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 44Program at a Glance 4 Workshops & Symposia at the 2017 ACCP Annual Meeting are identified as being part of either the “Discovery Track” (DT) or the “Application Track” (AT) to make it easier for attendees to determine which courses they prefer to attend. Emergin Alte Special Populations Big Data SATURDAY, SEPTEMBER 16, 2017 Pre-meeting Workshop 1 l 8:00 am – 12:00 pm Should Off-patent Medications Be Labeled for Pediatric Use? ACCP/PPAG Jointly-sponsored Symposium (AT) This Workshop has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American College of Clinical Pharmacology and the Pediatric Pharmacy Association. The American College of Clinical Pharmacology is accredited by the ACCME to provide Continuing Medical Education for physicians. CO-CHAIRS: Michael D. Reed, RPh, PharmD, Director, Rainbow Clinical Research Ctr, Rainbow Babies & Children’s Hosp, Case Western Reserve Univ School of Medicine and Gilbert J. Burckart, PharmD, Associate Director of Pediatrics, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration Pre-meeting Workshop 2 l 8:00 am – 12:00 pm Best Practice Approaches to Physiologically-based Pharmacokinetic Modeling for Labeling Initiatives: Industry & Regulatory Perspectives (AT) CO-CHAIRS: Karthik Venkatakrishnan, PhD, Senior Director, Quantitative Clinical Pharmacology, Takeda Pharmaceuticals Co Ltd and Karen Rowland Yeo, PhD, Vice President, Simcyp (part of Certara) Pre-meeting Workshop 3 l 1:30 – 5:30 pm Therapeutic Drug Monitoring in Advancing Patient Care: Is This Time Different? (AT) CO-CHAIRS: Neeraj Gupta, PhD, Senior Scientific Director, Takeda Pharmaceuticals Co Ltd and Manish Gupta, PhD, Group Director, Bristol- Myers Squibb Co Pre-meeting Workshop 4 l 1:30 – 5:30 pm Modeling & Simulation Strategies for Dose Selection of Targeted Anticancer Agents (DT) CO-CHAIRS: Ahmed H. Salem, PhD, Associate Director, Clinical Pharmacology & Pharmacometrics, AbbVie Inc and Murad Melhem, PhD, Principal Scientist, Amgen Inc SUNDAY, SEPTEMBER 17, 2017 Plenary Session l 8:00 – 9:30 am Predicting Pharmacokinetics/Pharmacodynamics in the Individual Patient: Separating Reality from Hype (AT) Leslie Z. Benet, PhD, Professor & former Chairman (1978–1998), Dept of Bioengineering & Therapeutic Sciences, Schools of Pharmacy & Medicine, Univ of California, San Francisco Symposium 1 l 10:00 am – 12:00 pm Innovative Scientific & Risk-based Quantitative Approaches to Post-marketing Surveillance of New & Generic Drug Products (AT) CO-CHAIRS: Lawrence J. Lesko, PhD, Professor & Director, Ctr for Pharmacometrics & Systems Pharmacology, Dept of Pharmaceutics, Coll of Pharmacy, Univ of Florida and Lanyan (Lucy) Fang, PhD, Team Leader, US Food & Drug Administration Symposium 2 l 10:00 am – 12:00 pm Optimizing Dose/Dosing Frequency for a Biologic: Clinical, Regulatory & Commercial Perspectives (AT) CO-CHAIRS: Gaurav Bajaj, PhD, Associate Director, Clinical Pharmacology & Pharmacometrics, Bristol-Myers Squibb Co and Sumit Rawal, PhD, Research Scientist, Regeneron Pharmaceuticals Inc Symposium 3 l 1:30 – 3:30 pm Master Protocols in Drug Development (AT) CO-CHAIRS: Dionna J. Green, MD, Medical Officer & Policy Lead, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration and Kevin Watt, MD, PhD, Assistant Professor of Pediatrics, Duke Univ Medical Ctr, Duke Clinical Research Inst Symposium 4 l 1:30 – 5:30 pm Next Wave in Cancer Medicine: Mechanisms & Progress for Emerging Therapeutics (DT) CO-CHAIRS: Lucy Lee, PharmD, Director, Clinical Pharmacology, Infinity Pharmaceuticals Inc and Luna Musib, PhD, Senior Scientist, Clinical Pharmacology, Genentech Research and Early Development (gRed) Symposium 5 l 4:00 – 5:30 pm Clinical Trial Simulations in Pediatric Drug Development (AT) CO-CHAIRS: Janelle Baker, MD, Pediatrician & Commissioners Fellow, Office of Clinical Pharmacology, US Food & Drug Administration and Daniel Gonzalez, PharmD, PhD, Assistant Professor, Div of Pharmacotherapy & Experimental Therapeutics, UNC Eshelman School of Pharmacy, The Univ of North Carolina at Chapel Hill SUNDAY, SEPTEMBER 17, 2017 SATURDAY, SEPTEMBER 16, 2017