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 4415 ng Trends Data Analysis Biosimilars ernative Medicine Individualized Care Data Analysis Data Analysis SATURDAY, SEPTEMBER 16, 2017 Data Analysis SATURDAY, SEPTEMBER 16, 2017 Data Analysisl Pre-meeting Workshop 3 l 1:30 – 5:30 pm Therapeutic Drug Monitoring in Advancing Patient Care: Is This Time Different? APPLICATION TRACK CO-CHAIRS: Neeraj Gupta, PhD, Senior Scientific Director, Takeda Pharmaceuticals Co Ltd Manish Gupta, PhD, Group Director, Bristol-Myers Squibb Co TARGET AUDIENCE: This Workshop will be useful for attendees from academia, industry and clinicians. It should also benefit an audience who is engaged in the clinical development of large molecules and oncology or pediatric drugs, as well as attendees that may be interested in the reimbursement landscape for biologics. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Apply therapeutic drug monitoring in various disease settings such as inflammatory and malignant diseases, including pediatrics; 2. Compare a newly-available, user-friendly decision support tool (currently being tested in clinical trials in adult and pediatric patients with inflammatory bowel disease) with the other available tools. 1:30 – 1:35 pm Introduction Neeraj Gupta, PhD, Senior Scientific Director, Takeda Pharmaceuticals Co Ltd 1:35 – 2:05 pm Why Most Therapeutic Drug Monitoring is Not as Useful as It Should Be: Opportunities & Challenges Lawrence J. Lesko, PhD, Professor & Director, Ctr for Pharmacometrics & Systems Pharmacology, Dept of Pharmaceutics, Coll of Pharmacy, Univ of Florida 2:05 – 2:35 pm Therapeutic Drug Management for Monoclonal Antibodies in Inflammatory & Malignant Diseases Alexander A. Vinks, PharmD, PhD, Professor, Pediatrics & Pharmacology, Director, Div of Clinical Pharmacology, Cincinnati Children’s Hosp Medical Ctr, Univ of Cincinnati, Coll of Medicine 2:35 – 3:00 pm Application of Therapeutic Drug Monitoring in Pediatrics Jeffrey S. Barrett, PhD, Vice President & Global Head of Translational Informatics, Global Head of Pediatric Clinical Pharmacology, Sanofi 3:00 – 3:30 pm Therapeutic Drug Monitoring in Oncology Jeannine McCune, PharmD, Professor, City of Hope Cancer Ctr & Affiliate Professor, Dept of Pharmacy, Univ of Washington 3:30 – 4:00 pm / Break 4:00 – 4:30 pm Pricing & Reimbursement Challenges Facing Payers Regarding Tumor Necrosis Factor Inhibitors TBD 4:30 – 5:00 pm Clinical Decision Support Tools for Therapeutic Drug Monitoring for Monoclonal Antibodies Diane R. Mould, PhD, President, Projections Research Inc 5:00 – 5:30 pm Panel Discussion Pre-meeting Workshops