Project

What is EU-PEARL?

EU-PEARL is a strategic partnership between the public and private sectors to shape the future of clinical trials. This innovative and challenging enterprise aims to create a framework for patient-centric integrated research platform (IRP) trials, through which novel techniques and treatments developed by multiple companies and organizations are tested in a platform trial. 

To achieve this objective, EU-PEARL promotes cooperation amongst pharmaceutical companies, clinicians, patients and researchers and encourages knowledge sharing and open discussion amongst all stakeholders, including regulators. 

This sustainable and reusable systematic approach to platform trials conceived to test multi-sourced compounds, is to be supported by a management structure designed by EU-PEARL which will be able to meet complex regulatory, ethical, legal, statistical and data requirements.

EU-PEARL is also developing the specific IRPs frameworks for platform trials ready to operate in four disease areas still facing high unmet needs:

  • Major Depressive Disorder (MDD),
  • Tuberculosis (TB),
  • Non-Alcoholic Steatohepatitis (NASH) and
  • Neurofibromatosis (NF).

Public and private alliances have formed around these four disease areas and are now ready to support innovative clinical drug research of new techniques and treatments. EU-PEARL is set to create trial-ready clinical networks in these four disease areas, so that platform trials can be initiated shortly after the project is completed and funding secured.

This project is funded by the Innovative Medicines Initiative (IMI), a large, far-reaching public-private partnership integrated by the European Union and the pharmaceutical industry to support research and innovation in life-science. 

Vision

EU-PEARL aims to improve health outcomes for patients by shaping the clinical trials of the future. To achieve this vision, we have joined forces to create a sustainable and replicable framework that will produce a systematic approach to patient-centric, cross-company, multi-compound trial platforms.

Mission

EU-PEARL has set itself four objectives:

  1. Create a trusted, sustainable and replicable entity, ready to setup and coordinate the operation of integrated research platforms​ (IRPs) in any disease area with unmet needs.
  2. Set up an open, dynamic and patient inclusive IRP Governance structure to manage regulatory, ethical, legal, statistical and data requirements.
  3. Disseminate and exploit the EU-PEARL paradigm by providing the necessary common tools, procedures, expertise and operational skills that meet the highest scientific, regulatory and ethical standards and best practices. These are to be developed jointly by public and industry partners in a consensus-based approach.
  4. Create trial ready IRP networks to operate on Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis (NASH) and Neurofibromatosis.

Pillars

The EU-PEARL conceptual framework is based upon five main pillars:

THE PATIENTS

They are the backbone of the project as they will become the main beneficiaries of the Integrated Research Platform Trials that EU-PEARL promotes. Creating structured, systematic and sustainable patient engagement procedures on trial design and clinical R&D is a core objective to the project which the European Patient’s Forum (EPF) is contributing to develop.

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Patient-centricity is increasingly recognised as a priority in research and development of medicines and a founding principle of the common values in European Union Health Systems. The patient’s voice underpins Research and Development (R&D) of new medicines towards better health outcomes.

The basis of a successful patient research partnership requires both the ability of researchers to engage meaningfully with patients, and their ability to contribute proactively and meaningfully with researchers, both from industry and from academia

In order to build and reinforce partnerships between patients and researchers, current practices need to evolve. The basis of a successful patient research partnership requires both the ability of researchers to engage meaningfully with patients, and their ability to contribute proactively and meaningfully with researchers, both from industry and from academia. The patients’ contribution focus on providing high quality cross-disease or disease-specific knowledge, as well as expertise to guide and refine research priorities, development and assessment processes. The different stakeholders involved in medicine development widely acknowledge that innovative approaches, creative thinking and robust, trusted and ethical practices are necessary to orientate research and medicines development towards better patient health outcomes.

“In principle, patient-centricity is on everyone’s agenda, but the means and methods are often lacking or disparate inducing a lack of effective operationalisation”.

In principle, patient-centricity is on everyone’s agenda, but the means and methods are often lacking or disparate inducing a lack of effective operationalisation. The adoption of a patient-centred approach and meaningful patient engagement in medicines R&D varies greatly across countries and across disease areas. The R&D system has to become more responsive and responsible. The transformation from a linear development system, into one that focuses on societal impact and the active involvement of civil society in the R&D process, is called Responsible Research and Innovation. RRI is gaining ground, especially within the European Commission.

