Welcome to the Marbach Castle Drug-Drug Interaction Workshop Series
The DDI workshop series is a non-profit programme to exchange research-based knowledge on drug-drug interactions (DDIs) among all interested stakeholders from pharmaceutical industry, regulatory authorities, academic and health care delivery backgrounds and perspectives.
The overall objective of the international Marbach Castle DDI Workshop series is to improve and disseminate the scientific knowledge about drug-drug interactions (incl. food-drug and herb-drug interactions), and to foster communication for efficient preclinical and clinical investigation of DDIs across disciplines and organisational boarders.
The goal is safer use of pharmaceutical products especially in geriatric and medically complex patient populations with various co-morbidities and increasing poly-pharmacotherapy.
The upcoming Workshop will take place from May 26th to May 28th, 2024.
The Workshop Programme 2024
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