EP PerMed Fast Track

Beneficiary & submission

All information concerning the EP PerMed Fast Track call, including the call text outlining the aims and scope of the call can be found here: https://www.eppermed.eu/funding-projects/calls/fast-track-call/. Timeline: 13 March 2025 Deadline for Call submission 11 June 2025 Deadline for submission of Validation Plans 20 June 2025 Funding decision notification 23 June – 31 December 2025 Validation studies 30 January 2026 Deadline for final report submission Submission: The EP PerMed Fast Track Validation Programme is open to start-ups and small teams, seeking to incorporate into a start-up, who are looking to advance their PM innovations through rigorous validation studies. The programme targets solutions that are at least at the proof-of-concept stage (TRL3). The application can be submitted with or without an already selected validation centre. When applying without a validation centre, the application must present a clear view on what kind of validation partner is needed for the project. This will help facilitate matching the application with an appropriate validation centre. Applicants must submit their applications via EIT Health Application Platform: https://apply.eithealth.eu/s_Login.jsp. Please follow the instructions to complete account registration. If there are any questions, please see the “⁠Guide for applicants” or contact smartsimple@eithealth.eu. Main steps in process: 1. Apply Applicants submit their proposals through the EIT Health Smart Simple application platform. Applicants may apply with or without a validation centre. During the on-line webinar, suggested validation centres will be introduced. 2.Match Selected projects, that do not have validation centres will receive 2-3 suggestions as part of a positive funding note. Projects are free to find a match with the EP PerMed suggested centres or select other suitable validation centres based on individual needs as described in their application. 3.Plan The applicant and their validation centre of choice formulate a detailed project plan on how they will work together during the programme. If ethical approval is required for the study, the approval application should be submitted before contracting. 4.Funding Decision The final funding decision is made based on the project plan provided by the applicant together with the validation centre of choice. 5.Validate A six-month long joint validation study is conducted. 6.Final Report The applicant, together with the validation centre, will file a full report from the validation study at the end of the project. Selected projects will receive funding of up to 80,000 EUR per project, which can be used to cover validation services and other eligible costs. At least 70% of the budget should be allocated to user validation services. The funding will be provided through lump sum contracts, with 50% pre-payment and the remaining 50% disbursed upon approval of the final activity report. Eligibility criteria For an application to proceed to evaluation, it must meet all the below eligibility criteria. Each application will be reviewed for this eligibility criteria by EP PerMed Partners. Applicants must submit their applications via the application platform before the deadline on 13 March 2025 at 16:00 CET. Applications can be submitted either by a start-up or by an academic or health care research organisation registered in one of the EU Member States or Horizon Europe associated countries. Applications must be formulated in English.   Criteria for Validation Centres Readiness to contribute: The validation centre is ready to contribute to the project in the given time frame and fulfil the tasks in the given budget range. Comprehensive Service Offering: Provides a wide range of services that align with the specific needs of applicants, with flexibility to tailor support or customise services to meet unique project requirements. Support for Early-Stage Innovations: Demonstrates a successful track record in supporting start-ups or early-stage innovations, especially in validation. Quality Management and Protocol Adherence: Ensures strict adherence to quality management protocols in lab operations and clinical diagnosis, upholding high standards for reliability and accuracy. Requirements for biobanks The requirements of Biobanks as providers of samples and/or data for validation tests are as follow: Biobanks shall have readiness to provide samples and/or data, or other services and support for commercial purposes. Biobanks shall have broad consent for retrospective samples and/or data, that allows the samples and data to also be used for “commercial use”. Biobanks complying to European and International Standards for preanalytical samples processing and/or ISO 21899:2020 (Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks). Biobanks operations should be verified by complying to ISO 20387:2018 (Biotechnology – Biobanking – General requirements for biobanking) (accredited or quality labeled by BBMRI-ERIC). Biobanks that can support the applicant to obtain ethics clearance within max 1-3 months. Biobanks associated with institutes at university/hospital level as potential validation centers: Biobanks that operate under ISO 15189:2022 (Medical laboratories – Requirements for quality and competence) or ISO/IEC 17025:2017 (General requirements for the competence of testing and calibration laboratories) or ISO 20658:2023 (Requirements for the collection and transport of samples for medical laboratory examinations). Evaluation process and criteria   The selection process for this Call will involve a single proposal submission. Applicants will submit a single proposal through EIT Health’s Smart Simple application platform. Applications will then be reviewed and evaluated by an independent panel of experts and scored according to a set of evaluation criteria on a scale of 1 to 5. The evaluation criteria for admission into the EP PerMed Fast Track Validation Programme include:        Innovativeness of Idea: The solution must present a novel approach that significantly advances the current state of Personalised Medicine. oWeight = 25%        Management Capacity: The team should have the necessary skills and experience to successfully execute the project. oWeight = 25%        Market Opportunity and Impact: The solution should address a clear market need with potential for substantial impact. oWeight = 20% Co-creation and validation: There must be a demonstrated need to refine and validate the solution. oWeight = 15%        Business Model and Development Strategy: The applicant should have a clear and feasible plan for further development and commercialisation. oWeight = 15% The evaluation will be calculated according to the following formula: Final score = Weight(1)×Score(1)+⋯+Weight(5)×Score(5) Each proposal will be evaluated by 3 external programme evaluators. The final score will be the average of the scores of the three evaluators. As the programme uses lump sum funding, pre-selected projects should provide the detailed cost plan. In case of misbalance, suggestions will be provided and should be taken into account before signing the contract. Programme admission Once projects receive the final scores from evaluators, they will then be ranked and the top 10 projects (rank one to ten) will be invited to the next step – creation of the study plan with validation centre of their choice. The TOP 5 ranked projects that meet all the funding criteria, will be funded. To obtain access to the funding, the pre-selected projects should meet the following criteria: Both start-up and validation centers have signed the three-party-grant agreement (between EIT Health as funder, the validation centre, and the PM solution owner/applicant). Have provided a detailed validation plan, including detailed cost plan. If the cost plan anticipates changes, the amendments should be accepted. If the study plan foresees ethical approval, it must be submitted to the respective Ethical Board(s). A copy of the application should also be provided. Based on previous experience, there may be a serious fall out from the funding list, therefore, we encourage the TOP 6-10 ranking teams to work on the study plan, as there is still high probability that some of the TOP 5 ranked will be not able to meet all the funding criteria. Detailed validation plans must outline the scope, actions, timeline, and resources required for the validation activities and be presented no later than eight weeks following the selection notification. Before a final granting decision is confirmed, these validation plans will be meticulously checked by EIT Health for completeness and accuracy. This review will focus on the feasibility and comprehensiveness of the plan, the suitability of the validation centre, the adequacy of resource allocation, and the readiness of the project team. Selected projects that successfully conclude a contract with a chosen validation centre will receive funding of up to 80,000 EUR per project. Redress procedure Applicants can appeal against the final award decision if they suspect a breach in 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 experts/evaluators.  Applicants should submit their appeal to EIT Health via email (appeals@eithealth.eu) within seven calendar days following notification of the application outcome. The outcome notification 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 team to which the appeal relates;   Only one appeal per proposal will be considered;  The appeal must be submitted via email within seven calendar days of the outcome notification email. 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 may be judged as not suitable for redress.  Procedure Upon receipt of an appeal, an acknowledgement of receipt will be sent by EIT Health within seven 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 within the seven calendar days deadline will be processed together. The decision will be communicated to the appellant within 2 weeks from the deadline for submitting the appeals. 

