Kristi Miller leads the team of regulatory professionals in providing strategic and tactical guidance across therapeutic areas and disciplines (CMC, Nonclinical, Clinical, Device and Regulatory Writing). She has over 15 years of experience in the pharmaceutical industry in delivering both regional and international regulatory strategy for pharmaceutical and biotech drug development teams. Her experience encompasses providing regulatory leadership and execution of strategy for products across development (pre-IND through post marketing) in multiple therapeutic areas of immunology/inflammation, ophthalmology, oncology and other rare diseases. Her accomplishments include leading teams to successful global health authority interactions, INDs, orphan drug applications, fast track applications, pediatric strategies, and marketing applications.
Kristi received her PhD in tumor cell biology and her previous roles have included positions at Pharmacyclics, and Genentech.