Drug repurposing represents an opportunity to develop meaningful treatments for some of the most under-served populations. Remembering that this is the goal throughout your project helps guide decision-making and improve chances of success. Patient insight and experience can and should be considered at each and every stage of a project.
Drug repurposing Digital AcademySharing knowledge
THE DIGITAL ACADEMY FOR MEDICINES REPURPOSING
Building a sustainable European innovation platform to enhance the repurposing of medicines for all
Discover
Our Core
Modules
Our Core Modules cover the key steps of the scientific pathway associated with drug repurposing.
While traditionally these steps are completed one after the other, our Core Modules suggest when in your project timeline to consider thinking about each aspect, with some steps overlapping.
THE ROUTE TO REPURPOSING
Patients are the driving force behind any repurposing project
We have created the interactive “Route to Repurposing” to help guide you through the learning content on the Digital Academy.
Development stages serve as a timeline for the repurposing pathway.
Core Modules sit on arrows which show when learners should think about them.
Submodules make up the core and foundation modules. They contain content to learn.
Foundation Modules sit below the timeline, underpinning all the other learning.
Development stagesThe development stages define the main phases of your repurposing journey and provide a suggested timeline for completing specific repurposing activities. Drug development isn't a fully linear process and many aspects of the project will overlap at different times. You may need to go back to earlier activities or complete the topics in a different order. However, the development stages are here to guide you through the process and can be thought of like a loose timeline. |
General InformationAt the beginning of your project, it's important to gain a thorough understanding of repurposing and the disease area you're interested in. You should create a target product profile and assess the regulatory landscape. Now is also the time to upskill on foundational skills like project management and begin forming relationships with patient groups and all relevant stakeholders. You'll be introduced to the funding landscape as you move through your repurposing project. |
StrategyIn the strategy phase, you need to start getting more specific with your plans. You should identify a candidate and create a repurposing development plan of exactly how it will get to patients. Planning your funding strategy and strengthening your connections to other stakeholders will be crucial to the success of the project. You could think of this as a major planning stage, preparing you for everything still to come. |
Candidate DevelopmentCandidate development is where the main preclinical research occurs, but it's not just about proving safety and efficacy in models. You also need to start preparing for clinical research. The connections you've built so far with companies and patients will be really important here. It's a good idea to get scientific advice at this stage as it is easy to be led by the science at this stage, rather than being guided by your Target Product Profile (TPP). If your aim is to develop a drug for patients, a good candidate development phase will focus on only the most critical experiments to prove a drug can work for patients. |
Proving Patient ImpactClinical trials are your main opportunity to prove to the patient community, regulators and payers that your repurposed drug is safe and will make a difference to patient's lives. Carefully consider how to design and deliver a trial for the patient population in question. Throughout this phase, you'll need to rely on your project management and collaboration skills in order to be successful. Communication is key throughout this process, especially with patients. |
LicensingLicensing refers to getting marketing authorisation to allow a company to sell a drug for a particular condition (sometimes called an indication). This phase is all about meeting the regulatory requirements and showing that the drug works. You should have gathered all the data you need in the previous stages but may need to go back and gather more. Throughout the licensing process, you need strong relationships with other stakeholders, a good understanding of the regulatory process, and the ability to form good collaborations and contracts. |
Market AccessThis is the stage you've been working towards the whole time - it is now time to persuade payers to reimburse the repurposed drug and ensure that patients can access it. Success here relies on having done a thorough investigation in the first few stages and developing a realistic plan. But that doesn't mean the work is over: you still need to show your business case and work closely with payers and other stakeholders across the EU and around the world to bring your treatment to as many patients as possible. |
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| Core Modules | Introduction to drug repurposing |
Introduction to drug repurposingintroductionIt's time to begin your repurposing journey. Click 'visit submodule' to learn about course and get an overview of the repurposing pathway. |
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| Target product profile |
Target product profileThe TPPKeep your project on track with a target product profile. This document helps you plan exactly what the end product of your repurposing project should be. Target product profileDirect DataDirect data refers to data to the disease or drug you are studying and, where available, the interaction between the two. Accessing this early on can help guide later project steps. Target product profileOther DataThis data can support direct data and reflect the needs and desires of the patient community. From patient registries to real-world evidence and medical records there is so much data you can make use of in a repurposing project. Target product profileNeed IdentificationUnderstand who will benefit from a repurposed drug and what exactly they need. Target product profileFrom TPP to RDPTake your project to the next level by creating a repurposing development plan. Define your critical path and outline exactly how the drug will get to patients. |
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| Finding a repurposing candidate |
Finding a repurposing candidateCandidate IdentificationExplore how to search for repurposing candidates and identify the most promising. Finding a repurposing candidateScreeningLearn about the different ways you can screen candidates to understand their properties and potential. Finding a repurposing candidateValidationUnderstand how and why obtaining high-quality pharmacological information can show the potential of your repurposing candidate. |
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| Preclinical Development |
Preclinical DevelopmentPre-Clinical Strategy and DataA sound preclinical strategy involves identifying what data you need and how you'll manage it, as well as looking ahead to marketing authorisation, sponsorship and scientific advice. Preclinical DevelopmentExploring Your CandidateNow you've identified your most promising repurposing compound, it's time to learn more about it. You'll need to establish its mechanism of action and safety profile. Preclinical DevelopmentPreparing a patient ready candidateWhat do patients need from a drug? Here you'll explore reformulation, pharmacokinetics and pharmacodynamics, as well as biomarker development and dosing. Preclinical DevelopmentPreparing a market ready candidateHow will you ensure the drug gets to market? This submodule explores ways to solidify your candidate from a regulatory, marketing and manufacturing perspective, by building a relevant data package. |
