ISSX President’s Message...4 ISSX President’s Message By Thomas Baillie, ISSX President Thomas Baillie, Ph.D. ISSX President. seen in the previous issue of this Newsletter, only

With the advent of the New Year, I would like to welcome to ISSX all the new members who have joined the Society for the first time, in addition to those returning members who have renewed their annual dues. At year-end 2018, ISSX membership stood at 1,014, and we hope to exceed that total this year following a membership drive that currently is in progress. We are especially interested in recruiting graduate students and postdoctoral researchers to our ranks and, as you will have read in previous editions of this Newsletter, we have implemented several initiatives intended specifically to benefit this group, e.g. the ISSX Mentorship Program and the New Investigators sessions at our conferences. I would ask you to bring these free benefits of Society membership to the attention of promising young investigators as they plan for careers in fields that involve the

study of foreign compounds in animals and humans. I would also encourage all members to consider joining one or more of the three Focus Groups (Biotransformation Mechanisms & Pathways, Bioanalysis in ADME Science, and Modeling & Simulation) that have been established to provide a forum for online discussions on relevant topics and in-person networking at our annual meetings. See the ISSX web site for information on these Focus Groups and to sign up.

Along with those of you who are new to the general membership of ISSX, I would also like to add a warm welcome to two new members of ISSX Council, namely Jash Unadkat (University of Washington) and Eric Chan (National University of Singapore), who were elected to positions vacated by Jas Sahi and Natalie Hosea who had completed their two-year terms of office at the

end of 2018. My sincere thanks to Jas and Natalie for all of their many contributions to the Society during this period!

As you will have

Changes on the ISSX Council

Book Reviews

ISSX2019: The 12th International ISSX Meeting

ISSX Membership Ambassador Program

ISSX Mentorship Program

New Members

Save the Date for the December ISSX Workshop

21st International Conference on Cytochrome P450 (ICCP450)

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ISSX President’s MessageBy Thomas Baillie, ISSX President

Thomas Baillie, Ph.D.ISSX President.

seen in the previous issue ofthis Newsletter, only one ISSX meeting will be held in 2019 since this year’s event is designatedas an International Meeting.Specifically, this meeting will be the 12th International ISSX Meeting, scheduled to take place in Portland, OR, from July 29-31. The meetingco-chairs, Aleksandra Galetin, Deepak Dalvie, and Hiroyuki Kusuhara, together with theirMeeting Organizing Committee, have

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Changes on the ISSX CouncilAs the New Year begins we welcome the newest Council members Eric Chan and Jashvant (Jash) Unadkat to the ISSX Council.

Eric and Jash began their two-year terms of service on Council January 1, 2019. Eric and Jash are the first members of Council elected under the new system of region-based voting which was approved by the ISSX membership to ensure equitable geographic representation among the leadership.

Eric Chan is a pharmaceutical scientist and an associate professor in the Department of Pharmacy, National University of Singapore (2011–present). His research interests are (1) metabolism-driven systems biology modeling of diseases, pharmacology, toxicology, and mammalian host-bacteria

interactions and (2) xenobiotic-derived reactive metabolite research with specific focus on interaction with biological proteins and physiological-based pharmacokinetics-pharmacodynamics (PBPK-PD) modeling of pharmacology and toxicology.

Eric’s academic career has been developed successfully based on his active participation in meetings and workshops organized by ISSX over the years. As a Scientific Affairs Committee member of ISSX, Eric further gains experience in evaluating proposals to ensure high-quality scientific meetings and workshops via the collaborations between academia, industry, and regulatory agencies.

Jashvant (Jash) Unadkat, Ph.D. is the Milo Gibaldi Endowed Professor in the Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle. Jash is a dual US and British citizen. He received his Bachelor degree in Pharmacy (B.Pharm.) from the University of London (1977), his Ph.D. from the University

of Manchester (1982; advisor Prof. Malcolm Rowland) and his postdoctoral training in Clinical Pharmacology at the University of California at San Francisco (1982–85; advisor the late Dr. Lewis B. Sheiner).

Jash has served on numerous committees within scientific organizations (e.g. AAPS) including NIH review panels and as an Associate Editor for the Journal of Pharmaceutical Sciences. He has organized or co-organized numerous national and international conferences, the most recent being the 21st North American ISSX Meeting in Rhode Island. He was also the co-organizer of the ISSX-sponsored workshop on “Towards Reaching a Consensus on Using Quantitative LC-MS/MS Proteomics in Translational DMPK/PD Research,” held September 27–28, 2018 in Cambridge, Mass.

ISSX also wishes to extend our thanks and appreciation for the work of our outgoing Council members, Natalie Hosea and Jasminder (Jas) Sahi.

