HUM-MOLGEN events: IBC's Immunogenicity of Recombinant Biological Therapeutics: A Practical Approach

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IBC's Immunogenicity of Recombinant Biological Therapeutics: A Practical Approach

September 18, 2003

-, Courtyard San Diego - Kearny Mesa, San Diego, CA
October 23-24, 2003

This course is designed to assist attendees in understanding the immunological mechanisms underlying immunogenicity, how immunogenicity is impacted by the nature of the therapeutic (e.g. protein structure, formulation, delivery and patient population) and how one can predict and help prevent immunogenicity of biotechnology products. In addition, extensive practical information covering the methods for the analysis of the immune response, including their design, execution, analysis and validation will be discussed. The course will also identify the regulatory (FDA, EMEA, ICH) guidelines for immunogenicity testing and cover strategies for addressing immunogenicity during product development, licensure and post licensure/Phase IV studies.

Organized by:

IBC Life Sciences

Invited Speakers:

Course Instructors:

Anthony Mire-Sluis, Ph.D., Head of Analytical Sciences and Standards, Office of the Director CBER, OTRR, US FDA

Stephen Indelicato, Ph.D., Associate Director, Biotechnology Development, Schering-Plough Pharmaceuticals

Steven J. Swanson, Ph.D., Director and Head, Clinical Immunology, Amgen, Inc.

Deadline for Abstracts:

Registration:

Phone (508) 616-5550 Fax (508) 616-5522 Online www.LifeSciencesInfo.com/2929

E-mail:

reg@ibcusa.com