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.
SOT FDA Colloquium—Alternative Toxicological Approaches for Process-Formed Constituents in Food
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Hosted by: SOT and US FDA Center for Food Safety and Applied Nutrition (CFSAN)
Co-Chairs:
- Steven J. Hermansky, PharmD, PhD, DABT, FDA CFSAN
- Paul Hanlon, PhD, DABT, Abbott Nutrition
Speakers:
- Dori Germolec, PhD, then-SOT Vice President, NIEHS/NTP
- Steven Hermansky, PharmD, PhD, US FDA CFSAN
- Jessica Beekman, PhD, US FDA CFSAN
- Matthew Dent, PhD, IDT, Unilever
- Lauren Robin, PhD, US FDA CFSAN
- Sean Taylor, PhD, Verto Solutions
- Paul Hanlon, PhD, Abbott Nutrition
Moderator: Paul Hanlon, PhD, DABT, Abbott Nutrition
Panelists: Speakers and Suzanne Fitzpatrick, PhD, US FDA CFSAN
Compounds such as acrylamide, 4-MEI, furan, PAH, and 3-MCPD created during food processing, including cooking at home, have been identified as constituents of food. Hundreds of such process-formed compounds have been identified in food, and improvements in analytical methodology are likely to lead to identification of more in the future. While the discovery of these compounds in food has been relatively recent, it is recognized that most have been a component of food for centuries. Never-the-less, there is increasing interest to understand the potential human health risk associated with these compounds and using risk-based prioritization, developing techniques to reduce or eliminate compounds from the diet that could be expected to pose risk to consumers. Experience with acrylamide and other process-formed compounds demonstrate that the resources expended for traditional toxicology studies are not practical for the high number of these compounds known to exist in food. Furthermore, when compounds such as these are found unexpectedly in the diet, there can be a need for a rapid risk assessment that would benefit from methods that can be executed faster than traditional in vivo methods. Thus, these compounds represent an interesting test case to leverage new approach methods (NAMS) to help risk assessors and regulators better understand the biological effects of these compounds and prioritize them for additional investigation. This colloquium brought together researchers, risk assessors, and regulators to discuss opportunities to leverage a mixture of traditional testing and NAMS to help solve real-world, complex toxicology problems.
SOT FDA Colloquium: The Evolving Science in Developmental Immunology and Immunotoxicity
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Hosted by: SOT and US FDA Center for Food Safety and Applied Nutrition (CFSAN)
Co-Chairs:
- Leigh Ann Burns Naas, Magnolia Toxicology Consulting LLC
- Patrick Crittenden, US FDA CFSAN
Speakers:
- Dori Germolec, PhD, 2023-2024 SOT President, NIEHS-NTP, Durham, NC
- Leigh Ann Burns Naas, PhD, DABT, ATS, ERT, Magnolia Toxicology Consulting, LLC
- Hollie Skaggs, PhD, Horizon Therapeutics
- Kjersti M. Aagaard, MD, PhD, FACOG, Baylor College of Medicine
- Eliver Ghosn, PhD, Emory University School of Medicine
- Fenna Sille, PhD, Johns Hopkins Bloomberg School of Public Health
Moderator: Patrick Crittenden, US FDA CFSAN
Over the past two decades the interest in developmental immunotoxicology (DIT) has grown substantially as a result of the need to more fully understand age-related susceptibility to a variety of potentially toxic compounds. The immature immune system is especially vulnerable to environmental insults, and immunotoxic exposures during critical prenatal and postnatal periods in development may lead to persistent immune dysfunction. Epidemiological evidence suggests that there is an increasing incidence of immune-mediated developmental disorders in children related to exposures to chemical substances in their environment. In recent years, the role of the microbiome in immune system development has also become evident and this extends to the role of the mother in seeding the fetal/infant microbiome both in utero and at birth, which may impact several aspects of development, including immune system maturation. Therefore, alterations in both maternal and fetal environmental exposures mediated by things such as nutrition and chemical exposure have the potential to result in varied risks to the developing immune system that can influence the risk of immune-related disease in children and adults. Understanding how to assess the risk to the developing immune system in animal studies is of high importance. As interest in DIT has grown, our understanding of the mammalian immune system has continued to swell, including a more sophisticated understanding of the developing immune system and the comparative developmental timelines across mammalian species. While the general stages of immune development are quite similar, it clear is that in terms of temporal development, a rat is not a dog is not a monkey is not a human. This makes it paramount to understand these differences when conducting and interpreting nonclinical safety studies. This colloquium presented the state of the science of developmental immunotoxicology and the challenges to supporting hazard identification and risk evaluation.
