The Workshop Programme 2023

DDI Workshop 2024 – Save the Date

The upcoming Workshop will take place from May 26th to May 28th, 2024.

In its 13th year, and as we return to face-to-face modality for ­second time after one-year COVID down­time, the Workshop will cover a number of highly important and current DDI topics in depth.

The 2023 Workshop will open with a plenary lecture on pharmacodynamic (PD) drug interactions and whether these could be predicted from the first principles under the framework of ‘Model-Informed Drug Development’ (MIDD). This will be followed by a talk presenting selected examples of PD interactions of clinical importance.

The second session will be entirely dedicated to the recently issued first draft version of the International Council for Harmonization (ICH) drug interaction guideline M12.  Attendees will hear separate talks on the in vitro and in vivo aspects of the guideline.  In addition, a represen­tative on behalf of IQ, will present the industry perspective on the current version of ICH M12 and links with ongoing debates over ICH M13 on modelling.  Finally, a panel discussion with representatives from various regulatory bodies will complete the session, and is expected to bring valuable insights into regulatory thoughts towards global harmonization.  

The third session on Day 1 of the meeting will feature for the first time the emerging topic of biomarkers for detection of clinical DDIs. Specifically addressed will be biomarkers reflecting DDIs affecting OATP transporters, and the role of liquid biopsy in assessing the induction / suppression of enzymes and drug transporters. Finally, a general overview will be presented to review where we currently are in the field of DDI biomarkers, and to shed light on what has been settled yet, and what has not. This talk will also address the specificity and feasibility of developing tools to identify biomarkers for the detection of DDIs.

On Day 2 of the Workshop for the first time a session will be dedicated to the rarely acknowledged field of smoking interaction studies. The key talk of this session will comprehen­sively review methodological aspects of smoking interaction studies that have been applied over the last three decades, and will discuss implications for future smoking interaction trials. 

A following panel discussion will reflect and compare methodological standards of food effect studies vs. smoking interaction studies, thereby highlighting important differences.  

The second session on Day 2 of the meeting will address DDIs that are caused by pharmaceutical excipients. The first talk will present information on FDA scientific efforts on the investigation of excipient DDIs, while the following talk will share existing industry ­experience. The last talk of this session will provide an overview on the DDI potential of major pharma­ceutical excipients on transporters and enzymes.

Another regulatory session will conclude Day 2 of the Workshop. The first talk of this session will provide an overview of 2022 NDA reviews with the aim to foster understanding of the risks of metabolism- and transporter-based DDIs with novel drugs approved by the US FDA. The final talk of the meeting will ­provide an update on the current PBPK ­model repository.

As always, there will be an opportunity for Workshop participants to submit abstracts for poster presen­tations throughout the Workshop. 

All sessions will provide plenty of oppor­tunity for scientific and regulatory exchange and networking. 

As always, the topics of the 13th inter­national DDI Workshop will be covered by distinguished inter­national scientists, representatives from various national regulatory agencies, and experts from academia, pharmaceutical companies, contract research organizations as well. 

The Workshop Organizers:

Robert Hermann, MD, FCP

Amin Rostami-Hodjegan, PhD, FCP

Ping Zhao, PhD



Workshop Programme 2023

Final Announcement

Marbach DDI Workshop 2023 – Final Announcement [PDF-Download | 2,0 MB]

