Tox News: Issue 19, December 2025

The UK Government has published a strategy to support the development, validation and uptake of alternative methods.  

The NC3Rs will play a prominent role in its delivery, and our Chief Executive Vicky Robinson welcomed its publication: “The new government strategy will help to speed up efforts to replace animal research and testing, while also recognising the continued need for high standards of animal welfare where alternative methods currently do not exist. The strategy is ambitious and will ensure that the UK maintains its world leading position. The NC3Rs is at the heart of delivering the strategy and I am excited about the opportunities to turn the ambitions into reality.” 

The Organisation for Economic Co-operation and Development (OECD) has committed to develop new guidance on measuring the biomarker vitellogenin (VTG) in fish in endocrine disruption studies. This will provide clear best practices for laboratory measurements and statistical analysis to make results more reliable, reduce repeated or additional testing and to harmonise approaches in laboratories around the world. Development of the new guidance is a result of several years of NC3Rs-led and collaborative work to understand and solve challenges in VTG measurement which impact on fish use, with input from contract research organisations, companies and regulators who conduct, submit and assess the tests.

Co-sponsored by the NC3Rs, Health and Environmental Sciences Institute (HESI), the US Environmental Protection Agency (EPA) and the International Collaboration on Cosmetics Safety (ICCS), this inaugural summit brought together academic, government and industry experts to discuss how to accelerate the use of NAMs in environmental safety assessment.

Natalie and Amy Marriott co-organised the three-day meeting, held 7 – 9 October in Reykjavik, Iceland. The meeting focused on the application and implementation of alternative methods to reduce and replace acute fish testing and to advance science for evaluating endocrine activity potential in fish and amphibians.

A joint report from the NC3Rs, the Association of the British Pharmaceutical Industry (ABPI) and the Medicines and Healthcare products Regulatory Agency (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 report describes insights from a cross-sector workshop with 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.

Jointly hosted by the NC3Rs NAMs Network and the British Toxicology Society (BTS) Mechanistic & Discovery Toxicology Specialty Section, this webinar explored how Artificial Intelligence (AI) and approaches such as machine learning can be used to improve toxicity prediction, support regulatory science and reduce the reliance on animal use. Speakers included experts from the Broad Institute (Harvard/MIT), Health and Environmental Sciences Institute (HESI) and DesignPlus Chemoinformatics. 

We are seeking speakers for our upcoming Technology Partn3Ring webinar, focused on NAMs for safety assessment. This is an opportunity to showcase your NAMs technology to the wider scientific community and identify new partners for further development, qualification and use. The webinar will provide a space for researchers, industry scientists and other stakeholders to connect and collaborate to accelerate NAMs development.

Thursday 29 January 2026, 12.30 – 13.30 (GMT)
The next session in our welfare webinar series on evidence-based refinements for laboratory animals will cover practical guidance for habituating dogs, minipigs and non-human primates to cooperate with procedures and minimise stress during inhalation studies, blood sampling and ophthalmological exams.

Wednesday 14 January 2026, 9.00 – 16.30 (GMT) 
The British Toxicology Society (BTS) and British Pharmacology Society (BPS) are hosting a one-day online meeting to explore how AI is transforming drug development, with a focus on both efficacy and safety. Key topics include AI applications in drug discovery, drug development, clinical and regulatory assessment.

Wednesday 29 April 2026, 13.30 – 18.00
This collaborative workshop will bring together experts from academia, government and industry to explore how modern exposure science and innovative assessment frameworks can help shape a more protective and forward-looking UK regulatory system for environmental safety assessment. Following presentations from three expert speakers, group breakout discussions will focus on key challenges and opportunities. Delegates have the opportunity to present posters on relevant work.

Express your interest in attending by Friday 30 January.

A new publication summarising the discussions and outcomes of our EUROTOX 2024 workshop on dose setting for developmental and reproductive toxicity (DART) studies is now available. The workshop was co-organised by the NC3Rs, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Charles River Laboratories and European Chemicals Agency (ECHA), bringing together global stakeholders from across sectors to share perspectives on this important topic.

We have co-authored a publication with the Health and Environmental Sciences Institute (HESI) DART Committee in Regulatory Toxicology and Pharmacology. The paper describes a weight-of-evidence framework to guide decisions on when the inclusion of non-human primates in DART studies may be warranted.

Elisa Passini has co-authored a paper in Nature Reviews Drug Discovery that explores the latest developments in quantitative systems toxicology, including key outcomes from the TransQST project she participated in during her previous position at the University of Oxford. The paper highlights the use of these models for assessing drug effects on cardiovascular, gastrointestinal, hepatic and renal functions, and provides recommendations for applying these alternative models in drug development.

French Society of Toxicology Annual Conference 2025

11 – 12 December
Paris, France
Fiona Sewell presented ‘Considerations for dose level selection for developmental and reproductive toxicity studies: 3Rs and scientific perspectives’ in a session on DART regulations. The conference theme was ‘From mother to child: Identifying and understanding reprotoxic risks’.

46th American College of Toxicology (ACT) Annual Meeting

16 – 19 November 
Phoenix, Arizona, USA
We showcased our latest work relevant to drug development including:

• A talk on ‘Accelerating the Development and Impact of New Approach Methodologies (NAMs) in Pharmaceutical Development’ in the session ‘Navigating the Frontier of Science and Regulation: Exploring the Latest Breakthroughs in New Approach Methodologies’.
• Posters on our project to review the use of two species in regulatory toxicology studies and our work on applying the 3Rs to urinalysis assessments.

17th International Congress of Toxicology (ICT)

15 – 18 October 
Beijing, China
We chaired and presented in sessions exploring 3Rs opportunities in various aspects of safety assessment:

• ‘In silico approaches to modernising safety assessment’ showcased how computational tools are being used to inform regulatory decision-making and reduce reliance on animal testing.
• ‘Refining and replacing acute toxicity tests’, where we presented an overview of our acute toxicity testing programme to remove global requirements for mammalian acute toxicity testing and refine the procedures involved.

Safety Pharmacology Society (SPS) 2025 Annual Meeting

13 – 15 October 
Utrecht, Netherlands 
Elisa presented in the Respiratory Safety Pharmacology session on ‘Current and Future Opportunities for Applying the 3Rs in Safety Pharmacology’. The talk highlighted innovative in vitro and in silico approaches aimed at replacing animal testing in this area, as well as opportunities to reduce animal use and refine procedures to minimise pain and distress where animals are still required. 

EUROTOX 2025 

14 – 17 September 
Athens, Greece 
Elisa showcased our latest work on the use of two species and urinalysis. Fiona chaired the session on ‘Dose level selection for DART studies under REACH’ and presented an overview of our work in this area. Fiona was also interviewed by ECETOC to discuss her involvement with their Task Force on dose selection, how the initiative began and key achievements to date

Other events

We have been sharing perspectives on implementation of NAMs at the ChemAcademy Endocrine Disruptors conference, International Fragrance Association UK Members’ Information Day, and the Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies event: ‘AI applications in preclinical assessment of Advanced Medicine Therapy Products’. Find out more on our work to facilitate the development and uptake of NAMs.

We also presented an overview of the NC3Rs Toxicology Programme at the Labcorp ‘NAMs/3Rs and the considerations’ symposium in Copenhagen and contributed to discussions at the European Food Safety Authority (EFSA) workshop on waiving dog studies. 

Get involved/Share your news

If you have anything you would like to highlight in the next issue of Tox News, please email Amy at Amy.Marriott@NC3Rs.org.uk.