Workshop Archive

10th International Marbach Castle DDI Workshop

May 26th – 28th, 2019

The 10th Anniversary of the International Drug-Drug Interaction (DDI) Workshop at Marbach Castle Enjoyed Continued Attention, Appreciation and Endorsement by International Academic, Industry and Regulatory Scientists

More than 80 experts attended the 10th International DDI Workshop and discussed current topics of regulatory requirements and scientific aspects of drug-drug interactions. The meeting was once again fully booked several weeks in advance, indicating that the DDI Workshop series has become a focal point in the calendar for those concerned with the topic and its unmet needs. Thus, the workshop continues to enjoy from an unbroken popularity, appreciation and endorsement by the participating speakers and attendees.

The meeting began with a session on ‘Past, Present and Future of the Investigations of DDIs’ and was started with a historical perspective by Prof. Malcolm Rowland from the University of Manchester who led the audience through 50 years of DDI investigations. Prof. Rowland gave numerous examples. Often regarded clinically as all or none phenomena, drug-drug interactions (DDI) are graded with the extent varying with the concentrations of the interacting species and hence with their pharmacokinetics (PK) and dosage regimens. Initially, DDIs were identified from clinical observations, often adverse outcomes, and sometimes even drug withdrawals.

… read more

Their origins were often unbeknown pharmacokinetic. To minimize such problems, studies in healthy subjects became part of drug development, with choice of study often governed by the high likelihood that the drugs would be co-administered in the patient population, rather than based on scientific principles. Changes were driven with improvements in analytical methods and mechanistic understanding of ADME processes, coupled with increasing adoption of physiologically based organ models, linking in vitro investigations with in vivo observations, heralding in the era of in vitro-in vivo extrapolation (IVIVE). Originally confined primarily to studies of competitive metabolic inhibition in preclinical species they rapidly extended to non-competitive inhibition and enzyme induction, and while animal studies were used to test methodologies underlining IVIVE, the availability of human tissue and cell-based systems allowed prediction of events in human. Early PK models assumed perfusion rate limited tissue distribution, which needed to be extended to allow for a membrane permeability rate limitation, increasingly apparent with larger and less lipophilic compounds, and a realization of the role of transporters, sometimes coupled with metabolic events. And while the use of in vitro findings was helping to identify likely risks of a DDI in vivo, incorporated into regulatory guidances, there was still much concern for false negatives, and false positives. As such, emphasis remained on undertaking clinical DDI investigations, but now on a more mechanistic basis. Also, many drugs produced multiple interactions at multiple sites within the body, which could no longer be considered discretely, a problem addressed with the use of whole body physiologically based PK (PBPK) models, dynamic models that integrated biochemical, physiological, pathophysiological, genetic and ontological information with drug specific information. However, with concerns for ensuring quality of associated studies and the PBPK software platforms, regulators have issued PBPK guidances, in which issues of validation and qualification play a significant part. Still, confidence is sufficiently high in many cases to both avoid the need for undertaking some DDI studies and allow statements to be made in the label based on PBPK predictions. The next presentations in the regulatory session was on ‘An industry view on the evolution of modelling and simulation in drug development with emphasis on DDI studies over the past decade’ given by Dr. Richard Lalonde, University of Florida. He showed numerous examples how modeling and simulation has made the drug development process more evidence-based and unbiased.

In the second session on “Changes in the International Regulatory DDI Landscapes” there were presentations on ‘Update on EMA Guidances Impacting the Assessment of DDIs’ given by Kevin Blake, PhD, from the EMA and on ‘The Japanese (PMDA) DDI Guideline and application of PBPK’ by Kiyomi Ito, PhD, Musashino University, Tokyo, Japan, followed by a lively discussion.

The subsequent program on Day 1 consisted of two more scientific sessions, as well as a concluding Questions & Answer session.

The third session of Day 1 was called ‘PBPK Modeling of Metabolism-Based DDIs’ with a presentation on ‘Predicting DDI with Integrated MiDD Capability’ given by Ping Zhao, PhD, Bill and Melinda Gates Foundation, Seattle.

The fourth session was about ‘Clinical Management of DDIs’ and featured presentations on ‘Getting Over Fatigue of DDI Warnings: What the Future Decision Support Tools Hold for Clinicians in the Era of Precision Dosing’ by Jean-Luc Reny, MD, Geneva University Hospital, Geneva, as well as ‘Late Breaking Topic! Ketoconazole and Liver Injury – A Five-Year Update’ by Gerd Mikus, MD, Heidelberg University Hospital where he made a strong point against banning ketoconazole in favor of itraconazole in DDI studies.

Day 2 started with a session titled ’Transporter-Based DDIs Revisited’. The first presentation was on ‘The Role of Intestinal Influx Transporters in Drug-Nutrient, Drug-Excipient and Drug-Drug Interactions’ presented by Kathleen Giacomini, PhD, University of California at San Francisco. Intestinal transporters play critical roles in the absorption of drugs and nutrients. Drug-drug interactions, mediated by intestinal transporters, are widely recognized as important determinants of drug toxicity and/or non-response. In marked contrast, transporter-mediated excipient drug interactions in which excipients co-formulated with therapeutic drugs inhibit intestinal drug transporters are less well studied, and very little is known about transporter-mediated drug-nutrient interactions in the intestine. Dr. Giacomini described excipient drug interactions with the intestinal absorptive transporter, OATP2B1. She demonstrated the complex interplay between formulation and drug absorption and suggested that intestinal transporters are important determinants of not only drug-drug interactions, but drug-nutrient and drug-excipient interactions.

