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Fort Mill, SC

Jennifer Burke

Senior Specialist

Jennifer has 30 years of experience in drug, biologic, and cell therapy development with a focus on regulatory affairs and pre-clinical development. She has extensive regulatory experience in the field of infectious disease, oncology, immuno-oncology, liver disease and various rare diseases. At Halloran, Jennifer provides regulatory support for product development programs ranging from early-stage to late-stage development. She is skilled in developing regulatory strategies and FDA submissions, including FDA meeting requests and packages, IND submissions and amendments, safety reporting and special designations.

Before joining Halloran, Jennifer was with Agenus Inc. (formerly Antigenics Inc.) where she was responsible for all regulatory activities for several active INDs, orphan drug designations and drug master files. Prior to her regulatory work, Jennifer managed the laboratory animal science department at Agenus since its inception. She developed animal models for oncology, infectious disease and autoimmunity. She managed departmental budgets and timelines, designed studies and was responsible for writing SOPs, study protocols and study reports. Prior to Agenus, she worked in clinical data management at MTRA and as a study coordinator at TSI Mason Laboratories.

Anna Maria College, Master of Arts, Biological Studies
Saint Anselm College, Bachelor of Arts, Biology