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 44Big Data Emergin Alte Special Populations 20 SUNDAY, SEPTEMBER 17, 2017 l Symposium 3 l 1:30 – 3:30 pm Master Protocols in Drug Development APPLICATION TRACK Offers both CME and CPE Credit UAN #0238-0000-17-010-L01-P ACPE – 2 CONTACT HOURS/APPLICATION-BASED CO-CHAIRS: Dionna J. Green, MD, Medical Officer & Policy Lead, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration Kevin Watt, MD, PhD, Assistant Professor of Pediatrics, Duke Univ Medical Ctr, Duke Clinical Research Inst TARGET AUDIENCE: The primary audience includes clinicians and scientists from industry, regulatory and other government agencies, academia and non-profit organizations who are involved in the development of medical products. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Describe the current drug development landscape and the inefficiencies that can be associated with clinical trials; 2. Demonstrate the utility of master protocols in increasing efficiency in drug development and speeding new therapies to patients; 3. Cite examples of master protocols employed in the areas of oncology, pediatrics and rare diseases and apply the practical, statistical, regulatory and scientific considerations when designing a master protocol. 1:30 – 2:00 pm The Evolution of the Master Protocol & Current Experience in the Pre-competitive Space Kevin Watt, MD, PhD, Assistant Professor of Pediatrics, Duke Univ Medical Ctr, Duke Clinical Research Inst 2:00 – 2:30 pm Utility & Challenges for Master Protocols in Oncology Clinical Trials: An Industry Perspective Andrew Chang, PharmD, PhD, Clinical Pharmacology Lead, Pfizer Oncology Group, Pfizer Global Product Development 2:30 – 2:55 pm Regulatory Considerations for Master Protocols Lynne Yao, MD, Director, Div of Pediatric & Maternal Health, Office of New Drugs, Ctr for Drug Evaluation & Research, US Food & Drug Administration 2:55 – 3:15 pm Statistical Considerations for Master Protocols Dionne Price, PhD, Director, Div of Biometrics IV, Office of Biostatistics, Ctr for Drug Evaluation & Research, US Food & Drug Administration 3:15 – 3:30 pm Panel Discussion Symposia