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Fourth Workshop on Membrane Transporters in Drug Development

Webinar Recording - March 31 and April 6

Use of Extended Clearance Concept and PBPK Modeling in New Drug Discovery and Development: Predicting Target Tissue Exposure from In Vitro to In Vivo
​Presented by ​Yuichi Sugiyama, PhD, RIKEN Baton Zone Program
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​Professor Sugiyama will describe the “extended clearance concept” and inform participants on how to establish a physiologically-based pharmacokinetic (PBPK) model that includes the transporter-mediated membrane transport and enzyme-mediated metabolism processes. In addition, changes in transporter (influx, efflux) function and metabolizing enzyme function affects the pharmacokinetics of drugs in the blood and the liver and, ultimately, the pharmacological and/or toxicological effects will be discussed.

Related to the above-described objectives, the webinar will also cover recent studies on the following three topics:
1. Necessity of incorporating albumin-mediated hepatic uptake mechanism to obtain better in vitro/in vivo extrapolation of hepatic clearance.
2. Substrate-dependent and/or pre-incubation time dependent Ki values of OATP1B inhibitors.
3. Use of endogenous biomarkers to facilitate subject phenotyping and DDI Prediction.

ITCW4 Virtual Meeting Schedule - April 19-21, 2021

Link to Registration at ASCPT
ITCW4 Agenda (PDF)
File Size: 84 kb
File Type: pdf
Download File

​All Times are USA Eastern Daylight Savings Time.
Day 1 - Monday, April 19, 2021
9:00 - 9:05 am
​Welcome and Opening Remarks
​Session 1: Breakthrough Topics in Transporters
Moderators: Kathy Giacomini (UCSF) and Xiaoyan Chu (Merck)
9:05 - 9:25 am


9:25 - 9:45 am


​9:45 – 10:05 am

​10:05 – 10:35 am
​10:35 - 11:00 am
​RESOLUTE: Accelerating research in Solute Carriers, SLCs, an untapped source of drug targets
Giulio Superti-Furga (Austrian Academy of Sciences)
Precision medicine goes microscopic: interactions between the microbiome and intestinal drug transporters
Peter Turnbaugh (UCSF)
Genomewide Association Studies: Uncovering New Roles for Solute Carrier Transporters

Kathy Giacomini (UCSF)
Panel Discussion
​Break

Session 2:  New and Emerging Transporters
Moderators: Maciej Zamek-Gliszczynski (GlaxoSmithKline) and Lei Zhang (Silver Spring, MD)
11:00 - 11:20 am


​11:20 - 11:40 am


11:40 - 12:00 pm

​12:00 - 12:30 pm
​Emerging importance of hepatic and renal OAT2: can we substantiate 
clinical relevance in drug pharmacokinetics and DDIs?

Hong Shen (Bristol-Myers Squibb)
​Folate transport pathways: What do we know of their roles in drug interactions and toxicity?
Reina Bendayan (University of Toronto)
Revisit of previous ITC recommendations on OATP2B1 and MRPs
Maciej Zamek-Gliszczynski (GlaxoSmithKline)
Panel Discussion
Poster Walk 1
Moderators: ​Xinning Yang (U.S. FDA) and Xiaomin Liang (Gilead)
12:30 - 1:00 pm
​1:30 - 2:00 pm
​Poster Walk 1
​Interactive Poster Q&A

Day 2 - Tuesday, April 20, 2021
9:00 - 9:05 am
​Welcome and Opening Remarks
Session 3: New Implications for Transporters in Clinical Pharmacology
Moderators: Aleksandra Galetin (University of Manchester) and Xinning Yang (FDA)
9:05 – 9:25 am


9:25 - 9:45 am

9:45 - 10:05 am

10:05 - 10:35 am
10:35 - 11:00 am
Ontogeny of SLCO1B1 expression and function: Implications for statin disposition in children
J. Steven Leeder (Children’s Mercy Hospital, Kansas City)
Transporter endogenous biomarkers in clinical drug development
Kenta Yoshida (Genentech)
Modelling of creatinine-drug interaction in chronic kidney disease population 
Aleksandra Galetin (University of Manchester)
Panel Discussion
​Break

