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TOPIC : Translational Safety Biomarker Pipeline (TransBioLine): Enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease

Topic identifier: IMI2-2017-13-11
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:

Early and reliable detection and monitoring of adverse events is essential for improving of patient safety, reducing late attrition of drug candidates, and enhancing understanding of toxic mechanisms. In particular, biomarkers that provide insights into mechanisms of tissue injury have the potential to revolutionise drug development as well as diagnosis of diseases. Therefore, the development of innovative, non-invasive biomarkers of tissue injury is of great interest to drug developers, regulators and the broader scientific community. Recent progress in biomarker development including the previous SAFE-T (http://www.imi-safe-t.eu/) that identified several promising biomarker approaches as well as the latest scientific advances in analysis of circulating microRNA provide excellent opportunities for biomarker research. Furthermore, the recent progress in regulatory science of biomarker qualification achieved by the Critical Path Institute and the Foundation for the National Institutes of Health (FNIH) provides a blueprint for conduct of formal qualification of emerging biomarkers via an innovative translational paradigm that relies on tissue injury caused by diseases and only limited clinical and non-clinical studies for assessment of biomarker performance. This approach optimises resource use and accelerates biomarker development.

Scope:

The TransBioLine project will focus on development of biomarkers of injury for liver, kidney, pancreas, vasculature, central nervous system (CNS) and the development of non-invasive liquid biopsies. The project will have four strategic goals:

1. Develop data sets enabling the implementation of emerging safety biomarkers in clinical trials and/or diagnosis of disease;

2. Develop non-invasive mechanistic biomarkers of tissue damage called “liquid biopsy” that will have a potential to revolutionise drug development and diagnosis of disease;

3. Develop standardised assays and technologies for detection of biomarkers and data interpretation;

4. Achieve regulatory acceptance for biomarkers.

Expected Impact:

The biomarkers developed during TransBioLine are expected to accelerate drug development by providing innovative drug development tools and also significantly improve diagnosis of disease by enabling non-invasive interrogation of disease mechanisms. The availability of qualified biomarkers as drug development tools will have a broad positive impact on patient safety in clinical trials as well. The TransBioLine will open new markets by introducing new commercially available diagnostic products and services by diagnostic companies and SMEs. This will strengthen the competiveness and industrial leadership of Europe. TransBioLine will enable the development of new innovative biomarker approaches derived from genomics applicable as non-invasive “liquid biopsies” providing tools for precision diagnosis of mechanisms of toxicity or disease at the molecular level. Although the formal qualification of biomarkers as drug development tools by regulatory agencies is the ultimate deliverable, the biomarker data produced by TransBioLine will enable the acceptance of biomarkers by regulatory agencies under individual Investigational New Drug (INDs) even before the biomarkers are fully qualified.

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.


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Type of Action Research and Innovation action [IMI2-RIA]
Topic Translational Safety Biomarker Pipeline (TransBioLine): Enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease - IMI2-2017-13-11
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