Events

Protein Degraders: Part 1

Hosted by the SOT Women in Toxicology Special Interest Group and Drug Discovery Toxicology Specialty Section

Nonclinical Safety Assessment of Targeted Protein Degraders: An Industry Perspective

The nonclinical toxicology assessment for protein degraders—either molecular glues or heterobifunctional targeted protein degraders (TPDs)—shares the same principles as for classical small molecules with some additional considerations due to the modality. The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) convened a Protein Degrader Working Group to benchmark the current preclinical safety assessment practices for TPDs; a companion group addressed current ADME practices. The aim of the surveys was to aid in more rigorous, effective, and swift nonclinical safety and ADME assessments of TPDs being developed for treatment of human disease. This webinar will discuss the survey findings regarding current practices across the industry for in vitro and in vivo nonclinical safety assessments for heterobifunctional TPDs. Approaches for selecting a toxicologically relevant species for in vivo studies will also be discussed.

Industry Perspective on the PK and ADME Properties of Heterobifunctional Protein Degraders

TPDs, specifically bifunctional protein degraders, consist of two linked ligands for a protein of interest and an E3 ligase, resulting in molecules that largely violate accepted physicochemical limits (e.g., Lipinski's Rule of Five) for oral bioavailability. In 2021, the IQ Consortium Degrader DMPK/ADME Working Group undertook a survey of 18 IQ member and nonmember companies working on degraders to understand whether the characterization and optimization of these molecules were different from any other beyond the Rule of Five (bRo5) compounds. Additionally, the working group sought to identify pharmacokinetic (PK)/absorption, distribution, metabolism, and excretion areas in need of further evaluation and where additional tools could aid in more rapid advancement of TPDs to patients. An overview of the survey results will be shared in this webinar. Based on the survey results, the Degrader DMPK/ADME Working Group concluded that TPD evaluation does not fundamentally differ from other bRo5 compounds but requires some modification compared with traditional small molecules and proposes a generic workflow for PK/ADME evaluation of bifunctional TPDs.

Speakers:
Jessica Sims, PhD, DABT, Genentech
Laurie Volak, PhD, Volak PharmaKinetic Solutions

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Protein Degraders: Part 2

Hosted by the SOT Women in Toxicology Special Interest Group and Drug Discovery Toxicology Specialty Section

Considerations for Nonclinical Teratogenicity Safety Assessment of CRBN-engaging TPDs

Targeted protein degraders are an emerging small molecule drug modality with transformative therapeutic potential. Currently, most degraders are developed for severe life-threatening disorders and engage the E3 ligase cereblon. One barrier to the broader use of degraders is the potential risk of embryofetal toxicity with cereblon-engaging degraders, exemplified by thalidomide. Thalidomide (and analogs, known as immunomodulatory drugs) binds cereblon and modifies its substrate repertoire, leading to degradation of intended and multiple unintended neosubstrates. Some cereblon-engaging degraders have been engineered to avoid the degradation of unintended neosubstrates implicated in teratogenicity, specifically SALL4. Mechanistic links between SALL4 degradation by thalidomide and human teratogenicity have been established; further, SALL4 degradation by thalidomide (and its analogs) has been linked to teratogenicity in susceptible nonclinical species. It is generally accepted that SALL4 degradation is unlikely to be the only mechanism of teratogenicity associated with thalidomide and its analogs. Currently, best practices to evaluate the teratogenicity risk of cereblon-engaging degraders have not been established. Here, we present points to consider in the teratogenicity safety assessment of cereblon-engaging degraders from the perspective of an IQ Consortium working group.

Current Practices and Considerations for Preclinical Safety Assessment of Targeted Protein Degraders

This presentation provides an overview of current practices employed across the pharmaceutical industry and academia to identify and evaluate potential safety concerns associated with TPDs. Insights from stakeholders were gathered through workshops conducted by the HESI TPD Safety Committee (a public private collaborative group of 90 technical experts, representing 23 companies, 5 academic or research institutes, and 2 government agencies) highlighting emerging strategies such as proteomics-based target profiling, degrader selectivity assessment, and species selection for in vivo studies. In addition, case studies and a stakeholder survey were used to collect detailed input on study design considerations, including the use of in vitro systems, analytical methodologies, in vivo selectivity profiling, and data interpretation. Together, these efforts provide a snapshot of safety evaluation strategies currently in use and identify key challenges in translating mechanistic insights into predictive toxicology frameworks. Overall, current practices reflect a pragmatic integration of established small molecule safety principles with emerging, modality-specific approaches tailored to TPDs.