Natalie Hosea completed her second term of service on the ISSX Council at the end of 2019. Natalie concurrently served as Chair of the ISSX Membership Affairs Committee and was therefore crucial in providing timely membership related matters directly to Council. She served as a member of the Meeting Organizing Committee for the joint ISSX/JSSX meeting in 2014, was an inaugural member of the Continuing Education Committee, and has served as a moderator for ISSX webinars.

Jasminder (Jas) Sahi served four years as a member of Council. Jas has been instrumental to the governance of the Society in many ways and recently served as one of the chairpersons of the 6th Asia Pacific ISSX Meeting held in Hangzhou, China. Jas will remain active with ISSX in her role as Chair of the still new ISSX Continuing Education Committee. We are grateful to Jas for all of her contributions past and those to come.

ISSX is grateful to both Jas and Natalie for their service and commitment to ISSX. Both were awarded their ISSX Service Award during the last in-person meeting of Council in Montreal in July 2018.

HANDBOOK OF DRUG METABOLISM (DRUGS AND THE PHARMACEUTICAL SCIENCES)Editors; PG Pearson, Wienkers LCCRC Press, Taylor & Francis Group: 696pp. ISBN-13: 978-1482262032. 3rd Edition. 2019

As stated by the editors in the preface to the 2nd edition of this book (2008), “the goal of the first edition was to provide a comprehensive text to serve as a graduate course in drug metabolism, a useful reference for academic and industrial drug metabolism scientists, but also to serve as an important reference tool for those pursuing a career in drug metabolism.”

Nearly twenty years have passed since this first edition was published and now a third is available providing testament to the enduring and comprehensive nature of this work. The third edition has been updated to include revised chapters on drug transporters, aspects of metabolic activation, large molecule disposition and stereochemical factors influencing drug metabolism. The contents are divided into four basic sections; (1) Fundamental aspects of drug metabolism, (2) Factors which affect drug metabolism, (3) Technologies to study drug metabolism, (4) Applications of metabolism studies in drug discovery and development.

If you missed the first two editions now is the chance to acquire this one. If you have any previous edition now is the time to update. An excellent text that is well worth obtaining.

Notified by Steve Mitchell, B.Sc., B.Phil., Ph.D., D.Sc.Faculty of MedicineImperial College London

ALEXANDER URE AND THE BIRTH OF DRUG METABOLISMAuthors; SC Mitchell, RH WaringPrinted.com: London42pp. Monograph. 2018

This short monograph is a timely reminder of the role that Alexander Ure played in the discovery of xenobiotic metabolism. Since both authors have a long association with the city of Birmingham, England, it is apt to quote from another son of the city, J.R.R. Tolkien …“and some things that should not have been forgotten were lost. History became legend. Legend became myth” (The Fellowship of the Ring, 1954). Regrettably, the part played by Alexander Ure has become obfuscated and almost lost in time. This monograph is like the “Phoenix bird rising from the ashes;” a rebirth for Alexander Ure.

The monograph is superbly written and the referencing was clearly a labour of love in terms of the depth and breath. The tenacity of the authors has to be admired. The opening paragraphs quickly introduce the fascination of xenobiotic metabolism, from the first anecdotal reports of orally ingested turpentine producing urine that smelt of violets to the wonderful stories of the production of malodourous urine following the consumption of asparagus. This leads the reader on to the history of the conjugation of benzoic acid with the amino acid glycine to form hippuric acid. For those individuals in the field of xenobiotic metabolism what unfolds will be an informative read which redresses the role that Ure played in this discovery. For those with a passing interest, this will be a delightful journey through the mists of time. The detail of the story of the discovery of hippuric acid as a metabolite of benzoic acid is very thorough and extremely well referenced. The information provided about the life of Alexander Ure is wonderful, the figures and photographs used add to and aid the telling of this fascinating story. For those devotees of xenobiotic metabolism and anyone with an interest in the history of science, they will enjoy reading this monograph.

Reviewed by Glyn B. Steventon, Managing Director, ADMET Solutions Ltd, Basingstoke, UK

Book Reviews

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You’re Invited to Join us for the 12th International Meeting

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Why You Should Attend the 12th International ISSX MeetingThis meeting provides a wonderful opportunity for members of the international scientific community to exchange ideas and expertise, to develop a common vision, and to create and nurture fruitful collaborations in fields related to the study of chemicals that are foreign to the body.

Enjoy state-of-the-art scientific sessions, poster presentations and commercial exhibits in a relaxed and friendly environment. Please take this unique opportunity to expand and share your knowledge on the interaction of foreign chemicals with living systems, renew or develop friendships with your colleagues from around the world, and enjoy everything the wonderful city of Portland has to offer.

