WELCOME NOTE AND INTRODUCTIONS
Dr. Lorraine Rusch, President
High Point Clinical Trials Center
EPIDEMIOLOGY AND SCIENCE BEHIND NASH
Dr. Sabina Paglialunga, Metabolic and Pharmacodynamic Specialist
NON-INVASIVE METABOLOMIC ASSAYS FOR DIAGNOSING HEPATIC STEATOSIS AND NASH
Tim Montgomery, Manager, Technology and Commercial Development
EFFECTIVE PATIENT OUTREACH, RECRUITMENT/SCREENING INITIATIVES
Dr. Margarita Nunez, Medical Director
High Point Clinical Trials Center
DEVELOPMENT OF NOVEL BIOMARKERS FOR THE ASSESSMENT OF DISEASE PROGRESSION AND CLINICAL STUDY ENDPOINTS
Dr. Michael Murphy, Laboratory Director, BD/Strategic Relations
Dr. Nuñez is the Medical Director and Principal Investigator at High Point Clinical Trials Center. She has over 20 years of clinical research experience and has conducted over 450 trials in both early and late phase. She received her medical degree from New York Medical College and completed her residency in internal medicine at the University of South Florida College of Medicine.
Upon the completion of her residency, she completed a two-year fellowship in geriatric medicine and subsequently joined the faculty at the University of South Florida where she taught Internal Medicine and Geriatrics for three years. Her responsibilities at USF including being the associate medical director at Hospice of Hillsborough County in addition to working at the Memory Disorder Clinic. Before entering her work in clinical trials, she practiced internal medicine at a rural health clinic in Central Florida for an additional three years before becoming Principal Investigator and Medical Director at Comprehensive Clinical Development in St. Petersburg Florida. Dr. Nuñez joined the team at High Point Clinical Trials Center in January of 2013.
Dr. Sabina Paglialunga, a Metabolic and Pharmacodynamic Specialist, joined Celerion, a full-service clinical research organization which specializes in phase I and II clinical studies, in 2015. As Celerion’s metabolic disease subject matter expert, Dr. Paglialunga works with clients from the pharmaceutical and biotech sector to provide scientific and operational support for early clinical studies with an obesity, diabetes, or fatty liver disease indication. With over 10 years of research experience, her extensive metabolic expertise is highlighted through more than 30 peer-reviewed publications.
Prior to joining Celerion, Dr. Paglialunga completed postdoctoral fellowships at the University of Waterloo (Canada), the University of Guelph (Canada), and Maastricht University (the Netherlands). Her research focused on energy metabolism and glucose homeostasis in the context of health and disease. Sabina earned her doctorate in Biochemistry at McGill University (Canada), concentrating in lipid metabolism.
Tim is an enthusiastic life science advocate with 20 years of global healthcare experience with a keen understanding of international medical requirements in the fields of cardio-metabolic molecular diagnostics, implantable medical devices, and pharmaceuticals.
His current role is Manager, Technology and Commercial Development for the Europe-based biotech firm, OWL Metabolomics. The OWLiver® and OWLiver® tests are the world’s first non-invasive metabolomic assays for diagnosing hepatic steatosis and NASH. Much of the company’s focus involves collaborative scientific support for pharma, CRO’s, academia and research centers, focusing on novel molecular diagnostics and associated treatments for fatty liver disease.
Dr. Michael Murphy originally joined Pacific Biomarkers in 1997 as Director of Laboratory Services. He served in that role until 1999 before returning to the commercial clinical reference laboratory industry. Dr. Murphy returned to Pacific Biomarkers in 2005 as Senior Vice President, Operations and was later named Chief Operating Officer in 2009. Dr. Murphy managed all aspects of the service business including laboratory operations, client and information services, and quality assurance. Dr. Murphy worked with senior management to execute business development initiatives as well.
Currently, Dr. Murphy serves as the Laboratory Director/BD Strategic Client Relationships. He provides CAP/CLIA regulatory lab oversight and is very active in fostering strategic relationships with client and vendor partners. Dr. Murphy has served as a principal investigator in research and diagnostic studies. Areas of expertise include biomarker validation and standardization, quality assurance, laboratory operations, informatics and laboratory automation.