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.
Biological Evaluations for European Union Medical Device Regulation: Challenges, Experiences, and Tips
Hosted by: SOT Medical Device and Combination Product Specialty Section
Speakers:
- Lina Burman, PhD, Senior Scientific Affairs Manager, Biocompatibility and Toxicology, Veranex
- Monica Grekula, ERT, MSc, Senior Director Scientific Affairs, Biocompatibility and Toxicology, Veranex
Adapting the biological evaluation to the market you want to put your product in is sometimes called regulatory toxicology. While there are usually underlying reasons for the approval requirements, they are sometimes difficult to interpret. The ultimate goal is to have safe products while also gaining quick market access. This webinar offers perspectives from speakers based in Europe who have extensive experience in working with different Notified Bodies and products of different risk classes. They also highlight how the requirements differ from the US Food and Drug Administration and share challenges and experiences gathered during their time as consultants in the field.
Emerging Threats to Indoor Air Quality (IAQ) and Human Health
Hosted by: SOT Inhalation and Respiratory Specialty Section
Speakers:
- Cristi Bell-Huff, PhD, Research Manager, Chemical Insights Research Institute of UL Research Institutes
- Christa Wright, PhD, Research Director, Chemical Insights Research Institute of UL Research Institutes
According to the US Environmental Protection Agency (US EPA), most Americans spend 90% of their time indoors. Although outdoor air pollution is thought to be a primary public health concern, short- and long-term exposure to indoor air pollutants may have profound effects on human health and well-being. Recent studies have shown indoor air contaminants consisting of biological or chemical pollutants can lead to a variety of health conditions, including increased susceptibility to infections and chronic respiratory conditions such as asthma and lung cancer. In this webinar, the speakers highlight threats to indoor air quality that stem from the use of various consumer products, such as emissions from 3D printers and electronic nicotine delivery systems (ENDS) or e-cigarettes. Additionally, they describe how extreme heat events propagated by climate change may also jeopardize indoor air quality.
Exploring Careers in Translational Toxicology: The Life of a Clinical and Translational Toxicologist
Speakers:
- Hartmut Jaeschke, PhD, ATS, FAASLD, University Distinguished Professor, Chair of Pharmacology, Toxicology & Therapeutics, University of Kansas Medical Center
- James Dear, PhD, FRCP, Professor, Personal Chair of Clinical Pharmacology, Deanery of Clinical Sciences, University of Edinburgh
- Nena Bowman, PharmD, DABAT, Managing Director and Adjunct Faculty, Tennessee Poison Center and Vanderbilt University Medical Center
- Shashi Ramaiah, DVM, PhD, DACVP, DABT, Vice President, Global Head of Discovery, Investigative and Translational Sciences, Pfizer
One of the major challenges facing human toxicology research is bridging the gaps between scientific discovery and human health—as it is often hindered by limitations in model systems or applicable results. To meet the responsibilities of toxicologists to carry out studies connecting science to human medicine, the spectrum of translational toxicology research has since expanded to closely integrate research to human health. As a main pillar of translational research, clinical research and implementation has since evolved to encompass a wide range of applications in toxicology studies.
This webinar explores the current career possibilities in clinical toxicology while highlighting future prospects in incorporating translational methodologies into toxicology research practices. During this session, panelists target key elements of clinical translational toxicology through
- Highlighting their career trajectory in parallel with evolving research interests
- Addressing the responsibilities and tasks of their respective positions
- Discussing current job prospects and strategies for finding the best fit in the field.
Along with sharing narratives from current clinical and translational toxicologists, the objectives of this webinar are on how trainees and early career scientists can integrate clinical toxicology into their careers and the role of clinical and translational toxicologists in an interdisciplinary framework. The webinar consists of presentations from clinical and translational toxicologists from academia, industry, regulatory, and medical institutes; a discussion of current job prospects available and growing; and questions from the audience.
