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

11th International DDI Workshop 30.05. – 01.06.2021

Keynote Lecture

1. The Philosophy of Drug Interactions
Philip D. Hansten, PharmD, Professor Emeritus, University of Washington, USA

Session I: Food-Drug Interactions & Beyond

2. Gut Feeling – Proteomics of Gut Wall and Relevance to Drug Absorption and Interactions
Stefan Oswald, PhD, University of Greifswald, Germany

3. Assessing Food-Drug Interactions: Highlights from New FDA Guidance
Rajanikanth Madabushi, PhD, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA

4. Food-Drug Interactions – Considerations from the IQ Working Group
Tycho Heimbach, PhD, Biopharmaceutics, Sterile & Specialty Products Group, Pharmaceutical Sciences, Merck & Co., Inc., Rahway, New Jersey, USA

5. Can we Predict Formulation-Dependent Food-Drug Interactions?
Rodrigo Cristofoletti, PhD, Division of Therapeutic Equivalence, Brazilian Health Surveillance Agency (ANVISA), Brasilia, Brazil

Session II: Pharmacodynamic Interactions

6. Revisiting Pharmacodynamic Interactions: Benefits and Watch-outs in Oncology
Jin Yan Jin, PhD, Genentech, San Francisco, California, USA

7. Common Pharmacodynamic Interactions of Clinical Importance
David Juurlink; MD, PhD, FRCPC, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Session III: The Final FDA Guidance on In Vitro Drug Interactions

8. 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

Session IV: Pediatric DDIs

9. 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 Medical Center, Washington, DC USA & University of Basel Children’s Hospital, Basel, Switzerland

10. 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

Session V: Translational DMPK Session

11. “SLC-Phenotyping”: Quantifying Contribution of Transporters to the Hepatic uptake Clearance of Drugs
Manthena V Varma, PhD, Pfizer, Groton, CT, USA

12. 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

13. Liquid Biopsy, its Applications, Limitations, and Potential Role for Precision Dosing.
Brahim Achour, PhD, University of Manchester, UK. Appointed Assistant Professor at the Faculty of the College of Pharmacy, University of Rhode Island (URI) with start of appointment in September 2021.

14. Additional Talk Proposed: Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective
Tycho Heimbach, PhD, Biopharmaceutics, Sterile & Specialty Products Group, Pharmaceutical Sciences, Merck & Co., Inc., Rahway, New Jersey, USA

Session VI: Herb-Drug DDIs

15. Herbal drug-drug interactions. A meta-analysis and novel insights.
Ingolf Cascorbi, MD, PhD, University of Kiel, Germany

16. Translational Approaches to Untangle Herb-Drug Interactions
Mary Paine, RPh, PhD, Washington State University, Spokane, Washington, USA

17. Looking back 2 decades: Revisiting clinically relevant drug interactions with St. John’s wort
Veronika Butterweck, PhD, Max Zeller und Söhne, Romanshorn, Switzerland

Session VII: The Final FDA Guidance on Clinical Drug Interaction Studies

18. 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

Workshop Programme 2021

Download: DDI-Workshop – 2021 – 1st Announcement (PDF)

AfternoonIndividual 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 – 9:00Reflections 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