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.

Insilica’s Multi-Stage AI Workflows for Regulatory Toxicology: From Chemical Structure to Complete Risk Assessment

April 9, 2026

1:00-2:00 pm ET / 17:00-18:00 UTC

Featuring: Tom Luechtefeld, PhD, Insilica Founder & CEO

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Regulatory toxicology assessments require synthesizing evidence across dozens of data sources, computational tools, and regulatory frameworks. Traditional approaches require toxicologists to manually execute each step: query databases, run QSAR models, extract literature claims, format outputs, and compile sections into standardized templates. This manual orchestration is time-consuming, error-prone, and limits the number of chemicals that can be assessed.

This webinar will demonstrate a multi-stage workflow architecture where specialized AI agents execute discrete stages—database queries, tool execution, evidence synthesis, section writing—in dependency-ordered sequences. Each stage produces structured outputs that feed downstream stages, enabling complete regulatory documents (REACH dossiers, OECD reports, risk assessments) to be generated from a chemical structure input.

During a live walkthrough covering workflows spanning substance identification to risk characterization, Dr. Luechtefeld will show real-time stage execution and evidence retrieval from a knowledge graph spanning thousands of databases—condensing weeks of manual work into a 15-minute demonstration.

Attendees will see:

• How dependency graphs ensure correct execution order across toxicological endpoints
• How agents handle data gaps by routing to predictive models when experimental data is absent
• How provenance tracking maintains regulatory traceability (every claim linked to source)
• How the same workflow infrastructure generates multiple output formats (HTML reports, IUCLID XML, custom templates)

Key Learning Objectives:

• Learn workflow design principles applicable to attendees’ own NAM pipelines
• Understand how multi-agent orchestration maintains regulatory credibility
• See practical strategies for audit-ready AI-generated assessments

About Our Presenter

Dr. Tom Luechtefeld is the founder and CEO of Insilica, a computational toxicology company pioneering agentic AI for regulatory science. Under his leadership, Insilica has developed multiple platforms including Sysrev for systematic literature review, and ToxIndex, an AI platform that orchestrates prediction tools and regulatory workflows through autonomous agents to generate comprehensive, regulatory-grade toxicology assessments.

Dr. Luechtefeld’s vision centers on AI agents performing single, constrained tasks that collectively execute scientific workflows and produce regulatory-grade documents. This approach has positioned Insilica at the forefront of computational toxicology, supported by grants from federal agencies and commercial partnerships with pharmaceutical, agrochemical, and chemical companies worldwide.

He holds a PhD in computational biology and is a frequent speaker on the intersection of AI, regulatory science, and the future of chemical risk assessment.

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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)

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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Implementing agentic AI workflows for safer products with Human Chemical

Friday, January 16, 2026

Featuring Mattson Thieme, PhD, Co-Founder & CTO, and Isaac Wilks, Co-Founder, from Human Chemical Co. 

At the presenters’ request, the recording of this webinar will not be made available. However, you can learn more about Human Chemical Co. in the webinar program and the written Q&A report.

Do you have an idea for a topic you would like to see covered by NURA? Do you have feedback you would like to share with us? We want to hear from you!

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