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 44Table of Contents 14 Pre-meeting Workshops Big Data Emergin Alte Special Populations Best Practice Approaches to Physiologically-based Pharmacokinetic Modeling for Labeling Initiatives: Industry & Regulatory Perspectives APPLICATION TRACK CO-CHAIRS: Karthik Venkatakrishnan, PhD, Senior Director, Quantitative Clinical Pharmacology, Takeda Pharmaceuticals Co Ltd Karen Rowland Yeo, PhD, Vice President, Simcyp (part of Certara) TARGET AUDIENCE: Clinical pharmacologists, pharmacists and clinicians would be interested in this Workshop and those in an industry setting are likely to derive the most benefit. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Describe the basic concepts of physiologically-based pharmacokinetic (PBPK) modeling and its value as an emerging technology in clinical pharmacology; 2. Identify clinical questions that warrant the application of PBPK modeling in drug development, particularly for informing the drug label to optimize therapeutic use across patient populations; 3. Implement best practice approaches for PBPK model development, including data requirements, aligned with regulatory expert opinion, in order to increase confidence in model-informed applications in drug development and pharmacotherapy; 4. Appreciate the data required to support modeling initiatives in special populations, including pediatrics and organ impairment; 5. Reflect upon examples of successful translation of PBPK to labeling for small molecule drugs to inform next-generation applications to solve problems unique to emerging biotherapeutic modalities. 8:00 – 8:05 am Introduction Karthik Venkatakrishnan, PhD, Senior Director, Quantitative Clinical Pharmacology, Takeda Pharmaceuticals Co Ltd 8:05 – 8:35 am PBPK Modeling: Concepts & Best Practice Approaches Karen Rowland Yeo, PhD, Vice President, Simcyp (part of Certara) 8:35 – 9:05 am Application of PBPK Modeling to Support Labeling Initiatives: Case Studies Jan Snoeys, PhD, Scientific Director & Fellow Pharmacokinetics, Dynamics & Metabolism, Janssen R&D Belgium 9:05 – 9:35 am Strategic Application of PBPK Modeling in an Industry Setting to Support Labeling Initiatives: Case Studies Lisa von Moltke, MD, Vice President, Clinical Research, Alkermes plc 9:35 – 10:00 am / Break 10:00 – 10:30 am Application of PBPK Modeling to Support Labeling Initiatives: A Regulatory Perspective Shiew-Mei Huang, PhD, Deputy Office Director, Office of Clinical Pharmacology, Office of Translational Sciences, Ctr for Drug Evaluation & Research, US Food & Drug Administration 10:30 – 11:00 am PBPK Modeling in Pediatrics: Current Status J. Steven Leeder, PharmD, PhD, Director, Div of Clinical Pharmacology, Toxicology & Therapeutic Innovation, Children’s Mercy Hosp 11:00 – 11:30 am PBPK Modeling of Biologics: Current Status Donald E. Mager, PharmD, PhD, Professor of Pharmaceutical Sciences, Univ at Buffalo, SUNY 11:30 am – 12:00 pm Panel Discussion SATURDAY, SEPTEMBER 16, 2017 l Pre-meeting Workshop 2 l 8:00 am – 12:00 pm