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.Â
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
2:00 pm Afternoon Break
Workshop C
3:00 pm Harmonizing Analytical Development & Quality Control to Enable Seamless Tech Transfer Across Sites
Analytical Development and Quality Control teams often approach assays from very different angles – innovation and flexibility on one side, reproducibility and compliance on the other. The challenge is making sure methods can travel smoothly between both worlds without losing robustness or reliability.Â
Join to:
- Understand why methods developed flexibly in AD often struggle in QC – from reliance on new technologies and reproducibility – to ensure assays remain reliable when moved into regulated testing environments
- Building strategies to adapt and validate assays for QC environments to secure regulatory compliance, enable timely batch release, and prevent costly delays
- Overcoming site-to-site variability with platformization principles to streamline method transfer, reduce revalidation burden, and accelerate readiness from development to QC and commercial release