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