The Workshop Programme 2025

SAVE THE DATE – DDI Workshop 2025

The upcoming Workshop will take place from June 1th to 3rd, 2025.

Now in its 15th year, the Marbach­ Workshop continues to offer a comprehensive exploration of ­timely and pivotal topics in the study of drug-drug interactions (DDIs) and dealing with them in modern clinical settings.

On day 1, the Workshop will ­commence with a session addressing possibilities and difficulties for personalised DDI management in clinical versus such provisions as part of the drug development ­practice. Key presentations will ­cover the implementation of PBPK to enhance individualized dosing in clinical settings and under­standing the distinct DDI landscapes in various disease populations when they act as covariates in determining differences in DDI that is seen in healthy volunteers.

A subsequent session will ­critically examine the respective roles of static and dynamic modeling approaches in assessing DDIs. Presentations will debate pros and cons of each practice, and prudency of waivers on clinical DDI studies based on their application.

The third session will focus on managing DDIs caused by cytokine storms, a complex area with significant implications for patient safety. Presenters will provide case studies on using PBPK modeling to address cytokine storm-related DDIs, as well as discussions on the model ­predictability and limitations. Attendees will have the opportunity to explore real-world applications and debate the utility of PBPK in these high-stakes clinical scenarios.

On the second day, the Workshop will spotlight the potential role of artificial intelligence (AI) and ­natural language processing (NLP) in DDI research. Presentations will highlight emerging AI applications, including their impact on DDI ­assessment and case studies ­showcasing AI-enabled advancements. The closing session will delve into microphysiological systems (MPS) and their relevance in preclinical DDI studies. Experts will discuss the utility of MPS in ­generating physiologically relevant data for DDI assessment and enhancing in vitro to in vivo ­extrapolations.

As with previous meetings, selected posters will be given opportunity of short oral presentation during the workshop and early submission of abstracts for posters are highly encouraged.

Throughout the event, each session will facilitate interactive discussions, and attendees are encouraged to submit abstracts for poster presentations. As always, the Workshop’s topics will be addressed by leading international scientists, regulators, and industry experts, promoting a unique environment for knowledge exchange and networking.

The Workshop Organizers

Robert Hermann, MD FCP
Amin Rostami-Hodjegan PhD, FCP
Ping Zhao, PhD
Karen Grave-Hermann, MSc

 


 

Workshop Programme 2025

First Announcement

Marbach DDI Workshop 2025 – First Announcement [PDF-Download | 1,8 MB]

