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 22 SUNDAY, SEPTEMBER 17, 2017 l Symposium 5 l 4:00 – 5:30 pm Clinical Trial Simulations in Pediatric Drug Development APPLICATION TRACK Offers both CME and CPE Credit UAN #0238-0000-17-011-L05-P ACPE – 1.5 CONTACT HOURS/APPLICATION-BASED CO-CHAIRS: Janelle Baker, MD, Pediatrician & Commissioners Fellow, Office of Clinical Pharmacology, US Food & Drug Administration Daniel Gonzalez, PharmD, PhD, Assistant Professor, Div of Pharmacotherapy & Experimental Therapeutics, UNC Eshelman School of Pharmacy, The Univ of North Carolina at Chapel Hill TARGET AUDIENCE: The application of clinical trial simulations in pediatric drug development would be relevant for clinical pharmacologists and clinicians working in academia, industry and regulatory agencies. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Inform the audience about the regulatory, industry and academic perspectives on the use of clinical trial simulations in pediatric drug development; 2. Present examples of how integration of clinical trial simulation can improve pediatric drug development; 3. Provide suggestions on the future direction of clinical trial simulation as an important tool in optimizing pediatric clinical trial design. 4:00 – 4:10 pm Clinical Trial Simulations as a Tool to Guide Pediatric Drug Development Daniel Gonzalez, PharmD, PhD, Assistant Professor, Div of Pharmacotherapy & Experimental Therapeutics, UNC Eshelman School of Pharmacy, The Univ of North Carolina at Chapel Hill 4:10 – 4:30 pm The Use of Clinical Trial Simulations to Support the Validation of Mobile, Pharmacometric, Individualized Dosage Web Applications in Pediatric Drug Development Seth Berry, PharmD, Senior Scientific Advisor, Clinical PK/PD Modeling & Simulation, QuintilesIMS Holdings Inc 4:30 – 4:50 pm Clinical Trial Simulation for Pediatric Efficacy Trials: Case Studies William Prucka, PhD, Director, Innovation Computational Statistics, Biometrics & Advanced Analytics, Eli Lilly & Co 4:50 – 5:10 pm Regulatory Perspective on the Use of Clinical Trial Simulation in Pediatric Drug Development Kevin Krudys, PhD, Pharmacometrics Team Leader, Office of Clinical Pharmacology, US Food & Drug Administration 5:10 – 5:30 pm Panel Discussion Moderator – Janelle Baker, MD, Pediatrician & Commissioners Fellow, Office of Clinical Pharmacology, US Food & Drug Administration Symposia