Hai Luong
About Hai Luong
Hai Luong is the Associate Director of Cell Therapies at Kite Pharma, where he oversees regulatory submissions and strategy. With over 15 years of experience in the biopharmaceutical industry, he has held key roles at Gilead Sciences, Astellas Pharma US, and UCLA.
Work at Kite Pharma
Currently, Hai Luong serves as the Associate Director of Cell Therapies at Kite Pharma, a position he has held since 2019. In this role, he is responsible for overseeing operational and lifecycle management aspects of Regulatory Chemistry, Manufacturing, and Controls (CMC) submissions for both commercial and developmental programs outside the United States. He ensures global harmonization and timely registration of regulatory submissions, contributing to the company's commitment to advancing cell therapy solutions.
Previous Experience in Biologics and Quality Analysis
Before joining Kite Pharma, Hai Luong worked at Gilead Sciences as a Senior Associate Scientist in Biologics from 2012 to 2019. His responsibilities included developing adaptive strategies to support new projects in the evolving cell therapy landscape. Prior to Gilead, he was a Senior Quality Analyst at Astellas Pharma US, focusing on Antibody Drug Conjugates from 2009 to 2012. His early career included a position as a Senior Research Scientist at the David Geffen School of Medicine at UCLA, where he specialized in peptides from 2005 to 2009.
Education and Expertise
Hai Luong holds a Doctor of Regulatory Science (DRSc) from the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences. He also earned a Master of Science (M.S.) in Regulatory Sciences from The Johns Hopkins University. Additionally, he obtained two Bachelor of Science (B.S.) degrees in Biochemistry and Microbiology, Immunology, and Molecular Genetics from the University of California, Los Angeles. His educational background supports his expertise in developing peptides, monoclonal antibodies, antibody drug conjugates, and cell therapies.
Regulatory CMC Strategy Leadership
In his current role at Kite Pharma, Hai Luong serves as the Global Lead for Regulatory CMC strategy program teams. He ensures that technical and regulatory requirements are met for M3 contents across various applications. His leadership in this area is crucial for the successful navigation of regulatory landscapes and the advancement of cell therapy initiatives.
Professional Experience Overview
With over 15 years of experience in the biopharmaceutical industry, Hai Luong has developed a comprehensive skill set in regulatory science and project management. His career trajectory reflects a strong focus on the development and regulatory approval of innovative therapies, particularly in the fields of peptides, monoclonal antibodies, and cell therapies. His extensive background equips him to address the complexities of regulatory submissions and project strategies in a rapidly evolving industry.