For over 30 years, Bambi Grilley has worked primarily in the field of Clinical Research, focused predominately on oncology. She worked in and supervised the lnvestigational Drug Pharmacy at MD Anderson Cancer Center for 10 years and following that, she accepted a position as the Administrator of the IRB and IACUC at Baylor College of Medicine and served in that position for 2 years. For 25 years she served on the BCM IRB and for the majority of that time, as a vice-Chair. She is currently a Professor, Pediatrics at BCM and the Director of Clinical Research and Early Product Development for the Center for Cell and Gene Therapy where she is responsible for coordinating the development, implementation, and conduct of clinical research protocols for use in four affiliated hospitals and institutions. Her expertise has helped to establish the Protocol Review Committees, the Data Review Committees, the Clinical Research Quality Control Program and the Clinical Research Quality Assurance Program. In the 26 years she has been with CAGT, she has assisted investigators in conducting over 2000 clinical research studies and the submission of 113 Investigator Initiated, cell/gene therapy related INDs and currently, 29 of those clinical research treatment studies are active with CAGT. 

Bambi is owner of QB Regulatory Consulting, LLC through which she has expanded her skillset to include support of several start-up companies, primarily in the cell and gene therapy space by providing regulatory affairs consulting and project management support. She has helped those start-up companies develop regulatory strategies, make regulatory submissions (including a company sponsored IND), and in some cases conduct clinical trials. She is a regular reviewer on the California Institute for Regenerative Medicine (CIRM) panel which awards grants to further clinical and translational work. Bambi is also a very active member of the International Society for Cell & Gene Therapy (ISCT), currently serving on its Board of Directors as Chief Regulatory Officer, Chair of Cross Border Working Group, and executive/leadership roles on several other of its committees. She is a patient advocate and works tirelessly to address the “valley of death” of academic GMCT products, most recently by joining the American Society for Transplantation and Cellular Therapy’s (ASTCT) task force, ACT To Sustain (Adoptive Cell Therapy to Sustain), publishing a paper in Transplant and Cellular Therapy titled “ACT To Sustain: Adoptive Cell Therapy To Sustain access to non-commercialized genetically modified cell therapies”. Her most recent publications can be found in this year’s January and February online ahead of print issues of Cytotherapy - “Sickle cell disease gene therapy drug expenses and reimbursement: a litmus test for commercial pricing strategy and patient access for curative therapies” and “International Society for Cell & Gene Therapy Expanded Access Working Group position paper: key considerations to support equitable and ethical expanded access to investigational cell- and gen-based interventions”. 

Bambi is the recipient of The Norton Rose Fulbright Faculty Excellence Award and the 2021 AACR Team Science Award for her work with the St. Baldrick’s Foundation - Stand Up To Cancer Pediatric Cancer Dream Team.