Chairs: Clive Roper & Natalie Burden
The barriers to uptake, use and regulatory acceptance of NAM data in safety assessment are well understood and include personal, cultural and societal barriers, technical and scientific barriers, varying approaches to benchmarking of NAM data, relevance, comfort with established methods, guidelines and law, validation processes, and economic. What are the solutions? How can NAMs become the testing paradigm of choice?
Though we have identified many of the hurdles to adoption (Sewell, 2024) and discussed some of these blockers from a legal perspective (Čavoški, 2025) there are now opportunities to break down these walls by identifying solutions and applying them in all aspects of scientific research.
There are uniquely different problems to overcome from industry and academia. For example, there can be perceptions of regulatory blockers, although it is not always the case that regulatory agencies across different geographies and disciplines hold these opinions. In academia, there are established careers and concerns about the acceptance of non-traditional approaches in scientific journals. In all areas, there is a habit and a fear of change from the tried and tested. There are organisations such as the UK NC3Rs (https://nc3rs.org.uk/) and the US 3Rs Collaborative (https://3rc.org) working internationally with a multisectoral approach, on initiatives in the NAMs and 3Rs spaces who are well positioned to support researchers in implementing solutions towards their quest for broad NAMs use and acceptance.
This session will identify some of the solutions to improve NAMs adoption. This will then be opened to a panel session to discuss the proposed solutions with the wider in vitro and computational toxicology community, giving ESTIV members the opportunity to identify further solutions to enable enactment of these paths forward.
Čavoški A et al. (2025). https://doi.org/10.1093/jel/eqae030.
Sewell F et al. (2024). doi: 10.1093/toxres/tfae044.
Speakers
- Gavin Maxwell – ACCELERATING REGULATORY USE OF NAMS & NGRA: COMMISSION ROADMAP TOWARDS PHASING OUT ANIMAL TESTING FOR CHEMICAL SAFETY ASSESSMENT
- Donna Macmillan – Turning science advancements into practice – Establishing a New ‘Gold Standard’
- Robert Lee – The place of law and technology transitions; a case study from chemical risk assessment
- Jay Dawick – A Chemical Industry Case Study Outlining Use and Adoption of NAMs and NGRA in an EU REACH Context