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Cosponsored with the U.S. Food and Drug Administration 

Background  |  Goals and Objectives  |  Who Should Attend 


   

Background

The Joint AAPS/ITC Workshop on Drug Transporters in 2016 will deliver cutting edge science in a focused and “state-of-the-art” meeting. Key areas of focus will include:

  • novel science on transporter expression and function at the blood-brain barrier and how to target such transporters for optimization of CNS drug delivery,
  • current knowledge on transporters in “nontraditional” tissues such as the eye, lung, and testis,
  • emerging transport proteins and their role in health and disease,
  • recent advances in guiding drug development teams to achieve hepatoselectivity and optimizing clearance for OATP substrate drugs,
  • utility of animal models for the study of transporter-mediated pharmacokinetics and drug-drug-interactions,
  • clinical correlation of transporter polymorphisms,
  • correlation between transporter pharmacology and transporter toxicology,
  • transporter considerations in pediatric populations, and
  • a review of the upcoming U.S. Food and Drug Administration (FDA) regulatory guidance on transporter-mediated drug-drug interactions.

Goals and Objectives

Drug transporter research continues to grow at an unprecedented pace. These rapid advances have been driven, in part, by the emergence of regulatory guidance documents from the FDA, European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) in the last 5 years. Although considerable progress has been made over the past 20 years, the field of drug transport continues to evolve, particularly with respect to clinical translation of preclinical (i.e., in vitro, in vivo, in silico) data, understanding the role of transporter polymorphisms on drug pharmacokinetics, molecular machinery involved in regulation of drug transporters, and the role of transporters in health and disease. The AAPS workshop in 2016 aims to continue on the success of preceding AAPS workshops on drug transporters in ADME meetings (2003, 2005, 2007, 2009, 2011, 2013, 2015) to provide an opportunity for pharmaceutical scientists to exchange ideas and learn novel/cutting edge science in a focused and “state-of-the-art” meeting. Key areas of focus will include:

  • blood-brain barrier and targeting transporters for optimization of drug delivery to the brain,
  • utility of in vitro and in vivo transporter data in predicting drug hepatoselectivity, pharmacokinetic changes, and drug-drug interactions,
  • state-of the art sessions on novel transporter targets in health and disease, transporter regulation and functional expression in tissues that are not typically studied such as the testis, eye, and lung, role of transporter polymorphisms in predicting clinical pharmacokinetics and drug efficacy,
  • involvement of transporters in drug toxicity,
  • transporter considerations in pharmacotherapy of children, and
  • regulatory guidance review of transporter-mediated drug-drug interaction data.

Who Should Attend

The target audience is international and includes attendees from industry, academia including graduate students and postdoctoral fellows, and regulatory authorities (i.e., FDA, EMA, PMDA). The poster sessions and poster podium attract a wide range of submissions. This session is intended to highlight cutting-edge transporter science and to emphasize the contributions of graduate students, postdoctoral fellows, and early-career scientists.