The next presentations in that session was on the question ‘Can Endogenous Biomarkers be Applied in Phase I Clinical Trials to Facilitate Subject Phenotyping and DDI Prediction?’ by Yuichi Sugiyama, PhD; RIKEN, Yokohama. He showed recent progress in using endogenous compounds as biomarkers for assessing DDI susceptibility of compounds and genetic polymorphism based interindividual differences involving hepatic transporters in humans. Use of multiple biomarkers will enhance the confidence in the prediction of clinical DDI using endogenous biomarkers. The session concluded with a presentation by Peter Stopfer, PhD, Boehringer Ingelheim on ‘The Effect of Inhibitors of Drug Transport on a Probe-Drug Cocktail Consisting of Digoxin, Furosemide, Metformin, and Rosuvastatin.’

The final session of the meeting was titled ‘DDIs with Hormonal Contraceptives Revisited’ and featured presentations on ‘Regulatory Guidance Versus Clinical Guidance on Drug Interactions of Combined Hormonal Contraceptives’ by Larry Lesko, PhD, University of Florida, ‘Closing the Knowledge Gap on Potential Differences in the Sensitivity to CYP3A4 Induction between Common Progestins used in Oral Contraceptives Relative to Midazolam’ by Joachim Höchel, PhD, and Herbert Wiesinger, PhD, Bayer AG, and ‘Assessment of Drug Interactions with Oral Contraceptives using PBPK Modelling: A Best Practice Approach Using Case Studies’ by Karen Rowland Yeo, PhD, Certara, Sheffield.

The meeting then concluded with five excellent presentations from selected posters presentations and as usual, the final wrap-up discussion of the workshop. As in every year, a wide variety of DDI-related topics were discussed including experimental, clinical and regulatory issues.

Finally, this meeting report would not be complete without mentioning the beautiful Fingerstyle Guitar and Soul, Pop & Jazz Double Concert by Simon Wahl, Michael Diehl and 2enjoy as well as the many networking opportunities for the attendance to engage in informal interaction with colleagues form industry, academia and the regulatory agencies.

… read less


Speakers 2019

Rowland, Malcolm (PhD, DSc)
Professor Emeritus, University of Manchester, Manchester, UK

Lalonde, Richard (PharmD)
University of Florida, Florida, USA

Blake, Kevin (MD, PhD)
EMA, London, UK

Ito, Kiyomi (PhD)
Research Institute of Pharmaceutical Sciences, Musashino University, Tokyo, Japan

Zhao, Ping (PhD)
Bill and Melinda Gates Foundation, Seattle, Washington, USA

Reny, Lean-Luc (MD)
Geneva University Hopital, Geneva, Switzerland

Mikus, Gerd (MD)
Heidelberg University Hospital, Heidelberg, Germany

Giacomini, Kathleen (PhD)
University of California, San Francisco, USA

Sugiyama, Yuichi (PhD)
RIKEN Innovation Center, Yokohama, Japan

Stopfer, Peter (PhD)
Boehringer Ingelheim, Biberach, Germany

Lesko, Lawrence (PhD)
University of Florida, Lake Nona, FL, USA

Höchel, Joachim (DVM, PhD)
Bayer Pharma AG, Berlin, Germany

Rowland Yeo, Karen (PhD)
Certara, Sheffield, UK


Attendee Quotations 2019

  • Dear Robert, thank you to you and the organising committee for a great 10th anniversary meeting. The scientific content was world class as always, I learnt a lot and loved the hospitality at Marbach.
  • Hi Amin – I want to thank you for introducing me to such a great meeting. I enjoyed every minute there, the talks, the posters and conversations with the meeting attendants. Thank you for building a great scientific community on DDI, from in vitro all the way to patients. I learned a lot from various perspectives, and will share with my colleagues.
  • Like the previous year, the whole meeting was a great experience – I personally didn’t miss the castle much, thanks to your excellent organisation, we’ve been compensated generously for this loss…
  • Enjoyed the meeting so much. The talks cover a wide range of DDI related topics.
  • What were the best moments of the workshop for you? The opportunity to share our results with leading experts and receive feedback. Receiving update from the same top experts on hot topics; Environment, atmosphere, social interaction – all priceless!

Workshop Programme 2019

9th International Marbach Castle DDI Workshop

May 27-29, 2018

The 9th International Drug-Drug Interaction (DDI) Workshop at Marbach Castle Enjoyed Continued Attention, Appreciation and Endorsement by International Academic, Industry and Regulatory Scientists

More than 80 experts attended the 9th international DDI Workshop and discussed current topics of regulatory requirements and scientific aspects of drug-drug interactions. The meeting was once again fully booked several weeks in advance, indicating that the DDI Workshop series has become a focal point in the calendar for those concerned with the topic and its unmet needs. Thus, the workshop continues to enjoy from an unbroken popularity, appreciation and endorsement by the participating speakers and attendees.

The meeting began with a session on ‘Changes in the US/EU Regulatory Landscapes’ and was started with a presentation by Dr. Joseph Grillo from the FDA on ‘Drug Interactions From Lab to Labeling: A Regulatory Perspective’.

