NAM Use for Regulatory Application

The New Approach methodology (NAM) Use for Regulatory Application (NURA) program aims to train scientists, regulators, and others interested in learning about toxicology-relevant NAMs. Each webinar in the NAM Spotlight series highlights one method seeking approval for 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.

Implementing agentic AI workflows for safer products with Human Chemical

Friday, January 16, 2026 
1 pm ET / 18:00 UTC

Presenters

Mattson Thieme, PhD, Co-Founder & CTO, Human Chemical Co.

Isaac Wilks, Co-Founder, Human Chemical Co.

Presentation Summary

This training from the co-founders of Human Chemical, an AI lab focused on safer chemistry, will equip toxicologists to leverage cutting-edge AI as a force multiplier for their expertise. Agentic AI are systems that autonomously plan and execute complex tasks and represent a step-change in computational capability. However, toxicology has only just begun to harness these tools.

Human Chemical is working to introduce a new paradigm: fleets of specialized AI agents working in parallel to support expert toxicological judgment. Dr. Thieme and Mr. Wilks will demonstrate how agentic workflows can accelerate comprehensive hazard and risk assessment and attendees will gain hands-on experience directing agents to simultaneously conduct in silico assessments, perform targeted literature searches, and execute regulatory-standard tools as part of a weight-of-evidence approach.

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Presenter Biographies

Mattson Thieme, PhD is the Co-Founder and CTO of Human Chemical, where he builds predictive tox models and agentic AI systems. Prior to joining Human Chemical, he built ADMET models in drug discovery at a major pharmaceutical company. He has also developed and deployed machine learning systems in high energy physics, advanced manufacturing, quantitative finance, and social good.

Isaac Wilks is the Co-Founder of Human Chemical, where he focuses on partnerships, strategy, and regulatory engagement. At Human Chemical, he has established research collaborations with NIEHS experts and deployed partnerships spanning academia, industry, and nonprofits. Before co-founding Human Chemical, he worked in startups, venture capital, and technology consulting.

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 FDA 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 Randolph Ashton, PhD, co-founder of Neurosetta LLC.

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

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

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

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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 and view the Q&A Report.

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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.

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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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Introduction to NAMs.Network - The Tool for Regulators, Academics & Industry

December 3, 2025

Featuring Karolina Jagiełło, PhD, Maciej Stępnik, MD, PhD, DSc, and Marta Swirog from QSAR Lab and special guest Helena Hogberg-Durdock from NICEATM.

Find more information about NAMs.Network, QSAR Labs, the NTP CAMERA program, and the presenters in the webinar program.

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