Katie Miller Bayer

Katharine (“Katie”) Miller, Ph.D. is a biotechnology/biopharmaceutical executive with 30+ years of industry experience leading multiple CMC functions (Analytical and Product Development, Quality Control, Quality Assurance) in the development and commercialization of advanced therapeutics including cell and gene therapies, inhalation and parenteral formulations, multi-active solid oral dosage forms, in vitro diagnostics, and device/combination products.

She has a successful track record of supporting multiple programs from pre-IND/IMPD through marketing authorizations (BLA, MAA, NDA, NDS), commercial launches, and product lifecycle management in diverse geographies (US/CAN/EU/AUS/Asia/ME/SA). Katie is an experienced and effective lead based on a broad foundation of technical expertise, a demonstrated ability to manage multiple projects to tight timelines and evolving regulatory requirements, and active cross-functional collaboration and long-view strategic planning. Katie has a particular focus on building forward-looking and holistic product characterization plans, demonstration of potency/mechanism of action, and comparability for advanced therapeutics.