The Innovative Health Initiative (IHI) is a public-private partnership (PPP) between the European Union and the European life science industries, and these partners sit on our Governing Board. Its main objective is to translate healthcare research and innovation into tangible benefits for patients and society. It is also looking for Europe to become a reference in the fields of interdisciplinary, sustainable and patient-centered health research.

Any organisation established in the EU or a country associated to Horizon Europe is eligible to receive IHI funding. In practice, IHI funding primarily supports the participation in its projects of organisations like universities, research organisations, patient organisations, small and medium-sized enterprises (SMEs), and mid-sized companies. Depending on the type of call for proposals, larger companies may also be eligible to receive IHI funding. Details of who can receive funding is spelt out in the call texts.

Contributing to IHI: industry partners and contributing partners

Large companies that are members of the IHI industry partners contribute to the programme, primarily through 'in-kind' contributions (e.g. their researchers' time, laboratories, data, compounds). They can also make cash contributions. IHI contributing partners provide resources to IHI in the same way.

At least 45% of each project's budget has to come from industry partner / contributing partner contributions (in exceptional cases, a lower percentage may be allowed).

Explanation of this specific topic

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 cost effective development of ATMPs and other related innovative therapeutic modalities for rare diseases.

To fulfil this aim, the proposals should:

• Establish a network of scientific and technical centres of excellence (new and/or existing laboratories/institutions) complementing each other to enable translational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of genetically defined diseases. These scientific and technical centres are expected to provide access and advance translatable, quality controlled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs.
• Develop tools and methods and define key characteristics of ATMPs, and quality standards that are critical to later stages of development of ATMPs and other related innovative therapeutic modalities, in particular those targeting rare diseases with no approved treatment option.
• Develop and support the uptake of standardised analytical assays, methods and technological platforms, other non-clinical methods and design strategies as well as translation processes for:
  • reducing the timeframe and costs and improving the future development of ATMPs and other related innovative therapeutic modalities and/or
  • optimising manufacturing processes to maintain product quality while ensuring broad accessibility of critical manufacturing materials and demonstrating the economy of scale for ATMPs or other related innovative therapeutic modalities.
• Demonstrate the translatability, scalability, and robustness of technologies suitable for the development of subsequent ATMPs and other related innovative therapeutic modalities.
• Assess the methods and technological platforms developed for their translational and regulatory validity/utility.
• Validate the performance of the methods and technologies developed and demonstrate their higher performance in comparison to existing methods for addressing the bottlenecks in the development and manufacturing cycles of ATMPs and other related innovative therapeutic modalities. To achieve this, the submitted proposals must plan for an open expression of interest / call process to invite third parties, external to the initially established consortium, to submit use cases at least twice during the lifetime of the project. These use cases must:
• showcase the utility and validity of the methods and technologies developed and verify that they are fit for purpose in the context of the scientific, technological or regulatory challenges
• measure and help adjust the capability and performance of centres and networks of excellence in assisting industrial and academic developers of ATMPs in their translational research
• Contribute to strengthening the European rare disease ecosystem by engaging all relevant stakeholders, especially patients and patients' representatives for rare diseases, carers, clinicians, and regulators.
• Define relevant metrics and measure the use of centres of excellence by relevant stakeholders for the development of their assets or novel technological solutions/therapies.
• Define a plan for sustainability beyond the lifetime of the project, including consideration for potential expansion to additional promising technological areas.

Proposals should plan for synergies and collaborations to ensure complementarity while avoiding duplication

In case of interest, both as possible coordinator or partner,  please click on "m'interessa" and we will contact you.