Our top five reasons to attend are:

1. Learn the latest information in this dynamic and specialized field through our Short Course program, a variety of timely scientific symposia, and topical keynote and plenary sessions.

2. Expand your knowledge of drug metabolism and disposition by learning from our outstanding faculty assembled from leading experts in the field worldwide.

3. Gain recognition and feedback on your research by submitting an abstract and presenting a poster. All accepted abstracts will be printed in a special supplemental issue of Drug Metabolism and Pharmacogenetics. Students and postdocs may enter the poster competition and compete for prizes and recognition.

4. Scientific meetings organized by ISSX offer numerous outstanding scientific sessions and many opportunities for substantive conversations with scientists worldwide. Our exhibitors will be showcasing the products and services important to you in your research and development.

5. Enjoy informal social interactions with fellow researchers, and also enjoy exploring Portland, Oregon!

Preliminary Schedule (Schedule is subject to change)

July 28–Sunday

10:00–13:00 | Concurrent Short Courses 1 and 2

Short Course 1: Advances in the Role of Transporters in Drug DevelopmentChair: Yingying Guo, Eli Lilly and Company, Indianapolis, Indiana, USA

The Next Frontier in ADME Research: Predicting and Verifying Tissue Drug Concentrations Using a Proteomics and PET Imaging ApproachJashvant Unadkat, University of Washington, Seattle, Washington, USA

Advancing Predictions of Tissue and Intracellular Drug Concentrations Using in vitro and PBPK Modeling ApproachesYingying Guo, Eli Lilly and Company, Indianapolis, Indiana, USA

Influence of Transporter Polymorphisms on Drug Disposition and Response: A Perspective from the International Transporter ConsortiumSook Wah Yee, University of California San Francisco, San Francisco, California, USA

Can BSEP Inhibition Testing in Drug Discovery and Development Reduce Liver Injury Risk? An International Transporter Consortium PerspectiveGerry Kenna, Safer Medicines Trust, Kingsbridge, Devon, United Kingdom

Transporter DDIs—A Regulatory Perspective “Transporters in Drug Development: Scientific and Regulatory Considerations”Lei Zhang, Silver Spring, Maryland, USA

Speaker Panel Discussion

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Short Course 2: Non-P450 Enzymes in ADMET for Drug Discovery and DevelopmentCo-Chairs: Cyrus Khojasteh, Genentech, South San Francisco, California, USA, and Kouichi Yoshinari, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan

An Overview of Non-P450-mediated Metabolism in Drug DevelopmentCyrus Khojasteh, Genentech, South San Francisco, California, USA

Role of Glucuronidation in Drug Metabolism and ToxicityRyoichi Fujiwara, University of Arkansas, Little Rock, Arkansas, USA

Enzymology and Clinical Importance of Reductases and HydrolasesMatt Cerny, Pfizer Inc., Groton, Connecticut, USA

Significance of Hydrolases and Aldehyde Oxidase in Drug ToxicityTatsuki Fukami, Kanazawa University, Kanazawa, Japan

14:00–17:00 | Concurrent Short Courses 3 and 4

Short Course 3: State of the Art PKPD and QSP Modeling Chair: Piet van der Graaf, Certara, Sheffield, United Kingdom, and Marjoleen Nijsen, Abbvie, Chicago, Illinois, USA

Introduction to QSPPiet van der Graaf, Certara, Sheffield, United Kingdom

Tutorial: How to Build a QSP Model in Less than One HourAndrzej Kierzek, Certara, Sheffield, United Kingdom

Application of QSP in Drug DiscoveryR. Adam Thompson, Abbvie, Chicago, Illinois, USA

Therapeutic Area Case Study: QSP in Immuno-oncologyShihem Bihorel, University of Florida, Orlando, Florida, USA

Therapeutic Area Case Study: QSP in Inflammatory DiseaseKapil Gadkar, Genentech, South San Francisco, California, USA

Short Course 4: Idiosyncratic Drug-induced Liver InjuryCo-Chairs: Gerry Kenna, Safer Medicines Trust, Kingsbridge, Devon, United Kingdom, and Ann Daly, Newcastle University, Newcastle upon Tyne, United Kingdom

The Role of Inflammatory Mediators in Idiosyncratic Drug-induced Liver InjuryJack Uetrecht, University of Toronto, Toronto, Ontario, Canada

Clinical aspects of Hepatocellular and Cholestatic Drug-induced Liver InjuryEinar S. Björnsson, Landspítali - The National University Hospital of Iceland, Reykjavik, Iceland

Cellular and Animal Models of Idiosyncratic Drug-induced Liver InjuryTsuyoshi Yokoi, Nagoya University, Nagoya, Japan

Progress Made in Understanding Genetically-inherited Susceptibility Factors, Including HLA GenotypeAnn Daly, Newcastle University, Newcastle upon Tyne, United Kingdom

18:30–20:30 | Attendee and Exhibitor Meet and Greet

July 29–Monday

07:45–08:45 | New Investigator SessionChair: Bhagwat Prasad, University of Washington, Seattle, Washington, USA

All investigators within their first ten years of receiving their highest earned degree are welcome to attend and participate in this session. Continental breakfast will be available to attendees.