“Patients have different perceptions to clinicians or researchers about what innovations would bring most value to their lives. Their early engagement is key.”

Patients have different perceptions to clinicians or researchers about what innovations would bring most value to their lives. Their early engagement is key to ensure consideration of patients’ views when identifying the research topic and when defining questions and overall trial design, especially in the context of IRP trials that add further levels of complexity. It is because of this that patient engagement drives the patient-centredness approach in research. EU-PEARL will facilitate structured, systematic and sustainable patient engagement around three key principles:

– patient education and training (connecting with IMI EUPATI);
– guidance on engagement (connecting with IMI PARADIGM and the Patient Focused Medicines Development (PFMD) initiative); and
– sustainability of patient engagement in terms of concept, resources and process.

By working on the convergence of all three aspects in the EU-PEARL structure, we are embedding patient engagement in the design of the IRPs framework.

EU-PEARL partner European Patients’ Forum (EPF) an umbrella patient organisation that works with patients’ groups in public health across Europe, co-ordinates the patients’ perspectives and ensure the provision of deep cross-disease or disease-specific knowledge, as well as expertise to guide and refine research priorities and outcome measures from patients’ perspectives. EU-PEARL represents the perfect vehicle to structurally embed patients in the process of clinical R&D and to engage with Responsible Research and Innovation (RRI) practices.

“European Patients’ Forum (EPF), an umbrella patient organisation that works with patients’ groups in public health across Europe, co-ordinates the patients’ perspectives.”

EU PEARL plans to establish a Patient Engagement Platform as an online portal with resources to support patient and public awareness about IRP trials. This platform will ultimately facilitate the creation of partnership and early engagement of patients and patient associations in the design of clinical trials, placing the patients in the centre of the process, centralising the initiatives of patient engagement in research clinical trials and making them visible to the public.

“EU PEARL plans to establish a Patient Engagement Platform as an online portal with resources to support patient and public awareness about IRP trials”.

The Patient Engagement Platform will be led by patients, built on established patient networks, providing a match-making system between the patients and the patient engagement opportunities in the design of clinical trials. Educational group workshops where both clinicians and patients actively learn from each other resulting in patients’ more active engagement will also be delivered at the early stages of the project.

THE HOSPITAL HUBS

This network lead by centers associated to the European University Hospital Alliance (EUHA) provides an experienced environment to carry out platform trials. It also facilitates an ideal space to foster the interactions with patients and all stakeholders.

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Patient-centric adaptive IRP trials are widely considered the future of clinical development as they provide clear advantages for patients, industry and healthcare systems. However, such platform trials require intensive collaboration between and amongst the biopharmaceutical industry and public institutions. EU-PEARL will collaborate with the European University Hospital Alliance (EUHA), established in April 2017. The EUHA boasts over 30,000 publications and more than 8,000 active clinical trials per year.

“EU-PEARL will collaborate with the European University Hospital Alliance (EUHA), established with the goal of advancing the state of the art in research-intensive healthcare”.

EUHA partners in EU-PEARL include Assistance Publique – Hôpitaux de Paris (AP-HP) (link to partner text), Charité Universitätsmedizin Berlin (link to partner text), the Erasmus Medical Centre Rotterdam (EMC) (link to partner text), the Vienna General Hospital (MUW) (link to partner text), the San Raffaele Hospital Milan (USR) (link to partner text), the King’s College London (KCL) (link to partner text), the Universitair Ziekenhuis Leuven (KU Leuven) (link to partner text) and the University Hospital Campus Vall d’Hebron Barcelona (VHIR) (link to partner text).

“They are well positioned to rapidly adopt the IRP framework developed by EU-PEARL”.

The EUHA alliance was established with the goal of advancing the state of the art in research-intensive healthcare. Many institutions have been accredited by the European Clinical Research Infrastructure Network (ECRIN), the European Research Infrastructure dedicated to facilitating multi-national clinical trials and as they are connected to the InSite Platform, they are well positioned to rapidly adopt the IRP framework developed by EU-PEARL.

THE OPERATIONAL FRAMEWORK

The sound framework EU-PEARL is building will be based on an integrated set of statistical methods, tools and standardised procedures. Once it is fully developed, it will accommodate the evaluation of multiple treatments, whilst producing statistically valid results. Ultimately, this operational framework will serve a wider community, beyond the scope of EU-PEARL.

