Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Assurance and certification in secure Multi-party Open Software and Services. (AssureMOSS)

Framework: Horizon 2020 — Industrial Leadership
Programme: Information and Communication Technologies
Action type: Research and Innovation actions
Countries involved: Austria,Germany,Germany,Italy,Germany,Italy,Italy,Sweden,Hungary,Hungary,France,Netherlands,Netherlands
Call: Building blocks for resilience in evolving ICT systems (H2020-SU-ICT-2019, 2019)
Start date: 2020-10-01
End date: 2023-09-30
Duration (months): 36.0
Total project cost (EUR): 4689425.0
EU funding (EUR): 4689425.0
Participants: 14
Project status: SIGNED

Continuous, distributed changes rule today's European Digital Single Market as no single company does master its own national, in-house software. Software is mostly assembled from “the internet” and more than half come from Open Source Software repositories (some in Europe, most elsewhere). Security & privacy assurance, verification and process certification techniques designed for large, controlled updates over months or years, must now cope with small, continuous changes in weeks, happening in sub-components and decided by third party developers one did not even know they existed. AssureMOSS addresses these challenges to the fullest extent: « Open Source Software - Designed Everywhere, Secured in Europe ». AssureMOSS proposes to switch from process-based to an artefact-based security evaluation by supporting all phases of the continuous software lifecycle (Design, Develop, Deploy, Evaluate and back) their artefacts (Models, Source code, Container images, Services). The key idea is to support mechanisms for lightweigth and scalable screenings applicable automatically to the entire population of software components by - Machine intelligent identification of security issues across artifacts, - Sound analysis and verification of changes by tracing the security and privay side effects, - Business insight by risk analysis and security evaluation. This approach supports fast-paced development of better software by a new notion: continuous (re)certification. AssureMOSS has assembled a team including 5 leading Universities (Delft, Gotheborg, Trento, Vienna, VU Amsterdam), 3 innovative SMEs (FrontEndART, Search-Lab, Pluribus One), 3 Large Enterprises (E&Y, SAP, Thales) and 1 Special Interest Group Organization (EU-VRi) and an Advisory Board with key figures from OSS and industry at large. The project will generate not only a set of innovative methods and open source tools but also benchmark datasets with thousands of vulnerabilities and code that can be used by other researchers.

Keywords: open source software,continuous development,deployment and certification,security design and verification,machine learning,vulnerability dataset,security evaluation,risk analysis,benchmarking
Reduced Certification Costs for Trusted Multi-core Platforms (RECOMP)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Embedded Computing Systems
Action type: Collaborative project
Partnership: ARTEMIS (Art-185)
Countries involved: Finland,Czechia,Germany,Denmark,Spain,Spain,United Kingdom,Germany,Denmark,Denmark,Denmark,Czechia,Germany,France,Germany,Portugal,Spain,France,France,France,Germany,United Kingdom,Ireland,Denmark,Germany,Germany
Call:  (ARTEMIS-2009-1, 2009)
Start date: 2010-04-01
End date: 2013-03-31
Duration (months): 36.0
Total project cost (EUR): 24357120.0
EU funding (EUR): 4067639.03
Participants: 40
Project status: CLOSED