07:45–08:45 | Focus Group Session 1: Bioanalysis in ADME ScienceChair: Kevin Bateman, Merck and Co-Chair: Jens Sydor, Abbvie

REGISTRATION

Registration is now open!

Visit www.issx2019.org/register to take advantage of the early

registration discount.

Act fast—advantage pricing ends 31 March!

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09:00–10:00 | Plenary Lecture: How Technology, Big Data and Systems Approaches are Transforming 21st Century HealthcareLeroy Hood, Providence St. Joseph Health, Renton, Washington, USA

10:00–11:00 | ISSX Membership MeetingISSX President, Tom Baillie, University of Washington, Seattle, Washington, USA

ISSX Members are invited to attend this special member session to learn about Society updates and initiatives.

13:00–15:00 | Concurrent Sessions Symposia 1 and 2

Symposium 1: Personalized Medicine: Use of Pharmacogenomics and Other Patient-specific Factors to Individualize Drug Dosing and TreatmentCo-Chairs: Ann Daly, Newcastle University, Newcastle upon Tyne, United Kingdom, and Tsuyoshi Fukuda, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA

Warfarin: A Paradigm for Individualized DosingMunir Pirmohamed, University of Liverpool, Liverpool, United Kingdom

Relevance of Transporter and Metabolic SNPs to Pediatric TreatmentTsuyoshi Fukuda, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA

CPIC Guidelines and Implementation to DateKelly Caudle, St Jude Children’s Research Hospital, Memphis, Tennessee, USA

Personalized Treatment of CancerHoward McLeod, Moffitt Cancer Center, Tampa, Florida, USA

Symposium 2: State of the Art for Organs on ChipsCo-Chairs: Edward Kelly, University of Washington, Seattle, Washington, USA, and Roos Masereeuw, Utrecht University, Utrecht, the Netherlands

Kidney Organoids for Disease Modeling and High Throughput ScreeningBenjamin Freedman, University of Washington, Seattle, Washington, USA

Lecture Title to be ConfirmedPaul Vulto, Mimetas, Lieden, Netherlands

"Tissues on Chips"—A Novel Tool for Toxicity and Efficacy Testing on Human TissueBo Yeon Lee, NCATS, NIH, Bethesda, Maryland, USA

Biofabrication of Liver Constructs for Drug Toxicity StudiesKerstin Schneeberger, Utrecht University, Utrecht, Netherlands

15:30–17:30 | Concurrent Sessions Symposia 3 and 4

Symposium 3: Quantitative Pharmacokinetic and Pharmacology Methods and Strategies in the Discovery and Development of BiotherapeuticsCo-Chairs: Hannah Jones, Pfizer Inc., Cambridge, Massachusetts, USA, and Joe Balthasar, University of Buffalo, Buffalo, New York, USA

Development and Application of a PBPK Model for Large Molecules in PfizerHannah Jones, Pfizer Inc., Cambridge, Massachusetts, USA

PBPK and PKPD Modeling to Investigate Engineered AntibodiesTatsuhiko Tachibana, Chugai Pharmaceutical Co., Ltd., Shizuoka, Japan

PBPK Models for Predicting Human PK for Monoclonal Antibodies and Other Large Molecule ModalitiesIain Gardner, Certara UK Limited (Simcyp Division), Sheffield, United Kingdom

ABSTRACT SUBMISSIONS

Submit an abstract at www.issx2019.org/ abstracts. Present a poster in the general abstract poster sessions. Presentation sessions will be held on Monday, 29 July–Wednesday, 31 July.

Compete in the student poster awards competition—Open to the categories of predoctoral and postdoctoral students, six finalists from each category will be chosen to present their posters. The awards presentation will be held on Wednesday, 31 July.

Before you submit, review the guidelines and ensure that at least one author is a current ISSX member. The deadline for Abstract Poster Presentations submissions and for Predoctoral and Postdoctoral Poster Awards Competition submissions is Sunday, 31 March at 11:59 p.m., Eastern Time (US).

