Despite their limitations, 3D in vitro models are relevant for studying idiosyncratic and delayed toxicity pathways, including immune-mediated responses and effects in susceptible populations {e.g., pediatric, geriatric, or genetically predisposed individuals), which are often poorly predicted by current preclinical approaches.

This session will explore how advanced 3D in vitro models are adding additional tools to toxicity testing by enabling more human-relevant and mechanism-based assessments. Topics will include the evaluation of inflammation-mediated toxicity, strategies to model vulnerability in specific patient subpopulations, and case studies highlighting regulatory and industry uptake. Presentations will cover both scientific advancements and implementation challenges, fostering discussion on how to accelerate adoption in the toxicology community. 

—Presentation Schedule—

Welcome and Introduction
Jan Lichtenberg, lnSphero and Matt Wagoner, Takeda

Combining NAMs and AI
Thomas Hartung, Johns Hopkins University

Pharma Use Case
Matt Wagoner, Takeda 

Pharma Use Case
Piyush Bajaj, Sanofi

Regulatory Perspective
Steven Hermansky, US FDA

Chemical Industry Perspective
Kim Boekelheide, Brown University 

Scalable NAMs for Automation
Madhu Nag, Insphero

—Polling, Panel Discussion, and Q&A—

Intro: NAMs Plus X—What are Missing Building Blocks for Increasing NAMs Adoption?
All Speakers

—Session Chairs—

Jan Lichtenberg, lnSphero

Matt Wagoner, Takeda

—Moderator—

Gary Minsavage, President, The Toxicology Forum

The revised Guidance on the Application of the CLP Criteria under ECHA was published in November 2024 and now includes criteria for the classification and categorization of endocrine disrupters. The application of this guidance for hazard classification of substances that will be evaluated for ED potential will be reviewed compared to the current EFSA/ECHA guidance (2018) for identification of EDs. Overall, for human safety, ED assessments are based on human relevant adversity with a biologically plausible link to activity associated with EATS modalities where there is now a large knowledge base. Inclusion of non-EATS modalities in the evaluation of substances increases complexity of an ED evaluation because at this present time, it is unclear what data will be reviewed that map to non-EATS modalities with adverse outcomes including, metabolic disorders, diabetes, obesity, or non-alcoholic fatty liver disease (NAFLD). This session will cover the current EFSA/ECHA criteria for EATS pathways with examples of classification under CLP criteria along with highlighting the differences between these two guidance documents partly based on differences in regulatory legislations. In addition, a case study, with data that may suggest non-EATS modalities will be assessed and how these data will be viewed considering the lack of specific validated assays and Adverse Outcome Pathways where a biologically plausible link between endocrine activity and adversity has not yet been established.

—Presentation Schedule—

Session Introduction
Leah Zorrilla, Bayer Crop Science

Endocrine Disruptors and EU Regulations: Navigating Scientific Assessment and Classification Challenges for Plant Protection Products
Helen Tinwell, Bayer Crop Science

EATS Evaluation of Agrochemical According to CLP Regulations
Brandy Riffle, BASF

A Pathway-Based Mechanistic Evaluation of Non-EATS Modalities; A Case Study
Amanda Buerger, ToxStrategies, Inc

—Panel Discussion —

All Speakers
Alinne Oliveira, Bryant Christie Inc
Erik Rushton, LyondellBasell

—Session Chairs—

Susan Borghoff, ToxStrategies
Leah Zorrilla, Bayer Crop Science