Speakers:
Lise Loberg, PhD, Abbvie
Katie Stamp, PhD, Bristol Myers Squibb

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NAMs in Toxicology: Current Insights and Future Horizons

Hosted by the SOT Association of Scientists of Indian Origin and Women in Toxicology Special Interest Groups and the SOT In Vitro and Alternative Methods Specialty Section

The integration of New Approach Methodologies (NAMs) is transforming the landscape of nonclinical toxicology, offering the potential to enhance human relevance while reducing reliance on animal testing. This webinar will explore the current scientific and industrial perspectives on NAMs, focusing on their evolving role in modern safety assessment and their trajectory toward broader regulatory acceptance. The session will begin with an overview of the regulatory context, highlighting the implications of the FDA Modernization Acts 2.0 and 3.0 and recent FDA roadmaps and guidance that encourage the adoption of NAM-based strategies in drug development. These initiatives mark a pivotal policy shift supporting alternative models—ranging from high-content in vitro systems to computational and in silico platforms—as scientifically valid tools for hazard identification and risk characterization. From an industry standpoint, we will discuss where and how NAMs can be optimally integrated across the developmental timeline, from early target selection and candidate prioritization to mechanism-based safety risk de-risking and regulatory submissions. Illustrative case studies will highlight successful applications of NAMs across modalities alongside retrospective analyses demonstrating the predictive value of CIVMs in assessing hepatotoxicity and neurotoxicity. Looking ahead, the session will examine future opportunities to embed NAMs into international regulatory frameworks, particularly within ongoing ICH revisions that seek to harmonize approaches for reducing animal use while maintaining robust safety assessments.

Speaker:
Payal Rana, MS, MBA, PhD, DABT, Scientific Director, Abbvie

Dissecting Sex and Gender in Toxicology

Hosted by the SOT Out Toxicologists and Allies; and the Women in Toxicology Special Interest Groups

This panel will focus on how to define, study, and communicate about “sex” and “gender”. Both sex and gender are continuously evolving concepts, extending beyond traditionally viewed binary phenomena. Sex- and gender-related research has enormous potential to improve our understanding of physiology, toxicology, and disease risk, and transform disease treatments, but also has important social implications. While clinical and basic science have been infamously male-centric, important strides have been made recently by increasing female inclusion in research (by the NIH SABV initiative) and promoting women’s health initiatives (through new centers and initiatives). However, as the gender landscape in the society expands and anti-trans legislations spread throughout the country, there is an urgent need to reexamine how we study, teach, and communicate about sex and gender. Sex is a complex and context-dependent variable—how do we account for this in our study designs and interpretations? Where does “sex” end and “gender” begin? How can the SABV policy and women’s health initiatives be shaped to preserve their positive impacts while making sure that they account for gender inclusivity? These and many other questions will be discussed in this panel with the central question on how to study sex/gender in the most scientifically accurate and the most socially responsible way.

Speakers:
Megan Massa, PhD, Assistant Teaching Professor, Emory University
Liisa Galea, PhD, Professor, University of Toronto and Center for Addiction and Mental Health Canada
Patricia Silveyra, PhD, Professor, Indiana University

Materials:
Webinar Recording and Materials

Rethinking Chemical Carcinogenicity Assessment in the Context of NAMs: Current Frameworks, State of the Science, and New Horizons

Hosted by the SOT Carcinogenesis Specialty Section and SOT Women in Toxicology Special Interest Group

Science is rapidly evolving for a better understanding of cancer disease pathophysiology upon chemical exposure. However, the need to maintain adequate protection of human health against cancer hazards remains. A critical component of regulatory toxicology is the assessment of adverse health effects, and thus risks, in humans exposed to chemicals.
Fast advancements in the development of New Approach Methodologies (NAMs) to assess systemic toxicity have led to an increased understanding of chemical carcinogenicity and to the possibility of replacing (or at least reducing and refining) vertebrate animal testing for future hazards evaluation.

