Uditha deAlwis

Uditha deAlwis

Company: Sarepta Therapeutics

Job title: Vice President - Analytical Development & Quality Control


Designing Activity Assays for Non-Enzymatic/Structural Protein Products to Confidently & Robustly Measure Potency 9:00 am

Generating a release assay for measuring downstream protein effects to supplement binding assays and prove potency What kind of in vitro assays are acceptable? Assessing and clarifying agency expectations on binding assay data versus gene-knockdown versus true activity assays Establishing alternative assays to prove that binding studies are meaningful and indicative of potencyRead more

day: Day 2

PANEL: Partnering & Communicating Effectively with CROs – Finding a Company That Understands Your Specific Scientific Needs & Potency Assay Requirements 5:00 pm

Moderated by Shashwat Mishra, Principal Scientist – Analytical Development, Regeneron Overcoming the bottlenecks of lengthy GMP training periods and high CRO turnover rates Analysing the impact of limited CRO capabilities and the need to reduce assay complexity for a smoother tech transfer Balancing timelines between gene therapy developers and CROs to expedite development processesRead more

day: Day 1

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