NAM Use for Regulatory Application

The New Approach methodology (NAM) Use for Regulatory Application (NURA) program aims to train scientists, regulators, and anyone else interested in learning more about toxicology-relevant NAMs. Each webinar in the NAM Spotlight series highlights one method seeking use or currently used in regulatory applications, including through the OECD guidance pipeline.

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

We 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, NGOs, and academia, followed by an audience-led Q&A session. We are looking for:

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

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

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

September 25, 2024

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

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

October 17, 2024

Featuring Marc Audebert, PhD from INRAE Toxalim.

Find more information about Dr Audebert and this presentation in the webinar program and watch the recording.  Additionally, you can read more about the validation of the γH2AX biomarker for genotoxicity assessment.

Advancing Respiratory Sensitization Research with ALIsens® in vitro Model

January 30, 2025

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

Find more information about Sabina Burla, Dr. Arno Gutleb, and Invitrolize, in the webinar program, watch the recording, and view the Q&A Report.

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

February 11, 2025

Featuring Dan Roberts, MS from Toxys.

Find more information about Dan Roberts, MS and Toxys’ ToxTracker in the webinar program and watch the recording.

Additional resources:

• Presentation slides
• ToxTracker Suite Flyer
• Interlaboratory validation of the ToxTracker assay: An in vitro reporter assay for mechanistic genotoxicity assessment (Giel Hendriks et. al 2023)

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