The Workshop Programme 2022
The 2022 Workshop will open with a keynote lecture on 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. The keynote lecture will be immediately followed by a session on applying RWDA to assess DDI risks. We hope the discussions around RWDA will bring attendees up to speed in realizing the strength, realities, and use cases of RWDA to manage clinical DDIs.
The next “regulatory session” follows workshop’s tradition. International Council for Harmonization (ICH) decided to publish its first DDI guideline M12. Attendees will hear updates from global regulators on respective DDI requirements. A panel discussion is designed to bring together thoughts towards global harmonization.
After the regulatory session there will be a panel discussion on the utility of dosing apps that are based on in silico models. In a digital world that we live in today, a mobile or computer app helping physicians to make timely decisions on optimal dosing considering a patient’s potential complex co-medication seems highly desirable. We will hear perspectives from app developers on current features and challenges.
Day 2 of the workshop will begin with the session on “Conduct of DDI under the COVID-19 pandemic”. The ability to conduct in-silico trials using existing virtual physiology models and to investigate plausible pharmacology using mechanistic models have made impact on decisions at many levels of drug R&D and clinical use since the beginning of the COVID-19 pandemics. Attendees will hear cases in the area of drug repurposing as well as acceleration of the development and registration of investigational drugs.
The COVID-19 DDI session will then be followed by a session on the role of pharmacogenetics in DDI, and a talk on DDI assessment for therapeutic proteins. The following session will be dedicated to absorption DDIs, and will comprise two presentations: The first being and IQC update on pH-Dependent DDIs and food effects, while the second will be about absorption DDIs by drugs affecting GI-tract motility.
The last session is a new format called “Marbach Debate”. We will select one of the several hot topics in 2021 based on Q&As and panel discussions and invite perspectives from industry, academic, and regulators.
As situations on travel restrictions continue to improve, we are hoping to welcome you in the newly renovated facilities at Marbach in May of 2022!
The Workshop Organizers:
Robert Hermann, MD, FCP
Amin Rostami-Hodjegan, PhD, FCP
Ping Zhao, PhD
Workshop Programme 2022
Marbach DDI Workshop 2022 – Very Final Announcement [PDF -Download | 2,3 MB]
| Afternoon | Individual Arrival & Check-in at Marbach Castle |
| 03:00 p.m. | Registration & Coffee |
| 04:00 p.m. | Come Together Activities |
| 07:30 p.m. | Come Together Dinner |
| 09:00 p.m. | Social Event – Details to be Determined |
| 08:00 – 08:30 a.m. | Registration & Coffee |
| 08:30 – 08:45 a.m. | Welcome Address and Introduction into the Workshop Ping Zhao |
| Keynote Lecture | |
| 08:45 – 09:20 a.m. | Concepts and Utility of Real-World Data Analyses to Evaluate DDIs Douglas McNair, MD/PhD, BMGF, USA |
| 09:20 – 09:30 a.m. | Discussion |
| Session I: Real-World DDI Evidence Chair: Ping Zhao |
|
| 09:30 – 09:50 a.m. | Understanding Contraceptive DDIs through Combining Pharmacology Models and RWDA Stephan Schmidt, PhD, University of Florida, Gainesville, USA. |
| 09:50 – 10:00 a.m. | Discussion |
| 10:00 – 10:30 a.m. | Coffee Break |
| 10:30 – 10:50 a.m. | DDI Labelling: Can RWE Complement Regulatory Decisions on DDI Management in Product Labels? Joseph A. Grillo, PharmD, Winchester, VA, USA |
