Dr. Sue Lim, Principal of Insight Biologics LLC
Dr. Sue Lim is Principal of Insight Biologics LLC, where she provides strategic regulatory and scientific advice to companies with biological products in the FDA and EMA approval process. Prior to that, she has 12+ years’ experience in FDA CDER, most recently as Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars and previously in roles in the office now known as the Office of Infectious Diseases. She currently advises on biological product development from early stage through post-approval across a broad range of disease areas including oncology, hematology, autoimmune/inflammatory, gastroenterology and dermatology. Dr. Lim is also a licensed physician with specialty training in infectious diseases and she holds an M.D. and M.Sc. in Health Policy from the University of Toronto.