Dr. Grillo pointed out that unanticipated, unrecognized, or mismanaged drug-drug interactions (DDIs) are major causes of preventable morbidity and mortality, and have occasionally caused the withdrawal of approved drugs from the US market. The overarching goal of FDA’s DDI program is to promote public health by effectively leveraging the totality of information submitted or reported throughout a drug or biologic product life-cycle to determine the potential for clinically significant DDI, develop appropriate management strategies for them, and effectively convey this information to the healthcare provider and ultimately the public. In December 2017, FDA published two draft guidances

… read more

to update and replace the 2012 revised draft DDI guidance for industry. The “In Vitro Metabolism and Transporter-Mediated Drug-Drug Interaction Studies” draft guidance focuses on in vitro experimental approaches for evaluating metabolizing enzyme- and transporter-based drug interaction potential and how to extrapolate in vitro data to decide on the need for clinical DDI studies. The “Clinical Drug Interactions Studies—Study Design, Data, Analysis, and Clinical Implications” draft guidance focuses on clinical studies that evaluate the potential for DDIs and advises sponsors on the timing and design of the clinical studies, interpretation of the results, and options for managing DDIs in patients. A DDI-specific prescription drug labeling and other problem specific “modular” guidances are also planned to support these foundational documents. In the US, the prescription drug labeling is the primary mechanism through which FDA and drug manufacturers communicate essential, science-based prescribing information to healthcare providers. The prescription drug labeling should include a summary of essential DDI information that is needed for the safe and effective use of the drug by the healthcare provider. This information can include data and results from prospective clinical DDI studies, population-based analyses, modeling and simulations, postmarketing reports, or data extrapolated from other information. As part of the Agency’s labeling initiative, guidances and best labeling practices for communicating DDI-related information in prescription drug labeling are planned or being created as well as innovative approaches to enhance clarity, utility, and comprehension (e.g., tables, figures, structured text, etc.).

The next presentations in the regulatory session was on ‘The new FDA Guidance on In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies’ given by Aleksandra Galetin, PhD, Centre for Applied Pharmacokinetic Research, The University of Manchester, and on ‘The new FDA In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Guidance – A Perspective from Practice’ given by Andrew Parkinson, PhD, XPD Consulting, Shawnee KS, USA.

The three presentations were followed by an intense podium discussion. One focus was the call for even more harmonization between the different guidances to avoid unnecessary duplication of work and different interpretation of the same scientific data in different parts of the world.

In the second part of this Session on “Changes in the US/EU Regulatory Landscapes” there were presentations on ‘PBPK Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective’ given by Edgar L. Schuck, PhD, Modeling and Simulation, Clinical Pharmacology Sciences, MDC, Eisai, USA. The next presentation focused on ‘Dynamic Drug Labels for Optimal Management of DDIs in Patient Care’ and was given by David Burger, PharmD, Radboud University Medical Center, Nijmegen, The Netherlands. The session then concluded with a presentation on ‘Assessment of Two DDIs Involving a Distinct Enzyme and Their Consequences on Morbi-Mortality’ given by Béatrice Saint-Salvi, PhD, DDI Unit, ANSM, France. These presentations again were followed by a lively podium discussion with the three speakers.

The subsequent program consisted of three more scientific sessions, as well as selected oral presentations of some of the poster presentations and a concluding Questions & Answer session.

The first session was called ‘Phenotyping Revisited’ with two presentations on ‘Can DDIs of Direct-Acting Oral Anticoagulants (DOACs) be Predicted by Using a Micro-Dosed DOAC Cocktail Approach?’ given by Gerd Mikus, MD, Heidelberg University Hospital, Heidelberg, Germany, and another on ‘Mechanistic Assessment of Pharmacokinetic DDIs – Phenotyping Revisited’ by Uwe Fuhr, MD, University of Cologne, Cologne, Germany.

The second session was about ‘Sensitivity Assessment in PBPK: Foe or Friend’ and featured presentations on ‘Deciphering Sensitivity Analysis in PBPK: Model Credibility, Uncertainty, Verification and Validation’ by George D. Loizou, PhD, Head of Computational Toxicology Team, Health Risks, HSL: HSE‘s Health & Safety Laboratory, Buxton, Derbyshire, UK, as well on ‘In Search of Sensitive Endogenous Markers for Transporter DDIs – Mechanistic Models for Creatinine and Coproporphyrin I’ by Aleksandra Galetin, PhD, Centre for Applied Pharmacokinetic Research, The University of Manchester, Manchester, UK.

The final session on ‘Non-CYP Related Metabolic DDIs’ featured a presentation on ‘Non-CYP Related Metabolic DDIs with Particular Emphasis on UGT-based DDIs’ by Janne T. Backman, MD, Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

The meeting then concluded with five excellent presentations from selected posters presentations and as usual, the final wrap-up discussion of the workshop. As in every year, a wide variety of DDI-related topics were discussed including experimental, clinical and regulatory issues.

Finally, this meeting report would not be complete without mentioning the beautiful guitar concert by Eckhard Freund and Özkan Yalkinoglu with inspiring and meditative guitar music, as well as the many networking opportunities for the attendance to engage in informal interaction with colleagues form industry, academia and the regulatory agencies.

The Workshop Organizers

Hartmut Derendorf, PhD, FCP
Robert Hermann, MD, FCP
Amin Rostami-Hodjegan, PhD, FCP
Oliver von Richter, PhD, FCP

… read less


Speakers 2018

Grillo, Joseph A (PharmD)
FDA, Waschington D.C., USA

Galetin, Aleksandra (PhD)
Centre for Applied Pharmacokinetic Research, Manchester, UK

Parkinson Andrew (PhD)
XPD Consulting, Shawnee KS, USA

Schuck Edgar L. (PhD)
Eisai, USA

Burger David (PharmD)
Radboud University Medical Center,Nijmegen,The Netherlands

Saint-Salvi Béatrice (PhD)
DDI Unit, ANSM, France

Mikus, Gerd (MD)
Heidelberg University Hospital, Heidelberg, Germany

Loizou, George D. (PhD)
HSE‘s Health & Safety Laboratory, Buxton, Derbyshire, UK

Fuhr, Uwe (MD)
University of Cologne, Cologne, Germany

Backman, Janne T. (MD)
University of Helsinki and Helsinki University Hospital, Helsinki, Finland


