Michael (Micky) Cohen-Wolkowiez, MD, PhD, an associate professor of pediatrics in the Division of Infectious Diseases, has been named director for the Duke Clinical Research Unit (DCRU), one of just a handful of state-of-the-art hospital-based early phase research units in the country.
Cohen-Wolkowiez currently leads the Pharmacometrics Center (PMC) at the Duke Clinical Research Institute (DCRI), which was established to provide scientific expertise and clinical pharmacology support for clinical trials. The PMC specializes in developing programs that adapt to each sponsor’s unique requirements, resulting in maximized trial efficiency and success within the context of regulatory compliance.
“Dr. Cohen-Wolkwiez is a respected researcher with extensive experience in designing and implementing pharmacokinetic studies in children,” said Coleen Cunningham, chief of the Division of Infectious Diseases and vice-chair of research in the Department of Pediatrics. “In his new role, he will be charged with improving the functionality of the DCRU to effectively support investigator-initiated, government, and industry sponsored early clinical drug development studies.”
The creation of the DCRU has enabled Duke investigators to conduct proof-of-concept research, including efforts to identify and validate novel biomarkers, while leveraging advances at the forefront of technology. In addition to early-stage investigator-initiated studies and NIH-funded research, Duke researchers also work with pharmaceutical, biotechnology, and medical device companies in generating exponentially greater volumes of data in early phase studies than what has traditionally been possible.
“It’s an honor to take on this leadership role with the DCRU,” Cohen-Wolkwiez said. “The potential for groundbreaking research advances through the DCRU is exceptional.”
Cohen-Wolkwiez received his medical degree from Central University of Venezuela in 2001. He completed his residency at Miami Children's Hospital (Florida), where he served as chief resident in 2005-2006. Cohen-Wolkwiez came to Duke in 2006 to pursue a fellowship in pediatric infectious diseases and later joined the faculty in the Department of Pediatrics (Infectious Diseases). He received a PhD in pharmaceutical sciences at the UNC Eshelman School of Pharmacy in 2012 and is board-certified in pediatrics and pediatric infectious diseases. His clinical interests include pharmacokinetics and pharmacodynamics of drugs used in children and critically ill infants.
The DCRU is under the direction and management of the Duke Clinical Research Institute, which was established in October 2006 with a grant from the National Institutes of Health National Center for Research Resources (NCRR) Clinical Translational Science Award (CTSA). The mission of the DTMI is to expedite the translation of new scientific discoveries into clinical practice while promoting measurable improvements in community health, and making personalized medicine a reality.