A comprehensive set of work practices implemented in the VHP4Safety project
-The Virtual Human Platform was developed in the VHP4Safety project. Here you can find more information about the VHP4Safety project.
-VHP4Safety is a Dutch national project focused on developing the Virtual Human Platform (VHP) to transform safety assessment of chemicals and pharmaceuticals. The project integrates human-relevant data, innovative in vitro models, and in silico tools to enable transparent risk assessment based on human biology. VHP4Safety combines these innovations into structures workflows that support expert decision making.
-Traditional safety testing relies on animal studies, which raise ethical concerns and often fail to predict human responses accurately. New Approach Methodologies (NAMs) and data science, including AI, offer new opportunities to perform human-relevant animal-free safety assessment.
-VHP4Safety is developed in co-creation with risk assessors, regulators, industry, and societal stakeholders, to ensure usability and regulatory relevance. The consortium aims to establish a reliable, transparent, and sustainable platform for safety assessment, setting a new standard for human-relevant risk assessment.
-The project is organised into three research lines:
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- The VHP4Safety project was funded by the Dutch Research Council (NWO) through the ‘Netherlands Research Agenda: Research on Routes by Consortia’ (NWA-ORC 1292.19.272). With a 9.9 million euro grant from NWO and additional contributions from foundations, government bodies, and private sector organizations, the project’s total funding amounted to 11.2 million euros.
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-Solving complex integration challenges and transforming ideas into practical solutions requires focused, hands-on teamwork. VHP4Safety used Hackathons to accelerate innovation and foster rapid progress across disciplines.
-Hackathons were organized in VHP4Safety several times a year. Hackathons were organized as short, intensive events where consortium partners worked side-by-side to address specific technical, scientific, or regulatory questions. In multidisciplinary teams, participants developed prototypes, integrated new data and tools, and tackled the VHP4Safety regulatory case studies. Preparation included prioritizing urgent topics that could only be addressed interdisciplinary, using the diversity of expertise within the VHP4Safety consortium.
-Hackathons delivered working prototypes, integrated platform components, and direct feedback from users. Unfinished tasks were tracked for future sprints, keeping momentum high. These events not only speeded up development of the Virtual Human Platform, but also strengthened collaboration and ensured that the platform continuously evolved to meet user needs.
-To develop a future-proof platform for safety assessment for chemicals and pharmaceuticals without the need for animal testing, VHP4Safety organized Designathons as a way of interdisciplinary co-creation. Bringing together expertise from academia, industry, regulatory bodies, and societal organizations ensures that the Virtual Human Platform (VHP) is robust, relevant, and widely supported.
-During the course of the project, VHP4Safety organized biannual Designathons. These were interactive, consortium-wide workshops where all partners collaborated intensively. During these sessions, participants co-designed the platform’s structure and workflows, aligned on shared goals, and discussed the needs and perspectives of different stakeholders. Special task forces were established to connect the projects research lines, work packages and disciplines, while creative exercises helped shape a common vision for the VHP.
-Designathons resulted in actionable workflow designs, a unified vision, and prioritized development steps for the platform. They promoted building the VHP4Safety community, thereby fostering open dialogue. Designathons helped to ensure that the Virtual Human Platform is a true product of its stakeholders. ready to meet the real-world needs of next-generation safety assessment.
-The interdisciplinary research in VHP4Safety demands flexibility and continuous adaptation. Traditional project management often lacks the agility needed to respond to fast-changing scientific insights and evolving stakeholder needs. To address these challenges, VHP4Safety adopted the Scrum approach, ensuring the project remains dynamic and user-focused.
-TInspired by the Scrum framework and agile working method, VHP4Safety worked in short, iterative cycles known as sprints. The team held weekly scrum meetings to coordinate efforts, set priorities, and quickly resolve obstacles. Every three weeks, sprint reviews enabled the team to evaluate progress and gather feedback, making it possible to adjust plans when necessary. Clearly defined roles, such as Product Owner and Scrum Master, provided the VHP4Safety agile working method with structure and clarity. The collaborative hackathons and designathons that were organised in VHP4Safety were integrated into the Scrum workflow, promoting co-creation, interdisciplinary alignment, and responsiveness to new developments.
-The Scrum approach has significantly improved transparency, teamwork, and stakeholder engagement within VHP4Safety. It allowed for rapid integration of technological innovations and ensured that user feedback could be incorporated throughout the project. Team members experienced greater ownership and satisfaction, while the platform evolved iteratively to meet real needs of its end-users.
-Constructive technology assessment is a way of researching into the design, desirability, costs and impacts of technologies. People interested, affected and influenced by a technology are put at the centre of definition, development and implementation and their active involvement is required from the start.
-The virtual human platform has been developed with the contribution of multiple stakeholders from academia, industry and regulation. Through designathons and hackathons the perspectives of these stakeholders have been actively involved. Some of these stakeholders have also been addressed as potential users of the platform.
-A matrix with 9 potential user profiles that could be served by the platform has been defined by focusing on expert users. In addition, expected transformations of the field through the implementation of the platform are proposed. Industry, regulators, and academia each have different needs from a shared platform. Meeting those needs collectively may enable a field-wide shift away from traditional animal testing toward New Approach Methodologies.
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-Strategies for future use of the Virtual Human Platform focusing on innovation, acceptance, and impact creation
-In the VHP we identified five key routes to impact through which research and development projects on New Approach Methodologies (NAMs) pursue societal impact. Each route reflects a set of impact activities that target specific audiences.
-The most prominent route is changing policy and regulation, targeting risk assessors, policymakers, and regulators. Community and capacity building focus on training and education to support wider adoption and use of NAMs. Advancing scientific development aims to strengthen the NAM ecosystem through coordination, infrastructure, and harmonization. In addition, projects engage in commercialization and industrial partnerships to bring innovations into industrial practice. Mobilizing civil society, though least common, seeks to involve the general public and civil society organizations.
-Typically, projects organize11–15 activities across multiple routes to impact. To maximize impact, however, projects should dedicate their efforts to specific routes, as time and capacities are often limited in projects. Moreover, projects should be encouraged to move beyond one-way dissemination toward two-way engagement, fostering active exchange with stakeholders—an area where many initiatives still have room to grow.
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-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.
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- 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:
-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.
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-Training and education to master the Virtual Human Platform and the principles of NAMs in human-based safety assessment
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