Further information

On-line webinar Join the on-line webinar for interested applicants of Fast Track call on 21 January 2025, 11am - 12pm CET. Register here. You can also register for our Q&A, before the Call closing date, on 4 March 2025, 11am - 12pm CET. Join us here. Call contact information: -Please visit https://www.eppermed.eu/funding-projects/calls/fast-track-call/  -or contact: Mohammed Ilyass Rahmouni at calls_eppermed@eithealth.eu List of Validation Centres  The validation centers listed below are NOT official partners of this call. The provided links refer to publicly available sources. Applicants are encouraged to approach potential validation partners directly and provide more context on their needs and the scope of the call to help improve the call process.   TEF project: 83 virtual testing facilities and 93 physical testing facilities - https://tefhealth.eu/    EITH database of biobanks and health registers - https://biobankshealthdata.eithealth.eu/  Database of European biological and biomedical imaging - https://www.eurobioimaging.eu/validation/  HMA-EMA Catalogues of real-world data sources - https://catalogues.ema.europa.eu/   Catalogue of validation centers in European Network of Living Labs: https://enoll.org/wp-content/uploads/2024/09/ENoLL_Member_catalogue_2024_web.pdf.  BBMRI database of samples and data in biobanks - https://directory.bbmri-eric.eu/ERIC/directory/#/catalogue. Some biobanks that have given the confirmation to be part of Fast Track project in case of suitable match:  Latvian National Biobank - Latvia: https://www.genomadatubaze.lv/en/  Center of Excellence in Biobanking and Biomedical Research - Cyprus biobank.cy  Integrierte BioBank Jena (IBBJ) – Germ any https://www.uniklinikum-jena.de/ikcl/ibbj.html  Leipzig Medical Biobank, University Leipzig - Germany: life.uni-leipzig.de   Uppsala Biobank /Uppsala BioLab – Sweden: www.uppsalabiobank.uu.se   7.BBMRI-ERIC Expert Centers as potential validation centers in collaboration with biobanks:  CNAG  CBmed  ATMA Platform