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Development of a Clinical Meaningful Immunogenicity Assessment Program
Tuesday, November 13
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-533-l04
Immune response to a biotherapeutic can affect the drug safety and efficacy in patients. Assessment and characterization of immune response is a critical element of biotherapeutic development. Immune response may result in cellular and humoral immunity with transient appearance of anti-therapeutic antibodies (ATA) with consequences from no significant clinical impact to a severe and life threatening condition. The demand on the measurement of ATA and immunogenicity evaluation has been increased dramatically over the last few years. Appropriate strategies for the assessment and management of immunogenicity are essential for the successful development of biotherapeutics. However, due to the nature of immune response and limitations of the current available technologies, we are facing great challenges to develop clinical meaningful immunogenicity program. This symposium will review and discuss the current practice, analytical challenges and clinical aspects of immunogenicity assessment.
Moderators
Patrick M. Liu, Ph.D.
Tanox, Inc.
Russell S. Weiner, Ph.D.
Bristol-Myers Squibb Company
Patricia Siguenza, Ph.D.
Genentech, Inc.
Fit-for-Purpose Strategy for Immunogenicity Assessment of Biotherapeutics
Patrick M. Liu, Ph.D.
Tanox, Inc.
Regulatory Perspectives on Immunogenicity Assessment of Biotherapeutics
Amy N. Rosenberg, M.D. (Invited)
U.S. Food and Drug Administration
Anti-therapeutic Antibodies and Their Impact on Drug Safety, Efficacy and Pharmacokinetics/Pharmacodynamics
Valerie Quarmby, Ph.D.
Genentech, Inc.
Clinical Aspects of Growth Hormone Immunogenicity
Phillip D. Lee, M.D.
EMD Serono, Inc.