General Considerations of Using Nonhuman Primate in Nonclinical Ocular Drug Research
Hosted by: SOT Ocular Toxicology Specialty Section
Speaker: Eric (Wankun) Xie, MD, PhD, Director of Ophthalmology, JOINN Laboratories
Nonhuman primate (NHP) is widely used in the nonclinical research of ocular drugs due to its unique anatomy and physiology. In this webinar, we discuss the basic biology of the NHP eye compared to human and other species (rabbit and rodents) in anatomy and physiology, as well as the advantages and concerns of using the NHP eye in preclinical ocular research and drug discovery. We share major background findings in ocular toxicity studies in different types of test articles (biologics and gene therapy) in different species. The origin and principle of immunogenicity in preclinical ocular studies will be discussed, along with representative images of ocular immunogenicity findings and experience in risk mitigation strategies. We introduce NHP ocular disease models and present examples of using these models for efficacy studies with different routes of administration. We also discuss the ophthalmic endpoints for ocular efficacy and toxicity studies and present typical ocular findings related to the immune and test articles. Additionally, we briefly discuss the differences in toxicological study practices in the US and China. Lastly, we summarize our ocular study capabilities and experience at both sites, including efficacy and toxicology studies.
Hazard Characterization and Grouping of PFAS Using a Compendium of Human Cell Lines from Different Organs
Hosted by: SOT Risk Assessment Specialty Section
Speaker: Lucie Ford, PhD Student, Interdisciplinary Faculty of Toxicology, Texas A&M University
Per- and poly-fluoroalkyl substances (PFAS) are extensively used in commerce, leading to their prevalence in the environment. Due to their chemical stability, PFAS are considered persistent and bioaccumulative; they are frequently detected in both the environment and humans. Because of this, PFAS as a class (composed of hundreds to thousands of chemicals) are contaminants of very high concern. Little information is available for the vast majority of PFAS, and regulatory agencies lack safety data to determine whether exposure limits or restrictions are needed. Cell-Based assays are a pragmatic approach to inform decision-makers on potential health hazards; therefore, we hypothesized that a targeted battery of human in vitro assays can be used to determine whether there are structure-bioactivity relationships for PFAS and to characterize potential risks by comparing bioactivity (points of departure) to exposure estimates. We tested 56 PFAS from eight structure-based classes in concentration response (0.1-100 μM) using six human cell types selected from target organs with suggested adverse effects of PFAS—human-induced pluripotent stem cell (iPSC)–derived hepatocytes, neurons, and cardiomyocytes; primary human hepatocytes; endothelial cells; and HepG2 cells. While many compounds were without effect, certain PFAS demonstrated cell-specific activity highlighting the necessity of using a compendium of in vitro models to identify potential hazards. No class-specific groupings were evident except for some chain length- and structure-related trends. In addition, margins of exposure (MOE) were derived using empirical and predicted exposure data. Conservative MOE calculations showed that most tested PFAS had an MOE in the 1–100 range; ~20% of PFAS had MOE<1, providing tiered priorities for further studies. Overall, we show that a compendium of human cell–based models can be used to derive bioactivity estimates for a range of PFAS, enabling comparisons with human biomonitoring data. Furthermore, we emphasize that establishing structure-bioactivity relationships may be challenging for the tested PFAS.
Interindividual Variability Assessment through Application of Machine Learning with In Vitro Molecular Profiles to Understand Key Mechanisms of Emerging Inhaled Toxicants
Hosted by: SOT Risk Assessment Specialty Section
Speaker: Elise Hickman, PhD, Postdoctoral Fellow, Department of Environmental Sciences and Engineering, University of North Carolina at Chapel Hill
Human health risks are known to significantly vary across individuals in a population. However, it can be difficult to model and identify factors underlying this interindividual variability. The use of in vitro systems that utilize cells isolated directly from a range of individual human donors (i.e., “primary” cells) provides a novel opportunity to simultaneously increase the physiological and public health relevance of in vitro new approach methodologies. At the same time, technological advances have made measuring molecular signatures in experimental samples much more feasible and affordable, but analyzing overall differences in molecular signatures between groups and extracting meaningful biological conclusions from these signatures can be challenging. Here, we highlight examples of recent efforts leveraging supervised and unsupervised machine learning to understand key biological mechanisms of inhaled toxicants and interindividual variability in response to inhaled toxicant exposure. Our research team has successfully applied machine learning to address (1) whether there are overall differences in human respiratory protein profiles in users of different types of e-cigarette devices, (2) whether these protein profiles in e-cigarette users are similar to protein profiles found in subjects with chronic obstructive pulmonary disease (COPD), and (3) identification of variables underlying interindividual variability in response to acrolein exposure using benchmark dose-response analyses of data derived from an in vitro co-culture model of the respiratory system. Notable findings from these studies include demonstration that users of newer e-cigarette devices have distinct overall mediator profiles that share some similarities with COPD subjects and potential sex-based differences in in vitro response to acrolein exposure. Future studies will continue to incorporate in vitro screening using primary cells to understand and quantify health risks and identify susceptible populations through incorporation of advanced machine learning approaches.
