds. They are treated as full partners and their information, including budget indications, must be included in the pre- and full proposal templates as such. Please note that no more than one partner on own funds is allowed in consortia comprising at least 3 partners eligible for funding, i.e. a consortium of min. 4 project partners. A letter of commitment must be included as an annex to the proposal, at the full proposal stage, summarising the commitment of the partner participating in the project on own funds and demonstrating the source of funding.

To collect the necessary patient data or samples for the proposed study, a consortium may need to collaborate with other centres. If the only role of those centres is to provide patient data or samples for the study, they will not be treated as partners of the consortium, but can be included otherwise, e.g. via cooperation agreements or subcontracting.

Number of partners in the proposal[1]	Pre-proposal					Full proposal (only by inclusion of one underrepresented region/country)
	3	4	5	6	7	+1
Maximum number of partners on own funds[2]	0	1	1	1	1	1
Maximum number of partners per country[3]	1	2	2	2	3	3 (if the number of partners in the full proposal stage sums up to 7 or 8)

1 minimum of three partners eligible for funding from three different EU Member States countries, or two EU Member States and at least one Associated Country whose funders participate. Patient/citizen representing organisations are not included in this calculation.

2 patient/citizen representing organisations are not included in this calculation and can be added as partners participating on own funds at the pre- and full proposal stage.

3 maximum number of partners in the pre-proposal phase can be 7 if the consortium includes a 3^rd partner of the same country (condition: funding requested from at least 2 different funders of the respective country; applies to only one country per consortium, including partners on own funds). Patient/citizen representing organisations are not included in this calculation and can be added as additional partners in the pre-proposal or full proposal stage. They can participate either on own funds or apply for funding, if eligible, from the regional/national funding organisation or EP PerMed. Please note: within one consortium, not more than 2 partners can request funding from the same funding organisation, including patient/citizen organisations. For some funding agencies, the maximum number of eligible partners who can be funded in one project is one.

Although proposals will be submitted jointly by research teams from several regions/countries, research groups will be funded by the respective funding organisation of the region/country from which they have applied. Applicants are therefore subject to the eligibility criteria of the respective funding organisations (see also Annex III of the “Guidelines for Applicants”). They should therefore read the funding rules and eligibility criteria of their funding organisations carefully. Applicants (including non-coordinating partners) are strongly advised to contact their relevant funding organisation (see also Annex I) prior to submission; please note that this step might be mandatory for some funding organisations.

If a partner is found to be ineligible by one of the funding organisations after the formal check, the entire proposal may be rejected without further review. For a definition of eligible partners, see “Guidelines for Applicants”, the regional/national regulations, and contact your regional/national funding organisation (see also Annex I).

A consortium can apply for a redress procedure in the case a proposal has been rejected (see also section 11).

For regional/national eligibility reasons, applicants must indicate during pre-proposal submission if the study submitted is subject to other evaluation processes, such as other JTCs and regional/national calls. Applicants shall not apply to different calls for same research activities. Double funding is not allowed.

C. Financial and legal aspects

A maximum project duration of 3 years may be applied for in accordance with EP PerMed funding organisation regulations. The studies performed should be finalised at the latest within the third year of the funding period. Eligible costs and funding provisions may vary according to the respective funding organisation’s regulations. Project partners must refer and adhere to their own regional/national regulations and scientific remits, as detailed in the relevant regional/national announcements (see Annex II of this document).

D. Submission of joint proposals

A two-step submission and evaluation procedure has been established for joint applications: pre-proposals and full proposals. In both phases, one joint proposal document shall be prepared by the partners of a joint transnational project. The document must be submitted to the JCS by the project coordinator by uploading it via the electronic submission system (https://ptoutline.eu/app/eppermed2027). The proposals must be written in English, must follow the template form in terms of overall size and section page and character limits, and must strictly adhere to the “Guidelines for Applicants”. The pre-proposal form can be downloaded from the EP PerMed website (www.eppermed.eu). Pre-proposals that do not use the respective template will be declared ineligible. Pre-proposals must be received by the JCS in electronic format no later than 20 January, 2027 at 14:00 CET.

The decision on which applicants are selected to submit a full proposal will be communicated to applicants solely by the JCS around 09 April, 2027. The JCS will provide a full proposal application template to the coordinators of those research proposals invited to the full proposal stage.

Full proposals must be received by the JCS in electronic format no later than 25 May, 2027 at 14:00 CEST. Please note that joint full proposals will be accepted only from those applicants explicitly invited by the JCS to submit. Full proposals that do not use the respective template are ineligible.

Any fundamental changes between the pre- and full proposal concerning the composition of the consortium, project objectives or requested budget must be communicated to the JCS and to the regional/national funding organisations. In exceptional cases, these changes may be accepted if detailed justification is provided and if they are accepted by the Call Steering Committee (CSC).

