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Takeda Development Centre Europe Ltd.
Country: United Kingdom
19 Projects, page 1 of 4
  • Funder: European Commission Project Code: 821513
    Overall Budget: 2,353,120 EURFunder Contribution: 1,199,120 EUR

    The main aim of NEURONET is to set up an efficient platform to boost synergy and collaboration across the IMI projects of the Neurodegenerative Disorders (ND) portfolio, assisting in identifying gaps, multiplying its impact, enhancing its visibility and facilitating dovetailing with related initiatives in Europe and worldwide. This will be achieved through the following specific objectives: 1) creation of an overall platform for efficient collaboration, communication and operational synergies among present and future IMI ND projects; 2) designing systems to map and analyse information regarding actions, initiatives and partnerships, assessing impact of the individual projects, remaining gaps and global value of the programme for stakeholders; 3) supporting the management of the programme (timelines, dependencies, synergies and key results across projects); 4) proactively detecting needs, opportunities and transferable best practices of projects and to connect them; 5) providing support to the projects by organising tools, services, expert advice and guidelines/recommendations on common issues; 6) promoting enhancement and coordination of communication across the IMI neurodegeneration projects, increasing programme visibility, outreaching to key stakeholders and establishing relationships with initiatives in the field; and 7) preparing and securing the long-term sustainability of NEURONET itself. Achievement of these objectives will necessarily rely on buy-in from existing and future projects in the IMI ND portfolio, and effective connections with other programmes and initiatives in Europe and beyond, including stakeholder representation. For this, the Consortium has been constituted by very active partners in a variety of IMI ND projects and related initiatives with specialists in areas like complex/project management, data sharing & re-use, drug development, patient engagement, communication, sustainability and regulatory/HTA interactions.

  • Funder: European Commission Project Code: 807012
    Overall Budget: 3,100,690 EURFunder Contribution: 1,750,000 EUR

    The GetReal Initiative brings together partners from the IMI GetReal project to drive the adoption of tools, methodologies and best practices from IMI GetReal and increase the quality of real-world evidence (RWE) generation in medicines development and regulatory/HTA processes across Europe. We will establish, in Work Package (WP) 1, a Think Tank, a number of Task Forces and a RWE Research Community. The Think Tank will consist of international thought leaders and will discuss, assesses and give recommendations on the opportunities and barriers to the generation, use and acceptability of RWE. They will act as ambassadors for the use of RWE during the project and beyond, enagaging with key stakeholder groups to drive policy debate and facilitate the uptake of the outputs of IMI GetReal and the GetReal Initiative. The GetReal Taskforces will drive the focused development of tangible solutions to the key challenges identified in IMI GetReal and the Think Tank. The initial three task forces will be: (i) Pragmatic Trials (design, operational feasibility and analysis/the GetReal PragMagic tool), (ii) network meta-analysis and benefit risk assessment (incl. the GetReal ADDIS tool) and (iii) Statistical Approaches for enriching RCTs with real-world data. The GetReal Research Community will consist of researchers and organisations active in the field of RWE generation, regulators, HTAs, physicians and patients. The Community will review and comment on any GetReal Initiative guidelines, recommendations or white papers ahead of their finalisation, will have access to all the GetReal tools and outputs, receive regular newsletters and receive invitations to attend stakeholder events. The project will also invest in long term sustainability of the GetReal Initiative and the tools on a not-for-profit basis (WP2). The project is supported by professional experienced consortium management (WP3) and an ethics work package (WP4).

  • Funder: European Commission Project Code: 806999
    Overall Budget: 7,659,120 EURFunder Contribution: 4,999,760 EUR

