Shian-Jiun Shih's Biography

Shian-Jiun Shih, Partner, Kiang Consulting Services

Shian-Jiun (SJ) is a consultant serving pharmaceutical and biotechnology industry, with more than twenty years’ of industrial experience and expertise in biological product development and biomarkers.
From 2009 to 2015 she worked at the Translational Medicine Research Centre, Merck Research Laboratories, Merck Sharp & Dohme, most recently as the Director and Site Lead of Molecular Biomarkers and Diagnostics. She lead scientists with broad translational research skills, including immunoassays, nucleic acid-based assays and next generation sequencing, mass spectrometry, flow cytometry, cell-based assays, immunohistochemistry, and bioinformatics. Her group developed clinical biomarker assays to support early phase clinical trials, including those for Keytruda, collaborated with academic leaders in biomarker discovery, and established primate disease models for target validation studies.
Prior to joining Merck, she was with Cell Genesys, a biotechnology company in the San Francisco Bay Area, developing cell-based immunotherapy, GVAX, and oncolytic adenovirus-based gene therapy products from 2001 to 2008. As the Director of Assay Development, her group developed and validated quality control and clinical monitoring assays for phase 3 clinical trials, and conducted product characterization studies for BLA filing to FDA and global regulatory authorities.
While at Bayer Pharmaceuticals (2000-2001), SJ successfully developed liquid parenteral formulations and explored several novel drug delivery routes for biological drugs. From 1994 to 2000 she worked at Aventis (currently Sanofi) in various capacities, including characterization and purification of therapeutic monoclonal antibodies, development of a cell isolation medical device for bone marrow transplantation, liquid formulation and enhanced cellular delivery for gene therapy products. She started her industrial career in 1993 at BioSource (currently Invitrogen) responsible for producing antibody reagents for research and in vitro diagnostic use.
SJ received her BS degree in Chemistry from National Taiwan University, and Ph.D. in Biochemistry from University of Wisconsin–Madison, and completed the post-doctoral training in the department of Molecular Pharmacology, Stanford University.