| 10:50 – 11:00 a.m. | Discussion |
| 11:00 – 11:20 a.m. | Utility of Clinical Practice Research Datalink (CPRD) to Evaluate Drug-Drug Interactions and DDI in Special Populations Justin Hay, PhD, Certara, UK |
| 11:20 – 11:30 a.m. | Discussion |
| 11:30 – 12:00 p.m. | Panel Discussions and Q&A on RWD – DDIs |
| 12:00 – 01:30 p.m. | Lunch |
| Session II: Roadmap to ICH-M12 Chair: Robert Hermann |
|
| 01:30 – 02:00 p.m. | Highlight of DDI Guideline of Chinese NMPA Li Li, PhD, National Medical Products Administration, China |
| 02:00 – 02:10 p.m. | Discussion |
| 02:10 – 02:40 p.m. | EMA DDI Guideline and ICH M12 Carolien Versantvoort, PhD, Medicines Evaluation Board, The Netherlands |
| 02:40 – 02:50 p.m. | Discussion |
| 02:50 – 03:20 p.m. | Regulatory Panel Discussions and Q & A for Session II |
| 03:20 – 04:00 p.m. | Coffee Break |
| Session III: Usefulness of PBPK Modelling to Address Complex/Network PK Interactions Chairs: Rodrigo Cristofoletti (University of Florida), Ping Zhao and Amin Rostami-Hodjegan |
|
| 04:00 – 05:00 p.m. | Panel Discussion on Complex/Network PK DDIs |
| 05:00 – 05:15 p.m. | Planning of a European Professional Development Curriculum for the Comprehensive Assessment of Drug-Drug Interactions. Béatrice Saint-Salvi, PhD, DDI Unit, ANSM, France |
| 05:15 – 05:20 p.m. | Discussion |
| 07:00 p.m. | Dinner |
| Session IV: COVID-19 & Conduct of DDI Chair: Amin Rostami-Hodjegan |
|
|---|---|
| 09:00 – 09:20 a.m. | Informing Dosing Decisions Early in Pandemics Dongyang Liu, PhD, Peking University, Third Hospital, Beijing, China |
| 09:20 – 09:30 a.m. | Discussion |
| 09:30 – 09:50 a.m. | Remdesivir Approval Supported by Mechanistic Modelling Ramesh Palaparthy, PhD, Gilead Sciences, South San Francisco, CA, USA |
| 09:50 – 10:00 a.m. | Discussion |
| 10:00 – 10:20 a.m. | PBPK Modelling to Support DDI Assessment for Regulatory Submissions – General Observations during the COVID Era Hannah Jones, PhD, Certara, UK |
| 10:20 – 10:30 a.m. | Discussion |
| 10:30 – 11:10 a.m. | Coffee Break |
| Session V: Pharmacogenetics Chair: Ingolf Cascorbi |
|
| 11:10 – 11:30 a.m. | Drug-Drug-Gene Interactions Henrike Bruckmüller, PhD, Institute of Experimental and Clinical Pharmacology, University Hospital Schleswig-Holstein, Kiel, Germany; University of Tromsø, The Arctic University of Norway, Norway |
| 11:30 – 11:40 a.m. | Discussion |
| Session VI: Biologics DDIs Chair: Amin Rostami-Hodjegan |
|
| 11:40 – 12:00 p.m. | Assessing Therapeutic Peptide DDIs During Drug Development Carolina Säll, PhD, Novo Nordisk, Denmark |
| 12:00 – 12:10 p.m. | Discussion |
| 12:10 – 01:40 p.m. | Lunch |
| Session VII: Gut DDI Chair: Ping Zhao |
|
| 01:40 – 02:00 p.m. | Physiology Based Biopharmaceutics Modeling (PBBM) based food effect predictions: Current state and future perspectives. Christian Wagner, PharmD/PhD, Merck KGaA |
| 02:00 – 02:10 p.m. | Discussion |
| 02:10 – 02:30 p.m. | Absorption DDIs by Drugs Affecting GI-Tract Motility – A Case Example of a Fixed Drug Combination Development Robert Hermann MD, FCP, cr.appliance, Gelnhausen, Germany |
| 02:30 –02:40 p.m. | Discussion |
| 02:40 –03:00 p.m. | Coffee Break |
| 03:00 – 04:00 p.m. | Marbach Debate Question to be Updated Based on Hot Topics in 2021 Meeting |
| 10 min | Reactions from Regulatory Attendees |
| 10 min | Reactions from Industry/Academic Attendees |
| 40 min | Discussions – All |
| 04:00 p.m. | Concluding Remarks – Amin Rostami-Hodjegan End of Meeting & Departure |
Last Update: 01.04.2022