The following two IMI2 calls were announced on 17th December 2014:
Call 4:
Call ID: H2020-JTI-IMI2-2015-04-two-stage
Action type: Coordination and Support Action
Deadline: 11/2/2015 (stage1), 14/4/2014 (stage 2)
Topic 1: Enabling Platform on Medicines Adaptive Pathways to Patients
The consortium of applicants is expected to have knowledge of the following:
- Knowledge and expertise in medicinal products’ life cycle;
- Sound understanding of the R&D pathways and their challenges;
- Ability to develop outreach and communication strategies on the role and challenges of MAPPs to the stakeholders and public at large;
- Proven expertise for managing and coordinating major projects of this complexity and scale;
More Information:
http://www.imi.europa.eu/content/stage-1-15
Call 3:
Call ID: H2020-JTI-IMI2-2015-03-two-stage
Action Type: Research and Innovation Action
Deadline: 24/3/2015 (stage1), 22/9/2014 (stage 2)
Topic 1: Remote assessment of disease and relapse – CNS
Applicant consortium will be multidisciplinary:
- device and sensor companies to bring the latest remote assessment technologies that could be further developed or modified for use as intended in CNS diseases;
- Academic, clinical and disease area experts will help to design the clinical study (end-points, inclusion criteria etc.) and interpret results for clinical significance;
- IT/ analytics partners will help develop data management architecture, state-of-the-art algorithms to derive biosignatures of symptoms and relapse from collected streaming data;
- Regulatory and health-care systems experts will help define regulatory and clinical-care pathways respectively for the remote assessment solutions.
Topic 2: Assessing risk and progression of prediabetes and type 2 diabetes to enable disease modification
Applicant consortium will be multidisciplinary:
- basic, translational, clinical research;
- regulatory aspects;
- economic or public health modelling;
- project management.
- complementary expertise in:
- biomarker discovery and clinical assay implementation across the range of relevant technologies, in human pancreatic beta cell, hepatic, muscle, and adipose biology,
- conducting intensive clinical phenotyping of prediabetes and type 2 diabetes patients, and
- prospective and retrospective assembly and assessment of large longitudinal cohorts and biobanks from subjects with prediabetes and type 2 diabetes
Topic 3: Linking clinical neuropsychiatry and quantitative neurobiology
Applicant consortium will be multidisciplinary:
- statistics and study design;
- clinical study support;
- IT – Data communication and data basing;
- quantitative clinical technologies and biomarkers;
- pre-clinical technologies that are aligned with those identified for use clinically;
- regulatory expertise
- translational medicine expertise;
- project management.
Topic 4: The consistency approach to quality control in vaccine manufacture
The Applicant Consortium is expected to provide both pre-clinical (safety, CMC, assay development) and clinical expertise and ability for interdisciplinary and inter-sectorial work and to cover the following critical fields:
- Physicochemical techniques for conformational fingerprinting of antigens
- Proteolytic susceptibility of antigens to mimic APC action
- Immunochemical assay development
- Manufacturing processes and production consistency
- Antigen-adjuvant interactions
- In vitro cell models of Immune responses
- Genomic and proteomic profiling
- Regulatory expertise
- Understanding of GLP, QA
- Animal models and laboratory animal science
Topic 5: Pertussis vaccination research
- Expertise in in vitro , preclinical and clinical B. pertussis research or pertussis vaccination
- Expertise in the development of bioassays or immunoassays suitable to assess pertussis infection and functional and memory immune responses to pertussis vaccination.
- Expertise in the identification of human biomarkers of infectious disease progression, immunological memory and/or vaccine efficacy
- Expertise in molecular epidemiology and use on in silico tools to investigate pathogen biodiversity and epidemiology of infectious disease
- Expertise and infrastructure needed to set up preclinical disease models, including in non -human primates
- Expertise and infrastructure to perform prospective clinical studies with licensed pertussis vaccines, as well as access to relevant vaccination cohorts
- Institutional expertise /infrastructure to develop and perform control bacterial/respiratory pathogen challenge studies in human volunteers
- Expertise or access to epidemiological data on pertussis disease and effectiveness of pertussis vaccination
- Banking and Documenting clinical isolates of B. pertussis or biological samples from infected or vaccinated individuals
Topic 6: Knowledge repository to enable patient focused medicine development
- Experience with Patient Advocacy
- Regulatory Expertise
- Health Services Research
- Clinical Informatics
- Infrastructure and Software
- Advanced Knowledge Management
- Point of Care Know-how and Integration
- Community Education and Learning
- Education Systems
- Learning and training Management
- Analysis and complex clinical workflow experience
- Drug Development Life Cycle
- Innovation
- Requirements Engineering
- Product Development
More Information: