Registration is open for the basic and advanced workshops on Pharmacometrics in
2014
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Pharmacometrics is the science of interpreting and describing pharmacology,
physiology, disease, and patients’ characteristics in a quantitative fashion by
integrating and applying mathematical and statistical models to characterize,
understand, gain insights into the determinants of efficacy and safety
outcomes, predict a drug’s and biomarker-outcome, optimize drug development
plans and enable critical decision making. The gain in efficiency (cost to
decision) associated with the implementation of a pharmacometrics strategy is
measured by the saving in time necessary to conduct a study, by the ratio
between information gathered and the cost of the trial, by the early detection
of signal of efficacy or lack of efficacy triggering the decision to terminate
the product development and to redirect resources more productively, and
finally by the overall time requested for filing new drug applications.
http://www.pharmacometricaworkshop.webs.com
www.pharmacometricaworkshop.webs.com
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Program for 2014
Workshop on Quantitative Methods in Pharmacology: Introduction to
Pharmacometrics
USA: March 24-26, 2014: The Carolina Inn on the Campus of the University of
North Carolina at Chapel Hill, NC
Europe: November 10-12, 2014: Château de Longcol, La Fouillade (France)
This is a 3-day course designed to help scientists to understand and use
fundamental pharmacometrics concepts for increasing efficiency in drug
discovery and development. The workshop includes lectures and hands-on training
on concepts, applications, and software tools for pharmacometrics. A Clinical
Trial Simulator developed in R will be used to illustrate the use of R in a
pharmacometrics framework including the population PK and PK/PD concepts, inter
and intra subject variability and the impact of covariates on the clinical
trial outcomes. As a working example, the simulator will be used to generate
data of a virtual clinical trial in non-small cell lung cancer. The model will
include a semi-mechanistic PK/PD tumor growth component, the link between PK
and adverse events and the link between tumor growth and survival. The virtual
data will then be used to illustrate the population analysis in NONMEM. The R
scripts (including the trial simulator) and the NONMEM control streams used
will be distributed to the participants.
Special Course on Predictive Models and Enrichment Study Design Strategies
Europe: April 21-23, 2014: Château de Longcol, La Fouillade (France)
USA: October 20-22, 2014: The Carolina Inn on the Campus of the University of
North Carolina at Chapel Hill, NC
This is a 3-day advanced course designed to help scientists to develop and use
predictive models for implementing enrichment study design with particular
emphasis in CNS diseases. The workshop includes lectures and hands-on training
on concepts, applications, and software tools. Examples will be presented and
discussed for:
Decreasing heterogeneity in the response – excluding patients with improvement
in clinical scores for reasons other than a response to the test treatment
(spontaneous improvement, or placebo response). A case-study in Major
Depressive Disorders (MDD) where a model of placebo response will be used for
implementing a placebo-lead in enrichment design and an adaptive enrichment
approach.
Prognostic enrichment strategies − choosing patients with a greater likelihood
of having a substantial worsening in condition. Two-case-study in Alzheimer’s
disease and in a Rare Diseases (Amyotrophic Lateral Sclerosis) will be used to
implement study design where patients with more rapid progression are selected
based on a disease-progression model.
A Clinical Trial Simulator developed in R will be used to simulate clinical
trials and to evaluate the benefit of implementing enrichment strategies. The R
scripts for the trial simulator will be distributed to the participants.
Additional details are available at:
http://www.pharmacometricaworkshop.webs.com
www.pharmacometricaworkshop.webs.com
Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC
PharmacoMetrica
Longcol, 12270 La Fouillade (France)
E-mail: <mailto:[email protected]>
[email protected]
Mobile: +33(0) 760 45 1976
http://www.pharmacometrica.com/ www.pharmacometrica.com
Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com
Advanced and Basic Workshops on Pharmacometrics in 2014
Program for 2014
Workshop on Quantitative Methods in Pharmacology: Introduction to
Pharmacometrics
USA: March 24-26, 2014: The Carolina Inn on the Campus of the University of
North Carolina at Chapel Hill, NC
Europe: November 10-12, 2014: Château de Longcol, La Fouillade (France)
Special Course on Predictive Models and Enrichment Study Design Strategies
Europe: April 21-23, 2014: Château de Longcol, La Fouillade (France)
USA: October 20-22, 2014: The Carolina Inn on the Campus of the University of
North Carolina at Chapel Hill, NC
Additional details are available at:
http://www.pharmacometricaworkshop.webs.com
www.pharmacometricaworkshop.webs.com
-.-.-.-.-.-
Workshop on Quantitative Methods in Pharmacology: Introduction to
Pharmacometrics
This is a 3-day course designed to help scientists to understand and use
fundamental pharmacometrics concepts for increasing efficiency in drug
discovery and development. The workshop includes lectures and hands-on training
on concepts, applications, and software tools for pharmacometrics. A Clinical
Trial Simulator developed in R will be used to illustrate the use of R in a
pharmacometrics framework including the population PK and PK/PD concepts, inter
and intra subject variability and the impact of covariates on the clinical
trial outcomes. As a working example, the simulator will be used to generate
data of a virtual clinical trial in non-small cell lung cancer. The model will
include a semi-mechanistic PK/PD tumor growth component, the link between PK
and adverse events and the link between tumor growth and survival. The virtual
data will then be used to illustrate the population analysis in NONMEM. The R
scripts (including the trial simulator) and the NONMEM control streams used
will be distributed to the participants.
-.-.-.-.-.-
Special Course on Predictive Models and Enrichment Study Design Strategies
Europe: April 21-23, 2014: Château de Longcol, La Fouillade (France)
USA: October 20-22, 2014: The Carolina Inn on the Campus of the University of
North Carolina at Chapel Hill, NC
This is a 3-day advanced course designed to help scientists to develop and use
predictive models for implementing enrichment study design with particular
emphasis in CNS diseases. The workshop includes lectures and hands-on training
on concepts, applications, and software tools. Examples will be presented and
discussed for:
Decreasing heterogeneity in the response – excluding patients with improvement
in clinical scores for reasons other than a response to the test treatment
(spontaneous improvement, or placebo response). A case-study in Major
Depressive Disorders (MDD) where a model of placebo response will be used for
implementing a placebo-lead in enrichment design and an adaptive enrichment
approach.
Prognostic enrichment strategies − choosing patients with a greater likelihood
of having a substantial worsening in condition. Two-case-study in Alzheimer’s
disease and in a Rare Diseases (Amyotrophic Lateral Sclerosis) will be used to
implement study design where patients with more rapid progression are selected
based on a disease-progression model.
A Clinical Trial Simulator developed in R will be used to simulate clinical
trials and to evaluate the benefit of implementing enrichment strategies. The R
scripts for the trial simulator will be distributed to the participants.
Additional details are available at:
http://www.pharmacometricaworkshop.webs.com
www.pharmacometricaworkshop.webs.com
Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC
PharmacoMetrica
Longcol, 12270 La Fouillade (France)
E-mail: <mailto:[email protected]>
[email protected]
Mobile: +33(0) 760 45 1976
http://www.pharmacometrica.com/ www.pharmacometrica.com
Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com