Join us in celebrating our 50th Anniversary!
Join us in celebrating our 50th Anniversary!
Kelly S. Oliner, Member, CLSI

Kelly S. Oliner, PhD

Member, CLSI

Deputy Director, Division of Immunology and Hematology Devices in FDA’s Office of In Vitro Diagnostic Devices and Radiological Safety, US Food and Drug Administration

Kelly S. Oliner, PhD, is the Deputy Director, Division of Immunology and Hematology Devices in the US Food & Drug Administration (FDA)’s Office of In Vitro Diagnostic Devices and Radiological Safety. She has held this position since 2015. In this position, she participates in FDA review and approval of traditional and point-of-care in vitro diagnostics for autoimmune diseases, neurological disorders, flow cytometry diagnostics, devices used for hematology and coagulation assessment, genetic health risk tests and serum biomarkers for cancer. Immediately prior to joining the FDA, Dr. Oliner was at Amgen (2003 to 2015) where she held successive positions from Staff Scientist to Scientific Director. Initially, she managed a laboratory group that developed and validated therapeutic drug potency assays in a GLP testing environment. In 2006, Dr. Oliner transferred to the clinical biomarker group where she was responsible for leading biomarker development efforts for clinical programs from early preclinical stage to marketed products. In this position, she had a small laboratory group that developed and validated biomarker assays (ELISA, RT-PCR, NGS) for use in Amgen clinical trials. Dr. Oliner also led extensive outsourcing efforts (ELISA, IHC, FISH, PCR, and NGS) to small and large clinical testing laboratories in the US, Europe, and China to support global clinical trials. Several clinical biomarker efforts were successful. In 2012, Amgen formed a small, specialized in vitro diagnostic group to specifically support companion diagnostic programs at Amgen. Through collaborative partnerships with diagnostic companies, clinically validated biomarker assays were developed. Dr. Oliner led long-term efforts to develop, validate, and obtain global regulatory approval for KRAS and RAS biomarkers for the use of panitumumab, and EGFR antibody for colorectal carcinoma. She earned her PhD in Molecular Genetics from the Johns Hopkins University School of Medicine and subsequently held two post-doctoral fellowships at Somatix Gene Therapy Corporation and Chiron Corporation. Following these fellowships, she was a research scientist at Chiron Corporation, Protein Pathways, and Amgen. Dr. Oliner joined the CLSI Board of Directors in 2017.