TOPIC : Nanoformulation of biologicals
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Opening date:||two-stage 15 October 2015||Deadline: 2nd stage Deadline:||
08 December 2015 17:00:00
24 May 2016 17:00:00
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
Many biomolecules (e.g. proteins, peptides, nucleic acid, enzymes), in opposition to classical small molecules, have demonstrated interesting therapeutic activities in vitro. However, they are too often not druggable because once in pre-clinical in vivo development, they show disappointing loss of efficacy and/or unacceptable toxicity. For example, a high in vitro efficacy of a therapeutic biomolecule can disappointedly become low in vivo, because the biomolecule is processed by the immune system or by enzymes of the host before reaching its targeted tissue. Nanotechnology represents a promising opportunity to overcome these drawbacks. Indeed, the formulation of nanocarriers containing biomolecules ('biologicals') for drug/vaccine delivery can greatly improve their in vivo efficacy and/or decrease their toxicity and provide the capability to cross biological barriers (e.g. intestinal, blood-brain barrier, nasal, ocular, pulmonary, skin).Scope:
This call addresses nanoformulation of biologicals (like proteins, peptides, nucleic acids and enzymes). With an appropriate formulation the biologicals can be effectively transported through the relevant biological barriers to the targeted organs, tissues and cells.
Formulation of nanomedicines has in general been empirical and often produced in an amorphous or undefined structure, which produces regulatory and manufacturing control issues. The aim of the research is to achieve excellent quality control of the assembly by using self-assembling systems. The resulting processes should provide a high degree of control over the physico-chemical parameters like shape, size and chemical composition while incorporating non-Lipinski molecules such as nucleics acids, proteins or peptides. Characterisation aspects of the nanoformulations therefore have to be properly addressed. The benefit will be easier manufacturing and process control, as well as optimised nanoformulation of biologicals with tailored transport through biological barriers.
Projects will develop a nanoformulation of biomolecules to provide a solid pre-clinical proof of concept, address scale-up to the quantities needed for late pre-clinical and clinical study and prepare for future clinical testing. Partners will also have to describe how the various barriers for advancing their new therapy to clinical application will be overcome; they will especially take into account the medical regulatory requirements and the scale-up production for clinical study. As relevant, the proposed activities should address sex and gender specific aspects.
The clinical focus should be notably on age related diseases, neglected diseases and rare diseases or inflammatory diseases, but excluding cancer and infectious diseases.
Activities are expected to commence at Technology Readiness Levels 3 /4 and reach 5/6.
This topic is particularly suitable for SMEs.
The Commission considers that proposals requesting a contribution from the EU between EUR 5 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:
- Developments of new solutions for the particularly needed delivery of biologicals;
- Radical improvement of therapy through the development of new nanoformulation solutions for the delivery of biologicals;
- Foster the translation of nanoformulation of biomolecules towards clinical development / application;
- Improvement of the competitiveness of the European healthcare industry through accelerated introduction of new nanotechnology enabled therapies;
- Improved understanding by academics and research organisations of the requirements of the pharmaceutical and medical devices industry and of medical regulators.
Proposals should include a business case and exploitation strategy, as outlined in the Introduction to the LEIT part of this Work Programme.Cross-cutting Priorities:
See definition of the 'gender dimension approach' in the introduction of this Work Programme part.
Topic conditions and documents
Please read carefully all provisions below before the preparation of your application.
- LIST OF COUNTRIES and APPLICABLE RULES FOR FUNDING
described in part A of the General Annexes of the General Work Programme.
Note also that 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 (follow the links to Australia, Brazil, Canada, China, Hong Kong &Macau, India, Japan, Republic of Korea, Mexico, Russia, Taiwan).
- ELIGIBILITY and ADMISSIBILITY CONDITIONS
described in part B and C of the General Annexes of the General Work Programme.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
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:
For single-stage and second-stage evaluations, the threshold for the criteria Excellence and Impact will be 4.
The overall threshold, applying to the sum of the three individual scores, will be 12.
In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except that proposals will be ranked on the basis of individual scores for the Impact criterion before the Excellence criterion.
In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except, when comparing ex aequo proposals of different topics, the proposals will be ranked first according to the position in the topic ranked lists
3.2 Submission and evaluation process: Guide to the submission and evaluation process
- INDICATIVE TIMETABLE for EVALUATION and GRANT AGREEMENT
Information on the outcome of two-stage evaluation:
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
- PROVISIONS, PROPOSAL TEMPLATES and EVALUATION FORMS
for the type of action under this topic
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
- ADDITIONAL PROVISIONS
Horizon 2020 budget flexibility
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Financial support to Third Parties – where a topic description foresees financial support to Third Parties, these provisions apply.
- 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
Legal basis: Horizon 2020 - Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
H2020 Work Programme 2016-17: Introduction
H2020 Work Programme 2016-17: Introduction to Leadership in enabling and industrial technologies (LEITs)
H2020 Work Programme 2016-17: Nanotechnologies, advanced materials, advanced manufacturing and processing, biotechnology
H2020 Work Programme 2016-17: Cross-cutting activities (Focus Areas)
H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
H2020 Work Programme 2016-17: General Annexes
No submission system is open for this topic.
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