€ 25 M
funding from IMI, EFPIA
partners in Europe and the US
RADAR-CNS* is jointly led by King’s College London and Janssen Pharmaceutica NV, with funding from the Innovative Medicines Initiative (IMI) and contributions in-kind from commercial partners. Its goal is to predict and pre-empt relapses in patients with major depressive disorders, epilepsy, and multiple sclerosis, and to improve their quality of life. The consortium brings together experts from diverse fields including clinical research, engineering, computer science, information technology, data analytics and health services. Both patients and health care providers will be involved.
*RADAR-CNS: Remote Assessment of Disease and Relapse – Central Nervous System
Managing of a multi-disciplinary program, combined with data analysis and regulatory expertise
Lygature, is a member of the Management Team. In addition, together with linked partner The Hyve, Lygature is leveraging expertise developed during its Translational Research IT (TraIT) project to address the data analysis challenge. It is also looking at regulatory issues and ways in which such devices can be qualified.
- Coordination and communication. Lygature is co-lead of the Project Management work package in RADAR-CNS and coordinates this large and multi-disciplinary program on a day-to-day basis. Activities include monitoring the effective execution of the work plan and its progress, creation and alignment of work processes, resource management and internal communication. In addition, Lygature provides the backbone for knowledge sharing and is responsible for the design and development of the public website.
- Data analysis. RADAR-CNS requires ground-breaking work to isolate successfully normal biosignatures, as recorded by wearable devices. Patients are being followed from doctors’ perspectives, for correlation with device data. Lygature is using its data management expertise to integrate data from various sources, relating werables-derived data to disease symptoms and allowing scientists to assess if measured changes are predictive.
- Regulatory requirements. The project is also exploring new territory around regulation, posing important questions concerning the use of everyday devices for medical monitoring. Lygature will be looking at how such devices will be deployed, what requirements need to be met and how they can be qualified across different jurisdictions for this application.
The contribution made by Lygature to RADAR-CNS is an example of how cross-disciplinary expertise built up during major projects can be applied in new areas. An ability to extract meaningful data from complex data sets has been proven during the TraIT project, and the Lygature team offers, through its Escher platform, all of the experience needed to overcome diverse regulatory hurdles.
Lygature together with
King's College London, Provincia Lombardo-Veneta - Ordine Ospedaliero di San Giovanni di Dio, Università Vita-Salute San Raffaele, Fundacio Hospital Universitari Vall d'Hebron - Institut de Recerca, University of Nottingham, Centro de Investigacion Biomedica en Red, Software AG, Region Hovedstaden, Stichting VU-VUmc, Universitaetsklinikum Freiburg, Stichting imec Nederland, Katholieke Universiteit Leuven, Northwestern University, Universität Passau, Università degli Studi di Bergamo, Charité, Intel Corporation (UK) Ltd, GABO:mi Gesellschaft Fur Ablauforganisation:Milliarium Mbh & Co Kg, Janssen Pharmaceutica NV, Biogen Idec Limited, H. Lundbeck A/S, UCB Biopharma SPRL, MSD IT Global Innovation Center s.r.o.
Consultation meeting at EMA: Joint effort of the RADAR-CNS and RADAR-AD consortium members
On the 4th of February 2020, RADAR-CNS and RADAR-AD project members visited the European Medicines Agency (EMA) in Amsterdam, The Netherlands for a consultation meeting with the Innovation Task Force (ITF). The objective of EMA’s ITF briefing meetings is to set the stage for scientific and regulatory discussions that relate to the development of new medicinal products and technologies. The purpose of this meeting was to inform the IMI on the both RADAR projects, and to exchange thoughts on a number of items that are associated with remote measuring technologies and the development of digital endpoints.
RADAR-CNS team gathers in Athens to share ideas and explore challenges
Nearly 80 members of the RADAR-CNS team met in May in Athens, Greece for three days of problem solving, sharing of ideas and assessing progress on outcomes. The RADAR-CNS Annual Meeting is an opportunity for people working on the full range of work streams to come together to explain and explore challenges and solutions, as well as to investigate new applications of the technology and plan ahead for its translation to real life settings.
RADAR-base platform being used to measure atrial fibrillation
The RADAR-base platform, developed as part of RADAR-CNS, is now being used to study patients with atrial fibrillation (AF). The University of Birmingham, which is a project partner of the BigData@Heart consortium, is conducting a year-long study as part of the follow-up phase of the RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial.