Tox news: Issue 12, November 2022

Thursday 15 December 2022, 14.00 – 17.00 (GMT), online via Zoom

Use of non-human primates (NHPs) continues to be necessary as part of the drug development process for various reasons, including current regulatory requirements and scientific justifications of human relevance, to ensure the safety of new pharmaceuticals in humans. With the increase in the development of biotherapeutics within the pharmaceutical industry in recent years, the number of NHPs used for testing has also increased. However, due to the COVID-19 pandemic and the concomitant export ban from China, there is a current NHP shortage.

The aim of this webinar is to provide an overview of the opportunities that are currently available or being considered to minimise NHP use in drug development. This includes the work of various industry consortia (IQ DruSafe and NHP Reuse Working Group, Biosafe and EFPIA) on diverse aspects to minimise NHP use whilst continuing to develop new medicines for patients:

• Recommendations for minimising NHP use from NC3Rs working groups
  
  Helen Prior, NC3Rs
• DruSafe initiatives supporting conservation of non-human primates in drug development
  
  Joanne Birkebak, Gilead Sciences
• Reuse of protein non-naïve monkeys in pharmaceutical research and development
  
  Charles Mattis, Abbvie
• Non-human primates in the PKPD evaluation of biologics: needs and options to reduce, refine and replace. A BioSafe white paper.
  
  Hongbin Yu, Boehringer-Ingelheim and Karelle Menochet, UCB
• Analysis of EFPIA Survey 2022: impact of current NHP shortage on the pharma industry
  
  Fred Brouta, UCB

There will be a panel discussion at the end of the webinar, with an opportunity for audience members to ask questions.

The NC3Rs has a long history of projects that have identified opportunities to minimise the use of NHPs in toxicology programmes.

Recordings now available!

In collaboration with the British Toxicology Society (BTS), the NC3Rs hosted a webinar in September 2022 to raise awareness of the microsampling technique and encourage wider adoption across both discovery and regulatory toxicology studies. Originally run as a session at the BTS Annual Congress 2022, the webinar consists of six presentations:

• Preclinical to clinical use of microsamples – start small, stay small
  
  Dr Neil Spooner, Spooner Bioanalytical Solutions Ltd
• Current use, 3Rs benefits and barriers for microsampling: results from a 2021 cross-sector survey
  
  Dr Helen Prior, NC3Rs
• Leveraging experience from small molecule microsampling towards large molecules and other drug modalities
  
  Dr Amanda Wilson, AstraZeneca
• Incorporating microsampling for agrochemical TK data to improve risk assessment
  
  Dr Derek Angus, Syngenta
• Microsampling of main test animals without detriment to clinical pathology parameters
  
  Carol Strepka, Charles River Laboratories Edinburgh
• Animal welfare benefits of microsampling for any purpose
  
  Hollie Blunt, Sequani

The British Toxicology Society (BTS) Executive Committee recently approved a new Speciality Section for Ecotoxicology, that Natalie will be coordinating. This Speciality Section represents members involved with or interested in basic ecotoxicology research, as well as applied ecotoxicology testing and assessment for regulatory/product registration purposes. It crosses the boundaries of industry, government/regulatory bodies and academic institutions, and is relevant to all industry sectors of the BTS membership, including those in the pharmaceutical, industrial chemical, food and agrochemical industries. The aim of the Speciality Section is to provide a forum for networking, communication, collaboration, discussion and professional representation both within the BTS and the wider (eco)toxicology community.

The first activity of this Specialty Section will be a Symposium at the next BTS Annual Congress in April 2023.

The NC3Rs will be at the ACT 43rd Annual Meeting in Denver, Colorado (USA) and the 15^th European Bioanalysis Forum (EBF) Open Symposium in Barcelona (Spain) next week. Click below to see what we'll be up to, and please come visit us if you are attending!

The BTS in silico/Mechanistic and Discovery Toxicology speciality sections’ joint workshop:

hands-on modelling of safety data for non-experts

Tuesday 29 November 2022, 14.00 – 17.00 (GMT), online via Zoom

While machine learning (ML) / artificial intelligence (AI) models are gaining popularity across scientific fields, their inner workings are not transparent to everyone, and hence they are often approached with hesitation. This hands-on workshop will make the construction, and use, of machine learning models clear to a non-expert audience with a general life science/safety sciences background.

Next level non-animal testing symposium

Friday 2 December 2022, Utrecht (NL)

This symposium will showcase work undertaken by a consortium of research organisations and companies in the last four years, to develop animal-free methods to test the potential harmful effects of chemical substances on human health. This includes results from the NC3Rs CRACK IT Challenge “DARTpaths”, which led to the development of an in silico platform that allows integration of chemical in vitro and in vivo toxicity data, based on molecular mechanisms of action.

We are currently inviting applications from talented researchers to join our funding panels. The panels are responsible for assessing the scientific excellence and 3Rs impact of diverse, innovative applications for research and career development.

Applications from currently under-represented groups, including women, members of minority ethnic groups, and researchers with disabilities or long-term conditions, are especially welcomed.