21st North American ISSX Meeting Program

Rhode Island Convention Center Province, Rhode Island, USA September 24 - 28, 2017

Program

Welcome

Welcome to the 21st North American ISSX Meeting

The 21st North American ISSX Meeting is made possible through the support of the following companies:

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Table of Contents

Schedule Overview........................................................................................................................................................................4 Meeting Information......................................................................................................................................................................7 Meeting Committees.....................................................................................................................................................................8 ISSX Leadership and Staff..........................................................................................................................................................9 21st North American ISSX Meeting Awards....................................................................................................................10 Scientific Program........................................................................................................................................................................ 12 Poster Information....................................................................................................................................................................... 25 Industry-Sponsored Symposia.............................................................................................................................................. 28 Exhibitor Directory...................................................................................................................................................................... 29 Notes Pages.................................................................................................................................................................................... 35 Exhibit Hall Floor Plan............................................................................................................................................................... 39

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Schedule Overview SUNDAY, SEPTEMBER 24

MONDAY, SEPTEMBER 25

8:00 am - 7:00 pm

7:30 am - 5:00 pm

Exhibit Hall CD Foyer

Exhibit Hall CD Foyer

Meeting Registration Desk Open

8:00 am - 5:00 pm

Exhibitor Set-Up Exhibit Hall CD

9:00 am - 12:15 pm

Concurrent Short Courses 1 and 2* Ballrooms BC and DE 12:15 pm - 1:30 pm

Lunch for All Short Course Registrants* Ballroom A Foyer

1:30 pm - 4:45 pm

Meeting Registration Desk Open

7:30 am - 9:00 am

Poster Set-Up

Ballroom A Foyer and Exhibit Hall CD 7:45 am - 8:45 am

BioreclamationIVT Industry-Sponsored Symposium Ballroom DE

9:00 am - 9:45 am

Plenary Lecture 1 Ballroom A

Concurrent Short Courses 3 and 4*

9:45 am - 10:15 am

5:30 pm - 6:00 pm

Exhibit Hall CD

Ballroom A

10:15 am - 12:15 pm

6:00 pm - 7:00 pm

Ballrooms A and DE

Ballrooms BC and DE

Welcome Remarks

Opening Keynote Lecture

Refreshment Break with Exhibitors and Posters

Parallel Symposia 1 and 2

Ballroom A

12:15 pm - 1:00 pm

7:00 pm - 9:00 pm

Exhibit Hall CD

Opening Welcome Reception with Exhibitors Exhibit Hall CD

Meet with Exhibitors / Lunch on Own 12:45 pm - 2:00 pm

Postdoctoral Poster Awards Finalist Poster Presentations Ballroom A Foyer

1:00 pm - 2:00 pm

Poster Presentation Session 1 and E-Poster Theater Session 1 Exhibit Hall CD

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Schedule Overview 2:00 pm - 4:00 pm

12:15 pm - 1:00 pm

Ballrooms A and DE

Exhibit Hall CD

Parallel Symposia 3 and 4 4:00 pm - 4:30 pm

Refreshment Break with Exhibitors and Posters

Exhibit Hall CD

4:30 pm - 6:00 pm

Postdoctoral Poster Awards Finalist Oral Presentations Ballroom A

6:00 pm - 7:00 pm

Poster Viewing Hour

Ballroom A Foyer and Exhibit Hall CD

TUESDAY, SEPTEMBER 26

Meet with Exhibitors / Lunch on Own

12:45 pm - 2:00 pm

Graduate/Pre-doctoral Poster Awards Finalist Poster Presentations Ballroom A Foyer

1:00 pm - 2:00 pm

Poster Presentation Session 2 and E-Poster Theater Session 2 Exhibit Hall CD

2:00 pm - 4:00 pm

Parallel Symposia 7 and 8 Ballrooms A and DE 4:00 pm - 4:30 pm

Refreshment Break with Exhibitors and Posters

Exhibit Hall CD Foyer

Exhibit Hall CD

4:30 pm - 6:00 pm

7:45 am - 8:45 am

Ballroom A

7:30 am - 5:00 pm

Meeting Registration Desk Open

Lonza Industry-Sponsored Symposium Ballroom DE

9:00 am - 9:45 am

Plenary Lecture 2 Ballroom A

9:45 am - 10:15 am

Refreshment Break with Exhibitors and Posters Exhibit Hall CD

10:15 am - 12:15 pm

Graduate/Pre-doctoral Poster Awards Finalist Oral Presentations

6:00 pm - 7:00 pm

Poster Viewing Hour

Ballroom A Foyer and Exhibit Hall CD 6:00 pm - 8:00 pm

New Investigators Forum: Career and Leadership Development Ballroom DE

*These events require a ticket. Please inquire at the registration desk to purchase tickets.

Parallel Symposia 5 and 6 Ballrooms A and DE

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Schedule Overview WEDNESDAY, SEPTEMBER 27 8:30 am - 5:00 pm

4:30 pm - 6:00 pm

Podium Presentations of Selected Abstracts

Meeting Registration Desk Open

Ballroom A

EXHIBIT HALL CD FOYER

6:00 pm - 7:00 pm

Plenary Lecture 3

Ballroom A Foyer and Exhibit Hall CD

Exhibit Hall CD Foyer 9:00 am - 9:45 am Ballroom A

9:45 am - 10:15 am

Refreshment Break with Exhibitors and Posters Exhibit Hall CD 10:15 am - 12:00 pm

Poster Removal

6:30 pm - 9:30 pm

Meeting Reception*

Rooftop @ the ProvidenceG

THURSDAY, SEPTEMBER 28

Presentation of 21st North American ISSX Meeting Awards

8:30 am - 1:00 pm

Ballroom A

Exhibit Hall CD Foyer

Meeting Registration Desk Open

12:00 pm - 1:00 pm

Meet with Exhibitors / Lunch on Own Exhibit Hall CD

9:00 am - 9:45 am

Plenary Lecture 4 Ballroom A

1:00 pm - 2:00 pm

Poster Presentation Session 3 and E-Poster Theater Session 3

9:45 am - 10:00 am

Refreshment Break

Exhibit Hall CD

Ballroom A Foyer

2:00 pm - 4:00 pm

10:00 am - 12:00 pm

Parallel Symposia 9 and 10

Parallel Symposia 11 and 12

Ballrooms A and DE

Ballrooms A and DE

4:00 pm - 4:30 pm

12:00 pm - 12:15 pm

Refreshment Break with Exhibitors and Posters

Closing Remarks Ballroom A

Exhibit Hall CD

*These events require a ticket. Please inquire at the registration desk to purchase tickets.