    There is an urgent need for novel approaches assessing functional decline in early AD. The main goal of the RADAR-AD project is to develop a digital platform to detect subtle functional deficits in early Alzheimer’s disease (AD) individuals by integrating a meaningful combination of smartphone, wearable and/or home sensor based parameters. The system developed will be suitable for future longitudinal studies, including trials. The objectives are to 1) Identify the most relevant functional domains and the most promising remote measurement tools (RMTs) for these domains based on reviewing the literature and piloting of RMTs in small studies; 2) Optimise the RADAR-CNS platform for use in AD studies; 3) Test the platform and selected RMTs in a real world environment clinical study with 240 participants across the AD spectrum ranging from the preclinical AD to the dementia stage; 4) Perform statistical modelling to estimate longitudinal predictions; 5) Discuss results with regulatory agencies in order to obtain guidance about how to develop a path for formal qualification as outcome measurements in future therapeutic interventions. Considering the limited budget and project duration, we will rely upon already available technology platforms and on available longitudinal datasets where possible. The consortium includes experts in clinical dementia studies, computer science, bioinformatics, regulatory policies, ethics, and patient and public involvement (PPI). Additional strengths of the consortium are the deep and broad interface with RADAR-CNS and related IMI projects, and the access to large amount of patient-level data from key European cohort studies for modelling purposes.

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  • Funder: European Commission Project Code: 821362
    Overall Budget: 8,999,610 EURFunder Contribution: 4,599,650 EUR

    EBiSC2 builds on the achievements of the European Bank for iPSCs (EBiSC1) in centralising existing capacities across Europe in a unique banking and distribution infrastructure for research use in response to the increasing demand for human induced pluripotent stem cells (iPSC). Significant progress towards this aim has been made by EBiSC1; further resources, however, are required to ensure self-sustainability. Key partners of EBiSC1 who have delivered major assets of the current bank, join efforts to establish EBiSC2 as self-sustainable, central bank. Based on a gap analysis of the EBiSC1 endeavours towards sustainability, and focussing on user demand, scientific excellence and productivity, EBiSC2 will deploy a business strategy for a sustainable, non-for-profit bank providing access to disease-relevant and quality-controlled iPSCs, along with comprehensive data and freedom to operate for academic and commercial use. To meet evolving requirements from industry and academia, the cell catalogue will be constantly enriched through on-demand generation of new iPSC lines, including gene-edited lines and isogenic controls, iPSC-derived and progenitor cells. EBiSC2 will distribute cell lines and develop a range of additional cell services (incl. screening panels of disease-relevant iPSC and control lines in ready-to-use-formats) to extend its offer, while reducing operational costs through state-of-the-art upscaling and automation enabling bulk production of standardised high-quality cells. Proof-of-concept studies performed jointly by academia and industry will demonstrate the reliability and robustness of the lines for disease modelling and screening and enrich the EBiSC2 catalogue with extensive data. To bundle resources, EBiSC2 focuses on collaboration with iPSC programmes and aims to serve as central hub for EU-funded projects to bank their iPSC lines, and thus, enable long-term access by the research community to the results of European investments.

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  • Funder: European Commission Project Code: 115916
    Overall Budget: 16,195,900 EURFunder Contribution: 8,080,000 EUR

    The current nosology of neuropsychiatric disorders allows for a pragmatic approach to treatment choice, regulation and clinical research. However, without a biological rationale for these disorders, drug development has dramatically stagnated in the past decades. In a coordinated effort encompassing academic experts, SMEs, patient and family organizations, regulators, ECNP and EFPIA partners, this project aims to develop a quantitative biological approach to the understanding and classification of neuropsychiatric diseases to accelerate the discovery and development of better treatments for patients. This project will concentrate on Schizophrenia (SZ), Alzheimer’s disease (AD), and Major Depression (MD), as these disorders share part of their symptomatology, in particular social withdrawal and certain cognitive deficits, such as deficits in attention, working memory and sensory processing. By applying innovative technologies (e.g. EEG, cognitive tasks, (f)MRI, smartphone monitoring, and (epi-)genetics) to deep phenotype a clinical cohort of SZ and AD patients combined with a wider analysis of existing clinical data sets from major European and global disease cohorts that also include MD, we will define a set of quantifiable biological parameters best able to cluster and differentiate SZ, AD, and MD patients that do, or do not, exhibit social withdrawal. First, by mining large European SZ, AD and MD cohort datasets with already available social and cognitive proxy measures, and, second, by obtaining objective measures of social exploration levels (using a novel smartphone application), phenotypic relationships with social and cognitive measures will be further tested. For instance we might predict that socially withdrawn individuals may have lower cognitive functioning and poorer clinical course compared to those who are more socially engaged.

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