Tox news: Issue 12, November 2022
Sharing the latest news from the NC3Rs Toxicology and Regulatory Sciences programme.
If you would like to subscribe to Tox News, send us an email to request that we add you to our mailing list.
In this edition
- Webinar: Minimising non-human primate use in drug development
- Visit our new dedicated resource page on minimising NHP use
- Webinar: Microsampling in Toxicology - Maximising the scientific, business and 3Rs advantages
- Natalie Burden to coordinate the new BTS Speciality Section for Ecotoxicology
- Promoting the 3Rs internationally: upcoming events
- Other relevant events
- Opportunities to join our Funding Panels from January 2023
Webinar: Minimising non-human primate use in drug development
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.
Register for our upcoming webinar: Minimising non-human primate use in drug development, aimed at regulatory and industry scientists.
Visit our new dedicated resource page on minimising NHP use
The NC3Rs has a long history of projects that have identified opportunities to minimise the use of NHPs in toxicology programmes.
Visit our new web page on minimising NHP use for an overview of all the NC3Rs activities and recommendations in this area.
Webinar: Microsampling in Toxicology - Maximising the scientific, business and 3Rs advantages
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
Presentation recordings of Microsampling in Toxicology: Maximising the scientific, business and 3Rs advantages, can be accessed on our resource page. This webinar is relevant for all academic, regulatory and industry scientists interested in applying the 3Rs in rodent and non-rodent studies.
Natalie Burden to coordinate the new BTS Speciality Section for Ecotoxicology
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.
Promoting the 3Rs internationally: upcoming events
The NC3Rs will be at the ACT 43rd Annual Meeting in Denver, Colorado (USA) and the 15th 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!
Helen has organised and will co-chair a workshop on “Chronic Toxicity Study Designs: Exploring Greater Flexibility for Appropriate Dosing Duration, Recovery Groups, and Species Selection to Support Human Safety Assessment While Balancing 3Rs Considerations” on Tuesday 14 November 2-5pm. This includes presentations from the IQ-DruSafe chronic toxicity predictivity project, the EPAA/MEB/NC3Rs project on optimal duration of chronic studies for mAbs and Helen will present on “Inclusion of Recovery Animals: Opportunity for Further Optimization Remains”. We will also have a booth in the exhibition hall (#813).
There will be a 3Rs Workshop on Thursday 17 November. The discussion will focus on identifying opportunities and solutions to minimise usage of experimental animals in relation to in vivo toxicity and pharmacokinetic studies, and will feature some of our recent work on microsampling presented by working group member Amanda Wilson (AstraZeneca).
Other relevant events
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.
Registration for the hands-on modelling of safety data for non-experts workshop from BTS is free and open to all.
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.
Next level non-animal testing symposium: further details and registration. This interactive conference is open for all stakeholders, researchers, companies, regulatory agencies, policy makers and NGOs.
Opportunities to join our Funding Panels from January 2023
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.