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 44ng Trends Data Analysis Biosimilars ernative Medicine Individualized Care Data Analysis Data Analysis 29 TUESDAY, SEPTEMBER 19, 2017 Data Analysis TUESDAY, SEPTEMBER 19, 2017 Data Analysis l Data Analysis l Data AnalysisSymposium 12 Data AnalysisSymposium 12 Data Analysis l 8:00 – 9:30 am Assessment of Drug Effect on Pediatric Bone Health DISCOVERY TRACK Offers both CME and CPE Credit UAN #0238-0000-17-015-L01-P ACPE – 1.5 CONTACT HOURS/APPLICATION-BASED CHAIR: Gilbert J. Burckart, PharmD, Associate Director of Pediatrics, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration TARGET AUDIENCE: This Symposium will be useful for pediatric drug developers (industry, regulators) and pediatric clinical pharmacologists. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Describe (a) normal patterns of growth and development in children, (b) pathophysiology of drug-induced changes in bone development in pediatric patients, (c) current FDA guidances relating to assessment of pediatric growth studies and (d) an example of a long- term assessment of bone growth in pediatric patients on inhaled and oral corticosteroids; 2. List the currently-established biomarkers for bone health assessment; 3. Describe the current understanding of using bone mineral density in assessing drug effect; 4. Synthesize a plan for data analysis of bone biomarkers from a pediatric drug development study. 8:00 – 8:25 am The Importance of Pediatric Bone Health in the Safety Evaluation of a New Drug Lynne Yao, MD, Div of Pediatric & Maternal Health, Office of New Drugs, Ctr for Drug Evaluation & Research, US Food & Drug Administration 8:25 – 8:50 am Bone Biomarkers in the Assessment of Pediatric Bone Health Skorn Ponrartana, MD, MPH, Assistant Professor of Radiology, Children’s Hosp Los Angeles, Keck School of Medicine, Univ of Southern California 8:50 – 9:15 am Critical Clinical Pharmacology Factors in Measuring Bone Effects of Drugs in Pediatric Patients Gilbert J. Burckart, PharmD, Associate Director of Pediatrics, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration 9:15 – 9:30 am Panel Discussion Symposia