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Innovative Medicines Initiative, Call 14
4 Topics:
- Targeted immune intervention for the management of non-response and relapse
The action generated by this topic aims to provide better control of immune-mediated diseases, in particular:
o characterise human immune-mediated diseases;
o profile and analyse immune cells obtained from non-blood tissues;
o discover individual disease and cross-disease biomarkers predictive of treatment response, non-response, relapse and flare-up;
o perform early phase clinical trials (e.g. enriched study populations for certain molecular pathways; adaptive and basket trial designs etc.) and identify potential novel patient-centric treatment approaches. The focus will be on patients from well-characterised immune-mediated diseases (SLE, RA, MS, UC, CD, Asthma and COPD).
The ultimate goal is to develop a translational research platform that will improve patient management and personalised treatment by identification/validation of predictive biomarkers for non-response, rapid progression and remission. This would lead to an increased likelihood of treatment success with decreased costs for both patients & society and pharmaceutical companies.

- Non-invasive clinical molecular imaging of immune cells
This topic aims to establish a consortium that can develop and validate a quantitative, non-invasive, immune cell imaging platform, which includes novel and target-specific molecular imaging agents, (hybrid) imaging modalities, and image processing algorithms. The topic aligns with the IMI2 Strategic Research Agenda, as it aims to validate immune cell targets based on human biology and to facilitate precision medicine by identification and stratification of patients and prediction of therapeutic outcomes. In addition, it is expected that these agents will facilitate early diagnosis of the disease and/or classification of disease based on the immune phenotype.

- Development of a platform for federated and privacy-preserving machine learning in support of drug discovery
The delivery of a federated and privacy-preserving machine learning platform, initially validated on publicly accessible data, that is demonstrably safe enough (privacy-preserving in the face of legitimate and illegitimate (attempted) access and use) and scalable enough to be deployed to a significant representation of private data in the actual preclinical data warehouses of the participating major pharmaceutical companies in yearly evaluation runs. This effort will be mainly driven by the applicant consortium and enabled by the EFPIA partners.

- Centre of excellence - remote decentralised clinical trials. Das Verfahren ist zweistufig.
The action will focus on disaggregating the current model of running clinical trials, defining building blocks and mapping new technologies (e.g. telemedicine, mobile health…) to support the new DCT model. The objectives are: to demonstrate the feasibility of running remote DCTs in Europe. This will increase access of patients to clinical research, enriching clinical trial data from more diverse and representative patient population and improve patient experience during the trials, with a higher speed of recruitment and better retention.

Bei IMI-Projekten ist die Zusammenarbeit mit EFPIA-Unternehmen (Europäischen Dachverband der pharmazeutischen Industrie) eine Voraussetzung. Dabei werden die Aufrufe im Allgemeinen in einem zweistufigen Verfahren ausgeschrieben. Auf die jeweiligen Ausschreibungsthemen können sich in der 1. Antragstufe 'öffentliche' Konsortien bestehend aus nicht EFPIA-Organisationen bewerben. In der zweiten Antragsstufe wird das erstplatzierte 'öffentliche' Konsortium der Stufe 1 mit dem hinter dem jeweiligen Topic stehenden EFPIA-Konsortium zusammengeführt und zur Einreichung eines Vollantrages aufgefordert. In den meisten Fällen erfolgt in dieser Phase ein Wechsel der Projektkoordination vom Koordinator des Konsortiums zum federführenden EFPIA-Unternehmen. Die 2. Antragsstufe kann durch das BMBF mit 10.000 ¤ z.B. für Rechtsberatung, Meetings unterstützt werden.

Zur Vorbereitung für Antragsteller gibt es Webinare online:
o Non-invasive molecular imaging of immune cells, Monday 9 April, 15:00 - 16:30, Register https://register.gotowebinar.com/register/7366972386708582913
Weitere Infos: http://www.imi.europa.eu/apply-funding/open-calls/imi2-call-14

10.04.2018 | Bonn Expertenworkshop zum Thema Immunologie in der Innovative Medicines Initiative 2 (IMI 2)
Die Nationale Kontaktstelle Gesundheit lädt zum interaktiven Austausch über die geplanten Ausschreibungsthemen im Bereich Immunologie mit IMI2-Industrieexperten. Anmeldefrist für die Teilnahme am Workshop: 5. April 2018
Weitere Infos: http://www.nks-lebenswissenschaften.de/de/2072.php

Further information: