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. 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).

 

Workshop Programme 2016