Brittany Dustman, Pharm D, Ms, Rac
About Brittany Dustman, Pharm D, Ms, Rac
Brittany Dustman, Pharm D, Ms, Rac, is the Director of Global Regulatory Affairs for Cell Therapy at Bristol Myers Squibb, with extensive experience in regulatory affairs and cell and gene therapy.
Current Position at Bristol Myers Squibb
Brittany Dustman is currently serving as the Director of Global Regulatory Affairs for Cell Therapy at Bristol Myers Squibb. In this role, she develops and implements the US strategy for marketed cell therapies. She coordinates major submissions such as supplemental Biologics License Applications (sBLA) and leads meetings with the FDA. Her responsibilities also include managing the planning and execution of pre-Phase 3 meetings with regulatory authorities to align on the design of pivotal studies for new indications.
Previous Experience at GSK
Before her current role, Brittany spent six years at GSK in various positions. She was the Associate Director of Global Regulatory Affairs for Oncology, Cell, and Gene Therapy from 2020 to 2022, the Manager of Global Regulatory Affairs from 2018 to 2020, and a Postdoctoral Global Regulatory Affairs Fellow from 2016 to 2018. She also gained early experience as a New Product Research Intern in Respiratory Health in 2014.
Pharmacy and Regulatory Foundations
Brittany Dustman has a solid foundation in both pharmacy and regulatory affairs. She worked as a pharmacist for CVS Health from 2011 to 2022, giving her extensive experience in the field. Additionally, she completed a Doctor of Pharmacy (PharmD) at Temple University School of Pharmacy from 2012 to 2016 and earned a Master's Degree in Global Clinical and Pharmacovigilance Regulations from Temple University School of Pharmacy Graduate Program between 2015 and 2016. Her academic background equips her with the knowledge required to navigate complex regulatory landscapes.
Early Career in Regulatory Affairs
Brittany's career in regulatory affairs began with a student externship at the FDA in 2016 in the Divisions of Neurology and Psychiatry, CDER. This provided her with firsthand experience in understanding regulatory expectations and requirements. Her practical training continued at GSK, where she progressed from a postdoctoral fellow to managerial positions in global regulatory affairs.
Expertise in Cell and Gene Therapy
Brittany Dustman has specialized expertise in cell and gene therapy. At Bristol Myers Squibb, she has served as the Global Regulatory Lead for early-phase cell therapies, including a gene-edited cell therapy and a therapy for systemic lupus erythematosus entering clinical studies. She advises cross-functional teams on global regulatory expectations and manages activities for IND/CTA submissions, ensuring that health authority feedback is implemented effectively.