Attendee Quotations 2018

  • Most valuable – DDI perspectives from regulatory agencies and presentations on the changes in the regulatory landscape.
  • The meeting provided an excellent and comprehensive overview on drug interactions from lab to labelling.
  • Wishing to expand my pharmacometrics researches into the translational side, this was a precious chance to get in depth knowledges on current issues of PBPK and DDI.
  • I am to hold internal seminars for my team members with slides and references shared in Marbach workshop. – Tons of tasks to learn further!
  • Thank you for organizing such a nice meeting and all the hospitalities. It was a pleasure to participate in this interactive workshop to learn key DDI issues in depth.
  • I’ll take this opportunity to let you know how vastly I enjoyed the meeting, both its professional and social aspects.
  • The vivid discussions around the topic were truly stimulating.
  • Thank you for the perfect organization of the workshop. I’ve enjoyed the workshop as it has been a great opportunity to discuss challenging topics and to meet interesting people.
  • It was a very good workshop, very well organized. This was a good selection of topics.
  • Many thanks for an excellent and enjoyable workshop! I sincerely hope that you will go on with this tradition!
  • I did enjoy the meeting a lot and had a lot of inspiration and carried new ideas with me home. Also, very valuable contacts of a lot of nice people that I met.
  • The poster session and the related discussions were very good.
  • I’ve enjoyed the open discussions and the collaborative environment.
  • Contact to interesting people, relaxing atmosphere, great place.
  • Great discussions with colleagues at this marvellous location.

Workshop Programme 2018

8th International Marbach Castle DDI Workshop

May 28 to 30, 2017


Speakers 2017

Huang, Shiew-Mei (PphD)
FDA, Silver Spring, MD, USA; 2017

Sinha, Vikram (PhD)
MSD, North Wales, PA, USA

Cole, Susan
MHRA, London, UK

Nordmark, Anna (PhD)
Medical Products Agency (MPA), Uppsala, Sweden; 2017

Reddy, Venkatesh Pilla (PhD)
AstraZeneca, Cambridge, UK; 2017

Blume, Henning (PhD)
SocraTec R&D GmbH, Bad Homburg, Germany; 2017

Olivares-Morales, Andrés (Pharm D, PhD)
F. Hoffmann-La Roche, Basel, Switzerland; 2017

Scherrmann, Jean Michel (PhD)
Inserm, UMR-S Université Paris Descartes, Paris, France; 2017

Unadkat, Jashvant (PhD)
University of Washington, Seattle, WA, USA; 2017

Zolnerciks, Joseph K (PhD)
Solvo Biotechnology, Seattle, USA; 2017

Stopfer, Peter (PhD)
Boehringer Ingelheim, Biberach, Germany; 2017

Neuhoff, Sibylle (PhD)
Certara, Sheffield, UK; 2017

Parkinson, Andrew (PhD)
XPD Consulting, Shawnee, Kansas, USA; 2017


Attendee Quotations 2017

  • The whole meeting was very relevant.
  • All great speakers with interesting and relevant talks. Great for networking as it is a small meeting. Stunning location. Perfect agenda with mix of talks and breaks.
  • I enjoyed all the talks. This is my first Marbach DDI meeting – great location, talks …; looking forward again for this meeting!
  • Overall it’s an excellent workshop. For me the most valuable contents are the formulation dependent DDI and Blood Brain Barrier session.
  • The discussion with colleagues and the presentations of the speakers were most valuable. Panel discussions and Q&A sessions were very informative.
  • Complete and comprehensive presentations, very good and useful examples.
  • High quantity of PBPK presentations (and quality!), good mixture between industry/academic/regulatory presentations. Good number of participants.
  • Hearing from representatives from the FDA and EMA is very valuable!
  • Most valuable to me were the Guideline presentations by different representatives from Health Authoritie.
  • I found the ‘Transporter Probe-Drug Cocktail’ presented by P. Stopfer and discussion extremely valuable.
  • The discussion after each talk, especially when the questions involved the regulatory colleagues and the exchange that occurred.
  • Networking during dinners etc., personal interaction with regulators.

Workshop Programme 2017

7th International Marbach Castle DDI Workshop

May 29 – 31, 2016

THE 7TH INTERNATIONAL DRUG-DRUG INTERACTION (DDI) WORKSHOP AT MARBACH CASTLE ENJOYED CONTINUED ATTENTION, APPRECIATION AND ENDORSEMENT BY INTERNATIONAL ACADEMIC, INDUSTRY AND REGULATORY SCIENTISTS

More than 80 experts attended the 7th international DDI Workshop and discussed current topics of regulatory requirements and scientific aspects of drug-drug interactions. The meeting was once again fully booked several weeks in advance, indicating that the DDI Workshop series has become a focal point in the calendar for those concerned with the topic and its unmet needs. Thus, the workshop continues to enjoy from an unbroken popularity, appreciation and endorsement by the participating speakers and attendees.

The meeting started with a mind-opening key note lecture on “Approaches to DDI Challenges in Global Health” presented by Steven E. Kern from the Bill and Melinda Gates Foundation, Seattle.

Dr. Kern emphasized that treatment of people in a global health context for communicable diseases presents numerous challenges for drug development scientists. Therapies for a single condition typically require multiple therapeutic agents to successfully provide cure. For malaria, this usually involves 2 drugs, for HIV 3 drugs, and tuberculosis 4 drugs as standard therapy.

… read more

Treatment of parasitic diseases may include from 1 to 3 additional agents given concomitantly; and for women of child bearing age, these therapies may be administered on top of a long acting contraceptive agent. With these conditions, the potential for DDIs that produce a clinically significant impact is great. Dr. Kern reported that scientists at the Bill & Melinda Gates Foundation, are working with drug development partners to bring the full strength of model based drug development tools to support development of new therapeutics for these diseases and where relevant, improved use of existing therapeutics. This approach includes significant effort in understanding the mechanisms and risks of drug/drug interactions with the standard therapeutic agents used across disease areas so that developers of new therapeutic agents can benefit from these insights as they move forward with development efforts for these agents.

