Read the latest issue of AOP News

The latest edition of AOP News, our news bulletin for scientists, risk assessors and regulators with an interest in pathways-based approaches, is now available.

Features include:

• A public health/regulatory perspective: Dr Nicole Kleinsteuer, NICEATM.


• AOP Spotlight: Interview with Dr Luigi Margiotta-Casaluci, Brunel University.


• Ask the experts: Scientists consider what is needed to increase the value of AOPs in toxicology.


• Latest publications and event highlights.

Workshop: Application of non-animal approaches for decision-making in chemical safety assessment

10-11 December 2018 (Central London)

In collaboration with Unilever, we are jointly hosting a two-day workshop exploring how non-animal approaches (in vitro and in silico) can provide useful information to inform decision-making for chemical safety assessment in product development programmes.

The workshop will be attended by expert scientists from academia, government and regulatory agencies and the (agro)chemicals, consumer products, and pharmaceutical industries. Its key objectives are to:

• Showcase how non-animal approaches are currently being used to enable and improve decision-making for chemical safety assessment, including the use of AOPs/mechanistic approaches and incorporation of exposure science.


• Increase awareness and acceptance of non-animal approaches to accelerate their uptake to support decision-making, particularly in a regulatory setting.


• Identify scientific gaps that if addressed could have a significant impact on the application and uptake of non‑animal approaches.


• Encourage collaboration between sectors, to share knowledge and 'lessons learned' to maximise the impact of non-animal approaches and to improve safety and efficacy decision-making.

The workshop will be chaired by Professor Ian Kimber OBE (Professor of Toxicology at the University of Manchester and NC3Rs Toxicology Ambassador). Discussions will focus on what is needed to give confidence in these new approaches to make decisions for safety assessment.

Delegates are encouraged to submit poster abstracts on a topic relevant to the theme of the meeting and highlighting the potential 3Rs benefits. To present a poster, please complete the abstract submission form and submit by 2 November 2018. We will let you know if you have been successful by 16 November 2018.

Attendance is free, but registration is essential. The closing date for registration is 12 November 2018.

Join the NC3Rs Tox Team

Do you have a demonstrable commitment to the 3Rs and a passion for driving scientific excellence?

We will soon be recruiting for a new Science Manager to support our programme in Toxicology. More details will be published on our website shortly.

Opportunities to meet members of the NC3Rs toxicology team and find out more about our work at conferences and events over the upcoming months.

Find a full list of NC3Rs events on our website calendar.

The 54th Congress of the European Societies of Toxicology (EuroTox)

2-5 September 2018 (Brussels, Belgium)

The theme for 2018 is Toxicology Out of the Box. We will have a stand within the exhibition hall (booth number 10). Two posters with preliminary results from the NC3Rs/ABPI working group project 'Review of the use of a second species in regulatory studies' will be presented (4 September), 'Reviewing the use of two species in toxicology studies supporting drug development' and 'Use of recovery animals for human safety assessment across the pharmaceutical development package'. Professor Ian Kimber will be also presenting on 'In vitro alternatives: progress, challenges and opportunities' in session 2, 'Ensuring validity of in vitro replacements: what is needed for regulatory decision making?' (3 September 10am-12pm).

Dr Manasi Nandi (King's College London) is presenting the HESI CITE Lecture 'Big data for biologists: A maths in medicine case study' on 5 September (12pm-1pm). This lecture highlights where mathematical modelling can help advance the 3Rs by improved analysis of cardiovascular data. This work originated from a Maths in Medicine Study Group organised by the NC3Rs in 2013.

Safety Pharmacology Society (SPS) European regional meeting

6 September 2018 (Braine-l'Alleud, Belgium)

The theme for the meeting is 'Safety Pharmacology Meets Toxicology', bringing together scientists from both disciplines to discuss integration of safety pharmacology parameters in toxicology studies and the concept of adversity (No Adverse Effect Levels - NOAEL) related to safety pharmacology parameters. Dr Helen Prior (NC3Rs Programme Manager) will be speaking during the first session on 'Inclusion of cardiovascular recordings in non-rodent toxicology studies and social-housing refinements' and also helped to organise the following session of cardiovascular case studies.

Safety Pharmacology Society (SPS) Annual meeting

30 September-3 October 2018 (Washington DC, USA)

Dr Luigi Margiotta-Casaluci (Brunel University) will be presenting a poster on 'Development of an Adverse Outcome Pathway (AOP) for Cardiotoxicity Mediated by the Blockade of L-Type Calcium Channels' resulting from the recent NC3Rs Strategic award. Dr Margiotta-Casaluci is the recipient of an SPS Junior Investigator Travel Award, which funded his participation at this meeting.

Dr Elisa Passini (Oxford University) will be presenting a poster on 'Human in Silico Trials on Drug-Induced Changes in Electrophysiology and Calcium Dynamics using the Virtual Assay software' resulting from the NC3Rs' Infrastructure for Impact award.

