Tox News: Issue 9, September 2021

Top banner: Tox News, issue 9, September 2021
 

Tox Team welcomes back Dr Natalie Burden

NC3Rs Programme Manager Dr Natalie Burden has returned from maternity leave. Her main focus will be on current 3Rs challenges and opportunities in ecotoxicology, including areas such as fish acute toxicity and endocrine disruptor testing.

Portrait of Dr Natalie Burden  
 

 
 

New publication: the forced swim test is not a regulatory requirement for the development of new antidepressants

A new paper in Regulatory Toxicology and Pharmacology co‑authored by staff at the NC3Rs and the UK Medicines and Healthcare products Regulatory Agency (MHRA) has clarified that the forced swim test is not a regulatory requirement for the development of new antidepressants.

 

Further information
White mouse peeks out of its nest  
 

 
 

Vacancy: Join the NC3Rs team and help promote replacement technologies

We are recruiting a Replacement Technologies Programme Manager to facilitate an increase in the availability and use of approaches that replace in vivo studies in academia and industry. If you have a PhD in a biological science and post‑doctoral experience, as well as a demonstrable commitment to the 3Rs, this could be the role for you.

 

The deadline to apply for this role is Thursday 2 September.

 

Further information
Icon of white briefcase on purple background  
 

 
 

New resource for in vitro researchers: supporting the use of animal‑free reagents

The new resource provides information and guidance for adopting animal‑free reagents to deliver improved science, increased reproducibility and reduced animal use.

 

Further information
Icons representing the topics of the animal-free <em>in vitro</em> resource: antibodies, culture media, scaffolds and further resources  
 

 
 

Survey deadline extended: help us understand 3Rs opportunities and barriers in biologicals testing 

If you are involved in the quality control and batch/lot release testing of biological products, we have extended the deadline for you to share your experiences of implementing 3Rs and non‑animal approaches within these tests. Please take 30 minutes to fill in our survey by Friday 24 September and help inform the recommendations we make as part of our collaboration with the WHO on the wider integration of 3Rs approaches within their guidelines.

 

Further information
A needle and syringe inserted into a vial of clear liquid  
 

 
 

2021 CRACK IT Challenges

We are launching two Challenges for 2021 that tackle areas of significant scientific need and 3Rs potential: Virtual Second Species and SAFE (Innovative Safety Assessment of Fish adverse Effects). Both Challenges are toxicology‑focused and include our first three‑phase 'Mega‑Challenge'. Further information about the CRACK IT Challenges competition process can be found on our Innovation Platform.

 

We are hosting webinars on Tuesday 7 and Thursday 9 September to launch the new Challenges. Each webinar will focus on a specific Challenge and will give you an opportunity to learn more about the competition, ask the Sponsors questions and find out how to submit a competitive application.

 

Register for the Virtual Second Species briefing webinar on Thursday 9 September, 2‑4pm (BST)

 

Register for the SAFE briefing webinar on Tuesday 7 September, 2‑3.30pm (BST)

Composite image of an abstract network and zebrafish in a tank, representing the 2021 Challenges  
 

 
 

A new collaboration opportunity: gain early access to new non‑mammalian approaches for toxicology testing

 

Are you interested in early access to new 3Rs approaches that could improve your developmental neurotoxicology and developmental and reproductive toxicology studies? Newormics is seeking industry partners to connect via konfer and provide reference compounds to validate their toxicology assays, which use C. elegans as an alternative to mammalian models.

 

Further information
Newormics logo  
 

 
 

Promoting the 3Rs internationally

Fiona gave a keynote presentation at the 11th Congress of Toxicology in Developing Countries (CTDC11) on 'Global harmonisation – working together to apply and promote the 3Rs within toxicity assessments of chemicals and pharmaceuticals'.

 

We gave two presentations at the 11th World Congress on Alternatives and Animal Use in the Life Sciences 2021 (WC11, held as a full virtual congress).

  • Natalie presented 'Reducing, replacing and refining aquatic vertebrate testing in the identification of endocrine disruptors' in the session S199: Can non‑animal models identify environmental endocrine disruptors?

  • Helen presented 'Applying the 3Rs within Regulatory Toxicology Studies in Drug Development' in the session S127: Implementing the 3Rs in Safety Assessment and Drug Development.

Our collaborative work with the European Partnership for Alternative Approaches (EPAA) was also featured in a presentation by Dr Peter Van Meer (The Netherlands Medicines Evaluation Board): 'Optimal duration of safety studies with monoclonal antibodies' in the session S69: Promoting the use of 3Rs through partnership: EPAA.

 

 
 

Guest Lectures and Courses

Natalie will be lecturing on The Organisation for Professionals in Regulatory Affairs (TOPRA) MSc in Regulatory Affairs (Medicines) module 'Regulatory Strategy for a New Active Substance: Non‑clinical Development' on Wednesday 20 October.

 

Natalie will be presenting on 'Applying the 3Rs in ecotoxicology' at the 21st International Akademie Fresenius ECOTOX Conference "Aquatic and Terrestrial Ecotoxicology and Risk Management", taking place on 2 and Friday 3 December.

 

 

Helen will attend the Safety Pharmacology Society 2021 virtual meeting from 4 to 8 October, where she will co‑chair sessions on Seizure Liability and Global Perspectives on Safety Pharmacology.

 

Natalie will attend the SETAC Latin America 14th Biennial Meeting from 26 to 29 September, where she will present 'Applying the 3Rs in ecotoxicology' during the professional training course 'Overview and practical application of alternative approaches to animal testing in ecotoxicity testing and risk assessment' on Sunday 26 September.

