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Preclinical Safety Evaluation for High Risk Therapeutic Proteins
Tuesday, November 13
8:30 am – 11:00 am
Symposium
ACPE #073-999-07-532-L04
In light of the very serious adverse reactions that occurred in the first-in-man clinical trial of TGN1412 at Northwick Park Hospital London in March 2006, future non-clinical safety assessment for what are now called “high-risk” biologics will most likely differ from other therapeutic proteins in a number of ways. This symposium will focus on defining the definition of high risk therapeutic proteins as well as outlining the expected non-clinical safety testing requirements for such molecules, including those that have high species specificity.
Moderator
Steven Martin, Ph.D.
Pfizer, Inc.
Scientific Strategies and Regulatory Expectations for Preclinical Safety Evaluation of High Risk Therapeutic Proteins and Monoclonal Antibodies
Hanan Ghantous, Ph.D.
U.S. Food and Drug Administration
Predictability of Monoclonal Antibody Treatment Related Immunotoxicity from Preclinical Data – What Have Regulators Learned from March 13, 2006?
Bernd Leidert, Ph.D.
Paul-Ehrlich Institute
In Vitro Assays for Preclinical Safety Assessment of Therapeutic Protein
Jina Min
Pfizer, Inc.