The Workshop Programme 2021
In its 11th year, the Workshop will cover a number of highly important DDI topics in depth.
In brief, the Workshop will open with a new feature, a keynote lecture on the philosophy of drug interactions.
This will be followed by a session about food-drug interactions, starting with an overview on the current knowledge of the gut wall proteomics and its relevance to drug absorption and interactions. The following presentation will address the question whether or not formulation-dependent food-drug interactions can be predicted. Implications to drug development strategies will be debated. The third talk in this session will familiarize the audience with the IQ Working Group considerations on food-drug interactions, including some food effect case studies. The final presentation in this session details the highlights of the new FDA Guidance on the assessment of food-drug interactions.
As requested by many participants and on the Workshop agenda for years, we will feature a session on pharmacodynamic (PD) drug interactions, with an overview of common PD interactions of clinical importance, and one talk revisiting beneficial and safety-relevant PD interactions in oncology.
The last session of Day 1 will be dedicated to the presentation and discussion of the final 2020 FDA Guidance Documents on Drug Interactions (i.e. in vitro and clinical studies).
Day 2 of the workshop will kick off by a translational DMPK session focusing on in-vitro aspects of DDI studies with an introduction in the liquid biopsy methodology, and its potential role for the characterization of individual hepatic drug elimination capacity. Thereafter, do’s and don’ts in metabolic reaction phenotyping, and recent developments in SLC-transporter phenotyping as a new means to quantify the contribution of transporters to the hepatic uptake clearance of drugs will be presented.
For the first time, the workshop will include a new session on evaluating drug interactions in pediatric populations with clinical as well as regulatory implications.
Finally, the Workshop will conclude with a session on DDIs between herbal drug products and prescription drugs, which will be opened by a presentation of a meta-analysis and novel insights in this topic. A second talk in this session will review 2 decades of clinically relevant DDIs with St. John’s Wort, and finally translational approaches to untangle herb-drug interactions will be presented.
All sessions will provide ample opportunity for attendees to ask questions and provide comments.
The topics of the 11th International DDI Workshop will be covered by distinguished international scientists and experts from academia, pharmaceutical companies, contract research organizations, consultancies as well as government and regulatory agencies. All topics will be presented from different angles including non-clinical information (especially from in vitro studies), clinical information, as well as in silico simulations (e.g., using PBPK models that integrate non-clinical and clinical knowledge).
We are hoping to welcome you in the newly renovated facilities at Marbach in May of 2021!
The Workshop Organizers:
Robert Hermann, MD, FCP
Amin Rostami-Hodjegan, PhD, FCP
Ping Zhao, PhD
Workshop Programme 2021
Download: DDI-Workshop – 2021 – 1st Announcement (PDF)
| 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. | Live Music – TBD |
| 08:00 – 08:30 a.m. | Registration & Coffee |
| 08:30 – 08:50 a.m. | Welcome Address and Introduction into the Workshop Amin Rostami |
| 08:50 – 09:25 a.m. | Keynote Lecture – The Philosophy of Drug Interactions Philip D. Hansten, PharmD, Professor Emeritus, University of Washington, USA |
| 09:25 – 09:35 a.m. | Discussion |
| Session I: Food-Drug Interactions & Beyond Chair: Amin Rostami | |
| 09:35 – 10:00 a.m. | Gut Feeling – Proteomics of Gut Wall and Relevance to Drug Absorption and Interactions Stefan Oswald, PhD, University of Greifswald, Germany |
| 10:00 – 10:10 a.m. | Discussion |
| 10:10 – 10:35 a.m. | Can we Predict Formulation-Dependent Food-Drug Interactions? Rodrigo Cristofoletti, PhD, Assistant Professor at the Center of Pharmacometrics & Systems Pharmacology, University of Florida, Gainesville, USA. |
| 10:35 – 10:45 p.m. | Discussion |
| 10:45 – 11:10 a.m. | Coffee Break |
