In his role, Dr. Steven Oh leads the effort to reach regulatory decisions on product safety and quality of cellular and gene therapy products, tissue-engineered products, and point-of-care devices submitted to Office of Tissues and Advanced Therapies in CBER. Dr. Oh is actively engaged in developing regulatory policies and guidelines that address challenges involving combination products, cross-cutting science, and emerging technologies in regenerative medicine therapy. He also participates in efforts to develop standards for manufacturing and testing cellular, tissue-engineered, and gene therapy products as well as in activities promoting international regulatory convergence for these products. Before joining FDA in 2007, Dr. Oh served on the faculty of Tufts University School of Medicine in Boston. He was trained as a cell biologist and biochemist at Massachusetts Institute of Technology, Johns Hopkins University School of Medicine, and the University of Michigan.
Deputy Director, Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research
US Food and Drug Administration