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Kelly Lindblom, PhD, RAC is an Associate Director of Regulatory Affairs in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Lindblom works with a team of Regulatory Affairs professionals who are responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. Dr. Lindblom also oversees and manages implementation of new educational and collaborative initiatives within ORAQ.
Dr. Lindblom performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Lindblom assists project teams developing or studying investigational drugs, biologics, and devices. She has conducted numerous meetings with the FDA and has assisted with successful regulatory applications for both a Breakthrough Device Designation Request and an Emergency Use Authorization.
Dr. Lindblom received her undergraduate degree in chemistry from the University of North Carolina-Chapel Hill. She conducted her graduate research at Duke University, where she earned her PhD in Pharmacology with a certificate in Cell and Molecular Biology. Her research focused on the regulation of cell death in the context of Non-Alcoholic Steatohepatitis and different types of cancer. During her graduate training, Dr. Lindblom was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. Dr. Lindblom was the Assistant Director of Research Initiatives in the Office of the Vice Provost for Research at Duke University before joining ORAQ.