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Honoring Professor Shein-Chung Chow’s 40 years of Contributions to Statistical and Regulatory Sciences

Chairs: Mark Chang (Boston University), Herbert Pang (Genentech) and Xiaofei Wang (Duke)

Speaker: Yi Tsong, PhD (FDA)

Speaker: Thomas Gwise, PhD (Independent Contractor)

Speaker: Mark Chang, PhD (Boston University)

Speaker: Chinfu Hsiao, PhD (NHRI)

Shein-Chung Chow (Duke)

Shein-Chung Chow, Ph.D. is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina. Dr. Chow was also a special government employee (SGE) appointed by the United States Food and Drug Administration (FDA) as an Oncologic Drug Advisory Committee (ODAC) voting member and Statistical Advisor to the FDA (2015-2017, 2019-2022). Between 2017-2019, Dr. Chow was on-leave for the FDA as an Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA. Dr. Chow was the Editor-in-Chief of the Journal of Biopharmaceutical Statistics (1992-2020) and is the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group. He was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. 

Dr. Chow is the author or co-author of over 350 methodology papers and 33 books including Design and Analysis of Bioavailability and Bioequivalence Studies, Biosimilars: Design and Analysis of Follow-on Biologics, Biosimilar Product Development, Analytical Similarity Assessment in Biosimilar Drug Development, Advanced Statistics in Biosimilar Product Development, Advanced Statistics in Regulatory Critical Clinical Initiatives, and most recently, Innovative Methods for Rare Disease Drug Development.