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Anti-Infective Drug Development in Neonates September 15, 2016 Anti-Infective Drug Development in Neonates September 15, 2016 Page 1 1 FOOD AND DRUG ADMINISTRATION (FDA) 2 3 PUBLIC WORKSHOP: 4 FACILITATING ANTI-INFECTIVE DRUG DEVELOPMENT FOR 5 NEONATES AND YOUNG INFANTS 6 7 September 15, 2016 8 9 10 Sheraton Silver Spring 11 8777 Georgia Avenue 12 Silver Spring, Maryland 20910 13 14 15 16 17 18 19 20 21 Reported by: Chaz Bennett 22 Capital Reporting Company www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 2 1 P A R T I C I P A N T S 2 3 John Alexander, MD, MPH 4 Deputy Director 5 Division of Pediatric and Maternal Health (DPMH) 6 Office of Drug Evaluation IV (ODEIV), CDER 7 Food and Drug Administration, Silver Spring, Maryland 8 9 Gerri Baer, MD 10 Medical Officer, Office of Pediatric Therapeutics 11 Food and Drug Administration, Silver Spring, Maryland 12 13 Danny Benjamin, MD, PhD, MPH 14 Kiser-Arena Distinguished Professor of Pediatrics 15 Chair, Pediatric Trials Network 16 Faculty Associate Director, Duke Clinical 17 Research Institute 18 Duke University, Durham, North Carolina 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 3 1 P A R T I C I P A N T S 2 (Continued) 3 4 John Bradley, MD 5 Professor and Chief of the Division of Infectious 6 Diseases in the Department of Pediatrics 7 University of California, San Diego 8 9 Maria Fernandez Cortizo 10 PDCU 11 12 John Farley, MD, MPH 13 Deputy Director 14 Office of Antimicrobial Products (OAP), CDER 15 Food and Drug Administration, Silver Spring, Maryland 16 17 William Hope, PhD 18 Professor of Therapeutics and Infectious Diseases 19 University of Liverpool, Liverpool, U.K. 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 4 1 P A R T I C I P A N T S 2 (Continued) 3 4 Laura Kovanda 5 Director, Global Development Project Leader 6 Astellas Pharma Global Development, Inc., 7 Northbrook, IL 8 9 Susan McCune, MD, M.A.Ed. 10 Deputy Director 11 Office of Translational Sciences, CDER 12 Food and Drug Administration, Silver Spring, Maryland 13 14 Lily Mulugeta, Pharm.D. 15 Lead Scientist for Pediatrics 16 Division of Pharmacometrics, Office of Clinical 17 Pharmacology, CDER 18 Food and Drug Administration, Silver Spring, Maryland 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 5 1 P A R T I C I P A N T S 2 (Continued) 3 4 Sumathi Nambiar, MD, MPH 5 Director 6 Division of Anti-infective Products (DAIP), OAP, CDER 7 Food and Drug Administration, Silver Spring, Maryland 8 9 Gary Noel, MD 10 Senior Director in the Child Health Innovation 11 Leadership Department (CHILD) 12 Johnson and Johnson, Raritan, New Jersey 13 14 Christopher Rubino, Pharm.D. 15 Executive Vice President of Pharmacometrics 16 Institute for Clinical Pharmacodynamics, Inc., 17 Schenectady, New York 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 6 1 P A R T I C I P A N T S 2 (Continued) 3 4 Brian Smith, MD, MHS, MPH 5 Professor of Pediatrics 6 Steering Committee Member, Pediatric Trials Network 7 Duke Clinical Research Institute 8 Duke University, Durham, North Carolina 9 10 Thomas Smith, MD 11 Clinical Team Leader, Division of Anti-Infective 12 Products 13 OAP, CDER, FDA 14 15 Mark Turner, PhD 16 Senior Lecturer in Neonatology (Clinical) 17 University of Liverpool, Liverpool, U.K. 18 19 Yuliya Yasinskaya, MD 20 Medical Officer, Division of Anti-Infective Products 21 OAP, CDER, FDA 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 7 1 P A R T I C I P A N T S 2 (Continued) 3 4 Anne Zajicek, MD, Pharm.D. 5 Chief, Obstetric and Pediatric Pharmacology and 6 Therapeutics Branch 7 Eunice Kennedy Shriver National Institute of Child 8 Health and Human Development 9 National Institutes of Health, Bethesda, Maryland 10 11 12 13 14 15 16 17 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 8 1 T A B L E O F C O N T E N T S 2 PAGE 3 4 Session 1: Current State and Challenges 5 Associated With Neonatal Anti-infective 6 Drug Development 12 7 8 Introductory Remarks 12 9 Sumathi Nambiar, CDER, FDA 10 11 The Landscape of Neonatal Anti-infective 12 Drug Development 17 13 John Farley, CDER, FDA 14 15 FDA Perspective on