Xiaobin Victor Lu | Biologist
Gene Therapy Branch , Division of Cellular and Gene Therapies , OCTGT, FDA CBER

Xiaobin Victor Lu, Biologist, Gene Therapy Branch , Division of Cellular and Gene Therapies , OCTGT, FDA CBER

Dr. Xiaobin Victor Lu received his Bachelor’s degree in Biochemistry from Fudan University in Shanghai China and his Ph.D. in molecular virology from State University of New York at Buffalo. His Ph.D. thesis work was focused on HIV molecular biology related to mechanisms of HIV-1 Rev and Tat regulation of post transcriptional RNA processing. He was a post-doctoral fellow at UCSF where he studied HIV transcriptional regulation and HIV-1 Nef protein and Nef associated proteins. He worked at ONYX Pharmaceutical as a research scientist and continued work on HIV-Nef-associated kinases. At VIRxSYS Corporation, he served as a senior scientist and later a senior director for development of HIV and SIV based lentiviral vectors for clinical studies. He played an important role in the development of the first HIV-1 based lentiviral vector for human clinical studies for HIV infected individuals. Later, he served as a senior scientific liaison at the United State Pharmacopeia in charge of the Vaccines and Virology expert committee. Currently Dr. Lu is a product reviewer in the Office of Tissues and Advanced Therapies, in the Center for Biologics Evaluation and Research, of the US FDA.


Advanced Therapies and Regenerative Medicine Day 2 - Thursday 17th May 2018 @ 14:30

Videolink presentation: A Chemistry Manufacturing and Controls (CMC) Perspective on Late Stage Development for a CAR T Cell Product

  • Familiar with the overall lifecycle of a CAR T cell therapy product development pathway
  • Familiar with the basic US FDA regulatory expectations for a CAR T cell product BLA with emphasis on chemistry, manufacturing (CMC) and controls perspective
  • Learn practical “points to consider” for a well-defined CAR T cell manufacturing process in preparation for late stage clinical trials and a biologics license application (BLA)

back to speakers



Erica Baeta
+44 (0)207 092 1152


Jessica Robinson
t/ +44 (0)207 092 1150


Issa Mauthoor
+44 (0)207 092 1257