The Workshop Programme 2024

SAVE THE DATE – DDI Workshop 2025

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

In its 14th year, the Marbach Workshop remains a forum that offers comprehensive coverage of various important and timely topics related to drug-drug interactions (DDIs).

The 2024 Workshop will open with a session on the latest science on transporter-based drug-drug interactions. This session will be initiated by a regulatory keynote address on Prudent Assessment of Transporter-Based DDIs. This will be followed by 3 presentations on various aspects of the role of endogenous biomarkers in the assessment of transporter-mediated drug-drug interactions.

In the second session, 3 presentations will revisit and expand the concepts and utility of real-world data analyses (RWDA) to evaluate DDIs. Complementing other quantitative methods, RWDA is increasingly used in drug development to inform safe and effective use of medicines. One presentation will introduce the audience into RWDA-tools to estimate the clinical and operational risks related to DDIs in clinical drug development. We hope the discussions around RWDA will bring attendees up to speed in realizing the strength, realities, challenges, and use cases of RWDA to manage clinical DDIs.

On Day 2 of the Workshop a session entitled “Too young or too old for drug-drug interactions?” will be featured to shed light on drug-drug interactions in speial populations, with a particular focus on pediatric and elderly populations. A Q&A session as follow-on to the lectures in the previous session will offer the opportunity for in depth discussions of the multiple challenges in the DDI assessment in special populations.

The second session on Day 2 of the meeting will provide an update on DDIs with biologics including a review of the final 2023 FDA Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins.

A regulatory PBPK session will conclude Day 2 of the Workshop. The line-up of this session will consist of a “Point – Counter-Point” debate on the regulatory success of PBPK submissions. The first talk of this session will provide regulatory insights on “How to determine the adequacy of PBPK for assessing DDI as part of regulatory submissions?” with examples of common shortfalls. The subsequent counter-point presentation will focus on gaps and opportunities moving forward.

All sessions will provide plenty of opportunity for scientific and regulatory exchange and networking. Workshop participants can also submit abstracts for poster presentations throughout the Workshop.

As always, the topics of the 14th 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

Karen Grave-Hermann, MSc

 


 

Workshop Programme 2024

Final Announcement

Marbach DDI Workshop 2024 – Final Announcement [PDF-Download | 1,8 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 – 09:00 a.m. Registration & Coffee
09:00 – 09:15 a.m. Welcome Address and Introduction into the Workshop
Ping Zhao
Session I Latest Science on Transporter-Based Drug-Drug Interactions
Chair: Amin Rostami
09:15 – 09:50 a.m. Keynote Lecture on Prudent Assessment of Transporter-Based DDIs
Shiew Mei Huang, PhD; Silver Spring, MD, USA
09:50 – 10:00 a.m. Discussion
10:00 – 10:30 a.m. Use of Endogenous Biomarkers for Predicting Transporter-Mediated Drug Interactions Quantitatively; The Importance of Using PBPK Modeling
Yuichi Sugiyama, PhD; Innovation Base, Josai International University (JIU), Tokyo, Japan
10:30 – 10:40 a.m. Discussion
10:40 – 11:10 a.m. A Metabolomic Analysis of Sensitivity and Specificity of Biomarkers for Renal Transporter-Mediated Drug-Drug Interactions
Arne Gessner, PhD; Institute for Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
11:10 – 11:20 a.m. Discussion
11:20 – 11:50 a.m. Networking Over Coffee Break
11:50 – 12:20 p.m. Modelling Endogenous Biomarkers of Renal OAT1/3 to Assess Transporter-Mediated DDI in Healthy and Patients with Chronic Kidney Disease
Shawn Pei Feng Tan, PhD Student; Centre of Applied Pharmacokinetics Research, ­University of Manchester, UK
12:20 – 12:30 p.m. Discussion
12:30 – 02:00 p.m. Networking Over Lunch
Session II Real World Data on Drug-Drug Interactions
Chair: Ping Zhao
02:00 – 02:30 p.m. There and Back Again …
A Journey to Predict a Complex DDI and Confirm in the Real World – Implications for Drug Lifecycle Management

