Kate Imhoff

Background

About Kate Imhoff

20+ years experience in the Pharmaceutical Business in various business functions including Regulatory Affairs (RA; 15+ years) across Global Markets, Quality Systems, Quality Control, Manufacturing/Product Support, and Research and Development. Currently, I serve as VP of RA at Abeona Therapeutics. As Global Regulatory Lead for 2 AAV gene therapy products for treatment of retinoschisis and Stargardt disease, and as co-lead for our gene-corrected autologous cell therapy product for treatment of recessive dystrophic epidermolysis bullosa (RDEB), I plan, manage and drive to completion regulatory strategy in the US. Currently authoring, collaborating, and building a BLA resubmission with the team for the RDEB gene-corrected cell therapy. Participates and leads communications and multiple meetings with the FDA during the BLA preparation and review process. Participates on Senior Management cross-functional teams with other RA functions, Quality, Commercial, Clinical, Non-Clinical, and CMC to collaborate on program strategy and issue resolution. In previous roles at three gene therapy and rare disease companies, I served in Global Regulatory Lead roles and planned, directed, and executed on regulatory strategy in the US, EMEA, Japan, Canada, LATAM, and APAC from product development through post-market for gene therapy products with direct report support. Presented product overview and complex changes to Regulatory Authorities in the US, EMEA, Brazil, Canada, Australia, Korea, and Taiwan on Clinical, Non-Clinical, and CMC topics for gene-correcting and gene therapies and gained agreement on the regulatory pathway for submission. Presented gene therapy product information at industry/Health Authority conferences in APAC and LACAN regions. Served as Clinical Trial Regulatory Lead for multiple clinical trials, including in the US and internationally. In previous RA roles across all regions (100+ countries), I prepared and executed on RA strategy for the entire product life cycle across various therapeutic areas (TAs) for small molecule and biological products, including NDA, IND, and FDA meeting request/briefing book submissions. Presented product overviews to Regulatory Authorities, obtaining agreement on information required for successful submissions. Earlier in my career over several Quality, R&D, and RA roles at Abbott Laboratories, I performed Quality Control testing, developed analytical methods, authored CMC sections for regulatory submissions, and provided regulatory support for products across various TAs.