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September 17, 2012

Immunogenicity Testing Considerations for Biosimilar Drug
Development

SPEAKER FOR THIS EVENT:
  • Chris Beaver, Director, Immunochemistry and Cell Biology Operations, PharmaNet/i3 Learn More
  • The development of biosimilar products is a growing and prominent component of drug development portfolios. Due to their size and molecular complexity, large molecules (e.g., proteins, peptides, antibodies) induce immune responses in preclinical and clinical studies, a feature that is not an issue in small molecule development programs. Determination of similarity for biosimilar programs is based on the assessment not only of the degree to which pharmacokinetic and efficacy parameters are equivalent but also of relative immunogenicity profiles of the innovator and comparator products.

    Immunogenicity during the preclinical or clinical development phase, particularly if unexpected or not equivalent between
    innovator and comparator products, may halt or suspend the progress of a development program until it can be satisfactorily understood. The appropriate design, implementation and interpretation of immunogenicity data are therefore critical to the success of these types of studies. This
    presentation will discuss the challenges and solutions to developing and validating appropriate immunogenicity assays for preclinical and clinical biosimilar programs.

    This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies

    Part 1 - Archive available (contact Xtalks per bottom of page)
    September 17, 2012
    Immunogenicity Testing Considerations for Biosimilar Drug Development
    Part 2 - Archive available (click url for more information)
    October 15, 2012
    Reduce Filing Time - Fast Turnaround of Innovator and BE First-to-File Analysis
    Part 3 - Archive available (click url for more information)
    December 17, 2012
    Application of GC/MS/MS in Monitoring Steroids as a Pharmacokinetic and Pharmacological Biomarker

     

    THIS PROGRAM IS INTENDED FOR:

    Bioanalytical scientists; laboratory, outsourcing, and project managers and directors.

    This webinar series invites you to find out more about our innovative approaches and specialized techniques to bioanalytical studies to help you meet your project objectives.

    ABOUT OUR SPEAKER:
     

    Chris Beaver, Director, Immunochemistry and Cell Biology Operations, PharmaNet/i3

    Dr. Beaver has extensive CRO leadership experience and technical expertise in large molecule bioanalysis. He joined PharmaNet in November 2010 and is responsible for leading the immunochemistry team within the Company’s bioanalytical laboratories and expanding its large molecule services, including assay development and sample analysis for biomarker, ELISA, radioimmunoassays, immunogenicity and cell-based assays.

     

    Previously, Dr. Beaver served as Scientific Director of Ligand Binding/Cell Based Assays at another clinical research organization with macromolecule bioanalysis operations. He completed his PhD in Neuroscience at Dalhousie University in Halifax, Canada, followed by post-doctoral training at Yale University.  Dr. Beaver is published in multiple scientific publications, including Drug Discovery World and Nature Neuroscience.

    OUR XTALKS PARTNER FOR THIS EVENT:

    inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 70 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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