SOT Component Groups (Regional Chapters, Special Interest Groups, and Specialty Sections) and Committees host webinars throughout the year. Webinars are an effective distance-learning method intended to impart scientific knowledge to members of each group as well as the SOT membership at large. These webinars are just one of the many benefits of SOT membership.
Upcoming webinars for February and March 2020 are listed here.
US FDA Experience in the Regulatory Application of (Q)SAR Modeling
Date and Time: Wednesday, February 5, 2020, 11:00 AM–12:00 Noon (ET)
Host: Computational Toxicology Specialty Section (CTSS)
Registration is required.
Speaker:
Naomi Kruhlak, PhD
US FDA/CDER
The US Food and Drug Administration (US FDA) actively promotes and supports research into state-of-the-art computational toxicology approaches including (quantitative) structure-activity relationship, also known as(Q)SAR, modeling for regulatory decision-making. Within the US FDA Center for Drug Evaluation and Research, a significant focus of this research is on the safety assessment of drug impurities under the ICH M7 Guideline, where a (Q)SAR prediction can be used as an alternative to empirical testing to assess mutagenic potential. The successful implementation of the ICH M7 Guideline has led to the development of best practices for the conduct of (Q)SAR analyses, evaluation of model outputs, and submission of (Q)SAR data to regulators. Building on this success, new opportunities for the regulatory application of (Q)SARs are being explored for other endpoints, including carcinogenicity and endocrine disruption, as well as for other components of US FDA–regulated products beyond impurities.
This presentation will provide an in-depth look at current regulatory practice and expectations for the use of (Q)SAR models under ICH M7, as well as highlight emerging applications of the methodology to chemical entities and endpoints of regulatory importance to the US FDA.
Challenges and Opportunities in Assessing Health Risk from Unconventional Oil and Gas Development
Date and Time: Wednesday, February 12, 2020, 3:00 PM–4:30 PM (ET)
Host: Risk Assessment Specialty Section (RASS), co-sponsored with the International Society for Exposure Science
Registration is not required.
Speaker:
Donna Voorhees, PhD
Director of Energy Research
Health Effects Institute (HEI)
Boston, MA
Onshore development of oil and natural gas from unconventional resources (unconventional oil and gas development, abbreviated in this presentation as “UOGD”) has expanded rapidly in the United States during the last decade and concern about its potential health effects along with it. While UOGD shares many attributes of conventional oil and gas development that has been around since the 1800s, it is occurring in locations and at a scale not always familiar to those living nearby. This presentation will summarize methodologic challenges and opportunities in understanding the potential for health effects, especially through risk-based analyses.
Beginning in 2012, academic scientists and public health authorities published human health risk assessments and risk-based screening assessments that combined information about potential UOGD-related chemical concentrations with relevant toxicity information to predict risk to communities in Colorado, North Dakota, Pennsylvania and the broader Marcellus region, Texas, and Wyoming. Nearly all assessments quantified risk to community members associated with potential exposure to UOGD-related chemicals in air, but several assessed risks involving water. Assessments varied in their complexity, from screening-level comparisons of chemical concentrations, to health-based benchmarks, to more involved assessments measuring potential exposure specific to a population, including control for baseline, or background, conditions. Conclusions differed among the risk assessments and were subject to important sources of uncertainty about exposure and toxicity and the judgments made by investigators to address them. The body of work also was limited in its relevance to operations, regions, and populations beyond those that were the subject of each assessment. Future investigators must grapple with the extensive temporal and spatial variability in potential exposure as a function of numerous factors (e.g., differences in regulations, environmental conditions, and practices among UOGD operators), the uncertainties about potential exposure (e.g., when and where will operations happen, the identity of chemicals being used, and the efficacy of noise mitigation), and the lack of toxicity information for some chemicals associated with UOGD operations.
Modernization of Cancer Risk Assessment
Date and Time: Wednesday, February 19, 2020, 11:00 AM–12:00 Noon (ET)
Host: Carcinogenesis Specialty Section (CSS)
Registration is required.
Speaker:
Warren Casey, PhD
NIEHS/NTP
Presentation Title: Advances in Carcinogenicity Assessment at the National Toxicology Program
Since the early 1980s, the US National Toxicology Program has served as a national and world resource for conducting the two-year rodent bioassay to assess the (human) carcinogenic potential of industrial and agricultural chemicals, food additives, environmental pollutants, and other exposures of public health concern. However, the acknowledged limitations of the rodent bioassay include high cost, extensive time to conduct and report, and limited translational relevance. In building on its history of innovation, excellence, and impact, the National Toxicology Program is now leading the development of a new framework for assessing human cancer risk from environmental exposures. This talk will discuss the approaches being developed to better understand and interrogate the initiation/promotion and progression processes of human carcinogenesis as well as the etiology of a set of human cancers potentially associated with environmental exposures. The rationale for selecting these specific cancer targets and progress made on developing the associated adverse outcome pathways will be discussed. Other topics covered will include a description of ongoing efforts to develop a suite of in vivo, in vitro, and in silico approaches to screen and prioritize substances, utilization of longitudinal human cancer data, and opportunities for future engagement with stakeholders.
Speaker:
Sabitha Papineni, DVM, PhD
Corteva Agriscience
Presentation Title: ReCAAP—Carcinogenicity Case Study Waivers for Food-Use Pesticide Registration
Reviews of the rodent cancer bioassay over the past 40 years have raised questions about its relevance and regulatory need to assess risk to human health. As a result, a working group composed of experts from government, industry, and nongovernment organizations has formed the Rethinking Carcinogenicity Assessment for Agrochemicals Project (ReCAAP) to evaluate the appropriateness of waiving rodent bioassays for the registration of food-use pesticides. This presentation will provide case study examples of carcinogenicity waivers formulated through a weight-of-evidence-based (WoE) approach. The WoE includes information on pesticide exposure, mode of action, physiochemical properties, and subchronic toxicological data from defined endpoints. The results of these WoE reviews will be used to establish the criteria for when the mouse and/or rat cancer bioassay can be waived with sufficient confidence to protect public health.
