EPND

About EPND

Currently, there is no treatment that prevents or modifies the progression of neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease. In Europe these conditions affect millions of people. Despite research efforts in the past years to accelerate biomarker discovery, there are very few secure and accessible ways for the discovery and sharing of clinical samples and data within the neurodegenerative disease research community.

The discovery of biomarkers detecting the early onset of neurodegenerative diseases is a necessary step towards the development of effective treatments for neurodegenerative diseases. These biomarkers aid with the assessment of treatment efficacy and patient stratification. To this end, EPND will spend the next five years building a self-sustaining network that will support the discovery, harmonization, storage and analysis of high-quality clinical samples and data from neurodegenerative disease research.

EPND will bring together 29 partners from the public and private sectors and will be managed by two public partners, University of Maastricht and University of Leicester, and two private partners, Gates Ventures and UCB Biopharma. EPND will leverage and connect existing European research infrastructures, including BBMRI, EATRIS, ELIXIR and EBRAINS. EPND receives funding from the European Commission and European pharmaceutical industry (via EFPIA), under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking. EPND has an initial budget of 19 million euros.

For more information, contact info@epnd.org or visit www.epnd.org

Lygature in EPND

Lygature was involved in the set-up phase of EPND, and will provide partnership management, aid in stakeholder engagement, provide communication support and will bring regulatory expertise to the project.

• Program management. Lygature co-leads the management of the EPND project. Together with Gates Ventures, Lygature coordinates and manages this multi-stakeholder program on a day-to-day basis. Among others, Lygature is responsible for facilitating internal communication and information distribution within the consortium. Moreover, Lygature ensures transparency, stimulates collaboration between partners and monitors the effective execution of the work plan and its progress. Other activities include creation and alignment of work processes, resource management and timely reporting of project deliverables and activities. 
   
• Stakeholder engagement. Lygature will assist in the development and deployment of effective stakeholder engagement. Through Delphi rounds, Lygature will identify and prioritize needs, requests and expectations of different stakeholders relative to active engagement within EPND. This will include hurdles (e.g., unclear language), facilitators (support needed) and subject perception (distrust, empowerment). This will help clarify the scope and modality of stakeholder collaboration, how contributions will be used within EPND, and the benefit to stakeholders. Results will include optimized tools and methodologies for stakeholder engagement to be used within EPND and possibly exported to other contexts.
   
• External communication and dissemination. Lygature supports the development and implementation of the Communication and Dissemination plan for EPND. The project will make use of multimedia approaches to disseminate information on EPND to its target audiences - the scientific community, healthcare professionals, industry, regulators, policymakers, patients and the general public. Among others, Lygature will aid in developing the multimedia content and tools identified in the plan, such as the website, social media channels, newsletters, brochures, briefing packs, videos and others.
   
• Regulatory expertise. Lygature co-leads the consultations with Expert Advisory Groups for EPND. Lygature will co-organise multi-stakeholder workshops, round-table interviews and Delphi surveys to address topics of particular relevance and to gain insights and input from a broad range of stakeholders (both within the EU and beyond) on key project developments. Importantly, in order to increase the impact of EPND on the regulatory validation of biomarkers/diagnostics, scientific advices, opinions and reviews issued by the European Medicines Agency and other regulatory authorities (e.g. FDA) will be scrutinized for a number of questions related to biomarker validation, including quality of the data and principles related to sharing and access of data and samples. In particular, advice will be sought on the application of the EPND platform in the context of supporting biomarker use or qualification for use in trials, which will also inform about the future regulatory requirements for the EPND platform

Lygature together with

Acknowledgement of support

This project has received funding from the IMI 2 Joint Undertaking (JU) under grant agreement No. 101034344. The IMI JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. See www.imi.europa.eu for more details.