Jennifer Burke has more than 25 years of experience in pharmaceutical and biologic drug development with a focus on Regulatory Affairs and Pre-clinical Development. She has extensive regulatory experience in the field of oncology and immuno-oncology including the development of therapeutic antibodies and personalized immune-modulating vaccines for the treatment of various cancers. At Halloran, Jennifer provides regulatory support for product development programs ranging from early-stage to late-stage development. Jennifer has experience with Pre-IND and Type C meetings, original IND submissions and amendments, expedited pathways, and orphan 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.