Establishing Efficacy 16 for Common Indications in the Neonatal 17 Population 35 18 Tom Smith, CDER, FDA 19 20 CNS Dissemination in Neonatal Infections 44 21 Danny Benjamin, Duke 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 9 1 T A B L E O F C O N T E N T S 2 (Continued) 3 PAGE 4 5 Pharmacokinetic and Pharmacodynamic 6 Considerations in Neonates 54 7 Lily Mulugeta, FDA 8 9 Adequate and Well-Controlled Trials 10 in Neonates: Lessons Learned from 11 Neonatal Candidiasis Program 70 12 Laura Kovanda, Astellas 13 14 The Role of Clinical Trial Networks 15 in Neonatal Studies 85 16 Brian Smith, Duke 17 18 Clarifying Questions From Audience/Panelists 100 19 20 Lunch 152 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 10 1 T A B L E O F C O N T E N T S 2 (Continued) 3 PAGE 4 5 Session 2: Resources and Path Forward in 6 Neonatal Infections/Studies 152 7 8 Use of In Vivo and In Vitro Models 9 to Guide Dose Selection for Neonatal 10 Infections 152 11 William Hope, University of Liverpool 12 13 Using Pharmacometrics to Facilitate the 14 Design and Analysis of Anti-Infective 15 Drug Studies in Neonates 182 16 Chris Rubino, Institute for Clinical 17 Pharmacodynamics 18 19 Obtaining Clinical Safety and Efficacy 20 Data in Neonatal Infections 202 21 Gary Noel, Johnson and Johnson 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 11 1 T A B L E O F C O N T E N T S 2 (Continued) 3 PAGE 4 5 Neonatal Master Protocols in Neonatal 6 Infections: Pharmacokinetic, Safety 7 and Outcome Assessment 222 8 Mark Turner, University of Liverpool 9 10 Break 245 11 12 Panel Discussion (Covering All Topics) 245 13 14 Concluding Remarks 282 15 16 17 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 12 1 P R O C E E D I N G S 2 Session 1: Current State and Challenges Associated 3 With Neonatal Anti-infective Drug Development 4 Introductory Remarks 5 DR. NAMBIAR: So welcome to today's "Public 6 Workshop on Facilitating Anti-Infective Drug 7 Development in Neonates and Young Infants." My name 8 is Sumathi Nambiar, and I am the Director of the 9 Division of Anti-Infective Drugs at the FDA. 10 We do sincerely appreciate all of you taking 11 the time to attend today's workshop and look forward 12 to a very productive and fruitful discussion. 13 We are here today to discuss a very 14 important topic that lies very close to my heart as a 15 pediatrician and poses challenges on multiple fronts, 16 and we, as a group, have to work together to recognize 17 the challenges and find workable solutions so that 18 safe and effective therapies can be developed for 19 neonates and the neonate patient population. 20 So I think we'll start by introduction of 21 our panelists. So Dr. Mulugeta, maybe we can start 22 with you. www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 13 1 DR. MULUGETA: My name is Lily Mulugeta. 2 I'm a pediatric clinical pharmacologist at the FDA in 3 the Office of Clinical Pharmacology. 4 DR. MCCUNE: Good morning. I'm Susan 5 McCune. I'm the Deputy Director for the Office of 6 Translational Sciences in CDER, FDA, and I'm a 7 neonatologist. 8 DR. ALEXANDER: John Alexander. I'm the 9 Deputy Director for the Division of Pediatric and 10 Maternal Health. And I've previously been working in 11 the Anti-Infectives Division for many years. 12 DR. KOVANDA: Hi. Laura Kovanda, from 13 Astellas. I've worked on the anti-infective programs 14 for Astellas for many years. 15 DR. TURNER: Mark Turner. I'm a 16 neonatologist from Liverpool. I'm interested in any 17 phase drug development, particularly antimicrobials in 18 neonates, and also the number of international 19 collaborations. 20 DR. RUBINO: Hi. Chris Rubino, Executive 21 Vice President for Pharmacometrics at the Institute 22 for Clinical Pharmacodynamics. We are involved in www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 14 1 lots of different anti-infective drug development 2 programs. And I particularly have a specialized 3 interest in pediatrics. 4 DR. ZAJICEK: I'm Anne Zajicek. I'm a 5 pediatrician clinical pharmacologist, Chief of the 6 Obstetric and Pediatric Pharmacology Branch at NICHD.
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