IHI Call 13 - Lettre d'intention

Organisme : Innovative Health Initiative
Programme : IHI Call 13
Financement : 9 à 35 M€
Durée : 36-48 mois

Description 

Topic 1: A network to boost the next wave of European innovations in healthcare

The action under this topic is expected to achieve the following impacts and contribute to the following EU policies/initiatives:

• deliver innovative, early technology solutions that contribute to addressing strategic unmet public health needs across multiple therapy areas to improve prevention, early diagnosis, and treatment;
• leverage the unique network and scale of IHI JU members to create a pipeline to support innovative startups in the health industry, fully integrated into European initiatives in support of start-ups and entrepreneurship;
• drive early cross-sector health R&D and innovation to strengthen the European healthcare industry’s global competitiveness, contributing to the EU Industrial Strategy and Pharmaceutical Strategy objectives;
• create a sustainable network of European healthcare incubators to guide and support highly talented and innovative early-stage companies;
• harness digital health and data-sharing technologies (e.g., AI and big data) to enable interoperable health solutions, contributing to the European Health Data Space (EHDS) and improved evidence based care;-
• the action should generate a portfolio of early‑stage companies that have undergone rigorous multi‑industry validation, significantly increasing their credibility with investors, regulators, and healthcare systems. This ‘industry quality seal’ should enhance the selected startups’ ability to secure follow‑on financing;  
• by integrating corporate expertise into a pan‑European incubator network, the action should reduce fragmentation, support faster clinical and eventually commercial decision‑making, and enable more innovators to navigate regulatory and reimbursement pathways successfully. This should contribute to the objectives of the EU to accelerate the translation of research into deployable health technologies. The Network should serve as a feeder mechanism into wider EU support structures, ensuring that promising companies can transition smoothly into later‑stage funding and scale‑up opportunities. This complementarity should maximise the added value of EU public funding while avoiding duplication and reinforcing Europe’s position as a globally competitive hub for health innovation.

Topic 2: An AI foundation toxicology model and framework to support waiving a second species in drug safety studies

Expected Impact:

The action under this topic is expected to achieve the following impacts:

• Faster and more informed decision-making through the use of an AI-driven NAM (AI Foundation Toxicology Model) and increased efficiency through rapid processing of vast amounts of data [1].
• Increased consistency and standardisation in a NAM-based approach, specifically an AI model, used by industry in the efficient development, testing and production of safe and effective innovative health technologies, improving industrial competitiveness.
• Regulatory adoption of a NAM-enabled second species waiver model (AI Foundation Toxicology Model) and weight-of-evidence framework, in line with recommendations and more consistent global decision-making on waiving second species testing.
• Reduction in animal use, accelerated timelines and lower costs, enhancing the competitiveness of the European health industry through economical and ethical benefits.
• Improved public health as patients will benefit from safe and effective medicines developed faster using validated NAMs.

Topic 3: Decode the immuno-science of age-related immune-mediated diseases

The action under this topic is expected to achieve the following impacts:

• Accelerate EU access to more cost-effective interventions in an increasingly ageing population by identifying personalised treatment approaches for elderly-onset immune diseases.
• Decrease disease risk later in life by defining specific prevention strategies based on ageing biomarkers and risk factors.
• Halt age-associated disease exacerbation by the identification of predictive and digital biomarkers that can stratify patients for early intervention.
• Improve quality of life for healthy individuals and patients by preventing further health decline, avoiding escalating care costs, and properly stratifying individuals earlier in the diagnostic pathway.
• Accelerate adoption of innovative diagnostic, preventative, and therapeutic strategies, strengthening the EU’s position as a healthcare innovator.
• Evaluate digital biomarker as potential regulatory endpoints in the ultimate goal to develop medicines for ‘healthy ageing’.
• Integrate fragmented research efforts by bringing together health industry sectors and stakeholders to develop clinical and multi-omics data integration capabilities.
• Enable new data-driven research by building AI infrastructure on existing data and cohorts that no single organisation could develop independently

Patients and citizens will benefit from improved medical practice and healthcare solutions, new targeted prevention strategies and ultimately healthier ageing.

(contenu tiré du site IHI)

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