ISSX2019: 12th International ISSX Meeting Onsite Program Book

PORTLAND, OREGON

28—31 JULY 2019

ISSX2019 12TH INTERNATIONAL MEETING Connecting Scientists Worldwide!

PROGRAM

WELCOME TH TO THE 12 INTERNATIONAL ISSX MEETING

WELCOME TO PORTLAND AND TO THE 12TH INTERNATIONAL ISSX MEETING The broad range of highly relevant short courses, symposia and poster presentations designed to serve the interests of all its scientific and geographical constituencies is a hallmark of the ISSX International Meeting and we could not be happier that you chose to invest your time and resources to join us here in Portland as we explore the latest research highlighting drug/xenobiotic research.

With nearly 700 attendees from 25 countries, this is truly an international meeting of the Society and it promises to bring attendees a wealth of information, perspectives, and opportunities for engaged conversations with fellow investigators and suppliers to our area of science in our exhibitor showcase.

2

The 2019 meeting app is again packed with content – download it and give it a try. The entire schedule is there with live updates and you can search by presenter or session as well as build your own personal schedule complete with reminders to keep you on time.

We would like to point out several opportunities so that they do not get lost in the busy schedule. First is the Membership Meeting on Monday morning. This is a meeting of all members and we encourage everyone to attend to learn about the Society’s activities and future strategic goals. Second are the Focus Group sessions that are presented to enhance the exchange of the most current scientific research information and open doors to opportunities for collaboration. Third is our networking happy hour, sponsored by Frontage,

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

taking place on Tuesday where you can enjoy snacks, beverages, and games at a neighborhood sports bar.

These are just some of the activities we want you to be aware of but do not miss the scientific symposia, the exhibitor showcase, the opening welcome, and all of the other opportunities we prepared for you in Portland.

Deepak Dalvie Celgene San Diego, California, USA

We hope you reserved some time to experience the essence of Portland and that you take home great memories, new contacts, and increased understanding of the latest research related to xenobiotic metabolism.

Enjoy!

Aleksandra Galetin University of Manchester Manchester, United Kingdom

Hiroyuki Kusuhara University of Tokyo Tokyo, Japan

SPECIAL THANKS.......................................................................................................................................... 4 SCHEDULE OVERVIEW................................................................................................................................... 5 MEETING INFORMATION ............................................................................................................................. 7 MEETING COMMITTEES ............................................................................................................................... 8 ISSX LEADERSHIP AND STAFF ................................................................................................................... 9 AWARDS......................................................................................................................................................... 10 SCIENTIFIC PROGRAM................................................................................................................................ 12 POSTER INFORMATION ............................................................................................................................. 21 POSTER NUMBER REFERENCE GUIDE ..................................................................................................... 22 INDUSTRY-SPONSORED SYMPOSIA ....................................................................................................... 23 ISSX FOCUS GROUP SESSIONS................................................................................................................. 24 EXHIBITOR DIRECTORY ............................................................................................................................. 33 EXHIBIT HALL E FLOOR PLAN ................................................................................................................... 45

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

3

SPECIAL THANKS GRANT SUPPORT This activity is supported by grants from these companies.

GOLD SPONSORS

SILVER SPONSOR

BRONZE SPONSORS

4

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

SCHEDULE OVERVIEW SUNDAY, 28 JULY

MONDAY, 29 JULY

Exhibit Hall E Lobby Meeting Registration Desk Open: 09:00‒19:00

Exhibit Hall E Lobby Meeting Registration Desk Open: 07:00‒17:00

10:00‒13:00

07:30‒08:45

Concurrent Short Courses 1 and 2

New Investigator Session

*

Portland Ballrooms 252 and 253

Room E141

11:00‒17:00

07:45‒08:45

Exhibit Hall E

Portland Ballroom 252‒253

Exhibitor Set-Up

Focus Group Session 1

11:00‒17:30

09:00‒10:00

Exhibit Hall E

Portland Ballroom 254‒255

Poster Set-Up

Plenary Lecture 1

13:00‒14:00

10:00‒11:00

Portland Ballroom 251

Portland Ballroom 254‒255

Short Course Attendee Lunch* 14:00‒17:00

ISSX Membership Meeting 11:00‒13:00

Concurrent Short Courses 3 and 4

Lunch Break Poster Award Finalist Poster Presentations

*

Portland Ballrooms 252 and 253 17:30‒17:45

Sponsored by Vertex

Portland Ballroom 254‒255

Poster Presentation Session 1

17:45‒18:30

Exhibit Hall E

Exhibit Hall E Lobby

Welcome Remarks

Sponsored by Certara

Keynote Lecture

Portland Ballroom 254-255

13:00‒15:00

18:30‒20:30

Portland Ballrooms 252‒253 and 254‒255

Parallel Symposia 1 and 2

Opening Welcome Reception with Exhibitors

15:00‒15:30

Refreshment Break with Exhibitors and Posters

Sponsored by Eurofins Exhibit Hall E

Exhibit Hall E 15:30‒17:30

Parallel Symposia 3 and 4

Portland Ballrooms 252‒253 and 254‒255 17:30‒19:30

Poster Viewing Hours Exhibit Hall E *The short courses are separately-ticketed activities.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

5

SCHEDULE OVERVIEW TUESDAY, 30 JULY Exhibit Hall E Lobby Meeting Registration Desk Open: 07:30‒17:00 08:00‒09:00

Plenary Lecture 2

Portland Ballroom 254‒255 09:00‒09:30

Refreshment Break with Exhibitors and Posters Exhibit Hall E 09:30‒11:30

Parallel Symposia 5 and 6

Portland Ballrooms 252‒253 and 254‒255 11:30‒14:00

Lunch Break Poster Award Finalists Attend Posters Exhibit Hall E Lobby

Poster Presentation Session 2 Sponsored by Simulations Plus

Exhibitor Showcase Presented by Covance Exhibit Hall E 14:00‒16:00

Parallel Symposia 7 and 8

Portland Ballrooms 252‒253 and 254‒255 16:00‒16:30

Refreshment Break with Exhibitors and Posters Exhibitor Showcase Presented by Q2 Solutions Exhibit Hall E 16:30‒17:30

Parallel ISSX Focus Group Sessions 2 and 3 Portland Ballrooms 252‒253 and 254‒255 17:30‒18:30

18:30‒19:30

Networking Happy Hour Sponsored by Frontage Spirit of 77 500 NE MLK Jr. Blvd.

WEDNESDAY, 31 JULY Exhibit Hall E Lobby Meeting Registration Desk Open: 08:30‒18:30 09:00‒10:00

Plenary Lecture 3

Portland Ballroom 254‒255 10:00‒10:30

Refreshment Break with Exhibitors and Posters Exhibit Hall E 10:30‒12:30

Parallel Symposia 9 and 10

Portland Ballrooms 252‒253 and 254‒255 12:30‒14:30

Lunch Break Poster Presentation Session 3 Sponsored by Covance

Exhibitor Showcase

Presented by Pharmaron Exhibit Hall E 14:30‒17:00

Exhibitor Move-Out Exhibit Hall E 14:30‒16:00

ISSX Awards Session Portland Ballroom 254‒255 16:00‒18:00

Symposium 11

Portland Ballroom 254‒255

Parallel Industry-Sponsored Symposia:

18:00‒18:30

Portland Ballrooms 252‒253 and 254‒255

Portland Ballroom 254‒255

BioIVT (252‒253), MilliporeSigma (254‒255)

6

Closing Remarks

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

MEETING INFORMATION Meeting Venue

the presentation of the 2019 ISSX Poster Awards. These awards and lectures will be presented from 14:30‒16:00 on Wednesday, 31 July in Portland Ballroom 254‒255.

Additional information can be found on pages 10-11 and page 21 of this program.

Oregon Convention Center 777 NE Martin Luther King Jr. Blvd.

Portland, Oregon 97232 USA

Poster Awards Competition

Name Badges Name badges are required for admission to the meeting sessions, the exhibit space, and social functions. Badges help facilitate networking and communication with your fellow attendees. If you lose your badge, please visit the registration information desk in the Exhibit Hall E Lobby for assistance.

Registration Hours Sunday, 28 July Monday, 29 July Tuesday, 30 July Wednesday, 31 July

09:00‒19:00 07:00‒17:00 07:30‒17:00 08:30‒18:30

Abstracts and Posters Meeting abstracts are available for review in the abstract book provided to attendees at registration and online at www.issx.org/onlineabstracts. Abstracts will be published in an online supplemental issue of Drug Metabolism and Pharmacokinetics (DMPK).

General posters will be on display throughout the meeting in the Exhibit Hall E. Poster Awards Competition posters will be on display in the Exhibit Hall E Lobby. The posters will be presented in three presentation sessions and posters may be viewed during the scheduled viewing times outlined on page 21 of this program.

2019 ISSX Awards Session and Poster Awards Presentation All attendees are invited to be present for the 2019 R.T. Williams Distinguished Scientific Achievement Award, sponsored by Charles Crespi and Family, the 2019 Frederick J. Di Carlo Distinguished Service Award, and the Distinguished Accomplishments in Drug Discovery and Development Award. This awards session will also include

Finalists for the best Pre-doctoral/Graduate and Postdoctoral poster presentations will present their work during poster presentation sessions on Monday, 29 July in the Exhibit Hall E Lobby. Find all poster presentation details on page 21 of this program.

Opening Welcome Reception and Spirit of 77 Networking Happy Hour Fully-registered attendees and registered guests are invited to the Opening Welcome Reception on Sunday, 28 July from 18:30‒20:30 in Exhibit Hall E. This event is sponsored by Eurofins Discovery. Our exhibitors will be onhand to meet you and share information about their latest products and services. Posters will also be on display to provide attendees an early start to poster viewing and discussions.

All attendees are also invited to attend the Networking Happy Hour at the Spirit of 77 on Tuesday, 30 July from 18:30‒19:30. This event is sponsored by Frontage. Enjoy refreshments, the company of fellow attendees, and an opportunity to experience a true Portland sports bar.

Admission to these events is included in the full meeting registration fee and is open to registered guests.

Attendees must have their name badges to be admitted.

Internet Access Complimentary Wi-Fi is available in the ISSX Meeting Space and in select public areas at the convention center.

