Katherine Donigan

Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory at BIO where she leads BIO’s regulatory policy efforts for cell and gene therapies and diagnostics, as well as BIO’s international regulatory work.  Prior to joining BIO, Dr. Donigan held various positions at the US Food and Drug Administration in the Center for Devices and Radiological Health and in the Center for Drug Evaluation and Research.  At US FDA, Dr. Donigan worked on developing regulatory policies to address challenges posed by emerging technologies in personalized medicine.  Dr. Donigan holds a PhD in Genetics from Yale University with a focus on DNA repair and oncology.  She completed postdoctoral training at the National Institute of Child Health and Human Development with a focus on DNA damage bypass mechanisms.