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| Clinical Development |
Clinical DevelopmentClinical StrategyPlanning and running a clinical trial is a complex process. Understand the fundamentals of what is required in this submodule. Clinical DevelopmentTrial designLearn about designing a clinical trial suited to both your project’s goals and the patient population including selecting appropriate outcome measures and exploring adaptive trial designs. Clinical DevelopmentClinical Trial Regulations And EthicsHere, you'll learn about the aspects of getting a trial approved and how to make amendments to the protocol to ensure it continues to meet the needs of the project. Remember to look at the Clinical Trial Regulation submodule to get the full picture. Clinical DevelopmentClinical Trial RecruitmentRecruiting and retaining participants is essential for trial success. Dive in here to learn about developing patient-facing documents, consent, and more. Clinical DevelopmentClinical Trial DeliveryUnderstand the logistics of clinical trials and how to ensure impact. We'll explore who is responsible for what activities and how to mitigate risks. |
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| Securing patient access |
Securing patient accessSecuring Your Path To MarketUnderstand the needs of different stakeholders as well as the legal and intellectual property landscape around your drug in this submodule. Securing patient accessBuilding A Business CaseLearn about health technology assessments and managing the lifecycle of a repurposed drug in this submodule. Securing patient accessRoutes To MarketUnderstand the different routes to market and identify the most appropriate for your repurposed drug. Securing patient accessMarket Access Off-LabelSome medications reach patients without a marketing authorisation. Explore the pros and cons of off-label prescription and gain insights from case studies here. Securing patient accessMarket Access On-LabelGet to grips with label extensions and prescription regulations for on-label drugs here. |
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| Regulations |
RegulationsThe Regulatory LandscapeFamiliarise yourself with the different regulatory bodies and processes across the EU and UK. RegulationsRegulatory Activities And PathwaysGet an overview of the key regulatory steps, including obtaining scientific advice, clinical trial approval, and marketing authorisations. RegulationsRegulatory StrategyWhat data and evidence will you need to gather to convince regulators that your repurposed drug is safe and effective? Consider such questions early in the development journey and create a clear strategy for regulation - the gateway to patient access. RegulationsScientific AdviceLearn about the types of scientific advice and protocol assistance you can get from regulators to help you develop safe and effective medications. RegulationsClinical Trial RegulationHere, we explore clinical trial applications, grants, and investigational plans from a regulatory perspective. RegulationsSeeking a Marketing AuthorisationAcquiring marketing authorisation is essential if your drug is to reach patients. Explore how to go about this challenging process here. |
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| Foundation Modules |
RegulationsintroductionGain an overview of how drug repurposing projects get funded and understand where your project fits in. |
Regulationslandscape for applicantsThis submodule is for applicants seeking funding. Learn about different funding opportunities, how to cost your research and create funding agreements. |
Regulationsapplying for fundingNow you understand the landscape, it’s time to apply. This submodule shows you how to write great applications showcasing patient engagement, data, and market feasibility. |
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RegulationsFunding for fundersThis submodule is for funders looking to move into the repurposing space. Learn about joint funding calls, setting expectations, and selecting the right projects for your organisation. |
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Regulationspatient trainingPatients should be part of the decision-making process in drug repurposing projects. Learn how to give them the tools to contribute with confidence. |
Regulationspatient engagementLearn about the essential role that patients play in repurposing projects and how to harness the full potential of working with patients, families, and representatives. |
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RegulationsGeneral principals of project managementComplex projects need high-quality leadership. Learn what it takes to be a great project manager in this submodule. |
RegulationsManagement strategy in drug repurposingDive deeper into what being a good project manager means for a drug repurposing project. Learn about measuring success, technology transfer, and sustainability strategies. |
RegulationsPreclinical project managementUnderstand what needs to be done before, during, and after the preclinical development phase. |
Regulationsclinical project managementUnderstand what needs to be done before, during, and after the clinical development phase. |
RegulationsApprovals and access managementLearn about managing a project through the approvals and market access phase. |
Regulationspost authorisation managementAfter a drug has a marketing authorisation and is available to buy and sell, there's still work to be done to ensure continuous, reliable patient access. This could include setting up a patient registry or gathering real world data. |
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RegulationsBasic Principles of CollaborationUnderstanding the role, perspectives, and needs of each stakeholder group will help you work together effectively and get your project moving. |
RegulationsWhere and how collaborations should happenLearn from examples of effective collaborations and understand how to connect with patient organisations. |
Regulationscommunication as a toolHonest and effective communication is essential in any project. Learn how to build trust between partners and manage the expectations of patients, industry, and academics. |
RegulationsCollaboration templates, agreements and contractingNavigate contracts with confidence. From understanding freedom to operate to data sharing and access, this submodule covers what you need to know about agreements and contacts. |
Regulationsexisting supportDive into the wealth of resources designed to support and facilitate collaborations in drug repurposing. |
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The interactive roadmap is optimized for use on larger screens. Please visit this page from a desktop device or download the pdf version below.
Inspire
and encourage
drug repurpose-ers
REMEDi4ALL wants to inspire and encourage the next generation of drug repurpose-ers.
Whether you are a curious academic leading or supporting a repurposing project, a patient group seeking new opportunities or an industry representative looking to understand a patient-centric approach to repurposing, the Digital Academy is for you.
The Digital Academy aims to empower this next generation by providing an overview of what REMEDi4ALL partners consider to be the most important parts of a successful drug repurposing project. REMEDi4ALL defines a successful repurposing project as one that looks beyond great and interesting scientific publications and focuses on an ultimate end goal of delivering a product to patients in clinic.
Read the full story about the REMEDi4ALL Digital Academy About the Academy
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Partners actively contributing to the Digital Academy
