Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44Big Data Emergin Alte Special Populations 28 MONDAY, SEPTEMBER 18, 2017 l Symposium 11 l 4:00 – 5:30 pm Pioneering NAFLD/NASH Early- phase Clinical Pharmacology Study Designs DISCOVERY TRACK CO-CHAIRS: Lorraine Rusch, PhD, President, High Point Clinical Trials Ctr Sabina Paglialunga, PhD, Metabolic & Pharmacodynamic Specialist, Celerion TARGET AUDIENCE: This Symposium will be useful for clinical pharmacologists, physicians, metabolic scientists, hepatologists, research scientists, medical directors and bioanalytical scientists. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Implement study design considerations and discuss safety concerns for clinical NAFLD/NASH studies; 2. Compare invasive and non-invasive NAFLD/NASH measurements for diagnosis and treatment response assessments; 3. Explore strategic NAFLD/NASH biomarkers and implementation of these measurements in clinical studies and medical practice. 4:00 – 4:10 pm Introduction Lorraine Rusch, PhD, President, High Point Clinical Trials Ctr 4:10 – 4:30 pm Non-invasive Approaches to Diagnosing & Evaluating Treatment Response in NAFLD & NASH Dina Halegoua-De Marzio, MD, Assistant Professor of Medicine & Jefferson Fatty Liver Ctr Director, Thomas Jefferson Univ Hosp 4:30 – 4:50 pm Leveraging Soluble Biomarkers for NAFLD/NASH Studies Amar Sethi, MD, PhD, President & Chief Scientific Officer, Pacific Biomarkers Inc 4:50 – 5:10 pm Optimizing NAFLD/NASH Study Design in Early Clinical Trials Sabina Paglialunga, PhD, Metabolic & Pharmacodynamic Specialist, Celerion 5:10 – 5:30 pm Panel Discussion and Q&A Symposia