Innovative non-animal human-based tools and strategies for biomedical research

The proposal(s) should develop and/or use tools and strategies that address critical areas of biomedical research where animal-models are currently used but are of limited translational value for investigation and development of prevention and treatment. Such advanced tools and strategies should aim at a better understanding of the pathogenesis of disorders that feature a high impact on public health and exhibit a high rate of animal use or severe animal suffering, and enable to develop biomedical concepts with increased translational value, thereby ultimately leading to improved disease prediction, prevention and treatment.

The proposals should address all of the following aspects:

• The innovative tools and strategies should include a variety of technologies and methodological approaches such as –omics and other high-throughput procedures, human-derived cell-based material, organoids, micro-physiological systems, and in-silico models.
• The newly proposed tools and strategies should demonstrably advance the state-of-the-art in specific areas of biomedical research.
• Prospects and avenues for dissemination, knowledge sharing, uptake or translation into health policies of the proposed tools and strategies within the EU should be provided.
• Aspects such as harm and cost-benefit assessment as well as ease of production with respect to current practices should also be considered.
• Criteria for model qualification and standardisation should be developed in well-justified use-case contexts to demonstrate their translational values.

Proposals could consider the involvement of the European Commission's Joint Research Centre (JRC) to provide added-value regarding such aspects as supporting validation of emerging approaches, promotion of research results, and the interfacing with the regulatory community. In this respect, the JRC is open to collaborate with any successful proposal after the selection process has been completed.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.