Perspectives on Pediatric Trials from Investigative Sites

John van den Anker, MD Vice Chair of Pediatrics for Experimental Therapeutics and Director of Pediatric Clinical Pharmacology at Children’s National Medical Center (Washington, DC)

John van den Anker received his Medical Degree in 1983 from Erasmus University, Rotterdam, the Netherlands and was a resident in Pediatrics (1984-1988) and a fellow in Neonatal Medicine (1999-2001) at Sophia Children’s Hospital in Rotterdam, the Netherlands. After his clinical training he conducted clinical pharmacology studies investigating the impact of renal function development on clinical pharmacokinetics in the neonate that resulted in the successful defense of his PhD in 1995. In 1997 he became Director of Neonatology and Professor of Pediatrics and Neonatology at Erasmus University.

Currently Dr. van den Anker is the Vice Chair of Pediatrics for Experimental Therapeutics and Director of Pediatric Clinical Pharmacology at Children’s National Medical Center in Washington, DC, USA and is Professor of Pediatrics, Pharmacology & Physiology at George Washington University School of Medicine and Health Sciences. He is also appointed at the Erasmus Medical Center as a Professor of Pediatrics and Pediatric Clinical Pharmacology. Since 2005 he holds the Evan and Cindy Jones Chair in Pediatric Clinical Pharmacology at Children’s National Medical Center.

Dr. van den Anker has been granted several major awards from the National Institute of Health (NIH) and leads one of the only four NICHD-funded Research Centers Specialized in Pediatric Developmental Pharmacology in the USA.

He has published over 200 peer reviewed papers in the field of neonatal and pediatric clinical pharmacology and serves on the Editorial Board of several Clinical Pharmacology journals.

Dr. van den Anker’s continued commitment and active participation in pediatric clinical pharmacology in Europe has resulted in his election as President of the European Society of Developmental, Perinatal and Paediatric Pharmacology (2006-2008), past member of the Board of directors of the American Society for Clinical Pharmacology and Therapeutics and current member of the Board of Regents of the American College of Clinical Pharmacology and the Committee on Drugs of the American Academy of Pediatrics.

Ginger Steinhilber RN.MS. CCRC Clinical Research Manager, Children’s Hospital of Michigan and Wayne State University

Ginger Steinhilber RN.MS. CCRC is a clinical research manager for Children’s Hospital of Michigan and Wayne State University. She has been actively involved in Pediatric Clinical Research for over 14 years, working first as a study coordinator, then as Nurse Manager for the Children’s Hospital of Michigan Clinical Research Center.

Ms. Steinhilber was the Nurse coordinator for the NIH Pediatric Pharmacology Research Unit (PPRU) Network, located at Children’s Hospital of Michigan for 10 years. As such, she worked with multiple therapeutic areas and age groups including premature infants to young adults and had the opportunity to work with leading Pediatric Pharmacologists throughout the country. Her responsibilities now include monitoring of IND held clinical trials, management of a university wide Clinical Trials Management Software system and safety coordinator for an NIH grant funded clinical trial.

Ms. Steinhilber is a member of ACRP and SOCRA. She has been ACRP certified since 2001 and has presented at the national ACRP meeting. She has also presented at the national quarterly meetings of the PPRU network and numerous Investigator meetings. She is a member of the Coordinator Advisory Committee to the Human Investigation Committee at Wayne State University.

Ms. Steinhilber received her RN degree through Lankenau Hospital School of Nursing, B.S. from Cedar Crest College in Allentown, PA. and a Master of Science degree from St. Joseph’s University in Philadelphia.

Kathy Bohannon Principal Strategist, Pediatrics, INC Research

Ms. Bohannon provides global operational and strategic leadership for INC Pediatrics. She has 16 years of diverse operational and therapeutic experience within pharmaceutical research and development; including Phase I-IV clinical research, laboratory R&D, US and global project management, and sales & marketing. Ms. Bohannon has over 9 years of pediatric research experience including 5 years of pediatric study and program management within the Best Pharmaceuticals for Children Act – Coordinating Center (BPCA-CC) under the purview of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Ms. Bohannon has supported development and management of pediatric projects across multiple therapeutic areas (analgesia, cardiovascular, CNS, dermatology, infectious disease, hematology, metabolic disease and respiratory) and clinical settings (inpatient, outpatient, ICU, OR and ER), including rare diseases/orphan indications. Her pediatric experience includes protocol and program development in compliance with FDA PREA and BPCA legislation, and the European Paediatric Regulation; internal team training and management from project initiation through completion; recent presentations examining pediatric research practices and opportunities for further training and education; and strategy development for navigating the challenges of pediatric research.