Sianna Castillo

Company: Sangamo Therapeutics

Job title: Senior Director

Seminars:

Panel Discussion: What Are the Challenges & Future Directions for Potency Assay Development? 11:30 am

Defining the requirements of a matrix of potency assays from early to late stage regulatory Delving into strategies for aligning assay development with evolving regulatory expectations to ensure compliance and product quality Gaining insights into the future directions of potency assay development to cutting-edge technologies and methodologies and how these new approaches might alter regulatory…Read more

day: Conference Day Two

Shrinking the Rate-Limiting Step: How Can We Streamline Potency Assay Parameters for Trial Efficiency while Maintaining Proof of Concept 11:00 am

Understanding how and when to use potency assays within regulatory requirements to prove your product isn’t variable Evaluating the need for potency assays with associated quantification vs. simply proving gene function and delivery as a strategy to reduce the burden of a matrix of multiple assays Exploring current stances on flexibility towards demonstrating comparability with…Read more

day: Conference Day Two