Research & Innovation - Participant Portal

Personalising health and care

H2020-PHC-2014-single-stageSub call of: H2020-PHC-2014-2015
Opening Date 11-12-2013
Publication date 11-12-2013 Deadline Date 15-04-2014 17:00:00 (Brussels local time)
Total Call Budget €185,200,000 Main Pillar Societal Challenges
Status Closed OJ reference OJ C 361 of 11 December 2013
Topic: Clinical research on regenerative medicine
PHC-15-2014

Specific challenge: Translating basic knowledge on regenerative medicine into the clinic is held up by the difficulty in undertaking ‘first in man’ studies. Specific research is needed for proving safety, efficacy and repeatability of new treatments. The, very often iterative, dialogue between the relevant authorities and those developing regenerative medicine approaches is needed before specific regulatory requirements can be established.

As a new therapeutic field lacking established business models, financing is a particular obstacle to clinical-stage research in regenerative medicine. The challenge is to initiate a specific action to overcome this hurdle to in-patient research and to determine the potential of new regenerative therapies.                                        

 

Scope: Proposals should focus on regenerative medicine therapies which are ready for clinical (in-patient) research. Proposals should have at the time of proposal submission the necessary ethical and regulatory authorisations to carry out the work or provide evidence of regulatory engagement and that such approval is close. Preference will be given to proposals which have or are closest to having approvals in place for clinical work to start. Since the objective is to test new regenerative therapies, proposals may address any disease or condition but a justification for the choice must be provided. Clinical work should represent a central part of the project.       

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

 

Expected impact:

·         Obtain results of in-patient regenerative medicine research so that new therapies can be taken to the next level of testing or, if not successful, can be discarded.

·         Stimulate growth and competitiveness of European regenerative medicine including European small and medium sized enterprises and industry operating in the sector.

·         Increase the attractiveness of Europe as a location of choice to develop new therapeutic options.

·         Lever existing investments in fundamental research in regenerative medicine.

·         New approaches to currently untreatable diseases.  

Type of action: Research and innovation actions

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

  1. List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.

    In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under all topics in calls under the Societal Challenge ‘Health, demographic change and well-being’. 
     
  2. Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme 

     
  3. Evaluation

    3.1  Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme, with the following exceptions:
    -The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
    - If a proposal fails to achieve the threshold for a criterion at any stage, the evaluation of the proposal will be stopped. 
     

    3.2 Guide to the submission and evaluation process

     
  4. Proposal page limits and layout: Please refer to Part B of the standard proposal template.
     
  5. Indicative timetable for evaluation and grant agreement:
    Information on the outcome of one-stage evaluation: maximum 5 months from the final date for submission.
    Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

     
  6. Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:

    Research and Innovation Action:

    Specific provisions and funding rates
    Standard proposal template (administrative forms and structure of technical annex)
    Annotated Model Grant Agreement

    For information, a pdf. template of the evaluation form for this topic is available on the call page under call documents. In addition, to be consulted on the same page a specific template for essential information for clinical trials/studies/investigations is available.

     
  7. Additional provisions:

    Horizon 2020 budget flexibility

    Classified information


     
  8. Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. 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.

 

Additional documents

You can download the same documents as one zip file from the call page

  • Legal basis - Specific Programme H2020 en
  • WP H2020 - 1. Introduction en
  • WP H2020 - 8. Health, demographic change and wellbeing en
  • Legal basis - Framework Programme H2020 en
  • Legal basis - Rules for Participation en
  • WP H2020 - 19. General Annexes en
  • FAQ en
  • Evaluation form for H2020-PHC-2014-single-stage-topic 31 - RIA en
  • Evaluation form for H2020-PHC-2014-single-stage-topics 7-8-15-19-26 RIA en
  • Evaluation form for H2020-PHC-2014-single-stage CSA en
  • Essential information for clinical trials/studies/investigations en
  • Commission Decision_clinical study reimbursement based on unit costs en
  • A guide to ICT-related activities in WP2014-15 en

No submission system is open for this topic.