Neuronet Deliverables

NEURONET WP3 Tools and Services will develop specific tools and services to support IMI ND projects on key areas where unmet needs are detected, such as sustainability planning.
The Sustainability WG looks at exploitation activities and sustainability models (spanning business design, modelling, financial estimates, IP issues, organisational models, legal solutions, etc.) that can help projects with long-term sustainability.
In this report we will include the best practices and lessons learnt in terms of sustainability, as well as some additional resources and ideas that can be very useful for IMI neurodegeneration projects to improve the chances of successful sustainability decisions.

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The NEURONET Coordination and Support Action has the main objective of setting up an efficient platform to boost synergy and collaboration across the IMI projects of the Neurodegenerative Disorders portfolio, assisting in identifying its gaps, multiplying its impact, enhancing its visibility and facilitating dovetailing with related initiatives in Europe and worldwide.
Deliverable D2.4 Report #3 on activity of SCB, WGs and TFs constitutes a report on the activities of the Scientific Coordination Board, the four Working Groups, and two Task Forces as they happened between the beginning of May 2021 and the end of August 2022 (i.e., the project end).

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Work Package 1 (WP1) of Neuronet carried out an impact analysis to assess the scientific and socio-economic impact of the IMI ND portfolio across the European Union (EU). The impact analysis was conducted in two stages: an initial stage developed the scope of the project, impact
indicators and defined measures, and this report details the second and final stage of the impact analysis including the conduct, reporting and results of two surveys: one to European Federation of Pharmaceutical Industries and Associations (EFPIA) organisations and another to ‘non-EFPIA’ organisations including academic institutions and small and medium sized enterprises.

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The present final report on dissemination and outreach activities (including impact measures) represents an update of D4.3 Interim report on dissemination activities (M18), which compiles all undertaken dissemination activities and evaluates their impact, also reporting on all the tools developed to support these activities.
These include the Communications Experts Community (CEC), the creation and maintenance of NEURONET communications channels, as well as participation in three high-profile events. The report also includes an outlook on the possibilities for post project-funding maintenance of activity.

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In the present deliverable, we performed a content analysis of reports from IMI ND projects, including guidance documents on informed consent, data management plans, research study documentation, and other reports relating to patient privacy. This content analysis identified cross-cutting themes in how projects address patient privacy and informed consent. All projects had a strong awareness of the need to ensure privacy and confidentiality, with key responsibility often assigned to clinical sites and principal investigators. Reidentification and capacity to consent were frequently identified as ethical concerns for projects, with project reports describing the methods and measures used to ensure respect of confidentiality and autonomy.

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Neuronet included four Working Groups (WGs) for cross project discussions. One of these WGs was the HTA and Regulatory interactions WG that aimed to generate insight into regulatory and HTA challenges that are unique to neurodegenerative diseases. The WG activities included organising a workshop to discuss the projects activities around digital endpoints and the challenges faced in using them in regulatory and HTA submissions, and conducted/performed case studies to illustrate HTA and regulatory interactions for a number of IMI ND projects. This white paper summarises these activities as well as the key learnings, and is an output of Neuronet’s Work Package 3 (WP3) which explored tools and services for ND products.

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This paper outlines the key learnings from undertaking the impact analysis exercise. They span all stages of the impact analysis ranging from ensuring collective decision making on key items at exercise outset, design of data collection tools and considerations for a working group composition that ensures a diversity of roles and perspectives. The insights and lessons learned from this impact analysis can guide those undertaking similar endeavours to plan for efficient processes and avoid potential pitfalls.

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With this deliverable, Neuronet provides some learnings from the Neuronet WG ‘Data sharing and reuse’. Neuronet aims to facilitate the sharing of data amongst IMI projects, and with other interested research programs at European and global level.
In the current deliverable, practical challenges of efficient data sharing are discussed. The obtained learnings from the various IMI projects in the ND portfolio when it comes to data sharing are being integrated into the discussion. The aim is to provide the research community with best practices in order to enable efficient sharing and access to data, while taking into consideration all relevant data sharing barriers (e.g. General Data Protection Regulation (GDPR), legal, intellectual properties (IP), ethical, societal, technical).

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NEURONET is a Coordination and Support Action (CSA) aiming to support and better integrate projects in the Innovative Medicines Initiative (IMI) Neurodegenerative Disorders (ND) portfolio. WP1 Projects & Impact Analysis is a descriptive and methodological work package (WP) that collects information (e.g., scope, deliverables, funding etc.) about IMI ND projects to enable an integrated view of the IMI ND project portfolio in terms of relative specialisation, timelines, expertise, and outputs. As part of WP1 activities, NEURONET conducted an analysis of IMI ND projects at the programme level in order to obtain the first integrated view of the portfolio (Deliverable 1.2). This deliverable reports an update to the first approach, representing five new projects that have been added to the IMI ND portfolio. This deliverable also provides a refined understanding of the portfolio’s project outputs and potential synergies.

