Many of the webinars hosted by SOT Regional Chapters, Special Interest Groups, and Specialty Sections—collectively known as the SOT Component Groups—are recorded and added to the SOT Video Library so that SOT members and others can watch these valuable presentations at any time. SOT Committees, the Postdoctoral Assembly, and Graduate Student Leadership Committee also host webinars that are recorded. In this blog, you will find a listing of all the recent webinar recordings that have been added to the SOT Video Library.
Advancing the Science of PFAS Mixtures Assessment
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Hosted by: SOT Risk Assessment and Mixtures Specialty Sections
Speaker: Jason C. Lambert, PhD, US EPA/ORD
An evolving landscape of per- and polyfluoroalkyl substances (PFAS) co-occur in environmental media such as water; however, there are few studies or assessments of human health risks associated with exposure to mixtures of PFAS. The peer-reviewed literature to date suggests that mixtures of PFAS pose health risks greater than each substance on its own. As such, the US EPA Office of Water and Office of Research and Development have developed a draft “Framework for Estimating Noncancer Health Risks Associated with Mixtures of Per- and Polyfluoroalkyl Substances (PFAS).” This draft framework leverages existent US EPA component-based mixture assessment approaches, such as the hazard index, relative potency factors, and a mixture benchmark dose approach. The draft framework also advances approaches for the integration of new approach methodology–based data for data-poor mixture component PFAS. This framework, once final, will provide US EPA partners and stakeholders with flexible approaches needed to evaluate potential health risks associated with exposure to mixtures of PFAS in environmental media.
Advancing Toxicology in Drug Discovery Using Generative Adversarial Networks
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Hosted by: SOT Drug Discovery and Computational Toxicology Specialty Sections
Speakers:
- Weida Tong, PhD, US FDA National Center for Toxicological Research
- Zhichao Liu, PhD, Boehringer Ingelheim
Toxicological research is undergoing a transformative shift with the incorporation of advanced computational models. Among these, Generative Adversarial Networks (GANs) are emerging as a pivotal tool in addressing challenges associated with data scarcity, predictability, and the nuanced complexity of toxic responses. This webinar delves into the integration of GANs into toxicology, from their foundational principles to applications in drug discovery. It provides insights into the capabilities and potential of GANs, fostering a better understanding of their role in modern toxicological studies. This webinar caters to both novices and experts in the intersection of toxicology and generative artificial intelligence.
Carcinogenomics—Assessing the Tumorigenic Potential of Chemicals Through Genomic Biomarkers to Reduce the Reliance
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Hosted by: SOT Carcinogenesis Specialty Section
Speakers:
- Chris Corton, PhD, US EPA
- Connie Mitchell, MS, HESI
- Udayan Apte, PhD, University of Kansas Medical Center
As part of the safety assessment for new agrochemicals and pharmaceuticals, the rodent cancer bioassay has been a long-required study for regulatory assessment of carcinogenic hazard and risk. There is growing recognition across broad sectors of the scientific community that the use of genomic biomarkers has the potential to reduce the need for conventional rodent carcinogenicity studies of industrial chemicals, agrochemicals, and pharmaceuticals through a weight of evidence approach. The goal of this research is to construct and qualify liver transcriptomic biomarkers of key molecular initiating events in short-term rat studies that inform on liver tumorigenic risk in the rodent cancer bioassay. This webinar describes a collaborative approach launched to develop and qualify biomarker gene expression panels that measure widely accepted molecular pathways linked to tumorigenesis and their activation levels to predict tumorigenic doses of chemicals from short-term exposures. Success from these efforts will facilitate the transition from current heavy reliance on conventional rodent cancer bioassays to more rapid animal-and-resource-sparing approaches for mechanism-based carcinogenicity evaluation, supporting internal and regulatory decisions.
