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 31 TUESDAY, SEPTEMBER 19, 2017 Data Analysis TUESDAY, SEPTEMBER 19, 2017 Data Analysis l Data Analysis l Data AnalysisSymposium 14 l 10:00 am – 12:00 pm Full Extrapolation of Efficacy from Adults to Children of Antiepileptic Drugs Indicated for the Treatment of Partial Onset Seizures APPLICATION TRACK Offers both CME and CPE Credit UAN #0238-0000-17-017-L05-P ACPE – 2 CONTACT HOURS/APPLICATION-BASED CHAIR: Angela Men, PhD, MD, Pharmacology Lead, US Food & Drug Administration TARGET AUDIENCE: This Symposium will be useful for primary care physicians, specialty physicians (in pediatrics), pharmacists, clinical pharmacologists, physician assistants, nurses, nurse practitioners, clinical research associates and basic scientists. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Obtain the agency perspectives on the full extrapolation of efficacy from adults to children of antiepileptic drugs (AEDs) indicated for the treatment of partial onset seizures (POS) and required information to get approval of AEDs use in pediatric patients ≥4 years old of POS; 2. Differentiate POS similarity between adults and pediatrics; 3. Explain how quantitative pharmacokinetic/pharmacodynamic analysis supports the decision making on the new guideline. 10:00 – 10:20 am Full Extrapolation of Efficacy in Children for Partial Onset Seizures: An FDA-UMD-PEACE Collaborative Project Angela Men, PhD, MD, Pharmacology Lead, US Food & Drug Administration 10:20 – 10:40 am Disease Similarity of Partial Onset Seizures Between Adults & Children: PEACE White Paper Douglas Nordli, Jr, MD, Chief, Div of Pediatric Neurology & Co- director, Neurosciences Inst, Children’s Hosp Los Angeles 10:40 – 11:00 am Quantitative Analysis to Support Full Extrapolation of Efficacy in Pediatrics for Partial Onset Seizures Shailly Mehrotra, BPharm, PhD Candidate, Univ of Maryland 11:00 – 11:30 am Regulatory Impact of Drug Development of AEDs for Pediatrics TBD 11:30 am – 12:00 pm Q&A Symposia