Micky Cohen-Wolkowiez, MD, PhD, is Executive Director of i-Cubed, the Center for Clinical Research Innovation at the Duke Clinical Research Institute. i-Cubed partners with innovators to turn clinical research ideas into products, services, and companies. He is also the Kiser-Arena Distinguished Professor at Duke University and Founder/CEO of ExecRx, which provides fractional medical leadership to startups. Micky has over 15 years of experience designing and conducting clinical trials across diverse populations, including children, older adults, pregnant women, and healthy volunteers, using both traditional and decentralized models. He previously served as Scientific Advisor to the FDA’s Office of Pediatric Therapeutics and has consulted for pharmaceutical companies and startups. His research primarily focuses on computational and patient-centric methods to accelerate drug development. Dr. Cohen-Wolkowiez has served as the principal investigator for a diversified portfolio of research funded through peer-reviewed processes, including grants from the NIH, FDA, BARDA, various foundations, and industry sponsors. He has served as protocol chair, principal investigator, or held an investigational new drug application for 15 trials in children, resulting in the enrollment of more than 3,500 children. He has performed or led more than 50 pharmacokinetics/pharmacodynamics analyses across multiple therapeutic areas to support FDA data submissions. He is the author of more than 200 publications in competitive, peer-reviewed journals. He has mentored >40 trainees, including junior faculty, fellows, medical students, residents, and undergraduate students. Of these trainees, the majority (>70%) are either currently engaged in academic medicine and/or directly participating in patient-oriented research.

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