J. Kaitlin Morrison, PhD, is the Executive Director, LCCC Clinical Research for Lineberger Comprehensive Cancer Center (LCCC) at the University of North Carolina Chapel Hill and an Assistant Professor of Medicine in the Division of Hematology. Kaitlin leads the office that supports the regulatory strategy and translation of basic and translational findings and discoveries at LCCC and other UNC Centers and Departments working in cancer biology, into early phase clinical trials. Kaitlin also is responsible for the oversight of LCCC’s clinical development program that includes investigator-initiated trials using investigational drugs/biologics provided by pharmaceutical partners, and UNC developed and/or manufactured investigational products (e.g., CAR-T cells, personalized and adaptive neoantigen dose-adjusted vaccine (PANDA-VAC), C11-AMT, 68Ga-PSMA-11). Kaitlin collaborates with preclinical and clinical scientists to aid in the translation of UNC developed investigational products from the bench to the clinic through the authoring of clinical protocols, informed consent forms, patient education materials, Investigator’s Brochures and Investigational New Drug (IND) applications. Her work has contributed to the development of a successful portfolio of >60 clinical protocols and >40 INDs, and the receipt of a Regenerative Medicine Advanced Therapy (RMAT) designation with FDA and accelerated assessment of PRIority Medicines (PRIME) designation with the European Medicines Agency (EMA). Kaitlin is a member of the North Carolina Regulatory Affairs Forum (NCRAF) and the Regulatory Affairs Professional Society (RAPS). She is active in the regulatory community including serving as an invited speaker at multiple regulatory and clinical trial focused conferences and sitting on the UNC Regulatory Science External Advisory Committee for their proposed Master’s in Regulatory Science degree.
Kaitlin has served a variety of regulatory and clinical operations roles within LCCC including performing IRB submissions as a Regulatory Associate, serving as the interim Assistant Director for Multicenter Clinical Trial Operations, aiding in the operations of the Advanced Cellular Therapy (ACT) Good Manufacturing Practice (GMP) Facility, and acting as a regulatory project manager (Senior Regulatory Affairs Specialist) for FDA submissions.
Prior to joining UNC, Kaitlin received her BS in Chemistry from UNC and her PhD in Biochemistry from Brody School of Medicine at East Carolina University.