| The Toxicology Forum—2025 Winter Meeting Program |
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The Toxicology Forum—2025 Winter Meeting
The Toxicology Forum seeks to be the foremost platform among influential stakeholders for deliberative dialogue which shapes decision-making and outcomes on critical issues in toxicology and its applications. Each scientific session features time for questions along with an extended panel discussion of at least 30 minutes at the end of each session. The 2025 Winter Meeting will be held as an in-person meeting to facilitate dialogue and networking among participants. Registration includes lunches, breaks, networking receptions, and access to the sessions! The Toxicology Forum meeting supports unparalleled networking and discussion with other meeting attendees in an intimate atmosphere, not available at large professional conferences. February 11: February 12: February 13:
Meeting Schedule and Agenda
Characterizing effects on thyroid hormones from rodent studies at various life stages is critical for identifying potential hazards and conducting risk assessments. Thyroid hormones can contribute to cardiovascular, reproductive, immune, and nervous system development, making contextualizing and interpretating thyroid data quite challenging. With great strides in progressing our understanding of this biology also comes added consideration needed to interpret and leverage new approaches for decision making. While traditional testing has been conducted in vivo, a multitude of targeted in vitro assays have been developed and more recently computational models for kinetics have been integrated increasing the utility and complexity of alternative approaches. This session seeks to comprehensively discuss the state of the science for thyroid testing and address evolving methodologies developed to help mechanistically investigate chemical-mediated effects on the hypothalamic-pituitary-thyroid axis. Speakers will address in vivo studies' utility and limitations as well as the diversity of in vitro assay systems and customized computational modeling required for robustly conducting mechanistic evaluations of chemical effects on the thyroid system and what steps are needed for regulatory use. —Presentation Schedule— Thyroid Testing In Vivo: Characterizing Thyroid-Mediated Effects Interpretation of Thyroid-Relevant Bioactivity Data in ToxCast: Applying Generic High-Throughput Maternal-Fetal Toxicokinetic Models for Prioritization A New Mechanistic Modelling Approach for Human-Relevant Risk Assessment of Thyroid Toxicity
All Speakers —Session Chair— Agnes Karmaus, Syngenta
*The David Miller Scholar Session highlights a topic of emerging interest (both toxicological in nature or from allied fields of science and science policy) to Toxicology Forum meeting attendees.
According to the latest data, the Earth is warming faster than predicted, and the intensity of natural disasters is regularly overwhelming response and recovery resources. The climate crisis is arguably the greatest challenge of our time with sprawling consequences that encompass increased heat stress, wildfires, harmful algal blooms, catastrophic natural disasters, and droughts, along with changing agricultural and insect-borne disease patterns. The enormity of the crisis can make any single line of research seem futile. Against this backdrop, how do toxicologists design and conduct research to aid in our understanding of the consequences and potential interventions related to climate change? In this session we will hear from those leading and funding climate programs to begin a conversation about how to engage toxicological research to have an impact. The stage will be set with an overview of how climate information can be translated into useful knowledge for decision-makers, scientists, and communities. Next, information will be provided about current programs and priorities supporting the NIEHS Climate Change and Health portfolio and discuss transformative efforts that have arisen from the NIEHS-NSF Oceans and Human Health Program. Finally, a case study of designing translational toxicology research to elucidate the hazard drivers from wildfire exposure will be presented. Following the presentations, the panelists will engage in a question and answer session to discuss opportunities for developing consequential toxicology research on climate change. —Presentation Schedule— Translating the Science of Climate Change The Ocean and Human Health Center for Coastal Algae, People, and Environment: Tackling Emerging Toxic Algal Blooms Across North Carolina Using an Interdisciplinary Approach From Forest to Wildland Urban Interface: Variable Wildfire Health Risks Attributable to Differences Across Exposures, Biological Responses, and Socioeconomic Vulnerability
—Panel Discussion — All Speakers
Julia Rager, University of North Carolina at Chapel Hill