Further information on electronic submission of pre- and full proposals is available on the EP PerMed website (www.eppermed.eu) and in the “Guidelines for Applicants”. Applicants should take note of individual regional/national rules, and should contact their regional/national funding organisation if they have any questions.

Applicants from some regions/countries may be required to submit an additional regional/national proposal or other information (in some cases before the deadline of this call) directly to their relevant regional/national funding organisations. Applicants are therefore strongly advised to check their funding organisation’s specific regulations. See “Guidelines for Applicants” for more details.

Ethical and legal issues must be addressed in each application, according to the relevant region’s/country’s regulations.

The EP PerMed CSC will take all lawful steps to ensure the confidentiality of the information and documents obtained during the joint call evaluation and selection procedure.

E. Further information

Applicants should contact their corresponding regional/national representative to enquire about eligibility with their respective funding organisations prior to submitting an application (see regional/national contact details, Annex I). For additional information, please contact the JCS

(EPPerMed@anr.fr). Adherence to the regional/national funding regulations in the “Guidelines for Applicants” document is mandatory (www.eppermed.eu).

8 Formal check and evaluation of proposals

A. Formal check and evaluation of pre-proposals

The JCS will check all proposals to ensure that they meet the call’s formal criteria (see also “7. Applications, A. Eligibility Criteria”). In parallel, the JCS will forward the proposals to the regional/national funding organisations, which will perform a check for compliance with their regional/national regulations.

Please note that if a proposal includes an ineligible partner, the whole proposal may be rejected, without further review (for the definition of eligible partners see “Guidelines for Applicants” and regional/national funding regulations and contact your regional/national contact person listed in Annex I).

After passing the eligibility check (performed by the JCS and the participating funding agencies), pre-proposals will be sent to at least three independent reviewers for the first evaluation (see evaluation criteria below, “8. Formal check and evaluation of proposals, C. Evaluation criteria”). The reviewers will assess the pre-proposal and complete a written evaluation form with scores and comments for the evaluation criteria.

In addition, the independent reviewers will assess whether the projects described in the pre-proposal documents fit the aim and scope of the call.

The CSC members will meet to decide which pre-proposals will be invited for full proposal submission based on the reviewers’ scores and recommendations, and to ensure a reasonable balance of requested and available regional/national budgets.

B. Formal check and evaluation of full proposals. Rebuttal stage

The JCS will review the full proposals to ensure that they meet the call’s formal criteria and have not changed substantially from the respective pre-proposals prior to sending them to the independent reviewers. In parallel, the JCS will forward the proposals to the regional/national funding organisations, which will perform a check for compliance with their regional/national regulations.

Each full proposal will be allocated to at least three independent reviewers. The reviewers will assess the full proposal and complete a written evaluation form with scores and comments for each criterion (see evaluation criteria below).

Rebuttal stage: Before the PRP plenary meeting to discuss the full proposals, the JCS will provide the independent reviewers’ assessment (by email or other electronic means) to each project coordinator who will have the opportunity to study the assessments and to provide comments on the arguments and evaluations of the reviewers, who remain anonymous. This stage allows applicants to comment on factual errors or misunderstandings that may have been committed by the independent reviewers while assessing the proposal, and to reply to reviewers’ questions. However, issues that are not related to reviewers’ comments or questions cannot be addressed, and the work plan cannot be modified at this stage. Answers sent after the notified deadline, or not related to reviewers’ comments or questions, will be disregarded.

The independent reviewers will meet in a Peer Review Panel (PRP) to discuss all proposals (and the rebuttal letters), to produce a joint assessment report for each full proposal, to be sent by the JCS to the project coordinators, and a ranking list of proposals recommended for funding. The composition of the PRP may be communicated through the EP PerMed website at the end of the entire review process.

C. Evaluation criteria

Pre-proposals and full proposals will be assessed according to specific evaluation criteria using a common evaluation form. A scoring system from 0 to 5 will be used to evaluate the proposal’s performance with respect to the different evaluation criteria.

Scoring system:

0: Failure. The proposal fails to address the criterion or cannot be assessed due to missing or incomplete information.

1: Poor. The criterion is inadequately addressed, or there are serious inherent weaknesses.

2: Fair. The proposal broadly addresses the criterion, but there are significant weaknesses.

3: Good. The proposal addresses the criterion well, but a number of shortcomings are present.

4: Very Good. The proposal addresses the criterion very well, but a small number of shortcomings are present.

5: Excellent. The proposal successfully addresses all relevant aspects of the criterion. Any shortcomings are minor.

Evaluation scores will be awarded for the three main criteria, 1) Excellence, 2) Impact and 3) Quality and efficiency of the implementation, each as a whole, and not separately for the different aspects listed below the criteria. The three criteria are weighted equally and the maximum total score for the three evaluation criteria that can be achieved in the remote evaluation is 15 points. The threshold for every individual criterion based on the evaluation of the three independent reviewers will be 3 (overall threshold of 9 for proposals in both steps of the evaluation process).

