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Stat Approaches to Assess Biosimilarity from Analytical Data

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Contributors

  • Richard K. Burdick, Elion Labs

    Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc. for 10 years. He presently serves as Chief Statistician for Elion Labs, an analytical testing company in Colorado.

    His research and consulting interests consider several CMC statistical applications including comparability studies, stability data analysis, analytical method validation, quality by design process characterization, and analytical similarity for biosimilar products. He has written over 70 journal articles and three books.
    Burdick is a Fellow of the American Statistical Association (ASA) and a member of the American Society for Quality (ASQ) and the American Association of Pharmaceutical Scientists (AAPS). He has served on the USP Statistics Expert Committee since 2010. He received his Bachelor’s Degree in Statistics from the University of Wyoming. He received his Masters and Doctorate degrees in Statistics from Texas A&M University.

  • Kristof Vandekerckhove, QuintilesIMS

    Kristof works as a Senior Scientific Advisor and CMC subject matter expert within QuintilesIMS’s Strategic Drug Development unit. His main responsibilities include the review of CMC data packages and advising on the technical and regulatory requirements for pharmaceutical development of NBEs and biosimilars. He assist companies in the design of pharmaceutical experiments, supports EU / US regulatory pre-licensing procedures, and provides technical and strategic leadership of product development programs to clients.

    Kristof has worked on biosimilar projects since 2011. During this time, he has contributed to the product development plan of 15 different biosimilars for 12 different originator products; has led 11 EU Scientific Advice procedures for biosimilars; and acted as CMC subject matter expert on 5 US Pre-IND or BPD procedures.

    Kristof holds a Master Degree in Pharmaceutical Sciences and a Master Degree in Industrial Pharmacy (EU Qualified Person training), and has 13 years of experience in international regulatory affairs and strategic drug development.

November 3, 2016
Thu 12:30 PM EDT

Duration 1H 30M

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