Katie Miller, Ph.D.
Over 25 years of experience in the development and commercialization of advanced therapeutics in multiple geographies, with particular focus on characterization, analytical development/validation, and quality control for cell and gene therapies.
Katie is an accomplished biopharmaceutical executive with over 25 years of industry experience leading multiple CMC functions in the development and commercialization of advanced therapeutics including cell and gene therapies, inhalation and parenteral formulations, multi-active solid oral dosage forms, and device/combination products. Believing strongly in the criticality of robust product characterization for the success of the regenerative medicine industry, at Dark Horse Consulting she specializes in method development, validation and transfer, as well as quality control testing and specification strategies, comparability studies, and analytical capability build vs. buy analysis.
Before joining Dark Horse, Katie served as Vice President, Analytical Operations at Orchard Therapeutics, where she managed global analytical operations across 3 sites and was responsible for supporting a portfolio of 9 clinical and commercial programs for ex vivo stem cell-based gene therapies for rare diseases. As one of the original 10 employees, Katie helped build the company from the ground up, including establishing in-house vector and drug product testing capabilities within 6 months of hire. She was a key contributor to the successful tech transfer of the company’s programs from academic centers to CDMOs, as well as for regulatory filings in the US, UK, and EU including RMAT/PRIME, IND/IMPD/CTA and marketing authorization submissions.
Prior to her stint at Orchard, Katie spent almost 10 years at Gilead Sciences, where through a succession of roles of increasing scope and responsibility she established a successful track record supporting INDs, marketing authorizations, commercial launches, and product lifecycle management in diverse geographies (US/CAN/EU/AUS/Asia/ME/SA). In her last role as Senior Scientist, Commercial Analytical Operations she managed all analytical development/validation and quality control activities, both internal and outsourced, for a portfolio of 9 commercial programs at varying stages of maturity, including providing support for 3 successful pre-approval inspections and 4 commercial launches.
In her role as Director of Analytical Development and Quality Control at Xcyte Therapies, Katie received her introduction to regenerative therapies, managing operations for two departments with responsibility for method development and validation, as well as raw material, in-process, and final product release and stability testing for T cell therapies for oncology indications. Amongst other accomplishments, she oversaw validation of cell-based assays in support of pivotal trial launch, as well as successfully presented to – and obtained agreement from – FDA on the potency assay planned for commercial product release.
EXAMPLES OF RECENT WORK
- Developed and successfully transferred a novel cell-based potency assay to vector and cell therapy CDMOs
- Designed and successfully presented to regulatory authorities an in vitro comparability strategy for an ex vivo gene-modified cell therapy
- Performed pre-acquisition due diligence on a portfolio of multiple ex vivo gene-modified cell therapies
- Authored/reviewed CMC sections of the initial MAA for an ex vivo gene-modified cell therapy, enabling submission one quarter ahead of schedule
- In collaboration with other stakeholders, developed the initial design for a 150,000 sq. ft. commercial cell and gene therapy facility
Vice President, Analytical Operations
Senior Director, Analytical Development and Quality Control
Senior Scientist, Commercial Analytical Operations
Senior Scientist, Analytical Development
Scientist II, Analytical Development
Senior Manager, Quality Control
Quality Methods Consulting
Founder and Principal Consultant
Director, Analytical Development and Quality Control
Principal Scientist, Assay and Product Development
Senior Manager, Quality Systems and Product Applications
Manager, Quality Control
Supervisor, Quality Control
Scientist, Assay Development
University of California, San Diego
Ph.D. in Molecular Biology
University of California, San Diego
B.A. in Biochemistry and Cell Biology (Magna cum laude, Phi Beta Kappa)