Evaluation criteria:

• 1. Excellence:

  • a. Clarity and pertinence of the project’s objectives and them fitting to the scope of the call;

  • b. The extent to which the proposed work is ambitious, and goes beyond the state of the art;

  • c. Soundness of the proposed methodology, including the underlying concepts, models, assumptions, multidisciplinary and intersectoral approaches;

  • d. Inclusion of sex and gender research and appropriate consideration of underrepresented populations, or specific sub-groups in research and innovation content;

  • e. Consideration of sex aspects and underrepresented populations in research teams, if applicable;

  • f. Quality of open science practices including sharing and management of research outputs and engagement of citizens, patients or patient representatives, civil society and other concerned stakeholders where appropriate.

• 2. Impact:

  • a. Credibility of the pathways to achieve the expected outcomes and impacts specified in the call text;

  • b. The likely scale and significance of the contributions due to the project;

  • c. Potential translational impact with respect to the development of personalised medicine (e.g. translatability of the proposed research to practice in healthcare; elaboration on the translational aspect in a dedicated work package focussing on the quality specifications and preclinical regulatory requirements);

  • d. Suitability and quality of the measures to maximise expected outcomes and impacts, as set out in the dissemination and exploitation plan, including communication activities;

  • e. Added value of the transnational collaboration; sharing of resources (registries, diagnosis, biobanks, models, databases, diagnostic and informatics tools, etc.), platforms/infrastructures, harmonisation of data and sharing of specific know-how.

  Sub-criterium 2d will be evaluated at the full proposal evaluation stage.

• 3. Quality and efficiency of the implementation:

  • a. Quality and effectiveness of the work plan (including adequacy of the time schedule) and appropriateness of the effort assigned to work packages, and the resources overall;

  • b. Capacity and role of each participant, and extent to which the consortium as a whole brings together the necessary expertise. This includes: appropriate expertise of partners responsible for proposed work packages (including international competitiveness of participants in the field(s) and previous work supporting the proposed study with preliminary data);

  • c. Interdisciplinary and intersectoral collaboration: coherent integration of suitable project partners (e.g. academia, clinical/public health sector, industry partner/SME, patient/citizen representing organisations) to successfully accomplish the proposed work, i.e. to identify, develop or implement personalised medicine approaches;

  • d. Appropriateness of the management structures and procedures to address risk assessment, innovation management and RRI, including ethical considerations;

  • e. Sustainability of the research capacities initiated by the project (e.g. FAIR data management, Open Science practices). Quality of the Intellectual Property management.

  Sub-criteria 3d and 3e will be evaluated at the full proposal evaluation stage.

D. Conflicts of interest (Evaluation panel)

All necessary steps will be taken by the JCS and the CSC to ensure that there is no conflict of interest concerning the independent reviewers for those proposals assigned to them for review. The reviewers will be required to formally declare that no conflict of interest exists at any point in the evaluation process and to declare confidentiality concerning all documents and the entire review process. Any reviewer who breaches the conflict-of-interest rule will be excluded from the call. Projects assigned to that reviewer will be assigned to another reviewer.

A first review for conflicts of interest will be performed by the JCS when analysing the reviewers’ publications. After receiving the proposals, the independent reviewers are requested to indicate whether there is a conflict of interest with any of the researchers or research groups in the proposals for review. Reviewers will be asked to declare that they will not participate in the call, nor have any conflicting interests regarding the researchers or research groups participating in the projects that are reviewed.

9 Ethical clearance – Ethics and RRI evaluation

It is mandatory for applicants to complete at the full proposal stage an “Ethical self-assessment” (Annex 1 of the full proposal application form). After the PRP meeting, an Ethics and RRI evaluation will take place for the full proposals which are recommended for funding by the PRP and selected for funding by the CSC, to verify alignment with ethical norms and regulations. If further clarifications are necessary, the consortium will be contacted to take respective actions or submit additional documents. The ethics experts may put forward additional conditions that need to be fulfilled by the applicants. Only those proposals approved by both the scientific evaluation and ethical assessment, complying with the central Horizon Europe and regional/national ethical requirements, will be funded.

Please note: This ethical clearance process does not replace the ethical vote by a competent Research Ethics Committee. All ethical and legal requirements necessary must be met before the research can begin. To ensure this, is the responsibility of the applicant and cannot be substituted by the EP PerMed ethical clearance process.

10 Final decision on funding

Based on the ranking list established by the PRP, the ethical clearance and on available funding, the CSC will recommend those projects to be funded to the regional/national funding organisations. Based on these recommendations, final decisions will be made by the regional/national funding organisations, subject to budgetary considerations. The regional/national funding organisations will follow the ranking list established by the PRP members.

The project coordinator will be informed by the JCS of the decision. The project partners should be informed by their project coordinator.