Connect to ISSX WiFi. No password is needed to connect.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

7

MEETING COMMITTEES Meeting Organizing Committee Meeting Organizing Committee Chairs Deepak Dalvie, Celgene, San Diego, California, USA Aleksandra Galetin, University of Manchester, Manchester, United Kingdom Hiroyuki Kusuhara, University of Tokyo, Tokyo, Japan Meeting Organizing Committee Members Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom Roos Masereeuw, Utrecht Institute for Pharmaceutical Sciences, Utrecht, the Netherlands Karthik Venkatakrishnan, Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA Lei Zhang, Silver Spring, Maryland, USA Bhagwat Prasad, University of Washington, Seattle, Washington, USA Marcel Hop, Genentech Inc., South San Francisco, California, USA Xiaoyan Chu, Merck & Co. Inc., Rahway, New Jersey, USA Hannah Jones, Pfizer Inc., Cambridge, Massachusetts, USA Kouichi Yoshinari, University of Shizuoka, Shizuoka, Japan

Abstract Review Committee Jae Chang, Genentech Inc., South San Francisco, California, USA

Bhagwat Prasad, University of Washington, Seattle, Washington, USA Ylva Terelius, Medivir AB, Stockholm, Sweden Donald Tweedie, Merck & Co. Inc., West Point, Pennsylvania, USA Kouichi Yoshinari, University of Shizuoka, Shizuoka, Japan Mike Zientek, Takeda California, San Diego, California, USA

Scientific Affairs Committee R. Scott Obach, Chair, Pfizer Inc., Groton, Connecticut, USA Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom Eric Chan, National University of Singapore, Singapore Kathy Giacomini, University of California San Francisco, San Francisco, California, USA Marcel Hop, Genentech Inc, South San Francisco, California, USA Barry Jones, Pharmaron, Rushden, United Kingdom Ross McKinnon, Flinders University, Bedford Park, Australia Mario Monshouwer, Janssen Pharmaceuticals, Beerse, Belgium Yoichi Osawa, University of Michigan Medical School, Ann Arbor, Michigan, USA Ikumi Tamai, Kanazawa University, Kanazawa, Japan Ylva Terelius, Medivir AB, Stockholm, Sweden

Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom

C. Roland Wolf, University of Dundee, Dundee, United Kingdom

Hannah Jones, Pfizer Inc., Cambridge, Massachusetts, USA

Yasushi Yamazoe, Food Safety Commission, Government of Japan, Yamato, Japan

Roos Masereeuw, Utrecht Institute for Pharmaceutical Sciences, Utrecht, the Netherlands

Mike Zientek, Takeda California, San Diego, California, USA

R. Scott Obach, Pfizer Inc., Groton, Connecticut, USA

8

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

ISSX LEADERSHIP AND STAFF ISSX Council

ISSX Staff

President

Executive Director

Thomas Baillie, University of Washington, Seattle, Washington, USA

Steven Kemp Program Manager

President-Elect/Secretary Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom

ZoĂŤ Fuller Meeting Manager Ashley Pencak

Treasurer Sonia de Morais, SDM Biopharma Consultants, The Villages, Florida, USA

Exhibits Sales Manager Scott Narug

Treasurer-Elect Erin Schuetz, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA

Exhibits Associate Taraneh Ansari Accountant

Members of Council

Tatianna Padmanabhan

Eric Chan, National University of Singapore Aleksandra Galetin, University of Manchester, Manchester, United Kingdom William Griffith Humphreys, Aranmore Pharma Consultants, Lawrenceville, New Jersey, USA Jashvant Unadkat, University of Washington, Seattle, Washington, USA Lei Zhang, Silver Spring, Maryland, USA Michael Zientek, Takeda California, San Diego, California, USA Ex-Officio to Council R. Scott Obach, Pfizer Inc., Groton, Connecticut, USA

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

9

AWARDS C. Roland Wolf, Ph.D. R.T. WILLIAMS DISTINGUISHED SCIENTIFIC ACHIEVEMENT AWARD Sponsored by Charles Crespi and Family The R.T. Williams Distinguished Scientific Achievement Award is presented to an ISSX member from any region who has made substantial and seminal scientific contributions to the field over a sustained period and celebrates the individual’s scientific accomplishment. This award recognizes the best in the field on international level. The 2019 recipient is C. Roland Wolf, OBE, FRSE, FMedSci, FRSA, FBTS, University of Dundee, Medical Research Institute.

Roland Wolf graduated from the University of Surrey in 1972 with a BSc Honors in Chemistry followed by a PhD in Biochemistry. Until recently, he held position of Research Director at the University of Dundee Medical Research Institute and was Honorary Director at the Cancer Research UK Molecular Pharmacology Unit. In addition, he was a founder and the Scientific Director of CXR Biosciences (now Concept Life Sciences), based in Dundee, UK. Currently, he is Professor of Molecular Pharmacology at Dundee University.

Professor Wolf’s primary research interests are understanding the pathways which determine the sensitivity of cells to drugs, environmental agents and chemical toxins, particularly molecular and genetic studies on how chemical agents interact with cells, how this influences their therapeutic and toxicological properties and how genetic polymorphisms in the genes involved relate to disease susceptibility, adverse drug pharmacology and toxicology.

Specific current projects focus on preclinical drug development, the personalized treatment of cancer

10

and the development of novel transgenic models to study drug pharmacology, disease etiology and the mechanisms that underlie the deleterious effects of environmental pollution.

Professor Wolf has published 533 papers in peerreviewed scientific journals, cited more than 28,000 times and has an H index of 86. He has been a member of numerous national and international committees and advisory panels in academia, government and industry.

To recognize and celebrate Dr. Wolf’s substantial and sustained scientific contributions to the field of xenobiotic disposition spanning nearly five decades, he is awarded the 2019 R.T. Williams Distinguished Scientific Achievement Award.

Charles Crespi, Ph.D. THE FREDERICK J. DI CARLO DISTINGUISHED SERVICE AWARD The Frederick J. Di Carlo Distinguished Service Award is presented to an ISSX member from any region with an illustrious record of important service to the Society and its goals. The 2019 recipient is Charles Crespi, Ph.D. Charles Crespi received his Ph.D. in toxicology from the Massachusetts Institute of Technology. In the early 1980s Dr. Crespi and associates founded GENTEST Corporation, a company that became a leader in developing in vitro systems for the study of drug metabolism and safety. Areas of long-term research focus of Dr. Crespi include: the development of mammalian cells which are competent for the metabolism and transport of xenobiotics, the overexpression of xenobiotic metabolizing enzymes and transporters

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

in various host systems and the development of novel applications of these systems to the discovery, development and safety assessment of new chemical entities.

A distinguished scientists and entrepreneur, Dr. Crespi has been a member of the International Society for the Study of Xenobiotics since 1991. He served the Society in a variety of roles including poster awards committees, meeting organizing committees, as a member of the Finance Committee from 2006 – 2009 and as Treasurer for two years, 2010 - 2011. Dr. Crespi and his family generously endowed the R.T. Williams Distinguished Scientific Achievement Award.

For his active involvement, leadership, expertise, contributions, and commitment, ISSX is proud to honor Charles Crespi with the 2019 Frederick J. Di Carlo Distinguished Service Award.

Raymond Evers, Ph.D. DISTINGUISHED ACCOMPLISHMENTS IN DRUG DISCOVERY AND DEVELOPMENT AWARD

The inaugural recipient of this award is Raymond Evers, Director, Transporters and In Vitro Technologies, Drug Metabolism and Pharmacokinetics, Merck and Co. He is receiving this award for his significant and sustained contributions to the field of drug transporter science and enzymology that have had tremendous impact on his company’s portfolio and on the broader scientific and regulatory field.

Dr. Evers has had a tremendous impact with Merck and in the broader scientific community in the field of drug transporters and enzymology. His leadership and research have helped to improve the quality of the small molecule and peptide portfolio in discovery and development and have contributed to the approval of many registered drugs. Dr. Evers has continued to advance the discipline of drug transporters, drug-drug interactions, and DMPK in general, as evidenced by a strong and impactful record of publications and significant involvement in scientific societies.

For his high impact scientific accomplishments advancing the ADME characterization of drugs and drug candidates, Dr. Evers is awarded the ISSX Distinguished Accomplishments in Drug Discovery and Development Award.

The Distinguished Accomplishments in Drug Discovery and Development Award was created in 2018 to honor an individual or a team employed in an organization involved in drug discovery and/or drug development.

The award is bestowed on the basis of a single high impact scientific accomplishment that dramatically changed practices in the ADME characterization of drugs or drug candidates or a sustained body of scientific work that shows high impact on the ADME characterization of drugs.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

11

SCIENTIFIC PROGRAM SUNDAY, 28 JULY 10:00‒13:00

Concurrent Short Courses 1 and 2 Portland Ballrooms 252 and 253 10:00‒13:00

Short Course 1: Advances in the Role of Transporters in Drug Development Chair: Yingying Guo, Eli Lilly and Company, Indianapolis, Indiana, USA Portland Ballroom 252

10:00‒10:30 SC1.1. The Next Frontier in ADME Research: Predicting and Verifying Tissue Drug Concentrations Using a Proteomics and PET Imaging Approach Jashvant Unadkat, University of Washington, Seattle, Washington, USA 10:30‒11:00 SC1.2. Advancing Predictions of Tissue and Intracellular Drug Concentrations Using in vitro and PBPK Modeling Approaches Yingying Guo, Eli Lilly and Company, Indianapolis, Indiana, USA 11:00‒11:30 SC1.3. Influence of Transporter Polymorphisms on Drug Disposition and Response: A Perspective from the International Transporter Consortium Sook Wah Yee, University of California San Francisco, San Francisco, California, USA 11:30‒11:45 Refreshment Break 11:45‒12:15 SC1.4. Can BSEP Inhibition Testing in Drug Discovery and Development Reduce Liver Injury Risk? An International Transporter Consortium Perspective Gerry Kenna, Safer Medicines Trust, Kingsbridge, Devon, United Kingdom 12:15‒12:45 SC1.5. Transporter DDIs – A Regulatory Perspective “Transporters in Drug Development: Scientific and Regulatory Considerations” Lei Zhang, Silver Spring, Maryland, USA 12:45‒13:00 Speaker Panel Discussion

