Support for innovation and Research partnerships


Grants for carrying out mainly dissemination activities aimed at promoting the responsible research and innovation leading to achieve R&D&I results in line with values, needs and expectations of European society.
Topic / Target >IMI2-2015-03-01 Remote Assessment of Disease and Relapse (RADAR) programme - Central Nervous System (CNS)


DESCRIPTION


Background

The RADAR-CNS proposal seeks to address/utilise two important aspects of CNS diseases. Firstly, most CNS diseases are dynamic in nature with multiple reoccurrences and relapses each of which accelerate the downward spiral of the underlying disease pathology and lead towards chronification, morbidity and mortality.
Secondly, the onset of reoccurrences, exacerbations and relapses in CNS disease causes changes in parameters related to sleep, physical activity, speech, cognition, social connectivity, memory etc.; parameters that can increasingly be measured remotely and passively via unobtrusive on-body biosensors and
smartphones.
The vision of RADAR-CNS is to reduce cost and trauma to the patient and care-givers and reducing hospitalisations by predicting and pre-empting relapses and reoccurrences via the use of remote assessment technologies. RADAR-CNS will focus initially on unipolar depression, multiple sclerosis (MS) and epilepsy with the main goal of using available clinical information and streaming data from on-body sensors to predict relapse, symptom exacerbations and seizures respectively. Initial RADAR disease were selected on the basis of unmet need in terms of prevalence, disability caused, feasibility of developing a remote biosignature predictive of a change in disease state, and the therapeutic interests of contributing EFPIA companies. Depression, MS and epilepsy are prevalent, disabling conditions that effect all age-groups, and are characterised by rapid and distinct changes in disease states at varying time-scales that, if predicted and pre-empted, would result in significant improvement in overall patient outcomes. Furthermore, depression and MS are often co-morbid in a patient, thus offering opportunities to study both diseases in a common population. It should be noted that learnings in terms of sensor development, data management, analytics, privacy, regulatory and health-care policy issues etc. will transfer to other disease areas in this topic. Indeed, the long-term goal is to build upon the learning of the first three diseases and in the future include other disease areas such as bipolar disease, Alzheimer’s disease, schizophrenia and pain.

Objectives:

The aim of RADAR-CNS is the characterisation and prediction of changes in disease state in central nervous system (CNS) disorders via non-invasive remote sensing.
This topic is planned to be focused on the three diseases of unipolar depression, multiple sclerosis and epilepsy. For each disease it is proposed that a non-interventional/observational study of subjects is undertaken with three objectives:
* Characterisation of changes in disease state.
* Characterisation of changes in disease state due to drug effects.
* Prediction of change in disease state from remote sensing data.

To co-ordinate across all three disease areas a common set of measures and measurements tools will be used to track the sleep architecture, physical activity, speech, cognition, social connectivity, and memory of subjects of all of the target diseases.

Expected key deliverables

1) Candidate bio-signatures that predict relapse and track disease state changes in MS, depression and epilepsy using at least a common minimal set of metrics: sleep architecture, physical activity, speech, cognition, social connectivity, and memory.
2) Development of algorithms and an analytic infrastructure suitable for collecting and analysing data from the RADAR-CNS studies.
3) Proposal of actionable privacy and usability parameters that would drive eventual uptake of, and adherence to, remote assessment solutions in CNS diseases.
4) Delineation of putative regulatory pathways necessary for approval of remote sensing solutions in real-world patients. This deliverable will be developed in consultation with regulators.
5) Delineation of putative clinical care pathways and use cases of remote-sensing solutions and how they impact and interface with stake-holders such as patients, care-givers, case-managers, physicians etc.

 

H2020-JTI-IMI2-2015-03-two-stage
Start date: 17/12/2014
End date: 24/03/2015
Total budget
for this call: 112,860,000
Number of proposals to selectOnly the proposal ranked first at the 1st stage is invited for the 2nd.
CALL
(R&IA) H2020-JTI-IMI2-2015-03-two-stage Research & innovation actions
Indicative budget The indicative contribution from EFPIA companies is €11 million and financial contribution from IMI2 JU will be a maximum of €11 million. The indicative duration of the project is 5 years. EFPIA participants Janssen, BiogenIdec, UCB, Lundbeck, Merck. Applicant consortium must be multi-disciplinary (device and sensor companies; Academic, clinical and disease area experts; IT/ analytics partners; and Regulatory and health-care systems experts).
FINANCING
INSTRUMENTS
TOPIC INCLUDED IN...
JTI Innovative Medicines Initiative 2

The Innovative Medicines Initiative 2 (IMI 2) replaces and succeeds the Innovative Medicines Initiative and its goal is to develop next generation vaccines, medicines and treatments, such as new antibiotics.
The initiative will run from 2014 to 2024 and its total proposed budget is €3,276 million, of which the EU will contribute up to €1,638 million from Horizon 2020 and the European Federation of Pharmaceutical Industries and Associations (EFPIA), will commit €1,425 million in in kind contributions.

The strategic research agenda of IMI 2 establishes four major axis of research:
• Axis 1: Target validation and biomarker research (efficacy and safety)
• Axis 2: Adoption of innovative clinical trial paradigms
• Axis 3: Innovative Medicines
• Axis 4: Patient tailored adherence programmes

These axes will be implemented in each European health priorities to be addressed by IMI, which are:
• Antimicrobial resistance
• Osteoarthritis
• Cardiovascular diseases
• Diabetes
• Neurodegenerative diseases
• Psychiatric diseases
• Respiratory diseases
• Immune-mediated diseases
• Ageing-associated diseases
• Rare/Orphan Diseases
• Vaccines
Joint Technology Initiatives

Horizon 2020 may be implemented through public-private partnerships where all the partners concerned commit to support the development and implementation of research and innovation activities of strategic importance to the Union's competitiveness and industrial leadership or to address specific societal challenges.
Public-private partnerships can be based on a contractual arrangement between public and private actors and can in limited cases be institutionalised public-private partnerships (such as Joint Technology Initiatives and other Joint Undertakings).
OTHER TOPICS ARE:
 IMI2-2014-02-05 Rapid diagnostic tests


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