Datum objave: 20.07.2018. 18:25

Poziv za dostavljanje aplikacija u okviru programa Horizon 2020 za razvoj i validaciju translacionih platformi za podršku otkrivanju sinaptopatskih lijekova

TOPIC : Development and validation of translational platforms in support of synaptopathy drug discovery

Topic identifier:IMI2-2018-15-05

Publication date:18 July 2018

Types of action:IMI2-RIA Research and Innovation action

DeadlineModel: two-stage

Opening date: 18 July 2018

Deadline: 24 October 2018 17:00:00

2nd stage Deadline: 15 May 2019 17:00:00

Time Zone : (Brussels time)

Topic Description

Specific Challenge:

Central nervous system (CNS) disorders are some of the most prevalent, devastating and poorly treated illnesses that impact individuals, families and society. It is estimated that annually in Europe alone, approximately 38 % of the population will suffer from a CNS disorder.

The term ‘synaptopathy’ is typically used to describe CNS disorders caused by synaptic deficits, irrespective of whether the alterations are primary or caused by underlying pathophysiological processes Whilst our emerging understanding of how synapses are pathologically altered in certain brain disorders is leading to innovative opportunities for drug discovery, there are considerable challenges impeding effective research that still remain. Furthermore, the current technologies and platforms employed within early drug discovery are not fully characterised with respect to their predictive translational value, thus leading to a high risk of failure once compounds are progressed into the clinic.

What is desperately needed therefore is the identification and validation of robust, sensitive and translational platforms capable of quantifying synaptic alterations both preclinically and clinically. Such platforms should be fit for purpose to detect and quantify dynamically both disease and treatment effects. Finally, we need to demonstrate the value of these new tools and methods for supporting drug discovery and development efforts across a spectrum of therapeutic CNS indications, including neurodegenerative, neurodevelopmental and psychiatric disorders.

Scope:

The overarching aim of this topic is to develop an improved understanding of the causative or contributory role of synaptic alterations in CNS disorders, which must be valid and applicable to drug discovery and development across the diverse therapeutic CNS areas. The aim is to construct a precompetitive research consortium focused on furthering our scientific understanding of how synaptopathies can elicit or contribute to brain disorders. In addition, the focus will be to develop and validate both existing and innovative translational tools and platforms to facilitate drug discovery targeting synaptic health.

To achieve the overall aim of the topic, applicants should focus on at least one of the four major brain disorders namely Alzheimer’s, Parkinson’s disease, major depression and schizophrenia, and ideally at least two, one in the neurodegenerative and one in the psychiatric/neurodevelopmental field.

Specifically, the effort should be divided into two key areas.

1. Deep clinical phenotyping of CNS disorder patients to enable the development of robust tools to measure disease and treatment effects on the synapse.

2. Characterisation of existing and development of novel preclinical synaptopathy disease models

Expected Impact:

The expanded knowledge base generated to define the contribution that synaptopathies play in neurodevelopmental, psychiatric and neurodegenerative disorders will lead to improved disease pathway understanding and thus better position academia, SMEs and pharmaceutical companies to identify and validate tractable drug targets. The concerted and aligned efforts will minimise duplication and redundancy. The tools, platforms and technologies will ultimately drive success in both the discovery and clinical arenas by providing robust translatable evidence of early clinical efficacy as compounds are evaluated in patient populations. These achievements will facilitate the delivery of much needed, highly effective medicines and treatments for CNS disorders.

Topic conditions and documents

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

The IMI2 JU 15th Call for proposals topics 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 Conditions 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):

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

Proposal templates are available after entering the submission tool

Standard evaluation form

IMI2 Model 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. 

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

7. Additional documents:

Summary of the most relevant provisions for participating in IMI2 actions

3rd Amended IMI2 Annual Work Plan 2018

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

https://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020/topics/imi2-2018-15-05.html