Nitrosamine Potency Prediction: Reviewing the Carcinogenic Potency Categorization Approach
Hosted by: SOT Regulatory and Safety Evaluation Specialty Section
Speaker: Kevin Cross, PhD, Vice President, Regulatory Science, and PI, USA FDA Collaborations, Instem
Predicting N-nitrosamine potency for acceptable intake limits for compounds without rodent carcinogenicity assay data is challenging. However, in July 2023, the US Food and Drug Administration, European Medicines Agency, and Health Canada released updated guidelines describing an enhanced Ames test protocol suitable for hazard assessment of N-nitrosamines as well as a Carcinogenicity Potency Categorization Approach for calculating a categorical acceptable intake limit using an algorithm based upon the Structure Activity Relationship (SAR) for N-nitrosamine activity. In this webinar, this algorithm is reviewed in order to provide the audience with a view to how predictive structure-activity relationships can distinguish nitrosamine classes with different potency, thus enabling the development of acceptable intake limits.
Risk Assessment Syllabus: Overview of Regulatory Standards and Guideline Reference Values
Hosted by: SOT Risk Assessment Specialty Section (RASS)
Speakers:
- George Woodall, PhD, Toxicologist, US EPA
- Rachel Shaffer, PhD, Epidemiologist, US EPA
Moderator:
- Peter Goering, PhD, DABT, ATS, Retired, US FDA
Panelists:
- Richard Becker, PhD, DABT, American Chemistry Council
- Virunya Bhat, PhD, DABT, ATS, World Health Organization
- Jason Aungst, PhD, US FDA
The “Risk Assessment Syllabus” is a training series that complements the monthly RASS webinar series. The objective of the Syllabus is to provide participants with an introduction to the fundamental concepts and terminology associated with chemical risk assessment, as well as a practical perspective on the application of risk assessment principles to inform decision making. This training provides an overview of regulatory standards and guideline reference values.
You Got Your First Dream Job! Now What? Promotions, Negotiations, Management, and Networking
Hosted by: SOT Education and Career Development Committee
Panelists:
- Julie Castaneda, PhD, Pharmacology/Toxicology Reviewer at the US FDA
- Kimberly Norman, PhD, DABT, ERT, Senior Director, Safety and Regulatory Toxicology at Persona Care Products Council
- Phoebe Stapleton, PhD, Associate Professor, Department of Pharmacology and Toxicology at Rutgers, The State University of New Jersey
- Ray Zhang, PhD, DABT, Director at Neuron23
Moderators:
- Toufan Parman, PhD, DABT, Senior Director, Nonclinical Safety Evaluation at Sangamo Therapeutics
- Alexandra Noël, PhD, Associate Professor, Comparative Biomedical Sciences at Louisiana State University
- Ashley Woolard, PhD, Manager, Product Safety Group at Amway Innovation & Science
Maybe you are in an exciting, brand-new job or maybe you have already settled into a position for a few months or a couple of years, but your story does not end there. Have you heard of two- or five-year plans? Do you know what your next steps are now that you have your new job? To get to the next steps, you need to understand how promotions work, how to negotiate a promotion or salary, and how to manage up and network to move up the ladder.
This webinar provides the tools to use during these processes. The panelists are early- and mid-career individuals from academia, government, a contract research organization, and industry who have gone through this process and are willing to share their valuable experiences.
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