Joseph Sebastian, PhD
CEO, 25 Years in Pharma, Clinical Diagnostics, >100M in DX sales, LTD developer
Dr. Joe Sebastian serves as the Chief Executive Officer of Oraliva. He has more than 25 years of scientific leadership experience with extensive management roles in lab operations as applied to diagnostics and clinical trials. He has served as an independent consultant to assist in the completion of required prerequisites to transition R&D assays to standardized clinical assays for screening and diagnostics in the areas of Oncology and Liver diseases. As a consultant, he has interacted with emerging biopharma and large biopharma companies. Prior to this role, he served as the senior scientific advisor at Q2Solutions focusing on Liver, CNS, and Infectious diseases. At Q2Solutions, he was involved with business development of clinical trials for Infectious, Liver, and Alzheimer’s diseases. Before joining Q2Solutions, he was the associate VP and Managing director of the Molecular Oncology Lab at Labcorp. During his tenure at Labcorp, he also served as the National discipline director for Molecular infectious diseases. During this time, he was involved in the development and approval of several of the HPV, H1N1, HIV, HCV, and HBV diagnostic and treatment monitoring assays and oversaw the launch of several of these assays where the annual revenue was more than $120 million. He was instrumental in bringing HIV Genosure™, an HIV Genotyping assay as a standard of care (SOC) for assessing development of HIV drug resistance for patients who were treated with different classes of HIV drugs. He has published extensively from this work along with collaborators at UNC Chapel Hill. HIV genotyping in the long term replaced HIV phenotyping in assessing drug resistance monitoring in a cost-effective way. Following the same paradigm for predicting potential drug resistance initially developed for HIV patients, this methodology has now been applied to cancer drugs prior to FDA approval.
Dr. Sebastian worked with Biopredictive Inc (France) for regulatory approval and market acceptance of FibroTest™, a noninvasive alternative to liver biopsy. This test to assess liver fibrosis was initially a Lab developed test (LDT) for HCV patients. This noninvasive methodology replaced liver biopsy for the assessment of liver fibrosis for the vast majority of HCV patients. Most recently, Dr. Sebastian was involved with Siemens Healthineers (Berkeley, CA) bringing the Enhanced Liver Fibrosis (ELF)™ test for diagnosis and monitoring of liver fibrosis progression in Non-Alcoholic Steato hepatitis (NASH) patients. In addition to this, Genfit Pharma’s NIS4™ (France) is another noninvasive biomarker test used as a companion diagnostic to monitor the response to treatment for NASH. This noninvasive methodology was very useful as a companion diagnostic test to monitor the treatment response to drugs which are in clinical trials. He worked with Pharma companies to use these as a LDT prior to obtaining FDA approval for the clinical trials.
Dr. Sebastian received his Ph.D. in Biochemistry from Washington State University and completed postdoctoral work at UNC- Chapel Hill and NIEHS/NIH at RTP, NC. Dr. Sebastian has published 38 scientific publications in a variety of internationally renowned journals including PNAS along with 40 scientific poster presentations at national and international scientific conferences. He is a fellow of the National Academy of Clinical Chemists (AACC) and a member of the American Association of Molecular Pathology.