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 Big Data Emergin Alte Special Populations 16 SATURDAY, SEPTEMBER 16, 2017 l Pre-meeting Workshop 4 l 1:30 – 5:30 pm Modeling & Simulation Strategies for Dose Selection of Targeted Anticancer Agents DISCOVERY TRACK CO-CHAIRS: Ahmed H. Salem, PhD, Associate Director, Clinical Pharmacology & Pharmacometrics, AbbVie Inc Murad Melhem, PhD, Principal Scientist, Amgen Inc TARGET AUDIENCE: This Workshop will be useful for clinical pharmacologists and pharmacometricians from industry, academia and regulatory agencies who are involved in drug development. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Develop and apply more efficient dose selection approaches during oncology drug development; 2. Identify clinical design considerations for proper dose finding in oncology drug development; 3. Explain how a model-based approach can help in optimizing dosage regimens and compare the different modeling & simulation techniques that can be used; 4. List and address challenges specific to dose selection of combination therapies in oncology; 5. Explain regulatory perspectives on optimizing dosage regimens of oncology drugs. 1:30 – 1:35 pm Introduction Ahmed H. Salem, PhD, Associate Director, Clinical Pharmacology & Pharmacometrics, AbbVie Inc 1:35 – 2:00 pm Quantitative Clinical Pharmacology in Oncology Drug Development: Enabling Rational Dose Selection from Translational to Global Drug Development Karthik Venkatakrishnan, PhD, Senior Director, Quantitative Clinical Pharmacology (Oncology), Takeda Pharmaceuticals Co Ltd 2:00 – 2:30 pm Exposure-Response Analysis of Venetoclax in Multiple Myeloma: Application of Frequentist & Bayesian Approaches for Combination Therapy Dose Selection Kevin Freise, PhD, Assistant Director, Clinical Pharmacology & Pharmacometrics, AbbVie Inc 2:30 – 3:00 pm Application of Markov Structure-based Logistic Regression Modeling to Adverse Reactions Characterization in Oncology Ene Ette, PhD, President & Chief Executive Officer, Anoixis Corp 3:00 – 3:30 pm Clinical Study Design to Enable Proper Dose Finding in Oncology Kapil Mayawala, PhD, Director, Quantitative Pharmacology & Pharmacometrics, Oncology, Merck & Co 3:30 – 4:00 pm / Break 4:00 – 4:30 pm Utility of Exposure-Response Analyses in Drug Development for Leukemia Michelle A. Rudek, PharmD, PhD, Associate Professor, Johns Hopkins Univ 4:30 – 5:00 pm Data-driven Dose Selection in Oncology Drug Development Bahru Habtemariam, PharmD, Acting Team Leader, Office of Clinical Pharmacology, Div of Clinical Pharmacology V, US Food & Drug Administration 5:00 – 5:30 pm Panel Discussion and Q&A Pre-meeting Workshops