Programa de Trabajo IHI

CONVOCATORIAS DEL PROGRAMA INICIATIVA DE SALUD INNOVADORA (INNOVATIVE HEALTH INITIATIVE, IHI)

The Innovative Health Initiative (IHI) es una asociación público-privada (APP) entre la Unión Europea y las industrias europeas de ciencias de la vida. La misión del programa es traducir la investigación e innovación sanitarias en beneficios tangibles para los pacientes y la sociedad. Esto se buscará a través de:

  • Convertir la investigación y la innovación sanitarias en beneficios reales para los pacientes y la sociedad
  • Ofrecer innovaciones sanitarias seguras y eficaces que abarquen todo el espectro asistencial, desde la prevención hasta el  diagnóstico y el tratamiento, sobre todo en áreas donde hay una necesidad no cubierta en la salud pública.
  • Hacer que las industrias sanitarias europeas sean competitivas a nivel mundial

A continuación se detallan las temáticas/topics que se financiarán en las convocatorias 2023:

 IHI-INNOVATIVE HEALTH INITIATIVE CALL 3 2023

3.1 IHI-2023-03-01: Screening platform and biomarkers for prediction and prevention of diseases of unmet public health need

As the population of the EU ages, the rising burden of disease is an important challenge to the sustainability and resilience of healthcare systems. The identification of individuals at risk of developing an illness so that they can receive an appropriate treatment before the disease develops is an important factor to address this problem. However, for many health conditions, we lack full understanding of the underlying mechanisms, including the predisposition to disease and how environmental and genetic factors affect the occurrence of the disease.

Projects funded under this topic should address this challenge by developing an open platform for screening individuals who are not yet diagnosed with a disease with the aim of identifying people at risk.

  • Estimated budget: EUR 30 000 000.

Enlace al draft

3.2 IHI-2023-03-02: Patient-generated evidence to improve outcomes, support decision making, and accelerate innovation

The amount of health data generated by citizens themselves is rapidly increasing. Such data includes patient-reported outcome measures (PROMs), patient preference information (PPI), and patient-reported experience measures (PREMs), as well as other digital health data/digital biomarkers. While the potential for these data to be harnessed to improve individual healthcare is enormous, these data are often fragmented among multiple providers, so that neither the citizen, nor the healthcare ecosystem have a comprehensive overview.

 The challenge is using these data to provide reliable evidence for decision makers, and to improve health outcomes.

  • Estimated budget: EUR 24 000 000.

Enlace al draft

3.3 IHI-2023-03-03: Combining hospital interventional approaches to improve patiente outcomes and increase hospital efficiency

Patients admitted to hospital to undergo elective or non-elective procedures typically require recovery and rehabilitation to get back to normal life. New treatment approaches such as minimally invasive surgical approaches, locoregional interventions, novel imaging and diagnostic techniques, clinical decision support systems, and robotics have the potential to reduce complications, facilitate faster recovery, and help increase hospital efficiencies. However, due to limitations in interoperability, reliable evidence and suitable guidelines, these innovative approaches, treatment options and clinical decision support systems are not being optimally combined to provide the best patient care.

Projects funded under this topic should address this challenge by showcasing how existing hospital interventions, treatment approaches and technologies can be optimally combined to improve patient outcomes, enhance patient pathways, generate efficiency gains, reduce hospital staffing challenges, help to lower costs, and decrease societal burden.

  • Estimated budget: EUR 30 000 000.

Enlace al draft

3.4 IHI-2023-03-04: Strengthening the European translational research ecosystem for advanced therapy medicinal products (ATMPs) for rare diseases

There are over 7 000 rare diseases resulting in 30 million patients1 in Europe with a rare disease. Globally more than 300 million patients2 are affected. In Europe, less than 10 % of rare disease patients receive treatment and only 1 % are managed using an approved treatment. ATMPs such as gene and cell therapies and other related innovative therapeutic modalities, are very promising to treat patients with rare diseases, especially ultra-rare diseases. However, ATMPs rely on complex technologies where the development process is hampered by a lack of standardisation, scalability and reproducibility.

The overall aim of this topic is to optimise and streamline the future development of ATMPs and other related innovative therapeutic modalities for rare diseases by strengthening the ecosystem that facilitates the transition of early pre-clinical proof-of-concept research to clinical development. This topic focuses on the scientific, technological and regulatory barriers that are limiting translational research into rapid and costeffective development of ATMPs and other related innovative therapeutic modalities for rare diseases.

  • Estimated budget: EUR 30 000 000.

Enlace al draft

3.5 IHI-2023-03-05: Digital health technologies for the prevention and personalised management of mental disorders and their long-term health consequences

Mental health disorders represent an area of severe unmet public health need. This has been further negatively impacted by the COVID-19 pandemic, with a substantial increase in the number and severity of people affected for example by anxiety and depression1, which places substantial pressures on already strained mental health care systems. People with mental disorders have a reduced life expectancy compared to the general population, and this is linked to a greater risk of developing a range of chronic physical conditions2. The long-standing separation of psychiatry from other branches of medicine and the
lack of specific training on this issue further contribute to the poor attention dedicated to management of comorbidities of mental health disorders.

The scope of this topic is to investigate how digital health technologies might positively impact the healthcare pathway for people with mental disorders.

  • Estimated budget: EUR 24 000 000.

Enlace al draft

IHI-INNOVATIVE HEALTH INITIATIVE CALL 4 2023

4.1 IHI-2023-04-01: Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical safety assessment

The overall objective of this topic is to characterise the minipig for use in R&D of new therapeutics and innovative medical technologies. The knowledge generated in this proposal may facilitate innovative health solutions and improve disease understanding and human predictions. The goal is to advance biomedical R&D by generating background scientific data to evaluate if the minipigs could be a viable and feasible alternative to NHPs in key therapeutic areas, with a special focus on translatability from minipigs to humans.

  • Estimated budget: EUR 17 952 000.

Enlace al draft

4.2 IHI-2023-04-02: Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare

The overall aim of the project generated from this topic is to create and validate the infrastructure and logistics for blood collection by the patient and/or caregiver at home as a healthcare tool and an alternative to the current gold standard venous blood for routine clinical assays. This project will employ only commercially available CE-marked microsampling devices, according to their intended use. The development of new devices for blood sampling or of new clinical assays / analytes is not the focus of this project, and no new clinical assays will be evaluated. Similarly, given their current maturity, home sample analysis is out of scope.

  • Estimated budget: EUR 8 205 556.

Enlace al Draft

Requisitos específicos de la convocatoria:

– Puede participar cualquier entidad jurídica perteneciente a un país miembro o asociados de la UE.

– Será necesaria la formación de consorcios transnacionales constituido por, al menos, una entidad legalmente establecida en un estado miembro de la UE y dos entidades de países miembros o asociados.

– La modalidad de presentación y evaluación es en una fase en las convocatorias del Call 3, mientras las del Call 4 son en dos fases.

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