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 44Symposia ng Trends Data Analysis Biosimilars ernative Medicine Individualized Care Data Analysis Data Analysis 19 SUNDAY, SEPTEMBER 17, 2017 Data Analysis SUNDAY, SEPTEMBER 17, 2017 Data Analysis l Data Analysis l Data Analysis Symposium 2 Data Analysis Symposium 2 Data Analysis l 10:00 am – 12:00 pm Optimizing Dose/Dosing Frequency for a Biologic: Clinical, Regulatory & Commercial Perspectives APPLICATION TRACK CO-CHAIRS: Gaurav Bajaj, PhD, Associate Director, Clinical Pharmacology & Pharmacometrics, Bristol-Myers Squibb Co Sumit Rawal, PhD, Research Scientist, Regeneron Pharmaceuticals Inc TARGET AUDIENCE: This Symposium will be useful for clinical pharmacologists and pharmacometricians from the pharmaceutical and biotech industries, academia, clinicians, regulatory scientists and scientists working in the early/late development space. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Identify strategies for dose/dose regimen optimization during drug development; 2. List challenges specific to clinical pharmacology and the impact on changing dose/dose regimen during development of biologics; 3. Explain clinical design considerations for biologics; 4. Identify the advantages and disadvantages of changing dosing frequency for a biologic. 10:00 – 10:10 am Introduction Gaurav Bajaj, PhD, Associate Director, Clinical Pharmacology & Pharmacometrics, Bristol-Myers Squibb Co 10:10 – 10:30 am Optimal Dosing for Targeted Therapies in Oncology: Drug Development Cases Leading by Example Kapil Mayawala, PhD, Director, Quantitative Pharmacology & Pharmacometrics, Merck & Co 10:30 – 10:50 am Model-based Analyses to Optimize Dosing Regimen During Development & Post-approval Amit Roy, PhD, Group Director, Bristol-Myers Squibb Co 10:50 – 11:10 am Model-based Assessment of Dosing Strategies in Children for Monoclonal Antibodies Exhibiting Target-mediated Drug Disposition Stephan Schmidt, PhD, Assistant Professor & Associate Director, Univ of Florida 11:10 – 11:30 am Regulatory Perspectives on Optimizing Dose/ Dosing Frequency in Combination Settings Jeffrey Florian, PhD, Team Leader, US Food & Drug Administration 11:30 am – 12:00 pm Panel Discussion and Q&A