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There are many research activities focused on Alzheimer’s disease and other neurodegenerative diseases in the global research landscape. This deliverable aimed to map neurodegenerative disease research initiatives based on their strategic importance and carry out a gap analysis to identify gaps in our understanding of the evidence base and areas to prioritise for future research.
Using a framework of strategic importance, a survey was carried out of researchers to rate a list of initiatives on several variables and to add any initiatives they are aware of that are not on the list. People living with dementia and their supporters and health technology assessment and regulatory experts were consulted on gaps both generally and within the IMI neurodegenerative disease research portfolio and asked to identify priorities for future research.
The results of the mapping and gap analysis show that while there seems to be a busy landscape of neurodegenerative disease research, there is a need for better management, co-ordination, and communication of initiatives to achieve more impact. Furthermore, there are several gaps/areas where more research focus is needed to address the needs of various stakeholders, particularly those who are recipients of research outputs.

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Neuronet organises an annual networking and outreach event in collaboration with the individual projects, to shine a spotlight on the IMI neurodegeneration portfolio. The event proceedings are then disseminated to the general public through Neuronet’s communication channels, which include a website, regular newsletters and social media feeds.
Due to the COVID-19 pandemic, in 2021 Alzheimer Europe organised a virtual conference instead of an in-person event in which Neuronet participated.
This document provides an overview of the annual event as well as associated outreach activities that have been conducted in the third year of the Neuronet initative.

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The NEURONET Coordination and Support Action has the main objective of setting up an efficient platform to boost synergy and collaboration across the IMI projects of the Neurodegenerative Disorders portfolio, assisting in identifying its gaps, multiplying its impact, enhancing its visibility and facilitating dovetailing with related initiatives in Europe and worldwide.
Deliverable D2.3 Report #2 on activity of SCB, WGs and TFs constitutes a report on the activities of the Scientific Coordination Board, the four Working Groups, and two new Task Forces from March 2020 until the end of April 2021.

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The following document provides an overview of the public event proceedings and videos for the second year of the Neuronet initative. The event was organised virtually in October 2020, due to various COVID-19 restrictions throughout Europe that rendered an in-person event impossible to organise.

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The mission of IMI2 is to “improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need”1. Therefore, the ultimate impact that IMI projects can have is to enable the development, approval and access to effective and affordable medicines. There is an implicit assumption that spending on research and development (R&D) through the activities of the IMI neurodegeneration project portfolio might improve innovation in this disease area. Therefore, if we want to assess the impact of the IMI neurodegeneration project portfolio, we will need to identify :
(1) what factors are likely to facilitate pharmaceutical innovation in neurodegenerative diseases, and
(2) how is the IMI neurodegeneration project portfolio contributing to these factors

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The present Interim Report on dissemination activities provides a detailed list of communications activities that have been carried out halfway through the coordination and support action (CSA). These include the development of a Communications Experts Community and the creation and maintenance of NEURONET communications channels, as well as participation in two high-profile face-to-face events. The report assesses the impact of undertaken communication activities, analyses compliance with the initial plan and identifies future dissemination opportunities as updates to the communication strategy.

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Deliverable D3.6 describes the updates made on the design and structure of the NEURONET Knowledge Base since the submission of deliverable D3.1 INKB web platform v1 submitted in month 6.

The aim of the Knowledge Base is to provide a summary overview of the IMI ND programme, in the format of a dashboard, where users can find information about the portfolio of projects (e.g. work plan, deliverables, results, publications, tools developed, etc). It also includes a section with the contact details of project experts in six key areas (ethics, data sharing, regulatory interactions, sustainability, communication and project management). More recently, we have also included the first tools developed by NEURONET, namely the Asset map and the Regulatory and HTA engagement Decision Tool.

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In this report we compile knowledge and information derived from the NEURONET Working Group on Sustainability about the sustainability models used in or applicable to IMI neurodegeneration projects, as well as general lessons learned, as a resource for current and future projects to improve the chances of successful sustainability decisions through the IMI neurodegeneration portfolio.

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This deliverable focuses on developing specific guidance to aid projects on data sharing policies and tools, incentives, value propositions, infrastructural solutions, etc. With the support of the “Data sharing and re-use” WG, Task 3.2 will develop guidelines aimed at facilitating the sharing of and access to data, biological tools, and other materials amongst IMI projects, as well as with other interested researchers at a European and global level.

