Michael Cohen-Wolkowiez, MD, PhD
Director, Duke Clinical Research Unit
Associate Professor of Pediatrics
Dosing information of drugs prescribed to children is exceedingly scarce and can lead to treatment failures and unnecessary toxicities. Cohen-Wolkowiez dedicates his academic career to filling this knowledge gap using novel and feasible methodologies that can be adapted to the developing child. He has substantial experience in clinical trial design and operations, as well as expertise in pediatric pharmacology (i.e., pharmacokinetics [PK]/pharmacodynamics [PD]) to optimize dosing for children. His experience with novel trial design and PK methodologies includes opportunistic data collection (PK samples collected at the time of clinical care laboratory tests), micro-volume multiplex drug assays, scavenged sampling, population PK/PD modeling, physiologically-based PK modeling (PBPK), and dried matrix spot analysis.
His expertise in PK/PD modeling of early phase data led him to conduct early phase research in adults. He leads the DCRI Early Phase Research Unit (DEPRU), a state of the art 40-bed confinement unit for studies in healthy volunteers and proof-of-concept studies in patients. This unit conducts approximately 70 studies per year with about 3,000 outpatient and 300 confinement visits for industry and government sponsored programs.
Cohen-Wolkowiez is the author of more than 100 peer-reviewed publications and has led several multicenter pediatric studies, including trials for pediatric labeling. He spent two years as a scientific advisor to the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration and collaborated with the clinical pharmacology team on a series of projects related to pediatric dosing and ethical aspects of pediatric regulatory submissions. He has been continuously funded by multiple government and industry sponsored programs.