11 Redress procedure

Applicants can appeal against the evaluation outcome if they suspect a breach in the application of the evaluation and selection procedures. This redress procedure only covers the procedural aspects evaluation and central formal eligibility checks. Requests for redress on national/regional eligibility decisions will not be handled by the JCS and need to be addressed to the responsible national contact point. The redress will not call into question the scientific or technical judgement of appropriately qualified experts/evaluators.

Applicants shall submit their appeal to the JCS via email (EPPerMed@anr.fr) up to seven (7) calendar days following the dispatch of the evaluation outcome email by the JCS at the end of each stage (first and second step). The proposal outcome email containing the results of the evaluation will give information on the appeals procedure, which is described below.

Admissibility of appeals

For an appeal to be admissible the following conditions must be met:

• The appeal must be submitted by the coordinator of the proposal to which the appeal relates;

• Only one appeal per proposal will be considered;

The appeal must be submitted via email within a seven (7) calendar days deadline. The appeal must contain the following minimum information:

• The name of the call for proposals;

• The proposal acronym;

• The title of the proposal;

• A description of the alleged shortcomings of the evaluation procedure.

The appeal must demonstrate a procedural irregularity, factual error, manifest error of assessment, misuse of powers, or a conflict of interests. Appeals that do not meet the above conditions, or do not deal with the evaluation of a specific proposal or express mere disagreement with the result or the reasoning of the evaluation might be judged as not suitable for redress.

Procedure

Upon receipt of an appeal, an acknowledgement of receipt will be sent by the JCS within seven (7) calendar days. The acknowledgement shall report the redress process and the anticipated date by which a decision on the appeal will be communicated to the appellant.

All appeals received by the seven (7) calendar days deadline will be processed together, and the decision of the CSC will be communicated to the appellant by the JCS within seven (7) calendar days from the deadline for submitting the appeals.

12 Project Start, Consortium Agreement and Data Management Plan

Consortium members of projects selected for funding must fix a common scientific project start date, which will be the reference date for the submission of the different deliverables and the final scientific reporting (exception: the annual scientific reports will be on fixed dates for all projects). The common scientific project start date must be stated in the Project Consortium Agreement (CA).

Project coordinators will be responsible for drafting the mandatory CA specific to their consortium in order to manage the delivery of the project activities, intellectual property rights (IPR) and decision-making, and to avoid disputes that could compromise the completion of the project. The coordinator is responsible for sending the CA signed by all partners to the JCS. The CA must state that funding and administrative matters are not regulated by the CA and are issues addressed bilaterally between each project partner and its funder in the relevant Grant Agreement (GA). The CA will be made available to the relevant funding organisations. The project consortium is strongly encouraged to sign this CA before the official project start date and, in any case, the CA should be signed no later than six months after the scientific project start date. Please note that regional and national funding agencies’ regulations concerning the requirement for a CA may apply. Further instructions will be provided by the JCS to the coordinators of the projects selected for funding.

The consortia of projects selected for funding are required to submit a Data Management Plan (DMP) (template to be available: www.eppermed.eu). The project coordinator is responsible for sending the complete DMP to the JCS, no later than three months after the official start of the project and an updated DMP at the end of the project together with the final scientific report. Compliance with or updates of the DMP, must be reported in each annual scientific project progress report.

13 Reporting requirements and Open Access to publications

On behalf of all participating project partners, each project coordinator shall submit annual scientific progress reports, in English to the JCS, in the first and second year, and a final scientific report of the transnational project at the end of the project duration. A report template will be provided by the JCS stating the scientific progress, the goals that have been met and corrective measures in the event that the annual project plan has not been executed. The project partners’ principal investigators may also be required to submit individual reports to their respective funding agency/body in accordance with the respective regional/national regulations. In addition, project coordinators may be asked to present the project results at EP PerMed meetings and may be invited to attend at least two status seminars. Travel expenses to attend these mandatory meetings should be included in the proposal budget plans. In case of events being organised online, all partners of the consortia will be encouraged to participate. Funded project consortia shall participate in follow-up surveys up to two years after the project has officially be ended.

The coordinator must promptly inform the JCS in case of ANY significant changes in the work plan or in the consortium composition. The JCS will inform the relevant funding organisations, who will decide upon the proper action to be taken.

Upon notification, project coordinators are required to deliver a project abstract suitable for communication and dissemination purposes.

In addition, the funding recipients are expected to participate in, and contribute to, any communication activity or evaluation surveys initiated by EP PerMed during the funding period (mandatory) and beyond.

Publication of the scientific outcomes of the project is mandatorily subject to open access (see also section 8 of the “Guidelines for Applicants”), and a corresponding budget should be allocated for this in the proposal's budget plan. Research projects funded through EP PerMed are eligible to publish on Open Research Europe (ORE)⁹, an open access publishing platform of the European Commission (EC).

Importantly, all funding recipients must ensure that all outcomes (publications, etc.) of transnational EP PerMed-funded projects include proper acknowledgement of the EP PerMed and the respective funding partner organisations:

“This project received funding from [name of funding organisations, or an acknowledgment as requested by your regional/national funding organisation] under the frame of the European Partnership for Personalised Medicine, EP PerMed, (GA N° 101137129 of the EU Horizon Europe Research and Innovation Programme)”.