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Systems PK/PD Model Informed Discovery and Development of Cancer ImmunotherapyDhaval Shah, University of Buffalo, Buffalo, New York, USA

Symposium 4: Microbiome-Environment-Drug Interactions: Emerging Tools and ApplicationsCo-Chairs: Julia Yue Cui, University of Washington, Seattle, Washington, USA and Sumio Ohtsuki, Kumamoto University, Kumamoto, Japan

Impact of Intestinal Flora on Host Metabolism of Drug, Sugar, and LipidSumio Ohtsuki, Kumamoto University, Kumamoto, Japan

Activity-based Profiling of the Microbiome Response to Chemical ExposuresAaron Wright, Pacific Northwest National Laboratory, Richland, Washington, USA

Impact of the Human Gut Microbiome on Drug DispositionPeter Turnbaugh, NCATS, University of California San Francisco, San Francisco, California, USA

Developmental Reprogramming of the Gut Microbiota by Environmental ToxicantsJulia Yue Cui, University of Washington, Seattle, Washington, USA

17:30–19:30 | Poster Viewing in Exhibit Hall

July 30–Tuesday

08:00–09:00 | Plenary Lecture: Evaluation of Disease Progression / Drug Effects by Expanding the PK ConceptHiroshi Suzuki, University of Tokyo Hospital, Tokyo, Japan

Nominations are now being accepted for the following awards to be presented at the 12th International ISSX Meeting in Portland, Oregon. Nominations are due Friday, 5 April. Submit nominations at www.issx.org/awards/nominations.

The three awards to be presented at the 12th International ISSX Meeting are:

The R.T. Williams Distinguished Scientific Achievement Award—Sponsored by Charles Crespi and FamilyPresented to an ISSX member or non-member from any region who has made substantial and seminal scientific contributions to the field over a sustained period. The focus of this award is the individual's scientific accomplishments and it is intended to recognize the best in the field, internationally. The award will consist of a plaque/medal, an honorarium and travel support, and will be presented along with a lecture once every three years in conjunction with the Society's International Meeting.

The Frederick J. Di Carlo Distinguished Service Award Presented to an ISSX member from any region who has a record of important service to the Society and its goals. The award will consist of a plaque or medal, honorarium and travel support and will normally be presented in conjunction with the appropriate

international meeting. On occasion, one or two outstanding acts of service will justify the award or a long record of many acts of service without any single outstanding act will be recognized. Preferably, however, the recipient should have a record of many accomplishments some of which are major. The award will not be given for future promise, but on the basis of past service. The President-Elect and President of ISSX will be ineligible for the award for five (5) years after their term of office.

Distinguished Accomplishments in Drug Discovery and Development AwardPresented to an individual or to a team employed in an organization involved in drug discovery and/or development. The award will be presented to an individual or team on the basis of:(1) A single high impact scientific accomplishment that dramatically changed practices in the ADME characterization of drugs or drug candidates, or (2) A sustained body of scientific work that shows a high impact on the ADME characterization of drugs.

Award winners can reside in the pharmaceutical industry, CROs, regulatory agencies and not-for-profit organizations involved with drug discovery and development. This award is not restricted to any global region.

ISSX AWARDS PROGRAMSubmit a Nomination for the 2019 ISSX Awards by Friday, 5 April

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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 FunctionCo-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 TransportersTetsuya Terasaki, Graduate School of Pharmaceutical Sciences, Tohoku University, Sendai, Japan

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

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

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

Symposium 6: Advances in the Study of Drug MetabolismCo-Chairs: Iain Martin, Merck & Co. Inc., Boston, Massachusetts, USA and Mitchell E. Taub, Boehringer Ingelheim, Ridgefield, Connecticut, USA

Predicting Routes, Sites, and Products of MetabolismMatt Segall, Optibrium, Cambridge, United Kingdom

Substrate Recognition by Cytochrome P450sEmily Scott, University of Michigan, Ann Arbor, Michigan, USA

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

Biosynthesis of Drug Candidates and MetabolitesGriff 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 LagCo-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 UpdateGeoffrey Tucker, University of Sheffield, Sheffield, United Kingdom

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

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

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

EXHIBITION INFORMATION

The 12th International Meeting will feature an exhibition showcasing the products and services that researchers need to advance their work. The exhibition begins with a welcome reception on Sunday evening and continues throughout the meeting. Meet with representatives from top suppliers and maximize the value of your attendance!

Companies interested in exhibiting, sponsoring, or advertising should download the Exhibitor Prospectus at https://www.issx2019.org/exhibitissx2019/.

