Monica Hughes, M.S. has 18 years of combined regulatory affairs, inspections, and investigation experience at the U.S. Food and Drug Administration (FDA). She joined DataRevive in May 2020. Prior to joining DataRevive, Ms. Hughes was a Regulatory Health Project Manager (RPM) for four years, a Regulatory Project Manager Team Leader for five years, and a chief project manager for almost 10 years with the US FDA in the Office of at the Center for Drug Evaluation and Research (CDER) as part of the Office of Hematology Oncology Products (OHOP), Division of Oncology Products 2 (DOP2). 


During her time at FDA, from 2003 to 2007, she was an RPM and managed 150+INDs along with numerous marketing applications, including the approval of Vectibix.  As an RPM Team Leader from 2007-2012 she continued to manage applications, including the approval of Stivarga, while also training and mentoring the regulatory project management staff; and, from 2012-2020 where she served as a Chief Project Manager, supervising a regulatory project management staff in one of CDER’s busiest review divisions responsible for an average yearly incoming workload of 300+ new PDUFA/BSUFA meeting requests, 750+ new INDs, 250+ individual expanded access requests, 60+ efficacy supplements; and 5-10 NME NDA/BLA, 505 (b)(2), and biosimilar applications.  During recent years, DOP2 was responsible for managing the approvals of: Alecensa, Portrazzo, Cotellic, Tagrisso, Yondelis, Lonsurf, Odomzo, Unituxan, Lenvima, Lartuvo, Bavencio, Alunbrig, Mvasi, Vitrakvi, Lobrena, Libtayo, Vizimpro, Bravtovi, Mektovi, Lutathera, Azedra, Turalio; and Rozlytrek.

During her time working on oncology applications, and personal experience with her father battling cancer, she became passionate about broadening the knowledge on how physicians could access treatment for their patients using individual and emergency use INDs.  She helped develop a video series to provide an overview for physicians submitting these applications using the FDA form 3926 for the Agency.

Ms. Hughes earned her B.S, and M.S., degrees in Combined Science (Biology and Chemistry) and Molecular Biology respectively.  Early in her career, she worked for as a primary care pharmaceutical sales representative and served as an adjunct Biology faculty member at Youngstown State University, Cleveland State University, and at the University of Pittsburgh.