Session 4: Transporters and Regulatory Science
Moderators: Donald Tweedie (Independent) and Shiew-Mei Huang (FDA)
11:00 - 11:30 am


​11:30 - 12:00 pm

12:00 - 12:30 pm
​A regulatory perspective for transporter-mediated DDIs: current status and challenges
Xinning Yang (US FDA)

Transporter-mediated drug drug interactions - European regulatory perspectives
Carolien Versantvoort (Medicines Evaluation Board, The Netherlands)
​Panel Discussion to include ITC Members
Poster Walk 2
​Moderators: Kenta Yoshida (Genentech) and Noora Sjöstedt (University of Helsinki) 
12:30 - 1:30 pm
​1:30 - 2:00 pm
Poster Walk 2
​Interactive Poster Q&A

Day 3 - Wednesday, April 21, 2021
9:00 - 9:05 am
​Welcome and Opening Remarks
​Session 5: Transcriptional and Post-Transcriptional Regulation of Transporters: From the Bench to the Bedside
Moderators: Kim Brouwer (UNC) and Raymond Evers (J&J, Janssen Pharmaceuticals)
9:05 - 9:15 am


9:15 - 9:25 am


​9:25 - 9:25 am


9:35 – 10:05 am
​10:05 - 10:30 am
Transcriptional and post-transcriptional regulation of organic anion transporting polypeptides
Henriette E. Meyer zu Schwabedissen (University of Basel)
​Post-translational regulation of OATP1B1 and OATP1B3: Association with clinically significant polymorphism and implications in drug-drug interactions  
Wei Yue (University of Oklahoma Health Sciences Center)
Transcriptional and post-transcriptional regulation of transporters in the human intestine 
Stefan Oswald (Rostock University Medical Center)
Panel Discussion
Break

Session 6: Transporters and Toxicology
Moderators: Michael Hafey (Merck) and Yurong Lai (Gilead)
10:30 - 10:40 am

10:40 - 10:50 am

10:50 - 11:00 am

11:00 - 11:30 am
​Overview of metal/metalloid transporters and toxicity
Elaine Leslie (University of Alberta)
Solute carriers and chemotherapeutic induced toxicity
Alex Sparreboom (Ohio State)
Placental transport and environmental chemical exposures 
Lauren Aleksunes (Rutgers)
Panel Discussion
Session 7: Emerging Technologies for Transporter Studies
Moderators: Pär Matsson (University of Gothenburg) and YingYing Guo (Eli Lilly)
11:30 - 11:40 am

11:40 - 11:50 am

11:50 - 12:00 pm


12:00 - 12:30 pm
CRISPR/Cas9 models for drug transporters
Per Artursson (Uppsala University)
Intravital microscopy for studying transport processes – potential and limitations
Kenneth Dunn (Indiana University)
Dissecting transport barriers in cancer using intravital microscopy of single-cell pharmacology
Miles Miller (Harvard Medical School)
Panel Discussion
Whitepaper Breakout Sessions
​​12:30 - 1:30 pm
Breakout Sessions for Whitepapers
Link to ASCPT Registration Page

ITCW4 Planning Committee

We would like to thank the following members of the ITCW4 Planning Committee
Name
Affiliation
Kim Brouwer
University of North Carolina at Chapel Hill
Aleksandra Galetin
University of Manchester
Kathy Giacomini
University of California San Francisco
Mike Hafey
Merck and Co
Shiew-Mei Huang
U.S. Food and Drug Administration
Lawrence Lin
University of California San Francisco
Par Matsson
University of Gothenburg
Donald Tweedie
Independent
Xinning Yang
U.S. Food and Drug Administration
Kenta Yoshida
Genentech
Wei Yue
University of Oklahoma
Maciej Zamek-Gliszczynski
GlaxoSmithKline
Lei Zhang
Silver Spring, MD
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