NAM Use for Regulatory Application

The New Approach methodology (NAM) Use for Regulatory Application (NURA) program aims to train scientists, regulators, or anyone else seeking more information on the use of NAMs in toxicological applications. Each webinar in the NAM Spotlight series highlights one method currently seeking use or currently used in regulatory application, including through the OECD guidance pipeline.

Visit the NAM Spotlight portal to access all resources in this series, including agendas and webinar recordings.

Advancing Respiratory Sensitization Research with ALIsens® in vitro Model

January 30, 2025, 10 a.m. ET

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Featuring Sabina Burla, MSc, and Arno Gutleb, PhD from Invitrolize.

Presentation Summary: The development of in vitro models for the respiratory tract is crucial as an alternative to animal testing. ALIsens®, an in vitro model for the identification of respiratory sensitizers, is a complex three-dimensional (3D) model built using human cell lines. The model has been shown to correctly identify respiratory sensitizers belonging to acid anhydrides chemical class and differentiate them from skin sensitizers and non-sensitizers based on the increased expression of markers of the surface of dendritic-like cells, thymic stromal lymphopoietin receptor (TSLPr), cluster or differentiation (CD)86 and CD54, the profile of secreted messenger molecules (cytokines and chemokines) and gene expression.

You can learn more about the presentation and the speakers Sabina Burla, MSc and Dr. Arno Gutleb in the webinar program.

ToxTracker: A Genetic Toxicology NAM on Its Journey to Regulatory Acceptance

February 11, 2025, 10 a.m. ET

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Featuring Dan Roberts, MS from Toxys.

Presentation Summary: To advance NAMs from being scientifically justified endpoints to regulatory necessities takes trust, validation, and guideline creation. Together we will discuss this journey for ToxTracker, a murine stem cells-based genotoxicity NAM. This platform uses GFP-tagged reporter genes on endogenously regulated bacterial artificial chromosomes that, when induced, can discriminate between direct and indirect mechanisms of genotoxic stress. The assay has ~10 years of use across industrial sectors and has been used for everything from screening programs to “weight of evidence” justification in regulatory dossiers to support a non-DNA reactive mode of action (MOA).

You can learn more about Dan Roberts, MS, and this webinar in the webinar program.

Use of the γH2AX/pH3 in vitro genotoxicity method for genotoxicity mode of action determination in the context of chemical risk assessment

Featuring Marc Audebert, PhD from Toxalim.

Find more information about Dr Audebert and this  presentation in the webinar program, and watch the recording.

Additionally, you can also read more about the validation of the γH2AX biomarker for genotoxicity assessment.

RosetteArray® Platform for Quantitative High-Throughput Screening of Human Developmental Neurotoxicity

Featuring Randall Ashton, PhD, co-founder of Neurosetta LLC.

Find more information about Dr. Ashton and this presentation in the webinar program, and watch the recording.

Additional resources:

• Non-synaptic function of the autism spectrum disorder-associated gene SYNGAP1 in cortical neurogenesis (Birtele et al 2022)
• Engineering induction of singular neural rosette emergence within hPSC-derived tissues (Knight et. al 2018)
• RosetteArray® Platform for Quantitative High-Throughput Screening of Human Neurodevelopmental Risk (Lundin et. al, bioRxiv)
• Neurosetta DNT Battery Screening Flyer and Services Flyer

The NAM Use for Regulatory Application (NURA) program would like to feature your human-based nonanimal approach in a webinar.

You will have the opportunity to present your method to a diverse professional audience from industry, government, and NGOs, followed by an audience-led Q&A session. We are looking for:

• Case studies of NAMs that have been submitted in IND applications.
• NAMs currently being used in regulatory applications or have the potential to replace animal use in regulatory application.

Please submit your presentation title and abstract or speaker suggestion to eslankster [at] pcrm.org.

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