The subsequent programme consisted of six scientific sessions, as well as a meeting with poster presentations and a concluding Questions & Answer session.

The first session was dedicated to focus on current changes in the US regulatory landscape. Specifically the performance criteria of PBPK modeling for the regulatory assessment of DDI risks were presented (Ping Zhao, PhD, Bethesda, USA), and the latest tools and Guidances in the assessment of food-drug interactions in drug development (Tycho Heimbach, PhD, Novartis, USA).

The second session was about DDIs affecting the renal elimination of drugs, with one presentation elucidating the underlying mechanisms of renal DDIs (Maciej Zamek-Gliszczynski, PhD, Glaxo Smith Kline, USA), and another talk focusing on the clinical relevance of renal DDIs (Prof. Martin Fromm, University of Erlangen-Nürnberg, Germany).

The Marbach event has not been just a venue for presentation of the latest scientific discoveries but it has always dedicated a portion of the timetable to address fundamental principles governing various aspects of DDI. This year was not an exception. Hence, the third session was dedicated to revisiting key concepts such as the proper quantification of the fraction of drugs metabolized (fm; Prof. Amin Rostami-Hodjegan, University of Manchester, UK), and the fraction unbound (fu; Oliver von Richter, PhD; Sandoz Biopharmaceuticals, Holzkirchen, Germany).

The fourth session was designed to illustrate the multiple important aspects of DDIs with hormonal contraceptives including public health and drug development considerations (Prof. Lawrence J. Lesko, University of Florida, Orlando, USA), and the presentation of an industry perspective on their assessment during drug development (Joachim Hoechel, DVM, PhD; Bayer Pharma AG, Germany).

Session five addressed the challenges of the effective clinical management of DDIs. Prof. Walter E. Haefeli (University Hospital Heidelberg, Germany) reported about experiences and common challenges with DDI management systems in the hospital setting. He emphasized that whether or not an issued DDI alert by such systems is considered by the receiver/prescriber depends on the quality of the alert (specificity), setting and process, alert presentation (human factors), and alerting methods (e.g. interruptive alerting). Sustainable DDI decision support systems must therefore integrate the multitude of influential factors to be effective and to prevent alert fatigue of their users. In the second talk of this session, Helen Humphries (Certara, Sheffield, UK) presented approaches to the individualization of DDI management by highlighting the difficulties associated in determining some of the patient attributes which help in personalizing the management of DDI.

The final session comprised four talks on various aspects of complex DDIs, starting with the evaluation of incidence and relevance of complex DDIs in the clinical setting (Youssef Daali, PhD; Geneva University Hospital, Switzerland). Prof. Nina Isoherranen (University of Washington, Seattle, USA) presented considerations on what do when clinical DDI data does not agree with existing in vitro findings and predictions. The two final presentations addressed common pitfalls in the assessment of complex DDIs when conducting PBPK DDI studies (Mohamad Shebley, PhD; Abbvie, USA), and in vitro DDI studies (Brian Houston, BSc, PhD and DSc, University of Manchester, UK).

… read less


Speakers 2016

Daali, Youssef (PhD)
Geneva University Hospital, Geneva, Switzerland; 2016

Fromm, Martin (MD)
University of Erlangen-Nürnberg, Germany; 2016

Haefeli, Walter E. (MD)
Heidelberg University Hospital, Heidelberg, Germany; 2016

Heimbach, Tycho (PhD)
Novartis Pharma, East Hanover NJ, USA; 2016

Höchel, Joachim (DVM, PhD)
Bayer Pharma AG, Berlin, Germany; 2016

Houston, Brian (BSc, PhD and DSc)
Centre for Applied Pharmacokinetic Research, Manchester Pharmacy School, University of Manchester, UK; 2016

Humphries, Helen (PhD)
Certara Sheffield, UK; 2016

Isoherranen Nina (PhD)
University of Washington, Seattle WA, USA; 2016

Kern, Steven E. (PhD)
Bill and Melinda Gates Foundation, Seattle WA, USA; 2016

Lesko, Lawrence J. (PhD)
University of Florida, Lake Nona, FL, USA; 2016

Rostami-Hodjegan, Amin (PharmD, PhD, FCP)
University of Manchester, UK; 2016

Shebley, Mohamad (PhD)
Abbvie, Chicago IL, USA; 2016

von Richter, Oliver (PhD, FCP)
Sandoz Biopharmaceuticals, Holzkirchen, Germany; 2016

Zamek-Gliszczynski, Maciej (PhD)
Glaxo Smith Kline, King of Prussia, PA, USA; 2016

Zhao, Ping (PhD)
Bethesda MD, USA; 2016


Attendee Quotations 2016

  • All presentations were of high quality, notably the clinical aspects of DDI (clinical relevance);
  • Nice spectrum from in vitro to in vivo, in silico, clinical perspective; Construction / design of sessions;
  • The FDA point of view on DDI was really an interesting topic; Food effects in drug development was also an important topic for me as well as the key prinicples presentations about fm and fu;
  • Very good ratio from presentations / discussions; bring together the various standpoints, medicine / PBPK moddeling, in vitro, industry;
  • All presentations were of high quality, notably the clinical aspects of DDI (clinical relevance);
  • As PBPK modeller, I found regulatory presentation & comments very useful as well as many discussion with participants;
  • There is a lot time for discussion; Many opportunities to interact with the rest of participants;
  • I enjoyed the opportunities for interaction between participants & speakers;

Workshop Programme 2016

6th International Marbach Castle DDI Workshop

May 03 – 05, 2015

HIGHLY SATISFIED PARTICIPANTS AT THE SIXTH INTERNATIONAL DRUG-DRUG INTERACTION (DDI) WORKSHOP 2015 AT MARBACH CASTLE, GERMANY

At the sixth International Drug-Drug Interaction Workshop more than 80 experts discussed regulatory requirements and current scientific aspects on the preclinical and clinical investigation of drug-drug interactions. Several scientific highlights proved the high quality of this meeting and the DDI Workshop participants confirmed in the feedback protocols that they were highly satisfied with the 6th DDI Workshop at Marbach Castle.

