Lana Shiu
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
Tuesday 15th September 2026
Bridging Regulatory & Commercial Expectations to Restructure the Pathway to Commercialization & Long-Term Follow Ups
12:00 pm
- Clarifying CAR-T FDA regulations within existing biologics frameworks to understand current expectations for CMC, preclinical, and clinical development
- Interpreting evolving regulatory frameworks to enable adaptive decisions that balance patient safety, operational feasibility and commercial sustainability
- Adapting development and regulatory strategies to align with evolving FDA guidance, to advance novel cell therapy programs