The proposed RECOMP (Reduced certification cost for trusted multi-core platforms) research project will establish methods, tools and platforms for enabling cost-efficient certification and re-certification of safety-critical systems and mixed-criticality systems, i.e. systems containing safety-critical and non-safety-critical components. RECOMP recognizes the fact that the increasing processing power of embedded systems is mainly provided by increasing the number of processing cores. The increased numbers of cores is commonly regarded as a design challenge in the safety-critical area, as there are no established approaches to achieve certification. At the same time there is an increased need for flexibility in the products in the safety-critical market. This need for flexibility puts new requirements on the customization and the upgradability of both the non-safety and safety-critical critical part. The difficulty with this is the large cost in both effort and money of the re-certification of the modified software, which means that companies cannot fully leverage the advantages of modular software system. RECOMP will provide reference designs and platform architectures together with the required design methods and tools for achieving cost-effective certification and re-certification of mixed-criticality, component based, multi-core systems. The aim of RECOMP is to define a European standard reference technology for mixed-criticality multi-core systems supported by the European tool vendors participating in RECOMP. The RECOMP project will bring clear benefits in terms of cross-domain implementations of mixed-criticality systems in all domains addressed by project participants: automotive systems, aerospace systems, industrial control systems, lifts and transportation systems. RECOMP will thus provide solutions that will allow European industry to increase its market share in the growing market of mixed-criticality systems.
bioMARkers and molecular tumor classification for non-genotoxic CARcinogenesis (MARCAR)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative
Action type: Collaborative project
Partnership: IMI (Art-185)
Countries involved: Switzerland,United Kingdom,Austria,United Kingdom,Germany,Germany,France,Germany,Germany,Belgium,Denmark
Call:  (IMI-JU-01-2008, 2008)
Start date: 2010-01-01
End date: 2015-06-30
Duration (months): 66.0
Total project cost (EUR): 13110690.0
EU funding (EUR): 6049578.0
Participants: 12
Project status: CLOSED

MARCAR aims to establish reliable early markers and molecular classification of tumors in non genotoxic carcinogenesis, applying a mechanism-based approach. Benefits are improved drug safety, more efficient drug development, and progress with 3 R issues. MARCAR focuses on rodent liver, the major target organ of non-genotoxic carcinogens (NGC). However, this approach will facilitate predictions for other organs. Innovative industry-relevant experimental models will be developed: (i) Transgenic mice nulled or humanized for NGC-responsive nuclear receptors, (ii) transgenic mice excreting marker proteins in urine, including oxidative stress reporter mice to monitor ROS production, (iii) transgenic mice allowing in vivo bioirnaging of preneoplastic lesions (PNL) and tumors, and (iv) primary cultures of human/rodent hepatocytes and their co-cultivation with mesenchymal cells which modulate carcinogenesis by NGC. In these systems, novel molecular technologies will be used for profiling the genome, epigenome, transcriptome and proteome/phosphoproteome to provide global molecular signatures of NGC-induced signalling. These complementary technologies in conjunction with standardized data management and advanced marker identification algorithms will lead to molecular classification of tumors and PNL, and identify predictive molecular signatures of spontaneous vs drug induced tumors. Biomarker panels indicating the mechanisms of GC action will be derived and translated into assay systems. The validity, predictivity and robustness of biornarkers will be tested in collaboration with EFPIA, employing well—characterized pre—climcal models. For clinical translation humanized/human systems and materials from clinical trials will be tested for NGC effects on homologues of rodent biomarkers. The provision of high-quality deliverables is facilitated by complementary expertise in carcinogenesis/bioanalysis, in conjunction with know-how and in kind contributions of EFPIA partners.

Keywords: carcinogenesis,molecular mechanism,biomarker,epigenetic,microrna,tumour classification
SAFER AND FASTER EVIDENCE-BASED TRANSLATION (SAFE-T)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative
Action type: Collaborative project
Partnership: IMI (Art-185)
Countries involved: Switzerland,Germany,France,Spain,Belgium,Sweden,Germany,Germany,United Kingdom,France,Israel,France,Germany,Spain,Ireland
Call:  (IMI-JU-01-2008, 2008)
Start date: 2009-06-15
End date: 2015-06-14
Duration (months): 72.0
Total project cost (EUR): 36427294.0
EU funding (EUR): 13901971.0
Participants: 26
Project status: CLOSED

