Intensive 2-day Workshops (Intensive 2-day Workshops)
United States of America
10 September 2018
Pre-Consortium Focused Workshops
Due to previous success, the focused workshops will once again
run in parallel sessions before the Consortium meeting. All
workshops will be held in Sheffield at the Certara Simcyp offices.
Focused workshops offer an in-depth insight into specialist areas of modeling such as:
Best Practice in PBPK Model Building
Parameter Estimation and Pharmacodynamics (PE/PD)
Drug-Drug Interactions (DDIs)
From Discovery to First-in-human (FIH) Using IVIVE-PBPK Modeling
Simcyp workshops are an ideal way to enhance the continuous education of scientists working in clinical pharmacology and drug development. These events provide an excellent opportunity to develop skills, stay up-to-date with the latest scientific advances and network with delegates from industry, academia and regulatory agencies.
The model-informed approach to various aspects of drug development is rapidly being adopted by many of the leading pharmaceutical companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drug (IND) and New Drug Applications (NDA) and assists with the conduct and optimal design of clinical studies. The ultimate aim is to better understand drug PK/PD properties, reduce the cost and time of drug development, improve the quality of regulatory submissions and eventually implementing precision medicine.
Optional / Voluntary
Researchers, Regulators and policy-makers, Teachers and educators, Managers, Scientific officers / Project managers, Professionals (e.g. veterinarians)
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs), Consulting, SMEs
Continuing Professional Development
Full coverage (a dedicated course)
|Details on the topic or technology covered:||
Best Practice in PBPK Model Building:
The main aim of this
focused workshop is to demonstrate the application of best
practices in developing PBPK models and to indicate how to qualify
and refine model performance. Various case studies, including
some real-life examples, will be presented. The case studies will
cover various elements of model development, including DDIs,
special populations, transporters, and different formulations.
Optimal in vitro and clinical data sets will be discussed.
This workshop will highlight how the Simcyp
Simulator can be used to predict the pharmacokinetics and
pharmacodynamics of therapeutic proteins.
The ABC of modeling drug transporter data—
mechanistic approaches to predict the impact of drug transport
proteins on ADME/pharmacokinetics and toxicity.
Predicting age related changes to pharmacokinetics (PK)
and drug-drug interactions including associated variability—linking
this information to drug response in the pediatric population.
Participants will learn how PK behaviour can be modeled in
neonates, infants, and children and how it can be linked to PD.
Mechanistic oral absorption modeling and prediction
of bioavailability for drug products incorporating inter-subject
variability. Applications of the Simcyp Advanced Dissolution,
Absorption, and Metabolism (ADAM) Model.
Broadening the area and utilization of in silicobased
mechanistic prediction and analysis of drug absorption.
Mechanistic modeling of the topical drug application, development
of mechanistic physiologically-based in vitro-in vivo correlations
(IVIVCs), and virtual bioequivalence (V-BE) concepts. We strongly
recommend taking Absorption I before taking this workshop.
Parameter Estimation and Pharmacodynamics (PE/PD):
A systems pharmacology approach to modeling and simulation—
accelerating model building and covariate recognition in drug
development by combining top-down and bottom-up modeling
of pharmacokinetics linked to drug response.
Drug-drug Interactions (DDIs):
Predicting and evaluating
complex DDIs—application of the Simcyp Population-based
Simulator to real-life cases. Participants will learn good practices
in combining data from both in vitro and clinical studies, whilst
gaining experience in using such data within physiologically-based
dynamic models to evaluate the DDI liability of drug candidates.
From Discovery to First-in-human (FIH) Using IVIVE-PBPK
In this focused workshop, attendees will use the
dynamic models within the Simcyp simulator to prioritize
compounds for progress to the next stage of development using
information available in early drug discovery. Attendees will use
information on clearance, absorption, tissue distribution, and DDI
liability to inform compound selection. Finally, from the originally
large database, only a few compounds will be selected for FIH and
the simulation results compared with available clinical data.
Mechanistic approaches for the assessment of a
drug’s pro-arrhythmic potency within target populations. Druginduced
cardiovascular adverse events were one of the leading
causes of drug withdrawals from the market and of drug label
restrictions. At present, these safety concerns are among the main
reasons compounds’ development have stopped.
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