We are delighted to welcome Dr. Sang Bong Lee to Zencore Biologics as the VP and Head of US Regulatory Affairs, effective May 8, 2023. With 25 years of experience in academia and regulatory affairs directly related to the R&D and manufacturing of biopharmaceuticals, Dr. Lee will be responsible for developing global CMC regulatory strategies for Zencore Biologics and its clients.

Dr. Sang Bong Lee

(VP and Head of US Regulatory Affairs)

Prior to joining Zencore Biologics, Dr. Lee worked as a Product Quality (aka CMC) reviewer, reviewing Biologics License Applications (BLAs) and Investigational New Drugs (INDs) for biotechnology products under 351(a) and 351(k) BLA pathways. He was involved in the BLA approval process under PDUFA and BSUFA timelines, resulting in the approval of five BLAs and one Complete Response (CR). He also reviewed over 40 Supplement BLAs (PAS, CBE30, and CBE), specializing in assay method validation and manufacturing process validation for cell line changes, process scale-up, process changes, and analytical method changes. Dr. Lee is expert in FDA compliance regulations for developing biotech products, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), recombinant proteins, insulin, and biosimilar products.

Before his career in FDA, Dr. Lee led research and development teams in both public and private sectors, demonstrating excellent teamwork and communication skills. He served in the National Cancer Institute/Clinical Center Research (NCI/CCR), US R&D Branch/ISU Abxis Korea, and National Heart Lung and Blood Institute (NHLBI) for 12 years. Dr. Lee has published 16 papers and holds one US patent. Dr. Lee received his M.S.& Ph.D. of Pharmacology at Seoul National University.

Dr. Lee's appointment will significantly strengthen Zencore Biologics' management team and help our customers achieve their regulatory objectives.