HORIZON EUROPE
Europeo
Specific Challenge:Vaccination is one of the greatest achievements in healthcare. However, developing a vaccine remains costly, time consuming, and risky. Advances in immunology, disease modelling, in silico modelling, including the analysis of big data and the application of machine learning (ML) artificial intelligence (AI), provide opportunities to innovate, de-risk and accelerate the vaccine-development process. Many of these advances have occurred in the academic sector.
These advances can be harnessed to tackle scientific bottlenecks in vaccine development and to nurture and expand a vaccines innovation ecosystem by bringing together academics, small and medium-sized enterprises (SMEs) and industry to collaborate in four areas:
(i) in silico platform for knowledge management and mathematical modelling of the immune system;
(ii) novel controlled human infection models (CHIMs);
(iii) next-generation human in vitro systems and assays; and
(iv) mathematical modelling platforms for vaccine substance and product attributes in biomanufacturing.
A consortium of academics, SMEs and industry will provide...
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Specific Challenge:Vaccination is one of the greatest achievements in healthcare. However, developing a vaccine remains costly, time consuming, and risky. Advances in immunology, disease modelling, in silico modelling, including the analysis of big data and the application of machine learning (ML) artificial intelligence (AI), provide opportunities to innovate, de-risk and accelerate the vaccine-development process. Many of these advances have occurred in the academic sector.
These advances can be harnessed to tackle scientific bottlenecks in vaccine development and to nurture and expand a vaccines innovation ecosystem by bringing together academics, small and medium-sized enterprises (SMEs) and industry to collaborate in four areas:
(i) in silico platform for knowledge management and mathematical modelling of the immune system;
(ii) novel controlled human infection models (CHIMs);
(iii) next-generation human in vitro systems and assays; and
(iv) mathematical modelling platforms for vaccine substance and product attributes in biomanufacturing.
A consortium of academics, SMEs and industry will provide the opportunity to gather the best experts to address these challenges. Academia is at the forefront of scientific and technological advances; SMEs are adept at providing services and innovating those services; and industry has broad overlapping expertise in vaccine development and manufacture. Although the topic covers distinct scientific domains, there are numerous synergies among them. Hence, to address the challenges and to maximise these synergies, collaborations within-sector and cross-sector are needed, and therefore investment in a public-private partnership can provide the impetus to bring academics and SMEs into an alliance with industry partners.
Scope:The overall objective is to accelerate and de-risk the development of new vaccines by incorporating scientific and technological advances from the academic and biotech sectors into industry, and to develop more predictive biological and mathematical models of vaccine performance. The topic is composed of four subtopics with the following specific objectives:
Subtopic 1: to develop an open-data/open-source in silico platform focussed on immunobiological processes, and not on a given disease or vaccine indication.
Subtopic 2: to develop improved or novel CHIMs for influenza, RSV and C. difficile, to facilitate the generation of early efficacy data for vaccine candidates.
Subtopic 3: to develop (i) prototype next-generation in vitro systems for antigen identification/validation and drug substance and drug product characterisation/validation; and (ii) associated functional immune assays for clinically-relevant (surrogate) endpoints.
Subtopic 4: To develop an open data/open source in silico biomanufacturing platform incorporating models for (i) predicting vaccine-product stability; and (ii) the parameters to maintain process robustness for unit-operation scale up or scale down, and for process transfer.The overall objective is to accelerate and de-risk the development of new vaccines by incorporating scientific and technological advances from the academic and biotech sectors into industry, and to develop more predictive biological and mathematical models of vaccine performance. The topic is composed of four subtopics with the following specific objectives:
Expected Impact:The overall expected impacts are: a greater success rate in bringing vaccine candidates through clinical development; increased efficiencies in the transitioning of biomanufacturing processes during vaccine development; and a more vibrant ecosystem of vaccine innovation in Europe. This impact will be demonstrated by more extensive alliances between academia, SMEs and industry through sustainable in silico platforms, CHIMs, CHIM-challenge strains and next-generation in vitro systems and assays, as potential services and products, and case-study based guidance for the use of CHIMs and next-generation in vitro systems and assays. This should also result in the increased probability of successful phase 3 efficacy trials and the acceleration of vaccine development, leading to benefits for trial participants and ultimately those with the medical need for the vaccine.
For subtopic specific impacts, please see the topic text on the IMI website.The overall expected impacts are: a greater success rate in bringing vaccine candidates through clinical development; increased efficiencies in the transitioning of biomanufacturing processes during vaccine development; and a more vibrant ecosystem of vaccine innovation in Europe. This impact will be demonstrated by more extensive alliances between academia, SMEs and industry through sustainable in silico platforms, CHIMs, CHIM-challenge strains and next-generation in vitro systems and assays, as potential services and products, and case-study based guidance for the use of CHIMs and next-generation in vitro systems and assays. This should also result in the increased probability of successful phase 3 efficacy trials and the acceleration of vaccine development, leading to benefits for trial participants and ultimately those with the medical need for the vaccine.
For subtopic specific impacts, please see the topic text on the IMI website.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 20th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
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 submission, evaluation 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 o...
Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 20th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
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 submission, evaluation 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):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Standard Evaluation Form
Proposal templates are available after entering the submission tool
Proposal template stage 1
Proposal template stage 2
IMI2 Model 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.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
IMI2 JU Annual Work Plan 2020
IMI2 JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Información adicional de la convocatoria
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