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

Time: 10:00 am
day: Conference Day One

Details:

• 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 approval

Speakers:

Kate Imhoff 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 Read more

Carl Denny 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, Read more