Kate Imhoff

Company: Abeona Therapeutics

Job title: At Abeona Therapeutics Vice President, Regulatory Affairs

Bio:

Kate Imhoff is a seasoned regulatory strategy leader with over 20 years of experience in cell and gene therapy. At Abeona, she oversees global regulatory affairs for AAV and gene-based therapeutic candidates. Previously, she held senior regulatory roles at Sarepta/AveXis, MeiraGTx, Takeda, and Abbott—driving global IND, BLA, and post-approval submissions across the US, EMEA, and APAC. Known for her cross-functional leadership, Kate integrates quality systems, manufacturing validation, and analytical methodology into cohesive lifecycle strategies.

Seminars:

Wins & Lessons Learned from FDA BLA Submission & CRL Issuance, Through to BLA Approval of a Gene-Corrected Cell Therapy 10:00 am

Presenting a case study on US registration of an autologous RVV-based gene-corrected cell therapy for treatment of an ultra-rare, life-threatening skin disorder Evaluating the dossier for major risks and how to mitigate these Sharing wins and lessons gained during BLA preparation, FDA review, and approvalRead more

day: Conference Day One