HORIZON EUROPE
European
Specific Challenge:Although pathology is the cornerstone of the workup of many diseases such as cancer, autoimmune diseases, and transplant rejection, it still relies heavily on the subjective interpretation of a histology sample by a qualified pathologist who captures observations and conclusions in a report. Once the observations are captured, the slides are archived and only the pathologist’s report and diagnoses (considered as raw data in good laboratory practice (GLP) nonclinical studies) remain accessible. Therefore, significant information from the histology slides is no longer easily available. This hinders the discovery of new clinico-pathological entities that are relevant to patients’ prognosis and treatment.
The recent developments of high-throughput slide scanners offer a possibility for making the entire information contained in the millions of glass slides produced every year, available for search. Ensuring storage and access to digital slides will overcome the current limitations to accessing and sharing pathology material together with the associated metadata. It will facilitate case consultation, help identify sub-types of diseases, assess the transla...
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Specific Challenge:Although pathology is the cornerstone of the workup of many diseases such as cancer, autoimmune diseases, and transplant rejection, it still relies heavily on the subjective interpretation of a histology sample by a qualified pathologist who captures observations and conclusions in a report. Once the observations are captured, the slides are archived and only the pathologist’s report and diagnoses (considered as raw data in good laboratory practice (GLP) nonclinical studies) remain accessible. Therefore, significant information from the histology slides is no longer easily available. This hinders the discovery of new clinico-pathological entities that are relevant to patients’ prognosis and treatment.
The recent developments of high-throughput slide scanners offer a possibility for making the entire information contained in the millions of glass slides produced every year, available for search. Ensuring storage and access to digital slides will overcome the current limitations to accessing and sharing pathology material together with the associated metadata. It will facilitate case consultation, help identify sub-types of diseases, assess the translatability of nonclinical safety observations and animal models, and thereby rationalise the design of clinical trials and the use of animal models.
Scope:The overall scope of the Call topic is to collect, host and sustain virtual slides along with associated data and to support the collaborative development of artificial intelligence in pathology.
The funded action will also address the regulatory, legal and ethical challenges associated with the collection, sharing and mining of the virtual slides.
Objective 1: Sustainable infrastructure
To deliver the infrastructure hosting several petabytes of digital slides and making the data accessible for research. It represents the hardware layer of the funded action and could take the form of a data centre, either centralised or decentralised. The key factors of success for this objective are the storage capacity and the possibility to exchange rapidly large amounts of data.
Objective 2: Data
To compile digital histopathology slides from nonclinical safety studies, as well as from clinical series needed to populate the initial version of the repository, and contribute to developing tools and artificial intelligence models. The key factor of success is the diversity of lesions, tissues, and species while providing sufficient sample sizes. In addition, the slides will be made publicly available for the development of artificial intelligence in pathology in line with the sustainability model described in objective 1.
Objective 3: Tools
To deliver a mechanism of an honest broker (see ‘Expected key deliverables’ and ’Suggested architecture of the full proposal’ sections) by developing a software ensuring the optimal and secure contribution of clinical and nonclinical material. Efforts will also be undertaken to propose a unified open digital slide format and tools to search, access, upload, register, download, view and homogeneously annotate information. In addition, AI models and tools, such as assistance to general diagnosis, screening for slides for lesions, and content-based image retrieval will be developed at a later stage of the funded action.
Objective 4: Regulatory framework
To advance the regulatory framework around the utilisation of digital pathology slides for nonclinical safety testing, evaluation of clinical trials and dissemination/discussion of difficult clinical cases. This will accelerate the adoption of roadmaps for the qualification of the usage of digital slides for peer-review or primary slide reading, as well for the development of artificial intelligence based tools for pre-screening and assisted diagnosis. This objective should be achieved by building on already existing and ongoing interactions and efforts between health and regulatory authorities, and professional societies.
Expected Impact:Applicants should describe how the outputs of the project would contribute to the following impacts and include baseline, targets and metrics to measure impact:
Catalyse research in digital pathology by providing a unique combination of animal and human histopathology. By offering the first complete coverage of tissues and elementary lesions, this repository will offer an unprecedented opportunity to build holistic models and allow generic mining of histopathology, irrespective of a particular tissue or indication.Enable the development of artificial intelligence tools for rare diseases and uncommon conditions, which currently are left out of the models because of the paucity of cases.Help identify sub-types in common diseases, possibly unveiling new clinico-pathological entities amenable to specific therapeutic interventions. It could also contribute to assessing the translatability of animal models for disease modelling, safety and efficacy studies, and thereby rationalise the design of clinical trials and the use of animal models. Ultimately, it should accelerate and improve patient treatment and management, thereby enhancing patient health along with the more efficient use of healthcare resources.Clear the way for the use of digital slides in nonclinical safety and clinical consultation, and facilitate the approval of AI-based tools for slide screening and assisted diagnosis.In the long term, the repository delivered by the consortium will be maintained through sustainability mechanisms defined by the consortium and will provide the community with an infrastructure to host additional digital slides (e.g. associated with the publication of case reports, cases series for disease stratification and clinical trials). Applicants should indicate how their proposal will impact the competitiveness and industrial leadership of Europe by, for example engaging suitable SMEs.
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Consortium characteristics
:
The aid is European, you can apply to this line any company that is part of the European Community.
characteristics of the 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
Characteristics of financing
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
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 evaluation, submission 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.
Signat... Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
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 evaluation, submission 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
1st Amended IMI2 Amended Annual Work Plan 2019
IMI2 Regulators Guidance tool for researchers
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Additional information about the call
other advantages
