Strategic Learnings from Cell Therapy: Applying Study Design and Regulatory Experience to Gene Therapy Comparability
Time: 2:00 pm - 4:00 pm
day: Pre-Conference Workshop Day
Details:
Join us for an interactive workshop where experts from the cell therapy and gene therapy fields will share
their experiences, best practices, and key learnings. Discover how strategic insights from cell therapy can be
harnessed to enhance study design and regulatory success in gene therapy comparability assessments:
Join this workshop session to:
- Compare and contrast study design approaches between gene therapy and cell therapy
- Learn from cell therapy regulatory experiences and how they can inform gene therapy comparability studies
- Understand the similarities and differences in regulatory requirements for both therapies to optimize interactions with regulatory bodies
- Discuss novel analytical methods and study designs for assessing immune function in gene therapy, drawing inspiration from cell therapy advancements
- Assess the transferability of cell therapy learnings to gene therapy, considering the complexities and variables involved
