Explore the Agenda
8:30 am Morning Coffee & Registration
Workshop A
9:00 am Defining AD & QC Regulatory Expectations for mRNA Therapeutics to Strengthen Submissions & Reduce CMC Pushback
As mRNA pipelines diversify beyond infectious disease, regulatory clarity is more critical than ever. This interactive session arms you with a clear view of how regulators are thinking, where common analytical pitfalls trigger failures, and how to build assays and release strategies that stand up to scrutiny. Expect a practical, forward-looking discussion that translates evolving regulatory requirements and standards into actionable steps to safeguard submissions, avoid costly delays, and future-proof your AD & QC programs.
Join to:
- Navigate how shifting regulatory requirements impact assay development, release testing, and extended characterization to strengthen analytical robustness and keep pace with innovation
- Compare regulatory vs. industry priorities in building analytical and CMC packages to understand where expectations align and where gaps commonly arise
- Overcome analytical shortcomings to drive regulatory submission success and future-proof your AD & QC strategies and safeguard program success
11:00 am Morning Break
Workshop B
12:00 pm Evolving mRNA Potency Assays Across the Drug Development Lifecycle to Strengthen Analytical Robustness & Meet Rising Regulatory Expectations
Potency assays are the ultimate gatekeepers of mRNA therapeutic quality – and they’re also one of the most scrutinized elements in FDA review. This workshop takes you inside the journey of potency testing from Phase 1 to commercialization, showing how exploratory readouts must mature into validated, mechanism-linked assays that regulators can trust.
Join to learn:
- Mapping how potency assays must adapt from broad exploratory readouts in Phase 1 to robust, validated, and mechanism-linked methods by Phase 3 to withstand FDA scrutiny and enable product approval
- Tackling assay design challenges – from custom reagents and large constructs to modified nucleotides and secondary structure – to build potency tests that accurately reflect therapeutic activity and reduce regulatory risk
- Evaluate key differences between cell-based and cell-free potency assays to understand their impact on GMP-readiness and deliver scalable, compliant potency testing that supports sensitivity, reproducibility, and clinical relevance across development stages
- Explore the influence of formulation and LNP type on expression readouts and assay performance, and how to adapt analytical strategies accordingly