DIA 48th Annual Meeting
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Immunogenicity of Therapeutic Peptides: Regulatory Science Implications
Track
:
Track 14: Clinical Safety and Pharmacovigilance
Program Code:
422
Date:
Thursday, June 28, 2012
Time:
10:45 AM to 12:15 PM
EST
CHAIR
:
Jill Conner, Teva Pharmaceuticals, United States
PRESENTER
(S):
S. Russ Lehrman, Lehrman Biopharma, United States Laura Salazar Fontana, FDA, United States
Ety Klinger, Proteologics, Ltd., Israel
Description
Like proteins, synthetic peptide-based non-biologic complex drugs (NBCD) are immunogenic and can be immunotoxic. This session will review causes of immunotoxicity and suggests regulatory guidelines to ensure immunologic safety of new or follow-on peptide-based NBCD.
Learning Objectives:
Identify potential for, and causes of, unwanted immunogenicity of peptide therapeutics, including non-biologic complex drugs (NBCD)
Illustrate risks of inadequate clinical/preclinical testing of immunogenic peptides
Identify guidelines for new and follow-on peptide-based NBCD approval.
Learning Objectives:
Identify potential for, and causes of, unwanted immunogenicity of peptide therapeutics, including non-biologic complex drugs (NBCD)
Illustrate risks of inadequate clinical/preclinical testing of immunogenic peptides
Identify guidelines for new and follow-on peptide-based NBCD approval.
This session is a part of:
Handout Online
