Tox News: Issue 7, March 2020

 

The NC3Rs team are currently working remotely, but we are continuing our usual activities as far as possible – please get in touch at enquiries@nc3rs.org.uk if you have any queries.

 
 

 
 

Congratulations Helen and Fiona

Our Toxicology Team Programme Managers Dr Helen Prior and Dr Fiona Sewell have been accepted onto the UK and European Register of Toxicologists.

 
 

 
 

Opportunities for use of a single species in drug development

The results of our latest data-sharing collaboration with the pharmaceutical industry have now been published in Regulatory Toxicology and Pharmacology. The paper highlights opportunities to use one rather than two species for long-term toxicity studies, reducing animal use as well as potentially accelerating the drug development process.

 

 
 

 
 

Endocrine disruption workshop

In collaboration with HESI, we held a workshop in London on 25 February on ‘Investigating endocrine disrupting properties in fish and amphibians: Opportunities to apply the 3Rs’. 51 delegates across academia, regulatory bodies and industry attended from both North America and Europe to discuss the current state of the science regarding mandatory animal testing for endocrine disruptor identification, replacement approaches/new approach methodologies (NAMs), and applying 3Rs approaches in practice. A publication summarising the workshop discussions is in preparation.

 
 

 
 

Promoting the 3Rs internationally

  • Dr Natalie Burden travelled to Germany in November to present on ‘Conducting aquatic vertebrate tests for investigation of endocrine disrupting properties: Challenges and 3Rs implications’ at the 10th International Fresenius Conference ‘Endocrine Disruptors’. In Germany again in December she presented on ‘Applying the 3Rs in Ecotoxicology’ at the 19th International Fresenius ECOTOX Conference ‘Aquatic and Terrestrial Ecotoxicology and Risk Management’.

  • Helen and Fiona attended the American College of Toxicology (ACT) Annual Meeting in Phoenix, Arizona where Helen presented in a session organised by NC3Rs and SPS on Safety Pharmacology for Toxicologists: Incorporating Functional Endpoints into Toxicology Studies and Highlighting Proposals for Changes in Guideline Requirements.

  • In November, Fiona presented at the In-Silico Networking event in Cambridge on ‘Using in silico approaches to support the 3Rs in safety assessment’.

  • We are a partner institution in EU-ToxRisk – An Integrated European ‘Flagship’ Programme Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st Century. This is a European collaborative project funded by the EU Framework Programme for Research and Innovation, Horizon 2020. Natalie attended the project’s recent General Assembly/Open Symposium in Egmond aan Zee. Further information on this European collaboration can be found on their website.

  • In February, Fiona attended the Medicines Evaluation Board (MEB) Science Day 2020, in Utrecht, The Netherlands. The theme of the meeting was ‘Replacement, reduction and refinement of animal studies’ and Fiona gave a presentation on ‘Applying the 3Rs in Toxicology and Regulatory Sciences’ and participated in a panel discussion. Outputs from this meeting were recently published in the MEB’s regulatory science magazine.
 
 

 
 

Guest Lectures and Courses

Dr Briony Labram gave a lecture to third year undergraduate Biomedical Sciences students at St George’s Hospital Medical School, University of London on the 3Rs in research as part of their Biomedical Research Techniques for Drug Development module.

 

 

While many events have been cancelled or postponed due to the ongoing COVID-19 pandemic, the tox team will still be presenting at some virtual conferences. Visit our website events calendar for more details.

 
 

 
 

59th Annual Meeting of the Society of Toxicology

15-19 March 2020 (Anaheim, California)

 

This year’s SOT was cancelled, but we were due to present two posters, which can instead be downloaded from the SOT website: ‘Species Used for Toxicity Assessments of Small Molecules and Monoclonal Antibodies Approved by EMA (2016-2018)’ and ‘Incidence of new toxicities in biologics and small molecules upon long-term dosing’.

 
 

 
 

SETAC Europe 30th Annual Meeting

3-7 May 2020 (online)

 

The SETAC Europe 2020 meeting is now being held virtually. Briony was scheduled to speak in the session ‘Alternative Approaches to Animal Testing for Aquatic Ecotoxicity Assessments and Environmental Risk assessments’ with a presentation on ‘Reducing, refining and replacing fish acute toxicity tests’. This will now be pre-recorded and will be made available to all meeting registrants online, with viewing on demand.

 

 
 

A list of all NC3Rs publications in Toxicology and Regulatory Sciences can be found in our bibliography.

  • Prior H, Baldrick P, Beken S et al. (2020). Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation. Regulatory Toxicology and Pharmacology 113: e104624. doi:10.1016/j.yrtph.2020.104624

  • Rivetti C, Allen TEH, Brown JB et al. (2020). Vision of a near future: Bridging the human health-environment divide. Toward an integrated strategy to understand mechanisms across species for chemical safety assessment. Toxicology In Vitro 62: e104692. doi:10.1016/j.tiv.2019.104692

  • Clements JM, Hawkes RG, Jones D et al. (2020). Predicting the Safety of Medicines in Pregnancy: a Workshop Report. Reproductive Toxicology. 93: 199-210. doi:10.1016/j.reprotox.2020.02.011
 

 

Call for data: acute oral toxicity studies

In collaboration with the European Partnership for Alternative approaches to Animal Testing (EPAA) we request access to study reports from acute oral toxicity studies in order to develop a database of clinical signs observed during these studies.

 

This will be analysed and used to develop guidance on the use of evident toxicity as an endpoint to support the use of the Fixed Dose Procedure (FDP) for acute oral toxicity studies (OECD Test Guideline 420). This test uses fewer animals than other accepted methods and does not use death as an endpoint, giving clear animal welfare benefits.

 

Please contact fiona.sewell@nc3rs.org.uk for more information.

 
 

 
 

OECD Webinars: Webinar Series on Testing and Assessment Methodologies

The OECD webinars on Testing and Assessment Methodologies focus on selected ongoing projects that will result in the short to medium term in new methodologies to test and assess chemicals. These free webinars are open to potential end users among regulators and contract research organisations who want to get familiar with new standards and approaches. Video recordings of our webinars are made available online afterwards.