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Symposium 8: State-of-the-Art Approaches in Drug Metabolizing Enzymes and Transporters (DMET) Biomarker Research: Path from Discovery to ValidationCo-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 FunctionMartin F. Fromm, Friedrich-Alexander-Universität, Erlangen-Nürnberg, Erlangen, Germany

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

Knockout Mice, Transcriptomics and Metabolomics Approach for Discovery of Endogenous Biomarkers for Renal Drug TransportersSanjay 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 MetabolismBhagwat Prasad, University of Washington, Seattle, Washington, USA

16:30–17:30 | Concurrent ISSX Focus Group Meetings

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

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

17:30–18:30 | Industry-Sponsored Symposia

18:30–19:30 | Networking Happy Hour at Spirit of 77 sponsored by Frontage Laboratories, Inc.Join fellow attendees for arcade games, craft beers, and cocktails.

HotelHotel rooms have been blocked at four hotels. You’ll find the best rate at the DoubleTree by Hilton for $209 USD Single/Double. More information can be found at www.issx2019.org/hotels.

Transportation to the Oregon Convention CenterThe Oregon Convention Center is located at 777 NE Martin Luther King, Jr. Boulevard, Portland, OR 97232.

• Just eight miles from Portland International Airport (PDX), visitors can access the Oregon Convention Center (OCC) via Interstate 5 North from Exit 302A–Rose Quarter, or from Interstate 84 West Exit 1–Lloyd Boulevard.

• Portland’s TriMet MAX light rail stops 300 times a day at the convention center, connecting riders to downtown, surrounding neighborhoods, the Oregon Zoo, and Portland International Airport.

• Portland Streetcar’s Central Loop stops at the MLK Lobby entrance every 15 minutes.

VisaFor many people, letters of invitation help smooth the visa process and we wish to support international attendees in their efforts to secure the needed travel

documentation. However, in order to receive a letter of invitation, the meeting organizers must be assured that you intend to attend the meeting if your travel request is granted. Individuals that require an official letter of invitation in order to obtain a visa and authorization to attend the meeting must first register for the meeting and then request a Visa Letter of Invitation.

We require that you provide your full name, address, and email for us to process the official letter of invitation. The letter of invitation does not financially obligate the ISSX Scientific Meeting organizers in any way. All expenses incurred in relation to the meeting are the sole responsibility of the attendee.

ISSX cannot guarantee that you will receive a visa. The decision to grant visas is at the sole discretion of the embassy/consulate. The meeting organizers cannot change the decision of the governmental agency should your application be denied. We are not able to directly contact any government’s visa issuing authority on your behalf. We cannot send letters of invitation via express mail services.

To request a letter of invitation, please email (indicate "invitation letter" in the subject line) ISSX at [email protected].

HOTEL, TRAVEL, AND VISA INFORMATION

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ISSX THANKS THESE MEETING SPONSORS FOR THEIR SUPPORT:

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July 31–Wednessday

09:00–10:00 | Plenary Lecture: Drug Metabolism, Pharmacogenomics and the Quest to Personalize HIV Treatment and PreventionNamandje Bumpus, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

10:00–10:30 | Refreshment Break with Exhibitors and Posters

10:30–12:30 | Concurrent Sessions Symposia 9 and 10

Symposium 9: Role of Albumin in Drug Disposition RevisitedCo-Chairs: Malcolm Rowland, University of Manchester, Manchester, United Kingdom, and Stephen Hall, Eli Lilly and Company, Indianapolis, Indiana, USA

Albumin-mediated Hepatic Uptake of Organic Anion Transport Polypeptide SubstratesYuichi Sugiyama, Sugiyama Laboratory, RIKEN Baton Zone Program, RIKEN, Yokohama, Kanagawa, Japan

Effects of Albumin on Prediction of Liver Kpuu and Human Hepatic Clearance for Enzyme- and Transporter-Mediated MechanismsLi Di, Pfizer Inc., Groton, Connecticut, USA

Impact of Albumin and Plasma on the Renal Uptake of OAT1 SubstratesRoos Masereeuw, Utrecht University, Utrecht, the Netherlands

Symposium 10: Ontogeny of Enzymes and Transporters and their Implications in Pediatric PBPK Modeling to Inform Pediatric DosingCo-Chairs: J. Steven Leeder, Children's Mercy Hospital, Kansas City, Missouri, USA, and Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA

Ontogeny of Human Membrane Transporters: from Data to ApplicationSaskia de Wildt, Radboud University Medical Center, Nijmegen, Netherlands

Pediatric PBPK: Dealing with Uncertain Parameters and Deciding on Success Criteria for Predictability Trevor Johnson, Certara UK Limited (Simcyp Division), Sheffield, United Kingdom

Use of ‘Virtual Children’ to Inform Exposure-Controlled Dosing of Drugs in ChildrenJean Dinh, Children's Mercy Hospital, Kansas City, Missouri, USA

Building, Verifying and Validating Pediatric PBPK Models: Vulnerabilities and Knowledge DeficitsPing Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA

12:30–14:30 | Lunch with Exhibitors and Poster Presentations

14:30–16:00 | ISSX Awards Presentations and LecturesNominate a colleague for an ISSX Award: www.issx.org/awards/nominations

