Ehrlich II 2008 Workshop Program
The workshop program at the Ehrlich I meeting in 2004 was a great success and we are very pleased having many of the world class scientists and thought leaders in their fields to give the workshops at the Ehrlich II 2008 world conference.

Workshop participants will get the opportunity to hear a large variety of topics and opinions from a variety of perspectives and can personally discuss their questions with the professors in the question and answer sessions. This program offers great opportunities to make the first steps in a new field, get new knowledge, or learn about the pulse of cutting-edge research by leading scientists.


Friday – morning, October 3, 2008

Basic Concepts of pharmacokinetics (PK) and Pharmacodynamics (PD) Clinical Aspects & Applications of PK/PD WHOLE DAY BIOANALYTICAL WORKSHOP – Theory and Hands-on
PK1: Basic concepts in pharmacokinetics
Dr. Carl Kirkpatrick, 45 min

From human physiology, absorption / sampling sites, and routes of elimination to the
clearance & volume of distribution concept
ClinPK1: Introduction and Overview into PK/PD for patients, Dr. Roger Jelliffe, 45 min
Optimizing individualized patient therapy using nonparametric PK and PD models, multiple model (MM) dosage design, and Bayesian adaptive control.
Lecture on Chromatography in biomedical sciences, Dr. Matthias Unger, 45 min
Basic principles, applications, intricacies of HPLC
PD1: Basic principles in pharmacology
Dr. Donald Mager, 45 min

Receptor occupancy theory, Hill equation,
Examples of effect vs. concentration profiles
ClinPK2: Overview and comparison of parametric and non-parametric estimation techniques, Drs. Jelliffe & J. Bulitta, 45 min
Differences in algorithms used to estimate parameters of PK/PD models
Lecture on HPLC coupled with tandem mass spectrometry (LC-MS/MS)
Dr. Gérard Hopfgartner, 45 min

Strengths, applications, and intricacies of
LC-MS/MS for biomedical research
Case study 1: Group discussion PK1, PD1
Drs. Kirkpatrick and Mager, 30 min
Case study 1: Clinical problems. Solving them using PK/PD Adaptive Control, 30 min
MM dosage design, 4 types of Bayesian model individualization, and MM dosage adjustment.
Practical Issues of Bioanalytical Problems – How to Approach Assay Development,
Drs. Unger & Hopfgartner

Break (30 min)
PK 2: Absorption & Elimination Processes
Dr. Carl Kirkpatrick, 45 min

Determinants of rate & extent of absorption
Hepatic, renal, and other routes of elimination
ClinPK3: Therapeutic drug monitoring – how does the patient benefit
Dr. Alexander Vinks, 45 min

How can therapy be optimized by measuring drug concentrations and PK/PD modeling
Lecture on microdialysis: Measuring unbound concentrations in tissues,
Dr. Markus Zeitlinger, 45 min

Microdialysis as a powerful and versatile tool to measure unbound concentrations
PD 2: Pharmacokinetic / Pharmacodynamic Concepts, Dr. William Jusko, 45 min
Overview of basic and more advanced PK/PD models – when to consider which model?
ClinPK4: Optimizing cardiovascular therapy,
Dr. Jelliffe, 45 min

Example for use of modeling and individual therapy optimization (e.g. for digoxin)
Lecture on bioanalytical techniques: What do capillary electrophoresis (CE) and NMR spectrometry have to offer?
Dr. Ulrike Holzgrabe, 45 min
Case study 2: Group discussion PK2, PD2
Drs. Jusko and Kirkpatrick, 30 min
Case study 2: Discussion of benefits and applications of PK/PD for patients, Drs. Vinks and Jelliffe, 30 min Case study 3: Discussion of pros and cons of various bioanalytical techniques,
Drs. Zeitlinger and Holzgrabe, 30 min
to 1:45PM
Lunch break (75 min)
Friday – afternoon and evening, October 3, 2008
Basic Modeling & Simulation
(M&S) techniques
Clinical Aspects & Applications of PK/PD
How to implement this approach in real-life
Optimal therapy in special patient groups
M&S 1: Standard non-compartmental analysis, Dr. Samer Mouksassi, 45 min
Introduction to the most commonly used non-compartmental methods of PK data analysis
ClinPK5: Therapeutics: optimizing learning about the patient while treating him/her at the same time,
Dr. Jelliffe, 45min