Beyond the Bench: Using Exposure Science to Promote Toxicology in Policy, Decision-Making, and Public Health
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Hosted by: SOT Exposure Specialty Section
Speakers:
- Tom Luben, PhD, US EPA
- Jane Clougherty, ScD, Drexel University
In this webinar, scientists from Drexel University Dornsife School of Public Health and the US Environmental Protection Agency (US EPA) share some basic tools and methods of exposure science, the reasons for using these methods, and how the inclusion of exposure science tenets may increase what we learn from toxicology research.
The presenters discuss:
- The usefulness of exposure science in linking toxicological research results to human populations
- Improving the applicability of exposure science to regulatory decision-making to enhance public health protections
- The iterative process by which toxicological research can inform other scientific disciplines (and vice versa) by highlighting exposure science as a common link
- The presentations also include examples of toxicological evidence successfully informing regulatory decisions and indicate useful resources from the US EPA and other federal agencies that can aid in designing future experiments.
Cultivated Meat: Regulatory & Safety Challenges for a Developing Industry
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Hosted by: SOT Biotechnology; Ethical, Legal, Forensics, and Societal Issues; and Food Safety Specialty Sections
Speakers:
- David Block, PhD, University of California, Davis Department of Chemical Engineering
- Dave Tonnuci, PhD, SciFi Foods, Inc.
- Janet Tomiyama, PhD, University of California, Los Angeles Department of Psychology
The development of cultivated meat (e.g., chicken, beef, seafood) holds the potential of solving environmental, ethical, and health challenges associated with the production and consumption of traditional animal-based foods. At the end of 2021, more than 100 companies have emerged across the globe, all aiming to provide meat without slaughtering animals. This emerging technology has, however, raised the need for the rapid development of risk assessment protocols to address the safety of these novel products adequately. In addition, many global regulatory agencies also have found themselves quickly needing to adapt and develop regulations to determine how these products can be safely manufactured, distributed, and labeled. This session aims to provide viewers with (1) an overview of the molecular methodologies and challenges in the creation of cultivated meat, (2) an examination of the regulatory and safety challenges faced by this novel industry and regulators, and (3) a brief discussion on consumer expectations on the sustainability, nutritional, and ethical considerations associated with the production of cultivated meat. This webinar consists of three presentations followed by a panel discussion moderated by the SOT Biotechnology Specialty Section Secretary/Treasurer, René Viñas, PhD, DABT, Upside Foods.
Engineering Complex Systems for Predictive Toxicology in the Animal-Free Zone
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Hosted by: SOT Risk Assessment Specialty Section
Speakers:
- Chad Deisenroth, PhD, US EPA
- Thomas B. Knudsen, PhD, US EPA
Virtual tissues are poised to provide an important bridge between high throughput assays and in vivo data to best understand mechanistic determinants of key events in various adverse outcome pathways for risk assessment. This webinar explores advances in this important arena of novel approach methods (NAMs) regarding two important adverse outcomes.
Epidemiology Should Guide Toxicology of the Exposome
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Hosted by: SOT Association of Scientists of Indian Origin Special Interest group
Speaker: Vrinda Kalia, MPH, PhD, Columbia University Mailman School of Public Health,
Environmental determinants of health need to be measured and analyzed using system approaches that account for interactions between different agents that can elicit a biological response. The exposome offers a useful framework to examine the totality of exposures and their contribution to health and disease. Advances in exposure science, analytical chemistry, molecular epidemiology, and toxicology have primed us to investigate the health effects of exposure to mixtures and concomitant exposures.
This webinar presents applications of novel approaches in exposure assessment and molecular epidemiology that can identify priority chemicals associated with health outcomes using an exposomic approach. These approaches rely on high-throughput toxicology assays that can provide causal links between exposures and outcomes discovered in observational settings. Given the vast scope and complexity of the totality of exposures, letting epidemiology guide the toxicological pursuit of the exposome will ensure that human health is the focus.
Improving the Technical Quality of New Approach Methodologies and Nanotoxicity Methods
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Hosted by: SOT Risk Assessment Specialty Section
Speaker: Elijah Petersen, PhD, National Institute of Standards and Technology
New approach methodologies (NAMs) are in vitro, in chemico, and computational approaches that can potentially be used to reduce animal testing. For NAMs that require laboratory experiments, it is critical that they provide consistent and reliable results. Similarly, there are conflicting results in the nanotoxicity literature in part due to particle-induced artifacts and biases. In this webinar, we describe an overarching technical framework that details how to add measurement quality features into a protocol and show its application to a nanocytotoxicity assay for measuring cell viability after nanoparticle exposure. In addition, we describe a guidance document published by OECD in 2020 (GD 317) describing how to apply ecotoxicity test guidelines designed for use with dissolved substances to evaluate manufactured nanomaterials.
