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.

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

Wednesday, December 3, 2025 
10 am ET / 16:00 CET

Featuring

Karolina Jagiełło, PhD, QSAR Lab Co-owner, Senior R&D Specialist
Marta Swirog , QSAR Lab Marketing and Sales Manager, R&D Specialist
Maciej Stępnik, MD, PhD, DSc, QSAR LAB Senior Toxicologist

The presenters will begin with a brief introduction to QSAR Lab, including their definition of NAMs and strategies for searching for NAMs (ECHA contracts). The speakers will provide an overview of the NAMs.Network platform and its functionalities, including knowledgebase and database access, network features, and tools and resources for researchers and regulators. Real world applications will be highlighted with two case studies reviewing searches for NAMS of interest and providers of a NAM of interest. The webinar will conclude with an opportunity to engage in an audience-led Q&A session.

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Expert Biographies:

Karolina Jagiello, Eng, PhD, is a graduate of Gdansk University of Technology, where she obtained her Master’s and Engineer’s degrees in Biotechnology and a PhD in Chemical Sciences. She holds the position of a Senior R&D Specialist and Vice-Chief of the Scientific Council at QSAR Lab, as well as an Assistant Professor at the Environmental Chemoinformatics Laboratory at the University of Gdansk.

Her expertise lies in computational toxicology, chemoinformatics, and nanoinformatics, with a particular focus on machine learning- and AI-supported data analysis and the design and implementation of in silico New Approach Methodologies (NAMs) for chemical and nanomaterial safety assessment.

She actively contributes to the development and regulatory acceptance of non-animal testing strategies, collaborating on projects supporting ECHA and the implementation of REACHcompliant, mechanistically informed risk assessment approaches.

Her research integrates Quantitative Structure–Activity Relationship (QSAR/nano-QSAR) modeling with the Adverse Outcome Pathway (AOP) framework, enabling the identification of structural features that trigger transcriptomic and toxicological responses relevant to specific adverse effects.

Dr. Jagiello has co-authored over 55 peer-reviewed scientific publications in international journals (h-index = 19) and actively contributes to the advancement of predictive, mechanism-based NAMs in regulatory science and chemical safety.

Marta Swirog holds a Master’s degree in Analytics and Diagnostics from the University of Gdańsk. At QSAR Lab, she bridges the worlds of science, communication, and design, overseeing the promotion of R&D projects, strategic marketing activities, and client relations. She is also responsible for the visual identity of QSAR Lab’s digital tools like nams.network database, ensuring their alignment with the company’s mission to make advanced computational toxicology and NAMs accessible through intuitive digital solutions.

Maciej Stępnik, MD, PhD, DSc, is a senior toxicologist and expert in regulatory toxicology, nanotoxicology, and chemical safety assessment, with extensive experience in evaluating health hazards of chemical substances and nanomaterials. His scientific interests include mechanisms of mutagenic and carcinogenic effects and the development and regulatory implementation of New Approach Methodologies (NAMs) and alternative methods to animal testing in toxicological research and risk assessment.

He serves as a Member of the Scientific Committee on Consumer Safety (SCCS) in Luxembourg (Working Groups on Cosmetic Ingredients, Nanomaterials in Cosmetics, and Methodology) and as a Hearing Expert in the Cross-cutting Working Group on Genotoxicity at the European Food Safety Authority (EFSA).

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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