Solving the Complexities of T Cell Engager Development: Pharmacology, PK, and Bioanalysis

DATE

December 9, 2025

TIME

8:00 a.m. PST, 11:00 a.m. EST, 16:00 GMT, 17:00 CET - Duration: 60 Minutes

Overview

T cell engagers (TCEs) are emerging as a powerful therapeutic modality in oncology, capable of redirecting immune cells to recognize and eliminate tumor targets with high precision. However, their complex structure and mechanism of action demand a rigorous understanding of pharmacology, safety, and translational biology. This webinar will explore pharmacological evaluation approaches for TCEs, including the use of diverse humanized preclinical models such as PBMC/HSC tumor xenografts (CDX/PDX) and knock-in systems that recapitulate the immune-tumor microenvironment. Attendees will also gain insights into predictive pharmacodynamic biomarker detection and mechanistic studies that can inform efficacy and safety optimization from discovery to development.

In parallel, this session will address the bioanalytical complexities inherent to TCE therapeutics. Experts will discuss critical considerations in pharmacokinetic (PK) profiling, immunogenicity assessment—including anti-drug antibody (ADA) and neutralizing antibody (NAb) evaluations—and biomarker analysis. Through case studies and practical examples, participants will learn how to overcome analytical complexities and generate robust and regulatory-ready datasets to support drug development.

Key Learning Objectives:

Gain a comprehensive understanding of T cell engager (TCE) mechanisms of action and their expanding role in oncology and immunotherapy.
Learn about advanced humanized preclinical models (PBMC/HSC-derived CDX/PDX and knock-in systems) for translational pharmacology and efficacy evaluation.
Learn approaches for predictive pharmacodynamic (PD) and mechanistic biomarker analysis to guide clinical translation.
Tackle bioanalytical challenges in pharmacokinetics (PK), immunogenicity (ADA/NAb), and biomarker assessments.
Review real-world case studies to identify best practices in assay design, validation, and generation of robust, regulatory-ready data.

Who Should Attend:

Oncology and immunotherapy researchers
Drug discovery and translational scientists
Bioanalytical and pharmacokinetics professionals
Clinical development and regulatory experts
Biotech and pharma professionals interested in TCE development

Brought to you by:

Speakers

Jingxuan Yan
Assistant Director, In Vivo Pharmacology Unit,
WuXi Biology, WuXi AppTec

Xin Ning, PhD
Senior Scientist II, Bioanalytical Services (BAS),
Lab Testing Division (LTD), WuXi AppTec

Melissa O'Meara
Forensic Science Consultant
C&EN Media Group

Registration

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