Accelerating the implementation of New Approach Methodologies and other innovative non-animal approaches for the development, testing and production of health technologies
Scope: Animals and animal-derived materials are widely used in biomedical research and in the production and development of health technologies. This raises serious ethical concerns, and there is growing societal pressure to move towards alternative approaches and methods. Besides major ethical concerns, there is also scientific evidence that supports moving away from animal-based approaches and finding more human‑relevant methods and strategies for both the assessment of safety and efficacy of new health technologies and for manufacturing. Animal testing requires time-consuming protocols, high costs for animal supply, and the results are not always reproducible and applicable to humans. In addition, for the development and production of health technologies (e.g. in vitro diagnostics) as well as in biomedical research in general, materials of animal origin are required (e.g. biomolecules, sera). These animal-derived products require large amounts of animals for their production. Therefore, also in this context, there is a need to foster progress towards new alternatives (e.g. synthetic matrix, recombinant proteins, optimisation of production processes via artificial intelligence) to reduce the overall number of animals that are bred for these purposes.
NAMs and other innovative non-animal approaches have high potential to improve the development and/or production of health technologies, while contributing to the reduction and replacement of the use of animals. Recent improved biological knowledge, technological advances, computer simulations and innovative non‑animal approaches and methods (e.g. organoids, complex 3D cell models, microphysiological systems, in silico models, non-animal derived antibodies and other biomolecules provide the opportunity to move forward with safer and more effective tools for protecting human health and preventing/treating diseases that would in parallel entail an improvement of animal to human translation or better production processes, as well as helping progress towards the replacement of animals used in biomedical research in general.
While the potential for using non-animal approaches for the production, development and testing of new health technologies is enormous, more evidence and high-quality data for their performance evaluation in comparison with established animal-based approaches for a specific application (such as a production process, primary pharmacology, or next-generation-risk-assessment – NGRA) and for their validation are required by the industry and regulators to implement these alternative approaches in R&D and decision‑making processes. In addition, policy makers require a large body of up-to-date, high-quality knowledge to inform relevant health policies and ensure the long-term goal of full transition to non-animal approaches.
The current topic seeks to address these challenges by exploiting the latest relevant scientific advancements to develop NAMs and other non-animal approaches, which could be more readily available and more efficient than those involving animals, and which should improve either the development, including efficacy and safety assessment, of new health technologies for infectious/non-communicable diseases or the production processes of such technologies.
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.
Total budget: 115 M€
Per project: 10-12 M €
Open: 27 July 2023, Single Stage
Deadline:16 January 2024