The Innovative Medicines Initiative Joint Undertaking (IMI JU) is a unique pan-European public private partnership between the European Commission and EFPIA driving collaboration between all relevant stakeholders including large and small biopharmaceutical and healthcare companies, regulators, academia, and patients.
The 10th Call topic is:
Immunological Assay Standardisation and Development for use in Assessments of Correlates Of Protection for Influenza Vaccines
EXPECTED KEY DELIVERABLES
- Reach an agreement in both the private and the public sectors on the way to perform assays such as HAI which are currently utilised for influenza vaccine registration
- Establish common protocols for assays that will be used by all groups, either private or public, when testing influenza vaccines in humans
- Apply rigorous and unequivocal assays when establishing correlates of protection
- Understand and agree upon the relative or absolute benefit of different assays, such as HAI and VN (and the different ways the latter can be performed), in measuring functionally active anti-influenza antibodies
- Reach a consensus on the way(s) to measure neuraminidase inhibiting (NI) antibodies to be possibly applied to future clinical trials
Advance the understanding of the different immunological parameters (cellular, transcriptomic, etc) which could be tested in a clinical trial with influenza vaccine to dissect the quality of the immune response induced by the different existing or novel influenza vaccines.
The topic included in the 10th Call is associated with a group of pharmaceutical companies that are members of EFPIA (hereafter called the 'EFPIA Consortium') and which are committed to collaborate with public and private organisations eligible for funding by the IMI JU. The EFPIA members will provide 'in kind' contributions to support their activities within the research project.
The IMI JU applies a two stage Call process. In the first stage, ‘Applicant Consortia' (i.e. formed by academia, small- and medium-sized enterprises (SMEs), patient organisations, non EFPIA companies, etc.) are invited to submit, to the IMI JU, an expression of interest (EoI) in response to a Call topic.
The Applicant Consortium shall consider the research contribution that an EFPIA Consortium will make to a given project.
Each EoI submitted will be reviewed by independent experts according to predefined evaluation criteria.
Each Applicant Consortium with the highest ranked EoI will be invited to develop a full project proposal together with the EFPIA Consortium.
For each topic, the full project proposal will then be subject to a final review by independent experts according to predefined evaluation criteria.
Only a full project proposal that has been favorably reviewed in the evaluation process can be selected for funding. This project will then be invited by the IMI JU to conclude a Grant Agreement governing the relationship between the selected project consortium and the IMI JU. Consortia also must conclude a Project Agreement before the Grant Agreement can be signed.
In the following web sites you will find more information on the call, the rules for participations, and additional materials from the on-line web seminar on the 10th call, and a tool for partner search.