Deliverables

D1.1 SOP for the prioritisation process

This deliverable presents a first working version of a Standard Operating Procedure (SOP) framework
for prioritisation of new User projects for consideration for onboarding into the REMEDi4ALL project.
The framework aims to establish a transparent, systematic, and robust process to identify high-priority
projects.

Developed by a working group comprising relevant work package (WP) leaders, the framework aims
to ensure that project proposals are assessed based on their alignment with the consortium’s vision
for scientific rigor, patient engagement and market feasibility. Through a multi-step method, each
project proposal is evaluated and ranked based on its potential impact and resource requirements.
This structured approach to project prioritisation will help enable REMEDi4ALL to support initiatives
with the highest potential for impact and success.

D1.2 Interim outreach activities report

The quality of the REMEDi4ALL repurposing platform and the expertise support and resources it can offer is essentially irrelevant if nobody is aware of the project and its mission. Consequently, outreach and communication activities have been central to the project’s development in its first three years, with involvement across the majority of work packages. This report summarises our evolving outreach approach in the context of a comprehensive
communications and dissemination strategy, showing how it has pervaded the whole project, and helped us to establish REMEDi4ALL as a key player and partner in the global repurposing ecosystem even before the platform is actively seeking new projects.

Given the breadth of our work in the platform, the report works to provide a clear definition of an outreach activity, showing how each of these has been a stepping-stone to further engagement and impact for the REMEDi4ALL project. In particular, it explores the role of the iDR conference series, the Drug Repurposing Concierge, the Funders Network, and the Repurposing Academy as key pillars of our outreach endeavours, helping to build an active
repurposing community capable of feeding our drug repurposing platform and deliver long-term impact.

Finally, we review the vision for outreach in the final two years of the project, and its central role in our long-term sustainability.

D2.3 Operations Handbook and Services Catalogue

During its first two years, the REMEDi4ALL platform has focused on developing an efficient
operational framework to support the community and to prepare for the onboarding and end-to-end management of patient-centric drug repurposing and drug repositioning projects. This deliverable presents an overview of key operational tools developed to coordinate and optimize the expertise and resources within the Consortium for prioritising, supporting and managing ongoing “Demonstrator” and future “User” projects. These include: 1) the REMEDi4ALL Concierge – a portal for engaging with different repurposing stakeholders and triaging potential User projects; 2) a range of patient engagement tools to support drug repurposing projects
from inception through clinical implementation; 3) the creation of a drug repurposing Funders Network; 4) a novel “matchmaking” process for establishing and mediating interactions with potential industry sponsors for new drug product approvals and label variations. Finally, an overarching REMEDi4ALL Catalogue of Services is described together with an interactive interface for maximizing access and utilization by stakeholders both within the Consortium and across the drug repurposing ecosystem.

D3.1 Training landscape map

To understand what role REMEDi4ALL’s training will serve, it was crucial that there was an in-depth assessment of pre-existing training both specifically covering drug repurposing and covering different aspects of the drug repurposing/translational research pathway. Work Package 3 (WP3) believes that a strong training platform will not reinvent the wheel but use a collaborative approach and robust signposting to ensure REMEDi4ALL’s offering complements and enhances the existing training ecosystem. A number of methods were applied to build as full a picture of the current training landscape as possible. This included guided, targeted searching, one-to-one interviews, and the formation of a new, user-friendly and focused database of training. While many resources exist that offer signposting, information and guidance on drug repurposing, there is a significant gap in the formation of a centralized education and training platform that brings all stages of the process and all stakeholders together to offer a fully accessible and collaborative knowledge base. REMEDi4ALL’s training and education work package should aim to fill this gap.

D3.2 Mid-term report on repurposing academy activities 

This mid-term report showcases the work of Work Package 3 in researching and understanding the training needs of stakeholders with the aim of developing a training package that echoes the REMEDi4ALL ethos of being multi-stakeholder and patient-centric. 

The report outlines the need to deviate from our original strategy and highlights that this was the correct choice with evidence of initial success, highlighted throughout this report through our impact measuring and statistics. The report highlights the new strategy and the different training methods that now sit within the Repurposing Academy and the individual and collective aims and impact of these methods.   

Finally, the report presents our ambitious strategic plans for continued evolution of the Academy, highlighting upcoming activities, anticipated improvements, and the envisioned trajectory to maximise and maintain relevance and responsiveness to the ever-evolving field of drug repurposing.  

D4.1 Report on AI tools and data
resources

Work package 4 (WP4) of REMEDi4ALL focuses on surveying and developing open-source artificial intelligence (AI) tools and databases for supporting user-driven in silico drug repurposing applications. Starting with a landscape analysis, Task 4.1 surveyed 196 in silico resources (tools, methods, and databases) in terms of their usefulness and reliability for various drug repurposing applications. For each resource, we provide a comprehensive list of annotations, such as open-data statistics and open-implementation of the databases and tools, respectively, and a summary ranking of the resources among 26 experts of the drug repurposing field. The survey results have been made available as a sustainable and extendable catalogue online at https://idrc-r4a.com/. Furthermore, Task 4.1 carried out three demonstrator use cases using selected in silico resources to guide the drug repurposing process in the demonstrators of the REMEDi4ALL project. This comprehensive survey and expert evaluation demonstrate the benefits of using in silico resources for drug repurposing and highlights some limitations and missing gaps in the current resources.

D5.1 Interim report on data sets deposited onto in vitro database platforms 

This report documents the generation, curation, and public deposition of in vitro datasets created within the REMEDi4ALL demonstrator projects, which aim to advance drug repurposing through systematic data sharing. Four major studies are covered: (1) high-content assays of drug-induced phospholipidosis, supported by predictive machine learning models; (2) Cell Painting–based morphological profiling of antiviral activity against SARS-CoV-2; (3) a multi-centre ring study evaluating synergistic drug combinations in pancreatic ductal adenocarcinoma models; and (4) annotation workflows that harmonize chemical and bioactivity data from public repositories into standardized compound libraries. 

All datasets have been curated according to FAIR principles (Findable, Accessible, Interoperable, Reusable) and deposited in open-access platforms including ChEMBL, Zenodo, GitHub, and the Image Data Resource (IDR). Together, these resources provide high-dimensional phenotypic profiles, reproducible combination response data, predictive models of compound liabilities, and harmonized annotation pipelines. Beyond their immediate relevance to the demonstrator studies, the datasets are designed for broad reuse in areas such as benchmarking phenotypic assays, training machine learning models, validating synergistic drug interactions, and improving compound prioritization. 

By integrating wet-lab experimentation with computational workflows and ensuring open accessibility, REMEDi4ALL establishes a sustainable framework for collaborative, data-driven drug repurposing. These datasets serve as both reference resources and methodological exemplars, supporting reproducibility, transparency, and innovation across the wider biomedical community. 

D6.1 Catalogue of experimental standards and workflows

The cataloguing of preclinical development services began with a workshop emphasising the preclinical expertise of REMEDi4ALL (R4ALL) consortium partners. This effort led to the creation of the R4ALL Knowledge Graph (KG), a comprehensive repository of expertise and services from partner organizations for drug repurposing projects (as described in detail in deliverable D2.3). Additionally, ongoing activities are focused on developing a series of Standard Operating Guidelines (SOG) and Standard Operating Procedures (SOP) that outline critical processes for the early-stage identification and validation of repurposed hit compounds. These REMEDi4ALL operating documents will be integrated into the R4ALL KG continuously during the lifetime of the R4ALL project.

D7.1 Report on services, expertise barriers in the clinical development

Deliverable D7.1 summarises the capacities and expertise available to support clinical development for drug repurposing within the REMEDi4ALL consortium, and closely related ecosystem, and the challenges and barriers of the clinical development process pertinent to drug repurposing.

It was important to identify the key challenges being faced by the four pilot projects and the capacities that exist within the REMEDi4ALL consortium to support repurposing projects to streamline the future work towards adding, expanding, and upgrading the consortium resources and expertise to support the repurposing community.

WP7 performed this gap analysis using a mixed method approach: in-depth interviews with demonstrator projects, a survey, a literature search, and collaboration with other work packages within the consortium to identify barriers in specific domains (funding, policy etc) to evaluate the maturity and readiness of the consortium to provide clinical development services to drug repurposing projects. Based on past experiences, long-standing portfolio to support clinical development and clinical operational services by ECRIN, and available expertise within the consortium, a blueprint to cover clinical aspects of the Repurposing Development Plan is also provided which can be adaptable to possible drug repurposing projects.

