Exhibitor-hosted session on March 19, 10:45 a.m. - 11:45 a.m., SOT Annual Meeting 2025

This session will explore the latest advancements in New Approach Methodologies (NAMs) for predicting inhalation toxicity in humans. Experts will discuss innovative in-vitro approaches for hazard identification and characterization. Recent advances in assessing portal-of-entry effects from inhalation exposures will be presented, with a focus on dosimetry concepts, quantitative readouts, and metabolically competent human pulmonary barrier models to study uptake and metabolism.

Participants will learn how up-to-date biological test systems, including single-cell and complex primary models, can be combined with in-silico tools to inform human risk assessment. The derivation of in-vitro points of departure (PODs) will be demonstrated, and a strategy will be presented on how to use this information to predict toxicity following inhalation exposure to chemicals in humans.

Dr. Tanja Hansen has a background in veterinary medicine; she received her doctor’s degree in 1998 from the University of Veterinary Medicine in Hannover. She is a veterinary specialist in pharmacology and toxicology. Her work focuses on the development and validation of cellular in-vitro models with emphasis on airborne substances and uptake by inhalation. She is currently head of the Department of Mechanistic Toxicology. Her main research interest is the development of new-approach methodologies (NAMs) in the field of inhalation research both, for safe-by-design approaches and for the integration into next generation risk assessment (NGRA). Her team also develops in-vitro exposure systems such as the patented P.R.I.T.^®ExpoCube^®.

Dr. Sylvia Escher is a chemist and a human toxicologist by training. She joined the Fraunhofer ITEM in Hannover, Germany, in 2006. Fraunhofer ITEM is the leading public non-profit research institute in inhalation toxicology in Europe. She is currently Division Director of Safety Assessment and Toxicology and head of the Department of In-silico Toxicology. Her research interests include the integration of alternative methods into regulatory risk and hazard assessments, starting with in-silico approaches and progressing to in-vitro methods, such as omics. Her team also develops toxicological databases such as RepDose® or VICT3R, which are used to improve the TTC concept or to develop virtual control groups, respectively. Fraunhofer ITEM also is developing PBKiT, a bottom-up PBK model which predicts the kinetic properties of airborne compounds using in-vitro ADME assays.

At SOT 2024 Dr. Sylvia Escher will also give the following lecture:

Symposium Session:

Applicability Domain of PBK models to Chemicals and Regulatory Challenges

Session: Challenges of NAM-Based Toxicokinetic Assessment in Regulatory Risk Assessment (ID 121)

Tuesday, March 18, 8 a.m. - 10:45 a.m., Room W203A, Convention Center

Information on ADME/TK properties have useful regulatory applications e.g., for the estimation of half-life for bioaccumulation assessment, for substantiating read-across justifications, to improve the risk assessment, including route to route extrapolation, or interspecies and intraspecies extrapolation of toxicokinetics. The ability to perform reliable PBK modelling is also a prerequisite for Quantitative In-Vitro In-Vivo Extrapolation (QIVIVE).

To facilitate the application and implementation of physiologically based kinetic (PBK) modelling data in regulatory toxicology, this work aims to evaluate the applicability domain of both the PBK models, and the input parameters of these models, in particular the in-silico and in-vitro ADME parameters for the relevant substances within the REACH regulation, e.g., industrial chemicals.

Dr. Detlef Ritter is senior scientist at Fraunhofer ITEM and an experienced chemist with a background in technical chemistry and biochemistry.

He is a specialist in the development of technology and methods for in-vitro inhalation, specifically focusing on designing relevant in-vitro applications for respiratory toxicology.

Dr. Ritter’s expertise lies in combining competencies from cell biology and biochemistry, aerosol technology, safety assessment, and technical engineering to enhance the predictivity and relevance of in-vitro methods in research projects and cooperations with industry.