Webinar: Drug-Transporter Interactions: Regulatory Perspectives and Relevance to Drug Development

Definitive assessment and application of results to support a drug development program

There is an ever-increasing understanding of the role of transporters in drug disposition and specifically how transporters can contribute to drug–drug interactions and toxicity. At least 12 commercially available drugs have transporter-related information in their Product Labelling. Moreover, with the FDA Draft Guidance on Drug Interactions (2006), the inclusion of Transporters in the FDA’s Critical Path Initiative (2008), the publication of the International Transporter Consortium (ITC) Review Paper (2010) and the EMA Guideline on the Investigation of Drug Interactions (2010) as examples, there is now also clear and substantial regulatory expectation placed on the inclusion of Drug-Transporter Interaction (DTI) assessment as part of a drug development program.

Transporters are transmembrane proteins that mediate the ingress or egress of substances (e.g. drugs) into cells or out of cells and hence are known as uptake and efflux transporters, respectively.Transporters play a key role in homeostasis and protection of organs and tissues. Scientific and regulatory attention currently focuses on the following human transporters as key to drug disposition: P-gp (aka MDR1), Breast Cancer Resistance Protein (BCRP), Organic Cation Transporters 1 & 2 (OCT1 and OCT2), Organic Anion Transporters 1 & 3 (OAT1 and OAT3), Organic Anion Transporting Polypeptide 1B1 and 1B3 (OATP1B1 and OATP1B3), Multidrug Resistance-associated Protein 2 (MRP2) and Bile Salt Export Protein (BSEP).

This presentation will cover current scientific and regulatory perspectives on drug transporters, how we assess drug-transporter interactions and how to apply DTI results in support of a drug development program and regulatory submissions.