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.

Reimagining Carcinogenicity Assessment Beyond the Rodent Bioassay: Next-Generation Carcinogenicity Risk Assessment with Kaptis

Wednesday, June 10, 2026
10:00-11:00 am ET / 14:00-15:00 UTC

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Featuring:

Alex Cayley, PhD, Principal Scientist at Lhasa Limited

Pavlos Dimitriou, MSc, Business Partnerships Manager at Lhasa Limited

For decades, carcinogenicity assessments have relied on traditional animal-based approaches that are increasingly recognised as slow, costly, resource-intensive, and poorly predictive of human outcomes. As regulatory frameworks evolve, most notably through the ICH S1B(R1) addendum, clear pathways are emerging to apply weight of evidence (WoE) approaches that can reduce or replace full carcinogenicity studies when scientifically justified. However, practical implementation and best practice around these approaches are still emerging and understanding how these methods can be accepted and operationalised is crucial to their acceptance. Building on successful use cases and worked examples, this webinar will illustrate how next generation carcinogenicity assessment approaches can be implemented in practice with New Approach Methodologies (NAMs) within pharmaceuticals and beyond.

The session will conclude with a demonstration of Kaptis, a Lhasa Limited AOP-driven decision support solution. Attendees will see how Kaptis organises carcinogenicity knowledge, supports WoE assessments, predicts ICH S1 classifications, and streamlines testing strategies to enable faster, more transparent, and more cost effective human safety decisions that are resilient to future regulatory and scientific developments.

Learning Objectives

• Understand why current carcinogenicity testing approaches fall short in predictive value, efficiency, and regulatory relevance.
• Explore how approaches such as those described in ICH S1B (R1) enable the use of WoE strategies, including a practical case study illustrating how alternative evidence can support regulatory acceptance.
• See how Kaptis supports carcinogenicity decision making, enabling organisations to integrate diverse data streams, streamline regulatory submissions, and remain resilient amid evolving scientific and regulatory landscapes, including:
  • Access to curated carcinogenicity AOPs and knowledge frameworks.
  • ICH S1 classification predictions.
  • Guidance on relevant assays and key events.
  • Streamlined, transparent WoE assessments.
• Appreciate how integrated tools like Kaptis evolve with evolving knowledge and prepare organisations for future regulatory expectations, thereby enabling more efficient, human-relevant safety assessments.

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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.

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

April 9, 2026

Featuring Thomas Luechtefeld, PhD, Insilica Founder & CEO

Find more information about Insilica, their agentic AI tools, and Dr. Luechtefeld in the webinar program.

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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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