Uditha DeAlwis

Uditha DeAlwis

Company: Sarepta Therapeutics

Job title: Vice President, Analytical Development and Quality Control


(CASE STUDY) Where Is the Current Regulatory Focus? Key Insights Gained From Discussions With the Regulators 4:00 pm

Setting realistic expectations before entering discussions with regulatory experts Sharing regulatory perspectives on Validating Assays, Setting Standards, and Ensuring Data Integrity in Gene Therapy Analytical Development Highlighting how to interact effectively with regulatory authorities Read more

day: Day One

PANEL DISCUSSION: Discussing Strategies to Correlate the Outputs of a Potency Matrix Approach to Manage Regulatory Expectations 1:00 pm

Exploring the potency matrix and understanding the relevance of the constituent assays Aligning measures of infectivity, mRNA, protein, and biological activity to generate robust potency assay data Understanding correction factors and correlation coalitions in potency assay read-outs Upper and lower limits: discussing regulatory perspectives on infectivity titresRead more

day: Pre-Conference Focus Day

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