Meredith Packer
Director Nava Therapeutics
Meredith Packer is Director of Analytical Development at Nava Therapeutics, with deep expertise in analytical and process development for gene editing and nucleic acid–based therapeutics. She has over a decade of experience spanning Moderna, Tome Biosciences, and Mirai Bio, specializing in assay development, CMC analytics, and supporting advancement of next-generation genetic medicines.
Seminars
Thursday 19th November 2026
Panel Discussion: What Should Be Characterized at Drug Substance vs Drug Product Stage?
12:10 pm
- Explore which attributes should be controlled before formulation versus reassessed in the final LNP product
- Debate how much characterization is enough at different stages of development without creating unnecessary analytical burden
- Benchmark industry approaches for defining CQAs, release strategies, and regulatory-ready analytical packages
Thursday 19th November 2026
Controlling Lipid Impurities from Raw Materials Through Final Drug Product
11:30 am
- Characterize incoming lipid quality using tandem mass spec and HPLC, identify critical impurities, establish acceptance criteria
- Track impurity profiles through formulation process, understand degradation pathways, implement stability-indicating methods
- Demonstrate component stability in final drug product, meet regulatory expectations, ensure product consistency
