The Biopharmaceutical Section is offering another webinar on March 29th (Tue) 11:00AM-1:00PM. The webinar is entitled "Statistical Methods to Test for Biosimilarity" and will be given by Prof. Sujit Ghosh of NC State. Follow the link Web-Based Lectures for more details on how to register.
This webinar is free of charge for Biopharmaceutical Section members.
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Title: Statistical Methods to Test for Biosimilarity
Speaker: Sujit K. Ghosh
Affiliation: NC State University and SAMSI
Abstract:
In recent years there have been a lot of interest to test for similarity between biological drug products, commonly known as biologics. Biologics are large and complex molecule drugs that are generally produced by living cells and hence these are sensitive to the environmental changes.
In addition, biologics usually induce antibodies which raises the safety and efficacy issues. The manufacturing process is also much more complicated and costlier than the small-molecule generic drugs. Because of these complexities and inherent variability of the biologics, the testing paradigm of the traditional generic drugs cannot be directly used to test for biosimilarity. Taking into account some of these concerns a class of recently developed model based methodologies are presented that takes into consideration of the entire time course of the clinical study. The primary focus of this presentation is to present methodologies for establishing statistical equivalence based on clinical endpoints for biosimilar products. Although the illustrated methodologies are applicable to many types of diseases and other scenarios, in this presentation, the case studies are based on rheumatoid arthritis trials. Empirical results are presented to show that the one of the recently proposed approaches is more sensitive than the classical equivalence test approach, and may require much less sample size for detecting biosimilarity.
Brief Bio of the Speaker:
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Professor Sujit Ghosh is currently a tenured faculty member at the rank of full professor in the Department of Statistics at North Carolina State University (NCSU) and he also serves as the Deputy Director of SAMSI (www.samsi.info). He has over 20 years of experience in conducting, applying, evaluating and documenting statistical analysis of biomedical and environmental data. Prof. Ghosh has supervised over 33 doctoral graduate students and 5 post-doctoral fellows. He has also served as a statistical investigator and consultant for over 40 different research projects funded by various leading industries and federal agencies. Prof. Ghosh received the IISA Young Investigator Award in 2008; was elected a Fellow of the ASA in 2009; was elected as the President of the NC Chapter of ASA in 2013 and currently he is president-elect of IISA for year 2017. Prof. Ghosh has delivered several short courses and served as the short term visiting professor at leading institutions in various countries.
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Margaret Gamalo-Siebers, PhD
Principal Research Scientist
Eli Lilly & Co
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