FDA’s top gene-therapy regulator Vijay Kumar steps down amid leadership shake-up

Vijay Kumar, the acting director of the FDA office that reviews cell and gene therapies, has announced he will leave his position. In an email to staff, Kumar said he reflected on his tenure and decided it was time to move on, and agency leaders agreed not to renew his detail.

Kumar was promoted to the director role by CBER chief Vinay Prasad after Prasad removed former director Nicole Verdun a little over a year ago. Prior to that promotion, Kumar served as a lead physician within the same office.

His departure comes as the Center for Biologics Evaluation and Research experiences a turbulent year, with multiple leadership changes across the cell and gene therapy office and the broader agency.