Upcoming webinar: Jeffrey Sachs from Merck on MIDD
MIDD: Vaccine R&D Gets a Shot in the Arm from Pharmacometrics
Jeffrey R. Sachs, PhD
Senior Principal Scientist at Merck & Co.
Wednesday Jan 22, 2020, 12:00 to 1:00 pm EST
Register for free at https://www.rosaandco.com/webinars
Abstract:
The objective is to (1) inform the audience about pharmacometrics (PMX)
opportunities in vaccine discovery and development (D&D), and (2) to motivate,
by examples, PMX practitioners to impact vaccine D&D.
Prophylactic vaccines are safe and effective and have made an immense
contribution to human and animal health [1]. Pharmacometrics (PMX) has only
recently been introduced to vaccine discovery and development, and is now
becoming fully integrated into, and impactful on decision-making. This has
resulted in better scientific understanding, increased POS, substantial
savings, and other benefits that have been seen in the other therapeutic areas
that have adopted PMX. The impact of this work has included go/no-go decisions,
design of efficient pre-clinical and clinical trials, integration of
preclinical and clinical data, quantitative prediction for go/no-go and
dose-level decisions, and integration of data across multiple trials for more
informed decision-making. The methods used include QSP modeling, trial
simulation, Bayesian inference, and model-based meta-analyses ("comparator
modeling").
The presentation will start with a background on vaccine discovery and
development including a brief overview of: the risk/benefit considerations in
vaccines, the choices and uses of biomarkers to mitigate risk, vaccine
terminology, the immune system, and vaccine platforms (DNA, protein, VLP,
etc.). This will be followed by examples across the spectrum of applications
from discovery through development and across the many kinds of decisions
impacted and methods used. These will include applications of M&S that
* supported both Go and No-Go decisions
* increased power in trial design while saving considerable cost by
optimizing sampling of subjects' disease state.
* providing a novel phase 3 endpoint substantially increasing power of a
proposed trial design