The Drug-Drug Interaction Workshop series at Marbach Castle enjoys an unbroken popularity and the number of participants has remained consistently high over the years. The organizers of the DDI Workshop are highly pleased to see that the DDI Workshop is widely recognized and well established. This year the DDI Workshop was fully booked several weeks before the Workshop started.

Robert Hermann, member of the organization team, states: “Again the feedback of the participants was very positive and the organization team is very satisfied that the scientific programme was well accepted. All speeches and presentations of the meeting were scientifically on a very high level and the positive assessment of the Workshop participants generates a big challenge for the organization team to prepare such high quality meetings also in the upcoming years.”

Five scientific sessions were designed to focus on drug-drug interactions involving clinical aspects, regulatory aspects, determination of intracellular drug concentrations as well as influences on drug safety. The issues were covered by distinguished international scientists and experts from academia, pharmaceutical companies, contract research organizations, consultancies as well as governmental and regulatory agencies.

More (News release)


Speakers 2015

Antoine, Daniel J (PhD)
University of Liverpool, UK

Derendorf, Hartmut (PhD, FCP)
College of Pharmacy, University of Florida, USA

Faller, Bernhard (PhD)
Novartis Institutes for BioMedical Research, Basel, Switzerland

Gosh, Avijit (PhD)
Johnson & Johnson, Pennsylvania, USA

Hermann, Robert (MD, FCP)
cr.appliance, Germany

Juurlink, David (MD, PhD)
Sunnybrook Health Science Center, Toronto, Canada

Ke, Alice (PhD)
Certara, Cary NC, USA

Lesko, Larry (PhD)
University of Florida, Lake Nona, FL, USA

Nordmark, Anna (PhD)
Medical Products Agency (MPA), Uppsala, Sweden

Pollak, Sebastian (PhD)
Jagiellonian University, Krakow, Poland & Certara, Sheffield, UK

Snoeys, Jan (PhD)
Janssen, Beerse, Belgium

Sugiyama, Yuichi (PhD)
RIKEN Innovation Center, Yokohama, Japan


Attendee Quotations 2015

  • Practical and regulatory approaches of clinical DDI studies; Use of PBPK models to waive part of DDI studies: regulatory position & real experience from the field.
  • The program overall was very varied and at the same time very focused; Good networking opportunities.
  • The diversity – in vitro – in vivo – clinical – regulatory etc.; Organization – the slides are available. Q&A is encouraged.
  • The discussions and feedback during the breaks. Day I more interesting compare to day 2 (except Sugiyama).
  • Fruitful discussion with colleagues during the whole workshop.
  • All discussions were of high quality and interest, particularly data from modelisation, simulations!
  • DDIs clinical settings, real-world clinical practise DDIs, regulatory aspects, ketoconazole, FDA food-drug interactions, PBPK.

Workshop Programme 2015

5th International Marbach Castle DDI Workshop

May 25 to 27, 2014

THE 5TH DRUG-DRUG INTERACTION (DDI) WORKSHOP AT MARBACH CASTLE IS HIGHLY RATED BY PARTICIPANTS

More than 70 experts in drug development and drug-drug interactions from 14 countries took part in the scientific meeting entitled “DDI 2014 – 5th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions” at Marbach Castle on Lake Constance between 25 and 27 May. Feedback on the workshop from participants was consistently positive. The DDI Workshop is now confirmed as a scientific platform that has proven itself as an event for the exchange of ideas between representatives from academic, regulatory health authorities and industry. This was also evident at the anniversary event this year, which focussed on new approaches to studying drug-drug interactions in drug development, the significance of transporter based interactions, and the new draft of the Japanese guideline. These areas were also complemented by the topic of food-drug and herb-drug interactions. The new addition of a poster presentation was well received and is to be included in the programme again next year.

More (Press release)


Speakers 2014

Butterweck, Veronika (PhD)
Graduate School for Life Sciences / Institute for Pharmaceutical Technology,
Muttenz / Basel, Switzerland

