My Profile

Search abstracts

Lewis Sheiner


2019
Stockholm, Sweden



2018
Montreux, Switzerland

2017
Budapest, Hungary

2016
Lisboa, Portugal

2015
Hersonissos, Crete, Greece

2014
Alicante, Spain

2013
Glasgow, Scotland

2012
Venice, Italy

2011
Athens, Greece

2010
Berlin, Germany

2009
St. Petersburg, Russia

2008
Marseille, France

2007
København, Denmark

2006
Brugge/Bruges, Belgium

2005
Pamplona, Spain

2004
Uppsala, Sweden

2003
Verona, Italy

2002
Paris, France

2001
Basel, Switzerland

2000
Salamanca, Spain

1999
Saintes, France

1998
Wuppertal, Germany

1997
Glasgow, Scotland

1996
Sandwich, UK

1995
Frankfurt, Germany

1994
Greenford, UK

1993
Paris, France

1992
Basel, Switzerland



Printable version

PAGE. Abstracts of the Annual Meeting of the Population Approach Group in Europe.
ISSN 1871-6032

Reference:
PAGE 28 (2019) Abstr 9232 [www.page-meeting.org/?abstract=9232]


Keynote lecture


B-03 Jeff Sachs Pharmacometrics: A shot in the arm for vaccine discovery and development ~or~ Vaccines are not immune to the charms of pharmacometrics

Jeffrey R. Sachs

Pharmacokinetics, Pharmacodynamics, and Drug Metabolism – Quantitative Pharmacology and Pharmacometrics, MSD., Inc., Kenilworth, NJ, USA

Objectives:

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.

Overview/Description of presentation:

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 and 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 modelling, trial simulation, Bayesian inference, and model-based meta-analyses (“comparator modelling”).

The presentation will start with a background on vaccine discovery and development (contrasting with other therapeutic areas) 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

  • An application of M&S that supported both Go and No-Go decisions
  • An application of M&S that increased power in trial design while saving considerable cost by optimizing sampling of subjects’ disease state.
  • An application of M&S providing a novel phase 3 endpoint substantially increasing power of a proposed trial design

Conclusions/Take home message:

Application of PMX to vaccine D&D has developed into an opportunity to impact human health and to develop innovative PMX methods applicable to other areas.



References:
[1] Brian Greenwood, The contribution of vaccination to global health: past, present and future, Philos Trans R Soc Lond B Biol Sci. 369(1645), 2014. doi: 10.1098/rstb.2013.0433.