Career Development and Mentoring
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Hosted by: SOT Inhalation and Respiratory Specialty Section
Speakers:
- Beth Tigges, PhD, University of New Mexico
Dr. Tigges is a Professor and Regents’ Professor at the University of New Mexico College of Nursing. Dr. Tigges’ major areas of interest and research are evaluation of research centers, team science, collaboration, community engagement, and mentoring. She addresses mentoring trainees and early career faculty and its impact on organizational climate in academic research centers.
- Laura Van Winkle, PhD, University of California Davis
Dr. Van Winkle is a Professor of Anatomy, Physiology, and Cell Biology at the University of California Davis. Dr. Van Winkle is an established inhalation toxicologist, the Chair of a graduate program, and Director of an NIH T32 grant in environmental health sciences. Dr. Van Winkle addresses strategies for good mentoring relationships for both mentees and mentors.
Innovations in Exposure and Mixture Assessment Approaches
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Hosted by: SOT Risk Assessment and Exposure Specialty Sections and The International Society of Exposure Science
Speakers:
- Zach Stanfield, PhD, US EPA
"Using Biomonitoring Date to Infer Chemical Exposures and Inform High- Throughput Exposure Predictions"
Knowing which environmental chemicals contribute to metabolites observed in humans is necessary for meaningful estimates of exposure and risk from biomonitoring data. In this work, we set out to employ a high-throughput, chemical-independent modeling approach to estimate chemical daily intake rates with well-quantified uncertainty. Bayesian methodology was used to infer ranges of exposure for parent chemicals of biomarkers measured in urine samples from the National Health and Nutrition Examination Survey (NHANES). Metabolites were probabilistically linked to parent chemicals using the NHANES reports and text mining of PubMed abstracts. Chemical exposures were estimated for various population groups and translated to a risk-based metric for prioritization using toxicokinetic modeling and experimental data. Exposure estimates were investigated more closely for children aged three to five years, a population group that debuted with the 2015–2016 NHANES cohort. The methods described here have been compiled into an R package called bayesmarker and made publicly available on GitHub. These inferred exposures can help aid in the identification of public health priority chemicals and be used to evaluate high-throughput exposure models.
- Kyle P. Messier, PhD, NIEHS
“GeoTox and RGCA: Developing Extensible Software for Geospatial Exposure and Risk Assessment of Chemical Mixtures”
Comprehensive environmental risk characterization, encompassing physical, chemical, social, ecological, and lifestyle stressors, necessitates innovative approaches to handle the near infinite complexity. Individual and population-level variability in biological response to real-world exposures further magnifies the combinatorial challenges. In this seminar, we discuss the development of two software packages to support environmental exposure and risk assessment for individuals and populations. First, we introduce GeoTox, an open-source R software package in development for characterizing the risk of perturbing molecular targets involved in adverse human health outcomes based on exposure to spatially referenced stressor mixtures. Second, a key step of mixture risk characterization is predicting the combined response, which is typically derived from sparse information on individual stressor responses. Reflected Generalized Concentration Addition (RGCA) is a software and statistical approach that extends the Generalized Concentration Addition method for mixtures predictions to allow for 3+ parameter sigmoidal concentration-response models. With an objective toward software extensibility, we demonstrate the GeoTox usage in building computational workflows for individual and population-level exposure and risk assessment. The GeoTox package represents a significant advancement in environmental risk characterization, providing modular software to facilitate the application and further development of the GeoTox framework for quantifying the relationship between environmental exposures and health outcomes. RGCA will be interoperable with GeoTox, allowing a flexible approach for the combined mixture prediction step in the risk characterization. By integrating geospatial methods with cutting-edge exposure and toxicological frameworks, GeoTox and RGCA offer robust tools for assessing individual and population-level risks from combined environmental stressors.