The complete range of clinical stage services available within the REMEDi4ALL consortium is listed in the accompanying document ‘Clinical Stage Services Catalogue’. The WP7 team aims to help the drug repurposing projects through their clinical stage journey and is enthusiastic to get in touch with the teams developing repurposed medicines to support them in their clinical operational tasks.

D7.2 Report on implementation of Drug Repurposing clinical platform

This report summarises the necessary tools, services, and guidance developed and implemented to operationalize the clinical platform of REMEDi4ALL. During the first two years, the consortium emphasised developing its operational capacities by supporting the demonstrator projects and learning from the experiences gained through leading the demonstrator projects. The consortium’s strengths and weaknesses were brought to light by supporting the clinical stage demonstrator projects. The consortium was further reinforced by filling up the gaps. The platform matured and started extending its operational services to help other repurposing projects with the opening of the Concierge in March 2023. This mature clinical platform is now ready to onboard new User Projects and lead them through their repurposing journey with the implementation of operational workflows developed with experiences from the demonstrator projects.

D8.1 Barrier identification of key policy areas

Despite the frequently reported benefits of drug repurposing (DR), its full potential has not been unlocked yet. The objective of this deliverable is to map the policy barriers hindering DR. The secondary objective is to elicit stakeholders’ perception on different policy barriers.

A systematic literature review (SLR) has been performed and in parallel was complemented with twenty-four individual, 1-hour- long interviews conducted with Consortium members. Extracted sources included publications from PubMed, Embase, and grey literature sources. Barriers were
mentioned in 875 text extracts, which were processed for thematic analysis and iterative two-level coding of the information. A barrier tree of 32 individual policy barriers in 9 main themes was developed and validated with 80 experts representing all major stakeholder groups. Following that,
an online policy survey was developed to elicit responders’ perception by weighting barriers for both their perceived impact and actionability, which was completed by 60 experts.

After validation, 33 barriers (one had split into two based on feedback) were identified and categorized into 9 themes: Perception of repurposing of off-patent medicines; Business case for repurposing on-patent compound; Business case for repurposing off-patent medicines; Non-industry funded DR;
Ecosystem for non-profit or SME driven drug repurposing; Market Authorization; Exclusivity rights; Health technology assessment; and Pricing (Petykó et al. 2024). Interestingly, barriers having the highest weight varied across different stakeholder groups.

The comprehensive and validated list of barriers, together with the perceptions of individual stakeholders, will serve as input to identify potential policy intervention areas to improve the DR ecosystem. Dissemination: one manuscript on the SLR is under peer-review, another on the stakeholder’s perception is under internal review, one conference abstract on the SLR is published, and another on the stakeholders’ perception has been accepted for publication.

D9.1 Report on establishment of the Funders network

An active network of funders will be key to creating opportunities for synergising, exchanging best practices and reducing fragmentation in the drug repurposing funding landscape. It will enable the alignment of research agendas; help identify opportunities for joint calls and new funding collaborations and contribute to the development of new funding and business models. These, in turn, will promote/enable/incentivise drug repurposing projects and partnerships, and deliver high societal
impact and patient-oriented benefits.

In this deliverable we describe the (steps towards) establishment of an international broad and interactive network funders network for drug repurposing. The REMEDi4ALL Funders Network was
launched in October 2023 and as of January 2024 we have officially welcomed 23 members and three observers to the funders network. This comprises diverse funding entities – both equally public and private – from across the globe that are dedicated to advancing drug repurposing initiatives. We expect the network to grow in the coming months as more funders have expressed their interest. Funders are welcome to join at any point in the future.

D9.2 Starting pack of materials for creating joint calls

This deliverable offers a starting point for funders looking to create (joint-) funding calls. We have created a publicly available guiding document that provides pointers to information and materials to create calls specifically for drug repurposing projects. This guide primarily highlights and directs readers/users to relevant materials that already exist elsewhere. It does not replicate useful materials that have already been provided elsewhere but seeks instead to refer interested parties to excellent resources already available from ERA-LEARN, LifeArc and other experienced research funding institutions. In addition to highlighting this
wealth of existing information, new materials, where required, are included here. These are based on real-world examples from ZonMw, the Anticancer Fund and other members of the
REMEDi4ALL Funders Network. With this guide we aim to make the funding process as easy as possible for funders and stimulate funding of high-impact drug repurposing research.

