Carl Denny

Company: Abeona Therapeutics

Job title: Senior Vice President & Head of Regulatory Affairs

Bio:

Carl Denny has over 20 years of global regulatory and CMC experience in gene and mRNA therapies, including leadership roles at Sarepta, AveXis, GE Healthcare, Takeda, Catalent, Abbott, and Eli Lilly. At Abeona since 2021, he’s led regulatory strategy for pivotal BLA submissions, including AAV based and mRNA therapies like Zolgensma and AMONDYS 45. Carl is also Regulatory Affairs Certified (RAPS) and holds degrees in chemistry from Purdue and Illinois State University.

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