16:00–18:00 | Plenary Symposium 11

Symposium 11: ‘War Stories’—ADME Issues Encountered and Addressed in Drug Discovery and DevelopmentCo-Chairs: Marcel Hop, Genentech Inc, South San Francisco, California, USA and Deepak Dalvie, Celgene, San Diego, California, USA

Navigating through Clinical Development Painlessly: Snapshots within the Nav1.7 ProgramJae Chang, Genentech Inc, South San Francisco, California, USA

Elagolix: A Mechanistic Understanding of Drug-Drug Interactions Arian Emami-Riedmaier, Abbvie, Chicago, Illinois, USA

ZEPATIER: The Tale of Two NovelsChristine Fandozzi, Merck & Co. Inc., USA

Management of MIST in a Case of Multiple Metabolic Species DifferencesLars Weidolf, AstraZeneca, Mölndal, Sweden

18:00–18:30 | Closing Session

As a member of the Society, you know your connection to peers in the industry, access to industry news and resources, and admission to educational events are of great value for you and your professional and personal development.

Perhaps you have been looking for a way to inform your peers about how ISSX has helped you grow professionally or how your research has benefited from your membership.

Now you can!

ISSX has launched a Membership Ambassador Program to share information about the benefits of being part of the Society.

Becoming an ISSX Membership Ambassador is as simple as following these five steps:

1. Sign up for the program online at www.issx.org/ambassador.

2. Use this guide and the enclosed materials to inform your network of peers and colleagues about why you are a member of ISSX and why they should join.

3. Ask your colleague to list you as their ISSX member contact when they join at www.issx.org/join or send a direct link to join from your membership. This will ensure you receive credit for their new membership.

4. Follow up with your colleague after they join to ensure they are aware of the resources available to them as a newly minted member of ISSX.

5. Share your success with us! You could be a featured ISSX Membership Ambassador in an upcoming issue of the ISSX Newsletter! Tell us about your recruitment efforts and we will spotlight your accomplishments.

Become an ISSX Membership Ambassador

REFER NEW MEMBERS BY EMAIL

Find Your Link1. Login to your ISSX Membership Account

at www.issx.org.

2. Select the link to “My Profile”

3. Select the link to “Refer a Friend”

Send Your Invitations1. Use the referral form to send invitations

to up to ten colleagues or,

2. Copy your referral link and send invitations directly to your network

ISSX will feature ambassadors in the ISSX Newsletter and in our social media outreach. To ensure you will be featured, be sure

to sign up to become an ambassador between now and April 1, 2019.

Learn more online and volunteer for this program at www.issx.org/ambassador.

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Be a Part of the ISSX Mentorship Program this Year

President’s MessageContinued from page 1

put in place an outstanding scientific program, and given the attractive venue of the Pacific NW at the height of the summer, this should be a popular and highly successful event. Registration for the Portland meeting is now open and can be accessed via the Society website.

Although only one meeting is planned for this year, I am pleased to announce that ISSX will be sponsoring a workshop in December 2019, the topic of which is, “Disposition of Biologics,” a subject of growing importance in both academia and the biotech/pharmaceutical industries. The workshop, which will take place on December 12–13, 2019, at the Merck Research Laboratories facility in Boston, MA, is being organized by

Dhaval Shah (SUNY Buffalo) and Honghui Zhou (J&J). Special thanks to Nancy Agrawal and Ian Knemeyer of Merck for securing this excellent venue for the workshop! Please mark your calendars for what promises to be a very popular educational activity.

As always, comments and suggestions as to how ISSX can continue to best serve the needs of its members are encouraged and much appreciated.

Sincerely,Tom BailliePresident, ISSX

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Learning, growing, guiding, and giving back. These are all benefits associated with the ISSX Mentorship Program, powered by MentorcliQ- a fast and user-friendly cloud-based mentoring platform.

A complimentary benefit exclusively for members of ISSX, the ISSX Mentorship Program provides a rich opportunity for graduate students and newer investigators to be matched with more senior scientists within and across career pathways to discuss career options, review competencies for success, consider challenges and problems, and receive practical advice from experienced scientists.

For the second mentoring cycle ISSX will be allowing mentors and mentees to enroll on an ongoing basis, both prospective mentors and mentees will create a custom profile in the ISSX MentorcliQ portal and the system will then use a Nobel Prize-winning algorithm to evaluate all possible matches and optimize matches across the entire pool. Individuals then develop their mentoring relationships and work together to achieve mentoring goals. The mentoring portal provides the right structure, support, and guidance to help these relationships succeed. ISSX provides the mechanism, checkpoints, templates, logs, midpoint review tools, and more.

