February 18th, 2015
11am-12pm
Sponsored by
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
Bioanalytical
Pharmacokinetics
Regulatory affairs
Speaker Information:
John 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
johnkamerud@eurofins.com
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