Fromm, Martin (MD)
University of Erlangen-Nürnberg, Germany

Hermann, Robert (MD, FCP)
cr.appliance, Germany

Hisaka, Akihiro (PhD)
The University of Tokyo Hospital, Japan

Lesko, Larry (PhD)
University of Florida, Lake Nona, FL, USA

Maeda, Kazuya (PhD)
The University of Tokyo Hospital, Japan

Meyer zu Schwabedissen, Henriette (MD)
University of Basel, Switzerland

Parkinson, Andrew (PhD)
XPD Consulting, Shawnee, Kansas, USA

Rostami-Hodjegan, Amin (PharmD, PhD, FCP)
University of Manchester, UK

Schwab, Dietmar
Hoffmann La Roche Pharmaceuticals, Basel, Switzerland

Stevens, Lloyd (PhD)
Quotient Clinical, Nottingham, UK

von Richter, Oliver (PhD, FCP)
Dept. Exploratory Medicine, Merck Serono, Germany

Weitschies, Werner (PhD)
University of Greifswald, Germany


Attendee Quotations 2014

  • One of the best meetings joined within the last years; Highly interactive; Quite a few ‘mind-widening’ talks.
  • Discussion after the talks war very open and informative; I also found the broad range of backgrounds and quality of speakers was excellent.
  • Networking opportunities. Getting to knew colleagues on more professional and personnel level; Nice to see many regular and new attendees; Really enjoyed Henriette Meyers and Andrew Parkinson’s presentations.
  • Sufficient breaks for networking, program not overload, great food, great concert; Great location (except infrastructure).
  • Small group talks during spare time with other participants.
  • Room for easy interaction between participants; Bringing regulators, academia & industry together.
  • Interaction with other people; Poster session with presentation on protein content / transporter functionality; session on chemistry <–> transporter liability.
  • A very useful workshop; All issues – incl. social activities – were very useful and of high quality; Will join the workshop 2015
  • Congrats to the organisers, thanks.

Workshop Programme 2014

4th International Marbach Castle DDI Workshop

May 26 to 28, 2013

FOUR YEARS OF THE INTERNATIONAL DDI WORKSHOP IN MARBACH CASTLE – A REAL SUCCESS STORY

The organisation team of the international Drug-Drug Interaction (DDI) Workshop in Marbach Castle on Lake Constance was happy to report the great acceptance and success of the events series in its fourth year. More than 70 drug development experts and representatives of health authorities participated in the scientific event “DDI 2013 – 4th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions”. The fourth DDI Workshop (26th – 28th May) was once more represented internationally. In attendance were nine speakers from the USA, three from Great Britain, three from Germany and one from Switzerland and Sweden respectively. The participants came from 10 countries in total.

More (Press release)


Speakers 2013

Back, David J (PhD)
University of Liverpool, UK

Derendorf, Hartmut (PhD, FCP)
College of Pharmacy, University of Florida, USA

Gil Berglund, Eva (PhD)
Medical Product Agency (MPA), Sweden

Fahmi, Odette A. (PhD)
Pfizer Inc., Global Research & Development, Groton, USA

Greenblatt, David J (MD)
Tufts University, Boston, USA

Hennessy, Sean (PharmD, PhD)
University of Pennsylvania, USA

Meibohm, Bernd (PhD, FCP)
College of Pharmacy, University of Tennessee, Memphis, USA

Mikus, Gerd (MD)
University of Heidelberg, Germany

Obach, R. Scott (PhD)
Pfizer Inc., Global Research & Development, Groton, USA

Parkinson, Andrew (PhD)
XPD Consulting, Shawnee, Kansas, USA

Rodvold, Keith A. (PharmD, FCCP, FIDSA)
University of Illinois, Chicago, USA

Rostami-Hodjegan, Amin (PharmD, PhD, FCP)
University of Manchester, UK

Russmann, Stefan (MD)
University Hospital Zurich, Switzerland

Shepard, Terry (PhD)
Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK

von Moltke, Lisa (MD, FCP)
Genzyme, Cambridge, United States


Attendee Quotations 2013

  • Bringing together world-wide leaders in the field of DDI in an inspiring and “entertaining” setting.
  • Combining in-vitro/preclinical, clinical development and this year also post marketing views and perspectives on DDI in a well balanced way.
  • The time for discussion of questions.
  • Networking with others at break time & dinner.
  • Highly professional overall organization!
  • Very interesting guests to interact with.
  • Lots of interesting talks & discussions. Thank you very much.

Workshop Programme 2013

3th International Marbach Castle DDI Workshop

May 06 to 08, 2012

ALUABLE SCIENTIFIC DISCUSSIONS AT THE THIRD INTERNATIONAL DDI WORKSHOP AT MARBACH CASTLE, LAKE CONSTANCE

The organisation team of the Third International DDI (drug-drug interactions) Workshop has expressed great satisfaction with the course of the scientific meeting. The participants of the DDI Workshop commended the very high scientific level of the presentations and valuable and inspiring discussions of the different topics. Without a doubt, the DDI Workshop at Marbach Castle is a well established platform for the annual exchange between experts, scientists, members of the industry and regulatory bodies regarding DDI affairs. This year more than 80 experts from 14 countries attended the DDI Workshop. The speakers came from 6 different countries (USA, Germany, Great Britain, Finland, Sweden, and New Zealand), thereof 5 from the US. They presented scientific news, the content of the draft guidelines and state of the art lectures. The scientific sessions covered different aspects to current regulatory issues, UGT-based DDIs, transporter-based DDIs and pharmacodynamic DDIs.

More (Press release)


Speakers 2012

Derendorf, Hartmut (PhD, FCP)
College of Pharmacy, University of Florida, USA

Gil Berglund, Eva (PhD)
Medical Product Agency (MPA), Sweden

Hermann, Robert (MD, FCP)
cr.appliance, Germany

Härtter, Sebastian (PhD)
Boehringer Ingelheim Pharma GmbH, Germany

Keppler, Dietrich (MD)
German Cancer Research Center (DKFZ), Heidelberg, Germany

Lee, Caroline (PhD)
on behalf of the PhRMA ABCB1 IC50 consortium, USA

Lesko, Larry (PhD)
University of Florida, Lake Nona, FL, USA

Niemi, Mikko (MD)
University of Helsinki, Finland

Parkinson, Andrew (PhD)
XPD Consulting, Shawnee, Kansas, USA

Rostami-Hodjegan, Amin (PharmD, PhD, FCP)
University of Manchester, UK

Vieira, Manuela
College of Pharmacy, University of Florida, USA

von Richter, Oliver (PhD, FCP)
Dept. Exploratory Medicine, Merck Serono, Germany

Winter, Helen (PhD)
School of Pharmacy, University of Otago, New Zealand


Attendee Quotations 2012

  • Polling session was good attempt to foster discussion.
  • Many excellent presentations.
  • Information on all the in vitro studies available to perform DDI studies.
  • Very informative lectures.
  • Meeting colleagues/experts.
  • Wonderful location…
  • The regulatory perspectives were the most valuable; Besides, the poll session was very insightful.
  • The musical performance – Compliments to the organizers for a job well done!