Grillo, Joseph A., PharmD; Winchester, VA, USA
02:30 – 02:40 p.m. Discussion
02:40 – 03:10 p.m. Empowering Translational Research Through Transdisciplinary Data Integration
Stephan Schmidt, PhD, FCP; CPSP, University of Florida, Orlando, USA
03:10 – 03:20 p.m. Discussion
03:20 – 03:50 p.m. Networking Over Coffee Break
03:50 – 04:20 p.m. Real World Data Tools to Estimate the Clinical and Operational Risk ­Related to DDIs
Sebastian Haertter, PhD; Boehringer Ingelheim Pharma GmbH, Germany
04:20 – 04:30 p.m. Discussion
04:30 – 05:30 p.m. Short Presentation of Selected Posters
05:30 – 05:45 p.m. Q&A and Discussions on Transporter-Based DDIs and RWD
07:30 p.m. Networking Over Dinner
Session III Too Young or Too Old for Drug-Drug Interactions?
Chair: Robert Hermann
08:30 – 09:00 a.m. DDI in Special Populations – Drug Development Implications in Industry and Case Example Based on Experience at Roche
Michael Gertz, PharmD, PhD; Translational PK/PD and Clinical Pharmacology (TPCP), pRED, Roche Innovation Center Basel, Switzerland
09:00 – 09:10 a.m. Discussion
09:10 – 09:30 a.m. Opening Remarks – Pharmacotherapy in the Elderly
Petra A. Thürmann MD, PhD; Helios University Hospital Wuppertal; University ­Witten / Herdecke, Germany
09:30 – 09:40 a.m. Discussion
09:40 – 10:10 a.m. Using Real World Data to Assess Drug-Drug Interactions under ­Multiple Drug Therapy: Focusing on Antibiotics in Elderly
Tjeerd Pieter van Staa, MD, PhD, MSc; Division of Informatics, Imaging & Data Sciences (L5), Centre for Health Informatics, University of Manchester, Manchester, UK
10:10 – 10:20 a.m. Discussion
10:20 – 10:50 a.m. Networking Over Coffee Break
10:50 – 11:20 a.m. Drug-drug Interactions Coming-of-Age – The Challenge of Deciphering DDIs as Cause of Adverse Drug Reactions in Elderly Patients Undergoing Polypharmacy
Julia Stingl, MD; Institute of Clinical Pharmacology, University Clinic of the University of Aachen (RWTH Aachen)
11:20 – 11:30 a.m. Discussion
11:30 – 12:00 p.m. Q&A and Discussions on DDIs in Special Populations
12:30 – 02:00 p.m. Networking Over Lunch
Session IV Drug-Drug Interactions with Biologics Revisited
Chair: Amin Rostami
02:00 – 02:30 p.m. Update on DDIs with Biologics and Review of Final FDA Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins
Bernd Meibohm, PhD, FCP; College of Pharmacy, University of Tennessee Health Science Center, Memphis, USA
02:00 – 02:40 p.m. Discussion
Session V Point – Counter-Point: Regulatory – Success of PBPK Submissions
Chair: Ping Zhao
02:40 – 03:05 p.m. Point – How to Determine Adequacy of PBPK for Assessing DDI as Part of General Assessment? The Common Shortfalls.
Yuching Yang, PhD; Durham, North Carolina, USA
03:05 – 03:10 p.m. Discussion
03:10 – 03:35 p.m. Counter Point – How to Determine Adequacy of PBPK for Assessing DDI as part of Regulatory Submissions? Addressing the Gaps and Filling the Void
Eva Gil Berglund, PhD; Clinical Pharmacology and Regulatory Strategy, CDDS, Certara, NL
03:35 – 03:40 p.m. Discussion
03:40 – 04:00 p.m. Networking Over Coffee Break
04:00 – 04:20 p.m. Q&A and Discussions on DDIs in Special Populations
04:20 – 04:30 p.m. Concluding Remarks – Amin Rostami
End of Meeting & Departure
Last Update: 22.03.2024