20. Pharmacokinetics/Pharmacodynamics Expert Meeting
From April 14 till April 16, 2016
Event location: Novotel Berlin Am Tiergarten (Link)
Presentations and associated discussions will focus on the following topics:
- Systems Pharmacology
Methods, Applications, Opportunities and Challenges - Dose Finding in Phase II for Confirmatory Clinical Trials
Overview, Methods, Good Practices and Examples - PK/PD of Locally Applied Drugs
Considerations for (Sub-)Cutaneous and Ocular Administration of Pharmaceuticals
Since 2012 generous donations have enabled the Organizing Committee of the PK/PD Expert Meeting to reward outstanding
contributions by young scientists to the PK/PD field with the Hans Günter Schäfer Award issued in memory of the original initiator of the PK/PD Expert Meeting.
In this year, we would like to congratulate
Dr. Swantje Völler, Leiden Academic Center for Drug Research (LACDR), Leiden University, for her publication "Age-Dependent Pharmacokinetics of Doxorubicin in Children with Cancer", Clin Pharmacokinet. 2015. 54:1139-1149. DOI 10.1007/s40262-015-0272-4 ( Link )
Jens Markus Borghardt, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, for his publication
"Investigating pulmonary and systemic pharmacokinetics of inhaled olodaterol in healthy volunteers using a population pharmacokinetic approach",
British Journal of Clinical Pharmacology 2015. DOI:10.1111/bcp.12780 ( Link )
We thank Prof. Dr. Henning Blume for the sponsorship of this award which included free participation at the PK/PD Expert Meeting and the
opportunity to present key results of their work during the meeting in addition to the prize money.
The programme of the 20. Pharmacokinetics/Pharmacodynamics Expert Meeting
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Thursday, April 14th, 2016 |
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| 15:00 - 19:00 | Arrival Novotel Berlin Am Tiergarten Straße des 17. Juni 106-108, 10623 Berlin |
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| 19:00 | Joint Dinner |
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| 08:30 | Welcome Joachim Höchel on behalf of the Organizing Committee |
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Session 1: |
Systems Pharmacology - Methods, Applications, Opportunities and Challenges |
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| 08:40 | Introduction to Concepts and Methods of Systems Pharmacology Matthias Machacek, LYO-X ( Download ) |
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| 09:10 | Discussion | |
| 09:20 | In-silico Clinical Trials of Prandial Insulins: The FDA Accepted Type-1 Diabetes Simulator Thomas Klabunde, Sanofi ( Download ) |
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| 09:45 | Discussion | |
| 10:00 | Coffee break | |
| 10:30 | Scope of Quantitative and Systems Pharmacology (QSP) Models in Dose Optimization: A Case Study from Endocrine Therapeutic Area Manoj Khurana, USA ( Download ) |
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| 10:55 | Discussion | |
| 11:10 | Opportunities & Challenges with Systems Pharmacology Antje Walz, F. Hoffmann-La Roche ( Download ) |
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| 11:45 | Discussion | |
| 12:00 | Joint Lunch |
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Session 2: |
Dose Finding in Phase II for Confirmatory Clinical Trials - Overview, Methods, Good Practices and Examples |
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| 13:00 | To Set the Scene: Overview EMA Dose Finding Workshop December 2014 Alexander Staab, Boehringer Ingelheim ( Download ) |
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| 13:20 | Discussion | |
| 13:30 | Overview on Methods for Dose Finding Bill Gillespie, Metrum ( Download ) |
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| 14:15 | Discussion | |
| 14:30 | Coffee break |
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| 15:00 | Good Practice in Dose Finding – the Pfizer Approach Mike Smith, Pfizer ( Download ) |
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| 15:30 | Discussion | |
| 15:45 | Dose-Regimen Finding in Clinical Phase II – Some Principles and Examples Michael Looby, Novartis ( Download ) |
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| 16:15 | Discussion | |
| 16:30 | Hans Günter Schäfer Award Moderated by Wolfgang Mück, Bayer Pharma AG Age-Dependent Pharmacokinetics of Doxorubicin in Children with Cancer Swantje Völler, Leiden Academic Center for Drug Research (LACDR), Leiden University ( Download ) Investigating pulmonary and systemic pharmacokinetics of inhaled olodaterol in healthy volunteers using a population pharmacokinetic approach Jens Markus Borghardt, Boehringer Ingelheim ( Download ) |
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| 16:45 | Discussion | |
| 17:00 | End of Session | |
| 17:30 | Joint Jogging | |
| 19:00 | Departure for Social Event: River Cruise with Dinner (15 min walk from Hotel; boat leaves at 19:30 on time) |
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Session 3: |
PK/PD of Locally Applied Drugs - Considerations for (Sub-)Cutaneous and Ocular Administration of Pharmaceuticals |
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| 09:00 | Applications, Opportunities, Challenges of Subcutaneous Drug Administration Beate Bittner, F. Hoffmann-La Roche ( Download ) |
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| 09:30 | Discussion | |
| 09:45 | An In Vitro System to Model Specific Events Occurring at a Subcutaneous Injection Site Randall Mrsny, University of Bath ( Download ) |
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| 10:15 | Discussion | |
| 10:30 | Coffee break | |
| 11:00 | Structural and Pathophysiological Changes in Ocular Tissues Associated with Disease, and Current Treatment Options on the Example of Glaucoma and AMD Marcus Blum, Helios Klinikum Erfurt ( Download ) |
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| 11:25 | Ocular Drug Delivery and Pharmacokinetics: Mechanisms and Influence of Drug and Delivery System Properties Uday B. Kompella, University of Colorado Denver |
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12:00 | Discussion |
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12:15 | Locally Applied – Locally Acting Drugs: Predictive Value of Systemic vs Local Exposure for Efficacy Assessment with Focus on Dermal, Pulmonary and Ocular Application – Scientific Aspects and Regulatory Thinking Hartmut Derendorf, University of Florida ( Download ) |
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12:40 | Discussion |
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12:50 | Concluding Remarks Wolfgang Mück, Bayer Pharma AG |
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13:00 | Joint Lunch |
| 14:00 | End of Meeting |
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