Vorlesung: 5.04.5000 Pharmacometrics in Drug Development: A 3-Days Hands-On Workshop with MATLAB - Details

Vorlesung: 5.04.5000 Pharmacometrics in Drug Development: A 3-Days Hands-On Workshop with MATLAB - Details

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Veranstaltungsname Vorlesung: 5.04.5000 Pharmacometrics in Drug Development: A 3-Days Hands-On Workshop with MATLAB
Untertitel
Veranstaltungsnummer 5.04.5000
Semester WiSe22/23
Aktuelle Anzahl der Teilnehmenden 5
Heimat-Einrichtung Institut für Physik
Veranstaltungstyp Vorlesung in der Kategorie Lehre
Erster Termin Montag, 10.10.2022 09:00 - 16:00, Ort: W02 1-156, W02 2-249
Art/Form W
Lernorganisation Pharmacometrics is new discipline that originated from the need to integrate model-based techniques applied mainly in clinical drug development. In this 3-days hands-on workshop, basic elements of pharmacometrics are introduced and explored: Drug development phases, pharmacokinetics and pharmacodynamics, nonlinear mixed-effects modeling, and clinical trial simulation.
To alleviate or cure human diseases, drug treatment plays a major role. However, the development of innovative drugs is becoming more and more challenging. Traditional experimental methods alone cannot cope with the increasing factual knowledge about the functioning of a diseased human being. Particularly, how drugs exert their action and how they are optimally administered is a problem too big for pure experimentation. Actually, drug development suffers from many costly failures.
A natural means to overcome such shortcomings is to combine experimentation with mathematical modeling. Over the last 30 years, different groups within and outside the pharmaceutical industry suggested the application of “Model-based drug development”, “Systems Biology”, or “Quantitative Systems Pharmacology”. All these terms address the importance of mathematical modeling in the development of drugs.
Progress has been made in that nowadays the outcome of a clinical trial is simulated beforehand leading to better trial designs. Simulating clinical trials outcome comprises the quantitative consideration of how the drug reaches the site of action, how it acts on the body, and how disease processes are affected. Importantly, between and within variability in all measured responses needs to be taken into account.
At the end of the course, you will
- have an overview of Pharmacometrics and its promise for the pharmaceutical industry,
- have a better understanding on Pharmacokinetics (i.e., how to quantitatively model the uptake, level at the target organ, and elimination of drugs across time) and Pharmacodynamics (i.e., how to quantitatively model the effects of drugs on the diseased body)
- know how to combine exact mathematical modeling with insights from life science
- appreciate MATLAB as a tool to easily solve and explore systems of differential equations
Lehrsprache deutsch
Sonstiges Instructor: Dr. Ronald Gieschke
About the Instructor
Ronald Gieschke, MD MSc, studied Mathematics and Medicine at the Georg-August University at Göttingen. After joining F. Hoffmann-La Roche in 1986, he worked as a Pharmacometrician in Clinical Pharmacology, Biometrics and Disease Modeling groups. His primary interest is in the application of mathematical constructs to drug development questions; for example, how to optimally design a clinical trial; or more recently, addressing the fundamental question of how to establish a rationale between pharmacological target and disease, especially in brain disorders? Ronald was part of several working groups that discussed the foundations of clinical trial simulation and he supported development and implementation of respective software products. He contributed to the design of a number of Phase III studies, especially for erythropoiesis stimulating agents (ESAs) in Renal Anemia and anti-Alzheimer’s drugs. Together with his colleague Daniel Serafin, he summarized his industrial experience in the book “Innovative Drug Development with Modeling via MATLAB” published by Springer in 2014. After his retirement in 2017, Ronald works as a consultant to F. Hoffmann - La Roche in Basel.

Räume und Zeiten

W02 1-156
Montag, 10.10.2022 - Mittwoch, 12.10.2022 09:00 - 16:00
W02 2-249
Montag, 10.10.2022 - Mittwoch, 12.10.2022 09:00 - 16:00

Kommentar/Beschreibung

techniques applied mainly in clinical drug development. In this 2-days hands-on workshop, basic elements of pharmacometrics are introduced and explored.
To alleviate or cure human diseases, drug treatment plays a major role. However, the development of innovative drugs is becoming more and more challenging. Traditional experimental methods alone cannot cope with the increasing factual knowledge about the functioning of a diseased human being. Particularly, how drugs exert their action and how they are optimally administered is a problem too big for pure experimentation. Actually, drug development suffers from many costly failures.
A natural means to overcome such shortcomings is to combine experimentation with mathematical modeling. Over the last 30 years, different groups within and outside the pharmaceutical industry suggested the application of “Model-based drug development”, “Systems Biology”, or “Quantitative Systems Pharmacology”. All these terms address the importance of mathematical modeling in the development of drugs.
Progress has been made in that nowadays the outcome of a clinical trial is simulated beforehand leading to better trial designs. Simulating clinical trials outcome comprises the quantitative consideration of how the drug reaches the site of action, how it acts on the body, and how disease processes are affected. Importantly, between and within variability in all measured responses needs to be taken into account.
Reference: Ronald Gieschke, Daniel Serafin. Development of Innovative Drugs via Modeling with MATLAB. Springer (2014)
Prerequisites: Basic knowledge of Ordinary Differential Equations (numerical treatment) and Statistics (distributions, parameter estimation)
Course Software: Berkeley Madonna. Bring your own notebook to the course or use a computer from the CIP-cluster. Install Windows Version 8.3.18 (C-based) or Version 9.1.9 (macOS) from https://berkeley-madonna.myshopify.com/pages/download and explore its features; use “Continue in demo mode”

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