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Meeting Information MEETING VENUE

Rhode Island Convention Center One Sabin Street Providence, Rhode Island

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 desk in the Exhibit Hall CD Foyer for assistance.

REGISTRATION HOURS Sunday, September 24 Monday, September 25 Tuesday, September 26 Wednesday, September 27 Thursday, September 28

8:00 am - 7:00 pm 7:30 am - 5:00 pm 7:30 am - 5:00 pm 8:30 am - 5:00 pm 8:30 am - 1:00 pm

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 the online supplemental issue of Drug Metabolism and Pharmacokinetics (DMPK).

General posters will be on display throughout the meeting in the Exhibit Hall CD. Poster Awards Competition posters will be on display in the Ballroom A Foyer. The posters will be presented in three presentation sessions and posters may be viewed during the scheduled viewing times outlined on pages 26 and 27 of this program.

E-POSTER THEATER SESSIONS

New this year! Join fellow attendees in the Exhibit Hall CD from 1:00 pm - 2:00 pm Monday - Wednesday for selected electronic poster presentations.

POSTER AWARDS COMPETITION AND POSTER AWARDS PRESENTATIONS Finalists for the best Graduate/Pre-doctoral and Postdoctoral poster presentations will present their work both at their posters and as oral presentations. Postdoctoral finalists will present posters and oral presentations on Monday, September 25. Graduate/Pre-doctoral finalists will present posters and oral presentations on Tuesday, September 26. Additional information can be found on page 25 of this program.

21ST NORTH AMERICAN ISSX MEETING AWARDS SESSION

All attendees are invited to the presentation of the 2017 North American Poster Awards, the 2017 North American Scientific Achievement Award in Honor of Ron Estabrook, and the 2017 North American New Investigator Award in Honor of James R. Gillette. These awards and lectures will be presented from 10:15 am - 12:00 pm on Wednesday, September 27 in Ballroom A.

OPENING WELCOME RECEPTION

Fully-registered attendees and registered guests are invited to the Opening Welcome Reception on Sunday, September 24 from 7:00 pm - 9:00 pm in the Exhibit Hall CD. Our exhibitors will be on-hand to meet you and share information about their latest products and services.

Admission to the Opening Welcome Reception is included in the full meeting registration fee.

Attendees must have their name badges to be admitted. Unregistered guests or single-day registrants may purchase a reception ticket at the meeting registration desk.

INTERNET ACCESS

Complimentary Wi-Fi is available throughout the Rhode Island Convention Center.

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Meeting Committees MEETING ORGANIZING COMMITTEE

ABSTRACT REVIEW COMMITTEE

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

Jashvant Unadkat, Chair University of Washington, Seattle, Washington, USA

Jae Chang Genentech Inc., South San Francisco, California, USA

Allan Rettie, Co-Chair University of Washington, Seattle, Washington, USA

Nina Isoherranen University of Washington, Seattle, Washington, USA

Aleksandra Galetin University of Manchester, Manchester, UK

Amit S. Kalgutkar Pfizer Inc., Cambridge, Massachusetts, USA

Anshul Gupta Amgen Inc., Cambridge, Massachusetts, USA

Yurong Lai Gilead Sciences, Foster City, California, USA

Ross McKinnon Flinders University, Adelaide, Australia

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

Allan Rettie University of Washington, Seattle, Washington, USA

Mario Monshouwer Janssen Pharmaceuticals, Beerse, Belgium

A. David Rodrigues Pfizer Inc., Groton, Connecticut, USA

Yoichi Osawa University of Michigan Medical School, Ann Arbor, Michigan, USA

Nina Isoherranen University of Washington, Seattle, Washington, USA Yurong Lai Gilead Sciences, Inc., Foster City, California, USA Andrew Parkinson XPD Consulting, Shawnee, Kansas, USA Geoff Tucker, ISSX President University of Sheffield, Sheffield, UK Ping Zhao Bill & Melinda Gates Foundation, Seattle, Washington, USA

Yan Weng Pfizer Inc., Cambridge, Massachusetts, USA Ping Zhao Bill & Melinda Gates Foundation, Seattle, Washington, USA

SCIENTIFIC AFFAIRS COMMITTEE R. Scott Obach, Chair Pfizer Inc., Groton, Connecticut, USA

Eric Chan National University of Singapore, Singapore Marcel Hop Genentech, Inc., South San Francisco, California, USA Barry Jones AstraZeneca, Cambridge, UK

Ikumi Tamai Kanazawa University, Kanazawa, Japan Ylva Terelius Karolinska Institutet, Stockholm, Sweden C. Roland Wolf University of Dundee, Dundee, UK Yasushi Yamazoe Food Safety Commission, Government of Japan, Tokyo, Japan Mike Zientek Takeda California, San Diego, California, USA

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

ISSX Leadership and Staff ISSX COUNCIL

Members of Council

President Geoff Tucker University of Sheffield, Sheffield, UK President-Elect/Secretary Thomas Baillie University of Washington School of Pharmacy, Seattle, Washington, USA Treasurer James Halpert University of Connecticut, Storrs, Connecticut, USA Treasurer-Elect Sonia de Morais The Villages, Florida, USA

Maria Almira Correia University of California, San Francisco, California, USA Uwe Fuhr University Hospital of Cologne, Cologne, Germany Natalie Hosea Takeda California, San Diego, California, USA Aleksandra Galetin University of Manchester, Manchester, UK William Griffith Humphreys Bristol-Myers Squibb, Princeton, New Jersey, USA Jasminder Sahi Sanofi, Shanghai, China Michael Zientek Takeda California, San Diego, California, USA

Ex-Officio to Council R. Scott Obach Pfizer Inc., Groton, Connecticut, USA

ISSX STAFF Executive Director

Program Associate

Exhibits Sales Manager

Accountant

Steven Kemp, CAE

Diamond Coleman

Stephanie Young

Tatianna Padmanabhan

Program Manager

Meeting Manager

Exhibits Sr. Associate

ZoĂŤ Fuller

Ashley Pencak

Alessandra Cigna

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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North American Scientific Achievement Award in Honor of Ron Estabrook Kathy Giacomini, Ph.D. The North American Scientific Achievement Award is named in honor of Ronald W. Estabrook and is presented to an ISSX member who has made major scientific contributions to the field. The focus of the award is the individual’s scientific accomplishments and it is intended to recognize the best in the field within North America. The 2017 recipient is Kathy Giacomini, Ph.D., Professor, University of California San Francisco School of Pharmacy and Co-Director of the UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation.

Dr. Giacomini is a pioneer in the field of membrane transporters.

