The potential for drug-drug interactions (DDIs) involving membrane transporters has become an area of intense regulatory review over the past seven years. As our understanding of the central role transporters play in drug absorption, distribution, and elimination expands, regulatory agencies have increased expectations for drug developers to provide information regarding the contribution of transporters to the clinical efficacy and safety of therapeutic agents.
In an ongoing effort to provide expert review of the latest transporter developments, the International Transporter Consortium (ITC) recently published a series of white papers on a variety of topics related to transporters and their importance in drug development. The publication of these papers was initiated during the 2nd ITC workshop, held in Washington DC last year. The topics range from emerging clinically relevant transporters to the potential of transporter mediated DDIs at the blood-brain barrier (BBB). These white papers give clear directions on the transporters to study, the methods to use, and the development strategy to apply. Also included are industry case studies covering experience conducting clinical development programs under the regulatory guidelines on transporters, future perspectives, and recommendations on where additional research is required.
WHAT ARE THE TAKE HOME MESSAGES FROM THESE PAPERS FOR YOU TODAY?
- THERE ARE A NUMBER OF ADDITIONAL TRANSPORTERS YOU SHOULD SERIOUSLY CONSIDER
- CHOOSE YOUR METHODS WISELY
- ARE WE LOST IN TRANSLATION…?
- TAKE INTO CONSIDERATION CLINICALLY RELEVANT TRANSPORTER POLYMORPHISMS
- EFFLUX TRANSPORTER MEDIATED DDIS AT THE BB ARE UNLIKELY
- WE’VE ACHIEVED A LOT BUT WE STILL HAVE A LOT TO LEARN
DETAILS WILL COME SOON…