Lana Shiu, MD
About Lana Shiu, MD
Lana Shiu, MD, serves as the Global Head of Regulatory Affairs at Kite Pharma, bringing over 17 years of regulatory leadership experience, including significant roles at the FDA and Amgen.
Current Role at Kite Pharma
Lana Shiu serves as the Global Head of Regulatory Affairs at Kite Pharma, a position she has held since 2022. In this role, she oversees regulatory strategies and compliance for the company's innovative therapies. Her leadership is crucial in navigating the complex regulatory landscape, ensuring that Kite Pharma's products meet all necessary requirements for global markets. The position is based in Santa Monica, California, and operates in a hybrid work environment.
Previous Experience at Amgen
Lana Shiu worked at Amgen in various capacities from 2017 to 2020. Initially, she served as Medical Director for nine months before transitioning to the role of Executive Director of Regulatory Affairs. In this position, she focused on devices, combination products, in vitro diagnostics, digital health, and human factors. Her tenure at Amgen contributed to her extensive knowledge in regulatory affairs and product development.
Regulatory Leadership Experience
With over 17 years of regulatory leadership experience, Lana Shiu has spent more than 12 years at the FDA. During her time there, she spearheaded the development and policy for Combination Products. She also served as Senior Medical Advisor in the Office of Device Evaluation at the Center for Devices and Radiological Health, where she worked for four years. This experience provided her with a deep understanding of regulatory processes and agency expectations.
Educational Background
Lana Shiu earned her Doctor of Medicine (M.D.) from The George Washington University School of Medicine and Health Sciences in 1998. She completed her Internal Medicine Residency at Emory University School of Medicine from 2003 to 2005. Additionally, she undertook an Internal Medicine Internship at the National Naval Medical Center in Bethesda from 1998 to 1999. Her educational background is complemented by a Bachelor of Engineering (B.E.) in biomedical engineering and electrical engineering from Vanderbilt University, achieved from 1988 to 1993.
Fluency in Mandarin
Lana Shiu is fluent in Mandarin, which enhances her ability to communicate effectively in cross-cultural settings. This language skill is particularly beneficial in global regulatory affairs, allowing her to engage with diverse stakeholders and navigate international regulatory frameworks.