CEC03: Utilizing Computational Methods to Infer Dose-response Relationships in Chemical Risk Assessment[Continuing Education Courses (CEC)]
Computational methods are increasingly vital in modern chemical risk assessment, offering innovative approaches to infer dose-response relationships. The next-generation chemical risk assessment paradigm seeks to supplement and eventually supplant traditional animal-based toxicity testing through New Approach Methodologies (NAMs). This continuing education course session highlights recent advancements in leveraging computational tools to improve chemical safety evaluation. The first presentation introduces a mode of action (MOA)-based probabilistic dose-response modeling framework that integrates data from multiple sources to estimate reference doses (RfDs). The second presentation demonstrates the application of quantitative in vitro-in vivo extrapolation (IVIVE) to translate in vitro data into in vivo equivalent doses using the Integrated Chemical Environment (ICE) tool. The third presentation explores Bayesian benchmark dose (BMD) estimation of toxicogenomics data, providing insights into deriving genomic points of departure. The final presentation showcases mechanistic modeling of complex toxicity endpoints by organizing high-throughput screening (HTS) data into adverse outcome pathway (AOP) models. Together, these presentations illustrate how computational methods enhance chemical risk assessment by integrating diverse data streams, improving dose-response modeling, and addressing uncertainty and variability.
President:
NO.:1
An MOA-based dose-response modeling framework to integrate data from multiple sources for reference dose (RfD) estimation
NO.:2
Bayesian benchmark dose estimation of genomic data
NO.:3
Application of quantitative in vitro-in vivo extrapolation (IVIVE) to estimate reference doses from NAM Data
NO.:4
Mechanistic modeling of complex toxicity endpoints using public concentration-response metadata
CEC06: Advanced Toxicological Topics for Study Directors of Nonclinical Studies[Continuing Education Courses (CEC)]
An introductory study director course was held in China in 2019 and was developed to provide continuing education for Study Directors with up to five years of experience. Study Directors are conducting more complex studies with new modalities and with new methodologies that include gene or cell therapies, complex biological products, oligonucleotides, drug conjugates, etc. The outcome of nonclinical studies requires the Study Director to have an in-depth knowledge of the complexity of these drugs and drug products as well as the biological response to the administration of these substances. The tentative topics to be covered include nonclinical testing for biologics, gene and cell therapies, developmental and reproductive toxicology, carcinogenicity and advanced topics for study directors at all levels. Although this course is directed towards toxicologists and related professional in toxicological testing laboratories, this course would be valuable to a broad range of nonclinical, clinical, management and regulatory personnel across all industrial and governmental sectors. Regulatory and managerial personnel will gain a thorough working knowledge of preclinical development to facilitate planning, project management and development nonclinical regulatory strategies. The course will cover practical topics that apply to the interpretation, summarization and reporting of study results for any data collected and will include a separate lecture on the requirements of the Chinese FDA. If time permits, a panel discussion will be convened at the end of the session.
President:
NO.:1
Introduction to study director course
NO.:2
Complex methods and study designs for developmental and reproductive toxicology
NO.:3
Scientifically sound data interpretation and report writing for toxicology studies
NO.:4
Complex Study Director Issues and Resolution
NO.:5
The use and application of in vivo, in vitro and in silico models, artificial intelligence and ICH S1B
NO.:6
Study Director Training: Considerations from a Toxicology Study Monitor
