Dr. Kim McDowell has been appointed to oversee the regulatory affairs of the Program for Advanced Cell Therapy (PACT).
Her main duties will include crafting and managing investigational new drug (IND) and investigational device exemption (IDE) applications for PACT-sponsored clinical trials and regulatory compliance.
“Dr. McDowell brings with her the perfect combination of scientific and medical knowledge, FDA expertise, and passion for our program,” said Jacques Galipeau, MD, PACT director and associate dean of therapeutics development in the UW School of Medicine and Public Health.
This role at PACT is not her first at UW-Madison. McDowell has been an associate scientist in the UW department of pediatrics, where she worked with pediatric hematology/oncology physician-scientists to help translate immunotherapy research findings into investigator-initiated clinical trials.
Her contributions include clinical protocol development, numerous IND/IDE submissions to the FDA and biological studies assessing the effect of investigational therapies. In addition, she is engaged in educational activities for research staff, students and fellows.
McDowell earned a Ph.D. in anatomy and cell biology from the University of Iowa Carver College of Medicine, a medical degree from the University of Virginia School of Medicine, and a master’s degree in clinical investigation from UW-Madison. She has extensive experience in medicine, research and scientific writing.
“I am delighted to join the PACT team in their effort to provide cutting-edge cell therapies for the treatment of cancer, various non-malignant disorders and refractory viral infections following transplant,” she said.