Background, History, Scope & Aim

In June 2010, the International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions was held for the first time.

The Workshop was based on an initiative of experts in the field from academia and industry, who noted that the field of drug-drug interactions (DDIs) is increasingly important and complex in view of continuously emerging new therapies, new drug combinations, complex treatment algorithms for many widespread diseases and ageing populations.

These factors converge with poly-pharmacotherapy especially in elderly and medically complex patient populations with an increased risk of clinically significant DDIs.

Therefore, the meticulous investigation, informative labelling, and early recognition of DDIs represent substantial challenges for the pharmaceutical industry and regulatory bodies in the development, approval and post-marketing surveillance of new medicines.

Failures in the early recognition, mechanistic elucidation (i.e. understanding) or appropriate clinical management of DDIs have resulted in numerous drug product withdrawals from the market in the past. The same types of failure continue to cause a health burden to patients, an economic burden on healthcare systems, and render DDIs as serious public safety concerns.

Today, DDIs can be addressed in a more targeted and evidence-based fashion, because considerable progress has been made in the understanding of the underlying mechanisms of DDIs and the subsequent development of methodologies for the investigation of DDI susceptibility, and the extrapolation of outcomes of particular DDIs to other drug combinations.

Study of metabolism based DDIs, transporter based DDIs, DDIs involving therapeutic proteins, tools extrapolating in vitro results to predict clinical outcomes in vivo (IVIVE) as well as information technology guiding the detection and management of DDIs have all gained more importance during recent years.

Furthermore, pharmacodynamic DDIs have gained increasing interest given the steady increase in drug combinations in clinical development.

Since its inception in 2010, the International Marbach Castle DDI Workshop has been designed to comprise all of the elements above, to foster a holistic view on the complex field of DDIs. In order to facilitate an intense exchange on the topic and foster networking across company and organizational borders, the Workshop is an exclusive event and it is limited to about 70 participants from pharmaceutical industry, contract research organizations and drug regulatory agencies, thus providing a unique environment to learn and discuss the current state-of-the-art investigation of DDIs.