Prologue: Pharmacokinetics and Interaction Implications for LNP Therapy

Monday, October 17, 2022

8:30 AM – 9:00 AM ET

Location:204 AB

Prologue Speaker(s)

DB

Douglas Burdette, Ph.D.

Director, DMPK
Moderna Therapeutics

LNP encapsulated mRNA is a novel therapeutic modality classified as a gene therapy. Because of the unique characteristics of mRNA delivery, this modality does not fit perfectly into existing drug classes and the regulatory expectations for understanding the in vivo disposition of LNPs and their components are evolving as are the LNPs themselves. This presentation will summarize LNP characteristics established to date, propose a framework to map full LNP characterization, and share data consistent with this assessment for a therapeutic LNP.

Learning Objectives:

Discuss the generally accepted characteristics of LNP encapsulated mRNA therapeutic in vivo disposition
Understand the in vivo disposition of a xenobiotic LNP component critical to LNP therapeutic effectiveness and how it maps into the general regulatory framework exploratory medicines
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