NONMEM Users Network Archive

Hosted by Cognigen

Upcoming webinar: Jeffrey Sachs from Merck on MIDD

From: Rebecca Baillie <rbaillie>
Date: Tue, 14 Jan 2020 17:46:11 +0000

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) opp=
ortunities 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 contr=
ibution to human and animal health [1]. Pharmacometrics (PMX) has only rece=
ntly been introduced to vaccine discovery and development, and is now becom=
ing fully integrated into, and impactful on decision-making. This has resul=
ted 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 precl=
inical and clinical data, quantitative prediction for go/no-go and dose-lev=
el decisions, and integration of data across multiple trials for more infor=
med decision-making. The methods used include QSP modeling, trial simulatio=
n, Bayesian inference, and model-based meta-analyses ("comparator modeling"=
).
The presentation will start with a background on vaccine discovery and deve=
lopment including a brief overview of: the risk/benefit considerations in v=
accines, the choices and uses of biomarkers to mitigate risk, vaccine termi=
nology, 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 impac=
ted 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 opt=
imizing sampling of subjects' disease state.
  * providing a novel phase 3 endpoint substantially increasing power of =
a proposed trial design

Received on Tue Jan 14 2020 - 12:46:11 EST

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to: nmusers-request@iconplc.com.

Once subscribed, you may contribute to the discussion by emailing: nmusers@globomaxnm.com.