A major focus of her work is identifying genetic variation in transporter genes and understanding how those differences can alter drug response. As a leader in the field of pharmacogenomics, Dr. Giacomini helped discover about 50 coding and more than 100 promoter region variants in transporters that alter pharmacological effects in diverse populations. She applies these findings to investigate the interactions between gene variants and specific drugs, particularly the antidiabetic drug metformin. The Giacomini Research Group has found that certain variants reduce the uptake of metformin and produce different responses in two racial groups.

At the University of California, San Francisco, Dr. Giacomini is a Professor and Co-Chair of the Department of Bioengineering and Therapeutic Sciences. She is also a professor in the university’s Departments of Pharmaceutical Chemistry and Cellular and Molecular Pharmacology.

Dr. Giacomini received a B.S. in pharmacy from the University of Houston and she completed her Ph.D. in pharmaceutics at the State University of New York at Buffalo. She conducted postdoctoral research at the Stanford University School of Medicine.

Dr. Giacomini has co-authored more than 200 manuscripts in peer-reviewed journals and has received many awards for her research including the Dawson Award of the American Association of Colleges of Pharmacy, the Rawls Palmer Award of the American Society for Clinical Pharmacology and Therapeutics, and the Scheele Award from the Swedish Academy of Pharmaceutical Scientists. It is in addition to these that ISSX bestows her with our highest award for scientific achievements in North America. The award presentation and Dr. Giacomini’s lecture, Discovering the Endogenous Roles of Drug Transporters Through Genetic Studies, will take place on Wednesday, September 27 at 10:30 a.m.

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

North American New Investigator Award in Honor of James R. Gillette NamandjĂŠ Bumpus, Ph.D. Presented to ISSX members who have made significant contributions to the field during their early career years (normally within 10 years from the time of receiving his/her highest earned degree), the North American New Investigator Award encourages and recognizes developing scientists in the region. The North American New Investigator Award is named in honor of James R. Gillette and is awarded this year to NamandjĂŠ Bumpus, Ph.D. Dr. Bumpus is an Associate Professor and Vice Dean of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. She holds a secondary appointment in the Division of Pharmacology within the Department of Medicine.

Dr. Bumpus received her Ph.D. in pharmacology at the University of Michigan-Ann Arbor and performed thesis research in the laboratory of Dr. Paul F. Hollenberg where she investigated the effect of a naturally occurring cytochrome P450 (CYP) 2B6 mutation on the ability of the enzyme to become inactivated by known inactivators of the wildtype enzyme. As a postdoctoral fellow with Dr. Eric F. Johnson at The Scripps Research Institute, Dr. Bumpus studied the regulation of CYP4A and CYP4F genes in mice. Her research program is focused on defining the contribution of drug metabolism to the pharmacology and toxicology of drugs used to treat and prevent HIV infection.

Dr. Bumpus has authored or co-authored numerous peer-reviewed publications, serves as an editor on the editorial board of the journal Drug Metabolism and Disposition, and is a regular member of the National Institutes of Health (NIH) Xenobiotic and Nutrient Disposition and Action study section. In 2013, she was honored with the prestigious Tanabe Young Investigator Award from the American College of Clinical Pharmacology.

ISSX will honor her with the North American New Investigator Award in Honor of James R. Gillette at 11:20 am on Wednesday, September 27 when she will deliver her award lecture, Metabolism of Anti-HIV Drugs: A Quest to Personalize HIV Treatment and Prevention.

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Scientific Program SUNDAY, SEPTEMBER 24 9:00 am - 12:15 pm

Short Course 1: Reaction Phenotyping – Methods and Regulatory Requirements for Identifying the Role of Phase 1 and Phase 2 Enzymes in Drug Disposition Chair: Michael Sinz, Bristol-Myers Squibb, Wallingford, Connecticut, USA

Ballroom BC 9:00 - 09:45

SC1.1. Reaction Phenotyping for CYP Enzymes Michael Sinz, Bristol-Myers Squibb, Wallingford, Connecticut, USA

9:45 - 10:30

SC1.2. Reaction Phenotyping for non-CYP, Phase 1 Enzymes Tonika Bohnert, Biogen, Cambridge, Massachusetts, USA

10:30 - 10:45

Refreshment Break

9:00 am - 12:15 pm

Short Course 2: The Basics of Predicting Clearance Mechanisms for Human PK in Drug Discovery and Development and the Application of Extended Clearance Classification Systems Chairs: Ayman El-Kattan, Pfizer Inc., Cambridge, Massachusetts, USA, and Yurong Lai, Gilead Sciences, Inc., Foster City, California, USA

Ballroom DE 9:00 - 09:45

SC2.1. Prediction of Metabolic Drug Clearance in Humans Nina Isoherranen, University of Washington, Seattle, Washington, USA

9:45 - 10:30

SC2.2. The Role of Hepatic Transporters in Drug Disposition and Elimination Kim Brouwer, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA

10:30 - 10:45

Refreshment Break 10:45 - 11:30

10:45 - 11:30

SC2.3. The Application of BCS and BDDCS in Drug Discovery and Development

Michael Zientek, Takeda California, San Diego, California, USA

Leslie Benet, University of California San Francisco, San Francisco, California, USA

11:30 - 12:15

11:30 - 12:15

SC1.3. Reaction Phenotyping for UGT Enzymes

SC1.4. Unusual Pathways of Drug Metabolism – Unexpected Reaction Phenotyping Findings Faraz Kazmi, Janssen Research and Development, Spring House, Pennsylvania, USA

SC2.4. The Utility of Extended Clearance Classification in Predicting Human Drug Clearance in Early Drug Discovery Ayman El-Kattan, Pfizer Inc., Cambridge, Massachusetts, USA

12:15 pm - 1:30 pm

Short Course Attendee Lunch Ballroom A Foyer

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Scientific Program 1:30 pm - 4:45 pm

Short Course 3: Metabolism-Mediated Toxicity: Importance, Prediction, and Evaluation Chair: Amit S. Kalgutkar, Pfizer Inc., Cambridge, Massachusetts, USA

Ballroom BC 1:30 - 2:15

SC3.1. Predicting Metabolism-Mediated Toxicities of Drug Candidates

1:30 pm - 4:45 pm

Short Course 4: Predicting Human Transporter-related Clearance and Drug-Drug Interactions (DDIs) as Currently Practiced in Regulatory Agencies and Industry Chairs: Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA, and Yurong Lai, Gilead Sciences, Inc., Foster City, California, USA

Ballroom DE

Amit S. Kalgutkar, Pfizer Inc., Cambridge, Massachusetts, USA

1:30 - 2:15

2:15 - 3:00

Lei Zhang, Silver Spring, Maryland, USA

SC3.2. How Reactive Metabolites Induce an Immune Response that Sometimes Lead to an Idiosyncratic Drug Reaction Jack Uetrecht, University of Toronto, Toronto, Canada

3:00 - 3:15

Refreshment Break 3:15 - 4:00

SC3.3. Modeling Hepatic Drug Metabolism and Toxicity: Where are We Heading?

