HORIZON EUROPE
Europeo
Specific Challenge:Tuberculosis (TB) is the leading infectious cause of death worldwide.1 To achieve the target of TB elimination by 2035, the WHO estimates that there is a funding shortfall of over USD1 billion per year in TB research. The treatment of drug-sensitive TB is an onerous regimen of four drugs for two months followed by two drugs for four months (six-months total), and multidrug-resistant TB may require treatment for up to two years. Many patients find adherence difficult, and the current drugs are associated with significant tolerability issues. Shorter and safer treatment regimens are urgently needed. Tuberculosis has a low or negative expected return on investment and therefore fails to attract funding: this call addresses this high unmet medical and public health need.
Currently, TB drug development involves 14-day monotherapy trials for early bactericidal activity (EBA) to identify the maximally efficacious dose for a new chemical entity (NCE). The standard trial design contains no option to change doses or de-escalate in-stream in response to emerging Pharmacokinetic-pharmacodynamic (PKPD) or safety data, resulting in a flat dose-respose.2 In Phase 2...
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Specific Challenge:Tuberculosis (TB) is the leading infectious cause of death worldwide.1 To achieve the target of TB elimination by 2035, the WHO estimates that there is a funding shortfall of over USD1 billion per year in TB research. The treatment of drug-sensitive TB is an onerous regimen of four drugs for two months followed by two drugs for four months (six-months total), and multidrug-resistant TB may require treatment for up to two years. Many patients find adherence difficult, and the current drugs are associated with significant tolerability issues. Shorter and safer treatment regimens are urgently needed. Tuberculosis has a low or negative expected return on investment and therefore fails to attract funding: this call addresses this high unmet medical and public health need.
Currently, TB drug development involves 14-day monotherapy trials for early bactericidal activity (EBA) to identify the maximally efficacious dose for a new chemical entity (NCE). The standard trial design contains no option to change doses or de-escalate in-stream in response to emerging Pharmacokinetic-pharmacodynamic (PKPD) or safety data, resulting in a flat dose-respose.2 In Phase 2B, the efficacy of treatment combinations is then studied in eight weeks of dosing, with time-to-sputum-culture-conversion as the primary endpoint. This paradigm has multiple weaknesses: inadequate exploration of dose response; lack of innovative study designs to empirically determine optimal duration of therapy as well as inability to study multiple regimens in parallel. Moreover, there is a lack of Phase 2 biomarkers that adequately predict phase 3 outcome (relapse-free cure).3,4,5
Therefore, there is a critical need for innovative trial designs in TB. Efficient adaptive trial designs would accelerate clinical development in Phase 2, but cannot be implemented currently due to the lack of in-stream biomarkers for sterilising cure/relapse. Several RNA expression, cytokine, bacterial and radiological biomarkers have been proposed in the literature, but to date there has been neither comparison nor prospective validation of these biomarkers. A biomarker that predicts relapse at an individual level may further create opportunities for individualised medicine, or even permit creation/validation of trial simulations. These trial simulations could help optimise trial design, and facilitate in-stream decision-making in adaptive trials.
Scope:The objectives of this Call Topic are to develop and implement innovative, state of the art adaptive clinical trial designs for the field of TB regimen development able to define the therapeutic dose for existing experimental New Chemical Entities (NCE’s) within treatment combinations. The funded action will define the duration and composition of novel treatment combinations that will shorten or simplify the standard of care, as well as prospectively validating biomarkers against the relapse endpoint. In addition, the funded action is expected to develop clinical trial simulations, evaluate new technologies to monitor and enhance treatment adherence, and develop an understanding of population pharmacogenomics.
The funded action will develop innovative trial designs able to define optimal treatment duration against endpoints that better predict the current Phase 3 endpoint of relapse and will improve efficiency by comparing multiple regimens in parallel within the same study. Early interims will stop failing/futile arms, resulting in even greater efficiencies.
The funded action should also prospectively validate biomarkers against a relapse endpoint. The primary objectives of the biomarker work is to validate i) biomarkers able to accurately prioritise regimens for evaluation in phase 3, ii) biomarkers that are able to predict sterilizing cure/relapse at the individual patient level, and iii); a third, more ambitious objective, is to identify biomarkers that permit the building of a clinical trial simulation platform.
Expected Impact:The objectives, deliverables and impact of the resulting action are well aligned with the mission and goals of IMI2 JU to deliver increased success rate of biomarkers and priority medicines in innovative clinical trials. The expected impact of the funded action will also help attain 2030 UN Strategic Development Goals and 2035 End TB Targets by:
Providing new tools and understanding on how to progress TB science for the discovery and development of new clinical candidates and combinations thereof across the TB R&D landscape with special emphasis on innovative clinical trial design and development of novel biomarkerscontributing to the EU’s ambition of being a ‘best practice region’ for addressing AMR, and profit from its medical capacity to individualize and implement into medical practice combination therapies addressing MDR/XDR developing new knowledge and tools, innovative clinical trial designs, imaging technology, biomarkers and pharmacogenomics diagnostics and exploiting artificial intelligence for the development of new clinical candidates and combinations.enabling the progression of potential new safe, efficacious, shorter and affordable treatment solutions for TB patients worldwide, with the intent to improve the quality of life and life expectancy of TB patients;contributing to the development of a vibrant TB research environment in the EU, fostering private-public collaboration across EFPIA, Academia, NGO’s and SME’s and strengthening the competitiveness and industrial leadership of Europe providing a legal frame and agreement on IP terms and exploitation, as paradigm of public and private international collaboration in the development of combination regimes.Implementing agreement with other consortia facilitating prompt data sharing and data exploitation to accelerate TB drug regimen development.
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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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