Michael Cohen-Wolkowiez, MD, PhD, is the Kiser-Arena Distinguished Professor of Pediatrics at Duke University and Head of Pediatrics at the Duke Clinical Research Institute. His research focuses on computational and patient-centric methods to advance and accelerate pediatric and adult drug development as well as strategic leadership of large, federally sponsored programs and networks. In support of his research mission, he has used a diversified research portfolio that includes peer reviewed funding for which he is Principal Investigator from NIH, FDA, BARDA, foundations, and industry. In order to amplify the impact of this research, Dr. Cohen-Wolkowiez worked for two years as a Scientific Advisor to the FDA, Office of Clinical Pharmacology and Office of Pediatric Therapeutics. He has served as protocol chair, principal investigator, or held an investigational new drug (IND) application for 15 trials in children resulting in enrollment of more than 3,500 children. He has performed or led more than 50 PK/PD analyses across multiple therapeutic areas that were used to support data submission to the FDA. He is the author of more than 160 peer reviewed publications and has mentored numerous trainees.

Dr. Cohen-Wolkowiez completed his medical degree at the Universidad Central de Venezuela and his residency in Pediatrics at the Nicklaus Children’s Hospital in Miami, Florida. Board-certified in pediatrics and pediatric infectious disease, he completed infectious disease subspecialty training at Duke University and received a PhD in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill School of Pharmacy.