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Designing methodologically sound protocols to generate statistically valid results whilst evaluating multiple treatments in parallel is a paramount objective within EU-PEARL. The challenges, including regulatory acceptance of these data, are being addressed by timely engagement with all relevant stakeholders by the leading experts in the consortium. EU-PEARL remains aligned with existing efforts such as IMI EPAD and IMI EHDEN projects and will build upon existing know-how within EUHA and ECRIN.

“The common set of processes and methodologies will facilitate extension of the design to other disease areas to make the IRPs sustainable”.

The common set of processes and methodologies will facilitate extension of the design to other disease areas to make the IRPs sustainable. EU-PEARL plans to engage with regulators such as EMA and FDA and other decision makers to promote the IRP concept, involve them in requirements setting and in defining acceptance criteria for the methodologies and analyses conducted in IRPs.

“EU-PEARL plans to engage with regulators and other decision makers to promote the IRP concept, involve them in requirements setting and in defining acceptance criteria for the methodologies and analyses conducted in IRPs”.

The current capability of the InSite Platform) to connect to hospitals EHRs systems will be extended to provide the ability to connect to other sources of electronic health records, from observational and registries data bases. The new capabilities will upgrade the ability to conduct Natural Disease History analysis and enable patient recruitments for platform trials.

THE DATA GOVERNANCE ECOSYSTEM

Data sources, their integration and the quality of pre-existing Electronic Health Records (EHRs) and future research and patient data conforms a fourth pillar of this project. EU-PEARL it is set to build robust policies for access to global data and the creation of a governance structure that promotes transparency, engagement and utilisation for optimal future sustainability of the platform.

 

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EU-PEARL encourages the use of emerging standards in sharing EHR data and implement these standards with EU-PEARL partners in close collaboration with other IMI projects ( EHDEN , EMIF , etc). EU-PEARL does not intend to develop new standards for sharing observational data. EU-PEARL is set to adopting and/or define principles, policies, and codes of practice, quality guidelines and standard operating procedures consistently for all consortium partners and any external data access providers within the IRP network.

“EU-PEARL is set to adopt and/or define principles, policies, and codes of practice, quality guidelines and standard operating procedures consistently for all consortium partners and any external data access providers within the IRP network”.

EU PEARL will ensure that the collection and inclusion, processing and use of health and wellness data across the consortium complies with European and national data protection regulations and legislation (including the GDPR and national implementations, and the forthcoming ePrivacy regulation) and with Good Clinical Practice (GCP). Existing information, governance resources and data sharing from IMI/EU initiatives ( EHR4CR , EMIF , CORBEL , EOSC-Life , ECRIN i~HD , GO-FAIR , EHDEN and others) to which members of this consortium have contributed, are meant to be the basis for specification of the necessary project instruments. This will allow us to rapidly apply the policies and procedures necessary to begin sharing and working with data access providers, and then to define more specialised instruments as needed.

“EU PEARL will ensure that the collection and inclusion, processing and use of health and wellness data across the consortium complies with European and national data protection regulations and legislation”.

Specifically, WP3 is aligning with relevant initiatives to build further on the EIT Health EHR2EDC project facilitating the efficient and trustworthy reuse of EHR data into Electronic Data Capture (EDC) systems, and on EOSC-Life/ECRIN work on ethical and data protection requirements for secondary use of data EU countries. WP3 is leveraging and developing interactions initiated with standards organisations bodies, HL7, CDISC and IHE, as part of the EIT Health EHR2EDC project to facilitate re-use of existing interoperability mapping resources and avoid duplicative and competing efforts.

“This pillar also encompasses the legal framework that is needed to permit public and private partners to share information about compounds in development, as well as trial protocols and data, and insights derived from the data and strategies for regulatory approval.”

Finally, EU-PEARL aims to leverage the extensive experience of the EUHA network of hospitals in using observational data and complement it with the i~HD data quality assessment methodology. This pillar also encompasses the legal framework that is needed to permit public and private partners to share information about compounds in development, as well as trial protocols and data, and insights derived from the data and strategies for regulatory approval.