12

10:00‒13:00

Short Course 2: Non-P450 Enzymes in ADMET for Drug Discovery and Development

Co-Chairs: Cyrus Khojasteh, Genentech Inc., South San Francisco, California, USA and Kouichi Yoshinari, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan Portland Ballroom 253

10:00‒10:40 SC2.1. An Overview of Non-P450-mediated Metabolism in Drug Development Cyrus Khojasteh, Genentech Inc., South San Francisco, California, USA 10:40‒11:20 SC2.2. Role of Glucuronidation in Drug Metabolism and Toxicity Ryoichi Fujiwara, University of Arkansas, Little Rock, Arkansas, USA 11:20‒11:35 Refreshment Break 11:35‒12:15 SC2.3. Enzymology and Clinical Importance of Reductases and Hydrolases Matt Cerny, Pfizer Inc., Groton, Connecticut, USA 12:15‒13:00 SC2.4. Toxicological Relevance of Non-P450 Enzymes: Hydrolases and Aldehyde Oxidase Tatsuki Fukami, Kanazawa University, Kanazawa, Japan 13:00‒14:00

Short Course Attendee Lunch Portland Ballroom 251 14:00-17:00

Concurrent Short Courses 3 and 4 Portland Ballrooms 252 and 253 14:00‒17:00

Short Course 3: State of the Art PKPD and QSP Modeling

Co-Chairs: Piet van der Graaf, Certara, Sheffield, United Kingdom and Marjoleen Nijsen, AbbVie Inc., North Chicago, Illinois, USA Portland Ballroom 252

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

14:00‒14:10 SC3.1. Introduction to QSP Piet van der Graaf, Certara, Sheffield, United Kingdom 14:10‒14:40 SC3.2. Application of QSP in Drug Discovery R. Adam Thompson, AbbVie Inc., North Chicago, Illinois, USA 14:40‒15:20 SC3.3. Therapeutic Area Case Study: QSP in Immuno-oncology

16:15‒17:00 SC4.4. Progress Made in Understanding Geneticallyinherited Susceptibility Factors, Including HLA Genotype Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom 17:30‒18:30

Shihem Bihorel, University of Florida, Orlando, Florida, USA

Welcome Remarks and Keynote Lecture Portland Ballroom 254‒255

15:20‒16:00 SC3.4. Therapeutic Area Case Study: QSP in Inflammatory Disease

17:30‒17:45

Welcome Remarks

Kapil Gadkar, Genentech Inc., South San Francisco, California, USA 16:00‒16:15 Refreshment Break 16:15‒17:00 SC3.5. Tutorial: How to Build a QSP Model in Less Than One Hour Andrzej Kierzek, Certara, Sheffield, United Kingdom 14:00‒17:00

Short Course 4: Idiosyncratic Drug-induced Liver Injury Co-Chairs: Gerry Kenna, Safer Medicines Trust, Kingsbridge, Devon, United Kingdom and Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom Portland Ballroom 253

14:00‒14:40 SC4.1. The Role of Inflammatory Mediators in Idiosyncratic Drug-induced Liver Injury Jack Uetrecht, University of Toronto, Toronto, Ontario, Canada 14:40‒15:20 SC4.2. Clinical Aspects of Hepatocellular and Cholestatic Drug-induced Liver Injury Einar S. Björnsson, Landspítali - The National University Hospital of Iceland, Reykjavik, Iceland 15:20‒15:35 Refreshment Break

15:35-16:15 SC4.3. Cellular and Animal Models of Idiosyncratic Drug-induced Liver Injury Tsuyoshi Yokoi, Nagoya University, Nagoya, Japan

ISSX President, Thomas Baillie, University of Washington, Seattle, Washington, USA, and Meeting Chairs, Deepak Dalvie, Celgene, San Diego, California, USA, Aleksandra Galetin, University of Manchester, Manchester, United Kingdom, and Hiroyuki Kusuhara, University of Tokyo, Tokyo, Japan 17:45‒18:30

Keynote Lecture

Chair: Aleksandra Galetin, University of Manchester, Manchester, United Kingdom

K1. Model-Informed Precision Dosing at the Bedside: Scientific Challenges and Opportunities Lawrence Lesko, Emeritus Professor, University of Florida, Orlando, Florida, USA 18:30‒20:30

Opening Welcome Reception with Exhibitors Sponsored by Eurofins Discovery Exhibit Hall E

Try a Taste of Portland at the Opening Welcome Reception Attendees receive a tasting card to try a sampling of local wine and beer. Have your card handy when you tour the Exhibit Hall on Sunday evening.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

13

SCIENTIFIC PROGRAM MONDAY, 29 JULY

13:00‒15:00

07:30‒08:45

Portland Ballrooms 252‒253 and 254‒255

Concurrent Sessions: New Investigator Session and Focus Group Session 1 Room E141 and Portland Ballroom 252‒253 07:30‒08:45

New Investigator Session

Chair: Bhagwat Prasad, University of Washington, Seattle, Washington, USA Room E141

07:45‒08:45

Focus Group Session 1: Bioanalysis in ADME Science

Chair: Kevin Bateman, Merck & Co. Inc., West Point, Pennsylvania, USA and Co-Chair: Jens Sydor, GSK, Philadelphia, Pennsylvania, USA Portland Ballroom 252‒253 09:00‒10:00

Plenary Lecture 1

Chair: Thomas Baillie, University of Washington, Seattle, Washington, USA

L1. How Technology, Big Data and Systems Approaches are Transforming 21st Century Healthcare Leroy Hood, Providence St. Joseph Health, Seattle, Washington, USA Portland Ballroom 254‒255 10:00‒11:00

ISSX Membership Meeting

ISSX President, Thomas Baillie, University of Washington, Seattle, Washington, USA Portland Ballroom 254‒255 11:00‒13:00

Lunch Break, Visit with Exhibitors, and Poster Presentation Session 1 Sponsored by Certara Exhibit Hall E

Poster Awards Finalist Poster Presentations Sponsored by Vertex Exhibit Hall E Lobby

14

Parallel Symposia 1 and 2 13:00‒15:00

Symposium 1: Personalized Medicine: Use of Pharmacogenomics and Other Patient-specific Factors to Individualize Drug Dosing and Treatment Co-Chairs: Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom and Tsuyoshi Fukuda, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA Portland Ballroom 252‒253

13:00‒13:30 S1.1. Warfarin: A Paradigm for Individualized Dosing Munir Pirmohamed, University of Liverpool, Liverpool, United Kingdom 13:30‒14:00 S1.2. Relevance of Transporter and Metabolic SNPs to Pediatric Treatment Tsuyoshi Fukuda, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA 14:00‒14:30 S1.3. CPIC Guidelines and Implementation to Date Kelly Caudle, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA 14:30‒15:00 S1.4. Personalised Treatment of Cancer Howard McLeod, Moffitt Cancer Center, Tampa, Florida, USA 13:00‒15:00

Symposium 2: State of the Art for Organs on Chips

Co-Chairs: Edward Kelly, University of Washington, Seattle, Washington, USA and Roos Masereeuw, Utrecht Institute for Pharmaceutical Sciences, Utrecht, the Netherlands Portland Ballroom 254‒255

13:00‒13:30 S2.1. “Tissues on Chips”- A Novel Tool for Toxicity and Efficacy Testing on Human Tissue Bo Yeon Lee, National Institute of Health, NCATS, Bethesda, Maryland, USA

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

13:30‒14:00 S2.2. Kidney Organoids for Disease Modeling and High Throughput Screening Benjamin Freedman, University of Washington, Seattle, Washington, USA 14:00‒14:30 S2.3. Real-time Toxicity Assessment on Perfused 3D Epithelial Tubes Bas Trietsch, Mimetas, Leiden, the Netherlands 14:30‒15:00 S2.4. Biofabrication of Liver Constructs for Drug Toxicity Studies Kerstin Schneeberger, Utrecht University, Utrecht, the Netherlands 15:00‒15:30

Refreshment Break with Exhibitors and Posters Exhibit Hall E 15:30‒17:30

Parallel Symposia 3 and 4

Portland Ballrooms 252‒253 and 254‒255 15:30‒17:30

Symposium 3: Quantitative Pharmacokinetic and Pharmacology Methods and Strategies in the Discovery and Development of Biotherapeutics Co-Chairs: Hannah Jones, Pfizer Inc., Cambridge, Massachusetts, USA and Joe Balthasar, University of Buffalo, Buffalo, New York, USA Portland Ballroom 252‒253

15:30‒16:00 S3.1. Development and Application of a PBPK Model for Large Molecules in Pfizer Hannah Jones, Pfizer Inc., Cambridge, Massachusetts, USA 16:00‒16:30 S3.2. PBPK and PKPD Modeling to Investigate Engineered Antibodies Tatsuhiko Tachibana, Chugai Pharmaceutical Co., Ltd., Shizuoka, Japan

16:30‒17:00 S3.3. PBPK Models for Predicting Human PK for Monoclonal Antibodies and Other Large Molecule Modalities Iain Gardner, Certara UK Limited (Simcyp Division), Sheffield, United Kingdom 17:00‒17:30 S3.4. Systems PK/PD Model Informed Discovery and Development of Cancer Immunotherapy Dhaval Shah, University of Buffalo, Buffalo, New York, USA 15:30‒17:30

Symposium 4: MicrobiomeEnvironment-Drug Interactions: Emerging Tools and Applications

Co-Chairs: Julia Yue Cui, University of Washington, Seattle, Washington, USA and Sumio Ohtsuki, Kumamoto University, Kumamoto, Japan Portland Ballroom 254‒255

15:30‒16:00 S4.1. Impact of Intestinal Flora on Host Metabolism of Drug, Sugar and Lipid Sumio Ohtsuki, Kumamoto University, Kumamoto, Japan 16:00‒16:30 S4.2. Activity-based Profiling of the Microbiome Response to Chemical Exposures Aaron Wright, Pacific Northwest National Laboratory, Richland, Washington, USA 16:30‒17:00 S4.3. Impact of the Human Gut Microbiome on Drug Disposition Peter Turnbaugh, NCATS, University of California San Francisco, San Francisco, California, USA 17:00‒17:30 S4.4. Developmental Reprogramming of the Gut Microbiota by Environmental Toxicants Julia Yue Cui, University of Washington, Seattle, Washington, USA 17:30‒19:30

