As part of this 2012 quarterly webinar series focused on pediatric research, speakers John van den Anker, MD and Ginger Steinhilber, RN will discuss key elements for clinical research in pediatric patients from the point of view of the research site and the investigator. They will discuss what sites and investigators require from all stakeholders in the process: sponsors, CROs, ethics committees, patients and parents, IRBs, GCRCs, pediatric scientific committees and the FDA. They will cover how they evaluate participation in certain pediatric studies.
Speakers will also discuss how they document their processes, including development of informed consent and assent forms. They will share their roles in patient recruitment and strategies that have been effective (and not effective) in patient recruitment and retention for pediatric populations, including what resources and tools are needed and key reasons that families decline participation and drop out of studies. They will also explore the unique considerations for recruitment of PK studies and how to overcome challenges associated with those trials.
For those patients and families that do participate, there are many considerations and factors that drive patient and family compliance. Study design and format, therapeutic indication and length of trial weigh into decisions and compliance by patients and their families. Speakers will address what types of patients/parents are most compliant, why that is and what tools and resources are needed to help patients and families.
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.Message Presenter
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.Message Presenter
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.Message Presenter
Who Should Attend?
Clinical development executives, chief medical officers and other professionals involved in drug development who have interest in further insights in pediatric clinical research.
The webinar will be particularly useful for attendees from biotechnology or pharmaceutical companies worldwide that are seeking to conduct pediatric trials.
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women’s health trials. The company’s The Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina. For more information please visit www.incresearch.com
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