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DIA 2013 49th Annual Meeting
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Strategies for the Development and Registration of Antibody Drug Conjugates
Track : Track 12: Pharmaceutical Quality
Program Code: 234
Date: Tuesday, June 25, 2013
Time: 10:15 AM to 11:45 AM  EST
Location: 153C
CHAIR :
Sarah C. Pope Miksinski, PhD (SCHAGY), Acting Director, Div.2, Office of New Drug Quality Assessment, OPS, CDER, FDA, United States
SPEAKER (S):
Sarah C. Pope Miksinski, PhD, Acting Director, Div.2, Office of New Drug Quality Assessment, OPS, CDER, FDA, United States
 Nathan Ihle, PhD (SPKNON), Executive Director, Process Chemistry and Analytical Biochemistry, Seattle Genetics, Inc., United States
Fred Jacobson, (SPKNON), Principal Scientist and T-DM1 Technical Team Leader, Genentech, A Member of the Roche Group, 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.

Session Recording
(Code: 234)
DIA 2013 Attendee:
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This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Handout Online
(Code: 234)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Strategies for the Development and Registration of Antibody Drug Conjugates