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 |
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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