Biomarkers in NASH Drug Development: Using Cytokeratin 18 as a Secondary Endpoint in Clinical Trials

Naim Alkhouri, MD, Associate Professor of Medicine, Division of Gastroenterology, Adult & Pediatric Hepatologist, Liver Transplant Program, Texas Liver Institute

Dr. Alkhouri was most recently Assistant Professor of Medicine at the Cleveland Clinic Digestive Disease and Surgery Institute and Director of the Metabolic Liver Disease Clinic. He completed his medical degree at the University of Damascus in Syria before completing his internal medicine and pediatric residency at Albert Einstein Medical Center in Philadelphia. Dr. Alkhouri completed his pediatric gastroenterology, hepatology and nutrition fellowship at Cleveland Clinic and an adult transplant hepatology fellowship at the Digestive Disease and Surgery Institute, Cleveland Clinic. Dr. Alkhouri received the American College of Gastroenterology Junior Faculty Development Award to study the analysis of breath volatile organic compounds to diagnose nonalcoholic fatty liver disease. He also received the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Fellow Research Award for his prospective evaluation of the pediatric NAFLD fibrosis index and ELF markers in children with fatty liver disease. Dr. Alkhouri has over 100 publications and presents his work at both national and international medical conferences. Dr. Alkhouri is a member of several professional organizations, including the American Association for the Study of Liver Disease, the European Association for the Study of the Liver, American College of Gastroenterology, and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. His specialty interests include nonalcoholic fatty liver disease, viral hepatitis, autoimmune hepatitis, alpha 1 antitrypsin deficiency, and liver transplantation.

Sabina Paglialunga, PhD, Associate Director, Scientific Affairs, Celerion

Dr. Sabina Paglialunga is the Associate Director, Scientific Affairs at Celerion (www.celerion.com) where she provides scientific support for early clinical studies, client consultation and subject matter expertise for metabolic disease drug development programs. Her areas of expertise include the obesity, type 2 diabetes and nonalcoholic fatty liver disease indications. Sabina joined Celerion in April 2015 and previously held the position of Metabolic and Pharmacodynamic Specialist.

Sabina received her Ph.D. from McGill University in Canada in the department of Biochemistry. Her training also includes three Postdoctoral Fellowships at the University of Waterloo and University of Guelph in Canada, and Maastricht University in the Netherlands. Over her research career, Sabina has contributed to more than 30 peer-review articles and continues to publish on topics of metabolic diseases, pharmacodynamic tools and regulatory aspects of drug development.

Sumit Kar, Lead Scientist, Biomarkers, Celerion

Sumit Kar is the Lead Scientist for Biomarkers in Bioanalytical Services at Celerion (www.celerion.com). In this role, he is responsible for the development of immunoassays for biomarkers and biosimilars. Sumit received his B.S. from Creighton University and has over ten years of experience in molecular biology and disease pathophysiology. He has authored five peer-reviewed publications and numerous posters and presentations on the topics of bioanalysis, biomarkers, and biosimilars. He joined Celerion in 2017 and has an intimate understanding of the regulatory requirements for biomarkers in drug development.