Tox News: Issue 14, July 2023

Thursday 20 July, 16.00 – 17.00 (BST)

Hear from the winner, Dr Lisa Wagar, about how she aims to streamline vaccine development for global respiratory pathogens of concern using her entirely animal-free tonsil organoid model. Professor Alex Frangi and Dr Ali Sarrami-Foroushani will also present the first ever in silico trial for a medical device from their highly commended paper.

NC3Rs Head of Toxicology Dr Fiona Sewell has returned from maternity leave.

Her main focus will be on providing evidence to support the use of evident toxicity in acute oral toxicity studies; supporting the acceptance of NAMs for decision-making as part of safety assessment; and developing recommendations for appropriate dose-level selection in regulatory toxicology studies.

Tuesday 31 October 2023

10.00 – 18.00 (GMT)

Central London 

Urinalysis is routinely performed in regulatory toxicology studies. Sample collection usually requires animals to be individually housed in a metabolism cage and/or catheterised, raising animal welfare issues. It is not clear if urinalysis data are being used in practice and how often they play a role in decision-making, as the quality of the data can be highly variable, and there are other assessments (e.g. histopathology) that may provide detailed and reliable information. 

The NC3Rs and the Association for Comparative Clinical Pathology (ACCP) are jointly hosting a workshop to bring a fresh perspective to the topic of urinalysis assessments in toxicity studies. 

The workshop – chaired by Paul Baldrick (Fortrea) – will include: introductory talks on methods of urine collection and the value of urinalysis for decision-making; a series of industry case studies from the pharmaceutical and agro-chemical sectors; breakout discussion sessions. There will be the option to display posters to showcase refined procedures for urine collection or specific case studies - abstracts can be submitted during the registration process. 

In collaboration with the European Partnership for Alternative Approaches to Animal Testing (EPAA), this webinar provides an overview of the key results and recommendations emerging from an EPAA supported and funded project, focused on chronic toxicity studies for monoclonal antibodies (mAbs). 

The project involved a consortium including 14 pharmaceutical companies, the Medicines Evaluation Board (MEB) in the Netherlands and the NC3Rs, to evaluate whether a six-month toxicity study is still necessary to assess the long-term safety of mAbs. The data collected for the project also enabled a review of study designs and current practices on animal use during mAb development and identification of opportunities to minimise the use of non-human primates.

This webinar is relevant for all academic, regulatory and industry scientists interested in applying the 3Rs in rodent and non-rodent studies.

On 17 May 2023 a written Ministerial statement was published with a regulation update for animal testing for worker and environmental safety of chemicals used exclusively as cosmetic ingredients in Great Britain. The NC3Rs response to the Home Office’s statement and position on the use of animals in cosmetics testing can be found on our website.

27 - 31 August. Niagra Falls, Canada

Fiona Sewell will be attending the 12th World Congress on Alternatives and Animal Use in the Life Sciences, in Niagara Falls (Canada), together with several NC3Rs colleagues. We will be co-chairing multiple sessions, and presenting talks and posters, including:

• Session 403 (Symposium) on Advancements and Opportunities in the Replacement, Reduction and Refinement of Acute Toxicity
  
  9.00 - 10.30, Monday 28 August
  
  Chairs: Fiona Sewell (NC3Rs) & Glenn Myatt (Instem)
  
  
  
  In this session, Fiona will also deliver a talk (#441) on “Refining and removing global mammalian acute toxicity testing requirements”.
  
   
• Session 409 (Symposium) on Warp-Speed Replacement? Remaining Challenges in Vaccine and Biologics Batch Testing
  
  14.00 - 16.00, Tuesday 29 August
  
  Chairs: Laura Viviani (SciEthiQ) & Elliot Lilley (NC3Rs)
  
  
  
  In this session, Elliot will also deliver a talk (#122) on “Review of animal testing requirements in WHO Guidelines and Recommendations for biologicals: a proposal to implement 3Rs principles”.
  
   
• Session 457 (Symposium) on Advances in NAMs for EcoTox Testing & Risk Assessment, Part 2: Computational Tools and Frameworks
  
  11.00 - 12.30, Wednesday 30 August
  
  Chairs: Fiona Sewell (NC3Rs) & Kristin Schirmer (aQuaTox-Solutions)
  
   
• Fiona Sewell will present two posters from industry collaborations under the theme ‘Regulatory Acceptance and Global Harmonization’. The. The first (#560) presents the results from the EPAA/MEB/NC3Rs mAbs project (see webinar details above) entitled Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach. The second (#443) presents results from the EPAA acute oral toxicity project entitled New data supporting recognition of evident toxicity in acute oral toxicity studies (OECD TG 420).

