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Translational Aspects from Preclinical Animal Toxicology Studies to Early Human Health Risk Assessment: Needs and Limitations
Session Chair(s)
Celine Adessi, PhD
Senior Clinical Safety Scientist
F. Hoffmann - La Roche, Switzerland
The human health risk assessment and management plan in early clinical phase is based on a weight of evidences approach, integrating knowledge of the therapeutic agent from in vivo animal toxicology studies, mechanism of action, and class effect. This session will cover some of the needs and potential limitations of this translational approach with a particular focus on the interpretation of toxicity testing. Topics will address the dilemma for industries for the clinical development of drug-induced non-monitorable toxicity, focusing on vasculitis; cover the supportive information generated from nonclinical assessment of blood pressure changes, reviewing current challenges, new technologies, and translation to human; and discuss the importance of nonclinical juvenile animal guidance in pediatric drug development, sharing real-world experience.
Learning Objective : Identify gaps in managing human risk of drugs inducing non-monitorable toxicology findings in animals; Evaluate alternative approaches in refining animal testing for human health risk assessment; Discuss the importance of nonclinical juvenile animal guidance in pediatric drug development.
Speaker(s)
Drug-induced Vasculitis: A Non Monitorable Toxicology Finding and A Dilemma in Translational Medicine
Celine Adessi, PhD
F. Hoffmann - La Roche, Switzerland
Senior Clinical Safety Scientist
Nonclinical Assessment of Blood Pressure Changes: Challenges, New Technologies and Translation to Human
Andrea Greiter-Wilke, DVM, PhD
F. Hoffmann-La Roche AG, Switzerland
Head, Safety Pharmacology
Juvenile Animal Studies and Pediatric Drug Development: Systematic or Case-by-case?
Dinah Duarte, MSc
European Medicines Agency, Netherlands
Signal Management Lead
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