An Introduction to Chemical Exposure Estimation
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Hosted by: SOT Exposure and Risk Assessment Specialty Sections
Speaker: Jon Arnot, PhD, Arnot Research and Consulting Inc.
Exposure data are required for chemical risk and safety assessment for the general population, consumers, and workers. It is not feasible to measure all chemicals in all exposure scenarios, and exposure models are necessarily required to address data gaps and integrate existing measurements. This webinar introduces general exposure estimation concepts, required data, data sources, and models. A systematic method for addressing uncertainty in exposure characterization is described and case examples for applying models and data to obtain exposure estimates are presented.
Mixture Assessment Factors—Motivations, Derivations and Uses
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Hosted by: SOT Risk Assessment and Mixtures Specialty Sections
Speaker: Andreas Kortenkamp, PhD, Brunel University London, Centre for Pollution Research and Policy
Mixture assessment factors have been proposed as a regulatory instrument for dealing with combined exposures to multiple chemicals. Their use is motivated by the realization that risks from combined exposures may arise even when each component in the mixture complies with its regulatory exposure limits. Since assessment factors in common use for the setting of single chemical exposure limits cannot accommodate mixture risks, an additional factor, the mixture assessment factor, is suggested to mitigate mixture risks.
This presentation provides a brief historical introduction to the genesis of the idea of a mixture assessment factor. Case studies from human toxicology and ecotoxicology are used to illustrate the need for a mixture assessment factor. Various approaches for quantitative derivations of such factors are presented and discussed. Finally, a summary of the policy context for implementing mixture assessment factors in the European Union is provided.
National Capital Area Trainee Webinar
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Hosted by: SOT National Capital Area Regional Chapter
Speakers:
- Nicole Taube, PhD candidate, Johns Hopkins University Bloomberg School of Public Health
- Haley Garbus, PhD candidate, Johns Hopkins University Bloomberg School of Public Health
- Rahul Nandre, PhD, DABT, NIH/NCATS
In this webinar, trainees and young investigators present their research on exposure to inorganic arsenic during pregnancy, formaldehyde dehydrogenase-derived formate, and a dose range finding toxicity study of VK4-116.
Programs Supporting Underrepresented Undergraduate Students in STEM
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Hosted by: SOT Faculty United for Undergraduate Toxicology Recruitment and Education Committee
This webinar provides insight from successful STEM enrichment programs at two undergraduate institutions. Federal agencies support several grant programs to retain undergraduate students on STEM pathways and into STEM-based careers. Panelists review their experiences with federally funded programs to increase and support underrepresented students in research. They also suggest practices that might be employed at other institutions as well as respond to questions.
Risk Evaluation of Nongenotoxic Carcinogenic Pharmaceuticals
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Hosted by: SOT Regulatory and Safety Evaluation Specialty Section
Speaker: Jan Willem van der Laan, PhD, Medicines Evaluation Board, European Medicines Agency Representative, ICH S1 Carcinogenicity Regulatory Chair
Within the framework of the International Council of Harmonization (ICH) on the Technical Requirements for Pharmaceuticals for Human Use, in 2012, a process called S1 was started to study the possibility of an additional approach to predict the carcinogenic potential of human pharmaceuticals within conduction of a two-year rat study. Sponsors were encouraged to submit Carcinogenicity Assessment Documents (CADs) to Drug Regulatory Authorities for all investigational pharmaceuticals with ongoing or planned two-year rat carcinogenicity studies. The submitted CAD should address a weight of evidence (WOE) approach of the carcinogenic risk of the investigational drug and provide a rationale for why the conduct of long-term studies would not add value to that assessment.
Drug Regulatory Authorities, which are members of ICH and have mutually confidential agreements, have independently reviewed the submitted documents and evaluated the degree of concordance with sponsors. Data are collected solely for real-world experience. Submitted CADs were compared to the real outcome of the two-year carcinogenicity studies. The main objective has been the assessment of accuracy of the predictions. Eventually, 48 CADs have been collected, with 24 agreed cases with the outcome of “no added value.”