Such advances in the understanding of chemically induced malignancy (e.g., role of the microenvironment, plasticity and biological pathways of transformation) along with the development of state-of-the-art technology (e.g., single cell and multi-omics, Next-Generation Sequencing, models of cellular transformation), provide an opportunity to modernize the evaluation of health risk from exposures to chemicals. Specifically, updated regulatory guidance (e.g.,2022’s S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals) allows for the use of existing information and for NAMs to be used as part of an integrative framework for risk assessment.

In this session, we are rethinking chemical carcinogenicity assessment bringing together three women scientists working in basic research and risk evaluation from the US, Canada, and European Union. We will report about current frameworks, the state of the science in understanding and testing chemical carcinogenicity with NAMs and discuss new horizons in the field.

Speakers:
Amber Goetz, PhD, Syngenta CP LLC
Carole Yauk, PhD, University of Ottawa, Canada
Annamaria Colacci, PhD, Università di Bologna, Italy

Materials:
Webinar Recording and Materials

WIT Best Manuscript: Beyond Detection: Quantifying Micro/Nanoplastics Biodistribution with a Physiologically Based Toxicokinetic Modeling Approach

Hosted by: The SOT Women in Toxicology Special Interest Group

Join us in hearing from two scientists as they present cutting-edge research on the biodistribution and biological effects of micro/nanoplastics in the human body!

Dr. Priscila Falagan Lotsch will begin by discussing her work on the biological effects of micro/nanoplastics on human brain cells. Plastic pollution has evolved into a global public health issue, with microplastics (MPs) and nanoplastics (NPs) detected in food, water, air—and human tissues, including the brain. Human exposure to MPs/NPs primarily occurs through ingestion, inhalation, and dermal absorption, which can lead to their circulation within the body via the bloodstream. Oral ingestion is currently considered the main route of exposure, with a significant daily intake of MPs/NPs originating from plastic materials in contact with food and beverages. For example, the use of disposable drink cups may result in the annual ingestion of nearly 90,000 MPs particles when used every 4-5 days. Despite the growing awareness of widespread exposure, the health implications of these plastic particles remain largely unclear, especially those derived from real-world sources. In this presentation, Dr. Lotsch will discuss the biological effects of MPs/NPs generated from everyday consumer items—plastic cups and forks—on human primary-like brain cells. Unlike conventional studies that rely on pristine, spherical microbeads, this approach uses heterogeneous particles that better mimic environmental exposure and examines their effects across multiple biological layers, providing new insights into the potential neurotoxicity of MPs/NPs. 

Following Dr. Lotsch's talk, Dr. Chi-Yun Chen, Winner of the 2025 WIT Best Manuscript Award, will discuss her research quantifying micro/nanoplastic biodistribution using the first physiologically based toxicokinetic model. Evidence of microplastics (MPs) and nanoplastics (NPs) in foods and daily-use products, along with their frequent detection in the human body, has raised concerns regarding their potential health impacts via dietary ingestion. However, there is a lack of quantitative tools to simulate their bioaccumulation and tissue distribution following environmental exposure. To address this gap, Dr. Chen and her colleagues developed the first physiologically based toxicokinetic model for predicting the biodistribution of MPs and NPs in mice following oral exposure under various exposure scenarios. This model incorporated key kinetic mass transport processes, such as membrane permeability, albumin binding, and cellular uptake. They identified that the absorption rate in the gastrointestinal tract and fecal excretion rate constant had significant impacts on organ dosimetry. Their regression analysis indicated that the size-dependent dissociation constant and urine clearance rate constant sharply increased by a factor of 3 as NPs particle size increased to 1 µm. This presentation will also showcase an interactive graphical user interface that allows users to visualize simulations, explore parameter effects, and apply mouse‐derived insights to support human dietary exposure assessment using available food consumption data and MPs/NPs residue data.

Speakers:
Priscila Falagan Lotsch, PhD, Assistant Professor, Department of Biological Sciences, Auburn University
Chi-Yun Chen, PhD, Postdoctoral Research Fellow, University of Florida, Winner of the 2025 WIT Best Manuscript Award

Materials:
Webinar Recording and Materials

Nonclinical Safety Studies for Investigational New Drug and New Drug Application Filing for Small Molecules Part 2: Genetic Toxicology/Carcinogenicity and Reproductive and Developmental Toxicology

Hosted by: The SOT Women in Toxicology Special Interest Group and the Carcinogenesis Specialty Section

In two parts, this webinar will cover the different types of toxicology studies conducted to support Investigational New Drug (IND) and New Drug Application (NDA) filings for small molecules, including an overview of the nonclinical modules, safety pharmacology, genetic toxicology, carcinogenicity, and reproductive and developmental toxicology. This webinar will cover best practices and example case studies from leaders in the field. Part 1 is in collaboration with the Drug Discovery Toxicology Specialty Section and Part 2 is with the Carcinogenesis Specialty Section.

