Kin Tang, PhD

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Genentech
Senior Director in Pharma Technical Regulatory
Kin T. Tang, PhD, is a Senior Director in pharma technical regulatory at Genentech, where he and his team are responsible for CMC regulatory strategy for a portfolio of small molecule products across the development life cycle. Kin is a pharmaceutical scientist with a BS in pharmacy and MS and PhD in pharmaceutical sciences. He has contributed through various scientific and biopharma leadership roles in analytical, product development, quality, and regulatory toward the successful development, marketing authorization, and global launch of multiple novel medicinal products. Kin has published in multiple scientific journals and presented or moderated at a number of scientific events. He has also served on various industry expert groups in PhRMA, IQ Consortium, and AAPS, where he most recently served as chair of the CMC Community.

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During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across geographic regions. This article shares data that highlight instances where well-established ICH...