This presentation discusses the strengths and weaknesses of the CADs, and the reasons why the Drug Regulatory Authorities decided to deviate from the initial categorization by the sponsor. The Expert Working Group has developed a document as an addendum to ICH-Guideline S1B, which is now finalized.
In the criteria presented as important in the WOE approach, available pharmacology and toxicology data are crucial. Rodent carcinogenicity appears to be driven by pharmacological properties in a positive as well as in a negative sense. Furthermore, chronic (six-month) toxicity data are important to predict the outcome of a carcinogenicity study. An important category for discussion is those pharmaceuticals representing a new pharmacological class, where no outcomes for congeners are known. When using this additional WOE approach, a substantial reduction in the number of two-year rat studies might be reached to accommodate the 3Rs approach.
Revised Approach for Carcinogenicity Hazard Classification: Potency and Mode-of-Action Considerations
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Hosted by: SOT Carcinogenesis Specialty Section
Speakers:
- Douglas C. Wolf, DVM, PhD, Syngenta Crop Protection LLC
- John Doe, PhD, Liverpool John Moores University School of Pharmacy and Biomolecular Sciences
The Globally Harmonized System of Classification and Labeling approach by United Nations Economic Commission for Europe (UNECE) provides a classification scheme for the labeling of products to inform consumers and workers of potential product hazards. For systemic and local endpoints, classification categories inform toxic potency based on dose and allow for an understanding of potential risk (i.e., the more toxic the chemical, the higher the risk and the greater need to prevent or reduce exposure). In contrast, carcinogens are categorized in a binary manner based on the likelihood of causing human carcinogenicity. This is determined through observation of tumors in man or animal with consideration to carcinogenic potential based on a mutagenic mode of action. The dose, duration of exposure, and non-mutagenic modes of action that produce tumors are not considered in the categorization. A carcinogenic outcome depends on the context of exposure as well as the mode of action of the particular chemical under a repetitive dose-exposure scenario; thus, there is a significant opportunity to improve hazard classification to properly communicate potential concern from exposure to chemicals that are carcinogenic. This webinar proposes a new approach for carcinogenicity classification based on mode of action and dose ranges associated with a carcinogenic response.
The webinar consists of two 20-minute presentations and a 20-minute moderated question/answer session with the speakers.
Silicone Wristbands Personal Exposure Monitors to Help Support Research on the Exposome
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Hosted by: SOT Risk Assessment and Exposure Specialty Sections and the International Society of Exposure Science
Speaker: Heather M. Stapleton, PhD, Duke University Nicholas School of the Environment
This talk highlights current research that utilizes silicone wristbands to measure the external exposome, discussing the strengths and weaknesses of these wearable sensors. In addition, this talk highlights research that has used silicone wristbands to understand associations with internal dose and exposures over different life stages, to support One Health, and in occupational and non-occupational settings.
A Clinically Focused and Integrated Look at the Impact of Wildfire on the Cardiovascular-Pulmonary Systems
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Hosted by: SOT Cardiovascular Toxicology and Inhalation and Respiratory Specialty Sections and the SOT Collaborative Conferences Committee
Speakers:
- Sanjay Rajagopalan, MD, Case Western Reserve University
- Matt Campen, PhD, University of New Mexico
- Mary Rice, MD, Beth Israel Deaconess Medical Center
Exposure to ambient air pollution is a leading cause of death worldwide. It has been linked globally to seven million premature deaths and $5 trillion in costs per year. Air pollution exposure emerged as a leading cause of death worldwide that affects lung and cardiovascular functions and increases the risk for pulmonary and cardiovascular events. Although policies on the regulations of air pollution have decreased the levels of polluted air, due to climate change, the abundance of wildfires has increased. In the US, it is expected that, with the continuing climate change, the number of wildfires will increase by 50% by the year 2100. Climate change has not only extended the duration of the wildfire season but also led to more intensive wildfires due to extensive dry periods in the US and Europe.
Wildfire smoke consists of a mixture of gaseous components (e.g., carbon monoxide), polycyclic aromatic hydrocarbons, water vapor, and particulates, with particulate matter air pollution being the main component. These particles vary in shape and size and are made up of different components, such as inorganic and organic compounds, metals, and biological materials. Importantly, the harmful materials that are released by wildfires are not only a local hazard. On the contrary, they spread over hundreds of kilometers, such as the wildfires that swept through North America during 2021 that affected many parts of the United States and Canada.
This webinar provides a comprehensive overview that summarizes novel aspects and new clinical insights to understand the adverse effects of air pollutant exposure on cardiovascular and pulmonary health associated with wildfires.
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