Diplôme d’Université Pharmacometrics Modeling
Pharmacometrics is a modeling and simulation (M&S) tool to support decision making during the drug development process from preclinical to clinical studies. M&S facilitates the continuous integration of available information related to a drug or disease into constantly-evolving mathematical models capable of describing and predicting the behavior of studied systems to address the questions researchers, regulators, and public health care bodies face when bringing drugs to patients
This diploma used to train scientists in Quantitative clinical Pharmacology and in particular to PK-PD modeling, by using Pharmacokinetics and Pharmacodynamics knowledge in different therapeutic areas, such as oncology and cardiovascular diseases, to understand and optimize treatments according to clinical responses (dosage individualization) and to facilitate decision-making during the drug development process.
Pharmacists, pharmacologists, physicians, veterinarians, statisticians, engineers, scientists from academy, hospital or industry.
Professionals with a master or doctoral degree with some experience in medical product development who aspire to transform into decision-making pharmacometricians or quantitative translational scientists should apply.
The program is designed for professionals with full- or part-time jobs in areas such as pharmacology, engineering, statistics, pharmaceutical and medical sciences and epidemiology.
Compétences à l'issue de la formation
- Identify proper class of PK/PD models to describe different PK/PD relationships.
- Use software mainly in Pharmacometrics.
- Create, manipulate and manage Nonmem dataset and Develop a Modeling & Simulation framework.
- Interpret results in order to suggest answer to stakeholder.
- Develop Population PK/PD analysis and PK/PD modeling and Use R-Pharma in various situations.
- Create own PK/PD concept in clinical practice and/or in drug development.
This graduate education in Pharmacometrics Modeling is built in 4 consecutive modules as follows :
Module 1: Pharmacokinetics/Pharmacodynamics (PK/PD), as integral components of the drug development process
Session by e-learning (30 hours) – From 1st to 30 April 2020
- Introduction to Drug Development process
- Principles of PK/PD relationships and PKPD modeling
- Principles of clinical pharmacology and their applications to clinical development in oncology and cardiovascular diseases
Module 2 : Pharmacometrics : modeling and simulation tools
(5 days). From 15 to 19June 2020
- Introduction to pharmacokinetics modeling, the NONMEM suite, modeling strategy, model building and validation, Monte Carlo simulation, PKPD analysis.
- Initiation to software R for Pharmacometrics
- Application of M&S will be on cardiovascular and oncology therapeutic areas.
Module 3 : Concepts of PK/PD modeling
Session by e-learning (20 hours). October 2020
- PK-PD link models
- Population PK/PD analysis
- Intermediate and more complex PKPD modeling
- Understand and learn using R Pharma software in complex situations
Module 4 : PK/PD modeling based drug development approach
(5 days). January 2021
- Applications to PKPD analysis and modeling on oncology and cardiovascular or other therapeutic areas
- Create own PK/PD concept, analyze it, and establish a M&S system by establishing a project of clinical practice and/or in drug development.
All courses will be in English, modules 1 and 3 are delivered by e-learning
The hands on learning sessions with software and interface on PCs (modules 2 and 4) will take place in Strasbourg
After each module, a certificate of attendance is delivered and a notation is given (continuous control).
This graduate education in Pharmacometrics Modeling from the University of Strasbourg will be delivered after validation of the 4 modules and after writing a project about a specific case chosen by the student, using M&S tool and PK-PD modeling.
Dr Geneviève Ubeaud-Séquier, Professor of Pharmacokinetics in Faculty of Pharmacy and Hospital Pharmacist – Strasbourg University
In collaboration with international experts in M&S field
This training course is an “action d’adaptation et de développement des compétences” (ref. French law). A certificate of attendance is delivered after the course. An evaluation measures the trainees’ satisfaction and the achievement of learning objectives.