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NEURONET is a Coordination and Support Action (CSA) aiming to support and better integrate projects in the Innovative Medicines Initiative (IMI) Neurodegenerative Disorders (ND) portfolio. WP1 Projects & Impact Analysis is a descriptive and methodological work package (WP) that collects information (e.g. scope, deliverables, funding etc.) about IMI ND projects to enable an integrated view of the IMI ND project portfolio in terms of relative specialisation, timelines, expertise and outputs. As part of WP1 activities, NEURONET conducted an integrated analysis of IMI ND projects at the programme level in order to obtain a first integrated view of the portfolio. This deliverable reports on the approach, methodology and results of the exercise carried out.

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This deliverable aimed to map the global research landscape for neurodegenerative diseases to understand where the IMI neurodegenerative portfolio fits in globally and to enable a gap analysis with the IMI project portfolio.

The results demonstrated that the scale and volume of global research in comparison to the IMI portfolio is considerable. There was a clear focus on Alzheimer’s disease research, both globally and within the IMI portfolio.

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The NEURONET Coordination and Support Action has the main objective of setting up an efficient platform to boost synergy and collaboration across the IMI projects of the Neurodegenerative Disorders portfolio, assisting in identifying gaps, multiplying its impact, enhancing its visibility and facilitating dovetailing with related initiatives in Europe and worldwide.  Deliverable D2.2 Report #1 on activity of SCB, WGs and TFs constitutes a report on the activities of the Scientific Coordination Board and the four Working Groups in the first year of the project (no Task Forces have been established yet).

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Neuronet is a Coordination and Support Action (CSA) aiming to support and better integrate projects in the IMI Neurodegenerative Disorders (ND) portfolio. WP3 Tools and Services aims to develop tools and services to support the IMI ND projects in areas where unmet needs have been identified. One of these areas of unmet need is patient privacy, particularly following implementation of the General Data Protection Regulation (GDPR) in May 2018. Neuronet intends to compile and share learnings on patient privacy, to ensure best practice, reduce duplication of effort and create resources that will be of value to existing and future IMI ND projects.

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NEURONET also organises an annual networking and outreach event in collaboration with the leaders of the individual projects, to shine a spotlight on the IMI neurodegeneration portfolio. The event proceedings are then disseminated to the general public through NEURONET’s communication channels, which include a website, regular newsletters and social media feeds. This document provides an overview of the annual event as well as related outreach activities that have been conducted.

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This deliverable reports on the development of a Decision Tool aimed at identifying the key processes and procedures for engagement with regulatory, HTA bodies, and payers at key points in the development of an asset. The tool will help the IMI ND projects in identifying the most appropriate procedures and ways in which they can interact with different stakeholders, based on the project’s stage of research and type of asset being developed. This will help ensure that the outputs being developed by projects that are part of the IMI Neurodegeneration portfolio are relevant for regulatory and HTA settings, where applicable.

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This deliverable reports on the workflow and processes followed by WP1 to develop a full set of dimensions and indicators to be used for the IMI ND integrated portfolio analysis (Task 1.3) and impact analysis (Task 1.4), forming the foundation for all the subsequent tasks and deliverables of WP1 throughout the project duration. Moreover, the overall strategy to obtain information from IMI ND projects is also described.

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This first deliverable of WP5 CSA Management & Sustainability (D5.1)  constitutes the first version of the Data and Knowledge Management Plan (DKMP) for the NEURONET project, as required by the Innovative Medicines Initiative (IMI) JU guidelines. This DKMP represents a formal document describing in detail how data are handled for the entire duration of the NEURONET project (i.e complete data life cycle). It also outlines the strategies that NEURONET will implement to manage, analyse and preserve data and metadata.

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Deliverable D3.1 describes the design and structure of the NEURONET Knowledge Base, a web platform that will act as a portal for the whole Innovative Medicines Initiative (IMI) Neurodegenerative Disorders (ND) programme. The aim of the Knowledge Base is to provide a summary overview of the IMI ND programme, in the format of a dashboard, where users can find information about the portfolio of projects (e.g. work plan, deliverables, results, publications, tools developed, etc). Furthermore, it will include a section with contact details of experts in key project areas (i.e. ethics, data sharing, regulatory interactions, sustainability, communication and management).

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The communication strategy provides a framework with explanations on how the communication and dissemination activities will help NEURONET fulfil its overarching communication aims, ensuring that its goals are clear and achievable. The communication strategy will remain open to changes and undergo updates, enabling it to evolve with the development of the programme and launch of new projects.

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The deliverable D2.1 Report on establishment and procedures of SCB and foundational WGs constitutes a report on the steps and procedures followed for establishing NEURONET’s Scientific Coordination Board (SCB) and Working Groups (WGs), detailing their scope, membership and procedures

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