Center for Research on Ingredient Safety

Science Day 2023 explored New Approach Methodologies (NAMs) in Support of Weight of Evidence (WoE) Assessments for Regulatory Decisions

Kelly Magurany, M.S., NSF International

Talk Title: "Applying NAMs in Risk Assessment - A Framework Approach and Case Study"

Dr. Lindsay Marshall, Humane Society of the United States

Talk Title: “Replicating the human airways in vitro – from normal physiology to disease models for drug testing.”

Dr. Marshall completed her Ph.D. in cell biology and protein biochemistry at Dundee Medical School in Scotland.  Her post-doctoral studies at the Department of Medical Specialties, Southampton University, and then the School of Pharmacy and Biomedical Sciences at Portsmouth University investigated the inflammatory responses, repair processes, and innate immunity of the human airways. Her research throughout her academic career at Aston University in Birmingham, UK, where she was a Senior Lecturer in Immunology, continued the theme of human respiratory defenses with the development of multi-cellular, in vitro models of human airways.  

Dr. Marshall left academia in 2016 and is now working as a Science Advisor for the Humane Society of the United States (HSUS). Her overarching goal in this post is the encouragement of animal replacement in biomedical research, and she is specifically involved in identifying alternatives to animal models for investigating human disease mechanisms and treatments. It is Dr. Marshall’s view that the availability of reliable, robust human models is vitally important since they provide a useful and much-needed testing platform for novel drug candidates whilst removing the requirement for animal testing.

Dr. Amber Goetz, Syngenta

Talk Title: "Implementing Modern Approaches to Testing and Evaluation into Weight-of-Evidence"

Dr. Amber Goetz is a Principal Scientist in the North America Product Safety Science Strategy pillar of Syngenta. She received her Ph.D. in the toxicology program at North Carolina State University in 2007. She then joined Product Safety at Syngenta, where she is responsible for fostering advocacy and networking across multiple stakeholders to advance risk assessment paradigms and supports the development of novel science technologies to influence positive regulatory changes in North America. She participates in initiatives under the Health and Environmental Sciences Institute (HESI) and engages in various scientific collaborations in the areas of genomics.

M. Sue Marty, Ph.D., DOW, Inc.

Talk Title: “Using NAMs in a NextGen Safety Assessment for a Cosmetic Ingredient” 

Sue Marty, Ph.D., received her Ph.D. in toxicology from the University of Michigan (Ann Arbor, MI), investigating the effects of toxicants on labor onset and progression. She conducted postdoctoral work at Michigan State University, examining the effects of methylmercury on cerebellar granule cells and astrocytes. Currently, Sue is a Science Leader in Toxicology & Environmental Research and Consulting at the Dow Chemical Company. In her current role, she develops research strategies to evaluate and apply new approach methods (NAMs) for Dow’s Predictive Toxicology Program. She is a diplomate of the American Board of Toxicology and recently participated as an ad hoc member for the US EPA’s Board of Scientific Councilors, reviewing the EPA’s research strategy on NAMs. 

Zhichao Liu, Ph.D., Boehringer Ingelheim Pharmaceuticals, Inc.

Talk Title: “Generative AI Promoting New Approach Methodologies (NAMs) Development”

Dr. Zhichao Liu is the head of Computational Toxicology at Boehringer Ingelheim Pharmaceuticals’ Nonclinical Drug Safety (NDS) department. At BI, he is at the forefront of expanding in silico methodologies for drug safety assessments. Prior to joining BI, Dr. Liu was with the US FDA, where he headed the Artificial Intelligence Research Force (AIRForce). With an extensive background in chemistry, biology, and computer science, Dr. Liu has been instrumental in leading several groundbreaking projects over the past 15 years. He has been pivotal in designing, implementing, and deploying AI/machine learning solutions to foster advanced regulatory sciences within the pharmaceutical industry. Notably, he established a standard pipeline employing AI-powered tools to guide the industry in identifying the best approaches to expedite drug development in terms of safety and efficacy. Additionally, Dr. Liu utilized AI/machine learning technologies to advance predictive toxicology, with several of his models being embraced by both the industry and regulatory bodies. His illustrious career is marked by six FDA-wide awards, nine NCTR-level awards, two awards from the scientific community, and authorship of over 100 peer-reviewed publications.