10 - 13 September. Ljubljana, Slovenia

Fiona and Natalie Burden will be attending EuroTox in Ljubljana (Slovenia) this September.  

• Natalie is presenting a poster (P09-07, #226) on “Potential information requirements for endocrine disruption assessment under REACH: The reliance on animal data”. 

• Fiona is presenting a poster (P24-39, #738) on “New data supporting recognition of evident toxicity in acute oral toxicity studies (OECD TG 420)”. 

18 - 21 September. Brussels, Belgium

Elisa Passini and Helen Prior will be attending the Safety Pharmacology Society (SPS) Annual Meeting in Brussels (Belgium) this September. 

• Elisa is giving a presentation on “Current challenges and opportunities of in silico models for cardiotoxicity testing” within a session entitled “Novel in vitro/in silico models for cardiotoxicity testing”. 

• Helen is co-chairing a session entitled “Modernization and Future of S7A Core Battery Assessments” where she is also giving a talk on “Working Towards Replacement of Some Safety Pharmacology Animal Studies with Appropriate NAMs”. 

Wednesday 19 July, 14.00 – 15.00 (BST)

We are excited to launch our new Technology Patn3Ring webinar series that provides a platform for academics and SMEs to showcase their 3Rs technologies. Each technology pitch will highlight a unique opportunity for collaboration.

The inaugural webinar will showcase:

• Advanced isolated living organ systems to de-risk preclinical research (PBLBio)
• Artificial intelligence-driven predictive toxicity (ConsoneAI)
• An in vitro platform to assess deep lung toxicity (ImmuOne)

A recording from the first webinar in July will be available in the NC3Rs resource library shortly after the webinar.

A preprint of the RIVER recommendations (Reporting In Vitro 

Experiments Responsibly) is now available. This new set of reporting standards for in vitro experiments aim to improve the transparency and reliability of published in vitro research.

Recruiting in vitro researchers to test the recommendations

We are now seeking user feedback – if you work with in vitro models and would like to user test the recommendations, please get in touch via river@nc3rs.org.uk.

Tuesday 19 – Wednesday 20 September

Central London and online

Registration is now open to attend a two-day workshop showcasing the outputs from our project to review animal use requirements in WHO biologics guidelines focusing on quality control and batch release testing. The workshop will highlight the findings and recommendations for inclusion of the 3Rs from the last three-years’ work. 

The EPAA invites the submission of solutions based on new approach methodologies (NAMs) to inform the development of a future classification system for systemic toxicity of human health based on the activity and potential systemic availability of chemicals. 

DioScor is a new AI-driven predictive toxicology platform designed to predict the toxicity of compounds in multiple species based on their chemical structure. The technology aims to reduce testing of unviable compounds during drug discovery and development and to increase the translational data between preclinical and clinical trials. 

To further develop the models and refine the prediction of specific toxicity effects, the developers are seeking partners and collaborators from pharmaceutical companies, universities, hospitals, and research organisations who specialise in drug discovery to provide data to verify DioScor. Partners/collaborators will be offered a commercial agreement for early access to the platform for the prediction of compounds within their pipelines, with preferential terms for future licences. 

Grimm H, Biller-Andorno N, Buch T, Dahlhoff M, Davies G, Cederroth CR, Maissen O, Lukas W, Passini E, Törnqvist E, Olsson AS, Sandström J. (2023). Advancing the 3Rs: innovation, implementation, ethics and society. Frontiers in Veterinary Science 10:1185706. doi: 10.3389/fvets.2023.1185706.

Bishop PL, Brescia S, Brunner R, Casey W, Conlee-Griffin K, Currie RA, Domoradzki J, Embry M, Harris MI, Hartung T, Hilton GM, Hooberman B, Ingle B, Jang KJ, Kinter L, Krall C, Leedale J, Lowit A, Mehta J, Mendez E, Mingoia B, Munarriz E, Lynea M, Myer A, Ottoni A, Panzarea M, Perron M, Pina J, Ramsingh D, Sewell F, Swanson J, Tan YM, Terron A, Trainer MA, Campos Valadares M, Webb S, Webb E, Willett C, Wolf DC. (2023). Challenges and opportunities for overcoming dog use in agrochemical evaluation and registration. ALTEX 40. doi: 10.14573/altex.2302151.