Speakers:
Smita Salian-Mehta, PhD, DABT, ERT, Senior Project Toxicologist, Gilead Sciences
Dinah Misner, PhD, DABT, DSP, Vice President, Aligos Therapeutics
Toufan Parman, PhD, DABT, Senior Director of Nonclinical Safety Evaluation, Sangamo Therapeutics
Ellen McGlinchey, PhD, Senior Project Toxicologist, Gilead Sciences

Materials:
Webinar Recording and Materials

Nonclinical Safety Studies for Investigational New Drug and New Drug Application Filing for Small Molecules Part 1: Overview and Safety

Hosted by: The SOT Women in Toxicology Special Interest Group and the Drug Discovery Toxicology Specialty Section

In two parts, this webinar will cover the different types of toxicology studies conducted to support Investigational New Drug (IND) and New Drug Application (NDA) filings for small molecules, including an overview of the nonclinical modules, safety pharmacology, genetic toxicology, carcinogenicity, and reproductive and developmental toxicology. This webinar will cover best practices and example case studies from leaders in the field. Part 1 is in collaboration with the Drug Discovery Toxicology Specialty Section and Part 2 is with the Carcinogenesis Specialty Section.

Speakers:
Smita Salian-Mehta, PhD, DABT, ERT, Senior Project Toxicologist, Gilead Sciences
Dinah Misner, PhD, DABT, DSP, Vice President, Aligos Therapeutics
Toufan Parman, PhD, DABT, Senior Director of Nonclinical Safety Evaluation, Sangamo Therapeutics
Ellen McGlinchey, PhD, Senior Project Toxicologist, Gilead Sciences

Materials:
Webinar Recording and Materials

Vascular Disruption in Pregnancy—A Focus on the Placenta and its Role in Adverse Pregnancy Outcomes: 2023 Women in Toxicology LEAP Award Presentation

Speakers:
Colette Miller, PhD, Principal Investigator, US EPA ORD CPHEA
Tim Nurkiewicz, PhD, E.J. Van Liere Medicine Professor & Chairman, West Virginia University

Materials:

Webinar Recording and Materials

Weight of Evidence Approach to Assess the Human Carcinogenic Risk of Pharmaceuticals: Overview of The ICH S1B Addendum and Implementation

Speakers:
Alisa Vespa, PhD, Pharmaceutical Drugs Directorate, Health Canada Representative
Arianna Bassan, PhD, Principal Consultant, Innovatune

Materials:
Webinar Recording
Alisa Vespa
Arianna Bassan

All the Ways You Can Evaluate Lead Risks: My Pathway from Molecular Biology to Toxicology and Risk Assessment

Speaker:
Barbara Beck, PhD, DABT, ERT, ATS, AAAS Fellow, Principal, Gradient

Materials:
Webinar Recording
Challenges in Evaluating Risks from Lead Exposure

Women in Toxicology Special Interest Group Career Agility Panel Discussion

San Diego Convention Center
Marriott Marquis San Diego Marina, Grand Ballroom 8

Women in Toxicology Special Interest Group Reception

San Diego Convention Center
Marriott Marquis San Diego Marina, Grand Ballroom 8

Tailoring the Resume across Sectors

Speakers:
Terry Leyden and Ronald Hines

Co-Chairs:
Jennifer Cohen and Betina J. Lew

Materials:

Achieving Work Life Balance Across Career Stages

Speakers:
Elena Hernández-Ramón, Linda Birnbaum, Alison Sanders, and Nadia Moore

Materials:
Webinar Recording

Career Development for Female Toxicologists

Speakers:
Ruth Roberts, Judith Zelikoff, Myrtle Davis, Tao Wang, Jessica Sapiro, and Marie Fortin

Materials:
Webinar Recording
WIT: Webinar on Career Development

WIT Mentoring Workshop

Materials:
Mentoring 101—How to Mentor, How to be Mentored
Mentoring Graduate Students: Toto, We're Not In Kansas Anymore
Mentoring by Chance and Choice in the Biotech Industry