Lilia L. Bi, PhD FDA

Dr. Lilia Bi is a Master CMC reviewer in the Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, CBER, FDA.  She is responsible for review of pre-IND, IND, and BLA submissions for gene therapy products.  Dr. Bi actively participates in the intra- and inter-agency working groups and meetings focused on advanced cellular and gene therapy products and has contributed to regulatory guidance documents for gene therapy products.  She was the Chair of the BLA review committee for the first gene therapy product (LUXTURNA).  Prior to joining the FDA, Lilia received her PhD from the Johns Hopkins University and conducted postdoctoral studies at the National Human Genome Research Institute, NIH.