The rationale for this session centers on the need to enhance the predictive accuracy of non-clinical models for human health outcomes through the application of omics technologies, with a focus on fostering shared learnings across sectors such as pharmaceuticals and agrochemicals. Regulatory agencies, including the FDA, EPA, and their international counterparts, will benefit from improved methods that better translate findings from short-term, non-clinical studies to long-term human health predictions. The session will promote substantive and constructive dialogue by presenting advancements in omics research, highlighting opportunities for cross-sector collaboration, and discussing strategies for sharing data, analytics, and study designs. By engaging diverse stakeholders, this session will help bridge gaps between sectors, ultimately leading to more informed decision-making and improved public health outcomes. —Presentation Schedule— Introduction and Themes of the Session Systematic Analysis of High-Throughput Transcriptomics to Identify Potential Carcinogens Extracellular microRNA as Biomarkers of Environmental Chemical Health Hazard Identification —Panel Discussion — All Speakers —Additional Panelists — Brian Berridge, Independent —Session Chairs—
Chrissy Crute, HESI
Considering the general objective of ensuring the safety of the food supply, risk assessors routinely must estimate the likelihood that a potential hazard can come from dietary exposure. While risk assessment frameworks and evidence-based methods provide a structure for scientific decisions, the application of observational data to identify, control, prevent, or mitigate adverse health effects based on a particular dose (or point of departure) remains challenging in chemical risk assessment (particularly in the low dose region). As such, there is a need for continued conversation related to the use of observational data for use in risk assessment, and in particular, its use for dose-response modeling; and, on a larger scale, perhaps development and/or refinement of current guidelines and best-practices for using observational data in risk assessments. The central goal of this session is to provide support for using evidence-based methods to integrate observational data in food safety assessments. An overview of how the concept of food risk assessment came to fruition and how the methods have changed throughout the years will be reviewed. The general needs related to using epidemiological data in food risk assessment including the challenges in interpreting the findings from observational studies as related to confidence and uncertainty in hazard assessment and dose-response relationships will also be discussed. This session will offer guidance for synthesizing and integration of epidemiological and toxicological evidence and propose methods that can be used to assess–both qualitatively and quantitatively–the potential for risk of bias, as well as the impact of such, on measures of association reported in observational studies. Finally, pragmatic solutions for better using evidence-based methods to integrate observational data in food safety assessments will be captured. Following, a panel discussion will promote constructive dialogue among participants. —Presentation Schedule— Session Introduction —Panel Discussion — All Speakers
—Session Chair— Daniele Wikoff, ToxStrategies
The United States population is potentially exposed to thousands of different chemicals through multiple sources and pathways. Toxicity testing and human health assessments play a critical role in determining whether these exposures are likely to be without appreciable risk of deleterious effects; however, relatively few chemicals have traditional toxicity data and human health assessments due to their time and resource intensive nature. Over the past few years, the EPA Office of Research and Development (ORD) has developed new approaches to toxicity testing and human health assessment that significantly shorten the time and resources required, including the EPA Transcriptomic Assessment Product (ETAP) and the recently reviewed Database-Calibrated Assessment Product (DCAP). EPA ORD has also completed a socio-economic case study evaluating the trade-offs between timeliness, cost, and uncertainty associated with the ETAP compared with traditional toxicity testing and human health assessment. The presentation will provide an overview of the new toxicity testing and human health assessment approaches, the results from the socio-economic case study, and outline ongoing and potential future efforts in the area. The views expressed in this abstract are those of the author and do not necessarily reflect the views or policies of the U.S. EPA. Russel Thomas, US EPA
The rapid advancements in artificial intelligence (AI) and advanced informatics approaches present transformative opportunities for improving chemical risk assessments and the regulatory process. AI tools and methods such as machine learning (ML), natural language processing (NLP), and large language models (LLMs) offer new approaches to process and analyze data more efficiently at a time that regulators and public health professionals are faced with the increasing volume and complexity of research data necessary to support decision making in chemical safety, environmental exposures, and public health. When they are responsibly applied, these technologies have the potential to enhance not only speed and accuracy, but also the transparency and reproducibility of risk assessments. Regulatory bodies like the US Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Health Canada, and the US Food and Drug Administration (FDA) are exploring AI integration to optimize their workflows. This session will foster a collaborative discussion on how AI and informatics can be practically applied within existing risk assessment frameworks, addressing the benefits, challenges, and emerging best practices. —Presentation Schedule— Caution: Top 10 AI/ML Mistakes and Villains Ontologies, Templates, and Standards for Improved Data Discovery Use Cases of Strategic Application of ML/AI in the Risk Assessment Process
