Comment from University of California, Davis, Stem Cell and Gene Therapy Program

Summary: The University of California, Davis (UC Davis) expresses enthusiastic support for the FDA's proposed Expedited Investigational New Drug (IND) Pilot Program. They argue that their vertically integrated infrastructure, which combines GMP manufacturing, translational science, and clinical trial capabilities, makes them an ideal "Qualified Research Institution" (QRI) to help accelerate the development of complex therapies like cell and gene therapies.