Dominic Williams, AstraZeneca, Cambridge, UK

4:00 - 4:45

SC3.4. Integrating DILI Hazards in Predicting Toxicity of Drug Candidates: Assessment and Management of Human Risk in the Pharmaceutical Industry Gerry Kenna, Safer Medicines Trust, Macclesfield, UK

SC4.1. Evaluation of Drug-Drug Interactions to Inform Drug Use 2:15 - 3:00

SC4.2. Considerations of Communicating DDI Findings from Various Sources in US Prescription Information Joseph Grillo, Winchester, Virginia, USA

3:00 - 3:15

Refreshment Break 3:15 - 4:00

SC4.3. Static and Dynamic Models to Predict Human Hepatic and Renal DDIs Manthena Varma, Pfizer Inc., Groton, Connecticut, USA

4:00 - 4:45

SC4.4. Case Studies for Evaluating DDIs Related to Renal Drug Transporters Kate Hillgren, Lilly Research Labs, Indianapolis, Indiana, USA

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Scientific Program 5:30 pm - 6:00 pm

9:45 am - 10:15 am

ISSX President, Geoff Tucker, University of Sheffield, Sheffield, UK, and Meeting Chair, Jashvant Unadkat, University of Washington, Seattle, Washington, USA

Exhibit Hall CD

Opening and Welcome Remarks

Refreshment Break with Exhibitors and Posters

Ballroom A

10:15 am - 12:15 pm 6:00 pm - 7:00 pm

Keynote Lecture

Chair: Jashvant Unadkat, University of Washington, Seattle, Washington, USA

Ballroom A

S1. Regulatory Science: Evolution of a Discipline Issam Zineh, Office of Clinical Pharmacology, U.S. Food and Drug Administration, Baltimore, Maryland, USA

7:00 pm - 9:00 pm

Opening Welcome Reception with Exhibitors Exhibit Hall CD

MONDAY, SEPTEMBER 25

Parallel Symposium 1: Towards Understanding of Tissue Transporter Interactions: Impact on Drug Efficacy/Safety and Tissue Targeting Chair: Aleksandra Galetin, University of Manchester, Manchester, UK

Ballroom A 10:15 - 10:45

S3. Tissue Transporter Drug-Drug Interactions: Safety/Efficacy Concerns Not Readily Apparent from Systemic Exposure Aleksandra Galetin, University of Manchester, Manchester, UK

10:45 - 11:15

S4. Integration of Imaging Techniques to Study Tissue Distribution of Drugs Hiroyuki Kusuhara, University of Tokyo, Tokyo, Japan

11:15 - 11:45

9:00 am - 9:45 am

Plenary Lecture 1

Chair: Jashvant Unadkat, University of Washington, Seattle, Washington, USA

Ballroom A

S2. Targeting the Achilles Heel of Cancer: Nutrient Transporters Vadivel Ganapathy, Texas Tech University Health Sciences Center, Lubbock, Texas, USA

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S5. Drug Efficacy Associated with Renal Apical Transporter Caroline Lee, Ardea Biosciences, San Diego, California, USA

11:45 - 12:15

S6. Renal Transporters: Mediators of Drug Disposition and Action Kathy Giacomini, University of California San Francisco, San Francisco, California, USA

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Scientific Program 10:15 am - 12:15 pm

1:00 pm - 2:00 pm

Chairs: Marcel Hop, Genentech Inc., South San Francisco, California, USA, and Natalie Hosea, Takeda California, San Diego, California, USA

Exhibit Hall CD

Parallel Symposium 2: Drug Discovery and Development in the Trenches

Ballroom DE 10:15 - 10:45

S7. Venetoclax: DMPK Challenges and Opportunities from Discovery to Market Daniel Bow, AbbVie Inc., North Chicago, Illinois, USA

10:45 - 11:15

S8. Challenges in Human Projections for Prodrugs: GS-6620 for HCV Adrian S. Ray, Gilead Sciences, Inc., Foster City, California, USA

11:15 - 11:45

S9. Development of Daclatasvir: Opportunities and Challenges along the Way

E-Poster Theater and Poster Presentations E-Poster Theater Session 1

Chair: Yingying Guo, Eli Lilly and Company, Indianapolis, Indiana, USA

1:00 - 1:20

P219. New Insights of the Intestinal Localization of the Organic Anion Transporting Polypeptide 2B1 (OATP2B1)

Markus Keiser, University Medicine of Greifswald, Greifswald, Germany

1:20 - 1:40

P108. Global Proteomic Analysis of Transporter Proteins in the Human Small Intestine and Established Intestinal Cell Lines Stefan Oswald, University Medicine of Greifswald, Greifswald, Germany

1:40 - 2:00

11:45 - 12:15

P209. An Absolute Transporter Abundance Approach for in vitro-in vivo Extrapolation of Intestinal Transporter Activity

Martin Wild, AstraZeneca, Cambridge, UK

Poster Presentation Session 1: P1 - P75

Griff Humphreys, Bristol-Myers Squibb, Princeton, New Jersey, USA

S10. ADME Challenges Encountered During the Development of Osimertinib; an Irreversible EGFR Inhibitor

Matthew D. Harwood, Simcyp Ltd (a Certara company), Sheffield, UK

1:00 - 2:00

Posters Attended by Authors

12:15 pm - 1:00 pm

Meet with Exhibitors / Lunch on Own Exhibit Hall CD

12:45 pm - 2:00 pm

Postdoctoral Poster Awards Finalist Poster Presentations Ballroom A Foyer

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Scientific Program 2:00 pm - 4:00 pm

Parallel Symposium 3: Biomarkers of Safety and DDI (Transport and Metabolism) Chairs: Yurong Lai, Gilead Sciences, Inc., Foster City, California, USA, and José Manautou, University of Connecticut, Storrs, Connecticut, USA

Ballroom A 2:00 - 2:30

S11. Novel Genetic Determinants of Acetaminophen Toxicity with the Potential for Validation of Biomarkers José Manautou, University of Connecticut, Storrs, Connecticut, USA

2:30 - 3:00

S12. Endogenous Probes for Transporter-mediated Drug-Drug Interaction Yurong Lai, Gilead Sciences, Inc., Foster City, California, USA

3:00 - 3:30

S13. Novel Biomarkers in DILI: the Development of Novel DILI Biomarkers and Therapeutic Interventions Daniel Antoine, University of Liverpool, Liverpool, UK

3:30 - 4:00

S14. Applications and Challenges of Using Endogenous Biomarkers for CYP DDI Evaluation Yvonne Lin, University of Washington, Seattle, Washington, USA

2:00 pm - 4:00 pm

Parallel Symposium 4: When is a PBPK Model Fit for Purpose?

