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TOPIC : A sustainable European induced pluripotent stem cell platform

Topic identifier: IMI2-2017-13-06
Publication date: 30 November 2017

Types of action: IMI2-RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
30 November 2017
Deadline:
2nd stage Deadline:
28 February 2018 17:00:00
06 September 2018 17:00:00

Time Zone : (Brussels time)
  Horizon 2020
Topic Description
Specific Challenge:

In Europe, the EBiSC project (https://www.ebisc.org/) funded by the Innovative Medicines Initiative Joint Undertaking (IMI JU) has demonstrated the feasibility and challenges of coordinating existing organisational capacities across Europe to fast track the establishment of a centralised network and facilities to access a standardised resource of established human inducible pluripotent stem cells (hiPSC) lines and data. EBiSC has established a unique European-based iPSC repository and has delivered harmonised and publically accessible Standard Operations Procedures (SOPs) for tissue procurement, bio-sample tracking, iPSC expansion, cryopreservation, qualification and distribution to the research community. These were implemented to create a quality managed foundational collection of lines and associated data made available for distribution.

The critical challenge addressed by this topic is to build on these important infrastructure, capabilities and knowledge to create a fully sustainable European hiPSCs distribution platform with worldwide reach.

Scope:

The overall objective of the action generated from this topic is to establish a fully self-sustainable European human iPSC banking facility, that has to be operational within the first three months of the action by seamlessly building on and incorporating existing cell lines, knowledge and infrastructure established within former European-wide initiatives (e.g. EBiSC). The bank has to be able from the start to handle and deliver a minimum of approximately 500 quality-controlled, disease-relevant (in particular for neurodegeneration, Alzheimer’s disease and other tauopathies, Parkinson’s disease, cardiovascular disease, safety, diabetes, and auto-immune and selected monogenic diseases), research-grade iPSC lines, with integrated data and cell services which will be further built on as part of the research and technology work of the action. The ultimate goal is to transform significant pre-existing European banking infrastructures into a sustainable resource for European research and development.

Expected Impact:

Availability of iPSC lines derived from patients, as well as of a broad spectrum of lines from healthy donors of different ages, standardised according to how they were made and their in vitro behaviour, and the possibility of linking a gene code to cell line phenotype reflective of the disease, will enable the research community to refine original clinical diagnosis into one based on disease stratification and thereby design more precise experiments to discover novel pathogenic pathways, drug targets and new medicines. This is expected to significantly advance research and development activities across Europe by accelerating the progress of understanding certain disease aetiologies, as well as finding potential cures, thereby strengthening European competitiveness.

This European iPSC repository will be uniquely positioned to serve as the central European iPSC repository hub to accelerate and facilitate European research and development activities. Therefore, the consortium will have to continuously monitor the sale of cells produced by the banking entity, and its trend in order to develop in the runtime of the project a plan as to how to transform the repository into a self-sustainable business. Ultimately this will secure that the public and private investment will establish a resource that beyond the runtime of the project continues to support and fuel European basic research as well as drug development campaigns in pharma companies.

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.

The IMI2 13th Call for proposals topic text as well as the Call Conditions are available here.

 The budget breakdown for this Call is given at the end of the Call topics text, in the Call Condtions section, as well as the following information:

1.   Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.

2.   Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.

Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.

3.   Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.

4.   Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.

Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

5.   Proposal templates, evaluation forms and model grant agreements (MGA), clinical trials template:

IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):

Proposal templates are available after entering the submission tool.

Standard evaluation form RIA 

IMI2 Model Grant Agreement
:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !

IMI2 Coordination and Support Action (IMI2-CSA):

Proposal templates are available after entering the submission tool.

Standard evaluation form CSA

IMI2 Model Grant Agreement
:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !

6.   Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.

7. Additional documents:

Summary of the most relevant provisions for participating in IMI2 actions

IMI2 - 2nd Amendment to the Annual Work Plan 2017

IMI2 Regulators Guidance tool for researchers

IMI JU derogation to H2020 Rules for Participation  

Horizon 2020 Rules for Participation 

Horizon 2020 Regulation of Establishment

Horizon 2020 Specific Programme

 

Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

Submission Service

No submission system is open for this topic.

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H2020 Online Manual is your guide on the procedures from proposal submission to managing your grant.

Participant Portal FAQ – Submission of proposals.

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IMI2 Partner Search Tool
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CEN and CENELEC, the European Standards Organisations, advise you how to tackle standardisation in your project proposal. Contact CEN-CENELEC Research Helpdesk at research@cencenelec.eu

The European Charter for Researchers and the Code of Conduct for their recruitment