Poster Viewing Hours Exhibit Hall E

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

15

SCIENTIFIC PROGRAM TUESDAY, 30 JULY 08:00‒09:00

Plenary Lecture 2

Chair: Hiroyuki Kusuhara, University of Tokyo, Tokyo, Japan

L2. Evaluation of Disease Progression / Drug Effects by Expanding the PK Concept

Hiroshi Suzuki, The University of Tokyo Hospital, Tokyo, Japan Portland Ballroom 254‒255 09:00‒09:30

Refreshment Break with Exhibitors and Posters Exhibit Hall E 09:30‒11:30

Parallel Symposia 5 and 6

Portland Ballrooms 252‒253 and 254‒255 09:30‒11:30

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 Portland Ballroom 252‒253

09:30‒10:00 S5.1. Proteomics Based Studies of Disease Effects on the Brain Barrier Transporters Tetsuya Terasaki, Graduate School of Pharmaceutical Sciences, Tohoku University, Sendai, Japan 10:00‒10:30 S5.2. SLC16A11: From Human Genetics to Novel Mechanisms Underlying Type 2 Diabetes Eitan Hoch, Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA 10:30‒11:00 S5.3. Transporters in Polycystic Kidney Disease Kim Brouwer, University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA

16

11:00‒11:30 S5.4. Liver Transporter Activity in Patients with Renal Disease Aubrey Stoch, Merck & Co. Inc., Rahway, New Jersey, USA 09:30‒11:30

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 Portland Ballroom 254‒255

09:30‒10:00 S6.1. Predicting Routes, Sites, and Products of Metabolism Matthew Segall, Optibrium Limited, Cambridge, United Kingdom 10:00‒10:30 S6.2. Substrate Recognition

by Cytochrome P450s Emily Scott, University of Michigan, Ann Arbor, Michigan, USA 10:30‒11:00 S6.3. Application of in silico DMPK in Drug Discovery and Development Fabio Broccatelli, Genentech Inc., South San Francisco, California, USA 11:00‒11:30 S6.4. Biosynthesis of Drug Candidates and Metabolites Griff Humphreys, Aranmore Pharma Consultants, Lawrenceville, New Jersey, USA 11:30‒14:00

Lunch Break, Visit with Exhibitors, Poster Presentation Session 2 Sponsored by Simulations Plus Exhibit Hall E 12:30-13:00

Exhibitor Showcase: The Advantages of Using Radiolabelled Test Materials in ADMET Presented by Covance Exhibit Hall E

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

14:00‒16:00

14:00‒16:00

Parallel Symposia 7 and 8

Portland Ballrooms 252‒253 and 254‒255 14:00‒16:00

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 Portland Ballroom 252‒253

14:00‒14:30 S7.1. Prediction of Differences in Pharmacokinetics between Chinese, Japanese, and Caucasian Populations - An Update Geoffrey Tucker, University of Sheffield, Sheffield, United Kingdom 14:30‒15:00 S7.2. Transporter Polymorphisms Drive Interethnic Differences in Drug Response Kathy Giacomini, University of California San Francisco, San Francisco, California, USA 15:00‒15:30 S7.3. Enabling Asia-Inclusive Global Drug Development through Quantitative and Translational Science Karthik Venkatakrishnan, Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA 15:30‒16:00 S7.4. 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 Portland Ballroom 254‒255

14:00‒14:30 S8.1. Biomarkers for in vivo Assessment of Transporter Function Martin F. Fromm, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany 14:30‒15:00 S8.2. Mechanistic Models for Coproporphyrin I and Creatinine as Endogenous Biomarkers for Transporter Drug-Drug Interactions Aleksandra Galetin, University of Manchester, Manchester, United Kingdom 15:00‒15:30 S8.3. 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 15:30‒16:00 S8.4. 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 16:00‒16:30

Refreshment Break with Exhibitors and Posters Exhibitor Showcase: ADME Services to Enable Informed Decision Making in Drug Discovery & Development Presented by Q2 Solutions Exhibit Hall E

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

17

SCIENTIFIC PROGRAM 16:30‒17:30

Parallel ISSX Focus Group Sessions 2 and 3 Portland Ballrooms 252‒253 and 254‒255 16:30‒17:30

Focus Group Session 2: Biotransformation Mechanisms and Pathways

Chair: Amit Kalgutkar, Pfizer Inc., Cambridge, Massachusetts, USA and Co-Chair: Valerie Kramlinger, Amgen, Cambridge, Massachusetts, USA Portland Ballroom 252‒253 16:30‒17:30

18:30‒19:30

Networking Happy Hour Sponsored by Frontage Spirit of 77 500 NE MLK Jr. Blvd.

Attend the Networking Happy Hour at Spirit of 77 on Tuesday, 30 July!

Join fellow attendees for arcade games, upscale bar fare, craft beers and cocktails. Guests are welcome to attend with paid registrants!

Focus Group Session 3: Modeling & Simulation

Chair: Hartmut Derendorf, University of Florida, Gainesville, Florida, USA and Co-Chair: Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA Portland Ballroom 254‒255 17:30‒18:30

Parallel Industry-Sponsored Symposia (ISS)

Portland Ballrooms 252‒253 and 254‒255 17:30‒18:30

BioIVT: Potential Benefits of a Physiologically-Relevant Whole Cell Model to Assess CYP Inhibition with Complex Mixtures Amy L. Roe, Ph.D., DABT

Portland Ballroom 252‒253 17:30‒18:30

MilliporeSigma: Tapping the Potential of Gene Editing Technology to Improve Cell-Based Assays for Drug Disposition and Transporter-Mediated Drug-Drug Interactions David Thompson Ph.D., Sr R&D Manager, In vitro Safety Systems, MilliporeSigma Portland Ballroom 254‒255

WEDNESDAY, 31 JULY 09:00‒10:00

Plenary Lecture 3

Chair: Marcel Hop, Genentech Inc., South San Francisco, California, USA

L3. Drug Metabolism, Pharmacogenomics and the Quest to Personalize HIV Treatment and Prevention Namandjé Bumpus, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Portland Ballroom 254‒255 10:00‒10:30

Refreshment Break with Exhibitors and Posters Exhibit Hall E

18

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

10:30‒12:30

Parallel Symposia 9 and 10

Portland Ballrooms 252‒253 and 254‒255 10:30‒12:30

Symposium 9: Role of Albumin in Drug Disposition Revisited Co-Chairs: Malcolm Rowland, University of Manchester, Manchester, United Kingdom and Stephen Hall, Eli Lilly and Company, Indianapolis, Indiana, USA Portland Ballroom 252‒253 10:30‒10:35 Introduction 10:35-11:00 S9.1. Albumin-mediated Hepatic Uptake of Organic Anion Transport Polypeptide Substrates Yuichi Sugiyama, Sugiyama Laboratory, RIKEN Baton Zone Program, RIKEN, Yokohama, Kanagawa, Japan 11:00‒11:25 S9.2. Effects of Albumin on Prediction of Liver Kpuu and Human Hepatic Clearance for Enzymeand Transporter-Mediated Mechanisms Li Di, Pfizer Inc., Groton, Connecticut, USA 11:25‒11:50 S9.3. Impact of Albumin and Plasma on the Renal Uptake of OAT1 Substrates Roos Masereeuw, Utrecht Institute for Pharmaceutical Sciences, Utrecht, the Netherlands 11:50‒12:30 Speaker Panel Discussion 10:30‒12:30

Symposium 10: Ontogeny of Enzymes and Transporters and their Implications in Pediatric PBPK Modeling to Inform Pediatric Dosing

10:30‒11:00 S10.1. Ontogeny of Human Membrane Transporters: from Data to Application Saskia de Wildt, Radboud University Medical Center, Nijmegen, the Netherlands 11:00‒11:30 S10.2. Pediatric PBPK: Dealing with Uncertain Parameters and Deciding on Success Criteria for Predictability Trevor Johnson, Certara UK Limited (Simcyp Division), Sheffield, United Kingdom 11:30‒12:00 S10.3. Use of ‘Virtual Children’ to Inform Exposure-Controlled Dosing of Drugs in Children Jean Dinh, Children’s Mercy Hospital, Kansas City, Missouri, USA 12:00‒12:30 S10.4. Building, Verifying and Validating Pediatric PBPK Models: Vulnerabilities and Knowledge Deficits Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA 12:30‒14:30

Lunch Break, Visit with Exhibitors, Poster Presentation Session 3 Sponsored by Covance Exhibit Hall E 13:15-13:45

Exhibitor Showcase: Comparison of Metabolism and Rates/routes of Excretion between Human and Toxicology Species to Establish Metabolite Safety Presented by Pharmaron Exhibit Hall E

Co-Chairs: J. Steven Leeder, Children’s Mercy Hospital, Kansas City, Missouri, USA and Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA Portland Ballroom 254‒255

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

19

SCIENTIFIC PROGRAM 14:30‒16:00

18:00‒18:30

Chair: Ann K. Daly, Newcastle University, Newcastle upon Tyne, United Kingdom

ISSX President, Thomas Baillie, University of Washington, Seattle, Washington, and Meeting Chairs, Deepak Dalvie, Celgene, San Diego, California, USA, Aleksandra Galetin, University of Manchester, Manchester, United Kingdom, and Hiroyuki Kusuhara, University of Tokyo, Tokyo, Japan

ISSX Awards Session

Presentation of the ISSX 2019 Awards:

• R.T. Williams Distinguished Scientific Achievement Award, sponsored by Charles Crespi and Family • Frederick J. Di Carlo Distinguished Service Award • Distinguished Accomplishments in Drug Discovery and Development Award • ISSX Poster Awards Portland Ballroom 254‒255 16:00‒18:00

Symposium 11: ‘War Stories’ – ADME Issues Encountered and Addressed in Drug Discovery and Development

Closing Remarks

Portland Ballroom 254‒255

Connect with Fellow ISSX Members in the ISSX Booth #302 New this year! ISSX members are invited to stop by the ISSX Booth to meet with other members and to learn more about our upcoming meetings.