Seneca Fitch, ToxStrategies
Implementing AI End to End Across the Risk Assessment Pipeline
—Panel Discussion— All Speakers
—Session Chairs— Andrew A. Rooney, NIEHS*
*This presenter is unable to attend
Animal testing has been the traditional method employed by regulatory agencies to assess the acute toxicity hazards of chemicals. However, these animal tests have limitations and face increasing societal pressure to be replaced with human-relevant and ethical alternatives. There are several New Approach Methodologies (NAMs) that are representative of human biology and have the potential to refine the prediction of acute toxicity hazards. While the existing testing paradigm for single chemicals and formulations continues to have global variability and limitations, this session will highlight how NAMs can be leveraged. It will also discuss frameworks proposed by regulatory agencies and recent publications that can advance acute testing reform. Presentations will include metrics from a variety of sources on animal and non-animal methods, address in vitro and in silico approaches, and highlight where there remain gaps. The session will conclude with a panel discussion focused on future research initiatives and strategies for advancing and implementing NAMs in regulatory decision-making processes, offering an interactive opportunity for the audience to share their views on novel approaches that move beyond direct comparisons with animal data, exploring how we can collectively redefine our reliance on animal tests as the "gold standard”. The discussion will also address cross-sector needs for acute NAM adoption. This session is relevant to a broad chemical space and diverse stakeholder audience including industry and federal scientists, global regulatory community, method developers, and consultancy scientists. —Presentation Schedule— The Current Status of Acute Toxicity Alternatives and Adapted Validation Strategies Using a Skin Irritation Example
Kristie Sullivan, Institute for In Vitro Sciences, Inc. Predicting Inhalation Portal of Entry Effects from Pesticides
Colin North, BASF
Application of In Vitro Methods for Skin Sensitization for Agrochemical Formulations Paving the Way Forward: Implementing NAMs for Acute Toxicity Testing —Panel Discussion —
All Speakers
—Session Chair— Tiffany Yanez Zapata, Syngenta
The regulatory standard for safety of food substances is that there must be “reasonable certainty of no harm in the minds of competent scientists when used under the intended conditions of use.” The chemical space that food substances covers is extremely broad and includes substances used for a technological purpose in the food itself, recognized essential nutrients, and substances added for other nutritional purposes. As such, the regulation provides flexibility to food manufacturers as to how reasonable certainty of no harm is established for food substances. There is broad interest in adoption of New Approach Methodologies (NAMs) as an integral part of safety evaluation across all sectors, including food. A decision to replace traditional safety studies, that have a history of regulatory acceptance, with NAMs needs to be balanced with the possibility that data generated from NAMs may not have the same degree of regulatory acceptance. While some NAMs, such as the standard genotoxicity panel, have broad scientific consensus, replacement of other safety endpoints with NAMs is still evolving science. The purpose of this interactive session is to use the collective experience of Toxicology Forum attendees to explore hypothetical examples of new food substances and identify areas of opportunity and challenges in the application of NAMs for safety demonstrations for food substances. —Presentation Schedule— Current State of NAMs in Food Substance Safety Determinations
Travis Schmit, PepsiCo
Historical Perspective on Data Used to Substantiate Food Substance Safety Introduction of the Activity Breakout Group Report Out
—Session Chairs— Travis Schmit, PepsiCo
Please be sure to register in advance for the meeting. Registration includes access to all meeting sessions, lunch, and networking receptions.
Registration Fees:
Toxicology Forum Members and Returning Nonmembers: Please sign into your profile using this link before registering. {https://toxforum.site-ym.com/login.aspx} Questions: Please contact Shannon Frohm at The Toxicology Forum, either via email or phone {1.703.547.0876} Hotel/Location: Embassy Suites by Hilton Raleigh Durham Airport Brier Creek, 8001 Arco Corporate Drive, Raleigh, North Carolina 27617 Parking: Free Refund Policy: Full Refund (minus $50 processing fee) until the COB on Friday, January 24
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10/15/2025Summer Mtg recordings available to registrants
10/15/2025Awards Nominations open
10/1/2025 » 11/21/2025
Shubik and Scott Award nominations open
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