TOPIC : Innovation platforms for advanced therapies of the future
|Publication date:||27 October 2017|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Opening date:||single-stage 07 November 2017||Deadline:||18 April 2018 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
Advanced therapies are based on gene, cell or tissue-engineered products which are defined according to the terms of Regulation 1394/2007. So far, only a small number of these products have been placed on the market, and of these, most are for rare diseases. However, in recent years, important discoveries and developments, some unprecedented, have been made in molecular and cell biology and in cell technology, which offer improved opportunities for advanced therapies development. The challenge is to use the new knowledge and new technologies to introduce greater innovation into the advanced therapy development chain as a basis for tackling diseases and conditions affecting large patient groups.Scope:
Building on European strengths and using the definition set out in Regulation (EC) 1394/2007, projects should create knowledge, testing and exploitation platforms around innovative concepts for advanced therapy development. Platforms should comprise the components and expertise necessary to create a solid foundation on which to build possible new therapeutic approaches and/or aim to overcome particular development bottlenecks. Possible components could include studying the basic biology of the potential therapy and investigating its mode of action, proof of concept (in vitro, in animal models – where necessary - or first-in–man studies); safety, efficacy, characterisation, refinement and manufacturing of the product could be considered. Projects should also propose a business model for exploiting results and carry out appropriate outreach and public information activities. Examples of issues that have been identified as holding back the field include gene delivery to cells, reducing off-target effects in gene therapy, immunogenicity of potential new therapies, cell homing and tracking, lack of adequate pre-clinical models, or responding to regulatory concerns, such as potency assays, product characterization, or bank-to-bank variability (non-exhaustive list for illustrative purposes only). Sex and gender differences should be investigated, where relevant. Potential ethical issues should be addressed.
The Commission considers that proposals requesting a contribution from the EU of between EUR 12 and 15 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:
- Strengthened competitive position of European advanced therapy research and development.
- Improved perspectives for treating diseases and conditions in large patient groups with advanced therapies.
- Technological progress in the advanced therapy field.
OJ L 324, 10.12.2007, p. 121.
Topic conditions and documents
1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
- Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
- Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
6. Additional provisions:
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
7. 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 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.
8. Additional documents:
No submission system is open for this topic.
H2020 Online Manual is your guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
National Contact Points (NCP) - contact your NCP for further assistance in your national language(s).
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
IT Helpdesk - contact the Participant Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues
CEN and CENELEC, the European Standards Organisations, advise you how to tackle standardisation in your project proposal. Contact CEN-CENELEC Research Helpdesk at firstname.lastname@example.org
Partner Search Services help you find a partner organisation for your proposal.