Co-Chairs: Marcel Hop, Genentech Inc., South San Francisco, California, USA and Deepak Dalvie, Celgene, San Diego, California, USA Portland Ballroom 254‒255

16:00‒16:30 S11.1. Navigating through Discovery and Development Painlessly: Snapshots within the Nav1.7 Program Jae Chang, Genentech Inc., South San Francisco, California, USA 16:30‒17:00 S11.2. Elagolix: A Mechanistic Understanding of Drug-Drug Interactions David Stresser, AbbVie Inc., North Chicago, Illinois, USA 17:00‒17:30 S11.3. ZEPATIER: The Tale of Two Novels Christine Fandozzi, Merck & Co. Inc., West Point, Pennsylvania, USA 17:30‒18:00 S11.4. Management of MIST in a Case of Multiple Metabolic Species Differences Lars Weidolf, AstraZeneca R & D, Mölndal, Sweden

20

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

POSTER INFORMATION POSTER AWARDS COMPETITION POSTER PRESENTATIONS: EXHIBIT HALL E LOBBY DATE AND TIME

ACTIVITY

POSTER NUMBERS

Sunday, 28 July

Poster Set-Up

All Posters

11:00–17:30

Monday, 29 July 11:00–11:45

Monday, 29 July 12:00–12:45

Pre-doctoral/Graduate Awards Finalists Poster Authors Present at Posters Sponsored by Vertex Postdoctoral Awards Finalists Poster Authors Present at Posters Sponsored by Vertex

A1 - A12

Pre-doctoral/Graduate Finalists Poster Presentations A1 - A6

Postdoctoral Finalists Poster Presentations A7 - A12

Monday, 29 July 17:30–19:30

Poster Viewing Hours No scheduled presentations

All Posters

Tuesday, 30 July

All Finalists Attend Posters

All Posters

Wednesday, 31 July 14:30–16:00

Presentation of Postdoctoral and Pre-doctoral/Graduate Poster Awards in Portland Ballroom 254-255

Wednesday, 31 July

Poster Removal

11:30–12:00

18:30–19:00

A1 - A12 A1 - A12

All Posters

Three awards (first, second, third) will be presented for each category.

All Posters A1 - A12

GENERAL POSTER ABSTRACTS PRESENTATIONS: EXHIBIT HALL E DATE AND TIME

ACTIVITY

POSTER NUMBERS

Sunday, 28 July

Poster Set-Up

All Posters

Monday, 29 July

Poster Session 1 Sponsored by Certara Authors Attend Posters

Monday, 29 July

Poster Viewing Hours No scheduled presentations

All Posters

Tuesday, 30 July

Poster Session 2 Sponsored by Simulations Plus Authors Attend Posters

Session 2 Posters

Wednesday, 31 July 12:30–14:30

Poster Session 3 Sponsored by Covance Authors Attend Posters

Wednesday, 31 July

Poster Removal

11:00–17:30

11:00–13:00

17:30–19:30

12:00–14:00

18:30–19:00

P1 - P252

Session 1 Posters

P1 - P87 11:00–12:00 - Odd-numbered Poster Presentations 12:00–13:00 - Even-numbered Poster Presentations P1 - P252

P88 - P181 12:00–13:00 - Odd-numbered Poster Presentations 13:00–14:00 - Even-numbered Poster Presentations

Session 3 Posters

P182 - P252 12:30–13:30 - Odd-numbered Poster Presentations 13:30–14:30 - Even-numbered Poster Presentations

All Posters P1 - P252

Out of courtesy to the authors, taking photographs or video recording posters is prohibited.

Posters will be attended during designated presentation times. This is your opportunity to ask authors about their research.

To obtain a copy of specific information that is being presented, contact the author directly.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

21

POSTER NUMBER REFERENCE GUIDE POSTER NUMBER REFERENCE GUIDE POSTER

AWARDS

Assay Development for Biologics

P1

Bioanalysis

P2

Bioanalytical Method Development

P3

Bioavailability

P4

Clearance Prediction

P5 - P8

Conjugation Reactions and Enzymes

A1

P13 - P29

Differences in Metabolism (Species, Gender, Age, Diseases)

P30 - P40

Disposition

P41 - P50

Drug Discovery and Development

P51 - P68

Drug Interaction

P69 - P87

Drug-Induced Lung Toxicity

P88 P89 - P96, P251 and P252 P97 - P104

Enzyme Induction

A2

Enzyme Inhibition/Inactivation

A3

Epigenetics

P105

Extrahepatic Metabolism

P106 and P107

Hepatic Uptake

P108 and P109 A7

P110 - P120

Immunotoxicology

P121

in silico

P122 - P125

in vitro in vivo Extrapolation (IVIVE)

P126 - P132

in vitro Techniques

A8

P133 - P143

Metabolism

A9

P144 - P181

Metabolite Characterisation

P250

Methodology for Metabolite Profiling

P182

Microbiome

A4

P183

Non-P450 Phase 1 Enzymes

A10

P184 - P188 P189 - P194

Pharmacogenetics Pharmacokinetic Prediction

A5

Pharmacokinetic and Pharmacodynamics

P195 - P202

Pharmacokinetic Modeling

P203 - P208

Physiologically-Based Pharmacokinetic (PBPK)

A6

P209 - P222

Plasma Protein Binding, Safety Exposure Margins

P223

Proteomics

P224

Quantitative Proteomics

P225

Transporters UGT1A1 Inhibition

A11 and A12

ISSX is organizing two joint scientific meetings in 2020!

Submit an abstract and present with ISSX in 2020!

P9 - P12

Cytochrome P450

Hepatocytes

22

GENERAL

P226 - P248 P249

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

In 2020, ISSX will host the 15th European ISSX and EACPT Meeting in Geneva, Switzerland June 7‒10 and the 23rd ISSX North American and 35th JSSX Meeting in Waikoloa, Hawaii October 4‒8. The call for abstracts for these meetings will open soon. Don’t miss the opportunity to travel to these exciting destinations and present your work!

Benefits of presenting a poster include: • Publication: Accepted abstracts of original work will be published in a topranked journal.

• A Priceless Opportunity: Submitting an abstract affords opportunities to put your research on the world stage.

• Global Visibility: Meet international experts in the field of xenobiotic research and discuss your work during dedicated viewing and presentation times while receiving feedback from colleagues, faculty, and peers.

Visit www.issx.org to learn more about the meetings and to submit your abstracts when the calls open.

INDUSTRY-SPONSORED SYMPOSIA The Industry-Sponsored Symposia (ISS) are commercially supported educational sessions held in conjunction with ISSX2019: The 12th International ISSX Meeting. These sessions have been approved for presentation at our meeting. All attendees are invited to enjoy the education these sessions provide.

TUESDAY, 30 JULY 17:30‒18:30

Parallel Industry-Sponsored Symposia (ISS)

Portland Ballrooms 252‒253 and 254‒255 17:30‒18:30

17:30‒18:30

BioIVT: Potential Benefits of a Physiologically-Relevant Whole Cell Model to Assess CYP Inhibition with Complex Mixtures

MilliporeSigma: Tapping the Potential of Gene Editing Technology to Improve Cell-Based Assays for Drug Disposition and Transporter-Mediated Drug-Drug Interactions

Amy L. Roe, Ph.D., DABT

David Thompson Ph.D., Sr. R&D Manager, In vitro Safety Systems, MilliporeSigma

Portland Ballroom 252‒253 BioIVT will present results from a published study (Roe et. al., 2019 AIVT) to evaluate potential inhibition of CYP3A4/5 and CYP2C9 enzymatic activity by Boswellia serrata extract (BSE) using pooled human liver microsomes (PHLM) and a more physiologically-relevant sandwich-cultured human hepatocytes (SCHH) model. In the scientific literature, BSE has been shown to reduce the activity (55% to 65%) across major CYP450 enzymes, including CYP3A4/5 and CYP2C9, using baculovirusinfected insect cells. These reported results, contrasted with a seemingly history of safe use of BSE, led us to question the relevance of the PHLM model. We will show that potent CYP3A4/5 and CYP2C9 inhibition observed for BSE in microsomal systems was not observed in SCHH. SCHH are particularly useful for studying complex mixtures such as botanicals and are an effective model to evaluate BDI and DDI.

Portland Ballroom 254-255

Advances in gene editing technologies have generated a great amount of interest within the scientific community over the past few years.

In addition to the ability to make precise double stranded DNA cuts virtually anywhere in the human genome, new variations of these tools show promise in the ability to activate or repress the expression of individual genes. Besides the obvious interest in clinical applications for these tools, there are practical uses of these tools for modifying and improving in vitro cell-based assays in areas such as preclinical ADME/Tox. This talk will highlight these recent advances in gene editing technology and provide several examples of how this technology has been applied to ADME/Tox assays, including intestinal, hepatic and renal proximal tubule cell lines.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

23

ISSX FOCUS GROUP SESSIONS ISSX launched three Focus Groups in 2016 as an extension of the ISSX Strategic Plan and as a benefit of membership in the Society. ISSX Focus Groups are intended to foster networking with peers and colleagues on topics relevant to the day. Associating and actively participating in a Focus Group will ideally enhance the exchange of the most current scientific research information and open doors to opportunities for collaboration and career advancement. The aim is for active participation to provide personal growth and professional development to ISSX members.

The three ISSX Focus Groups will convene at this meeting and all attendees are invited to participate in these sessions.

MONDAY, 29 JULY Focus Group Session 1 07:45‒08:45

Focus Group Session 1: Bioanalysis in ADME Science

Chair: Kevin Bateman, Merck & Co. Inc., West Point, Pennsylvania, USA and Co-Chair: Jens Sydor, GSK, Philadelphia, Pennsylvania, USA

ISSX Membership Ambassador Program The ISSX Membership Ambassador Program is a volunteer activity developed to help increase awareness and understanding of the value of membership in the Society and to more broadly engage new ISSX members in the various activities we offer. Demonstrate your continued support and commitment to the premier scientific organization for researchers interested in the metabolism and disposition of xenobiotics by becoming an ISSX Membership Ambassador.

Please stop by the ISSX Booth #302 to learn more and to meet with other ISSX members.

Portland Ballroom 252‒253

Calling All New Investigators!

TUESDAY, 30 JULY Parallel ISSX Focus Group Sessions 2 and 3 16:30‒17:30

Focus Group Session 2: Biotransformation Mechanisms and Pathways

Chair: Amit Kalgutkar, Pfizer Inc., Cambridge, Massachusetts, USA and Co-Chair: Valerie Kramlinger, Amgen, Cambridge, Massachusetts, USA

In this session, we will be joined from scientists representing academia, government, and industry to cover these topic areas and questions:

16:30‒17:30

1. What current trends do you see in your area of work/research that may affect the job opportunities or research directions in the next 2-5 years?