THE REGULATORY FRAMEWORK

All stakeholders within the project are engaged in the alignment of their objectives to comply with European and national data protection & ethical regulations and legislation with a view to obtaining regulatory endorsement of IRPs.

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The complexity of cross-company collaborative, multi-drug IRPs poses both enormous opportunities and challenges for regulatory assessment. On the one hand, IRPs offer the possibility for patients and broader society to receive the best available treatment for their specific needs, in line with the latest advancements in biopharmaceutical R&D. On the other hand, however, the concept of IRPs is relatively new in clinical development and regulators have only recently started to develop recommendations to challenges such as the safety oversight of the trials, data transparency and integrity, how to control type I errors and more.

“The complexity of cross-company collaborative, multi-drug IRPs poses both enormous opportunities and challenges for regulatory assessment.”

Conscious of these challenges, the EU-PEARL consortium places regulatory endorsement as a key aspect for the successful and effective uptake of any IRP. EU-PEARL plans to engage with representatives of European Medicines Agency (EMA), EU national Health Authorities (HAs) and the U.S. Food and Drug Administration (FDA), to assess their latest guidance on the role of IRPs in the regulatory evaluation and approval of new medicinal products. An External Advisory Board is to be established with representatives from HAs, ethics committees’ experts and EMA representatives to receive their advice as the project is implemented. Furthermore, EU-PEARL counts on a dedicated EMA Liaison Officer assigned to EU PEARL to guide navigation of the applicable EU regulations and processes.

“An External Advisory Board is to be established with representatives from HAs, ethics committees’ experts and EMA representatives to receive their advice as the project is implemented”.

Dialogue with the FDA is to be maintained and encouraged, following initial discussions with FDA representatives during the proposal configuration phase, and the FDA’s willingness to engage with EU-PEARL from the outset. Paul Ehrlich-Institute (EPI) one of the German HAs for approval of clinical trials and marketing authorisation applications is a partner in EU-PEARL. Engagement with HTA bodies is envisaged through the participation of EUROSCAN as project partner. EUROSCAN is an International Information Network on HTAs, which embraces 11 European HTA Associations. Additionally, EUROSCAN will bring in the contribution of HTAi, the International Association of HTA bodies. HTAi will be involved in EU-PEARL as Third Party of EUROSCAN.

Regulatory feedback is to be obtained in two workshops in cooperation with disease-related WPs and other relevant stakeholders and potentially by a request for an EMA Qualification Procedure to qualify methods proposed for IRPs.

Governance

EU-PEARL has adopted a governance model that promotes the active participation of all involved stakeholders, including both academia and EFPIA partners as well as other interested parties such as pharmaceutical companies, patient groups, regulators, CROs, etc. in order to achieve maximum collaboration. The management structure of EU-PEARL has been developed to respond to the needs of an international large-scale multi-stakeholder project. It is based on traditional management structure adapted to the particular attributes of EU-PEARL.

EU-PEARL is a challenging project to manage due to its size, its ambition, the variety of activities and their interdependencies. The project aims to harmonise the interests of the public and EFPIA partners, therefore a strong internal trust and communication interface is crucial to setting the project up for success.

VHIR acts as EU-PEARL Coordinator and Janssen as Project Leader. They play a central role in driving the project strategy and chairing the governance bodies.

 

 

EU-PEARL management structure includes:

▪ EU-PEARL Forum (Forum)

Forum for discussion, dissemination and scientific community-building within the project.

The Forum consists of the project partners, third parties and the Associated Collaborators and has the purpose of stimulating discussion and promoting dialog on scientific issues.

The Forum does not have decision-making powers.

▪ General Assembly (GA)

This plenary assembly has the ultimate decision-making responsibility in matters affecting the overall project strategy and composition of the consortium and all other matters that the Executive Committee (ExCom) opts to refer to a higher level. This includes approval and disapproval of amendments to the grant agreement, any significant deviations and changes in the consortium composition.

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The GA is regularly informed by the ExCom of the progress of the project, hosts scientific discussions and supervises the correct implementation of the governance structure.

Several members of each organization can participate in the GA (but only one vote per institution is allowed). The GA meets twice per year.

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▪ Executive Committee (ExCom)

The ExCom is the primary decision‐making body, responsible for the determination of project policies and the overall scientific leadership of the project as well as its strategic oversight. The ExCom is composed by the following partner organizations: VHIR, EATRIS, Janssen, Novartis and (non-voting) Teamit Research.

