Anti-drug antibodies (ADAs), especially those with neutralizing potential, can significantly affect pharmacokinetics (PK) and complicate translational predictions. Understanding and accounting for neutralizing ADA early in drug development is critical for generating reliable PK models and accurate dose projections across species.
In this expert-led session, we’ll explore how neutralizing ADAs impact PK, why these effects are often not translatable between species, and the risks of ignoring ADA in your nonclinical data package. Through real-world case studies, we’ll demonstrate how structural and covariate models, built in Phoenix® NLME can be used to support interspecies scaling and human dose prediction when neutralizing ADA is present or suspected.
Key topics include:
- What are neutralizing ADAs and how do they affect pharmacokinetics?
- Challenges in translating ADA effects from nonclinical to clinical data
- Case studies highlighting modeling strategies to manage ADA-driven variability
- Application of Phoenix NLME for interspecies scaling and human dose projections
您将学到什么？
- Gain a deeper understanding of neutralizing ADA and its impact on PK in biologics development
- Learn how failing to account for ADA in nonclinical studies can compromise your translational models
- See real-world examples of how to model ADA effects effectively using Phoenix NLME
- Walk away with actionable insights to strengthen interspecies scaling and human dose prediction
演讲嘉宾：
- Elliot Offman BSc, Pharm, MSc, PhD, Vice President, Clinical Pharmacology & Translational Medicine, Certara Drug Development Solutions
- Martin Beliveau, PhD, Vice President, Quantitative Science Services, Certara Drug Development Solutions
- Keith Nieforth, PhD, Senior Director, Pharmacometrics Software, Certara