14 Annex I. Regional/National Contact Details

Name of participating organisation	Country/Region	Regional/National contact
Fondazione Regionale per la Ricerca Biomedica, (FRRB)	Italy (Lombardy)	Giulia Maria Rossignolo giuliamaria.rossignolo@frrb.it bandi@frrb.it Tel.: +39 0267650159
Tuscany Region, (RT)	Italy (Tuscany)	Teresa Vieri Tel.: +39 055 4383289 Monica Malacarne Tel.: +39 0554382334 eppermed@regione.toscana.it
Latvian Council of Science, (LZP)	Latvia	Uldis Berkis Uldis.Berkis@lzp.gov.lv Tel.:+371-29472349
Research Council of Lithuania, (LMT)	Lithuania	Živilė Ruželė zivile.ruzele@lmt.lt Tel.: (+370) 676 14383
National Research Fund, (FNR)	Luxembourg	Gideon Gießelmann gideon.giesselmann@fnr.lu Tel.: +352 691 362 805
The Research Council of Norway, (RCN)	Norway	Karianne Solaas, kso@rcn.no Tel.: +47 945 35 380
National Centre for Research and Development, (NCBR)	Poland	Anna Stępień anna.stepien@ncbr.gov.pl Tel.: +48 22 39 07 210
Fundação para a Ciência e a Tecnologia, (FCT)	Portugal	Rita Cavaleiro Tel.: +351 213911 541 Pedro Ferreira Tel.: +351 213924 445 EPPerMed@fct.pt
vicePresidency of Azores Regional Government, (VP-GRA)	Portugal (Azores)	Sara de Viveiros Pavão sara.v.pavao@azores.gov.pt Tel.: +351 296 308 903
Executive Agency for Higher Education, Research, Development and Innovation Funding, (UEFISCDI)	Romania	Mihaela Manole mihaela.manole@uefiscdi.ro Nicoleta Dumitrache nicoleta.dumitrache@uefiscdi.ro
Centrum vedecko-technických informácií Slovenskej republiky, (CVTI SR)	Slovak Republic	Maros Halama maros.halama@cvtisr.sk Tel.: +421 917 733 475
National Institute of Health Carlos III, (ISCIII)	Spain	María Adrio Lorente eppermed@isciii.es
Consejería de Presidencia, Sanidad y Emergencias de la Junta de Andalucía, (CPSEJA)	Spain (Andalusia)	Alicia Milano Curto ep.fps@juntadeandalucia.es
Health Department – Generalitat de Catalunya, (DS-CAT)	Spain (Catalonia)	Carme Pérez peris@gencat.cat Tel.: +34 935566103
Swedish Research Council, (SRC)	Sweden	Abraham Mellkvist-Roos abmr@vr.se Tel.: +46 76525 7613
Sweden´s Innovation Agency, (VINNOVA)	Sweden	Casper Ullsten-Wahlund casper.ullsten-wahlund@vinnova.se Tel.: +46 8 473 32 06
The Netherlands Organisation for Health Research and Development, (ZonMw)	The Netherlands	Rob Diemel Marcella de Boer Anna Wilbers EP-PerMed@zonmw.nl Tel.: +31 70 349 5252
The Scientific and Technological Research Council of Türkiye, (TÜBİTAK)	Türkiye	N. Selcan TÜRKER selcan.turker@tubitak.gov.tr Tel.: +90 312 298 1760

15 Annex II. Indicative funding commitments of the participating organisations of the EP PerMed JTC2027

(This table is provided for initial overview only. Please refer to the regional/national guidelines for details.)

