Sharin Roth

Director

Otsuka Pharmaceutical Development & Commercialization, Inc.

Biography

Sharin Roth is Director of Clinical Pharmacology, Bioanalysis and Biomarkers at Otsuka Pharmaceutical Development & Commercialization.  She has worked in the pharmaceutical industry for 14 years on development of both small chemical entities and biologics.  She currently manages a biorespository of specimens collected in clinical trials.  There is a need to reduce the cost of therapeutics and reach a larger, more representative population base during development.  Specimen management, particularly specimens in which clinical endpoints are generated from, are a critical element to this effort.  In her current role, Sharin oversees process automation for sample life cycle, including accountability and allowed analysis per consent, and generation of results that includes pharmacokinetics, pharmacodynamics and exploratory biomarker endpoints to support therapeutic development.  Tools evaluated for the facilitation of automation and streamlined analysis include block chain, tableau, and Watson.

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