The Safety Pharmacology Society is pleased to invite you to a webinar on Nonclinical Allergenicity of Biologics and PK Modeling and Simulation as Translational Tool on April 9, at 11:00 am ET.
Presenter: Kenneth Hastings, DrPH, DABT, Fellow ATS
Hastings Toxicology Consulting LLC
Summary: Over the last decade, an increasing number of biologics have entered drug development. Biotechnologies using human sequences can induce anti-drug antibodies or activate an immune reaction with consequences on nonclinical drug safety testing studies. While nonclinical allergenicity of biologics can cause important functional and also structural changes, the clinical relevance of drug allergenicity observed with human sequences delivered to animals is often limited. A broad perspective on allergenicity of biologics will be presented with a review of scientific considerations related to this important topic in drug development.
Title: Modeling and Simulation as a Preclinical to Clinical Translational Tool
Presenter: Martin Beliveau, MSc, PhD
Pharsight Consulting Services™
A division of Certara™
Summary: Often, the insight gained from preclinical studies gets lost when transiting to human clinical development. Modeling and simulation provides a simple framework with tools that can provide insight into doses or regimens in possible target populations, such as pediatric or elderly patients, based on current mechanistic understanding of efficacy, safety and pharmacokinetics in animals. This framework can be used for various molecule types (small and large), for stages of drug development or indications, potentially accelerating critical decision making.
Moderator: Simon Authier, DVM, MBA, PhD, DSP
Director Safety Pharmacology, CiToxLAB
We look forward to your participation. Register today!