Of all pediatric clinical trials, early phase studies (i.e., phase I and II) pose the greatest challenges as they: 1) are frequently “non-therapeutic” in nature (e.g., designed to characterize pharmacokinetics and/or find age-appropriate dose); 2) may involve drugs already being widely used “off-label” in children and as a consequence, only a regulatory imperative might exist for study and 3) must involve participants across a dynamic range of ages which in some instances (e.g., young infants and neonates) introduce technical challenges which may limit what can be done in an experimental context.
To traverse these hurdles, it is incumbent upon sponsors and investigators to design studies that are both age- and condition-appropriate, consider the impact of ontogeny on both physiology and psychosocial development and use methods which enable the data emanating from a study to be robust and thereby, sufficient for regulatory decision making.
This presentation will, through the use of actual illustrations, demonstrate some of the pitfalls encountered in early phase pediatric clinical pharmacology studies and by doing so, provide direction on how they might be avoided in the design and conduct of future studies.
GREGORY L. KEARNS, PharmD, PhD, Marion Merrell Dow/ Missouri Chair in Pediatric Medial Research
Dr. Kearns received his undergraduate degree (B.S. Pharm.) from the St. Louis College of Pharmacy in 1977 and his Pharm.D. degree from the University of Cincinnati in 1979. He also completed a 2 year residency in pediatric clinical pharmacy at the Children’s Hospital Medical Center in Cincinnati from 1977-1979, followed by a postdoctoral fellowship in Clinical Pharmacology and Toxicology at the Louisiana State University of Medicine in Shreveport (1979-1983). In October of 2002, Dr. Kearns received his Ph.D. degree in Clinical Pharmacology from the Erasmus University School of Medicine in Rotterdam, the Netherlands.
Dr. Kearns served as a faculty member in the departments of Pediatrics and Pharmaceutics at the University of Arkansas for Medical Sciences from 1983 through 1995 where he developed and directed a program in Pediatric Clinical Pharmacology at the Arkansas Children’s Hospital. In January of 1996, Dr. Kearns moved to Kansas City, MO where he was the first recipient of the Marion Merrell Dow / Missouri Chair in Pediatric Pharmacology at the University of Missouri-Kansas City where he holds professorial appointments in Pediatrics (Medicine) and Pharmacology (Pharmacy). As well, he served as the Chief of the Division of Pediatric Pharmacology and Medical Toxicology from 1996 through 2007 and currently, continues as the Director of the Pediatric Pharmacology Research Unit at the Children’s Mercy Hospitals and Clinics (CMHC). In October 2006, Dr. Kearns was named as the recipient of the Marion Merrell Dow / Missouri Chair in Pediatric Medical Research and also, the Director of Medical Research at CMHC. He was also appointed as the Associate Chairman of the Department of Pediatrics at the UMKC School of Medicine.
Dr. Kearns service to the discipline of Clinical Pharmacology includes past membership on the American Board of Clinical Pharmacology (1995-2000; chair of Examination Committee, 1997-2000), presidency of the American Society for Clinical Pharmacology and Therapeutics (2003-04) and two terms as a member of the Board of Regents of the American College of Clinical Pharmacology. He also serves as the Section Editor for the Pediatric Series in the Journal of Clinical Pharmacology (since 1996) and recently, served as an Associate Editor of Clinical Pharmacology and Therapeutics (2006 to 2008). Dr. Kearns continues to serve as a consultant to the Food and Drug Administration, the NIH and to various pharmaceutical companies as relates to issues pertaining to Pediatric Clinical Pharmacology. As well, he has worked with members of Congress and testified before several congressional subcommittees concerning legislation to require the inclusion of children in clinical drug trials. In 2005, Dr. Kearns served as a consultant to the Royal College of Paediatrics in the United Kingdom to develop a pediatric clinical pharmacology research network in the UK. In 2007, Dr. Kearns was selected as the pediatric clinical pharmacology representative from the U.S. to serve on the WHO Pediatric Subcommittee of the Essential Medicines Committee which produced the first Essential Medicines List for Children. In 2008, Dr. Kearns was appointed by WHO to a 4 year term as a member of the Essential Medicines Committee and in 2009, he served as a consultant to the National Health Service of Scotland to develop a paediatric clinical trial network.
Over the past 25 years, Dr. Kearns’ research has focused in the discipline of pediatric clinical pharmacology with a special emphasis on developmental regulation of pharmacokinetics/pharmacodynamics, the evaluation of mechanisms underlying adverse drug reactions in pediatrics and most recently, the integration of pharmacogenetics into Phase I-II clinical trials in children. He has received continuous research support from NIH for pediatric clinical pharmacology research since 1993. Throughout his career, Dr. Kearns has authored/co-authored over 280 peer-reviewed publications which include the 7th edition of the Handbook of Basic Pharmacokinetics. He has also been the recipient of the Young Investigator Award from the Southern Society for Pediatric Research (1982); the Distinguished Investigator Award from the American College of Clinical Pharmacology (2004); the Distinguished Alumnus Award from both the St. Louis College of Pharmacy (1997) and the University of Cincinnati School of Pharmacy (2008); the Sumner J. Yaffe Lifetime Achievement Award in Pediatric Clinical Pharmacology (2009) and the FDA/ASCPT Abraham’s Distinguished Lectureship (2010).
ALEXANDER CVETKOVICH MUNTANOLA, M.D., Senior Director Clinical Development, INC Research
Dr. Cvetkovich Muntañola has more than 20 years of medical and clinical research experience, including 10 years as a pediatrician in health institute and university hospital settings. He received his medical degree, cum laude, from the University Medical School in Belgrade with a specialization in pediatrics and sub-specialization of respiratory diseases for both adults and children. Dr. Cvetkovich Muntañola has worked as a pediatrician in two pediatric clinics in Belgrade and in Barcelona where he was responsible for in and outpatient clinics as well as the pediatric ICU. As a pediatrician he participated as an investigator in multiple pediatric clinical trials for asthma and cystic fibrosis. He also served as a lecturer for UNICEF for respiratory diseases and immunologic disorders. He has worked for the past 10 years in the CRO industry in phase I-IV international studies including PK/PD and immunogenetics.
Dr. Cvetkovich Muntañola brings integrated knowledge and experience from clinical settings and drug development and provides pediatric medical expertise to INC Research staff and customers for all aspects of pediatric program development and execution. His areas of expertise include Pediatric Investigational Plans, IP program development, study design, protocol review, site selection, site management and patient recruitment. In addition he serves as a liaison with medical experts in European clinical trial settings. His recent pediatric research experience includes respiratory, oncology, CNS, dermatology, endocrinology, immunology and GI indications.
Dr. Cvetkovich Muntañola is the author / co-author of more than 100 medical articles. The most recent publications related to pediatric clinical trials include a chapter on global pediatric study challenges “The Importance of Geographic differences in Pediatric Clinical Trials” for the textbook Pediatric Drug Development: Concepts and Applications (2009), an article “The Changing Landscape of Cystic Fibrosis Clinical Trials” (2011) and an article “One size doesn’t fit all”, Foresight (2011). Dr. Cvetkovich Muntañola is an invited speaker to international conferences on pediatric drug development. Among the latest conferences related to pediatric clinical research are the DIA / EMA pediatric Forum where he presented “Paediatric clinical trials – Recruitment issues and answers” and “Conducting Clinical Research in Neonate & Paediatric Patients” on the 20th Annual DIA EuroMeeting in Barcelona 2008. Dr. Cvetkovich Muntañola is a member of ERS. He is located in Barcelona, Spain.
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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