Senior Program Director, Diagnostics
Charlie Chrisawn has spent his entire career focused on diagnostic development and has amassed extensive experience designing and leading diagnostic trials including sample collection, validation, and utility studies. Mr. Chrisawn’s background consists of both small- and large-scale diagnostics studies, including management of several studies enrolling approximately 25,000 subjects worldwide.
Under his strategic direction, programs have successfully garnered PMA and LDT approvals. Mr. Chrisawn has also enabled 510(k) study execution and drug/device combination studies in the 505(b)(2) pathway. His expertise includes protocol and study design, domestic and international study startup, site management, sample accountability, staff training, and study closure.
Mr. Chrisawn earned a Bachelor of Science (BS) degree in Biology from Davidson College.