Afternoon Individual Arrival & Check-in at Marbach Castle
03:00 p.m. Registration & Coffee
06:00 p.m. Oral Poster Presentation
07:30 p.m. Come Together Dinner
08:00 – 09:00 a.m. Registration & Coffee
09:00 – 09:15 a.m. Welcome Address and Introduction into the Workshop
Amin Rostami
Session I Caring for Individual Patient – DDI in Hospital Setting vs. Drug Development
Chair: Robert Hermann
09:15 – 09:45 a.m. Management of Metabolic and Transporter-Related DDI in Clinic:
Implementing PBPK in Clinical Setting as the First Step Towards ­Personalised Dosing
Youssef Daali, PhD, Geneva University Hospital, Geneva, Switzerland
09:45 – 09:55 a.m. Discussion
09:55 – 10:25 a.m. Disease Population vs Healthy Volunteers – Understanding Practicalities during Drug Development vs Clinical Landscape of DDIs
Kunal S. Taskar, PhD; GSK Medicines Research Centre, Hertfordshire, UK
10:25 – 10:35 a.m. Discussion
10:35 – 11:05 a.m. Networking and Poster Viewing Over Coffee Break
Session II Assessing Metabolic DDI via Static vs. Dynamic Modeling ­Approaches
Chair: Amin Rostami
11:05 – 11:35 a.m. Drug Development vs Clinical Management of Metabolic DDI – Static vs Dynamic Models – What to Use When and How?
Italo Poggesi, PhD; Clinical Pharmacology Modeling and Simulation, GSK Verona, Italy
11:35 – 11:45 a.m. Discussion
11:45 – 12:15 a.m. Optimal Use of Mechanistic Static Models in Clinical Development
Sheila Annie Peters, PhD; Boehringer Ingelheim, Ingelheim, Germany
12:15 – 12:25 p.m. Discussion
12:25 – 02:00 p.m. Networking Over Lunch
02:00 – 02:30 p.m. Assessing the Risk of Metabolic DDI for Wide Range of Patients – ­Static vs. Dynamic Models – One Step Forward and Two Steps Backwards!
Aki T. Heikkinen, PhD; Certara Predictive Technologies, Certara Inc, UK
02:30 – 02:40 p.m. Discussion
02:40 – 03:10 p.m. Expectations and Over-Expectations from Static Calculations of ­Metabolic DDI: Implications for FDA Decision Tree and Clinical Study Waivers for DDI
Yuching Yang, PhD; Durham, North Carolina, USA
03:10 – 03:20 p.m. Discussion
03:20 – 03:50 p.m. Networking and Poster Viewing Over Coffee Break
Session III Revisiting DDIs Caused by Cytokine Storm
Chair: Ping Zhao
03:50 – 04:20 p.m. Using PBPK to Manage Clinical DDI Caused by Cytokine Storm – ­Case Studies
Marie-Emilie Willemin, PhD; Johnson & Johnson, Beerse, Belgium
04:20 – 04:30 p.m. Discussion
04:30 – 05:00 p.m. Is PBPK Useful to Inform DDI Caused by Cytokine Storm? Resetting Expectation on Model Predictability (Invited)
Xinyuan (Susie) Zhang, PhD; Simulations Plus, Lancaster, CA, USA
05:00 – 05:30 p.m. Q&A and Discussions on the Sessions of the Day
07:00 p.m. Networking Over Dinner
Session IV Artificial Intelligence Support for the Research and ­Management of DDIs
Chair: Ping Zhao
08:30 – 09:00 a.m. From Techniques to Applications: How Natural Language ­Processing and AI, Including ChatGPT-like Models, Could Transform DDI ­Assessment
Sophia Ananiadou, PhD; University of Manchester, Manchester, UK
09:00 – 09:10 a.m. Discussion
09:10 – 09:40 a.m. Case Examples of AI Applications and Their Performance in Generating Specific DDI Information
Merel van Nuland, PharmD, PhD and Paul D. van der Linden, PharmD, PhD; Department of Clinical Pharmacy, Tergooi Medical Center, Hilversum, The Netherlands
09:40 – 09:50 a.m. Discussion
09:50 – 10:20 a.m. Networking and Poster Viewing Over Coffee Break
Session V Is There a Role for Microphysiological Systems in Preclinical DDI Studies
Chair: Andrew Parkinson
10:20 – 10:50 a.m. Microphysiological Systems: How MPS Platforms Advance Physio­logically-Relevant DDI Studies for Both Perpetrator and Victim Drugs
Murat Cirit, PhD; Javelin Biotech, Woburn, MA, USA
10:50 – 11:00 a.m. Discussion
11:00 – 11:30 a.m. Micro-Physiological Systems: How They Help to Improve Early ADME Predictions and Reduce the Data Gap in In Vitro to In Vivo Correlations
Amélie Moreau, PhD, Servier, Paris- Saclay, France
11:30 – 11:40 a.m. Discussion
11:40 – 12:10 a.m. Micro-Physiological Systems: What are the Potential Contexts of use in Drug-Drug and Drug-Natural Product Interactions
Edward J. Kelly, PhD; School of Pharmacy, University of Washington, Seattle, WA, USA
12:10 – 12:20 a.m. Discussion
12:20 – 02:00 p.m. Networking Over Lunch
Session VI Poster Session
Chair: Amin Rostami
02:00 – 03:00 p.m. Short Presentation & Discussion of Selected Posters
03:00 – 03:30 p.m. Networking and Poster Viewing Over Coffee Break
03:30 – 04:00 p.m. Q&A and Discussions on the Sessions of the Day
04:00 – 04:15 p.m. Concluding Remarks – Amin Rostami
End of Meeting & Departure
Last Update: 11.02.2025