Portland Ballroom 252‒253

Focus Group Session 3: Modeling & Simulation

Chair: Hartmut Derendorf, University of Florida, Gainesville, Florida, USA and Co-Chair: Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA Portland Ballroom 254‒255

24

Attend the New Investigators Forum on Monday, 29 July from 07:30‒08:45 in Room E141. 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.

2. How should a young investigator make his/herself stand out among their peers during the application or interview process?

3. What are the factors to consider when selecting to pursue a position/career in industry, academia, or government/regulatory?

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

Get to the Clinic with our IND-Enabling

Solutions

See Our Industry-Leading Portfolio of Hepatic Products and Research Services

Stop by booth #301 to

ENTER

TO WIN! Win a free copy of

Experimental Cholestasis Research Co-Authored by Kenneth R. Brouwer, PhD, RPh, Vice President,

Attend Our Scientific Contributions Industry-Sponsored Symposium Tuesday, July 30, 5:30 - 6:30 pm Portland Ballroom 252-253 Potential Benefits of a Physiologically-Relevant Whole Cell Model to Assess CYP Inhibition with Complex Mixtures Speaker: Amy L. Roe, PhD, DABT, Principal Toxicologist, Product, Safety and Regulatory Affairs, The Procter and Gamble Company

Poster Presentations Observed vs. Predicted effects Of Protein Binding: Improving In Vivo Predictions of Hepatic Clearance, Intracellular Concentration and IC50 Values The Use Of Primary Cryopreserved Human Hepatocytes As A Model For Non-Alcoholic Fatty Liver Disease (NAFLD) Related Changes In Phase I And Phase II Enzyme Activities In Vitro Development Of Folate Transport And Endocytosis By PCFT, RFC, and FRα, In A Transwell System

Join us at the 15th Annual HRA Meeting, 5:30 to 8:30 pm, July 29, 2019 ©2019 BioIVT. BIOIVT andISSX ELEVATING SCIENCE are trademarks andMeeting registered trademarks BioIVT.2019 2019 12th International | 28-31ofJuly

| Portland, Oregon

25

ADME ADME ADM DMPK DMPK DMP SAFETY SAFETY S TOXICOLOGY TOX ADME ADME ADM DMPK DMPK DMP IMPROVE DRUG CANDIDATE SELECTION AT BOOTH #307

Learn about NEW comprehensive panels of ADME, Toxicology, and Safety Pharmacology assays

• Tier 1 ADME Panel – Quickly profile key compound pharmacokinetics (PK).

• Tier 2 ADME Panel – Generate IND-enabling data to progress compounds into clinical development.

• In Vitro Tox Panel – Predict potential compound mediated toxicities.

• In Vitro Safety Pharmacology Panels – Identify and mitigate potential off-target adverse effects.

Dig deep into your options at booth #307 and eurofinsdiscoveryservices.com

ME MPK SAFETY XICOLOGY Networking Happy Hour ME MPK JULY 30 Time: 18:30 - 19:30 Location: Spirit of 77

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

FRONTAGE LABORATORIES, INC. 700 Pennsylvania Dr Exton, PA 19341 (610) 232-0100 sales@frontagelab.com www.FrontageLab.com

DonorPlex Hepatocytes ™

Advancing pooled donor hepatocytes to the next level of consistency, robustness, and customizability.

Challenge us!

Play the “Match My Specs” Challenge at booth #320.

Challenge our scientists to match your pooled donor specifications and get a DonorPlex™ Hepatocyte pool designed in person and on site.

Stop by our booth for details.

Visit: www.lonza.com/pdh

©2019 Lonza. All rights reserved.

CD-AD112-1 05/19

in Vitro Safety Systems Innovative ADME-Tox Tools in 2D and 3D •

Hepatocytes & HepaRG™ for Discovery, Tox & Metabolism Studies

•

Caco-2 & MDCKII for Permeability & Transporter Assays

•

Kidney PTEC for Toxicity & Clearance Assays

•

3D Applications for In Vitro Liver & Kidney For more information, please visit SigmaAldrich.com/admetox

Visit us at Booth 200

© 2019 Merck KGaA, Darmstadt, Germany and/ or its affiliates. All Rights Reserved. MilliporeSigma and the vibrant M are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.

2019-22276

The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.

NOTES

Accelerate and enhance your discovery, preclinical and clinical programs with one of the world’s largest and most respected bioanalytical and ADME laboratories

Tailored Bioanalytical and ADME Solutions From 25+ years of experience we understand the unique challenges faced by our customers.

Our tailored solutions and extensive capabilities ensure customers get the highest quality data when they need it, through:

• Automated in vitro ADME screening • High throughput discovery LC-MS/MS bioanalysis • Metabolite identification • IND-enabling in vitro drug-drug interaction (DDI) risk assessment

View our poster presentations in the exhibit hall and visit us at Booth #311 www.Q2LabSolutions.com Copyright © 2019 Q 2 Solutions. All rights reserved.

30

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

• LC/MS bioanalytical services • Bioanalytical ligand binding assays & immunogenicity services • Fit-for-purpose biomarker services • Custom deliverables and processes • Industry renowned scientific leadership

AlliancePharmaCo.com

• • • • •

In Vitro ADME Services Drug transporter substrate & inhibition • Protein binding Metabolic stability • RBC partitioning Metabolite identification & profiling • UGT inhibition Permeability • Reacting Phenotyping CYP450 inhibition & induction

• • • • • • •

In Vivo Pharmacokinetics AAALAC accredited rodent vivarium IV, PO, SC, IM, IP, IN and dermal administration Sparse or serial sampling Automated sampling Metabolism cages Tissue collection and analysis Dedicated bioanalysis support

Contact us: 610-296-3152 17 Lee Boulevard, Malvern, PA 19355

Novel Hepatocyte and Enterocyte Products Hepatocytes: Hepatocytes are critical for all stages of drug development; available in human, monkey, dog, rat and mouse.

Enterocytes: Enterocytes are isolated and cryopreserved from regions of the duodenum, jejunum, and ileum and are responsible for intestinal metabolism. Enterocytes are the key cell type for assessing oral bioavailability. Enterocytes are a useful in vitro test system available in human, monkey, dog, rat and mouse.

CHIMTM (Cryopreserved Human Intestinal Mucosa): CHIM™ contains multicellular fragments of the human intestinal mucosal epithelium with in vivo cellular compositions and junctions. CHIM™ represents the most physiologically complete and relevant in vitro experimental system for the evaluation of enteric drug properties.

MetMaxTM: MetMax™ is a permeabilized and co-factor supplemented cell suspension system where metabolism is maximized. MetMax™ has the advantages of hepatocytes and enterocytes with the ease of liver fraction incubation, eliminating the need for centrifugation and microscopic quantification of yield and viability.

Media and Plates: The right media formulation can make a significant difference in a reliable test system performance and data confidence. IVAL has developed the highest quality media to provide the best culture conditions for hepatic and enteric products For more information: info@invitroadmet.com or visit www.invitroadmet.com

Meet the Pharmaron Team at ISSX Booth #417 & Wednesday, July 31 ▪ 1:15 pm ▪ Exhibit Hall Presentation Comparison of metabolism and rates/routes of excretion between human and toxicology species to establish metabolite safety Presented by Barry Jones, Ph.D. Senior Research Fellow, Pharmaron

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

31

After the great success of our events in SOLVO’s Meet the Experts: Transporter Conference series, we are pleased to announce that the ninth event will be held in Cambridge, MA on September 3 and 4-5, 2019.

Visit us at booth #101 Learn about our portfolio of Gibco™ products that can help get you started on 3D hepatic models today.

Find out more about ADME/tox products at thermofisher.com/admetox

For more information, please visit our website: www.solvo.com

32

For Research Use Only. Not for use in diagnostic procedures. © 2019 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. COL19253 0519

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

SOLVO ad 3,5x4,75in Boston.indd 1

2019. 06. 12. 14:16

EXHIBITOR DIRECTORY AIM RESEARCH COMPANY

BIOIVT

BOOTH #104

BOOTH #301

AIM Research Company is an international leader of innovation in the pharmaceutical research sphere. Founded in 1998, we have been dedicated to creating the best solutions for online radioactivity detection and offline counting fraction collection.

Our instruments offer cost-effective solutions with high reliability to companies and organizations worldwide.

BioIVT is the leading provider of high-quality, hepatic products and in vitro research services to inform R&D decisions and develop data for regulatory submissions. We set the standard for hepatocytes, microsomes and other hepatic products and offer innovative brands including TRANSPORTER CERTIFIED™ and LIVERPOOL® human hepatocytes, long-term HEPATOPAC® cultures.

ALLIANCE PHARMA

BIOTRANEX LLC.

BOOTH #219

Alliance Pharma is a contract research organization (CRO) established in 2008 that specializes in advanced bioanalytical research services for both small and large molecule drugs, as well as drug metabolism studies for pharmaceutical and biotechnology companies. Our facility is located at 17 Lee Boulevard in Malvern, PA

ALTIS BIOSYSTEMS

BOOTH #225

Altis Biosystems has developed a stem cell technology which recreates the human intestinal epithelium for compound screening and microbiome research. Our goal is to make drug discovery faster, cheaper, safer, and reduce the need for animal testing.

ALTURAS ANALYTICS, INC.

BOOTH #120

At Alturas Analytics, we deliver bioanalytical and PK analysis results on time with the highest level of integrity. Our business is built on developing long term collaborations with our clients by providing advanced MS/MS solutions for drug candidates through focused emphasis on teamwork, communication, and exceptional science.

BOOTH #116

Biotranex LLC is an innovative service company that offers a full range of drug metabolism, transport, pharmacokinetic, and analytic services to the biotech and pharmaceutical industries.

Our extensive collective experience in the successful discovery and development of many marketed drugs allows us to apply innovative solutions to your ADMET needs. We take pride in helping our clients succeed.

CERTARA Certara® is a global consultancy and technology organization that enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. >90+% of all novel drugs approved by the US FDA in the past 4 years were supported by Certara software or services.

