Events

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

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

A Deeper Understanding of Chemical Early Carcinogenesis for the Development of New and More Effective Preventive Strategies

Hosted by: The SOT Carcinogenesis and Molecular and Systems Biology Specialty Sections and the Toxicologists of African Origin Special Interest Group

Presenter(s): Jesse Salk, PhD, MD, Assistant Professor, University of Washington, Justin Colacino, PhD, MA, MPH, Associate Professor, University of Michigan, and Melissa Troester, PhD, Professor, University of North Carolina (UNC), Center for Environmental Health and Susceptibility, UNC Lineberger Comprehensive Cancer Center

Materials:
Webinar Recording and Materials