The Workshop Programme 2024
DDI Workshop 2024 – Registration is now open!
The upcoming Workshop will take place from May 26th to May 28th, 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
Workshop Programme 2024
Second Announcement
Marbach DDI Workshop 2024 – Second 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 Clinical and Experimental 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