Insights to Model Acceptance Criteria, Extrapolation to Different Populations, and Modeling Population Variability Chairs: Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA, and Nina Isoherranen, University of Washington, Seattle, Washington, USA

Ballroom DE 2:00 - 2:30

S15. Industry Perspective of FDA PBPK Guidance and EMA PBPK Guideline: Report from IQC Hannah Jones, Pfizer Inc., Cambridge, Massachusetts, USA

2:30 - 3:00

S16. Assessment of the Predictive Performance of PBPK Models Ping Zhao, Bill & Melinda Gates Foundation, Seattle, Washington, USA

3:00 - 3:30

S17. How Should a PBPK Model be Evaluated for Intended Use? Nina Isoherranen, University of Washington, Seattle, Washington, USA

3:30 - 4:00

Roundtable Discussion Hannah Jones, Nina Isoherranen, Lei Zhang, and Joseph Grillo

4:00 pm - 4:30 pm

Refreshment Break with Exhibitors and Posters Exhibit Hall CD

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Scientific Program 4:30 pm - 6:00 pm

Podium Presentations of Postdoctoral Poster Awards Finalists Chair: Allan Rettie, University of Washington, Seattle, Washington, USA

Ballroom A 4:30 - 4:45

5:45 - 6:00

A6. Transporter Expression in NonCancerous and Cancerous Liver Tissue from Subjects with Hepatocellular Carcinoma and Chronic Hepatitis C Infection Quantified By LC-MS/MS Proteomics Sarah F. Billington, University of Washington, Seattle, Washington, USA

A1. Comparison of Proteomic Quantification Approaches: Targeted Versus Multiplexed Global Quantitation 0f Hepatic Drug Transporters

6:00 pm - 7:00 pm

4:45 - 5:00

TUESDAY, SEPTEMBER 26

Anna Vildhede, Pfizer Inc., Groton, Connecticut, USA

A2. In vitro to in vivo Translation of OATP-Mediated Drug-Drug Interactions in Cynomolgus Monkey AyĹ&#x;e Ufuk, University of Manchester, Manchester, UK

5:00 - 5:15

A3. Mechanisms of CYP3A Induction During Pregnancy: Studies in HepaRG Cells Madhav Sachar, University Of Washington, Seattle, Washington, USA

Poster Viewing Hour

Ballroom A Foyer and Exhibit Hall CD

9:00 am - 9:45 am

Plenary Lecture 2

Chair: Andrew Parkinson, XPD Consulting, Shawnee, Kansas, USA

Ballroom A

S18. Making Drugs Great Again: Eliminating Idiosyncratic Drug Reactions Jack Uetrecht, University of Toronto, Toronto, Canada

5:15 - 5:30

A4. An LC-MS/MS Proteomics Based Methodology to Simultaneously Evaluate the Recovery, Enrichment and Purity of Microsomal and Cytosolic Fractions Isolated from Tissues for in vitro Drug Metabolism Studies

Meijuan Xu, University of Washington, Seattle, Washington, USA and Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China

5:30 - 5:45

A5. Pyridyloxobutyl, Pyridylhydroxybutyl and Methyl DNA Phosphate Adduct Formation in Rats Due to Metabolic Activation of 4-(Methylnitrosamino)-1-(3pyridyl)-1-butanone Bin Ma, University of Minnesota, Minneapolis, Minnesota, USA

9:45 am - 10:15 am

Refreshment Break with Exhibitors and Posters Exhibit Hall CD

10:15 am - 12:15 pm

Parallel Symposium 5: ADME/PK Considerations for Next Generation Therapeutics: ADCs, Antibodies, Oligonucleotides, and Liposomes Chairs: Anshul Gupta, Amgen Inc., Cambridge, Massachusetts, USA, and Steve Alley, Seattle Genetics, Inc., Bothell, Washington, USA

Ballroom A

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Scientific Program 10:15 - 10:45

S19. Targeted Drug Delivery and ADME of Antibody-Drug Conjugates Steve Alley, Seattle Genetics, Inc., Bothell, Washington, USA

10:45 - 11:15

10:45 - 11:15

S24. Understanding the Gut Microbiome-Liver Axis in Xenobiotic Biotransformation Julia Yue Cui, University of Washington, Seattle, Washington, USA

S20. Imaging and Kinetics of Nanoparticle Disposition in Tumors and Tissues

11:15 - 11:45

Mauricio Leal, Pfizer Inc., Pearl River, New York, USA

Lauren Aleksunes, Rutgers University, Piscataway, New Jersey, USA

11:15 - 11:45

S21. Pharmacokinetics and Pharmacodynamics of Oligonucleotide Therapeutics: Different, but Strangely Familiar Arthur A. Levin, Avidity Biosciences, La Jolla, California, USA

11:45 - 12:15

S22. In vitro & in vivo ADME Considerations for Guiding Engineering of Next Generation of Protein Therapeutics Josh Pearson, Amgen Inc., South San Francisco, California, USA

10:15 am - 12:15 pm

Parallel Symposium 6: Transporters and Enzymes: Novel Insights into the Regulation of Drug Disposition and Response Chairs: Hyunyoung Jeong, University of Illinois at Chicago, Chicago, Illinois, USA, and Guofeng You, Rutgers University, Piscataway, New Jersey, USA

Ballroom DE

S25. Genetic Regulation of Efflux Drug Transporters

11:45 - 12:15

S26. Post-Translational Regulation of Influx Drug Transporters Guofeng You, Rutgers University, Piscataway, New Jersey, USA

12:15 pm - 1:00 pm

Meet with Exhibitors / Lunch on Own Exhibit Hall CD

12:45 pm - 2:00 pm

Graduate/Pre-doctoral Poster Awards Finalist Poster Presentations Ballroom A Foyer

1:00 pm - 2:00 pm

E-Poster Theater and Poster Presentations Exhibit Hall CD

E-Poster Theater Session 2

Chair: Manthena Varma, Pfizer Inc., Groton, Connecticut, USA

10:15 - 10:45

S23. Role of lncRNAs in the Regulation of Drug Metabolizing Enzymes Xiao-bo Zhong, University of Connecticut, Storrs, Connecticut, USA

1:00 - 1:20

P53. Decreased CYP3A4 Activity and Protein in Nonalcoholic Fatty Liver (NAFL) and Nonalcoholic Steatohepatitis (NASH)

Rohitash Jamwal, University of Rhode Island, Kingston, Rhode Island, USA 18

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Scientific Program 1:20 - 1:40

