Introduction

The Innovative Medicines Initiative 2 (IMI2) isEurope's largest public-private initiative aimingto speed up the development of better and safermedicines for patients. IMI2 supportscollaborative research projects and buildsnetworks of industrial and academic experts inorder to boost pharmaceutical innovation inEurope. IMI2 is a joint undertaking between theEuropean Union and the pharmaceuticalindustry association EFPIA.

Objective of the call

The following topics are under consideration for inclusion in the expected call for proposals 11:

-Topic 1: Development and validation of technology enabled, quantitative and sensitivemeasures of functional decline in people with early stage Alzheimer’s Disease (RADARAD).The RADAR programme aims to test if new pre-emptive therapeutic development andclinical care strategies based on remote continuous monitoring are both scientificallyfeasible and also practically feasible as part of a wider healthcare system. The topic isfinalised to develop the foundational components of a digital platform to “Improve patientoutcomes through remote assessment”. The main goal of the action is to develop a digitalplatform to measure a valid and meaningful combination of smartphone, wearable and/orhome sensor based parameters that can detect early and subtle functional decline in earlyAlzheimer’s patients (mild AD, MCI or earlier). However, the system generated should betested in all stages of AD to establish validity. Duration: 36 months.

Topic 2: FAIRification of IMI and European Federation of Pharmaceuticals Industries andAssociations (EFPIA) data. The funded project will focus on IMI projects that have datascientifically valuable and amenable for making FAIR (Findable, Accessible, Interoperable,Reusable). All IMI projects will be assessed for the presence of such data. It is expected thatthe databases of more than 20 IMI projects will be made FAIR in this project. Duration: 36months.

Topic 3: Development of sensitive and validated clinical endpoints in primary Sjögren’sSyndrome (pSS). The objective of this proposal is to develop sensitive and validated clinicalendpoints for use in future clinical trials of pSS. The scope of this effort will be theidentification, development and validation of pSS-related outcome measures includingclinical, laboratory, bio-behavioural activity and imaging parameters (biomarkers), applyingthe following step-wise approach: a) Data generation and review; b) Development of newoutcome measures based on the review and analysis activities; c) Application and validationby prospectively testing of these proposed new pSS outcome measures, as well as existingones; d) Analysis of the outcome of the validation trial and validation of the newendpoint(s). Duration: 72 months.

Topic 4: European Screening Centre: unique library for attractive biology (ESCulab). TheEuropean Lead Factory (ELF) project, a public-private consortium, has offered a uniquehigh quality compound library and state-of-the-art industrial ultraHigh ThroughputScreening (uHTS) capabilities to targets submitted by the public (public targets). By havingtheir targets screened on the compound library at this top tier screening facility, public targetowners1 obtain a Qualified Hit List (QHL) that can be used either as probe compounds topre-clinically validate a disease hypothesis or as starting points for lead optimisation. Theproject is intended to lower the hurdles for academic groups and SMEs to translate earlyinnovative biology into chemical series that have the potential to be optimised into drugcandidates. The delivery of 7 mature lead series and 83 QHLs should cut timelines to arriveat clinical proof of concept in diseases with unmet medical need, such as cancer,immunological, respiratory, neurological and neurodegenerative diseases as well as antiinfectivesand neglected (tropical) diseases. ESCulab will also provide the opportunity foracademics/SMEs to collaborate with EFPIA partners and see their projects moving aheadalong the value chain. Duration: 60 months.

Topic 5: Exploitation of IMI project results. The objective is to ensure the optimalexploitation and sustainability of key results from IMI projects that have finished or arenearing completion, and where relevant activities had not been already included as a fundedactivity of the project. Results should be those with the greatest chance of significant impact,beyond the original project lifetime. Duration: no more than 24 months.

Partnership criteria

Topic 1: the applicant consortium must demonstrate the following expertise: AD clinicalresearch and trials and disease, regulatory science, patients and patient organizations, dataand knowledge management; project management and professional communication, designand conduct of clinical studies; expertise in clinical data management and clinical statistics;expertise in device and sensor development; IT/Analytics expertise; data privacy andsecurity; regulatory expertise and experience in development and qualification of novel endpointsusing digital technologies; clinical and general project management.

Topic 2: the applicant consortium must demonstrate expertise in pharmaceutical researchscientific subject matter, scientific data vocabularies and ontologies, the existing databaselandscape, legal expertise in database access, FAIR data principles, data stewardship,database management, computer programming, data hosting organisations and solutions.

Topic 3: the applicant consortium must demonstrate expertise in literature reviews and ondetermining relevant outcomes in collaboration with multiple stakeholders, developing andvalidating new patient reported outcome measures, data management and statisticalprogramming, medical research, scientific clinical expertise in biomarkers, biomarker assayimplementation per protocol, primary Sjögren’s syndrome.

Topic 4: the applicant consortium must demonstrate expertise in professional, industry-likemanagement of compound logistics process centred around a single entity for the collection,storage, distribution and management of the ESCulab compound library. The consortiummust include a specialized party who can manage and broker confidential information oncompounds and screening results data according to the Honest Data Broker concept. Strongexperience in assay development, miniaturization, validation for High ThroughputScreening (HTS). Capabilities to develop HTS ready target-focused and phenotypic cellularassays at a minimum of 2-3 sites equally spread across Europe. Extensive experience in theexecution of HTS to industry standards, providing solutions also for complex experimentalprotocols, e.g. with multiple liquid handling and signal detection steps, kinetic readouts, etc.Necessary expertise in molecular and cellular pharmacology and medicinal chemistry todrive a rigorous hit characterization process.

Topic 5: the consortium must include participants as appropriate to exploit the targetedresults in the most logical and efficacious manner. Applicant consortia should also ensurethat all relevant stakeholders are engaged appropriately and that the needs of patients areadequately addressed and, where appropriate, patient involvement is encouraged.

More information athttp://www.imi.europa.eu/content/future-topics