The Workshop Programme 2023

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

First Announcement

Marbach DDI Workshop 2023 – First Announcement [PDF -Download | 1,9 MB]

Afternoon Individual Arrival & Check-in at Marbach Castle
03:00 p.m. Registration & Coffee
04:00 p.m. Come Together Activities
07:30 p.m. Come Together Dinner
09:00 p.m. Social Event – Details to be Determined
08:00 – 08:30 a.m. Registration & Coffee
08:30 – 08:45 a.m. Welcome Address and Introduction into the Workshop
Ping Zhao
Keynote Lecture
08:45 – 09:20 a.m. Concepts and Utility of Real-World Data Analyses to Evaluate DDIs
Douglas McNair, MD/PhD, BMGF, USA
09:20 – 09:30 a.m. Discussion
Session I: Real-World DDI Evidence
Chair: Ping Zhao
09:30 – 09:50 a.m. Understanding Contraceptive DDIs through Combining Pharmacology Models and RWDA
Stephan Schmidt, PhD, University of Florida, Gainesville, USA.
09:50 – 10:00 a.m. Discussion
10:00 – 10:30 a.m. Coffee Break
10:30 – 10:50 a.m. DDI Labelling: Can RWE Complement Regulatory Decisions on DDI Management in Product Labels?
Joseph A. Grillo, PharmD, Winchester, VA, USA
10:50 – 11:00 a.m. Discussion
11:00 – 11:20 a.m. Utility of Clinical Practice Research Datalink (CPRD) to Evaluate Drug-Drug Interactions and DDI in Special Populations
Justin Hay, PhD, Certara, UK
11:20 – 11:30 a.m. Discussion
11:30 – 12:00 p.m. Panel Discussions and Q&A on RWD – DDIs
12:00 – 01:30 p.m. Lunch
Session II: Roadmap to ICH-M12
Chair: Robert Hermann
01:30 – 02:00 p.m. Highlight of DDI Guideline of Chinese NMPA
Li Li, PhD, National Medical Products Administration, China
02:00 – 02:10 p.m. Discussion
02:10 – 02:40 p.m. EMA DDI Guideline and ICH M12
Carolien Versantvoort, PhD, Medicines Evaluation Board, The Netherlands
02:40 – 02:50 p.m. Discussion
02:50 – 03:20 p.m. Regulatory Panel Discussions and Q & A for Session II
03:20 – 04:00 p.m. Coffee Break
Session III: Usefulness of PBPK Modelling to Address Complex/Network PK Interactions
Chairs: Rodrigo Cristofoletti (University of Florida), Ping Zhao and Amin Rostami-Hodjegan
04:00 – 05:00 p.m. Panel Discussion on Complex/Network PK DDIs
05:00 – 05:15 p.m. Planning of a European Professional Development Curriculum for the Comprehensive Assessment of Drug-Drug Interactions.
Béatrice Saint-Salvi, PhD, DDI Unit, ANSM, France
05:15 – 05:20 p.m. Discussion
07:00 p.m. Dinner
Session IV: COVID-19 & Conduct of DDI
Chair: Amin Rostami-Hodjegan
09:00 – 09:20 a.m. Informing Dosing Decisions Early in Pandemics
Dongyang Liu, PhD, Peking University, Third Hospital, Beijing, China
09:20 – 09:30 a.m. Discussion
09:30 – 09:50 a.m. Remdesivir Approval Supported by Mechanistic Modelling
Ramesh Palaparthy, PhD, Gilead Sciences, South San Francisco, CA, USA
09:50 – 10:00 a.m. Discussion
10:00 – 10:20 a.m. PBPK Modelling to Support DDI Assessment for Regulatory Submissions – General Observations during the COVID Era
Hannah Jones, PhD, Certara, UK
10:20 – 10:30 a.m. Discussion
10:30 – 11:10 a.m. Coffee Break
Session V: Pharmacogenetics
Chair: Ingolf Cascorbi
11:10 – 11:30 a.m. Drug-Drug-Gene Interactions
Henrike Bruckmüller, PhD, Institute of Experimental and Clinical Pharmacology, University Hospital Schleswig-Holstein, Kiel, Germany; University of Tromsø, The Arctic University of Norway, Norway
11:30 – 11:40 a.m. Discussion
Session VI: Biologics DDIs
Chair: Amin Rostami-Hodjegan
11:40 – 12:00 p.m. Assessing Therapeutic Peptide DDIs During Drug Development
Carolina Säll, PhD, Novo Nordisk, Denmark
12:00 – 12:10 p.m. Discussion
12:10 – 01:40 p.m. Lunch
Session VII: Gut DDI
Chair: Ping Zhao
01:40 – 02:00 p.m. Physiology Based Biopharmaceutics Modeling (PBBM) based food effect predictions: Current state and future perspectives.
Christian Wagner, PharmD/PhD, Merck KGaA
02:00 – 02:10 p.m. Discussion
02:10 – 02:30 p.m. Absorption DDIs by Drugs Affecting GI-Tract Motility –
A Case Example of a Fixed Drug Combination Development
Robert Hermann MD, FCP, cr.appliance, Gelnhausen, Germany
02:30 –02:40 p.m. Discussion
02:40 –03:00 p.m. Coffee Break
03:00 – 04:00 p.m. Marbach Debate
Question to be Updated Based on Hot Topics in 2021 Meeting
10 min Reactions from Regulatory Attendees
10 min Reactions from Industry/Academic Attendees
40 min Discussions – All
04:00 p.m. Concluding Remarks – Amin Rostami-Hodjegan
End of Meeting & Departure
Last Update: 01.04.2022