CHARLES RIVER LABORATORIES

BOOTH #408

Expediting product development with a full breadth of DMPK services including HT-ADME, in vitro/ in vivo ADME, transporter assays, PK/TK, tissue distribution, metabolite ID, bioanalysis, PK reporting and more.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

33

EXHIBITOR DIRECTORY CN BIO INNOVATIONS LTD

CYPEX LTD.

BOOTH #103

BOOTH #113

Our perfusion platform turns 2D culture into 3D tissues! CN Bio Innovations develop human organ-on-chip technologies which enable the formation of miniature models of human organs in the lab. Our platform recreates the physiological and mechanical micro-environment of organs as well as permitting long-term culture of primary human cells, iPSC and immortalized cell lines. We provide products and services to the biotechnology industry and have used our proprietary organ-onchip models in drug discovery and drug safety programs with over 25 pharmaceutical companies.

Cypex specializes in the production of high quality recombinant enzymes including human CYPs, AOX, ALDH, GSTs and SULTs, and a range of CYPs from other species. Also available are antibodies, purified CYPs, substrates and inhibitors. Contract services include CYP inhibition, protein expression (let us know if there is something not in our catalogue that you need) and metabolite generation. All products and services are covered by Cypex’s ISO9001:2008 accredited QA system.

COVANCE

BOOTH #206 Covance the drug development business of Laboratory Corporation of America Holdings (LabCorp), is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real® by providing high-quality nonclinical, clinical, commercialization and informatics services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development. Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing. We have helped pharmaceutical and biotech companies develop each of the top 50 prescription drugs in the marketplace today. We also offer laboratory testing services to the chemical, agrochemical and food industries and are a market leader in toxicology services, central laboratory services, discovery services and a top global provider of Phase III clinical trial management services.

Together with our clients, we create solutions that transform potential into reality. Learn more at www.covance.com

CURACHEM

BOOTH #326

Curachem, a Korean-based,is a global provider of 14C/H3 custom radiolabeled molecules as well as custom stable isotope labeled ones.Our expertise spans across virtually all investigational molecules including small molecules, peptides, polysaccharides, oligonucleotides, pesticides, proteins and complex antibody drug conjugate.We have capabilities and expertise for the manufacture GMP-grade radiolabeled APIs and Investigational Medicinal Products suitable for global drug registrations.

34

CYPROTEX

BOOTH #114

Cyprotex (www.cyprotex.com) was founded in 1999 and specialises in in vitro and in silico ADME-Tox. The company has sites in the UK and US. In 2016, Cyprotex was acquired

by Evotec AG (www.evotec.com). As a whole, the Group offer expert support from early discovery through to preclinical development and beyond.

EUROFINS DISCOVERY

BOOTH #307

Eurofins Discovery supports Drug Discovery through the combined expertise of Cerep, DiscoverX, Panlabs, Villapharma, and Selcia Drug Discovery. We offer a broad portfolio including medicinal and synthetic chemistry, in vitro pharmacology products and services, cell-based phenotypic assays, ADMETox, in vivo drug safety and efficacy, custom proteins, and assay development services.

FRONTAGE LABORATORIES, INC. Frontage is a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. We offer our clients comprehensive services in analytical testing and formulation development, drug metabolism and pharmacokinetics (DMPK), bioanalysis, preclinical safety and toxicology and early phase clinical studies

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

GENOMEMBRANE CO., LTD.

ISSX

BOOTH #302

BOOTH #204

GenoMembrane Co., Ltd specializes in the research and development of drug transporters.We provide transporterrelated products and research services. In order to contribute to pharmacokinetic study, we offer ABC transporter vesicle products and transiently expressed SLC transporter cells to help our clients to facilitate the discovery of their new drug.

HYPHA DISCOVERY LIMITED

ISSX advances research and education on the interplay of living systems with medicines and chemicals for the benefit of society worldwide. Stop by the ISSX booth to learn more about membership and our upcoming meetings.

KOREA DRUG DEVELOPMENT PLATFORM USING RADIO-ISOTOPE

BOOTH #122

BOOTH #100

Hypha Discovery make drug metabolites for clients using proven microbial and mammalian biocatalysis expertise. The technology is successful for Phase I oxidised metabolites and Phase II conjugates such as glucuronides and sulfates.

Scalability enables provision of mg to gram amounts of metabolites for MetID, DMPK/Tox. or use as analytical standards.

IIAM

KDePRI is a government-affiliated institution that specializes in radiolabeled ADME, bio imaging, radiopharmaceuticals GLP & GMP. As the only nonclinical facility that can handle radioisotopes in Korea, it houses the state-of-the-art equipment run by experts in the field. Its newly built 14,500 m2 facility is located in the campus of KIRAMS that is also a home to the Korea Cancer Center Hospital and the Research Institute, specializing in radiopharmaceuticals and radiation therapies.

At KDePRI, we are dedicated to help pharmaceutical companies and researchers utilize radioisotopes in drug R&D and provide one-stop services for radiopharmaceuticals development.

LHASA LIMITED

BOOTH #118 IIAM is a world-leading provider of non-transplantable, human organs and tissues for medical research, therapeutic applications and pre-clinical investigations. As a non-profit with more than 30 years of experience in the field, IIAM is a known and trusted partner to both organ procurement organizations and research institutions worldwide. www.iiam.org

IN VITRO ADMET LABORATORIES (IVAL)

BOOTH #313

Lhasa Limited creates expert predictive software for use by life scientists in a variety of workflows and regulatory submissions; for example, Meteor Nexus, with different methodologies for assessing metabolism, is well placed to assist in DMPK studies.

Other products include Derek Nexus and Zeneth for toxicity and degradation prediction, respectively.

LONZA

BOOTH #320

BOOTH #412

In Vitro ADMET Laboratories (IVAL) products include highly functional cryopreserved hepatocytes available in plateable, suspension grade and pooled (patented) lots and enterocytes; MetMax™ hepatocytes and enterocytes; and cryopreserved intestinal mucosa for drug development research. IVAL also provides contract research services for in vitro drug metabolism, drug-drug interactions and toxicity.

INTERVIVO SOLUTIONS

BOOTH #223

InterVivo Solutions is a preclinical in vivo CRO providing research services using translational animal models for efficacy, pharmacokinetics, and early safety, with a specialization in the neurosciences.

At Lonza, we manufacture and characterize a large selection of human primary cells, backed by decades of experience, a focus on products, and one-on-one support, for creating the next generation of in vitro ADME-Tox cell models. Stop by Booth 320 and start your journey towards more clinically relevant cell models.

MICROCONSTANTS

BOOTH #406

MicroConstants is a GLP-compliant Contract Research Organization focused on performing regulated bioanalysis, drug metabolism and pharmacokinetic analysis in support of discovery, preclinical and clinical drug development studies. We specialize in method development, validation and sample analysis for small molecules, macromolecules, biomarkers and metabolites using LC/MS/MS, HPLC/UV, immunoassay, multiplex and qPCR techniques.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

35

EXHIBITOR DIRECTORY MILLIPORESIGMA

PHARMARON

BOOTH #200

BOOTH #417

MilliporeSigma, the U.S. life science business of Merck KGaA, Darmstadt, Germany, develops innovative and top-quality high-tech products in healthcare, life science, and performance materials. With extensive expertise in genome engineering, cell model development, biomarker analysis, ADME-Tox and analytical workflows, MilliporeSigma provides continuous advancements for xenobiotic and the global scientific community.

Pharmaron is a premier R&D service provider supporting the life science industry. Founded in 2003, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development, including applications of 14C microtracer AMS technology. With operations in China, US and UK staffed by over 6,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. For more information, visit: www.pharmaron.com

NOVABIOSIS

BOOTH #221

Novabiosis isolates and sells cryopreserved primary human cell types from multiple organs, such as the liver, kidney, lung, and intestine, for the research community. Check out our HIGH quality plateable hepatocytes with multiple lots and large batch sizes!

OPTIBRIUM LIMITED

BOOTH #415

Optibrium provides software for drug design, optimisation and data analysis. Its lead product, StarDrop, is a comprehensive suite of integrated software enabling the seamless flow from the latest data through to predictive modelling and decisionmaking regarding the next round of synthesis and research, improving speed, efficiency, and productivity of discovery.

OXFORD BIOMEDICAL RESEARCH

BOOTH #102

Oxford Biomedical Research provides innovative tools for Drug Metabolism studies including recombinant human Glutathione S-transferases and antibodies to GSTs and P450s. The new CypExpress™ catalytic system provides individual human P450s with oxidoreductase and UGTs with UDPGDH in permeabilized yeast shells. This system is excellent for metabolite screening and synthesis scale-up.

36

PHOENIXBIO

BOOTH #212

PhoenixBio provides access to the PXB-Mouse® (chimeric mouse model featuring a humanized liver, up to 98% human hepatocyte engraftment) and PXB-cells® (human hepatocytes freshly isolated from PXB-mice) for in vivo and in vitro DMPK/ Toxicity & Safety research. PhoenixBio models accelerate pharmaceutical and chemical compound development by better predicting human outcomes.

PHOENIXSONGS BIOLOGICALS

BOOTH #126

PhoenixSongs is a life sciences company focused on producing physiologically relevant cellular model systems for research and drug discovery that include cells, lineage stage specific media for growth, differentiation and maintenance.

PYXANT LABS

BOOTH #111

Founded 19 years ago, Pyxant Labs is an independent CRO exclusively providing bioanalytical services to pharmaceutical and biotech development companies. We cover the entire development cycle, from twoday-turnaround non-GLP discovery PK assays, to GLP work for IND-enabling studies, and ‘GCP’ for all stages of clinical development through Phase 3 multi-center studies.We offer coverage spanning small-molecules, antisense oligonucleotides, RNA therapeutics, gene therapy programs, and peptides in an extraordinarily wide variety of biological specimen types, from plasma through 200 different solid and liquid tissues; umbilical cord, gut slurry, and fetal monkey lymph nodes being indicative of challenging examples. We also assay custom biomarkers daily, to both GLP and CLIA requirements.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

Q2 SOLUTIONS

SIMULATIONS PLUS, INC.

