Intended to be a single source of information, this book covers a wide range of topics on the changing landscape of drug R&D, emerging applications of big data, AI and machine learning in drug development, and the build of robust data science organizations to drive biopharmaceutical digital transformations.
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Harry Yang, Ph.D., is the Vice President and Head of Biometrics at Fate Therapeutics. He has 27 years of experience across all aspects of drug R & D, from early target discovery, through pre-clinical, clinical, translational science, and CMC programs to regulatory approval and post-approval lifecycle management. He played a pivotal role in the successful submissions of 5 biologics license appllications (BLAs) that ultimately led to marketing approvals of five biological products. He has published 8 statistical and data science books, 28 book chapters, over 100 peer-reviewed articles, and 3 industry white papers on diverse scientific, statistical, and data science subjects. He is a frequent invited speaker at national and international conferences. He has also developed statistical courses and conducted trainings at the United States Food and Drug Administration (FDA) and United States Pharmacopeia (USP).
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