Date: Thursday, October 8, 2009

Registration Fees: non-student ($500), student/fellow ($50)

Maximum Class Size: 30

Sponsor: Bayer Technology Services GmbH

Instructors/Teaching Assistants: Jörg Lippert, Stefan Willmann

Workshop summary:

Mechanistic modeling and simulation is a powerful methodology to integrate and to evaluate biochemical and pharmacological knowledge about a drug candidate into a comprehensive and consistent knowledge base. The thereby newly gained understanding of the complex interactions between drug and organism can be exploited along the whole drug development process which leads to better design of studies. A well established example for mechanistic simulation models are physiologically-based pharmacokinetic (PBPK) models.

In this workshop, state-of-the-art concepts of PBPK modeling will be introduced. A fictional clinical development candidate will serve as the story board for a modeling study supporting a pediatric development plan (PDP/PIP).

All crucial steps for reliable prediction of pharmacokinetics will be introduced and discussed. Along this process the concepts underlying the physiological modeling of clearance, excretion and distribution processes and their consequences for analysis and extrapolation tasks of all sorts (in-vitro/in-vivo, pre-clinical/clinical, volunteer/patient, subpopulation/subpopulation) will be covered. The challenge of standardization and quality assurance will also be addressed.

Lectures and hands-on training exercises (using the PBPK modeling software PK-Sim® and MoBi®) will alternate. Participants will need to bring their own laptops for hands-on exercises. Required software installation packages will be available for download prior to the workshop.

The workshop is especially valuable for scientists and decision makers dealing with late pre-clinical and clinical development projects.

Schedule:

9 - 10:45 am

• Introduction to PK-Sim (DEMO)
• Introduction of Case Study (DEMO)
• Human Reference Model (DEMO)
• Physiologically-Based Modeling and Simulation Basics (HANDS-ON)

10:45 am: Coffee Break

11 am - 12:15 pm

• Model Evaluation and Extension (MoBi) (DEMO)
• Questions & Answers (DEMO)
• Predicting Pharmacokinetics in Children (DEMO)

12:15 - 1:30 pm:  Lunch

1:30 - 2:30 pm

• CLEARANCE & EXCRETION
  • HANDS-ON
  • Concepts (THEORY)

2:30 - 2:45 pm  Break

2:45 - 3:15 pm  HANDS-ON

3:15 - 4:15 pm

• DISTRIBUTION
  • HANDS-ON
  • Concepts (THEORY)

4:15 - 4:30 pm  Break

4:30 - 5:00 pm  HANDS-ON

5:00 - 5:15 pm

• Automatic Reporting of Simulations (for Preparation of PIP/PDP) (DEMO)

5:15 - 5:30 pm

• Wrap up and Feedback
• End of Workshop / Discussion with Instructors