iPSC-Derived Retinal Pigment Epithelium Replacement Therapy for Macular Degeneration: From Bench to Bedside
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Hosted by: SOT Ocular Toxicology Specialty Section
Speaker: Arvydas Maminishkis, PhD, MD, NIH National Eye Institute
Induced pluripotent stem cells (iPSCs) can provide autologous and allogeneic replacement tissues. Autologous tissues have the advantage of not requiring immune-suppressive drugs that are known for their side effects. However, feasibility of autologous iPSC-based therapies hasn’t been established. Here, we developed an autologous iPSC-based therapy for age-related macular degeneration (AMD), a blinding eye disease that affects over 30 million people worldwide. AMD is caused by the progressive degeneration of retinal pigment epithelium (RPE), a monolayer tissue that maintains photoreceptor function and survival. Combining developmental biology with tissue engineering, we developed clinical-grade iPSC-derived RPE-patch on a biodegradable scaffold. This patch performs key RPE functions like photoreceptor phagocytosis, water transport, and polarized cytokine secretion. We confirmed the safety of this patch in an immune-compromised rat model and confirmed its efficacy in a swine RPE injury model. A phase I/IIa Investigational New Drug application for iPSC-derived ocular tissue to treat AMD was recently cleared by the US FDA. This Phase I/IIa clinical trial will test safety, feasibility, and integration of an autologous iPSC-derived RPE-patch in twelve advanced AMD patients. This work is helping leverage other similar autologous cell therapies in various other degenerative diseases.
My Path in Toxicology: To the Cosmetics Industry and Beyond
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Hosted by: SOT Association of Scientists of Indian Origin (ASIO) Special Interest Group
Speaker: Prajakta Shimpi, PhD, ERT, DABT, L’Oréal
There are a number of avenues available for a toxicologist. However, some opportunities or fields are less well-known to graduate students and postdocs. Respected ASIO member Prajakta Shimpi shares her perspectives and provides information about alternative careers in toxicology. Dr. Shimpi also discusses her experiences and career trajectory as a Senior Scientist in Toxicology at L’Oréal to provide an inside point-of-view on possible career paths.
Strategies for Boosting Student Undergraduate Engagement in the Classroom
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Hosted by: SOT Faculty United for Toxicology Undergraduate Recruitment and Education (FUTURE) Committee for the Undergraduate Educator Network
Speakers:
- Chris Curran, PhD, Northern Kentucky University
- Mindy Reynolds, PhD, Washington College
Within STEM, many educators at the undergraduate level have found themselves grappling with a noticeable decline in student engagement. This challenge has prompted educators to explore innovative approaches aimed at reigniting interest and enhancing the overall learning experience in their classrooms. This webinar highlights two examples of creative teaching techniques implemented by faculty teaching undergraduate toxicology and STEM courses to try to better engage their undergraduate students throughout the course of the semester.
Toxicological Risk Assessment of Medical Device Constituents: Consistent Application through Comprehensive Review—Part 1 “Biological Risk Management: Hazard Identification and Derivation of Tolerable Intake Values”
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Hosted by: SOT Medical Device and Combination Product Specialty Section
Speakers:
- Sherry Parker, PhD, SParker Toxicology Consulting LLC
- Todd Kennedy, PhD, DABT, WL Gore and Associates Inc.
- Alan Hood, PhD, US FDA
Chemical characterization of medical devices is conducted following the requirements and guidance in ISO 10993-18:2020. The purpose of generating an extractables profile of chemical constituents is to support a toxicological risk assessment that addresses systemic toxicity (acute, subacute, subchronic, and chronic), genotoxicity, carcinogenicity, and reproductive/developmental toxicity. Chemical characterization includes screening, through exaggerated or exhaustive extractions and non-targeted analytical methods, that often produces hundreds of extractables. ISO 10993-17:2023 provides new requirements and guidance for assessing toxicological risk of medical device extractables data that reduces the burden of conducting toxicological risk assessments. In this first part of a two-part webinar, the requirements and guidance related to hazard identification, including when and how to apply a toxicological screening limit (TSL) to prioritize chemicals for toxicological risk assessment, what factors to consider when deriving tolerable intake (TI) values, and when and how to apply the Threshold of Toxicological Concern (TTC) are presented. The selection and documentation of the point of departure (PoD), the use of appropriate uncertainty factors, and special considerations for infants six months or younger in accordance with ISO 10993-17:2023 are presented.
