Identification or Validation of Targets for Personalised Medicine Approaches (PMTargets)

Beneficiary & submission

All information and documents concerning the JTC2024, including the call text outlining the aims and scope of the call, as well as the Guidelines for Applicants document, the pre-proposal form, etc. can be found here: https://www.eppermed.eu/ Submission: There will be a two-step submission and evaluation procedure for joint applications consisting of a pre-proposal and a full-proposal stage. In both stages, one joint proposal (in English) shall be prepared by the partners of a joint transnational consortium, and must be submitted by only one spokesperson, the coordinator, by uploading it on the electronic submission system (available likely on 12th January 2024): https://ptoutline.eu/app/eppermed2024. Research project consortia who intend to submit a transnational proposal should register at https://ptoutline.eu/app/eppermed2024, click on “sign up” and follow the further instructions. The system will likely open on 12th January 2024. To register, please complete the different sections as soon as possible. Joint proposals consist of two parts: 1) The pre-proposal and full-proposal templates, provided in word format and allowing applicants to present mainly the description of the planned work, and 2) the electronic submission tool to provide particularly individual partner information and financial plans. Both parts should be completed jointly by all applying consortium partners and need to be started in due time. Please use the pre-proposal templates provided on the EP PerMed website (www.eppermed.eu) and the full-proposal form sent to coordinators by the Joint Call Secretariat (JCS) in the second stage. 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”. Only proposals using the official templates will be accepted. Deadline to submit pre-proposals:       05 March 2024 (17:00, CET) The decision on which applicants are selected to submit a full-proposal will be communicated to applicants solely by the JCS around 20 May, 2024. The JCS will send a full-proposal application template to the coordinators of those research proposals invited to the full-proposal stage. 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). Deadline to submit full-proposals:          20 June 2024 (17:00, CEST) After these deadlines, the electronic submission system will not accept proposals and it will not be possible to amend the proposal or to add further documents. In case of inconsistencies between the information registered in the online submission tool and the information included in the PDF of this application form, the information registered in the submission tool shall prevail. Eligibility Criteria: Only transnational projects will be funded. Each consortium must involve at least three partners from three different EU Member States or Associated Countries whose funding organisations participate in the call (see list above). 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 must be eligible to be funded by his/her regional/national participating funding organisation. 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 “Guidelines for Applicants” for individual funding rules). Pre-proposal stage: o Maximum number of partners is 6 (no more than 2 partners from the same country), o Maximum number of partners can be 7 if the consortium includes a 3rd 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). Widening concept: Consortia are allowed to include in the full-proposal phase 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). No more than one partner with their own funding is allowed in the consortia with at least three partners eligible for funding. Exception: To facilitate the integration of patient organisations in consortia, they can be added to a consortium as additional partners at the pre-proposal stage or full-proposal stage. Patient organisations can be added as additional partner(s) either on own funds or by applying for funding, if eligible, from the respective funding organisations. The consortia must follow all of the above-mentioned rules regarding the consortia composition without counting the patient organisations, except for the following rule: within one consortium, no more than 2 partners can request funding from the same funding organisation, including patient organisations. For some funding organisations, the maximum number of eligible partners who can be funded in one project is one. 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 “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) in the research teams is encouraged; C. Private for-profit (industry) partners, e.g. SME (small and medium-sized 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, the aims of the research project and should be reasonably balanced in terms of international participation. 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. 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. They should therefore read the funding rules and eligibility criteria of their funding organisations carefully. Applicants are strongly advised to contact their relevant funding organisation (see also Annex I of the call text) prior to submission; please note that this step might be mandatory for some regions/countries. 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 the regional/national funding organisation. A consortium can apply for a redress procedure in the case a proposal has been rejected (see also section 10 of the call text). Financial and legal aspects: The maximum duration of projects is three years 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. 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. 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. After passing the eligibility check, pre-proposals will be sent to at least three reviewers for the first evaluation. The reviewers will assess the pre-proposal and complete a written evaluation form with scores and comments for the evaluation criteria. In addition, the 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 reviewers. Each full-proposal will be allocated to at least three 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 Peer Review Panel (PRP) plenary meeting to discuss the full-proposals, the JCS will provide the 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 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. Peer Review Panel (PRP): The reviewers will meet in a 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. 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, 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 reviewers will be 3 (overall threshold of 9 for proposals in both steps of the evaluation process). Evaluation criteria: 1. Excellence: Clarity and pertinence of the project’s objectives (and them fitting to the scope of the call, including the demonstration of the stratification potential of the companion biomarker/s), and the extent to which the proposed work is ambitious, and goes beyond the state-of-the-art (including innovative potential); Soundness of the proposed methodology, including the underlying concepts, models, assumptions, multidisciplinary and intersectoral approaches; Appropriate consideration of the gender dimension, underrepresented populations, or specific sub-groups in research and innovation content; Consideration of sex aspects and underrepresented populations in research teams, if applicable; Quality of open science practices including sharing and management of research outputs and engagement of citizens, patients or patient representatives, civil society and other end users where appropriate. 2. Impact: Credibility of the pathways to achieve the expected outcomes and impacts specified in the call text, and the likely scale and significance of the contributions due to the project; Potential impact with respect to the development of personalised medicine (e.g. clinical and other health-related applications, translatability of the proposed research to practice in healthcare); Suitability and quality of the measures to maximise expected outcomes and impacts, as set out in the dissemination and exploitation plan, including communication activities; 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 2c will be evaluated at the full-proposal evaluation stage. 3. Quality and efficiency of the implementation: 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; 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); Interdisciplinary and intersectoral collaboration: coherent integration of suitable project partners (e.g. academia, clinical/public health sector, industry partner/SME, patient organisations) to successfully accomplish the proposed work, i.e. to identify, develop or implement personalised medicine approaches; Appropriateness of the management structures and procedures to address risk assessment, innovation management and RRI, including ethical considerations; 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 PRP members for those proposals assigned to them for review. The PRP members 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 PRP member who breaches the conflict-of-interest rule will be excluded from the panel. 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, 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. E.     Ethical clearance - Ethics and Responsible Reserach and Innovation (RRI) evaluation It is mandatory for applicants to complete and “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 some 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. 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. 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 of the call. 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@agencerecherche.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 or 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: o The name of the call for proposals; o The proposal acronym; o The title of the proposal; o 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 CSC2024 will be communicated to the appellant by the JCS within seven (7) calendar days from the deadline for submitting the appeals.

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 of the call text). For additional information, please contact the JCS (EPPerMed@agencerecherche.fr). Adherence to the regional/national funding regulations in the “Guidelines for Applicants” document is mandatory (www.eppermed.eu).