Kristi Miller, Ph.D., is a regulatory professional with over 20 years of industry experience providing regulatory leadership for small molecules and biologics that follow the 505(b)(1) or 505(b)(2) pathway. Her therapeutic areas of expertise include oncology, ophthalmology, inflammation, gastroenterology, neurology, pulmonary, and rare diseases. Her regulatory strategies have resulted in successful filings of Orphan Drug Designations, INDs, CTAs, and NDA/BLAs. She tailors her strategic guidance to fit the stage of development and has provided regulatory leadership for drug development programs that are preclinical through marketing applications. She has led cross-functional teams in Health Authority interactions to develop innovative and efficient development pathways to achieve regulatory objectives.

Kristi has a doctorate in Tumor Cell Biology from Northwestern University and a B.S. in Genetic Engineering from Cedar Crest College.