Ms. Sullivan has over 25 years of pharmaceutical development experience. Currently she is the program manager for an international phase 3 clinical trial with over 25 sites that enrolled 1,000 subjects where her efforts include contracting, quality management, and regulatory oversight, and management of investigational product supplies. She has been a consultant for small, start-up companies and academic programs whose primary funding comes from the US National Institutes of Health (NIH), US National Heart, Lung, and Blood Institute (NHLBI), or US Department of Defense.
She focuses on clinical trial management, including contracting, protocol development, budget oversight, and site monitoring as well as maintaining regulatory files (Trial Master File [TMF], Institutional Review Board [IRB], and Essential Documents). Previously, Ms. Sullivan was part of a small biotech company where the project team consisted of 15 people at its largest and 3 at its smallest. It was her responsibility to be the point person for external contract manufacturing organizations and release product for use in clinical trial.
Tangential to overseeing the CMOs, she implemented a right-sized quality system for the company and used quality agreements to ensure clear communication and delineation of quality responsibilities between the company and the CMOs. Throughout her career, Ms. Sullivan has been a leader for authoring and compiling CMC, nonclinical, and clinical sections of INDs, ANDAs, and NDAs.
Additional FDA interactions include authoring and submitting meeting requests, authoring and submitting briefing packages, and preparing the team for meetings with the Agency.
