30 July - Tuesday

Preliminary program - subject to change.

08:00 - 09:00

Plenary Lecture: Evaluation of disease progression / drug effects by expanding the PK concept

Hiroshi Suzuki, The University of Tokyo Hospital, Tokyo, Japan

09:00 - 09:30

Refreshment Break with Exhibitors and Posters

09:30 - 11:30

Concurrent Sessions: Symposia 5 and 6

Symposium 5: Disease Effect on Transporter Regulation and Function
Co-Chairs: Kathy Giacomini, University of California San Francisco, San Francisco, California, USA and Raymond Evers, Merck & Co. Inc., Kenilworth, New Jersey, USA

Proteomics Based Studies of Disease Effects on the Brain Barrier Transporters
Tetsuya Terasaki, Graduate School of Pharmaceutical Sciences, Tohoku University, Sendai. Japan

SLC16A11: From Human Genetics to Novel Mechanisms Underlying Type 2 Diabetes
Eitan Hoch, Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA

Transporters in Polycystic Kidney Disease
Kim Brouwer, University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA

Liver Transporter Activity in Patients with Renal Disease
Aubrey Stoch, Merck & Co. Inc., Rahway, New Jersey, USA


Symposium 6: Advances in the Study of Drug Metabolism

Co-Chairs: Iain Martin, Merck & Co. Inc., Boston, Massachusetts, USA and Mitchell E. Taub, Boehringer Ingelheim, Ridgefield, Connecticut, USA

Predicting Routes, Sites, and Products of Metabolism
Matthew Segall, Optibrium Limited, Cambridge, United Kingdom

Substrate Recognition by Cytochrome P450s
Emily Scott, University of Michigan, Ann Arbor, Michigan, USA

Application of in silico DMPK in Drug Discovery and Development
Fabio Broccatelli, Genentech, South San Francisco, California, USA

Biosynthesis of Drug Candidates and Metabolites
Griff Humphreys, Aranmore Pharma Consultants, Lawrenceville, New Jersey, USA

11:30 - 14:00

Lunch with Exhibitors and Poster Presentations

14:00 - 16:00

Concurrent Sessions: Symposia 7 and 8

Symposium 7: Driving Asia-Inclusive Global Drug Development through Translational Science and Clinical Pharmacology: Towards Enhanced Benefit-Risk and Decreased Access Lag
Co-Chairs: Lei Zhang, Silver Spring, Maryland, USA and Karthik Venkatakrishnan, Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA

Prediction of Differences in Pharmacokinetics between Chinese, Japanese, and Caucasian Populations - An Update
Geoffrey Tucker, University of Sheffield, Sheffield, United Kingdom

Transporter Polymorphisms Drive Inter-ethnic Differences in Drug Response
Kathy Giacomini, University of California San Francisco, San Francisco, California, USA

Enabling Asia-Inclusive Global Drug Development through Quantitative and Translational Science
Karthik Venkatakrishnan, Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA

Impact of Racial/Ethnic Differences in Drug Response: Regulatory Perspectives
Anuradha Ramamoorthy, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Symposium 8: State-of-the-Art Approaches in Drug Metabolizing Enzymes and Transporters (DMET) Biomarker Research: Path from Discovery to Validation
Co-Chairs: Xiaoyan Chu, Merck & Co. Inc., Rahway, New Jersey, USA and Hiroyuki Kusuhara, University of Tokyo, Tokyo, Japan

Biomarkers for in vivo Assessment of Transporter Function
Martin F. Fromm, Friedrich-Alexander-Universität, Erlangen-Nürnberg, Erlangen, Germany

Mechanistic Models for Coproporphyrin I and Creatinine as Endogenous Biomarkers for Transporter Drug-Drug Interactions
Aleksandra Galetin, University of Manchester, Manchester, United Kingdom

Knockout Mice, Transcriptomics and Metabolomics Approach for Discovery of Endogenous Biomarkers for Renal Drug Transporters
Sanjay Nigam, University of California San Diego, San Diego, California, USA

Integrated Quantitative Proteomics and Metabolomics Approach for Discovery and Validation of UGT2B17 Biomarker to Predict Drug Metabolism
Bhagwat Prasad, University of Washington, Seattle, Washington, USA

16:30 - 17:30

Concurrent ISSX Focus Group Meetings

Focus Group Session 2: Biotransformation Mechanisms and Pathways
Chair: Amit Kalgutkar, Pfizer and Co-Chair: Valerie Kramlinger, Amgen

The emphasis of this group is to focus on various aspects of metabolic biotransformation pathways associated with small molecule drugs and xenobiotics. This is a relatively broad topic for both academic and industrial research but some of the initial points for discussion will include: (a) metabolism-directed drug design (e.g., incorporation of D to reduce metabolic liability), (b) mechanisms underlying biotransformations that yield “unusual” metabolites and characterization of the metabolizing enzymes responsible for their formation, and (c) idiosyncratic immune-mediated toxicity via metabolism (e.g., reactive metabolites).
Learn more about this focus group and join the online discussion before the meeting.

Focus Group Session 3: Modeling & Simulation
Chair: Hartmut Derendorf, University of Florida and Co-Chair: Ping Zhao, Bill and Melinda Gates Foundation

The emphasis of this group is to focus on the role of modeling and simulation in drug development in all stages. Examples include translational extrapolations from preclinical data to clinical expectations, drug-drug interactions, extrapolations of PK/PD data to special populations, early dose optimization and selection of doses for clinical testing, physiologically based pharmacokinetics, population pharmacokinetics and many others.
Learn more about this focus group and join the online discussion before the meeting.

Industry-Sponsored Symposia

17:30 - 18:30

Networking Happy Hour at Spirit of 77

18:30 - 19:30

Join fellow attendees for arcade games, upscale bar fare, craft beers and cocktails.