There has been an unprecedented level of interaction between the U.S. Food and Drug Administration and the European Medicines Agency over the past 10 years under confidentiality arrangements originally signed in 2003 and updated in 2010. These arrangements enable scientific staff exchanges and visits, regular communication on specific “clusterspecific” areas such as drug interactions, informal dialogue between the respective regulatory leads on draft guidelines, and ad hoc meetings and workshops. Both FDA and EMA separately issued new guidance/guidelines on drug interaction studies in 2012 following a significant amount of interaction between scientist-reviewers at the two agencies. Drug interactions are complex. Pharmaceutical companies struggle with detailed interpretation of guidances/guidelines and must be aware of the subtle differences between the two drug interaction guidelines/guidances in order to develop efficient strategies for drug interactions studies that will impact product label claims and potentially post-marketing requirements. This presentation will focus on some of the major differences and similarities in evaluating drug interactions between the decision-tree laden FDA guidance and the considerably shorter EMA guideline. It will also discuss crucial issues that arise between companies and regulators when discussing drug interactions such as: greater clarity around transporters, validating mechanistic PBPK models, the acceptance PBPK models to waive clinical studies, generating user-friendly labeling, use of CYP and transporter cocktail studies and future system pharmacology approaches to understanding and predicting drug interactions. Aside from the regulations, the laws and the guidance/guidelines which govern the scientific and technical conduct of drug interaction studies, there is the “art” of regulatory decision making based on the “facts” rendered by these studies. This presentation will touch on huge uncertainties that can come into play because of the heterogeneity in judgment and values of individual assessors.

Our May 2013 meeting is generously sponsored by:

Silver Sponsors

Corning Life Sciences

Optivia Biotechnology

Bronze Sponsors

Waters Corporation