Lana Shiu
Vice President, Global Regulatory Affairs Kite Pharma Inc
Lana Shiu, MD is Global Head of Regulatory Affairs at Kite Pharma, where she leads global regulatory strategy supporting advanced therapy development and commercialization. She brings over 17 years of regulatory leadership experience with more than 12 of those years at FDA, driving programs from discovery to clinical development and advancing global filings including IND/IMPD/CTA and MAA/BLA/NDA submissions. A Board Certified in Internal Medicine physician with more than 20 years of patient care, she combines clinical expertise with deep regulatory insight to guide global drug development and cross-functional collaboration across international teams.
Seminars
Tuesday 15th September 2026
Bridging Regulatory & Commercial Expectations to Restructure the Pathway to Commercialization & Long-Term Follow Ups
10:00 am
- Evaluating long-term adverse event follow-up trends to determine clinically meaningful safety signals while reducing post-approval burden
- Interpreting evolving regulatory frameworks to enable adaptive decisions that balance patient safety, operational feasibility and commercial sustainability
- Aligning biotech, pharma, academia and patient advocacy stakeholders to support efficient commercialization strategies and evidence-driven long-term study design
