Kimberly McDowell, MD, PhD, has been named Director of Regulatory Affairs for the UW Program for Advanced Cell Therapy (PACT).
McDowell has served as the program’s associate director of regulatory affairs since 2019, and has previously worked as an associate scientist in the UW department of pediatrics.
With a background in both science and clinical research, McDowell was chosen for her expertise in investigational new drug (IND) and investigational device exemption (IDE) applications for PACT-sponsored clinical trials and regulatory compliance.
Since PACT manufactures and tests new, homegrown cell therapies – to improve health outcomes in children and adults with unmet medical needs – there are often numerous regulatory hurdles to clear and complex protocols to follow. Most universities do not manufacture their own therapeutics, making her job unique in academic medicine.
PACT director Jacques Galipeau, MD, likens her role to a ‘concierge’ between the FDA and UW researchers, especially when trying to obtain investigational licenses.
“These applications are incredibly complex and each one is different,” Galipeau said. “Pharmaceutical companies usually have a brigade of individuals who do this full time, but with her experience and her deep knowledge of what we do here, Kim is a highly capable ‘fixer’ in tackling this complex work for us.”
McDowell earned a PhD 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.
“I love being on this team, and can’t say enough good things about this program, my colleagues and the work that’s being done,” McDowell said. “I’m thrilled to be able to contribute to that in this new role.”