Name of participating organisation	Country / Region	Funding academic or clinical/academic partner[1]	Funding private partners[1]	Tentative initial funding commitment (M€ for 3 years)	Envisaged number of teams potentially funded with the tentative initial funding commitment
Austrian Science Fund, (FWF)	Austria	✓	✓	1.5	3–4
The Research Foundation – Flanders, (FWO)	Belgium (Flanders)	✓	x For-profit ✓ Not for-profit	0.7	2–3
Vlaams Gewest – VLAIO Flanders Innovation & Entrepreneurship, FIO/VLAIO)	Belgium (Flanders)	✓	✓	1.0	4
Fund for Scientific Research – FNRS, (F.R.S.-FNRS)	Belgium (Wallonia-Brussels Federation)	✓ academic partner x clinical partner	x For-profit ✓ Not for-profit	0.3	1
Service Public de Wallonie, (SPW EER)	Belgium (Wallonia)	✓ academic partner x clinical partner	✓	1.0	2–5
Canadian Institutes of HealthResearch, (CIHR)	Canada	✓	x For-profit ✓ Not for-profit	0.84	3
The Ministry of Health of the Czech Republic, (MZCR)	Czech Republic	✓	✓	0.5	2
Estonia Enterprise, (EIS)	Estonia	x	✓ For-profit x Not for-profit	0.5	2–4
Estonian Research Council, (ETAG)	Estonia	✓	x For-profit ✓ Not for-profit	0.3	1
Business Finland, (BFRK)	Finland	✓	✓ For-profit x Not for-profit	3.0	5–10
Agence Nationale de la Recherche, (ANR)	France	✓	✓	2.5	7–9
Federal Ministry of Research, Technology and Space, (BMFTR)/German Aerospace Center e.V. – Project Management Agency, (DLR)	Germany	✓	✓	3.0	10
Federal Ministry of Health, (BMG) / German Aerospace Center e.V. – Project Management Agency, (DLR)	Germany	✓	✓	2.0	6–8
Saxon State Ministry for Science, Culture and Tourism, (SMWK)	Germany (Saxony)	✓ academic partner x clinical partner	x	1.0	No limitation
General Secretariat for Research & innovation, (GSRI)	Greece	✓	✓	TBD	TBD
National Research, Development and Innovation Office, (NKFIH)	Hungary	✓	✓	0.5	2
Taighde Éireann-ResearchIreland, (TE-RI)	Ireland	✓ academic partner x clinical partner	x	TBD	TBD
Chief Scientist Office, Ministry of Health, (CSO-MOH)	Israel	✓	x	0.32	2
National Technological Innovation Authority, (IIA)	Israel	✓ academic partners (according to IIA’s guidelines) x clinical partners	✓ For-profit x Not for-profit	TBD	TBD
Italian Ministry of Health, (IT-MoH)	Italy	x academic partners ✓clinical partners	x For-profit ✓ Not for-profit	TBD	TBD
Regione Autonoma Friuli Venezia Giulia (FVG)	Italy (Friuli Venezia Giulia)	✓	✓ For-profit x Not for-profit	0.25	1–2
Fondazione Regionale per la Ricerca Biomedica, (FRRB)	Italy (Lombardy)	✓	x For-profit ✓ Not for-profit	1.0	6
Tuscany Region, (RT)	Italy (Tuscany)	✓	x For-profit ✓ Not for-profit	0.3	1–2
Latvian Council of Science, (LZP)	Latvia	✓	✓ For-profit x Not for-profit	0.6	2
Research Council of Lithuania, (LMT)	Lithuania	✓	✓	0.3	1–2
National Research Fund, (FNR)	Luxembourg	✓ academic partner x clinical partner	x For-profit ✓ Not for-profit	0.3	1–2
The Research Council of Norway, (RCN)	Norway	✓	✓	1.6	4–5
National Centre for Research and Development, (NCBR)	Poland	✓	✓	1.1	1–3
Fundação para a Ciência e a Tecnologia, (FCT)	Portugal	✓	✓	0.3	2–3
vicePresidency of Azores Regional Government, (VP-GRA)	Portugal (Azores)	✓	x For-profit ✓ Not for-profit	0.1	1
Executive Agency for Higher Education, Research, Development and Innovation Funding, (UEFISCDI)	Romania	✓ academic partner x clinical partner	✓	1.0	4–5
Centrum vedecko-technických informácií Slovenskej republiky, (CVTI SR)	Slovak Republic	✓	✓	0.6	2–3
National Institute of Health Carlos III, (ISCIII)	Spain	✓	x For-profit ✓ Not for-profit	TBD	TBD
Consejería de Presidencia, Sanidad y Emergencias de la Junta de Andalucía, (CPSEJA)	Spain (Andalusia)	✓	x For-profit ✓ Not for-profit	0.25	2
Health Department – Generalitat de Catalunya, (DS-CAT)	Spain (Catalonia)	✓	x For-profit ✓ Not for-profit	0.7	3–4
Swedish Research Council, (SRC)	Sweden	✓	x	1.5	4–5
Sweden´s Innovation Agency, (VINNOVA)	Sweden	✓	✓	2.25	4–6
The Netherlands Organisation for Health Research and Development, (ZonMw)	The Netherlands	✓	x For-profit ✓ Not for-profit	1.8	6
The Scientific and Technological Research Council of Türkiye, (TÜBİTAK)	Türkiye	✓	✓ For-profit x Not for-profit	0.4	2–3

1 subject to regional/national eligibility criteria and funding rules. All applicants and partners must comply with the State Aid rules (http://ec.europa.eu/competition/state_aid/overview/index_en.html). Please see more information from each individual funding agency in the “Guidelines for Applicants”.