 

Fiona will attend the  EuroTox 2021 Virtual congress from 27 September to 1 October, where she is co‑chairing a workshop on 'Increasing confidence in non-animal approaches for regulatory decision‑making'.

 

Visit our website events calendar for more details of upcoming virtual events.

 
 

The NC3Rs are regularly delivering webinars hosted by NC3Rs staff members and grant holders on different 3Rs topics. Recordings of past webinars can be found on the NC3Rs website. To receive regular updates on upcoming webinars and other new learning resources, subscribe to the NC3Rs newsletter.

 

We are running a monthly 'Ten years of CRACK IT' webinar series – visit our website to learn more, listen to previous webinars and register for upcoming ones.

One of the webinars showcased the technologies and platforms developed to address the 2013 InPulse CRACK IT Challenge, to develop a human‑based in vitro system to assess cardiotoxicity in new drugs. Speakers included Professor Chris Denning (University of Nottingham), who led the team that delivered the InPulse Challenge, and Dr Peter Clements (GSK), lead Sponsor of the Challenge.

 

Further information
 
 

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

  • Prior H and Holbrook M (2021). Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non‑rodents. Journal of Pharmacological and Toxicological Methods 108: 106959. doi: 10.1016/j.vascn.2021.106959

  • Burden N, Clift MJD, Jenkins GJS, Labram B, Sewell F (2021). Opportunities and Challenges for Integrating New in vitro Methodologies in Hazard Testing and Risk Assessment. Small (15): e2006298. doi: 10.1002/smll.202006298

  • Ortego L, Olmstead A, Weltje L, Wheeler J, Bone A, Coady K, Banman C, Burden N, Lagadic L (2021). The Extended Amphibian Metamorphosis Assay (EAMA): A thyroid‑specific and less animal‑intensive alternative to the Larval Amphibian Growth and Development Assay (LAGDA, OECD TG 241). Environmental Toxicology and Chemistry 40(8): 2135–2144. doi: 10.1002/etc.5078

  • Burden N, Embry M, Hutchinson T, Lynn S, Maynard S, Mitchell C, Pellizzato F, Sewell F, Thorpe K, Weltje L, and Wheeler J (2021). Investigating Endocrine Disrupting Properties of Chemicals in Fish and Amphibians: Opportunities to Apply the 3Rs. Integrated Environmental Assessment and Management. Online ahead of print. doi: 10.1002/ieam.4497

  • Sewell F, Waterson I, Jones D, Tricklebank M and Ragan I (2021). Preclinical screening for antidepressant activity – shifting focus away from the Forced Swim Test to the use of translational biomarkers.  Regulatory Toxicology and Pharmacology. Online ahead of print. doi: 10.1016/j.yrtph.2021.105002

  • Katsiadaki I, Ellis T, Andersen L, Antczak P, Blaker E, Burden N, Fisher T, Green C, Labram B, Pearson A, Petersen K, Pickford D, Ramsden C, Rønneseth A, Ryder K, Sacker D, Stevens C, Watanabe H, Yamamoto H, Sewell F, Hawkins P, Rufli H, Handy RD, Maynard SK, Jacobs MN (2021). Dying for change: A roadmap to refine the fish acute toxicity test after 40 years of applying a lethal endpoint. Ecotoxicology and Environmental Safety. Online ahead of print. doi: 10.1016/j.ecoenv.2021.112585
 

 

New publications: Simplified scoring systems to quantify the skin and eye irritation/corrosion potential of chemicals

 

The team from KREATiS that led delivery of the NC3Rs QSARs Mix CRACK IT Challenge has recently published two papers in collaboration with Challenge Sponsor Shell. These describe the Simplified Irritation Index as a new scoring system to quantify the skin and eye irritation/corrosion potential of chemicals, which can be directly translated to current classification systems. These tools were used in the development of iSafeRat®, a set of high accuracy QSARs for predicting skin and eye irritation. Further information about the QSARs Mix Challenge and iSafeRat® can be found on the NC3Rs Innovation Platform.

 

Skin irritation: Charmeau‑Genevois C, Sarang S, Perea M, Eadsforth C, Austin T, Thomas P (2021). A simplified index to quantify the irritation/corrosion potential of chemicals ‑ Part I: Skin. Regulatory Toxicology and Pharmacology. Online ahead of print. doi: 10.1016/j.yrtph.2021.104922

 

Eye irritation: Charmeau‑Genevois C, Sarang S, Perea M, Mayer N, Eadsforth C, Austin T, Thomas P (2021). A simplified index to quantify the irritation/corrosion potential of chemicals ‑ Part II: Eye. Regulatory Toxicology and Pharmacology. Online ahead of print. doi: 10.1016/j.yrtph.2021.104935

Kreatis logo  
 

 
 

Online workshop – 'A new toolbox for citizens’ protection: Implementing science into EU policy'

 

This workshop will provide an opportunity for dialogue between scientists working on next generation tools and policymakers. The objectives are to: 

  • Offer an overview of the current EU strategies for citizens’ health protection and their main aims.

  • Provide feedback and dialogue with two of the most relevant toxicological programs in the EU – PATROLS and EU‑ToxRisk – on how their results can help deliver EU strategies.

  • Identify further key steps for further implementation of the EU’s Chemical’s Strategy into future efforts from industry, scientists, regulators and policy makers. 

The workshop will take place on Thursday 9 September and will be divided into two events. The first event will be a technical meeting and will take place between 13:00 and 16:15 BST. It is an invitation-only event. The agenda and the log-in details will be shared with the chosen delegates by email.

 

Registration for the second event is open to all – the agenda is available via the registration page. This part will take place between 16:30 and 17:30 BST.

 
 

 
 

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