Nonclinical Safety Strategies for Gene Therapy
Host: Drug Discovery Toxicology Specialty Section (DDTSS)
Date and Time: Tuesday, February 25, 2020, 11:00 AM–12:00 Noon (ET)
Registration is required.
Speakers:
Timothy Maclachlan
Executive Director
PCS TA Head
New Indications Discovery Unit
Novartis
Kelly Flagella
Executive Director Toxicology
Ultragenix
Gene therapy has been a hot topic these recent years, with the first approvals allowing patients to be successfully treated. This increased interest in gene therapy resulted in a lot of potential therapies in preclinical and clinical development.
This webinar will cover the basis of what gene therapy is and the main toxicology concerns and considerations that need to be investigated when developing a nonclinical safety package.
Immunotoxicology: History and Current Advances
Host: American Association of Chinese in Toxicology (AACT)
Date and Time: Tuesday, February 25, 2020, 2:00 PM–3:00 PM (ET)
Registration is required.
Speaker:
Kenneth L. Hastings, DrPH, DABT, ATS
Hastings Toxicology Consulting LLC
Immunotoxicology research and testing have evolved from early studies of anaphylaxis to the robust and diverse field of immunotoxicology as we know it today. Early studies connecting immune dysfunction with exposure to exogenous agents focused on adverse reactions to vaccines, industrial chemicals, and ionizing radiation. Over time, immunologists described the fundamental mechanisms of immunogenic agents as well as understanding the concept of immunosuppression. These myriad achievements greatly improved public health and led to the development of immunotoxicology methods to determine all types of adverse immunological responses to designed agents such as drugs and biologics.
Transitioning to Independence Webinar Series Part 3: How to Get the Most out of Your Mentoring Relationships
Date and Time: Wednesday, February 26, 2020, 12:00 Noon–1:00 PM (ET)
Host: Postdoctoral Assembly (PDA)
Registration is required.
Speakers:
Laura Van Winkle, PhD
University of California Davis
Debra Laskin, PhD
Rutgers, The State University of New Jersey
John Wise, PhD
University of Louisville
This webinar series will focus on providing actionable advice on the early career transition to independence and will feature experts with diverse backgrounds, from newly hired assistant professors to members of faculty search committees. The target audience is trainees (postdocs and graduate students), as well as early career investigators.
This webinar will feature experienced faculty members who can provide input on mentoring issues and how to seek advice throughout your career, even as you transition to independence. The primary learning objectives will be (1) how to maintain mentoring relationships during the transition to independence, especially while trying to distinguish yourself from your mentor/PI; and (2) how to become a good mentor—while still junior yourself—as you build your lab and advise others from the role of PI. Moderator-led discussion will feature perspectives from three academic career stages (graduate student, postdoc, and Assistant Professor).
Cannabis: A Review of the Current State of Safety and Regulatory Considerations
Host: Lake Ontario Regional Chapter (LORC) and Regulatory and Safety Evaluation Specialty Section (RSESS)
Date and Time: Friday, February 28, 2020, 1:00 PM–2:00 PM (ET)
Registration is required.
In the last several years, the cannabis industry in North America has been burgeoning with the national legalization of recreational marijuana in Canada as well as in many US states. Although the plant has a long history of use across the globe both recreationally and medically, its increased legal recreational prevalence in our society has sparked increased safety concerns, especially in the areas of adolescent safety, mental health, impaired driving, and recent vaping incidents. With the possibility of increased use within our population, these concerns must be addressed with a pragmatic and evidence-based approach. But from a risk assessment perspective—what is the state-of-the-science surrounding cannabis safety?
In this webinar, our first presenter, Lois Haighton (board-certified toxicologist and Director in the Food and Nutrition Group of Intertek Scientific & Regulatory Consultancy), will discuss the current data relating to the safety of cannabis to provide a framework for understanding what is currently known regarding inhaled and ingested cannabis products and what safety concerns still exist. Our second presenter, Garrett Graff (Managing Attorney at Hoban Law Group and nationally recognized as a Cannabis Law Trailblazer by the National Law Journal), will discuss the legal and regulatory background for cannabis use in Canada and the US.
From Nanomaterials to Advanced Materials: A Health and Safety Perspective
Host: Nanoscience and Advanced Materials Specialty Section (NAMSS)
Date and Time: Wednesday, March 4, 2020, 1:00 PM–2:00 PM (ET)
Registration is required.
Speaker:
Dr. Charles Geraci
Associate Director of Emerging Technologies
NIOSH
Advances in nanoscale science have resulted in materials that are more active, more efficient, and more versatile in their commercial applications. A key outgrowth has been the development and deployment of “advanced materials.” These materials are chemically and biologically more active and more efficient for the specific functions for which they are designed. Advanced materials are combining with the development of new manufacturing technologies, such as additive manufacturing, 3D printing, and engineered/synthetic biology, to give us a vision of the new materials, processes, and products that make up “21st-Century Manufacturing.” The challenge for the EHS professional is to remain current on the issues of potential health hazards, the degree to which these materials are being introduced into new manufacturing technologies, and the way they are used and incorporated into products. The types of risk assessment and management approaches needed to support safe, responsible, and sustainable commercialization of nano- and advanced-material-enabled products can be challenging, but a lot of progress has been made in the past 10 years. Many of the lessons learned with nanotechnology will have direct reapplication opportunities in the rapidly emerging world of advanced materials and the 21st Century Manufacturing environment.