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The US Food and Drug Administration's Perspective on Immunogenicity
ASCPT Members-Only Webinar Presented by the Biologics and Pharmacometrics & Pharmacokinetics (PMK) Communities

Speakers: Eric Brodsky, MD, Kristina Howard, PhD, and Yow Ming Wang, PhD
Moderators: Jamie Connarn, PhD, and Lora Hamuro, PhD

Characterization of immunogenicity for therapeutic proteins and cellular therapies are required for the development and a successful approval by the Regulatory Health Authorities. While immunogenicity can impact multiple endpoints like safety and efficacy, there has been a recent shift to summarize these data relating to immunogenicity as a standalone subsection in the Clinical Pharmacology portion of the label. The purpose of this lecture is to provide an overview of immunogenicity and its relationship to pharmacokinetics, efficacy, and safety. Specifically, the lecture will focus on the expectation the US Food and Drug Administration has regarding immunogenicity in development. Finally, reviewing the recent Guidance for Industry: Immunogenicity for Labeling.

In this special presentation, the following learning objectives will be discussed:
1. How to summarize immunogenicity related to therapeutic proteins and cellular therapies including a broad landscape by therapeutic area?
2. What is needed to characterize immunogenicity and how to summarize these data in label to meet Regulatory Health Authorities expectation?

Dec 9, 2022 12:00 PM in Eastern Time (US and Canada)

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