The Administrative Core (Core A) will be managed by John van den Anker, Center Director, and Eric Hoffman, Director Pilot Programs. Dr. van den Anker is the Vice Chair of Pediatrics for Experimental Therapeutics at Children?s National Health System (CNHS) and brings expertise in the management of programs such as the Pediatric Pharmacology Research Unit and the current specialized center in Research in Pediatric Developmental Pharmacology (RPDP), and has extensive clinical and research expertise in several areas of developmental and pediatric pharmacology. He also serves as the Co-I of Project 1 (Basic/Translational Project; Dissociation of efficacy from side effects of anti-inflammatory therapies in Duchenne muscular dystrophy), and Project 2 (Clinical Project; Bridging pharmacodynamics biomarkers to endoscopic and clinical outcomes in pediatric inflammatory bowel disease). Dr. Hoffman is the founding Chair of the Department of Integrative Systems Biology at George Washington University, and the Director of Genetic Medicine at CNHS, and is currently the CEO of ReveraGen (leave of absence from CNMC until early 2017). Dr. Hoffman brings extensive expertise in pediatric drug development, clinical trials, clinical/translational research specifically in the area of DMD, and pharmacodynamics of steroids. He will also serve as the MPI of Project 1. Drs. Van den Anker and Hoffman have complementary capabilities that will allow them to effectively direct the Administrative Core. This Core has three specific aims.
In Specific Aim 1, fiscal management of all Projects and the Administrative Core, oversight of balancing of Core resources, convening of the Internal Steering Committee as well as annual meetings of the External Advisory Board, and solicitation and reviewing of Pilot Project applications will be the responsibility of Dr. van den Anker and his administrative team.
In Specific Aim 2, monthly conference calls of key personnel on all Projects and the Administrative Core, monitoring of research progress on each Project and Core, including timely achievement of milestones, oversight of annual scientific reports, and oversight and monitoring of human subjects and regulatory compliance will be carried out.
In Specific Aim 3, Dr .Hoffman will manage the RPDP Pilot Program. Finally, both Drs. van den Anker and Hoffman are tightly integrated into the CTSA efforts and this very active involvement of the CTSA within the RPDP investigations will ensure synergism with this nationally- based clinical and translational research effort.
