Ilya Shestopalov

Company: bluebird bio

Job title: Sr.Director, Analytical Development

Seminars:

Panel Discussion: Unifying the Approach to Method Validation Across Cell Therapy Potency Assay Development 12:00 pm

Adopting a matrix approach to assay development to support validation of the method Optimizing surrogate physicochemical assays to support cell therapy potency assays Outlining a time frame for method validation procedures and understanding when to implement planning to validateRead more

day: Day Two AM

Evaluating Analytical Strategy Following Regulatory Input to Provide Clarity to the Industry 12:00 pm

Establishing cell therapy-specific guidelines for potency assay development Exploring how potency assay approval has evolved over the past year Reaffirming the primary elements of attention required to maximize regulatory approval Read more

day: Day One AM