CHIASMA Partners from the University of Basel have published a paper entitled ‘Developmental neurotoxicity as a case example for a six-step framework for the sustainable regulatory implementation of NAMs’. The paper outlines a framework that guides new approach methodologies (NAMs) form development to regulatory approval using the developmental neurotoxicity (DNT) in vitro battery (IVB) as an example.
This DNT IVB lifecycle exemplifies the implementation of NAMs, continuously evolving with scientific progress. It supports initiatives like the European Roadmap towards phasing out animal testing and the Safe and Sustainable by Design (SSbD) framework under the European Green Deal. By providing a structured pathway, this lifecycle approach fosters NAM-based, human-centric risk assessments for a more sustainable future in chemical safety testing.
The six-step framework consists of:
- Step 1: a broad fundament of available test systems
- Step 2: development of a NAM-based testing roadmap
- Step 3: Test method evaluation and readiness criteria
- Step 4: fit-for-purpose scientific validation
- Step 5: OECD recognition
- Step 6: NAM availability through contract research organizations (CROs)
The paper describes the lifecycle of NAMs from the cell model to a regulatory uptake, exemplified by the comprehensive work concerning the DNT IVB. DNT might serve as a role model to guide other NAM development, like NAMs for assessing developmental and reproductive toxicity [31], through the process, as each step of this lifecycle has to be navigated. Thereby the NAM portfolio is not thought to be static, but adapts to the evolution of science.
Follow this link to download the full paper (PDF).
