This webinar, will start with an introduction to mAbs that target specific components of both the autoimmune response and the inflammatory cascade, followed by in-depth discussions of the following topics and speakers:
Introduction: Monoclonal Antibodies for the Treatment of Immune-Mediated Inflammatory Disease
Simone Nicholson, PhD, DABT
Senior Toxicologist, Biologics Safety Assessment, MedImmune LLC
Immune Safety Assessments for Immunosuppressive Agents: Tools and Applications
Hervé Lebrec, PharmD, PhD, DABT
Scientific Director, Nonclinical Safety Sciences, Amgen Inc.
Carcinogenicity Assessment of Biologics
Shawn Heidel, DVM, PhD
Vice President and Head, Global Safety Assessment, Covance Laboratories, Inc.
Regulatory Aspects and Interpretation of Immunosuppression AE in Nonclinical Studies
Ken Hastings, DrPH, DABT, ATS
Hastings Toxicology Consulting, LLC
Immune-Mediated Inflammatory Disease (IMID) encompasses a broad category of over 100 related diseases in which the person’s immune system attacks his or her own tissue. Pathogenesis is amplified by inflammatory cytokines and is self-perpetuating due to persistence of self-antigens and redundancy in inflammatory pathways. Over the years, the therapeutic goal in IMID has shifted from control of symptoms toward achieving clinical remission and tissue healing in order to prevent disease progression. Monoclonal antibodies (mAbs) have been used either individually or in combinations to combat the mechanisms that drive IMID pathogenesis.
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