BOOTH #311

BOOTH #217

Q2 Solutions is a leading, global clinical trial testing laboratory focused on transforming science and data into actionable insights. From routine central laboratory testing to more complex genomics testing, flow cytometry, anatomic pathology and extensive bioanalytical and ADME testing we can provide end-to-end solutions for your drug development requirements globally.

Simulations Plus, Inc. (Nasdaq:SLP) is the premier developer of modeling & simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. We partner with companies to provide a strategic, data-driven modeling methodology, starting in early discovery, continuing through preclinical/clinical development, and concluding with clinical trials/post approval. With our subsidiaries, Cognigen Corporation and DILIsym Services, we offer #1-ranked, easy-to-use software (GastroPlus®, ADMET Predictor®, KIWI™, DILIsym®, NAFLDsym®, PKPlus™, and more) to bridge data mining and compound library screening with QSAR models, PBPK/TK modeling & simulation in animals and humans following administration around the body, and quantitative systems pharmacology approaches. For over 20 years, Simulations Plus has partnered with our clients to reduce costs and accelerate research and development productivity by improving how scientists use knowledge and data to predict the properties and outcomes of pharmaceutical & biotechnology agents. Our technology is now licensed and used by regulatory agencies worldwide.

QUOTIENTSCIENCES

BOOTH #210

A world-leading provider of human ADME studies to the pharmaceutical industry generating data to support global regulatory submissions facilitated by our innovative approach to drug development, Translational Pharmaceutics®.

SEKISUI XENOTECH LLC.

BOOTH #110

Sekisui XenoTech is a global CRO with 25 years of ADME/ DMPK/DDI experience, trusted by 98% of top pharmas and numerous others for cell and tissue-based products, screening, radiolabeling, in vitro ADMET and pharmacology, in vivo ADMET and QWBA, metabolite ID and production, bioanalytical services and consulting. Learn more at www.xenotech.com.

SHANGHAI MEDICILON INC.

BOOTH #324

Medicilon offers fully integrated pharmaceutical services for the global scientific community. We focus on providing an exceptional client-centered experience and advancing the drug discovery process. Since 2004, our integrated services across biology, chemistry and preclinical services are uniquely designed to help clients developing their research and discovery programs from the initial idea stage to the IND filing phase.

SOLVO BIOTECHNOLOGY

BOOTH #410

Drug Transporter products and services from The Expert!

SOLVO Biotechnology is the leading provider of transporter assays, and over the past 20 years we have worked with over 600 clients in 50 countries worldwide. We are ready to support your ADME-Tox projects with high quality services and regulatory submission-ready reports.

SSX INDIA

BOOTH #425

Society for the Study of Xenobiotics, India (SSX) is an affiliate of ISSX. It was formed in 2016 with the main mission of creating ADMET knowledge ecosystem in India, by conducting annual conferences and workshops. The fourth conference is scheduled from 18th-21st September, 2019 at Indian Institute of Science (IISc), Bangalore, India. More details can be found at https://ssxindia.in.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

37

EXHIBITOR DIRECTORY SYGNATURE DISCOVERY

BOOTH #423

With two dedicated sites in the UK, Sygnature Discovery’s ADME-Tox/PK team has built an enviable reputation for technical excellence and thought leadership. This expertise is available within stand-alone projects (physicochemical, ADME-PK, PK/PD, bioanalysis, metabolite profiling, IND-enabling packages), or integrated with chemistry and pharmacology capabilities within the wider Sygnature group.

SYNGENE INTERNATIONAL LTD.

BOOTH #427

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an innovation focused global discovery, development and manufacturing organization providing integrated scientific services to pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’s clientele include world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Syngene’s innovative culture is driven by the passion of its 3500 strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, accelerate time to market and lower innovation costs. For more details, visit www.syngeneintl.com

TAYLOR & FRANCIS GROUP

BOOTH #107

Taylor & Francis Group, an Informa business, is a global publisher of print and online journals for medicine, science, and technology communities. Visit our booth to browse our journal selection and speak to a Taylor & Francis representative.

THERMO FISHER SCIENTIFIC

BOOTH #101

Thermo Fisher Scientific is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. Through our Gibco™ and Invitrogen™ brands, we help customers accelerate innovation and enhance productivity in the discovery & development of effective drugs. Our comprehensive portfolio of hepatocytes, media, and supplements provide the stable foundation you need to confidently screen compounds for potential effects on liver function in both 2D and 3D models; our team of hepatic scientists will help you integrate these powerful tools in addition to providing hands-on training as you continue to make breakthroughs that will change the world of research and develop better therapies.

TNO

BOOTH #421 Innovation is crucial to the pharmaceutical, biotech and health industry. To use science and creativity for your product innovations a thorough knowledge of your business needs is required. TNO supports these industries by offering researchbased expertise, high-end facilities and practical innovative solutions. We add value by combining knowledge and expertise in the area of microbiome related research.

THE UNIVERSITY OF WASHINGTON DRUG INTERACTION KNOWLEDGEBASE, PART OF DRUG INTERACTION SOLUTIONS

BOOTH #316

The University of Washington drug interaction knowledgebase, part of Drug Interaction Solutions (www.druginteractioninfo. org), includes two best-in-class applications (DIDB, e-PKGene) to support pharmaceutical scientists and clinicians in their evaluation of pharmacokinetic-based drug interactions and drug safety. The applications contain reliable, up-to-date information curated from preclinical and clinical drug interaction, organ impairment, and pharmacokinetic studies.

38

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

VISIKOL INC.

BOOTH #105

Visikol is a CRO focused on advanced drug discovery that is leading the field of bio-imaging, bioinformatics and image analysis. We conduct end-to-end drug discovery services that include both 2D and 3D in vitro models and assays, 3D whole mount tissue imaging, digital pathology and custom drug discovery projects. Visikol offers a portfolio of drug discovery services ranging from 2D and 3D cell culture model and assay development to in vitro screening, animal tissue histology and automated image processing. The focus of these services is to transform tissues into images and ultimately into quantitative data sets that can be mined for actionable insights that help our Clients make more informed decisions during the drug discovery process. Additionally, Visikol manufactures and sells a suite of tissue clearing reagents and 3D immuno-labeling kits. These products allow researchers to easily and rapidly image whole tissues and 3D cell culture models in 3D instead of traditional 2D sectioning.

WATERS CORPORATION

BOOTH #109

With 60 years of experience in specialty measurement instrumentation, Waters LC-MS, chemistries, informatics, and thermal analysis innovations help pharmaceutical companies efficiently accelerate and improve workflows.

WUXI APPTEC

BOOTH #227

DMPK scientists at WuXi AppTec perform a wide range of INDand NDA-enabling services from four state-of-the-art facilities across our global operations. Headquartered in Shanghai, China with a dedicated bioanalytical and DMPK/ADME facility in New Jersey, United States.

YECURIS

BOOTH #318 Whether you are building innovative gene therapies, targeting NASH, creating the next cure for a liver disease, or testing your small molecule for metabolism or toxicology, you need real data from from real human hepatocytes as early as possible. That’s why for more than a decade, researchers have trusted the FRG platform for their liver studies. Yecuris FRG are chimeric animal models with more than 70% of the liver replaced with human hepatocytes providing researchers with actionable insights into liver-specific questions at the cellular, tissue, and animal level.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

39

NOTES

40

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

41

NOTES

42

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

EXHIBIT HALL E FLOOR PLAN Exhibitor Showcase Theater

227

326

427

126

225

324

425

122

223

423 320

120

221

421

118

219

318

116

217

316

417

Posters

114

Posters

113

212

313

111

210

311

415

412

408 109 110

206

307

107 104

105

102

103

100

101

406 204

200

Posters

301

302

Entrance BOOTH 100 101 102 103 104 105 107 109 110 111 113 114 116 118 120 122 126 200 204 206 210 212 217 219

COMPANY HYPHA DISCOVERY LIMITED THERMO FISHER SCIENTIFIC OXFORD BIOMEDICAL RESEARCH CN BIO INNOVATIONS LTD AIM RESEARCH COMPANY VISIKOL INC. TAYLOR AND FRANCIS WATERS CORPORATION SEKISUI XENOTECH LLC. PYXANT LABS CYPEX LTD. CYPROTEX BIOTRANEX LLC. IIAM ALTURAS ANALYTICS, INC. KOREA DRUG DEVELOPMENT PLATFORM USING RADIO-ISOTOPE PHOENIXSONGS BIOLOGICALS MILLIPORESIGMA GENOMEMBRANE CO., LTD. COVANCE QUOTIENTSCIENCES PHOENIXBIO SIMULATIONS PLUS, INC. ALLIANCE PHARMA

BOOTH 221 223 225 227 301 302 307 311 313 316 318 320 324 326 406 408 410 412 415 417 421 423 425 427

COMPANY NOVABIOSIS INTERVIVO SOLUTIONS ALTIS BIOSYSTEMS WUXI APPTEC BIOIVT ISSX EUROFINS DISCOVERY Q2 SOLUTIONS LHASA LIMITED UNIVERSITY OF WASHINGTON DRUG INTERACTION KNOWLEDGEBASE, PART OF DRUG INTERACTION SOLUTIONS YECURIS LONZA SHANGHAI MEDICILON INC. CURACHEM MICROCONSTANTS CHARLES RIVER LABORATORIES SOLVO BIOTECHNOLOGY IN VITRO ADMET LABORATOREIS (IVAL) OPTIBRIUM LIMITED PHARMARON TNO SYGNATURE DISCOVERY SSX INDIA SYNGENE INTERNATIONAL LTD.

ISSX 2019 12th International Meeting | 28-31 July 2019 | Portland, Oregon

43

it ng ee M

n PT a e C d p A n o E r la r u d e 0 E z n H t T i 02 a w S ,2 15 SX , IS va - 10 e 7 n Ge une J

MEETING PRESIDENT

Jules Desmeules

Hôpitaux Universitaires de Genève

MEETING CHAIRS

Caroline Samer

Hôpitaux Universitaires de Genève

Christoph Funk

Roche Pharmaceutical Research and Early Development

ISSX/EACPT

23RD ISSX NORTH AMERICAN AND 35TH JSSX MEETING

MEETING CHAIRS: Allan Rettie, University of Washington Hiroshi Yamazaki, Showa Pharmaceutical University

October 4 - 8, 2020 Hilton Waikoloa Village Waikoloa, Hawaii, USA