How to maximize learning while treating
Dose optimization for cancer patients
Dr. Ulrich Jaehde, 40 min

Overview and issues of PK principles and applications for cancer therapy
M&S 2: Design, analysis, and key
aspects of bioequivalence studies,
Dr. Helmut Schütz, 45 min

Techniques and critical issues of bioequivalence assessment
ClinPK6: PK/PD modeling to optimize anti-infective therapy, Dr. Alan Forrest, 45min
Transition from theory to real life: How can a physician / pharmacist apply population PK/PD models at the bedside (HIV patient examples)
Dose optimization for pediatric patients
Dr. Alexander Vinks, 40 min

Using PK/PD to optimize therapy in children
Group discussion: Practical discussion on how to assess bioequivalence
Drs. Mouksassi and Schütz, 30 min
Group discussion: How to implement clinical PK/PD modeling for patient care
Drs. Jelliffe and Forrest, 30 min
Individual differences in effects of psychoactive drugs: Interactions, pharmacogenetics and other factors
Dr. Julia Kirchheiner, 40 min
Afternoon Break
Focus on Software Demos (demos will be available during the whole meeting)
Compartmental modeling and
Population PK/PD data analysis
Monte Carlo Simulations and
Disease Progression Modeling
Overview of PK/PD tools for estimation, optimal design, & clinical trial simulation
M&S 3: Introduction to Compartmental Modeling and Simulations,
Dr. Cornelia Landersdorfer, 45 min

Highlighting differences and similarities to
non-compartmental techniques
M&S 5: Monte Carlo Simulations to predict the behavior of a whole patient population
Dr. Vincent Tam, 45 min

What can we learn from incorporating between subject variability into simulations?
M&S 7: Overview of PK/PD software tools for estimation and optimal design
Dr. Jürgen Bulitta, 30 min

The most appropriate / feasible methods for each task – the pros & cons of PK/PD tools
M&S 4: Concept and basic principles of population PK modeling,
Dr. Carl Kirkpatrick, 45 min

How to best account for between subject variability & the effect of patient characteristics
M&S 6: Combining PK/PD with disease progression modeling,
Dr. Cornelia Landersdorfer, 45 min

Benefits of incorporating natural disease progression and long-term drug effects
M&S 8: Non-parametric population PK/PD tools for estimation and patient care
Dr. Roger Jelliffe, 40 min

How to achieve target goals most precisely – an efficient strategy for optimal patient care
Group discussion: How to apply modeling and simulation of clinical trials
Drs. Kirkpatrick, 30 min
Group discussion: How to integrate PK, PD, disease progression via Monte Carlo sims.
Drs. Tam and Landersdorfer, 30 min
M&S 9: Clinical trial simulation as a tool to design robust and effective clinical trials
Dr. Samer Mouksassi, 50 min

Pharsight Clinical Trial Simulator Case study
  Workshop Mentor Team (in alphabetical order):

1. Jürgen Bulitta
2. William Craig
3. Hartmut Derendorf
4. George Drusano
5. Alan Forrest
6. Gérard Hopfgartner
7. Ulrich Jaehde
8. Roger Jelliffe
9. William Jusko
10. Ulrike Holzgrabe
11. Julia Kirchheiner
12. Carl Kirkpatrick
13. Charlotte Kloft
14. Cornelia Landersdorfer
15. Thomas Lodise
16. Donald Mager
17. Johan Mouton
18. Samer Mouksassi
19. Helmut Schütz
20. Vincent Tam
21. Ursula Theuretzbacher
22. Paul Tulkens
23. Matthias Unger
24. Alexander Vinks
25. Markus Zeitlinger