The public-private consortium composed of complementary SMEs, academic and clinical centers of excellence and EMEA as partner proposes SAFE-T (Safer And Easter Evidence-based Iranslation) project for the establishment of a biomarker (BM) qualification process and its validation in clinical biomarker studies designed for the translation, performance testing and eventual regulatory qualifIcatIon of drug-Induced organ injury (DILl, DIKI and DIVI) safety BM5. SAFE-T objectives will be achieved through innovative biomarker approaches employing leading BM technologies. The consortium will deliver a validated generic qualification process for translational safety BMs that will be released for discussion to gain its acceptance as a reference guideline by stakeholders including EFPIA and health authorities. BM5 with probable translational utility for DIKI, DILl and DIVI and their assays will be qualified for human applications in an innovative “two step fo,ward” approach. First, Biomarker Proof of Translation (POT) studies will be conducted in human disease models for proving the translational value of the selected candidate BMs. Secondly, Biomarker Proof of Performance (PoP) studies will be conducted for BM performance testing in patients with drug-induced and non-drug-induced pathologies and with common disorders. Integrative Data Analysis will be carried out to demonstrate the performance and the added-translational-value of biomarkers in comparison to current standards. In addition, the consortium will investigate biologic/mechanistic understanding of DIVI-BMs in severe cardiovascular adverse events (sCVAE) that will allow us predicting drug-induced sCVAE risk by diagnostic kits. The Consortium will establish a database of human BM profiles and a Biobank for supporting future BM R&D.
Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative
Action type: Collaborative project
Partnership: IMI (Art-185)
Countries involved: United Kingdom,Denmark,United Kingdom,Germany,Spain,France,Italy,Netherlands,Netherlands,Sweden,United Kingdom,United Kingdom,France,Switzerland,Belgium,Germany,Germany,Sweden,Denmark,Poland,Denmark,Germany,Spain,Netherlands
Call:  (IMI-JU-01-2008, 2008)
Start date: 2009-09-01
End date: 2015-04-30
Duration (months): 68.0
Total project cost (EUR): 28617382.0
EU funding (EUR): 11009715.0
Participants: 35
Project status: CLOSED

Recent pharmacovigilance (PV) issues have led to questions regarding the ability of the current PV system to meet the global needs. Controversies around the assessment of spontaneous reports and conflicting results from pharmacoepidemiology studies may lead to delay in, or inappropriate, regulatory decisions. The PROTECT consortium, consisting of 20 core partners lead by the European Medicines Agency (EMEA), will develop and test methods of proactive monitoring of drug safety and benefit risk (B/R) assessment utilising a large range of EU data sources and expertise. in partnership with EFP1A companies, PROTECT will develop essential parameters, methodologies and algorithms to enable data mining, signal detection and evaluation in various types of data-sets including spontaneous reporting, registries and electronic health care databases (EHR). impact analysis methods will be used to enhance signal prioritisation. PROTECT will develop means of combining results from clinical trials, spontaneous reporting and observational data, strengthening continuous B/R monitoring in the post-authorisation phase. Bayesian modelling, multi-criteria decision analysis and other analytical methods will be compared. Methods for graphical expression of B/R will be tested with different stakeholders. Collection of data directly from patients is underutilized and may be essential when knowledge of total drug consumption or potential confounders is needed or conventional PV is disrupted. PROTECT will trial direct patient data collection in natural language using web-based, telephone and text messaging systems. As well as testing transferability of the data into a common language, PROTECT will explore linkage to data from EHR and electronic registries.

Keywords: protect
Prediction of cognitive properties of new drug candidates for neurodegenerative diseases in the early clinical development (PHARMA-COG)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative
Action type: Collaborative project
Partnership: IMI (Art-185)
Countries involved: United Kingdom,France,Spain,France,Germany,Spain,Germany,France,Italy,France,Luxembourg,Sweden,Germany,Switzerland,France,Belgium,Germany,Belgium,Denmark,Italy,United Kingdom,Netherlands,Greece,United Kingdom,Italy
Call:  (IMI-JU-01-2008, 2008)
Start date: 2010-01-01
End date: 2015-12-31
Duration (months): 72.0
Total project cost (EUR): 30715556.0
EU funding (EUR): 9658388.0
Participants: 38
Project status: CLOSED

