Bambi J. Grilley,RPh, RAC, CIP, CCRC, CCRP
Director, Regulatory Affairs
Ms. Grilley has 30 years of experience in the field of clinical research with wide-ranging expertise in investigational drugs, IRB review, regulatory affairs and the conduct of clinical trials. Ms. Grilley is currently the Director of Clinical Research and Early Product Development for the Center for Cell and Gene Therapy (CAGT), where she is directly responsible for coordinating the development, implementation, and conduct of all CAGT clinical research protocols at Texas Children’s Hospital, Baylor College of Medicine, and The Houston Methodist Hospital. Over the past 20 years she has overseen regulatory submissions for over 1,500 clinical research studies, almost half of which are therapeutic. She has assisted in the submission of over 70 investigator-initiated Investigational New Drug Applications with over 130 clinical studies conducted under them. Previously, she has supervised the Investigational Drug Pharmacy at MD Anderson Cancer Center and served as the Administrator and later both a member, vice-Chair of the Institutional Review Board at Baylor College of Medicine. For the past 4 years, Ms. Grilley has served on the National Council responsible for certifying over 1,300 IRB professionals with a goal of improving Human Subject Protection Programs. Ms. Grilley obtained a BS in Pharmacy from the University of Texas at Austin. She is also a Certified Clinical Research Coordinator, a Certified Clinical Research Professional, a Certified IRB Professional, and has a Regulatory Affairs Certification.