New approach methodologies (NAMs) in toxicology

New approach methodologies (NAMs) – replacement (full and partial) technologies for use in assessing chemical or drug toxicity – hold great promise in providing useful information for chemical hazard and risk assessment. We are leading projects to increase confidence in the use and application of NAMs for regulatory decision making. This will ultimately reduce the current reliance on animal toxicity tests and improve the science and predictivity of safety testing.

The VQN is a collaborative public-private partnership initiative that brings together regulators, industry, CROs and scientific organisations, including the NC3Rs, to accelerate the deployment and regulatory implementation of NAMs. Dr Natalie Burden (Head of NAMs Strategy) sits on the steering committee. Established by the US Foundation for the National Institutes of Health (FNIH) in collaboration with the National Institutes of Health (NIH), the VQN supports the NIH Complement Animal Research In Experimentation (Complement-ARIE) programme that is working to catalyse development, standardisation, validation and use of NAMs.

The VQN are inviting the scientific community to submit NAMs proposals that will form the basis of collaborative, precompetitive pilot projects. Proposals should clearly demonstrate how they support the 3Rs and contribute to the development of robust, validated alternatives to animal use.

Our report in collaboration with the ABPI and MHRA, explores how NAMs can transform the way new medicines are developed – harnessing cutting edge human relevant technologies and reducing reliance on animal testing.

The joint report describes insights from a cross-sector workshop convened by the NC3Rs, ABPI and MHRA, bringing together experts from regulatory agencies, industry and academia. Discussions focused on where NAMs are currently being used in medicines development, the scientific and regulatory challenges to broader adoption, and practical steps to accelerate progress.

There are clear opportunities to harness the strength of the UK science and technology sectors to place it as a world leader with innovative chemicals regulation grounded in the latest technologies. Working with the British Toxicology Society we have identified actions to optimise opportunities presented from exiting the EU to develop a world-leading regulatory framework that firmly embeds the 3Rs in chemical safety testing.

This work follows on from a workshop we held with Unilever, which brought together over 50 scientists across government departments, large and small industry and academia. The workshop was the first step in building a consensus vision across the UK science base on the future direction of domestic chemicals regulation.

Using cell-based and computational approaches to investigate how pharmaceuticals and environmental chemicals interact with biological systems, to help predict whether they are harmful to humans and/or the environment. 

• Publication: Development of an adverse outcome pathway (AOP) for cardiotoxicity mediated by the blockade of L-type calcium channels.
• Publication: The future trajectory of adverse outcome pathways: a commentary.
• Publication:  Adverse Outcome Pathways can drive non-animal approaches for safety assessment.
• Poster presented at the NC3Rs Toxicology Showcase, September 2016: Application of the AOP approach for cardiotoxicity (PDF, 1.5MB).
• 2016 Workshop report: Pathways-based approached across the biosciences - toward application in practice (PDF, 782KB).

You can also read more about our project around applying pathways-based approaches across the biosciences on our project page.

Increasing the use of cell biotransformation assays in regulatory safety assessment to reduce the numbers of in vivo carcinogenicity screens carried out.

You can read more about this project on our project page: In vitro approaches for carcinogenicity testing.

Exploring the use of in vitro approaches in the safety assessment of nanomaterials.

You can read more about this project on our project page: Opportunities to apply the 3Rs in the safety assessment of nanomaterials.