Workshop Programme 2012

2th International Marbach Castle DDI Workshop

May 01 to 03, 2011

HIGH SCIENTIFIC LEVEL AT THE SECOND INTERNATIONAL WORKSHOP ABOUT DRUG-DRUG INTERACTIONS AT MARBACH CASTLE, LAKE CONSTANCE

The organisation team of the Second International DDI (drug-drug interactions) Workshop has expressed great satisfaction with the course of the scientific meeting. This was also confirmed by the outcome of a feedback survey given to the participants. Both the scientific level of the presentations and discussions as well as the breadth of the topics covered were judged positively. Many already expressed interest in the third DDI Workshop in 2012. Thus the DDI Workshop at Marbach Castle is on its way to become an established platform for the annual exchange between experts, scientists, members of the industry and regulatory bodies regarding DDI affairs.

More (Press release)


Speakers 2011

Bolger, Michael (PhD)
Simulations Plus, Inc., Lancaster, USA

Christians, Uwe (MD, PhD)
University of Colorado, Denver, USA

de Mey, Christian (MD, PhD)
ACPS – Applied Clinical Pharmacology Services, Mainz-Kastel, Germany

Derendorf, Hartmut (PhD, FCP)
College of Pharmacy, University of Florida, USA

Gramatté, Thomas (MD, PhD)
Drug Development Consulting, Munich, Germany

Haverkamp, Wilhelm (MD, PhD)
Department of Cardiology, Charité Berlin, Germany

Hermann, Robert (MD, FCP)
cr.appliance, Germany

Machavaram, Krishna (PhD)
Simcyp Ltd., Sheffield, UK

Parkinson, Andrew (PhD)
XPD Consulting, Shawnee, Kansas, USA

von Richter, Oliver (PhD, FCP)
Dept. Exploratory Medicine, Merck Serono, Germany

Rostami-Hodjegan, Amin (PharmD, PhD, FCP)
University of Manchester, UK

Sparreboom, Alex (PhD)
St. Jude Children ́s Research Hospital, Memphis, TN, USA

Venkatakrishnan, Karthik (PhD)
Millennium, Cambridge, USA


Attendee Quotations 2011

  • Relevant presentations; venue & staff at venue!; organisers!!
  • Very good time discipline of speakers!
  • Great workshop were session I and the presentations on DDI in oncology were the most valuable for me. In addition the discussions following the presentations were very valuable as well.
  • Excellent meeting overall – great location/facility.
  • Excellent location/venue; Clinical aspects on DDIs; Concert.

Workshop Programme 2011

1th International Marbach Castle DDI Workshop

May 30 to June 01, 2010

Organizers of international workshop on drug-drug interactions register high acceptance from participants which are acknowledging the great benefit

The organisation team reports a big success regarding the drug-drug-interaction (DDI) workshop, which was held from May 30th to June 01st at Marbach Castle, Lake Constance in Germany. More than 60 experts from 11 countries and 5 participants at the industry exhibition joined the meeting on DDIs.

New methods and approaches for the investigation of drug candidates have become necessary due to the increasing complexity of this scientific area. Changes in the existing guideline on drug interactions must follow. Recently the European Medicines Agency (EMA) published a draft of the revised guideline, which was discussed in several talks at the DDI Workshop. In the US a new version of the existing FDA drug interaction guideline is under discussion but not published yet. Discussion of the current scientific status between representatives of the industry, regulatory bodies, and academia are of great importance and were successfully realized at the DDI Workshop.

More than 60 experts for drug development participated in the international DDI Workshop at Marbach Castle. Over a period of two days they listened to 14 expert presentations and discussed intensively the latest scientific and regulatory trends in the investigation of DDIs. Most of the participants were experts from the pharmaceutical industry. Almost all big companies were represented at the workshop. It was a big advantage that speakers and participants from regulatory bodies as well as academic institutions were also present generating useful and inspiring discussions and interdisciplinary exchange.

More (Press release)


Speakers 2010

Derendorf, Hartmut (PhD, FCP)
College of Pharmacy, University of Florida, USA;

Fuhr, Uwe (MD)
Clinical Pharmacology, University of Cologne, Germany;

Gil Berglund, Eva (PhD)
Medical Product Agency (MPA), Sweden;

Hermann, Robert (MD, FCP)
cr.appliance, German;

Parkinson, Andrew (PhD)
XPD Consulting, Shawnee, Kansas, USA;

Ragueneau-Majlessi, Isabelle (MD)
Dept. of Pharmaceutics, University of Washington, USA;

Rostami-Hodjegan, Amin (PharmD, PhD, FCP)
University of Manchester, UK;

von Richter, Oliver (PhD, FCP)
Sandoz Biopharmaceuticals, Holzkirchen, Germany;


Attendee Quotations 2010

  • The creation of such a platform is of great importance!
  • Small size allowed good interactions among participants & speakers;
  • This workshop provided a comprehensive overview of DDIs across the scientific, clinical and regulatory aspects, making it a unique educational experience and providing opportunity for active scientific and strategic discussion and debate in this emerging inter-disciplinary area;
  • Excellent overview and forum; Perfect timing for discussing the new guidance;
  • Providing presentation on a USB drive = excellent;
  • Boat trip, music, coffee, snacks etc = brilliant!

Workshop Programme 2010