Dorcas Koomson

Regulatory Strategy, Project Management, and IND Readiness in the Early Development of Ex Vivo CRISPR-Edited Autologous Cell Therapy for Hemoglobinopathies: A Case Analysis for Pre-IND Meetings and the IND Application for FDA

This article examines early drug development through the lens of regulatory affairs and project management, with emphasis on readiness for Pre-IND meetings and the IND application for FDA. Sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT) are inherited blood disorders that have long needed dura...