RAJEEV BOREGOWDA

Company: Sanofi

Job title: Associate Director

Seminars:

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

Interactive session: How Do we Best Measure Potency? Discussing the Implementation of Appropriate Statistical Tests & Success Criteria To Meet Regulatory Expectations 3:00 pm

Determining appropriate analytical methods for measuring product expression Implementing model-specific system suitable criteria to assess potency Understanding how to use appropriate statistical tests (line vs sigmoid analysis) when designing a potency strategy to competently assess comparabilityRead more

day: Pre-Conference Focus Day