Strategies for the Development and Registration of Antibody Drug Conjugates

Track:
Pharmaceutical Quality

Day & Time:
June 25, 10:15AM - 11:45AM

Session Number:
234

Room Number:
153C

Level:
Advanced

Type:
Session

Title:
Strategies for the Development and Registration of Antibody Drug Conjugates

Chair(s):
Sarah C. Pope Miksinski, PhD
Acting Director, Div.1, Office of New Drug Quality Assessment, OPS, CDER
FDA, United States

Description:
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(s):
Describe CMC challenges associated with the development of antibody drug conjugates; Discuss technical issues and regulatory submission challenges.

Presentation(s) & Speaker(s):
Gaining Enhanced Product and Process Understanding During ADC Development: Challenges and Opportunities
Fred Jacobson
Principal Scientist and T-DM1 Technical Team Leader
Genentech, A Member of the Roche Group, United States

Aspects to Consider in Defining the Control Strategies for the Small Molecule Components of Antibody Drug Conjugates
Nathan Ihle, PhD
Executive Director, Process Chemistry and Analytical Biochemistry
Seattle Genetics, Inc., United States