Speakers

Brian Folian is the Deputy Office Director in the Office of Study Integrity and Surveillance (OSIS), in FDA CDER’s Office of Translational Sciences. His work in OSIS focuses on ensuring the reliability of clinical and bioanalytical bioavailability and bioequivalence and good laboratory practice studies that support FDA decision-making on human drug and biologic product submissions. Specifically, Mr. Folian has well over a decade of experience stewarding CDER BIMO regulatory oversight and actions (administrative, advisory, and enforcement actions) that stem from the conduct of hundreds of OSIS inspections and remote regulatory assessments of the preclinical and clinical studies submitted to the FDA.