Half-Day Course
Date & time to be announced
Xiaohui (Sophia) Xu, Daiichi Sankyo, Basking Ridge, NJ
Dr. Zhi Chen, Bristol Myers Squibb, New Brunswick, NJ
COURSE DESCRIPTION
This half-day short course provides an overview of analytical and bioanalytical assays supporting antibody–drug conjugate (ADC) development and regulatory submission readiness. The program reviews key analytical technologies, major challenges, and current perspectives in ADC bioanalysis and CMC development. Emphasis is placed on generating high-quality PK and immunogenicity data to inform PK/PD, safety, and translational decision-making while ensuring data integrity and regulatory compliance. Participants will gain practical insights to support efficient development strategies and smarter decision-making across all stages of ADC development.
WHO SHOULD ATTEND
This course is designed for students with science backgrounds who are planning careers in the pharmaceutical industry, as well as industry professionals interested in antibody–drug conjugates (ADCs) seeking hands-on, practical guidance. Participants will benefit from real-world case studies and in-depth discussions covering ADC bioanalysis and CMC considerations. The course is ideal for scientists working in bioanalysis, pharmacokinetics (PK), DMPK, translational sciences, analytical, preformulation and formulation, and includes interactive discussions with experts in the field.
TOPICS
- Analytical and Formulation Considerations for ADC Drug Product Development
a. General introduction: CMC perspective
b. Analytical methods and control strategies
c. Formulation and process development - Bioanalytical Support in ADC Drug Development
a. Key Assays: PK, ADA, NAb, domain specificity, and target measurements
b. Technologies: LC–MS, immunocapture LC–MS, plate-based LBAs, cell-based assays, and emerging platforms
c. Development & Regulatory Considerations: assay development, production support, and global submissions
ABOUT THE INSTRUCTORS:
Dr. Zhi Chen is an Associate Scientific Director in the Sterile Product Development department at Bristol Myers Squibb. He leads a team of formulation and analytical scientists responsible for developing strategies to support formulation and process development for a wide range of drug product modalities, including antibodies, fusion proteins, antibody-drug conjugates (ADCs), oligonucleotides, lipid nanoparticles (LNPs), and long-acting injectable small molecules (LAIs). Dr. Chen has made significant contributions to numerous IND and BLA filings, playing a pivotal role in advancing drug products through various stages of development. Prior to joining BMS, Dr. Chen held key positions at Merck, Novartis, and legacy Schering-Plough. He was instrumental in the commercialization of several marketed products, including Keytruda®, Opdivo®, Opdualag™, and, most recently, Opdivo Qvantig™.
Dr. Xiaohui (Sophia) Xu is a Director of Clinical Bioanalysis at Daiichi Sankyo, Inc.. She is responsible for providing bioanalytical support for global drug development across small molecules, monoclonal antibody, and emerging therapeutic modalities. Prior to Daiichi Sankyo, she held roles of increasing responsibilities within the Bioanalytical organizations at Merck and Bristol Myers Squibb. Dr. Xu actively contributes to the scientific community in the American Association of Pharmaceutical Scientists (AAPS) and various AAPS working groups, as well as in multiple IQ Consortium working groups. She has authored numerous peer-reviewed publications, two book chapters, and served s co-editor of a scientific book