Toxicological Risk Assessment of Medical Device Constituents: Consistent Application through Comprehensive Review—Part 2 “Biological Risk Management: Calculating Estimated Exposure Dose and Margin of Safety Values”
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Hosted by: SOT Medical Device and Combination Product Specialty Section
Speakers:
- Sherry Parker, PhD, SParker Toxicology Consulting LLC
- Todd Kennedy, PhD DABT, WL Gore and Associates Inc.
- Alan Hood, PhD, US FDA
In this second part of a two-part webinar, the factors to consider and methods for calculating chemical specific worst-case estimated exposure doses (EEDmax) and margin of safety (MoS) values are presented. The application of EEDmax and MoS in accordance with ISO 10993-17:2023, based on the relevancy of the generated extractables data to the medical device intended use, for time-period specific exposures and harms of chemical substances are presented. To facilitate understanding of ISO10993-17:2023, the webinar concludes with examples in which ISO 10993-17:2023 approaches are demonstrated.
Understanding the US FDA Guidance on Nonclinical Evaluation of Immunotoxic Potential in Pharmaceuticals: Implications and Insights
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Hosted by: SOT Biotechnology and Immunotoxicology Specialty Sections
Speaker: David McMillan, PhD, DABT, US FDA Division of Pharmacology/Toxicology for Infectious Diseases
- Mary Ellen Cosenza, PhD, DABT, RAC, ERT, Fellow ATS, MEC Regulatory & Toxicology Consulting LLC
- Florence Burleson, PhD, Burleson Research Technologies
- Wendy Freebern, PhD, J&J Innovative Medicine
The pharmaceutical industry is constantly evolving, driven by advances in scientific knowledge and regulatory expectations. A pivotal aspect of drug development is the assessment of potential immunotoxic effects caused by pharmaceutical compounds. To provide clarity and consistency in this area, the US Food and Drug Administration (US FDA) released the “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals” guidance document. This webinar aims to provide the rationale behind the document, elucidate the key elements of this guidance, and engage in a panel discussion about its anticipated impact on drug development strategies. The speaker focuses on the rationale for the document and highlights the scope, objective, and key considerations. The panel discussion focuses on key areas such as (1) practical implications of the new guidance; (2) influence on study designs, nonclinical testing strategies, and the overall drug development process; and (3) challenges and opportunities for the new guidance.
Weight of Evidence Approach to Assess the Human Carcinogenic Risk of Pharmaceuticals: Overview of The ICH S1B Addendum and Implementation
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Hosted by: SOT Women in Toxicology Special Interest Group and Carcinogenesis Specialty Section
Speakers:
- Alisa Vespa, PhD, Pharmaceutical Drugs Directorate, Health Canada Representative
- Arianna Bassan, PhD, Innovatune
To assess the human carcinogenic risk of a small molecule pharmaceutical, carcinogenic potential is typically evaluated in two-year rat carcinogenicity study as well as a second rodent carcinogenicity study conducted in mice (two-year or short term). As a result of an independent prospective study conducted under the auspices of ICH, the testing scheme is being expanded to include a weight of evidence (WOE) approach, which is based on a comprehensive assessment of various weight of evidence factors, to inform if the conduct of a two-year rat study will or will not add value to the assessment of human carcinogenic risk. This session provides an overview of the WOE approach described in the ICH S1B Addendum. Since there is no “one size fits all” approach for the novel strategy described in the ICH S1B Addendum, its application must be tailored to the specific pharmaceutical being evaluated. To guide such a complex integrated assessment, more than 40 experts from different organizations have joined in an effort to establish a pragmatic consensus procedure supporting the ICH S1B WOE carcinogenicity assessment. This presentation also describes the process of this international working group, whose aim is to pragmatically standardize a procedure that frames the ICH S1B human carcinogenicity assessment. The resulting pragmatic consensus procedure is meant to serve both as a guide to organizing the studies and displaying the data in the proper format as well as to clarify what would be expected in terms of the types of integrated evidence to be presented in the Carcinogenicity Assessment Document.
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