| 11:10 – 11:35 a.m. | Food-Drug Interactions – Considerations from the IQ Working Group and Food Effect Case Studies Tycho Heimbach, PhD, Biopharmaceutics, Sterile & Specialty Products Group, Pharmaceutical Sciences, Merck & Co., Inc., Rahway, New Jersey, USA |
| 11:35 – 11:45 a.m. | Discussion |
| 11:45 – 12:05 p.m. | Regulatory Science on Assessing Food Drug Interaction – Highlights from New FDA Guidance Rajanikanth Madabushi, PhD, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA |
| 12:05 – 12:15 p.m. | Discussion |
| 12:15 – 01:45 p.m. | Lunch |
| Session II: Pharmacodynamic Interactions Chair: Robert Hermann | |
| 01:45 – 02:10 p.m. | Common Pharmacodynamic Interactions of Clinical Importance David Juurlink; MD, PhD, FRCPC, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada |
| 02:10 – 02:20 p.m. | Discussion |
| 02:20 – 02:45 p.m. | Revisiting Pharmacodynamic Interactions: Benefits and Watch-outs in Oncology Jin Yan Jin, PhD, Genentech, San Francisco, California, USA |
| 02:45 – 02:55 p.m. | Discussion |
| 02:55 – 03:20 p.m. | Coffee Break |
| Session III: The Final FDA Guidance Documents on Drug Interactions Chair: Amin Rostami | |
| 03:20 – 03:45 p.m. | Introductory Lecture: What did the FDA Change when it Finalized its In Vitro Drug Interaction Guidance in January, 2020? Andrew Parkinson, PhD, XPD Consulting, Shawnee KS, USA |
| 03:45 – 03:55 p.m. | Q & A Session with all Regulatory Attendees |
| 03:55 – 04:20 p.m. | Introductory Lecture: The Final FDA Guidance on Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions. Robert Hermann, MD, Clinical Research Appliance, Gelnhausen, Germany |
| 04:20– 04:40 p.m. | Q & A Session with all Regulatory Attendees |
| 07:00 p.m. | Dinner |
| Session IV: Translational DMPK Session Chair: Amin Rostami | |
|---|---|
| 08:50 – 9:00 | Reflections on Day 1 and Opening Remarks Day 2 |
| 09:00 – 09:25 a.m. | Liquid Biopsy, its Applications, Limitations, and Potential Role for Characterising Individual Hepatic Drug Elimination Capacity Brahim Achour, PhD, University of Manchester, UK. Appointed Assistant Professor at the Faculty of the College of Pharmacy, University of Rhode Island (URI) (from September 2021) |
| 09:25 – 09:35 a.m. | Discussion |
| 09:35 – 10:00 a.m. | Metabolic Reaction Phenotyping: Do’s and Don’ts, and the Oscar Nomination Process (is Metabolism the Best Actor or the Best Supporting Actor?) Andrew Parkinson, PhD, XPD Consulting, Shawnee KS, USA |
| 10:00 – 10:10 a.m. | Discussion |
| 10:10 – 10:35 a.m. | “SLC-Phenotyping”: Quantifying Contribution of Transporters to the Hepatic Uptake Clearance of Drugs Manthena V Varma, PhD, Pfizer, Groton, CT, USA |
| 10:35 – 10:45 a.m. | Discussion |
| 10:45 – 11:10 p.m. | Coffee Break |
| Session V: Pediatric DDIs Chair: Ping Zhao | |
| 11:10 – 11:35 a.m. | Are Neonates and Young Infants Protected against DDIs Despite their Exposure to a Multitude of Medicines? Johannes N. van den Anker, MD, PhD, Children’s National Hospital, University Children’s Hospital Basel, University of Basel, Switzerland |
| 11:35 – 11:45 a.m. | Discussion |
| 11:45 – 12:10 a.m. | Application of Pharmacometric Approaches and Real-World Data to Characterize Drug-Drug Interactions in Infants and Children Daniel Gonzalez, PharmD, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA |
| 12:10 – 12:20 p.m. | Discussion |
| 12:20 –01:45 a.m. | Lunch |
| Session VI: Herb-Drug DDIs Chair: Ping Zhao | |
| 01:45 – 02:10 p.m. | Herbal Drug-Drug Interactions. A Meta-Analysis and Novel Insights Ingolf Cascorbi, MD, PhD, University of Kiel, Germany |
| 02:10 – 02:20 p.m. | Discussion |
| 02:20 – 02:55 p.m. | Looking Back 2 Decades: Revisiting Clinically Relevant Drug Interactions with St. John’s Wort Veronika Butterweck, PhD, Max Zeller und Söhne, Romanshorn, Switzerland |
| 02:55 – 03:05 p.m. | Discussion |
| 03:05 – 03:30 p.m. | Translational Approaches to Untangle Herb-Drug Interactions Mary Paine, RPh, PhD, Washington State University, Spokane, Washington, USA |
| 03:30 – 03:40p.m. | Discussion |
| 03:40 – 04:05 p.m. | Coffee Break |
| Session VII: Q & A Session Day 2 Chairs: Ping Zhao & Amin Rostami | |
| 04:05 – 04:25 p.m. | Q & A Session Involving Sessions IV – VI |
| 04:25 – 04:30 p.m. | Concluding Remarks End of Meeting & Departure |
Last Update: 23.03.2021