Shian-Jiun (SJ) Shih

Dr. Shih is a consultant serving pharmaceutical and biotechnology clients, with more than twenty years’ of industrial experience and specializing in assay 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 29 scientists with broad translational research skills, including immunoassays, nucleic acid-based assays and next generation sequencing, mass spectrometry, flow cytometry, cell-based assays, immunohistory chemistry, and bioinformatics. Her group was responsible for developing clinical biomarker assays to support early phase clinical trials, including those for Keytruda, as well as for collaborating with academic leaders in biomarker discovery, and for building primate disease models for target validation studies.

Prior to joining Merck, she was with Cell Genesys, a biotechnology company developing cell-based immunotherapy and oncolytic adenovirus-based gene therapy products from 2001 to 2008. As the Director of Assay Development there, her group developed quality control and clinical monitoring assays for phase 3 clinical trials, and conducted product characterization studies to answer inquires from FDA, and from regulatory authorities from other countries. During her time 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) and produced antibody reagents for research and in vitro diagnostic use.

SJ received a BS degree in Chemistry from National Taiwan University, and a Ph.D. in Biochemistry from University of Wisconsin–Madison, and completed her post-doctoral training at the department of Molecular Pharmacology at Stanford University.