February 18th, 2015

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Webinar Description:

In assessing the comparability of proposed biosimilar compounds to the innovator counterparts, regulatory agencies have stressed the “totality-of-evidence” approach, which relies on both structural and functional characterization, as well as data from animal and clinical studies. We present as a case study a package of assay methods developed for one such biosimilar, trastuzumab, which will include characterization of target binding, Fc receptor binding and ADCC activity as well as PK and immunogenicity assays to be used in clinical studies. Challenges encountered and approaches taken in the development of these methodologies will be discussed.

Attendees will

  • Understand the regulatory testing requirements for biosimilars
  • Understand the technical challenges associated with the bioanalysis of trastuzumab
  • Learn about bioanalytical and characterization approaches for trastuzumab
  • Learn about cell-based assays for evaluating the biosimilarity of trastuzumab

You will benefit from attending this event if you are a vice president, director, or manager of a pharmaceutical or biotech company with responsibilities in the following areas:

Biosimilars development
Clinical Safety
Regulatory affairs

Speaker Information:

John KamerudJohn Kamerud, PhD., Scientific Director, Eurofins Pharma Bioanalytical Services

Dr. Kamerud is Scientific Director at Eurofins’ St Charles, Missouri site, where his role is to serve as scientific and technical advisor for both clients and internal teams for development, validation, and application of assays to comply with scientific goals and regulatory requirements. He received his PhD (Biochemistry) degree in 1987 from the University of Minnesota. Dr Kamerud has over 20 years of experience in the development, validation and implementation of immunoassay methods, holding positions with EMD Millipore, Covance Laboratories and Eli Lilly and Company.

John Kamerud, PhD
Scientific Director
Eurofins Pharma Bioanalytics Services US Inc

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