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.
DDI Workshop 2024 – Save the Date
The upcoming Workshop will take place from May 26th to May 28th, 2024.
DDI Workshop 2023 Summary
June 4 to June 6, 2023
2023 International Drug-Drug Interaction (DDI) Workshop at Marbach Castle
The 13th workshop extended previous year’s “back-to-normal success” with physical attendance reaching more than 60 participants and online attendance of 20 from a total of 13 different countries. With another exceptional program mixing top-notch presentations and panel discussions, the Marbach Castle DDI Workshop series is truly a go-to event for global researchers, drug developers, regulators, and practitioners.
On Day 1, Prof. Amin Rostami from University of Manchester kicked off the workshop by announcing the winner of Hartmut Derendorf Young Scientist Award to Dr. Kenta Yoshida, Genentech, US. He then kicked off the first session dedicated to Pharmacodynamic (PD) Interactions by introducing Prof. Don Mager (University of Buffalo, US) as this year’s plenary lecture speaker. Professor Mager reviewed the state-of-the-art models that can be used to predict PD-DDIs. His lecture was followed by Prof. Luca Marchetti (University of Trento, Italy) who presented “A Systems Approach to PD interactions: Implications for combination Therapy”.
Session II ICH M12 mirrored last year’s Roadmap to ICH M12 because a draft guideline of M12 has been published in late 2022. Three speakers, Drs. Brian Ogilvie from BioIVT/Xenotech, Raj Madabushi from FDA, and Vikram Sinha from Novartis reviewed in vitro aspects, in vivo aspects, and industry perspectives of the M12 guideline, respectively. Chaired by Dr. Ping Zhao (Bill & Melinda Gates Foundation), this session was immediately followed by a panel discussion with presenters joined by Drs. Baerbel Wittke (Swiss Medic), Esther Brandon (MEB of the Netherlands), and Xinning Yang (FDA). Panel members commented on the important roles of PBPK in guiding dosing decisions at initial approval stage for many complex DDI scenarios (some of which are difficult to study clinically), and called for a concerted effort by industry and regulators to compile and share experience of DDI assessments.
Session III Biomakers for Detecting Clinical DDIs was chaired by Prof. Rostami. The session featured lectures by Dr. Kenta Yoshida (Genentech) on “Industry Application and Kinetic Considerations of Transporter Endogenous Biomarkers” (Young scientist award lecture) and by Dr. Andrew Parkinson (XPD Consulting) on “Where are we in DDI biomarkers? What has been settled and what has not? Specificity and feasibility of developing tools to identify DDIs”. Discussions during Q&A session raised attention to the maturity of using certain biomarkers such as coproporphyrins along with PBPK modeling to assess OATP DDI risk for investigational drugs.
Day 2 continued the biomarker session with Prof. Andrew Rowland (Flinders University, Australia), who provided an update of the use of liquid biopsy in assessing the induction/suppression of enzymes and transporters.
Then, Dr. Robert Hermann (cr.appliance, Germany) chaired Session IV Smoking Interactions with Prof. Isabelle Ragueneau-Majlessi (Univ Washington, US) reporting the recent publication reviewing 30 years’ experience of clinical smoking DDI studies. A panel discussion of the session contrasted methodological standards between food effect studies and smoking studies, and critiqued the lack of updated recommendations by global regulators on this matter.
Session V Excipient DDIs is the first time for Marbach workshop to systematically offer a collection of novel research in this area. Along with the previous session on smoking DDI, this session represents Marbach’s recognition of interactions beyond those between drug substances, and its signature of mixing emerging research with real-world application of the findings through mechanistic modeling and simulations in its scientific programs. Chaired by Prof. Rostami, the session included lectures by Drs. Lei Zhang (US FDA), Yuan Chen (Genentech), and Mark Warren (BioIVT) on FDA’s effort to evaluate excipient-drug interactions, the use of PBPK to entangle excipient effect from CYP inhibition effect on the PK of an investigational oncology drug, and a systematic effort to generate in vitro inhibition data for major pharmaceutical excipients.
Session VI Regulatory Session, chaired by Dr. Zhao and Dr. Hermann, was in fact on knowledge integration. Dr. Jingjing Yu (Univ. Washington, US) updated the audience with a systematic review of DDI assessment in 2022 US FDA drug approvals. This was followed by Dr. Zhao who presented the vision on building PBPK model repository that can efficiently be employed to manage clinical DDIs in diverse populations around the world. The presentations echoed Day 1’s ICH M12 session with regards to knowledge sharing.
In summary, the 2023 Marbach workshop continues to offer highly relevant programs for DDI researchers, highlight the indispensable roles of PBPK in predicting a wide range of often complex, untested clinical scenarios, and transitions to a paradigm of evaluating substance-substance interaction.
Supporting organisations
