Integrating CMC, Nonclinical, and Clinical Evidence Into One eCTD IND for a Next-Generation mRNA-Lipid Nanoparticle Vaccine

Messenger RNA vaccines delivered via lipid nanoparticle formulation moved from a largely theoretical platform to a validated, scalable technology over the course of the COVID-19 pandemic, and the platform's reach beyond SARS-CoV-2 was confirmed when FDA licensed the first non-SARS-CoV-2 mRNA-LNP vaccine in 2024, extending the platform to prevention of a respiratory viral indication in an older adult population (Wu et al., 2026). For a regulatory operations team, this maturing platform raises a genuinely practical question: once a sponsor has taken one mRNA-LNP candidate through a complete eCTD IND, how much of that structural and procedural work transfers to the next candidate built on the same delivery platform, and how should the eCTD itself be organized to make that transfer efficient rather than ad hoc. This article addresses that question through a hypothetical new mRNA-LNP vaccine candidate's capstone IND assembly, integrating CMC, nonclinical, and clinical evidence into one submission structure.