Natalie Palmer-Deverill

Company: MeiraGTx

Job title: Senior Scientist - Cell Assay Development

Seminars:

Panel Discussion: Overcoming Challenges in Validation & Clinical Relevance of Potency Assays to Demonstrate Efficacy 2:10 pm

Potency Assay Validation Challenges: Validating potency assays, especially cell-based ones, is difficult due to their product-specific nature and the need to establish reliable biomarkers or functional outputs to demonstrate efficacy Unique Assays for Unique Products: Potency assays are often unique to each gene therapy product, requiring adaptation of academic or preliminary assays for use in…Read more

day: Day Two

Navigating the Ongoing Challenges of Potency Assays in Gene Therapy for Regulatory Alignment & Enhanced Validation 1:00 pm

The complexities surrounding potency testing, from early-stage assay workarounds to long-term validation in compliance with evolving regulatory requirements, continue to be a significant hurdle for the industry, and this workshop will provide insights into overcoming these challenges while aligning with best practices. Clarifying Potency Assay Purpose & Misconceptions: Delve into the recurring misunderstandings about potency…Read more

day: Pre-Conference Assay Development Track A - PM