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Using the necessary input from the Steering Committee (SCom), the ExCom follows up progress in the different WPs. It dynamically steers efforts, requires reports from the Project Management Office (PMO) and the SCom and intervenes as needed to solve conflicts.

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▪ Steering Committee (SCom)

The Steering Committee (SCom) is formed by the Coordinator, the Project Leader and each of the Work Package Leaders (WPLs). It is responsible for ensuring alignment, scientific coherence and coordination across WPs.

The SCom is the leadership team responsible for the day-to-day coordination and oversight of the Work packages (WPs) activities and interdependencies.

 

▪ Project Management Office (PMO)

The PMO is a support office and is lead by Teamit Research. VHIR, Janssen, Novartis and EATRIS are also members of the PMO. 

Teamit Research provides long-standing experience in managing complex Public-Private Partnerships including IMI projects (16 IMI Projects, among which EMIF, EHDEN and EPAD).

This PMO supports the ExCom and the SCom at the management and operational levels.

 

▪ External Advisory Board (EAB)

This is a consultative body established to provide advice directly to the ExCom on specific areas related to the project. It is composed of senior experts external to the consortium (between 4-8 members) including a senior EMA representative. It includes ethics experts who advise on the ethical perspectives for patients that are raised by the IRP design elements proposed by the project. Senior experts from the CROs sector are also invited to be part of the EAB.

The EAB is invited to project meetings to review the project’s progress and delivery outcomes.

▪ EU-PEARL Associated Collaborators (AC)

ACs are institutions and teams interested in supporting the project, but that do not become full partners and sign the Grant/Consortium Agreements.

This allows the project’s constituency to expand beyond the core consortium partners and to leverage third parties’ expertise, knowledge and connections with other relevant worldwide initiatives for the benefit of the project. All ACs sign a specific agreement and agree to basic engagement mechanisms. Most ACs have long-standing scientific relationships with core partners.

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One of the fundamental founding principles of EU-PEARL is to generate a critical mass of research capacity spanning all relevant stakeholders, in order to maximise its impact and create a long-lasting, far-reaching community effort in the field. In order to achieve this goal, EU-PEARL has been designed from the outset as an inclusive structure that encourages active participation of all members and in which their diverse perspectives can have proper exposure and consideration. At the same time, the Consortium needs to be manageable in order to not endanger the ambitious, pragmatic scientific goals of the project.

The solution for this trade-off, inspired by the successful experience acquired in other IMI projects (ADVANCE, RESCEU) is the Associated Collaborators (ACs) role.

The ACs are part of the EU-PEARL Forum and are informed and updated on project activities and invited to participate in discussions and work related to the project. ACs contribute to the project participating in the deliberations of the consortium, engaging with core partners on specific tasks, as required, while respecting:

  • access and IP rights comparable to the core partners;
  • the EU-PEARL governance model, in particular the decision-making processes;
  • confidentiality as described in the AC agreement;

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THE CONSORTIUM AS A WHOLE

To transform the current siloed approach to clinical trials into a collaborative IRP-based paradigm, a lasting culture shift is required throughout the entire ecosystem of stakeholders. The EU-PEARL consortium reflects the key players in this ecosystem and brings together:

· regulators, through the links established with EMA, and the participation of the regulatory body PEI

· patients, through the pan-European patient advocacy group EPF which represents 67 organisations and an estimated 150 million patients

· healthcare providers (VHIR, EMC, Charité, APHP, USR, LMU, KU Leuven)

· a university hospital (KU Leuven)

· academic institutions (UOXF, MUW, UNEW, KCL, USR, UMIL, KU Leuven, LMU, UoM)

· research centres (EATRIS, VHIR, IHD, ECRIN),

· a Health Technology Assessment body (EUROSCAN),

· small and medium-sized enterprises (SMEs) (BERRY, CUSTODIX, Teamit Research, DocuMental),

· EFPIA partners (Janssen, Novartis, Sanofi, Pfizer, Servier, Allergan, AZ, Novo Nordisk, Otsuka, Teva), and

· IMI Associated Partners (CTF, TB Alliance, SpringWorks).

The project is shaped through involvement of renowned research centres, IMI partners and subject matter experts in design and execution of research platforms.

