GSS EU Science Funding Gateway

The projects funded under this topic should aim to do the following:

• Develop new NAM/s or other non-animal approach/es (or a combination of those) or use existing ones in an innovative way to improve (early-stage) assessment of new health technologies (and animal to human translation where relevant), or to improve the production processes of health technologies (such as bio/pharmaceuticals, vaccines, medical devices including in vitro diagnostics, and radio-chemicals).
• Specify the context of use (e.g. primary pharmacology, toxicology, safety, quality control, production processes) of the novel approach/es, how it/they can be integrated efficiently in the relevant workflows and propose and implement a plan to carry out their performance evaluation and validation, as well as demonstrate their added value in comparison to relevant established animal-based approaches.
• Make a comparative evaluation of the different approaches to replace, reduce and refine animal use, including the identification and assessment of parameters that influence their usefulness such as their reliability, reproducibility, robustness and fitness for purpose.
• Generate evidence on the robustness, reliability, and applicability of these novel approaches in an industrial research and development (R&D) context and to support regulatory decision making in testing, development or production of health technologies, as relevant. Accordingly, applicants should develop a strategy/plan for generating appropriate evidence to support regulatory acceptance and engage with regulators in a timely manner (e.g. through the European Medicines Agency [EMA] Innovation Task Force or qualification advice).
• Gather and produce high quality datasets to generate a solid knowledge base for supporting the use of NAMs and other non-animal approaches in the field of health technology and drive 3Rs implementation. To ensure the sustainability of the results and foster future development and validation of innovative non‑animal approaches, applicants should develop a fit-for-purpose scalable digital data repository. Applicants should consider and leverage as much as possible existing infrastructures.
• Establish a collaboration platform between all relevant stakeholders from public and private sides, including regulatory agencies and policy makers, to exchange information, prepare white papers and guidelines to foster uptake or translation into health policies, supporting an adequately reflected transition to full implementation of non-animal approaches in health technology development and manufacturing. Patients and/or patient organisations may be included and actively contribute to such activities by providing, for example, their insight on the use of human-derived samples, as relevant.
• Accelerate the broad implementation of the NAMs and other non-animal approaches in research through a strong communication and dissemination plan, fostering also exchanges and cross fertilisation with other projects funded in this area.