Introduction
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, endotype, genotype), as well as lifestyle and 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, methodologies and information utilised is much broader, supporting improved healthcare, diagnostics and tailormade treatments, including rehabilitation, and prevention strategies.
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) through dedicated research, development and innovation funding.
Programme Timeline
| Date | Event |
|---|---|
| 10 December 2024 | Opening of the Call for Proposals submission |
| 13 March 2025 | Deadline for Call submissions |
| 14-18 March 2025 | Eligibility check |
| 19 March – 2 April 2025 | Remote evaluation |
| 11 April 2025 | Remote review notification |
| 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 |
Rationale of the Call
The EP PerMed Fast Track Validation Programme has been established to address a critical bottleneck in the development of PM solutions: the validation phase. Personalised medicine is a highly innovative and technology-driven field that holds immense potential for improving patient outcomes and optimising healthcare delivery. However, transforming groundbreaking innovations into market-ready products requires rigorous validation to ensure they meet the needs and expectations of end-users, including clinicians and patients.
Validation is essential for achieving and maintaining product-market fit, a key determinant of commercial success. It involves a thorough assessment of whether a product or feature effectively addresses the identified needs and bottlenecks. This process is often conducted in specialised validation centres, which provide the necessary infrastructure and expertise to test and validate innovations. Despite the availability of numerous validation centres across Europe, many innovators struggle to identify and access these resources, hindering the progress of their projects.
The main steps in programme:
- 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.
- 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.
- 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.
- Funding Decision: The final funding decision is made based on the project plan provided by the applicant together with the validation centre of choice.
- Validate: A six-month long joint validation study is conducted.
- 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.
Aim of the Call
The Fast Track Validation Programme aims to accelerate the development and adoption of at least 5 innovative PM solutions in 2025, fostering advancements that can transform healthcare and improve patient outcomes. The programme contributes to the overarching goal of Personalised Medicine: delivering tailored, effective, and efficient healthcare solutions that meet the unique needs of each patient.
Expected outcomes and impacts
Upon programme completion, participants will have rigorously tested and refined their innovations in realistic settings, elevating their projects by at least one TRL. This process ensures that solutions move to a higher level of technological and market readiness.
Please click here for more information on TRL levels.
The validation studies conducted in top-tier centres will provide essential evidence and, if applicable, user feedback, crucial for meeting regulatory requirements and demonstrating the efficacy and safety of the innovations. This rigorous validation process not only enhances the credibility of the projects but also reduces the time and risk associated with bringing new solutions to market.
By achieving higher TRLs, participants will be better equipped to attract investment and strategic partnerships, facilitating smoother transitions from development to commercialisation. Ultimately, the programme aims to foster the development of Personalised Medicine innovations that are ready for clinical application, thereby accelerating the availability of advanced, patient-specific healthcare solutions and driving forward the field of Personalised Medicine.
Application
The EP PerMed Fast Track Validation Programme is open to start-ups, or small teams and researchers 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 you have any questions, please see the “Guide for applicants” or contact smartsimple@eithealth.eu.
Registration Instructions:
For incorporated start-ups, make sure to register in the EIT Health Application Platform as a representative of a start-up or independent team. For Teams or Researchers affiliated with an academic or healthcare research organization, please register as a representative of an organization (excluding start-ups).
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 by either a start-up or a team/researcher affiliated with an academic or healthcare research organization registered in an EU Member State or a Horizon Europe-associated country. – If you are unsure about your eligibility, please do not hesitate to contact us using the information provided below –
- Applications must be formulated in English.
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.
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.
- Management Capacity: The team should have the necessary skills and experience to successfully execute the project.
- Market Opportunity and Impact: The solution should address a clear market need with potential for substantial impact.
- Co-creation and validation: There must be a demonstrated need to refine and validate the solution.
- Business Model and Development Strategy: The applicant should have a clear and feasible plan for further development and commercialisation.
As the programme uses lump sum funding, pre-selected projects will be invited to provide a detailed cost plan using a mandatory budget template (provided after the preselection). Before the signature of the Financial Support Agreement, the budget will be reviewed, and suggestions might be provided by the programme management team if necessary (i.e in case of misbalance).
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 Financial Support 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.
We strongly encourage teams ranked TOP 6–10 to work on their study plans, as they will serve as a reserve list of projects. In the event that any of the TOP 5 ranked projects are unable to meet all funding criteria, projects from the reserve list will be accepted in order of their ranking.
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.
Funding and grant payout
Selected projects that successfully conclude a contract with a chosen validation centre will receive funding of up to 80,000 EUR per project. This funding is intended to cover validation services and eligible costs, with at least 70% of the budget allocated specifically to validation services. The funding will be provided through a lump sum contract, structured to ensure efficient and effective use of resources.
The payment will be distributed in two instalments: an initial pre-payment of 50% of the total funding will be made at the start of the project, tied to Financial Support Agreement signature, to facilitate the commencement of validation activities. The remaining 50% will be disbursed upon approval of the final activity report, which will verify the completion of the validation plan and the achievement of the project’s objectives. This structured funding mechanism ensures that projects have the necessary resources to successfully complete the validation phase and progress towards market readiness.
For more information, please refer to the Financial Support Agreement for payout and reporting schedules.
On-line webinar and call contact information
Join the on-line webinar for interested applicants of Fast Track call on 21 January 2025, 11am – 12pm CET.
You can also register for our Q&A, before the Call closing date, on 4 March 2025, 11am – 12pm CET.
For further information contact: Mohammed Ilyass Rahmouni at calls_eppermed@eithealth.eu