21. Pharmacokinetics/Pharmacodynamics Expert Meeting
From May 4 till May 6, 2017
Event location: Heppenheim (Link)
Presentations and associated discussions will focus on the following topics:
- PK/PD Strategies to Streamline Early Clinical Drug Development
- Pulmonary Administration: Lung as Target Organ
- New Insights into Absorption and the ORBITO Initiative
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
Daniel Moj, Klinische Pharmazie, Univ. des Saarlandes , for his publication
"Clarithromycin, Midazolam, and Digoxin: Application of PBPK Modeling to Gain New Insights into Drug-Drug Interactions and Co-medication Regimens",
AAPS J 2017; 19: 298-312
We thank the anonymous donor 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.
We look forward to see you in Heppenheim in May 2017!
Kind regards,
the Organizing Committee
The programme of the 21. Pharmacokinetics/Pharmacodynamics Expert Meeting
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Thursday, May 04th, 2017 |
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| 17:00 - 19:00 | Arrival Hotel am Bruchsee 64646 Heppenheim |
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| 19:00 | Dinner |
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| 08:30 | Welcome Andreas Kovar on behalf of the Organizing Committee |
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Session 1: |
PK/PD Strategies to Streamline Early Clinical Drug Development |
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| 08:40 | The importance of PK/PD in regulation: FIH studies and dose-exposure-response analyses Justin Pittaway-Hay, MHRA ( Download ) |
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| 09:10 | Discussion | |
| 09:25 | Dose selection in EIH studies: Learnings from a retrospective survey on EIH studies with small molecules
conducted between 2004 and 2016 at Hoffmann-LaRoche Benedicte Ricci, Roche ( Download ) |
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| 09:55 | Discussion | |
| 10:10 | Coffee break | |
| 10:40 | PK/PD Strategies for First-in-Human Studies – Review & Assessment Georg Wensing, Bayer AG ( Download ) |
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| 11:10 | Discussion | |
| 11:25 | Strategies to Implement Concentration-QTc Analysis in Phase I to Avoid Thorough QT Studies Georg Ferber, Statistik Georg Ferber ( Download )--> |
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| 11:50 | Discussion | |
| 12:05 | Joint Lunch |
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Session 2: |
Pulmonary Administration: Lung as Target Organ |
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| 13:30 | Anatomy and physiology of the lungand pathophysiology of asthma, COPD and bronchiectasis Kay Tetzlaff, Boehringer Ingelheim |
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| 14:00 | Discussion | |
| 14:10 | How do preclinicalresults (in vitro and in vivo) correlate with humanpulmonaryand systemic concentrations Per Bäckman, Mylan ( Download ) |
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| 14:40 | Discussion | |
| 14:50 | Coffee break |
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| 15:20 | Drug inhalation - Impact of pulmonary diseases on pulmonary and systemic disposition Jens Borghardt , Boehringer Ingelheim ( Download ) |
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| 15:50 | Discussion | |
| 16:00 | Case Study: Dose finding for ciprofloxacin in noncyctic fibrosis bronchiectasis patients after inhalation Heino Stass, Bayer AG ( Download ) |
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| 16:30 | Discussion | |
| 16:45 | Hans Günter Schäfer Award Moderated by Andreas Kovar |
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| 17:05 | End of Session | |
| 17:30 | Joint Jogging | |
| 19:00 | Dinner |
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Session 3: |
New Insights into Absorption |
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| 09:00 | The IMI Oral Biopharmaceutics Tools project (Orbito) - An Overview Xavier Pepin, AstraZeneca ( Download ) |
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| 09:30 | Discussion | |
| 09:45 | Bio-relevant dissolution models for slow release formulations to generate input data for in-silico models Cord Andreas, Univ. Frankfurt ( Download ) |
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| 10:10 | Discussion | |
| 10:25 | Coffee break | |
| 10:55 | Decision Criteria for Oral Formulation Selection within Pharma Hille Gieschen/Uwe Münster, Bayer AG ( Download ) |
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| 11:20 | Discussion | |
| 11:35 | In-silico modeling to support and replace bioequivalence studies Xavier Pepin, AstraZeneca ( Download ) |
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12:00 | Discussion |
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12:15 | Concluding Remarks Andreas Kovar |
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12:30 | Joint Lunch |
| 14:00 | End of Meeting |
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