Cori Leonard is an experienced Regulatory Affairs professional with 20 years of experience in Regulatory, including 15 years developing drugs for rare diseases with multiple approvals globally. Her experience spans all regions (US, EU, Japan, Canada and ROW) and disciplines including clinical, nonclinical, CMC, advertising and promotion, and labeling. Cori is currently a Regulatory consultant with a focus on helping start-up companies develop drugs for rare diseases. Grace Science LLC is a good fit for Cori given her experience and passion for developing drugs in ultra-rare diseases.
Cori’s most recent experience was as Senior Vice President and Head of Global Regulatory Affairs at Ultragenyx Pharmaceutical Inc. She was one of the initial employees at Ultragenyx and was responsible for both Regulatory and Quality Assurance in the early years. While at Ultragenyx Cori developed innovative strategies for six programs, resulting in two drug approvals during her tenure, and managed the growth of the Regulatory department to a group of over 40 people including establishment of a European presence. Prior to Ultragenyx, Cori worked at BioMarin Pharmaceutical Inc. where she formed the Regulatory CMC group and then led the Clinical/Nonclinical function within Regulatory Affairs. Cori started her career in Regulatory Affairs at Cerus Corporation working on a drug-device combination product.
Cori’s background is in analytical and carbohydrate chemistry. She spent 14 years at the bench at Genentech and other companies characterizing recombinant glycoproteins and performing and developing assays in support of manufacturing and clinical studies. Cori holds a B.S in Chemistry and B.S. in Biology from the University of California at Irvine.