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Call key data

Modelling and simulation to address regulatory needs in the development of orphan and paediatric medicines

Call number

HORIZON-HLTH-2023-IND-06-04

deadlines

Opening
12.01.2023

Deadline
13.04.2023 17:00

Deadline - 2nd stage

Opening
31.01.2023

Funding rate

100%

Call budget

€ 25,000,000.00

Estimated EU contribution per project

between € 4,000,000.00 and € 6,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

Call objectives

In its "Regulatory Science Strategy to 2025", the European Medicines Agency included specific recommendations to optimise the capabilities of modelling and simulation in the medicines development process and in particular to benefit special populations and neglected patient populations.

Orphan drug development faces numerous challenges, including low disease prevalence, patient population heterogeneity and strong presence of paediatric patient populations. Consequently, clinical trials for orphan and/or paediatric medicines are often smaller than traditional large-scale randomised ones and they require the development of efficient trial designs relevant to small.

Model-based approaches are significantly advantageous in small populations, as extrapolation tools for rationalising and increasing the statistical robustness in clinical trial designs and pharmacometric studies.

The topic will support research and innovation activities focusing on the development of diverse modelling and simulation methods, as tools for addressing some of the regulatory needs in the clinical development cycle of new orphan and paediatric medicinal products. The topic is not intended to implement new preclinical/clinical studies but to use the existing knowledge/data for assessing and optimising the performance of mature in-silico models in the regulatory context with the goal of improving the clinical trial designs for small populations. Availability of the relevant data to address the requirements of the topic is an indispensable condition that must be demonstrated at the proposal submission.

Proposals should involve national healthcare product regulatory bodies and the European Medicines Agency (EMA) in order to catalyse an effective collaboration between the researchers and the regulators. The active involvement of patient representatives is required in all phases of the research and innovation activities. Furthermore, SME(s) participation is encouraged with the aim to strengthen their scientific and technological basis.

The proposals should address all of the following activities:

  • Establish a multidisciplinary approach for assessing the utility of mature computational models, as tools for supporting the optimal design of innovative clinical trials for small populations and as fit-for-purpose solutions for enabling the regulatory scientific advice and marketing authorisation assessment of orphan and/or paediatric medicines, including their pharmacovigilance follow-up.
  • Calibrate and optimise mature computational models for enhancing their clinical performance, by using relevant sources of patient data (e.g. natural history and observational clinical studies, medical records, registries, pharmacovigilance and longitudinal studies etc.). The models should include a variety of modelling methods and in particular hybrid solutions linking quantitative mechanistic modelling with advanced statistical modelling (e.g. quantitative systems pharmacology, disease mechanistic models, physiology-based pharmacodynamic/pharmacokinetic models, Bayesian modelling, artificial intelligence algorithms etc.).
  • Assess validated in-silico models for their capability to increase the statistical robustness, improve the risk/benefit assessment in small population clinical trials, and for their accuracy to predict and extrapolate the therapeutic and dose effects, taking into account the patient’s genotypes/phenotypes, disease characteristics/stage variables and/or clinical/surrogate endpoints for delivering robust evidence of safety and efficacy of the orphan and paediatric medicines under study. The assessment of the in-silico models should be demonstrated in use cases representing well-justified group(s) of rare and/or paediatric diseases with commonalities, such as shared molecular denominators/disease pathways within the same and/or across different medical areas, excluding cancer and infectious diseases.
  • Benchmark of diverse computational models by showcasing their simulation performance in virtual patient cohorts and by demonstrating that the models’ synthetic data estimates match to actual clinical trial data. This should lead to an assessment of the performance and credibility of a model simulation in the context of their specific use for regulatory purposes. Benchmark studies should be performed in the use cases mentioned above. Availability of clinical trials data and other relevant data is an indispensable requirement that must be demonstrated at the proposal submission.
  • Set-up the criteria for the performance and credibility assessment of any relevant computational models for small population clinical trials to progress on their regulatory qualification and acceptability. Further develop and disseminate standards for the design, performance assessment and reporting of modelling and simulation tools with an emphasis on those of high regulatory value for accelerating the clinical development of orphan and paediatric medicinal products.

The proposals should adhere to the FAIR data principles, adopt data quality standards, data integration operating procedures and GDPR-compliant data sharing/access good practices developed by the European research infrastructures, where relevant. Proposals are invited to consider adopting recommendations for in-silico models construction and validation. Data-intensive proposals, particularly those using data from patient registries, should take stock of the tools and services provided by the European Platform on Rare Disease Registration (EU RD Platform). For example, retrospective registry data are expected to be made accessible via EU RD platform, if reasonably feasible.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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Expected effects and impacts

Expected results

  • Developers and regulators have access to robust modelling and simulation tools to accelerate the effective development of orphan and/or paediatric medicinal products.
  • Clinical researchers, developers and regulators use accurate computational models to improve the statistical robustness in clinical trials intended for small populations and guide cost-effective clinical trial designs.
  • Clinical researchers and regulators have access to accurate in-silico tools for assessing the actionable use of real-world data and for successfully estimating the risk-benefit effects in clinical trials for small populations.
  • Regulators develop guidance for the use of validated computational models to support a robust extrapolation framework and facilitate the safety and efficacy assessment in the process of regulatory appraisal of orphan and/or paediatric medicinal products.

Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom

eligible entities

EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

Yes

Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating countries

Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country. 

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.

Additional information

Topics

Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

Relevance for EU Macro-Region

EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region

UN Sustainable Development Goals (UN-SDGs)

Additional Information

All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 45 pages.

The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

The rules for the legal and financial set-up of the grant agreements are described in General Annex G. The following exceptions apply: In order to optimise synergies and increase the impact of the projects, all projects selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities (and in determining modalities for their implementation and the specific responsibilities of projects). Depending on the scope of proposals selected for funding, these activities may include:

  • Attendance of regular joint meetings (e.g., common kick-off meeting and annual meetings). 
  • Periodic report of joint activities (delivered at each reporting period). 
  • Common dissemination and communication activities (which may include, for example: a common dissemination and communication strategy, web portal and visual identity, brochure, newsletters). 
  • Common Data Management Strategy and Common Policy Strategy (including joint policy briefs). 
  • Thematic workshops/trainings on issues of common interest. 
  • Working groups on topics of common interest (e.g. data management, communication and dissemination, science-policy link, scientific synergies)

Call documents

HE-Work Programme 2023-2024, Cluster 1, Destination 6HE-Work Programme 2023-2024, Cluster 1, Destination 6(452kB)

Contact

National Contact Points for Horizon Europe
Website

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