16 Annex III. Definition of early career researcher/scientist

Early career researchers/scientists must have been awarded their first PhD or equivalent medical degree (MD), up to 8 years’ prior to the proposal submission deadline of the EP PerMed JTC2027 (after 1^st January 2019). Extensions to this period may be allowed in the event of eligible career breaks, which must be properly documented and could be subject of verification by EP PerMed. However, there is no need to attach additional documentation when submitting the project proposal. Eligible career breaks are:

• For maternity: the effective elapsed time since the award of the first PhD/MD will be considered reduced by 18 months for each child born before or after the PhD/MD award;

• For paternity: the effective elapsed time since the award of the first PhD/MD will be considered reduced by the actual amount of paternity leave taken for each child born before or after the PhD/MD award;

• For long-term illness (over ninety days), clinical qualification or national service, the effective elapsed time since the award of the first PhD/MD will be considered reduced by the documented amount of leave taken for each event which occurred after the PhD/MD award.

• Eligible events that take place within the extension of the eligibility window may lead to further extensions. However, the cumulative eligibility period should not, under any circumstances, exceed 11 years and 6 months following the award of the first PhD/MD. No allowance will be made for principal investigators working part-time.

• Please refer to the regional/national guidelines for details and eligibility criteria (also see Annex III in “Guidelines for Applicants”).

Joint Transnational Call for Proposals (2027) for Cell and Gene Therapy for Personalised

Medicine (CGT4PM2027)

(EP PerMed Grant 101137129)

GUIDELINES FOR APPLICANTS

Important Deadlines

Submission of pre-proposals: 20 January 2027 at 14:00 (CET)

Submission of invited full proposals: 25 May 2027 at 14:00 (CEST)

Link to the electronic proposal submission tool: https://ptoutline.eu/app/eppermed2027

For further information, please visit our website: www.eppermed.eu or contact the EP PerMed Joint Call Secretariat (JCS) French National Research Agency (ANR)

