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Dr. Nina Lukinova reviews correlative science aspects in CTEP-sponsored early phase clinical trials with the specific focus on biomarkers for immunotherapy. She is an active member of Biomarker Review Committee and multiple working groups and research projects on biomarkers in cancer drug development.  Dr. Lukinova also makes site visits to monitor the regulatory compliance of the laboratories and biorepositories engaged in the CTEP-sponsored Precision Medicine clinical trials.  

Prior to joining CDP in 2016, she served as an Associate Director in a private biotech company. She was responsible for product development for clinical diagnostics.  She led a CLIA-certified contract service laboratory where she validated quantitative clinical assays for highly specific biomarkers in non-alcoholic fatty liver disease. She also monitored levels of 5-fluorouracil in plasma, developed and filed a patent on a new diagnostic assay for Lyme disease, and led proof-of-principle studies for an assay to detect blood levels of new oral anticoagulants.  Her Ph.D. thesis on early mechanisms of blood coagulation included the development of a clinical assay to detect pathologies in blood clotting and fibrinolysis.  Dr. Lukinova completed her postdoctoral training in molecular genetics at The University of Pennsylvania and publishing her findings in Nature and Genetics. She has transitioned to the biotech industry with a focus on clinical assay development under different platforms and technologies.

Selected Publications

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