Workshops

Join us for hands-on PBPK modeling, Quantitative Systems Pharmacology (QSP), and population PK/PD data analyses training near you. Space is limited, so register soon!

Niagara Falls, NY

A 3-day Introductory Workshop in Population PK Data Analysis with NONMEM®
Aug 27-29, 2020

Niagara Falls, NY

A 3-day Introductory Workshop in Population PK Data Analysis with NONMEM®

This introductory population PK training workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program and to provide the foundation for understanding the basics of NONMEM coding and interpretation of NONMEM output. The material is structured to impart both the theoretical and practical aspects of the population approach and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. Examples of the use of population PK studies in drug development programs will be presented to provide specific details of various implementations and better illustrate essential aspects of population PK methods. Emphasis will be placed on compliance with the FDA’s Guidance for Industry on Population PK and the EMA’s Guideline on Reporting the Results of Population PK Analyses; participants will gain an appreciation for the essentials of accurate and sufficient data collection and learn how to proactively plan in order to maximize study effectiveness.

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Mainz, Germany

September 14-18

More details coming soon.


Cambridge, Massachusetts

September 21-25

More details coming soon.


Aurora, CO

Applying PBBM/PBPK Modeling to Predict Absorption-Related Drug-Drug Interactions: Approaches and Special Considerations
Oct 3, 2020

Aurora, CO

Applying PBBM/PBPK Modeling to Predict Absorption-Related Drug-Drug Interactions: Approaches and Special Considerations

The focus of this ½-day workshop will be to discuss how the co-administration of proton pump inhibitors (PPIs) and acid-reducing agents (ARAs) impact gastrointestinal physiology and have been incorporated into physiologically based biopharmaceutics (PBBM) / pharmacokinetic (PBPK) models to predict absorption-related DDIs. A combination of presentations and interactive examples using the GastroPlus® PBBM/PBPK modeling platform will illustrate how to parameterize baseline models for several drugs and, once validated, apply them to predict the changes in absorption and systemic exposure when drug is co-administered with PPIs/ARAs. Proposed workflows to inform clinical development and regulatory interactions will be discussed, and gaps in the current methods will also be explored.

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QSP Modeling of Fibrosis Across Diseases
Oct 8, 2020

Aurora, CO

QSP Modeling of Fibrosis Across Diseases

Fibrosis is a critical aspect of many diseases that are yet untreated with adequate pharmaceutical intervention. This half day workshop covers the basic theories and applications of quantitative systems pharmacology (QSP) modeling focused on fibrosis, including special emphasis on the slow developing nature of the etiology and the upstream, downstream, and clinical outcome/biomarker indicators that must be considered. Fibrosis of the liver via NASH and fibrosis of the lung as with idiopathic pulmonary fibrosis (IPF) will be used as key examples. The NAFLDsym® and IPFsym® software tools will serve as example model platforms. Presentations, demonstrations, and interactive examples will illustrate typical data inputs utilized and address how to run simulations of expected outcomes and analyze results for impacting decisions. This course is useful for all individuals interested in these fields – prior QSP experience is not required, nor is a deep existing knowledge of fibrosis. Attendees will understand the following important aspects of modeling fibrosis: key components of the pathophysiology, including initiation and stimulation of collagen production via fibroblasts and/or stellate cells, interaction with the immune system, resolution of fibrosis, and biomarkers; examples of targets represented for in silico evaluation; and stratification of simulated populations to address a planned or possible clinical study. The process of representing fibrosis across different diseases and organs will also be discussed.

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Tokyo, Japan

November 16-20

More details coming soon.