86 rue Regnault, 75013 Paris, FRANCE

Mylène Vaillancourt, Dr. Mérick Machouri

Phone: +33 1 78 09 80 36, +33 1 72 73 06 72

Email:EPPerMed@anr.fr

The Netherlands

Funding Organisation	The Netherlands organisation for Health Research and Development (ZonMw)
Initial funding pre-commitment	1.800.000 € Anticipated number of funded research projects: ≈ 6 Maximum funding per grant awarded to a project is 300.000 euro (= total amount for all Dutch partners participating in a consortium project).
Regional/National contact for the EP PerMed JTC2027	Rob Diemel, PhD Marcella de Boer, MSc Anna Wilbers, MSc EP-PerMed@zonmw.nl +31 70 349 5252
Eligible institutions	In this National Annex an applicant is defined as a researcher based in the Netherlands applying for funding (i.e. the Dutch part of an international consortium project). Applicants from the Netherlands may submit an application (i.e. participate in a consortium and request funding) if they have an employment relationship with the following Dutch organisations: • Research organisations, that meet the definition of a research organisation as referred to in EU state aid legislation may receive the research grant (Framework for state aid for research and development and innovation (2014/C 198/01), i.e. the R&D&I framework. In this call ZonMw is only able to fund applicants from research organisations based in the Netherlands belonging to category ‘A. Academia’ and ‘B. Clinical/public health sector’ as eligible for funding. This includes applicants from Dutch universities and university medical centres. Applicants belonging to category ‘C. Private for-profit (enterprise) partners, e.g. SME and private non-profit partners’ are not eligible for funding by ZonMw in this call. To be eligible for ZonMw funding as a 'research organisation' under the European R&D&I framework, the organisation's legal status must be established in advance to prevent the granting of unlawful state aid. This process follows two routes: Route 1: Direct entry (universities and university medical centres). These organisations do not undergo a qualification assessment and can submit a grant application directly: – Universities are designated as research organisations by operation of law, in line with the R&D&I framework. – University medical centres (UMCs) confirm their status as research organisations by submitting a declaration. The declaration must be issued by, or on behalf of, an authorised signatory registered with the Chamber of Commerce (KvK). The declaration form is only required in the full proposal stage and can be submitted via kwalificatieOO@zonmw.nl with EP-PerMed@zonmw.nl in cc before the submission deadline of the full proposals. Route 2: Eligibility assessment (Other organisations). Other organisations that aim to apply for funding as a research organisation must submit the following mandatory documents: – Completed 'Research Organisation Eligibility’ questionnaire; – Digitally certified Extract from the Commercial Register (Chamber of Commerce/KvK), no older than 3 months; – Deed of incorporation and/or current articles of association; – Most recent complete, unpublished financial statements including an auditor's report (if legally required). Deadline for route 2: As soon as possible, but no later than 4 January 2027 by 14:00:00 CET via kwalificatieOO@zonmw.nl, stating the title of this call (EP PerMed JTC2027 CGT4PM) and with EP-PerMed@zonmw.nl in cc. Fast-track procedure: Organisations already recognised by ZonMw as a research organisation within the past 12 months, where its articles of association and activities remained unchanged since then, may use the fast-track procedure. The organisation must confirm this by submitting the designated declaration via kwalificatieOO@zonmw.nl with EP-PerMed@zonmw.nl Consequences of inability to confirm status: If the documents are not submitted on time, or if ZonMw cannot positively confirm the organisation's status as a research organisation, the organisation cannot submit an application in the capacity of a research organisation.
Additional eligibility criteria	• An applicant from the Netherlands may only request ZonMw funding for one project proposal (as part of an international consortium) in this call. • The Dutch part of an international consortium has a single national main contact person (i.e. Dutch Partner or Coordinator in the consortium project), who is responsible for scientific and financial management. • PhD student positions (‘promovendus, AIO, OIO’) cannot be applied for in this call.
Eligible costs	The General Terms and Conditions Governing Grants of ZonMw apply. Costs: Eligible costs of projects include: • Personnel costs • Bench fee • Costs of instruments and equipment to the extent and as long as they are used for the project • Other operational expenses: materials, travel costs for consortium meetings, costs for dissemination of results (implementation) of the project, open access costs with a maximum of 5000 € per project if the publication takes place according to the full golden route. Non-eligible costs of projects include: • Overhead is not allowed in most cases (e.g. university or University Medical Center). Personnel costs are funded in accordance with VSNU/NFU salary tables. Budget formats and salary tables can be downloaded from the ZonMw website. It is necessary to use these formats and salary tables in the preparation of the budget for the Dutch partners, both in the preproposal and full proposal stage. State Aid: No funding will be awarded by ZonMw if this would or could constitute unlawful state aid (section 107 of the Treaty on the Functioning of the EU (TFEU). Funding awarded to research organisation for the execution of non-economic research activities does not constitute state aid. Under this call, proposals may be submitted for projects involving fundamental research and industrial research while regarding the activities Research, Dissemination of results and/or Training, provided these falls within their primary task as research organisations. Note that accounting records must be kept separate.
Funding of public-private partnerships allowed	Yes, but ZonMw can only fund applicants from research organisations based in the Netherlands belonging to categories ‘A. Academia’ and ‘B. Clinical/public health sector’.
Further guidance	The aforementioned General Terms and Conditions Governing Grants of ZonMw are applicable to the part of the project’s budget covered by the grant from ZonMw. Any arrangements made regarding the part of the project’s budget covered by the grant from ZonMw must comply with the General Terms and Conditions Governing Grants of ZonMw amended on 1 April 2022 and the European legislation on state aid. You must take account of certain rights, conditions and obligations when applying for a ZonMw grant. Dutch partner(s) in research projects selected for funding need to submit the proposal at the national level (MijnZonMw): • Submission of the full proposal to ZonMw will be carried out once the international evaluation and the ranking list have been established and endorsed by the Call Steering Committee. ZonMw will send a letter to invite the selected researcher(s) to submit the selected full proposal. • Dutch partner(s) in funded research projects have to comply with ZonMw procedures for granted projects (e.g. uploading via ‘MijnZonMw’ – including the ZonMw budget format and reporting annually). Scientific personnel has to be appointed at a scientific institution in The Netherlands. Granted projects with a Dutch partner have to draw up and sign a Consortium Agreement in which also the intellectual property rights are incorporated. • A final draft version of the Consortium agreement (approved by all parties but not yet signed) will be required in order to assess conformity with applicable European state aid law, IP conditions and the ZonMw General Terms and Conditions. If the Consortium agreement is rejected, the funding by ZonMw cannot be granted. • Before the start of the granted project Dutch partner(s) in funded research projects needs to compose a data management plan and complete key items to explain how to make the data collection from the Dutch part of the research project FAIR. • Every year an annual scientific report will be requested through the national submission system to inform ZonMw about the results of the Dutch partner(s) in funded research projects. An indication of the annual costs may be asked.

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1 https://www.ema.europa.eu/en/search?search_api_fulltext=cell%20therapy&f%5B0%5D=ema_med_status%3Aauthorised&f%5B1%5D=ema_medicine_bundle%3Aema_medicine&f%5B2%5D=ema_medicine_type_fields%3Afield_ema_advanced_therapy&f%5B3%5D=ema_search_categories%3A83&f%5B4%5D=ema_search_custom_entity_bundle%3A001_ema_medicines_and_related

2 EMA – Reflection paper on classification of advanced therapy medicinal products.

3 Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

4 https://ec.europa.eu/research/participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm

5 Indications for Associated Countries and Third Countries to Horizon Europe: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021–2027/common/guidance/list-3rd-country-participation_horizon-euratom_en.pdf

6 If ERDF funds are used, the following applies: “(...) must involve at least three Member States, or alternatively two Member States and at least one associated country whose (...)” Please consult the “Guidelines for Applicants” document.

7 Widening concept: Consortia are allowed to include in the full proposal phase a new project partner that is eligible to receive funding from a funding organisation that is underrepresented in the first stage of the call and that agrees to participate in the widening option.

8 https://ec.europa.eu/growth/smes/business-friendly-environment/sme-definition_en

9 https://open-research-europe.ec.europa.eu/