Afternoon Individual Arrival & Check-in at Marbach Castle
03:00 p.m. Registration & Coffee
04:00 p.m. Come Together Activities – TBD
Poster Session – TBD
07:30 p.m. Come Together Dinner
08:00 – 08:30 a.m. Registration & Coffee
08:30 – 08:45 a.m. Welcome Address and Introduction into the Workshop
Amin Rostami
Session I Pharmacodynamic Interactions
Chair: Amin Rostami
08:45 – 09:15 a.m. Plenary Lecture on PD Interactions
Donald E. Mager, PharmD, PhD, Department of Pharmaceutical Sciences, University of Buffalo; Buffalo, USA
09:15 – 09:25 a.m. Discussion
09:25 – 09:55 a.m. A Systems Approach to PD Interactions: Implications for Combination Therapy
Luca Marchetti, PhD, Fondazione The Microsoft Research – University of Trento, Centre for Computational and Systems Biology (COSBI), University of Trento, Italy
09:55 – 10:05 a.m. Discussion
10:05 – 10:30 a.m. Coffee Break
Session II ICH M12
Chair: Ping Zhao
10:30 – 11:00 a.m. In Vitro Aspects of ICH M12, Industry and Technology
Brian Ogilvie, PhD, BioIVT/Xenotech, Kansas City, KS, USA
11:00 – 11:10 a.m. Discussion
11:10 – 11:40 a.m. In Vivo Aspect of ICH M12, Regulatory Input
Raj Madabushi, PhD, Office of Clinical Pharmacology, Center for Drug Evaluation and ­Research, FDA, Silver Spring, MD, USA
11:40 – 11:50 a.m. Discussion
11:50 – 12:20 p.m. Representative on Behalf of IQ, Industry Perspective
Vikram Sinha, PhD, Global Head, Therapeutic Areas PK Sciences / Translational Medicine, ­Novartis Institute of Biomedical Research (NIBR), Novartis Pharmaceuticals, Berwyn, PA, USA
12:20 – 12:30 p.m. Discussion
12:30 – 02:00 p.m. Lunch Break
02:00 – 02:30 p.m. Panel Discussion on ICH M12
Regulatory Attendees
02:30 – 03:00 p.m. Coffee Break
Session III Biomarkers for Detecting Clinical DDIs
Chair: Amin Rostami
03:00 – 03:30 p.m. Industry Applications and Kinetic Considerations of Transporter Endogenous Biomarkers
Kenta Yoshida, PhD, Genentech, USA
03:30 – 03:40 p.m. Discussion
03:40 – 4:10 p.m. Where Are We in DDI Biomarkers? What Has Been Settled and What Has Not? Specificity and Feasibility of Developing Tools to Identify DDIs
Andrew Parkinson, PhD, XPD Consulting, Shawnee, Kansas, USA
04:10 – 04:20 p.m. Discussion
06:00 p.m. Dinner
Session III Biomarkers for Detecting Clinical DDIs (ctd)
Chair: Amin Rostami
09:00 – 09:30 a.m. Role of Liquid Biopsy in Assessing the Induction / Suppression of Enzymes and Transporters
Andrew Rowland, PhD, BSc, Flinders University, Adelaide, Australia
09:30 – 09:40 a.m. Discussion
Session IV Smoking Interactions
Chair: Robert Hermann
09:40 – 10:10 a.m. Important Methodological Aspects of Smoking Interaction Studies – Review of Three Decades of Literature
Isabelle Ragueneau-Majlessi, MD, Drug Interaction Solutions, University of Washington, Seattle, WA, USA
10:10 – 10:20 a.m. Discussion
10:20 – 10:50 a.m. Reflecting Methodological Standards of Food Effect Studies vs Smoking Interaction Studies
Panel Discussion
10:50 – 11:10 a.m. Coffee Break
Session V Excipient DDIs
Chair: Amin Rostami
11:10 – 11:40 a.m. FDA Scientific Efforts on Investigating Excipient-Drug Interactions
Lei Zhang, PhD, Office of Generic Drugs, FDA, Silver Spring, MD 20993, USA
11:40 – 11:50 a.m. Discussion
11:50 – 12:20 p.m. Industry Experience
Yuan Chen, PhD, Genentech, South San Francisco, CA, USA
12:20 – 12:30 p.m. Discussion
12:30 – 02:00 p.m. Lunch
02:00 – 02:30 p.m. DDI Potential of Major Pharmaceutical Excipients on Transporters and Enzymes
Mark S Warren, PhD, BioIVT, Santa Clara, CA, USA
02:30 – 02:40 p.m. Discussion
Session VI Regulatory Session
Chairs: Ping Zhao & Robert Hermann
02:40 – 03:10 p.m. Overview of 2022 NDA Reviews: Understanding the Risk of Meta­bolism- and Transporter-Based Drug-Drug Interactions with Novel Drugs Approved by the US FDA
Jingjing Yu, MD, PhD, Drug Interaction Solutions, School of Pharmacy, University of ­Washington, Seattle, WA, USA
03:10 – 03:20 p.m. Discussion
03:20 – 03:40 p.m. Coffee Break
03:40 – 04:10 p.m. PBPK Model Repository and Implications for Facilitating Model Reusability
Ping Zhao, PhD, Bill and Melinda Gates Foundation, Seattle WA, USA
04:10 – 04:20 p.m. Discussion
04:20 – 04:30 p.m. Concluding Remarks – Ping Zhao
End of Meeting & Departure
Last Update: 27.04.2023