Follow this link to join the ISSX Mentorship Program: www.issx.org/ISSXMentorship

Mentoring is a personal and professional development experience that challenges one to reflect on their own actions and behaviors over time. For those who have benefited from a helpful mentor in their lives or careers, there is often a strong drive to pay this forward to others by serving in the same role. The act of helping someone develop, grow, and navigate life and career obstacles is incredibly rewarding.

Launched in 2018, this program has already connected a number of mentors and mentees for rewarding mentoring experiences.

Finding a true mentor is not always easy. The ISSX Mentorship Program can help and we are proud to offer this valuable resource and opportunity for new relationships to begin.

Marysol Almestica-Roberts, United States

Herve Aloysius, United States

Kavya Annu, United States

Yifan Bao, United States

Kyoungju Choi, United States

Cleavon Cloete, South Africa

Collet Dandara, South Africa

Xiao-na Dong, China

Basma ElBakary, United Kingdom

Jing-kai Gu, China

Xing Jie, China

Joshua Johnson, United States

Robert Jones, United States

Kendan Jones-Isaac, United States

Keith Kennedy, United States

Amanda King-Ahmad, United States

Hong-zhen Li, China

Shuaibing Liu, China

Ying-yun Lu, China

Riyazuddin Mohammed, India

Parusharamulu Molgara, India

Julie Murrell, United States

Boonsri Ongpipattanakul, Thailand

Mustafizur Rahman, Bangladesh

Jelle Reinen, Netherlands

Hong Ren, China

Yuanyuan Shi, United States

Ryota Shizu, Japan

Sheri Smith, United States

James Stygall, United Kingdom

Disha Thakkar, India

Larry Tremaine, United States

Pei Wang, China

Mandy Xu, China

Sheng-ju Yin, China

Junjie Zhu, United States

Welcome New Members

This December 12–13, ISSX will host the workshop “Disposition of Biologics” at Merck Research Laboratories in Boston, Massachusetts, USA.

Mark your calendars now and be one of the first to register to attend when registration opens this spring!

Save the Date! Disposition of Biologics

The International Society for the Study of Xenobiotics proudly welcomes the following new members. We greatly appreciate their support and hope that each remains aligned and affiliated with ISSX for many years to come.

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The 21st International Conference on Cytochrome P450 (ICCP450) organizing committee invites you to participate in the 2019 International Conference to be held from Sunday 23–Thursday 27 June 2019 at The University of Queensland, Brisbane, Australia.

The conference programme will consist of a rich schedule of presentations at the forefront of P450 research featuring their roles in the metabolism of drugs and other xenobiotics:

Join us in Brisbane, Australia's only sub-tropical capital city, with a perfect climate for international visitors. A sophisticated and multicultural city with a relaxed lifestyle, Brisbane hosts world-class museums, art galleries, performance venues and universities, and internationally recognized research institutes and hospitals. It is an ideal base for exploring some of the great attractions that Australia and New Zealand have to offer. The timing of ICCP450 2019 at the start of the northern summer provides a perfect opportunity to extend your trip ‘down under’ to enjoy some sightseeing. Brisbane is a short drive to the beaches of the Gold and

Sunshine Coasts, or to the rainforest in local national parks. It’s also just a short flight to the World Heritage-listed Great Barrier Reef, Uluru, Sydney with its iconic Opera House, cosmopolitan Melbourne and the wineries around Adelaide.

For updates about the scientific program and all conference related information please visit the conference website at www.iccp450brisbane.com or contact the conference secretariat, Expert Events at [email protected].

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HeaderHeaderChange of AddressIf your mailing address, telephone, fax number, or e-mail has changed or will change, please let us know as soon as possible. You may update your contact information at any time using the online membership directory, which you can access in the Member Only section of the website. If you have forgotten your username and/or password, please contact [email protected].

ADVERTISE WITH ISSX

The quarterly ISSX Newsletter is an online publication featuring Society updates, scientific articles of interest, book reviews, summaries of ISSX meeting proceedings,

and more. This publication is designed to update the ISSX membership on the activities and events of the organization

and to provide an information forum.

Not only is the ISSX Newsletter promoted directly to all ISSX members, it is also available to anyone

who visits the ISSX website.

Visit issx.org/advertising or contact Scott Narug at [email protected].

Editor Dr. Allen Cato, IIICato Research, LTD6480 Weathers Place, Suite 104San Diego, California 92121USATelephone: +1-858-452-7271Fax: +1-858-452-7784E-mail: [email protected]

ISSX Newsletter is published quarterly in the spring, summer, autumn, and winter. For information concerning advertising in this publication, including rates and specifications, please visit issx.org/advertising or contact Scott Narug at [email protected].