P192. Postnatal Expression and Tissue Distribution of Flavin-Containing Monooxygenase 3 (FMO3) Zhen Xu, University of Rhode Island, Kingston, Rhode Island, USA

1:40 - 2:00

3:30 - 4:00

S30. Aldehyde Oxidase in Drug Design and Drug Discovery R. Scott Obach, Pfizer Inc., Groton, Connecticut, USA

2:00 pm - 4:00 pm

P164. Fractional Contribution of CYP and UGT Enzymes to the Disposition of Cannabinoids

Parallel Symposium 8: Interplay of Transporters and Mitochondrial/ Lysosomal Drug Sequestration– Implications in Toxicity, Efficacy and Drug-Drug Interactions

Poster Presentation Session 2: P76 - P157

Chairs: Wei Yue, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA, and Yingying Guo, Eli Lilly and Company, Indianapolis, Indiana, USA

Gabriela Patilea-Vrana, University of Washington, Seattle, Washington, USA

1:00 - 2:00

Posters Attended by Authors

Ballroom DE

2:00 pm - 4:00 pm

Parallel Symposium 7: Molybdenum Coenzymes (e.g. AO and XO) – Basics and Application

2:00 - 2:30

Chair: R. Scott Obach, Pfizer Inc., Groton, Connecticut, USA, and Jeff Jones, Washington State University, Pullman, Washington, USA

Yingying Guo, Eli Lilly and Company, Indianapolis, Indiana, USA

Ballroom A 2:00 - 2:30

S27. Biochemical Aspects of Aldehyde and Xanthine Oxidase Jeff Jones, Washington State University, Pullman, Washington, USA

2:30 - 3:00

S28. Crystal Structure of Aldehyde Oxidase Maria João Romão, Universidade Nova de Lisboa, Caparica, Portugal

3:00 - 3:30

S31. Utility of Humanized Liver Mouse Model in Evaluation of Mitochondrial Transporters-Associated Hepatotoxicity

2:30 - 3:00

S32. Targeting the Lysosome with Novel Drugs to Overcome P-glycoprotein Mediated Resistance in Cancer Des R. Richardson, University of Sydney, Sydney, Australia

3:00 - 3:30

S33. The Contribution of Lysosomal Sequestration to Intracellular Drug Accumulation and its Assessment by in vitro and in silico Methods Ayşe Ufuk, University of Manchester, Manchester, UK

S29. Genetics, Regulation, and Endogenous Role for Aldehyde Oxidase Enrico Garattini, Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Scientific Program 3:30 - 4:00

S34. Impaired OATP1B1-mediated Transport Following Treatment with Lysosomotropic Drug Chloroquine: Implications in OATP-mediated Drug-Drug Interactions Wei Yue, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA

4:00 pm - 4:30 pm

Refreshment Break with Exhibitors and Posters Exhibit Hall CD

4:30 pm - 6:00 pm

Podium Presentations of Graduate/ Pre-doctoral Poster Awards Finalists Chair: Amit S. Kalgutkar, Pfizer Inc., Cambridge, Massachusetts, USA

Ballroom A

5:15 - 5:30

A10. Identification of the Amino Acid Residue Responsible for the Flavonoid Sensitivity of Human Proton-Coupled Folate Transporter Takahiro Yamashiro, Nagoya City University, Nagoya, Japan

5:30 - 5:45

A11. Are OATP1B1, OATP2B1, OATP1B3 and NTCP Transporters Exclusively Expressed in the Plasma Membrane of Transporter-Expressing Cells?

Vineet Kumar, University of Washington, Seattle, Washington, USA

5:45 - 6:00

A12. pH Sensing Mechanism of Human Equilibrative Nucleoside Transporter 3 Involved in Mitochondrial Transport of Nucleoside Analog Drugs Fazlur Rahman, The Ohio State University, Columbus, Ohio, USA

4:30 - 4:45

A7. Comparison of Proteomic Quantification Approaches: Targeted versus Multiplexed Global Quantitation of Hepatic Drug Transporters Jaydeep Yadav, Temple University, Philadelphia, Pennsylvania, USA

4:45 - 5:00

A8. Identification and Evaluation of Clinical Substrates of Organic Anion Transporting Polypeptides 1B1 AND 1B3 Savannah J. McFeely, University of Washington, Seattle, Washington, USA

5:00 - 5:15

A9. A Thorough Characterization of Subcellular Localization and Evaluation of the Impact of Processing Variables on Recovery and Enrichment of Drug Metabolizing Enzymes During Subcellular Fractionation Marc Vrana, University of Washington, Seattle, Washington, USA

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6:00 pm - 7:00 pm

Poster Viewing Hour Exhibit Hall CD

6:00 pm - 8:00 pm

The New Investigators Forum: Career and Leadership Development Co-Chairs: Jessica Hartman, Duke University, Durham, North Carolina, USA, and Cody Nichols, NIEHS, Durham, North Carolina, USA Panelists: Kim Brouwer, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA, James Dykens, EyeCyte Therapeutics, San Diego, California, USA, R. Scott Obach, Chair, Pfizer Inc., Groton, Connecticut, USA, and Lei Zhang, Silver Spring, Maryland, USA

Ballroom DE 6:00 - 6:30

Refreshments

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Scientific Program 6:30 - 7:30

Panel Discussion 7:30 - 8:00

Reception

WEDNESDAY, SEPTEMBER 27

11:20 - 12:00

North American New Investigator Award, Named in Honor of James R. Gillette, Award Presentation and Lecture: Metabolism of Anti-HIV Drugs: A Quest to Personalize HIV Treatment and Prevention NamandjĂŠ Bumpus, Ph.D.

9:00 am - 9:45 am

12:00 pm - 1:00 pm

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

Exhibit Hall CD

Plenary Lecture 3 Ballroom A

S35. Cancer Immunotherapy: Checkpoint Inhibitors, Adoptive Cell Therapy, and Beyond Samuel C. Blackman, Silverback Therapeutics, Inc., Seattle, Washington, USA

9:45 am - 10:15 am

Refreshment Break with Exhibitors and Posters Exhibit Hall CD

Meet with Exhibitors / Lunch on Own

1:00 pm - 2:00 pm

E-Poster Theater and Poster Presentations E-Poster Theater Session 3

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

1:00 - 1:20

P70. Evaluation of a Dual Parameter Mitochondria Toxicity Assay in Primary Human Hepatocytes Weixi Kong, Icagen, Oro Valley, Arizona, USA

10:15 am - 12:00 pm

Presentation of 21st North American ISSX Meeting Awards Chair: Thomas Baillie, University of Washington School of Pharmacy, Seattle, Washington, USA

Ballroom A 10:15 - 10:30

Postdoctoral and Graduate/ Pre-doctoral Poster Awards 10:30 - 11:20

North American Scientific Achievement Award, Named in Honor of Ronald W. Estabrook, Award Presentation and Lecture: Discovering the Endogenous Roles of Drug Transporters through Genetic Studies

1:20 - 1:40

P10. Rapid and Versatile MS-based immunoassays for Targeted Cytochrome P450 and Transporter Profiling in Tissue and Cell Culture Lysates Oliver Poetz, SIGNATOPE GmbH, Reutlingen, Germany

1:40 - 2:00

P46. Contribution of Cytochrome P450 and Other Enzymes to the Metabolism of FDA Approved Drugs between 2005-2016 Armin Sadighi, University of Rhode Island, Kingston, Rhode Island, USA

Kathy Giacomini, Ph.D.

