Shana Hardy Thomas, Ph.D.
About Shana Hardy Thomas, Ph.D.
Shana Hardy Thomas, Ph.D., serves as the Associate Director of Global Regulatory Affairs at Kite Pharma, where she specializes in CAR T cell product development. She has a diverse background in regulatory affairs, having worked at the FDA and the National Institute of Standards and Technology, and holds degrees from Tuskegee University and Purdue University.
Work at Kite Pharma
Shana Hardy Thomas, Ph.D., serves as the Associate Director of Global Regulatory Affairs at Kite Pharma. She has been in this role since 2021, contributing to the regulatory intelligence and strategy for CAR T cell product development. Her work focuses on advancing biotech-based treatment modalities, ensuring compliance with regulatory standards, and facilitating the successful navigation of the regulatory landscape for innovative therapies.
Previous Experience at FDA
Before joining Kite Pharma, Shana Hardy Thomas worked at the FDA in various roles related to cell and gene therapy. She served as a Master Cell & Gene Therapy Reviewer in Pharmacology/Toxicology from 2020 to 2021 and previously as a Cell & Gene Therapy Reviewer from 2017 to 2020. In these positions, she gained significant experience in the assessment and development of IND-enabling preclinical programs for complex products.
Educational Background
Shana Hardy Thomas holds a Ph.D. in Molecular Pharmacology from Purdue University, where she studied from 2011 to 2016. She also earned a Master's degree in Biology from Tuskegee University, completing her studies from 2009 to 2011. Additionally, she obtained a Bachelor of Science in Biology from Tuskegee University, graduating in 2009. This educational foundation has equipped her with the knowledge and skills necessary for her roles in regulatory affairs and biopharmaceutical development.
Research Experience at National Institute of Standards and Technology
Shana Hardy Thomas worked as an NRC Postdoc Fellow (Research Biologist) at the National Institute of Standards and Technology from 2016 to 2017. During her 11-month tenure in Gaithersburg, MD, she engaged in research that contributed to her expertise in the field of biological sciences, further enhancing her qualifications for her subsequent roles in regulatory affairs.
Professional Interests and Activities
In addition to her professional responsibilities, Shana Hardy Thomas is committed to the advancement of minority scientists in the field. She enjoys traveling abroad and watching Netflix series in her free time, reflecting her diverse interests outside of her career in regulatory affairs and biotechnology.