DDI Workshop, May 29 – June 1, 2022

2022 International Drug-Drug Interaction (DDI) Workshop at Marbach Castle a Back-to-Normal Success! 

The 12^th workshop was attended by academic, industry, and regulatory scientists around the world. With physical attendance reached 45 participants, the event had a true back-to-normal feel. This year, the workshop continued to use hybrid format with additional 35 virtual attendees. The workshop offered another exceptional program with top-notch presentations and unique opportunity for active dialogues. The Marbach Castle DDI Workshop series continues to be a go-to event concerning DDIs for many colleagues around the world.

Professor Amin Rostami from University of Manchester kicked off the workshop by announcing the winner of Hartmut Derendorf Young Scientist Award to Professor Henrike Bruckmüller, University Schleswig-Holstein, Kiel, Germany, and The Arctic University of Norway, and introducing Dr. Douglas McNair (Bill & Melinda Gates Foundation) to present on “Concepts and Utility of Real-World Data Analyses to Evaluate DDIs”. Real-world data analyses (RWDA) was specifically featured in the 2022 workshop. Hence, the first session, chaired by Dr. Ping Zhao, included three RWDA-related presentations: “Understanding Contraceptive DDIs through Combining Pharmacology Models and RWDA” by Professor Stephan Schmidt, University of Florida, “DDI Labelling: Can RWE Complement Regulatory Decisions on DDI Management in Product Labels?” by Dr. Joseph Grillo, US FDA; and “Utility of Clinical Practice Research Datalink (CPRD) to Evaluate Drug-Drug Interactions and DDI in Special Populations”, by Dr. Justin Hay, Certara, UK. These presentations conveyed attendees a flavor of how RWDA can be effectively applied to address different R&D and regulatory questions.

Session II titled “Roadmap to ICH M12” included two presentations and was chaired by Dr. Robert Hermann, Gelnhausen, Germany. “Highlight of DDI guideline of Chinese NMPA” by Dr. Li Li, NMPA, China, was the first time in Marbach history to include a regulatory update by a national authority that is outside the familiar group of stringent regulators such as US FDA, EMA, and Japan’s PMDA. The second presentation “EMA DDI Guideline and ICH M12” was given by Dr. Carolien Versantvoort, Medicines Evaluation Board, The Netherlands. Dr. Versantvoort is currently member of the ICH-M12 team as EU expert on the harmonisation of the DDI guidelines, and both presenters were joined by current and former regulatory colleagues in a lively panel discussion.

Session III was chaired by professor Rodrigo Cristofoletti (University of Florida). Titled “Usefulness of PBPK Modelling to Address Complex/Network PK Interactions”, the session was in panel discussion format and included two topics: excipient-drug interactions, and endogenous biomarkers for transporter DDIs. Panel members were faculty members, Professor Schmidt (Florida), and Dr. Hannah Jones (Certara). The session highlighted strong engagement of attendees and panelists in a lively discussion, a hallmark of Marbach DDI Workshop.

Day 1 was completed by a presentation by Dr. Beatrice Saint-Salvi, ANSM, France, introducing a proposal for an advanced training of scientific employees of European Health Authorities in DDI assessment. Her talk was entitled “Planning of a European Professional Development Curriculum for the Comprehensive Assessment of Drug-Drug Interactions.”

Day 2 started with Session IV titled “Covid-19 and Conduct of DDI” and was chaired by Professor Rostami. The session included “Informing Dosing Decisions Early in Pandemics” by Professor Dongyang Liu, Peking University Third Hospital, China, “Remdesivir Approval Supported by Mechanistic Modelling” by Ramesh Palaparthy, PhD, Gilead Sciences, USA, and “PBPK Modelling to Support DDI Assessment for Regulatory Submissions – General Observations during the COVID Era” by Dr. Hannah Jones, Certara, UK. These presentations offered a unique package on experiences and lessons learned in applying PBPK modeling in R&D of repurposed and investigational new medicines to combat the viral infection, highlighting the efficient and practical use of PBPK at different stages of the pandemic around the world.

Sessions V “Pharmacogenetics” was chaired by Professor Ingolf Cascorbi, University Schleswig-Holstein, Kiel, Germany, who introduced Dr. Henrike Bruckmüller to present a lecture on “Drug-Drug-Gene Interactions”; Session VI “Biologics DDIs” was chaired by Professor Rostami, who introduced Dr. Carolina Säll, Novo Nordisk, Denmark to present an industry case example on “Assessing Therapeutic Peptide DDIs During Drug Development”.

Session VII “Gut DDI” was chaired by Dr. Zhao. The first presentation “Physiology Based Biopharmaceutics Modeling (PBBM) based food effect predictions: Current state and future perspectives.” by Dr. Christian Wagner, Merck KGaA, Germany walked the audience through the evolution of PBBM from an earlier assessment of predictability of PBPK for food effect to progresses being made by the IQ consortium. The second presentation “Absorption DDIs by Drugs Affecting GI-Tract Motility –A Case Example of a Fixed Drug Combination Development” by Dr. Hermann, cr.appliance, Gelnhausen, Germany, provided a thought-process on understanding and interpretating complex DDIs associated with fixed dose combination (FDC) products.

The workshop ended with a new format “Marbach Debate”, which revisited two topics discussed extensively in 2021 workshop as well as this year’s workshop. These topics were the planning on DDI studies related to the use of herbal products, and the conduct of clinical studies evaluating the effect of CYP3A induction.

The event was blessed by beautiful late spring weather. As usual, the attendees enjoyed the tranquil surroundings and fresh products in season including different berries, lake fish, and white asparagus. We look forward to seeing many of you at 2023 workshop!