Hai Luong
Director, Cell and Gene Therapies @Kite Pharma
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WORK HISTORY
Director, Cell and Gene Therapies @Kite Pharma
Global Regulatory Affairs CMC, Early-to-Late Stage and Commercial
EDUCATION
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences
Doctor of Regulatory Science - DRSc., Regulatory Sciences
UCLA
Bachelor of Science - B.S., Biochemistry
UCLA
Bachelor of Science - B.S., Microbiology, Immunology, and Molecular Genetics
The Johns Hopkins University
Master of Science - M.S., Regulatory Sciences
ABOUT HAI LUONG
Over 20 years’ experience developing Peptides, mAbs, Antibody Drug Conjugates, and Cell Therapies with growing roles in Regulatory Affairs, Analytical Sciences, Quality Operations, and Process Development. At Kite, a Gilead Company, responsible for development, operational, and lifecycle management aspects of Regulatory CMC submissions (IND, IMPD, GMO, BLA, and MAA) Ex-US in support of both commercial and developmental programs. Global Lead for Regulatory CMC strategy program teams, ensuring technical and regulatory requirements are fulfilled for M2.3 and M3 contents across various applications for global harmonization and timely world-wide registration. Regulatory CMC expertise, leadership, and due diligence in support of new projects that are rapidly evolving due to unanticipated changes within the novel Cell Therapy landscape with adaptive strategies.
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