DDI Workshop, May 26-28, 2024

2024 International Drug-Drug Interaction (DDI) Workshop at Marbach Castle

The 14th workshop set a new record for onsite attendees at Marbach Castle. Experts from global regulatory bodies, industries, and academic centers delivered presentations. Nine posters were submitted, with Dr. Vijender Panduga (AstraZenica, Sweeden) winning the best poster presenter award (nearest to set target time limit!).

On Day 1, Dr. Ping Zhao opened workshop, announcing Mr. Shawn Pei Feng Tan (University of Manchester, UK) as the winner of this year’s Hartmut Derendorf Young Scientist Award. Prof. Amin Rostami then moderated the first session Latest Science on Transporter-Based Drug-Drug Interactions. Dr. Shiew Mei Huang (Currently works at US FDA) was this year’s keynote speaker. She discussed the assessment of transporter-based DDIs from a global regulatory perspective. Prof. Yuichi Sugiyama (Josai International University, Japan) spoke on using endogenous biomarkers and PBPK modeling for predicting transporter-mediated drug interactions. Dr. Arne Gessner (Friedrich-Alexander-University Erlangen-Nürnberg, Germany) presented on metabolomic analysis of biomarkers for renal transporter-mediated DDIs, and Mr. Shawn Pei Feng Tan (Manchester) modeled endogenous biomarkers for renal OAT1/3 to assess transporter-mediated DDIs.

Session II Real World Data on Drug-Drug Interactions was moderated by Ping Zhao. This session featured Dr. Joseph Grillo (currently works at US FDA) on predicting and confirming complex DDIs in the real world, Prof. Stephan Schmidt (University of Florida, USA) on translational research through data integration, and Dr. Sebastian Haertter (Boehringer Ingelheim, Germany) on using real-world data tools to estimate clinical and operational DDI risks. The session highlighted the utility of real-world data analysis complementing other methods to assess DDIs.

Day 1 concluded with four short presentations from the poster session. Dr. Ingrid Michon (Certara) used PBPK modeling to evaluate the impact of CYP3A inducers on Vonoprazan exposure followed by Dr. Aernout van Haarst (Celerion) who discussed overcoming rifampin impurity challenges and offering phenytoin as an alternative to study induction clinically. Dr. Eman El-Khateeb (Certara UK) developed subpopulations for predicting ethnic variability in pharmacokinetics and DDI before Dr. Daniel Scotcher (Manchester) presenting on validated rifampicin-mediated transporter inhibition of hepatobiliary uptake using MRI.

Day 2 began with Session III Too Young or Too Old for Drug-Drug Interactions? chaired by Dr. Robert Hermann. Dr. Michael Gertz (Roche, Switzerland) discussed DDI implications in pediatric drug development. Dr. Petra A. Thürmann (Helios University Hospital Wuppertal, Germany) covered pharmacotherapy in the elderly. Prof. Tjeerd Pieter van Staa (Manchester) used real-world data to assess DDIs under multiple drug therapy in the elderly, and Prof. Julia Stingl (University of Aachen, Germany) examined DDIs as a cause of adverse drug reactions in elderly patients. A panel discussion on DDI management in children and the elderly followed.

Session IV Drug-Drug Interactions with Biologics Revisited was moderated by Prof. Rostami, who introduced Prof. Bernd Meibohm (University of Tennessee, USA) to present on updates in DDIs with biologics and reviewed the final FDA guidance on DDI assessment for therapeutic proteins.

Session V Point – Counter-Point: Regulatory – Success of PBPK Submissions was chaired by Dr. Zhao. The first speaker Dr. Yuching Yang (currently works at US FDA) discussed determining the adequacy of PBPK for assessing DDIs and common shortfalls. Dr. Eva Gil Berglund (Certara) countered with strategies to address gaps in PBPK analysis for regulatory submissions.

In summary, the 2024 Marbach workshop was a great success by focusing on clinically relevant DDI scenarios and showcasing cutting edge research and quantitative solutions, and the attendees were asked to suggest the topics for the 2025 Marbach Workshop agenda.