2018 AAPS Workshop on Drug Transporters in ADME: From the Bench to the Bedside

Date:

April 16-18, 2018

Location:

Hyatt Regency Dulles
Dulles, Virginia

I. BACKGROUND

The Joint FDA and AAPS Workshop on Drug Transporters in 2018 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 optimize clearance for OATP substrate drugs,
Utility of animal models for the study of transporter-mediated pharmacokinetics and drug-drug interactions (DDIs),
Clinical correlation of transporter polymorphisms,
Correlation between transporter pharmacology and transporter toxicology,
Transporter considerations in pediatric populations, and
A review of global regulatory recommendations on transporter-mediated DDIs.

Goals and Objectives

The 2018 AAPS Transporter Workshop will be the ninth workshop developed to present the next generation of transporters and transport mechanisms that may contribute to absorption, distribution, metabolism and excretion (ADME ) properties of drugs in disease states that should be considered in drug discovery and development. This state-of-the-art workshop will present contributions of heteromeric transporters (ABCG5/G8, ABCD2, OSTα/β) to biliary excretion of cholesterol and disease states, as well as examining intracellular mechanisms of lysosomal sequestration, large molecule transport (antibody, siRNA, antisense RNA) and the current state-of-the-art in transporter imaging, 3D culture models, and in silico approaches to predicting transporter substrate and inhibitor activity. In collaboration with the newly formed AAPS Cellular & Molecular Toxicology Focus Group, we are presenting topics on clinical relevant mediators of drug toxicity, proteinuria contributed by oligonucleotide transport, and predictive safety of antibody drug conjugates. In addition, representatives from the International Transporter Consortium (ITC) will present their recent White Papers followed by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory agencies presenting their perspectives on the new FDA’s draft in vitro and in vivo DDI guidances related to transporters. Question and Answer panels will be scheduled for both ITC and FDA/EMA sessions.

There will be 3 main learning objectives to the 2018 Transporter Workshop:

To learn new transporters and models that may play a role in transporter-mediated ADME and disease(s).
To learn new transport mechanisms that may contribute to development of new therapeutics; for example, intracellular compound trafficking (lysosomal transporters) and large molecule transport (e.g., antibodies, siRNA, antisense RNA).
To understand regulatory perspectives on the new FDA’s draft in vitro and in vivo DDI guidances related to transporters.

The knowledge gained from this transporter workshop will help guide scientists at all levels to understand the current state-of-the-art of transporter research and areas of hot topics that may apply to their respective research from discovery to development in context of disease states and regulatory guidances.

Who Should Attend

This AAPS Workshop on Drug Transporters in ADME: From the Bench to the Bedside under the terms set out below is intended for a diverse group of scientists and experts, responsible for the evaluation of safety and efficacy of new drug products, interested parties regarding ongoing efforts on research and development of assays and tools to evaluate the role of transporters in health and disease, and program officers from various regulatory agencies such as U.S. FDA, EMA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Contact

Padmaja Mummaneni – Padmaja.mummaneni@fda.hhs.gov