D9.3 Framework for value assessment of repurposed medicines

This deliverable describes a comprehensive framework designed to provide an explicit and transparent assessment and ranking of potential drug repurposing projects for research funding organisations. This framework has been designed to be flexible, reflecting the various perspectives
of different research funders and the varying and specific attributes of individual repurposing projects. The framework development aligns with one of the overarching objectives of WP9, which is to create a range of incentives and tools to support funders with funding drug repurposing projects.

The planning of the framework was based on extensive exploratory work carried out by reviewing and processing published materials from different sources. This activity was also supported by regular consultations and meetings with WP9 partners. The contributing partners followed a deliberative
process to define the design, usage, features and outputs of the framework.

The framework has been implemented as an Excel-based tool with an approach that allows a flexible, yet thorough evaluation of repurposing projects. The tool aids in fostering alignment with funding strategies while maintaining scalability, comparability, and practical usability in the selection and
prioritization of drug repurposing initiatives. The assessment process within the tool includes the following steps:
1) The tool can be used for assessing a single project at the time. Defining the profile of the
project to be assessed is the first step.
2) The assessment involves evaluating the project against multiple predefined criteria. The
relevance and priority of these criteria may vary across funder organizations. Selecting the
relevant criteria that should be part of the assessment is the second step.
3) The selected relevant criteria are grouped in specific domains. The relative importance of
these domains differs across funder organizations and repurposing projects. Assigning
weights to each domain is the third step of the assessment.
4) The selected criteria with the specified weights are used to assess the projects. Scoring each
criterion within the domains is the fourth step of the assessment.
5) The overall score is the combination of the weights and the scores on each domain. Defining
the overall score is the final step of the assessment.

The framework and the associated Excel-based tool will be publicly available at REMEDi4ALL online platforms. It will also be shared with funders through the REMEDI4ALL Funders Network communication channels and via dedicated events, such as an online workshop.

D9.4 Report on co-funding models

Funding issues for drug repurposing relate to lack of funding, the existence of funding gaps and financial disincentives/market failure in certain scenarios. There is a need for innovative funding models to address these issues and that can complement the traditional modes of funding for drug development. A range of innovative models already exist or have been proposed, but the knowledge of these is dispersed and not easily accessible to the community.

In this report we aim to develop awareness of the need for innovative funding models for drug repurposing. We have collated and categorised a range of innovative funding models that were found through peer- and grey-literature reviews and through stakeholder interviews. We have made the information accessible to the repurposing community as a resource to encourage adoption and adaptation of these models for drug repurposing.

D12.1 Report on the strategy and roadmap for collaboration with other synergies

REMEDi4ALL was designed from its conception as a multi-disciplinary, multi-stakeholder collaborative project aimed at creating continuous engagement and fostering collaboration with high priority initiatives and stakeholders in all drug repurposing areas. In this context, WP12 “Internationalisation and Networking” provides the structure to ensure these goals are met.

This deliverable aims to provide an overview of the strategy and
roadmap for collaboration with other synergies and initiatives in the field of drug repurposing to be implemented during the project’s lifespan.  Besides outlining the main strategy, it establishes the methodological framework, the process, and sources for the identification of initiatives with which to build synergies upon. The deliverable also describes current progress with ongoing initiatives and synergies as part of Transnational collaborative activities in Task 12.2 to actively engage with expert repurposing community for the benefit of knowledge exchange and raising awareness of REMEDI4ALL platform development in this field.

D12.2 Report on the 1st Annual Conference

The inaugural REMEDi4ALL #iDR24 conference, titled “Bridging Boundaries: Innovating, Connecting & Reshaping Drug Repurposing”, united a global international and cross-disciplinary audience of over 230 attendees in March 2024 in Barcelona, Spain. With more than 50 speakers sharing insights and networking opportunities, the event provided a platform for experts to engage with key players in the drug repurposing ecosystem. A lively poster session showcased 28 posters, featuring both competitive and project-related entries. Attendees collectively rated their experience at 4.57 out of 5.00, reflecting the conference’s success in aligning with their expectations and interests. #iDR24
confirmed interest for a new series of conferences that brings together the global community with ambition to realise the potential of patient-centric drug repurposing.