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Strategies for the Development and Registration of Antibody Drug Conjugates
Session Chair(s)
Sarah Pope Miksinski, PhD
Executive Director, CMC Regulatory Affairs
Gilead Sciences, United States
The session will provide an overview of the current status of antibody drug conjugate development and regulations. The challenges associated with the regulatory submission (format and content) and the technical issues will also be discussed.
Learning Objective : Describe CMC challenges associated with the development of antibody drug conjugates; Discuss technical issues and regulatory submission challenges.
Speaker(s)
Aspects to Consider in Defining the Control Strategies for the Small Molecule Components of Antibody Drug Conjugates
Nathan Ihle, PhD
Seattle Genetics, Inc., United States
Executive Director, Process Chemistry and Analytical Biochemistry
Gaining Enhanced Product and Process Understanding During ADC Development: Challenges and Opportunities
Fred Jacobson
Genentech, A Member of the Roche Group, United States
Principal Scientist and T-DM1 Technical Team Leader
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