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, joining the Center for Cell and Gene Therapy in 1999. Nearly three decades later, she has become one of the field’s most direct voices on why access, not science, is now the binding constraint on cell and gene therapy.

Grilley works on the IND side of the field, the translation from laboratory to clinic, and holds the RPh, RAC, CIP, CRC, and CCRP credentials across pharmacy, regulatory affairs, and clinical research. Her argument is that regulatory approval is the beginning of the fight for patient access, not the end. Approved cell and gene therapies routinely stall on the way to patients because of reimbursement decisions, manufacturing scale, and the readiness of the hospitals meant to deliver them. If the field cannot solve access, she warns, the products are not viable.

Grilley appeared on Open Door Salon alongside Jaap Jan Boelens, Chief Medical Officer of ISCT, for a conversation with host Lori Ellis on why patients walk away from cures they qualify for. She walked through the reimbursement float that can leave a hospital waiting a year to be paid for a million-dollar therapy, the desperation economy that sends families abroad for unproven stem cell treatments, and what FDA turnover has and has not changed for cell and gene therapy submissions.