As gene therapy programs move rapidly toward IND/IMPD submissions, ensuring the right titer and potency assays are in place from the earliest stages is critical. This workshop will dive into essential early-stage assay design and long-term planning considerations to meet evolving regulatory expectations. Attendees will explore how to prioritize analytical methods, ensure assay suitability through qualification or validation, and build a lifecycle approach to support development through to commercialization.

Key discussion points:

• Defining Essential Early-Stage Assays: Establishing the core titer and potency assays needed to support IND/ IMPD submissions and ensure alignment with regulatory expectations
• Analytical Lifecycle Planning: Clarifying when to qualify vs. validate assays during development, and how to avoid rework during late-stage filings
• Future-Proofing for Regulatory Compliance: Building assay strategies that scale with your program, from early discovery through to pivotal trials and BLA submission