10th International Marbach Castle DDI Workshop

In its 10th anniversary year, the Workshop will cover a number of highly important regulatory topics in depth. The Workshop will open with a historic review of past, present and future of the investigation of DDIs, featuring presentations from an academic and industrial point of view. This will be followed by a session on changes in the regulatory DDI landscape from an European and international point of view. Recent international DDI guidelines on DDIs and PBPK will be reviewed and discussed. A special topic of great interest are DDIs with hormonal contraceptives. There will be a number of presentations to shed light on this issue from an academic, regulatory and industrial perspective.

On the second day we will be fortunate to have presentations from global leaders in the field of transporter-based DDIs, focusing on uptake transporters in the gut and the utility of endogenous biomarkers in early clinical trials. Also on the menu is an update on an ongoing transporter probe-cocktail study. The last session will focus on Metabolism-Based DDIs & Clinical Management of DDIs, reviewing approaches of predicting DDI with integrated model-informed drug development capability as well as the clinical management of DDIs.

As always, there will be an opportunity for Workshop participants to submit abstracts for poster presentations throughout the Workshop. The best abstract also will be selected for short oral presentations.

All sessions will provide plenty of opportunity to ask questions and provide comments.

The topics of the 10th International DDI Workshop will be covered by distinguished international scientists and experts from academia, pharmaceutical companies, contract research organizations, consultancies as well as government and regulatory agencies. All topics will be presented from different angles by presenting non-clinical information from in vitro studies, clinical studies as well as PBPK simulations linking non-clinical and clinical data.

We are hoping to welcome you in Marbach in May of 2019!

The Workshop Organizers:

Hartmut Derendorf, PhD, FCP

Robert Hermann, MD, FCP

Amin Rostami-Hodjegan, PhD, FCP

Workshop Programme 2019