mardi 29 septembre 2020
Innovative Medicines Intiative IMI2 23rd Call, Topic 3
A platform for accelerating biomarker discovery and validation to support therapeutics development for neurodegenerative diseases (Topic code: IMI2-2020-23-03)
The Innovative Medicines Initiative is a jointly fund
A platform for accelerating biomarker discovery and validation to support therapeutics development for neurodegenerative diseases (Topic code: IMI2-2020-23-03)
The Innovative Medicines Initiative is a jointly funded partnership between the European Union, represented by the European Commission, and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Indicative budget:
From EFPIA companies and IMI2 Associated Partners: EUR 47 360 000
From the IMI2 JU: EUR 47 790 000
Key dates and deadlines:
Draft topic texts published: 6 April 2020
Publication date: 23 June 2020
Stage 1 submission start date: 23 June 2020
Stage 1 submission deadline: 29 September 2020 (17:00 Brussels time)
Stage 2 submission deadline: 17 March 2021 (17:00 Brussels time)
Objectives in the scope of this topic:
- Create a set of agreed principles to enable sharing and access to data and samples, taking into consideration all the established legal and ethical research standards and principles (e.g. General Data Protection Regulation (GDPR), legal, intellectual property (IP), ethical, regulatory, societal issues) and their practical implementation.
- Establish a network that can house high quality data and samples, which could have federated and centralised elements. This must build on existing ongoing and relevant cohorts (see objective 4). The overall solution has to be interoperable (e.g. with other global data platforms), scalable and suitable for a broad variety of both data types (including digital), and samples, from public and private (e.g. proprietary clinical trials) sources, whether they be part of the consortium or provided from external donors. Activities related to building a biorepository or data management and sharing platform from scratch are out of scope for this topic. Instead, these must build upon existing resources (including ongoing longitudinal cohorts or studies), knowledge and infrastructures to deliver a novel solution able for seamlessly incorporating existing retrospective samples and data with prospective samples and data collections.
- Establish fair and transparent governance and processes specifically to enable sharing and access to data and samples.
- Test the above with the defined case studies and apply the learnings to fine-tune processes and use the outcomes to grow the platform. Case studies need to include (but are not limited to) the amyloid-tau-neurodegeneration (ATN) system (in cohorts with early Alzheimer’s disease) and the complement pathway (in Parkinson’s disease). Applicants have to include the well substantiated description of:
- cohorts with early Alzheimer’s disease, which will allow the evaluation of the ATN system, comparing more complex and expensive markers like cerebrospinal fluid amyloid β (Aβ) & tau, amyloid-positron emission tomography (PET) and magnetic resonance imaging (MRI) with potential liquid biopsy (blood, saliva,..) markers as alternate biomarkers and;
- cohorts with Parkinson’s disease to investigate the impact/relation of the complement system on diagnosis, severity and progression. This should be especially in light of new classes of minimally invasive neurodegenerative disease biomarkers (e.g. autoantibodies, DNA methylation, exosomes) and sample matrices (e.g. saliva).
- This platform must be a self-sustainable entity by the end of the project.
More information: IMI2_Call23_CallText
https://www.imi.europa.eu/apply-funding/open-calls/imi2-call-23
ed partnership between the European Union, represented by the European Commission, and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Indicative budget:
From EFPIA companies and IMI2 Associated Partners: EUR 47 360 000
From the IMI2 JU: EUR 47 790 000
Key dates and deadlines:
Draft topic texts published: 6 April 2020
Publication date: 23 June 2020
Stage 1 submission start date: 23 June 2020
Stage 1 submission deadline: 29 September 2020 (17:00 Brussels time)
Stage 2 submission deadline: 17 March 2021 (17:00 Brussels time)
Objectives in the scope of this topic:
- Create a set of agreed principles to enable sharing and access to data and samples, taking into consideration all the established legal and ethical research standards and principles (e.g. General Data Protection Regulation (GDPR), legal, intellectual property (IP), ethical, regulatory, societal issues) and their practical implementation.
- Establish a network that can house high quality data and samples, which could have federated and centralised elements. This must build on existing ongoing and relevant cohorts (see objective 4). The overall solution has to be interoperable (e.g. with other global data platforms), scalable and suitable for a broad variety of both data types (including digital), and samples, from public and private (e.g. proprietary clinical trials) sources, whether they be part of the consortium or provided from external donors. Activities related to building a biorepository or data management and sharing platform from scratch are out of scope for this topic. Instead, these must build upon existing resources (including ongoing longitudinal cohorts or studies), knowledge and infrastructures to deliver a novel solution able for seamlessly incorporating existing retrospective samples and data with prospective samples and data collections.
- Establish fair and transparent governance and processes specifically to enable sharing and access to data and samples.
- Test the above with the defined case studies and apply the learnings to fine-tune processes and use the outcomes to grow the platform. Case studies need to include (but are not limited to) the amyloid-tau-neurodegeneration (ATN) system (in cohorts with early Alzheimer’s disease) and the complement pathway (in Parkinson’s disease). Applicants have to include the well substantiated description of:
- cohorts with early Alzheimer’s disease, which will allow the evaluation of the ATN system, comparing more complex and expensive markers like cerebrospinal fluid amyloid β (Aβ) & tau, amyloid-positron emission tomography (PET) and magnetic resonance imaging (MRI) with potential liquid biopsy (blood, saliva,..) markers as alternate biomarkers and;
- cohorts with Parkinson’s disease to investigate the impact/relation of the complement system on diagnosis, severity and progression. This should be especially in light of new classes of minimally invasive neurodegenerative disease biomarkers (e.g. autoantibodies, DNA methylation, exosomes) and sample matrices (e.g. saliva).
- This platform must be a self-sustainable entity by the end of the project.
More information: IMI2_Call23_CallText
https://www.imi.europa.eu/apply-funding/open-calls/imi2-call-23