Dr Sam Jackson (NC3Rs Programme Manager) will be presenting preliminary results from work conducted by the NC3Rs FOB/Irwin working group, in a poster entitled 'Results of a Survey on the Use of the Functional Observational Battery (FOB) and Irwin Tests in Central Nervous System (CNS) Safety Pharmacology'.

Dr Jackson will also be hosting a lunchtime session on 3 October (1.30-3pm) on 'The Role of the Functional Observational Battery (FOB) and Irwin Test Model in Safety Pharmacology'. This session is sponsored by Charles River Laboratories.

Envigo Biologics Symposium

1-2 October 2018 (London, UK)

Dr Fiona Sewell (NC3Rs Programme Manager) will be presenting on: 'Are we fully exploiting the use of a single species for post-'First-in-Human' (FIH) studies allowed within ICHS6?'

The 4th International Conference on Toxicity Testing Alternatives and Translational Toxicology (TATT)

9-12 October 2018 (Guangzhou, China)

Dr Fiona Sewell will be giving a plenary presentation on: 'Evidence-building to influence changes in regulations and guidelines: pioneering better science by applying the 3Rs'.

Dr Helen Prior will be presenting a parallel session talk on: 'Applying the 3Rs within NHP use for biological development'.

American College of Toxicology (ACT) annual meeting

4-7 November 2018 (Palm Beach, USA)

The American College of Toxicology's annual meeting aims to update attendees on emerging trends in the discipline of toxicology. This year's meeting will include a diverse scientific programme and a traditional poster reception session for attendees and exhibitors.

Dr Helen Prior will be presenting work on 'When would data from a single species be sufficient for safe progression in humans?' in Symposium 10: 'Integration of consortia recommendations for justification of animal use within current and future drug development paradigms' on 6 November 9am-12pm. Professor Ian Kimber is a co-chair of this session, which was proposed and organised by the NC3Rs to bring together scientists and regulators from four separate industry consortia (IQ-DruSafe, EFPIA, Biosafe and NC3Rs/ABPI).

Two further posters with results from the NC3Rs/ABPI working group project 'Review of the use of a second species in regulatory studies' will be presented: 'Can we expand the use of one species for post-'First-in-Human' (FIH) studies, within and beyond ICHS6?' and 'Trends toward a reduction in the use of recovery animals for First-In-Human (FIH) studies from 2013 to 2017'.

We will also have a stand within the exhibition hall (booth number 503).

A list of all NC3Rs publications in Toxicology and Regulatory Sciences can be found in our bibliography. New publications co-authored by NC3Rs staff include:

• Prior H et al. (2018). Reviewing the utility of two species in general toxicology relating to drug development. International Journal of Toxicology. 37(2):121-124. doi: 10.1177/1091581818760564


• Jackson SJ, Prior H, Holmes A (2018). The use of human tissue in safety assessment. Journal of Pharmacological and Toxicological Methods. pii: S1056‑8719(18)30569‑0. doi: 10.1016/j.vascn.2018.05.003.


• Sewell F et al. (2018). The future trajectory of adverse outcome pathways: a commentary. Archives of Toxicology. 92(4):1657-1661. doi: 10.1007/s00204-018-2183-2.


• Myatt GJ et al. (2018). In silico toxicology protocols. Regulatory Toxicology and Pharmacology. 96:1-17. doi: 10.1016/j.yrtph.2018.04.014.

New ICH S9 Q&A adopted

The ICH S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers was released in June 2018. The Q&A includes statements about reduction of animal use or use of in vitro alternatives in these studies.

2018 CRACK IT Challenges: register now for the launch event

The 2018 CRACK IT Challenges competition consists of three Challenges identified jointly by the NC3Rs and Sponsors focusing on:

• Development of an immunologically competent liver model to assess yellow fever vaccines (Sponsor: Sanofi Pasteur EU).
   
• Raman spectroscopy for objective monitoring of rheumatoid arthritis (Sponsors: Galvani Bioelectronics and GSK; co-funder: EPSRC).
   
• An approach/device to accurately measure individual food intake in group-housed mice (Sponsor: MRC Harwell).

Full details of the Challenges and Sponsors can be found on the CRACK IT website.

We are hosting an event to launch the competition in central London on 6 September 2018, providing invaluable access to potential new partners and the Challenge Sponsors. Networking at the event is intended to stimulate discussion between applicants and Sponsors to help put together a winning application.

The launch event is free to attend but registration is essential.

Register for the launch event via the CRACK IT website before
31 August 2018.

New CRACK IT Solution: CombiDART

Researchers at the University of Oxford have developed CombiDART, a non-vertebrate model system to rapidly assess compounds for developmental and reproductive toxicity (DART). Industrial partners are sought to provide advice on the most commercially useful ways to develop the system, including detail on how to meet their end-user needs and support wider uptake.