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Scientific Program Poster Presentation Session 3: P158 - P235 1:00 - 2:00

Posters Attended by Authors

2:00 pm - 4:00 pm

Parallel Symposium 9: Mitochondrial Metabolism, Transport, and Toxicity Chairs: Allan Rettie, University of Washington, Seattle, Washington, USA, and Yvonne Will, Pfizer Inc., Groton, Connecticut, USA

Ballroom A 2:00 - 2:40

2:00 pm - 4:00 pm

Parallel Symposium 10: Hydrolases: Enzymology and Role in Drug Development Chairs: Griff Humphreys, Bristol-Myers Squibb, Princeton, New Jersey, and Andrew Parkinson, XPD Consulting, Shawnee, Kansas, USA

Ballroom DE 2:00 - 2:30

S39. Evaluating in vivo Esterasemediated Drug Metabolism: Should Be Easy, But Why Do We Fail?

S36. Introduction to Basic Mitochondrial Biology as it Relates to Drug-induced Toxicity

Philip Potter, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA

James Dykens, EyeCyte Therapeutics, San Diego, California, USA

S40. Chemical Biology Approaches to Profile Esterase Function

2:40 - 3:20

S37. P450 Metabolism and Effects on Drug Accumulation/Toxicity: Examples of Compounds Causing Liver Injury

2:30 - 3:00

Brent Martin, University of Michigan, Ann Arbor, Michigan, USA

3:00 - 3:30

Narayan Avadhani, University of Pennsylvania, Philadelphia, Pennsylvania, USA

S41. Genetic Polymorphisms of Carboxylesterases and their Clinical Implications

3:20 - 4:00

Haojie Zhu, University of Michigan, Ann Arbor, Michigan, USA

S38. Mitochondrial Toxicity: in vitro Testing Paradigm and Potential Biomarker Development Yvonne Will, Pfizer Inc., Groton, Connecticut, USA

3:30 - 4:00

S42. Functional Significance of Orphan Drug-metabolizing Esterases in Pharmacokinetics and Toxicities Tatsuki Fukami, Kanazawa University, Kanazawa, Japan

4:00 pm - 4:30 pm

Refreshment Break with Exhibitors and Posters Exhibit Hall CD

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Scientific Program 4:30 pm - 6:00 pm | Ballroom A

Podium Presentations of Selected Abstracts

Chair: Jae Chang, Genentech Inc., South San Francisco, California, USA

4:30 - 4:45

P35. Crystal Structure of CYP2B6 in Complex with an Efavirenz Analog: From Plasticity to PI Interactions in CYP2B Enzymes

Manish B. Shah, Albany College of Pharmacy and Health Sciences, Albany, New York, USA

4:45 - 5:00

P106. Transcriptional and Epigenetic Regulation of Metabolizing Enzymes and Transporter Proteins in the Human Intestine as Caused by Prototypical Inducers of Metabolism and Transport

Stefan Oswald, University Medicine of Greifswald, Greifswald, Germany

5:00 - 5:15

P191. Stereoselective Metabolism of Pyrido[3,2-d]pyrimidine-containing Compounds by Aldehyde Oxidase

Xiaowei He, Eisai Inc., Andover, Massachusetts, USA

5:15 - 5:30

P20. When Does the Rate-Determining Step in Hepatic Clearance of a Drug Switch from Sinusoidal Uptake Clearance to All Hepatobiliary Clearances?

Gabriela Patilea-Vrana, University of Washington, Seattle, Washington, USA

5:45 - 6:00

P29. Hepatic Lipid Accumulation in Experimental HepaRG Model for Steatosis Influences Bupropion Biotransformation

Anitha Saravanakumar, University of Rhode Island, Kingston, Rhode Island, USA

6:30 pm - 9:30 pm

Rooftop @ the ProvidenceG Meeting Reception This is a ticketed event. A limited number of tickets may still be available. Please inquire at the registration desk.

THURSDAY, SEPTEMBER 28 9:00 am - 9:45 am

Plenary Lecture 4 Chair: Geoff Tucker, University of Sheffield, Sheffield, UK

Ballroom A

S43. Pharmacogenomics to Parmaco-omics: Precision Medicine and Drug Response Richard Weinshilboum, Mayo Clinic, Rochester, Minnesota, USA

9:45 am - 10:00 am

Refreshment Break Ballroom A Foyer

5:30 - 5:45

P149. High-Throughput Microfluidic Platform for Culture of 3D-Kidney Tissue Models

Anthony D. Saleh, Mimetas, Rockville, Maryland, USA

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Scientific Program 10:00 am - 12:00 pm

10:00 am - 12:00 pm

Parallel Symposium 11: New Insights into P450 Structure, Emerging Transporters, and Application to Drug Development

Parallel Symposium 12: Emergent Technologies for Evaluating Drug and Xenobiotic Disposition

Chairs: Eric F. Johnson, The Scripps Research Institute, La Jolla, California, USA, and Joanne Wang, University of Washington, Seattle, Washington, USA

Chairs: Edward Kelly, University of Washington, Seattle, Washington, USA, and Jinping Gan, BristolMyers Squibb, Princeton, New Jersey, USA

Ballroom A

Ballroom DE

10:00 - 10:30

S44. Structural Differences Exhibited by Cytochrome P450s 3A5 and 3A4 Eric F. Johnson, The Scripps Research Institute, La Jolla, California, USA

10:30 - 11:00

S45. Utilizing Structures of 2D6 and BACE1 to Reduce Risk of Drug-Drug Interactions with a Novel Series of Centrally Efficacious BACE1 Inhibitors

10:00 - 10:30

S48. Utility of Microphysiological System (MPS) Technologies in Drug and Xenobiotic Safety Assessments Edward Kelly, University of Washington, Seattle, Washington, USA

10:30 - 11:00

Michael A. Brodney, Pfizer Inc., Cambridge, Massachusetts, USA

S49. What Can Single-Molecule Fluorescence Tell Us About the Disposition of Large- and Small-Molecule Drugs?

