Research & Innovation - Participant Portal

TOPIC : VALIDATION OF TRANSLATIONAL IMAGING METHODS IN DRUG SAFETY ASSESSMENT (TRISTAN)

Topic identifier: IMI2-2015-07-01
Publication date: 18 December 2015

Types of action: IMI2-RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
18 December 2015
Deadline:
2nd stage Deadline:
17 March 2016 17:00:00
06 September 2016 17:00:00

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

The development of imaging biomarkers both for the pre-clinic and the clinic has the potential to advance safety evaluation. However, in order for imaging biomarkers to become more mainstream, impacting the drug discovery process more widely, there needs to be technical advances, as well as a better standardization across the imaging community to ensure protocols, biomarkers, analysis and data interpretation are well recognized and equivalent. If properly validated, imaging methods will support establishment of the ADME concept and estimation of toxic effects of drug candidates and could additionally strongly support the efforts to identify the minimal (i.e. safest) dose providing useful therapeutic efficacy.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.

Scope:

The overall aim of the proposal is to leverage the potential of available imaging techniques in order to improve drug safety analysis and translatability of findings from animals to humans by validating imaging procedures as biomarker. The output from the resulting project should provide clear evidence that state-of-the-art imaging techniques, when validated properly, can support pre-clinical and clinical drug development and improve safety for individual patients. The following three areas are in scope: the assessment of liver toxicity; lung toxicity and the bio-distribution of biologicals.

Expected Impact:

The information and knowledge acquired will be of outmost value for further improving safety evaluation of novel drug candidates, small molecules as well as biologics. Imaging biomarkers have a strong potential to improve translatability of pre-clinical results to healthy volunteers and patients and thus help to avoid late stage attrition of development programs. In addition, functional diagnostic imaging methods used as biomarkers would offer the possibility to confirm drug toxicity mechanisms in humans, including the potential to determine drug-drug interactions.

The possibility to follow a drugs bio-distribution and its effect on tissues or molecules longitudinally by means of imaging intrinsically includes the potential to reduce animal numbers in pre-clinical studies. Hence the work in this program strongly supports the 3R principle (refinement, reduction, replacement) in substantially reducing the number of animals needed in pre-clinical research.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.

Topic conditions and documents

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

You can access the description of the different topics in the Call topics text.

The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section (page 78), as well as the following information : 
 

  1. List of countries and applicable rules for funding
     
  2. Eligibility and admissibility conditions
     
  3. Evaluation criteria and procedure, scoring and threshold : described in the IMI Manual for Submission, Evaluation and Grant award
     
  4. Indicative timetable for evaluation and grant agreement
     
  5. Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:

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

    Summary of the most relevant provisions for participating in IMI2 actions
    Standard proposal template
    Standard evaluation form
    IMI2 Model Grant Agreement
    Template for Essential Clinical Trials Information

    MI2 Coordination and Support Action (IMI2-CSA):

    Summary of the most relevant provisions for participating in IMI2 actions
    Standard proposal template
    Standard evaluation form
    IMI2 Model Grant Agreement
    Template for Essential Clinical Trials Information
     

 

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