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Design and Conduct of First-in-Human Studies for “High-risk” Therapeutic Proteins*
Wednesday, November 14
8:30 am – 11:00 am
Wednesday Morning Symposia are Funded by a Grant from
Symposium
ACPE #073-999-07-535-L04
Learning objectives: 1) The design and conduct of FIH trials for "high-risk" therapeutic proteins. 2) Translation of preclinical data to clinic for safe starting dose selection. Scientific Importance: The severe adverse events in the TGN1412 FIH trial illustrate the risks inherently associated with FIH trials for therapaeutic proteins. In view of these findings the symposium will focus on defining high risk therapeutic proteins as well as the design and conduct of FIH trials for such molecules to ensure they are developed at the lowest possible risk to human subjects. Speakers from MHRA (UK), PEI (Germany) and FDA have all agreed to take part and present on how they believe such studies should be conducted in future. Topics to be covered include Expert Report and Recommendations on the Tegenero TGN1412 Clinical Trial; ABPI/BIA Early stage clinical trial task force findings and recommendations following the Tegenero 1412 study; German regulatory perspective on the Tegenero study and recommendations; FDA presenter on how studies for high-risk monoclonal antibodies and other therapeutic proteins should be conducted.
Moderator
Steven Martin, Ph.D.
Pfizer, Inc.
CMC Requirements and In Vitro Characterization of Drug Product for FIH Studies for High Risk Monoclonal Antibodies
Barbara Rellahan, Ph.D.
U.S. Food and Drug Administration
Recommendations on the Design and Conduct of FIH Studies Following the Tegenero TGN1412 Study
Gordon W. Duff, M.D.
University of Sheffield
TGN1412 A Regulatory Perspective and Recommendations
Jan Mueller-Berghaus, M.D.
Paul-Ehrlich-Institut, Division of Immunology
Presentation Title to be Announced
Mark Peterson, Ph.D.
Amgen, Inc.
*Session tentatively scheduled to be recorded.
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