Impact

Moving towards human-relevant safety testing of chemicals and pharmaceuticals without the use of animals requires much more than scientific and technological innovation alone. Within the VHP4Safety project, an innovation system approach was developed in collaboration between innovation scholars and toxicologists to identify all the key processes needed to achieve this transition. The framework combines an established implementation curve for New Approach Methodologies (NAMs) with insights from innovation system theory. It can be used to assess for a specific NAM modality, sector or application context where efforts are currently concentrated, where gaps exist and where coordinated action is needed to accelerate the transition to animal-free and human relevant safety assessment.

The result is the framework visualised in the figure below. The framework maps seven interconnected key processes that together shape progress towards human-relevant and animal-free safety assessment. Three of these processes being knowledge development, knowledge diffusion, and market formation align with the phases of the established implementation curve for NAMs. Four additional processes that the implementation curve does not capture are also included: resource mobilisation (funding, talent, and infrastructure), entrepreneurial experimentation (private and public actors pioneering new approaches and business models), legitimacy creation (building trust and shifting belief systems among stakeholders and the wider public), and providing directionality (formulating missions, policy goals, and regulatory requirements that guide collective action). Crucially, the framework presents these processes not as a linear sequence but as an interconnected web, in which positive feedback loops between processes can accelerate the transition, while bottlenecks in one area can hamper progress across other processes.

The framework is designed to be used in workshop settings, bringing together a wide range of stakeholders to discuss both the structure and the functioning of the innovation system. To facilitate this, a masterclass was developed consisting of four interactive activities:

1. Mission specification and problem-solution diagnosis: to specify a mission in relation to human relevant safety assessment and to discuss which problem(s) the mission aims to solve and which (technical) solutions are proposed. This defines the scope for framework application in step 2-4.
2. Innovation system structure: to identify relevant actors, networks, and institutions (hard laws and regulations and softer norms) and to discuss the influence and interests of stakeholders in the identified mission.
3. Innovation system functioning: to assess the functioning of the innovation system based on the seven key processes, scored on a scale from 1 (function performs poorly and is hindering) to 5 (function performs well and is driving).
4. Towards action: to discuss activities that can contribute to strengthening the functioning of the innovation system and specifically how stakeholders participating in the workshop can contribute to realising progress towards human-relevant and animal-free safety assessment.

The framework has been applied to several cases in the VHP4Safety project including the three case-studies in the project. During one of the designathons, project participants and stakeholders also worked on their own cases ranging from very general missions (transition to human relevant chemical risk assesment) to very specific ones (e.g., serum-free medial compositions). Outside the VHP4Safety project, the framework has also been applied in the AFARA project which focuses on the identification of endocrine disrupting chemicals in regulatory contexts. The masterclass was also presented to the European Commission team developing the EU roadmap towards the phasing out of animal testing in chemical safety assessment.

To be added later.