Jabbing Clinical Pharmacology with Vaccines Boosted by Modeling and Simulation

Session Description

Although expected for small molecules and other biologics, model-based analysis to support drug development and regulatory decisions has not been used as frequently for vaccines. Application of MIDD in vaccines is specifically cited in the PDUFA VI commitment letter, opening additional avenues to develop and execute model-based strategies to inform vaccine R&D -- especially valuable for pandemic situations.

As a result, MIDD/QCP approaches have been used with increasing frequency and impact for vaccine discovery and development. The dissemination of these approaches will continue the pharmacometrics-supported progress towards improved pandemic preparedness and enhanced vaccine discovery and development. This session will look at specific examples of impact across the industry and pipeline stages, focusing in particular how the quantitative tools can help cover larger populations more quickly.

First, Dr. Stephen Greene of ModeRNA Therapeutics will discuss mechanistic and other modeling and simulation applications that have helped accelerate expansion of the COVID-19 vaccine coverage to pediatric populations, as well as supporting first in human dose selection for an mRNA cancer vaccine. Then Dr. Jeffrey Perley will share a different approach to COVID-19 vaccine dose-selection, and also illustrate how immune-system QSP model identifiability and its enhancement by model reduction enabled its direct application to multiple development decisions. And Dr. Josiah Ryman will show how interpretation of the immunogenicity of pneumococcal conjugate vaccines (“PCVs”) has been improved by modeling and simulation, enabling better prediction of public health impact by novel vaccines: randomized, placebo-controlled trials are typically not run for PCVs, so decisions on optimal vaccination policies are guided entirely by (safety and) immunogenicity data.

Learning Objectives

1. Upon completion, participants will be able to assess the potential utility of state-of-the-art quantitative tools for enhancing and/or accelerating vaccine discovery and development programs.

2. Participants will further be able to identify colleagues likely to be able to apply those tools, and to collaborate effectively in adapting them to programs of interest.

Session Schedule

3:45 PM - 3:48 PM ET
Introduction
Jeffrey R. Sachs, PhD

3:48 PM - 4:02 PM ET
Integrating Correlates of Protection into Mathematical Models of SARS-CoV-2 Viral Dynamics
Jérémie Guedj, PhD

4:02 PM - 4:16 PM ET
The Role of Pharmacometrics in Development and Approval of mRNA Vaccines
Stephen Greene, PharmD

4:16 PM - 4:30 PM ET
Application of Semi-mechanistic Quantitative Systems Pharmacology to Support Vaccine Development Decisions
Jeffrey P. Perley, PhD

4:30 PM - 4:45 PM ET
Q&A and Closing Remarks