PHARMA-COG aims to develop a new integrated model to accelerate the development of drug cindidates for MS, PKD and AD. The innovation relies on a 'multidimensional matrix' approach, integrating all available and renewed inputs (biomarkers/animal, human models/physiological and pharmcological challenges, Phase 0/1/1b to reduce the attrition rate, to allow an early and pertinent GO/NOGO decision before entering phase II trials for both symptomatic treatment and disease modifiers approaches. The hypothesis is that effective long term drugs will normalize markers artificially modified. The general objective is to test the efficiency of the 'matrix' on drug candidates for the enhancement/protection of cognitive functions. the final objective is to improve the detection and selection of new drugs candidates within a shorter teim-frame. Our consortium gathers 13 academics and clinicians, 8 SMEs, 1 European patient organization (Alzheimer Europe) as well as 1 regulatory body (EMEA), coming form six different EU Members States. Excellence Centres gather representatives of the different sectors: biomarkers (proteomics, transcriptomics), pharmacodynamic markers ( electrophysiology, psychophysiology, morphological and functional imaging), preclinical model specialists (cellular, transgenic mouse, monkey), clinicians, and clinical pharmacologists. By the end of this (-year project, the following achievements are expected; definition of the most predictive combination of pharmacodynamic markers; validation of parallel models (in healthy volunteers, ApoE 4 subjects,patients and animals) to establish effective exposure ranges and support proof of mechanism studies. The predictive value of the 'matrix' will be evaluated using different pharmacological target acting drugs. Suugestions for revised/new recomendations and guidellines will help to standardize the pre-clinical and clinical phases of drugs' development in neurodegenerative diseases.

Keywords: pharma-cog
The Open Pharmacological Concepts Triple Store (OPEN PHACTS)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative
Action type: Collaborative project
Partnership: IMI (Art-185)
Countries involved: United Kingdom,Austria,Denmark,Germany,Spain,Netherlands,United Kingdom,Netherlands,Spain,Netherlands,Spain,Germany,Sweden,Switzerland,Germany,Denmark,Netherlands,Germany,Belgium,Germany,United Kingdom
Call:  (IMI-JU-02-2009, 2009)
Start date: 2011-03-01
End date: 2016-02-29
Duration (months): 60.0
Total project cost (EUR): 20782066.0
EU funding (EUR): 11466433.0
Participants: 31
Project status: CLOSED

Drug discovery is data-hungry and all major pharmaceutical companies maintain extensive in-house instances of public data alongside internal. Analysis and hypothesis generation for drug-discovery projects requires assembly, overlay and comparison of data from many sources, requiring shared identifiers and common semantics. Expression profiles need to be overlaid with gene or pathway identifiers and reports on compound pharmacology. Alignment and integration of internal and public data and information sources is a significant effort and the process is repeated across companies, institutes and academic laboratories. This represents a significant waste and an opportunity cost. To address these challenges, the Open PHACTS project will develop an open access innovation platform, Open Pharmacological Space (OPS), via a semantic web approach. OPS will comprise data, vocabularies and infrastructure needed to accelerate drug-oriented research. This semantic integration hub will remove key bottlenecks in small molecule drug discovery: disparate information sources, lack of standards and common identifiers, guided by well defined research questions from drug discovery. Workflows for data capture, processing, interoperability, visualization, and chemogenomics will be developed creating a comprehensive Systems Chemical Biology Analysis Network. Security issues around proprietary data, shared via the Open PHACTS Discovery Platform and accessible for safe querying and reasoning will be properly addressed with expert trusted parties. The Open PHACTS consortium comprises 20 European academic and SME partners, with leading experts in the fields of data mining, annotation, small molecule data storage and manipulation, target bioinformatics, RDF information handling, massive in silico reasoning and chemical biology. The 10 EFPIA members of Open PHACTS will contribute drug discovery expertise, data sets, software engineering and programming capacity to the project.

Keywords: open pharmacological space
Biomarkers For Enhanced Vaccine Safety (BIOVACSAFE)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative
Action type: Collaborative project
Partnership: IMI (Art-185)
Countries involved: Italy,United Kingdom,Germany,France,Sweden,Netherlands,Germany,Belgium,Iceland,Denmark,Belgium,France,United Kingdom,Israel,Belgium
Call:  (IMI-JU-03-2010, 2010)
Start date: 2012-03-01
End date: 2018-08-31
Duration (months): 78.0
Total project cost (EUR): 30931370.0
EU funding (EUR): 17408770.0
Participants: 23
Project status: CLOSED

