Bambi Grilley

Bambi Grilley is President-Elect of the International Society for Cell and Gene Therapy (ISCT) and its former Chief Regulatory Officer. She entered oncology in 1986 and moved into research when it became clear that chemotherapy alone would not get patients where they needed to go. She joined the Center for Cell and Gene Therapy in 1999 and has worked in the field for nearly three decades.

Bambi Grilley serves as President-Elect of the International Society for Cell and Gene Therapy, and previously held the role of Chief Regulatory Officer there. Her work centers on the regulatory side of cell and gene therapy, including IND submissions and the translation of a therapy from laboratory to clinic.

Bambi Grilley holds the RPh, RAC, CIP, CRC, and CCRP credentials across pharmacy, regulatory affairs, and clinical research, and she served as Chief Regulatory Officer of the International Society for Cell and Gene Therapy. She entered oncology in 1986, joined the Center for Cell and Gene Therapy in 1999, and works on the IND side of the field, the translation from laboratory to clinic.

Bambi Grilley holds that regulatory approval marks the start of the fight to get a therapy to the patients who qualify for it. Approved cell and gene therapies routinely stall on the way to those patients because of reimbursement decisions, manufacturing scale, and the readiness of the hospitals meant to deliver them. On Open Door Salon she said: “We have multiple examples in the cell and gene therapy space of products that received regulatory approvals but never became available to patients.”

Bambi Grilley describes a reimbursement float that can leave a hospital waiting a year to be paid for a million-dollar therapy. She has also pointed to a desperation economy that sends families abroad for unproven stem cell treatments. Her position, stated on Open Door Salon: “This is really an existential threat to cell and gene therapy, because if we can't solve this, these products are not viable.”