The consortium is well equipped to tackle the complexity of this transformation based on its internationally recognised and complementary expertise with a broad span across Europe; the bandwidth to leverage and maximise synergies with existing related initiatives and projects; and the extensive experience in collaborating in large public-private partnerships with a variety of stakeholders.

Get to know all Partners

 

 

Work packages

WP1
IRP Governance, Quality Management and Sustainability

This work package focuses on the quality, governance and long-term sustainability of the IRP solution. WP1 will ensure the overall sustainability of the project and make sure that the outcomes can be used beyond termination of EU-PEARL. Its main tasks include the outline of a legal framework in compliance with GDPR regulations, involvement of patient engagement platform and evolving Data Management plans, IRP business plans and setting quality standards for IRPs.

 

Leading partners

WP2
Scientific, Regulatory and Operational Methodology

WP2 centers in establishing the statistical and methodological side of the IRP solution(s) by covering regulatory, ethics, statistical and operational aspects. This work package identifies current best practices and standardization of the IRP and develops statistical methods for trial designs and analysis. Regulatory frameworks for IRPs are being evaluated and developed in accordance to EU-PEARL specific requirements, which are then being assessed by ethic committees. WP2 is also focused in providing the necessary tools for the implementation of platform trials.

Leading partners

WP3
Clinical network and network of patient-level data

WP3 is responsible for identifying the common requirements for Clinical networks from all disease specific areas to develop a best-case scenario on what kind of network might be applicable for EU-PEARL. Existing clinical data network IT infrastructures in IRPs are being leveraged and extended to support the development of a suitable tool for EU-PEARL. Different existing IT solutions are being evaluated and a blueprint that integrates clinical investigator and patient data network resources for conducting IRPs is being developed. This work package will outline the clinical and patient network requirements necessary to develop a specific tool.

Leading partners

WP4
Integrated Research Platform for Major Depressive Disorder (MDD)

WP4 is working on a reusable and modular approach for the design and execution of IRPs in treatment resistant depression (TRD) and partially responsive MDD (PRD), focussing mainly on an early life development (Proof of Concept POC/Phase II).  To achieve this goal, WP4 is outlining scientific challenges and the digital phenotypes for TRD and PRD. A protocol on the Longitudinal Natural History Study in both MDD types will help provide feedback to WP2 and WP3 on key requirements for IRPs in PRD and TRD.

Leading partners

WP5
Integrated Research Platform for Tuberculosis (TB)

WP5 focuses on developing the framework for a clinical trial platform that allows accelerated progression of TB compounds through phase II and III studies. This work package sets a special interest on composing novel regimens that suit the requirements for high-burden and low-resource countries. WP4 works closely with regulators and discusses regulatory pathways for the novel approach. A crucial part are the patient cohorts, registries and EHRs and the evaluation of whether the capacity to perform platform trials is feasible across the relevant regions. A compilation of selected criteria to qualify drugs and drug combinations to enter platform studies should be available as part of the IRP approach in TB. WP5 works closely with WP1, WP2 and WP3.

Leading partners

WP6
Integrated Research Platform for Non-Alcoholic Steatohepatitis (NASH)

As of yet, there is no effective treatment available for patients suffering from NASH. WP6 is defining the scientific challenges of the illness in the context of IRPs and will formalise the requirements and infrastructure needed to operationalise a NASH IRP. This approach involves obtaining input from regulatory, ethics, scientific and patient organisations and therefore requires a strong liaison with WP1-WP3.

Leading partners

WP7
Integrated Research Platform for Neurofibromatosis (NF)

WP7 is defining the current challenges that a design of an IRP for NF1 and NF2 can face taking into account the disease progression, the identification of biomarkers and available treatments and patient recruitment. A protocol for a broad longitudinal natural history study is being developed as a base to create the infrastructure that is needed to operationalise an IRP for Neurofibromatosis.

Leading partners

WP8 – Project Oversight, Project Management and Outreach

WP8 provides management support and is responsible for the overall monitoring on tasks and interdependencies. For that purpose, a project plan is in place which also outlines possible risks that may arise during the project and mitigation strategies. This work package also engages in the reporting and the timely delivery of deliverables and milestones. Internal and external communication strategies have been laid out, whilst possible alliances with other ongoing initiatives are explored.

Leading partners