BioVacSafe is a concise consortium of selected academic, public, and SME participants used to co-working in industry-led projects, organised into focused Activity Cores to generate knowledge and tools to benchmark licensed vaccine reactogenicity, and create practical and generalizable guidelines and techniques to enhance immunosafety of novel vaccines from pre-development to post-marketing surveillance. A compact interlocking structure provides efficient and cost-effective goal delivery, while offering the full spectrum of functionality and capacity to match the needs for predictive biomarkers and models of inflammation/autoimmunity and clinical events classification. A Technology Core has transcriptomics, genotyping, proteomics, metabolomics and data mining, with depth and capacity to discover, validate and distribute novel biomarkers. A Models Core has a full range of ex vivo/in vivo murine, small animal and non-human primate models of inflammation and biomarker discovery, with advanced immunology and imaging. A Clinical Core has capability to safely and efficiently distribute clinical studies of vaccine immunosafety from small intensive trials to large-scale studies of adult, paediatric and other populations. A Populations Core has population-scale biobank discovery, clinical cohorts (with globalisation capability, autoimmune, chronic, inflammatory and infectious disease groups), large-scale genotyping and sequencing, and a safely accessible central database for online analyses of large datasets. A Regulatory Core with expertise to synthesise outputs to generate and disseminate classifications, guidelines, reference standards for vaccine development, and inform EFPIA activities. A Management Core with track record of successful public-private projects ensures Cores interoperate to maximise discovery - validation - application - re-discovery cycles, to deliver project goals on time, within budget, while maximising interactions with other actors (EFPIA, FDA, EMA).

Keywords: vaccine,biomarker,immunization,safety,immunosafety,inflammation,allergy,autoimmunity,databases,genetics
European Patients' Academy on Therapeutic Innovation (EUPATI)

Framework: FP7 — Cooperation
Programme: Joint Technology Initiatives (Annex IV-SP1)
Theme: Public-private partnerships
Destination: Innovative Medicines Initiative
Action type: Collaborative project
Partnership: IMI (Art-185)
Countries involved: Luxembourg,France,Belgium,United Kingdom,Denmark,Sweden,Germany,Germany,Italy,Spain,France,Germany,Switzerland,Denmark,Belgium,Germany,Ireland,United States,Spain,Poland
Call:  (IMI-JU-03-2010, 2010)
Start date: 2012-02-01
End date: 2017-01-31
Duration (months): 60.0
Total project cost (EUR): 10951178.0
EU funding (EUR): 5250000.0
Participants: 33
Project status: CLOSED

The proposed project "European Patients' Academy on Therapeutic Innovation" (EUPATI) contributes to IMI’s goal of raising patients’ awareness and participation in pharmaceutical R&D. This patient-led academy will provide scientifically reliable, objective, comprehensive information to patients on pharmaceutical R&D. It will increase the capacity of well-informed patients to be effective advocates and advisors, e.g. in pharmaceutical development, with regulatory authorities and in ethics committees. The Consortium, led by the European Patients' Forum, comprises a unique combination of pan-European patient organisations, academic and not-for profit organisations and 16 EFPIA member companies. It features excellence across disease areas in state-of-the art, high quality, objective education to patients about therapeutic innovation. Supported by an innovative e-platform, EUPATI's network of patients, experts, companies and communicators develops recognised blended learning courses for patients to become 'Patient Experts' in treatment development. It provides educational materials for patient organisations as well as a Wiki-type platform available to all patients in 6 areas of interest. It drives the newest thinking in content and delivery, and harnesses previously ad-hoc activities in a coherent, strategic, quality-oriented and sustainable way. It informs the lay and hard to reach patient community, raising public awareness of the development of new treatments. EUPATI makes a substantial and measurable difference to patients, laying the base for meaningful involvement and empowerment of patients in pharmaceutical innovation, safety of medicines and access to treatments. EUPATI creates synergies across its public and private partners to galvanize the most effective, transparent and credible partnership possible, nurturing the best that industry and patient organisations can offer in this field, whilst respecting core principles of quality and independence of information.

Keywords: patient education and training,therapy development,pharmaceutical innovation