Jing Han, Ph.D. joined Biologics Consulting as a Senior Consultant in January 2019. He is a molecular and cellular biologist and comes to Biologics Consulting with nearly 18 years of experience working at the Center for Biologics Evaluation and Research (CBER), at the U.S. Food & Drug Administration (FDA). As a CMC reviewer in the Division of Cellular & Gene Therapies, OTAT, he has reviewed numerous original INDs and IND amendments, pre-IND files, and Master Files, involving cancer vaccines, gene therapy and cellular therapy products. He has also reviewed cancer vaccine drug products including peptide vaccines, RNA and DNA vaccines, and recombinant protein products. Recently, Dr. Han has been working on personalized cancer vaccine products generated by NGS and related technology. Dr. Han’s experience in reviewing Master Files includes the manufacturing process of peptide and recombinant protein drug products, quality control, and specification of analysis. He has participated in various CBER regulatory working groups to develop guidance documents and policies for gene therapy and cellular therapy products. He was involved in statistics and bioinformatics analysis of gene expression and regulation, and standards development of genomic technology for regulatory policies. In addition, he has contributed to the development of guidance for pharmacogenomic data submissions and analysis of voluntary genomic data submissions. Dr. Han is familiar with FDA guidelines and regulations for gene and cellular therapy products.
As a research fellow at NCI/NIH, Dr. Han worked on a molecular cloning and gene targeting project, where he generated knockout constructs and developed a knockout cellular model to investigate gene functions. He utilized genomic technology to study genes involved in cancer proliferation and motility, tumor growth, and invasion. As a postdoctoral fellow at the University of Pennsylvania, his research focused on peptide/protein biochemistry, molecular biology of extracellular matrix, and functions of basement membrane components, including type II collagen, laminin 2-subunit, integrin receptors, and their roles in cancer cell adhesion and metastasis. Dr. Han has published many peer-reviewed scientific papers in journals devoted to cancer research, gene expression, bioinformatics analysis, genomic technology, etc.
Dr. Han had his undergraduate education in China and received a MS in Computer Science from the Department of Mathematics, Statistics, & Computer Sciences, the University of Illinois at Chicago in 1988. After that, he received a Ph.D. in Cell Biology from the Department of Anatomy & Cell Biology, College of Medicine, the University of Illinois at Chicago, in 1994.
PhD, Cell Biology, College of Medicine, the University of Illinois at Chicago, Chicago, IL (1994)
MS, Computer Science, the University of Illinois at Chicago, Chicago, IL (1988)
BS, Life Science, the University of Science and Technology of China, China (1981)