11:00 - 11:30

Abhinav Nath, University of Washington, Seattle, Washington, USA

S46. Renal MATE Function in the Context of Drug Development Stephen Wright, University of Arizona, Tucson, Arizona, USA

11:30 - 12:00

S47. Novel Organic Cation Transporter PMAT: Structure, Function, and Role in Drug Transport at the Blood-CSF Barrier Joanne Wang, University of Washington, Seattle, Washington, USA

11:00 - 11:30

S50. The Utility of 3D Hepatocyte Spheroids in Addressing Modern Problems in Drug Metabolism Jinping Gan, Bristol-Myers Squibb, Princeton, New Jersey, USA

11:30 - 12:00

S51. Visualizing Drug Disposition with MALDI Imaging MS Stephen Castellino, GlaxoSmithKline, King of Prussia, Pennsylvania, USA

12:00 pm - 12:15 pm

Closing Remarks

Meeting Chair, Jashvant Unadkat, University of Washington, Seattle, Washington, USA, and Meeting Co-Chair, Allan Rettie, University of Washington, Seattle, Washington, USA

Ballroom A

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21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Poster Information POSTER NUMBER REFERENCE GUIDE POSTER

AWARDS

GENERAL

Analytical

P1 - P10

Bioavailability

P11

Biomarkers

P12 - P14

Blood-brain Barrier

P15

Clearance Prediction

P16 - P21

Conjugation Reactions and Enzymes

P22 - P26

Cytochrome P450

P27 - P46

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

P47 - P54

Disposition

P56 - P61

Drug Delivery

P62 - P63

Drug Discovery and Development

P64 - P75

Drug Interaction

A2, A7, A8

P76 - P88

Enzyme Induction

A3

P89 - P95

Enzyme Inhibition/Inactivation

P96 - P100

Extrahepatic Metabolism

P101 - P102

Gene Expression and Regulation

P103 - P106

Genomics/Metabolomics/Proteomics

A1, A4

P107 - P113

Hepatocytes

P114 - P124

Herb-drug Interactions

P125

High Throughput Techniques

P126 - P128

In silico

P129 - P135

In vitro Techniques

A9

P136 - P149

Mechanisms of Xenobiotic Toxicities

A5

P150 - P157

Metabolic Profiling

P158

Metabolism

P159 - P186

Non-P450 Phase I Enzymes

P187 - P192

Pharmacogenetics

P193 - P197

Pharmacokinetics and Pharmacodynamics

P198 - P203

Receptors/Nuclear Receptors

P204 - P205

Transporters

A6, A10 - A12

SUBMIT AN ABSTRACT for the 2018 ISSX Meetings

The 6th Asia Pacific ISSX Meeting will be held at the Zhejian University in Hangzhou, China May 11 - 15, 2018. The 22nd North American ISSX Meeting will be held at the Palais des congrès de Montréal in Montreal, QC, Canada July 15 - 19, 2018. The call for abstracts for these meetings will open in late 2017.

Don’t miss this opportunity to present your work!

Benefits of presenting a poster include: 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.

P206 - P235

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Poster Information POSTER AWARDS COMPETITION POSTER PRESENTATIONS: BALLROOM A FOYER AND BALLROOM A DATE, LOCATION, TIME

ACTIVITY

POSTER NUMBERS

Monday, September 25 Ballroom A Foyer 7:30 am - 9:00 am

Poster Set-Up

All Posters A1 - A12

Monday, September 25 Ballroom A Foyer 12:45 pm - 2:00 pm

Awards Finalists Poster Session 1 Authors attend posters.

Postdoctoral Finalists A1 - A6

Monday, September 25 Ballroom A 4:30 pm - 6:00 pm

Postdoctoral Poster Awards Finalist Oral Presentations Authors present in session room.

Postdoctoral Finalists A1 - A6

Monday, September 25 Ballroom A Foyer and Exhibit Hall CD 6:00 pm - 7:00 pm

Poster Viewing Hour 1 Posters open for all attendees. No scheduled presentations.

All Posters A1 - A12 and P1 - P235

Tuesday, September 26 Ballroom A Foyer 12:45 pm - 2:00 pm

Awards Finalists Poster Session 2 Authors attend posters.

Graduate/Pre-doctoral Finalists A7 - A12

Tuesday, September 26 Ballroom A 4:30 pm - 6:00 pm

Graduate/Pre-doctoral Poster Awards Finalist Oral Presentations Authors present in session room.

Postdoctoral Finalists A7 - A12

Tuesday, September 26 Ballroom A Foyer and Exhibit Hall CD 6:00 pm - 7:00 pm

Poster Viewing Hour 2 Posters open for all attendees. No scheduled presentations.

All Posters A1 - A12 and P1 - P235

Wednesday, September 27 Ballroom A 10:15 am - 10:30 am

Postdoctoral and Graduate/ Pre-doctoral Poster Awards Presentation of Poster Awards

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

Wednesday, September 27 Ballroom A Foyer 6:00 pm - 7:00 pm

Poster Removal

All Posters A1 - A12

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.

26

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Poster Information GENERAL POSTER ABSTRACTS PRESENTATIONS: EXHIBIT HALL CD DATE AND TIME

ACTIVITY

POSTER NUMBERS

Monday, September 25 7:30 am - 9:00 am

Poster Set-Up

All Posters P1 - P235

Monday, September 25 1:00 pm - 2:00 pm

Poster Session 1 Authors attend posters.

Session 1 Posters P1 - P75

Monday, September 25 6:00 pm - 7:00 pm

Poster Viewing Hour 1 Poster hall open for all attendees. No scheduled presentations.

All Posters P1 - P235

Tuesday, September 26 1:00 pm - 2:00 pm

Poster Session 2 Authors attend posters.

Session 2 Posters P76 - P157

Tuesday, September 26 6:00 pm - 7:00 pm

Poster Viewing Hour 2 Poster hall open for all attendees.

No scheduled presentations.

All Posters P1 - P235

Wednesday, September 27 1:00 pm - 2:00 pm

Poster Session 3 Authors attend posters.

Session 3 Posters P158 - P235

Wednesday, September 27 6:00 pm - 7:00 pm

Poster Removal

All Posters P1 - P235

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.

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

27

Industry-Sponsored Symposia The Industry-Sponsored Symposia (ISS) are commercially supported educational sessions held in conjunction with the 21st North American ISSX Meeting. These sessions have been approved for presentation at our meeting. All attendees are invited to enjoy a light breakfast and the education these sessions provide.

MONDAY, SEPTEMBER 25 7:45 am - 8:45 am Presented by BioreclamationIVT

In vitro Prediction of Drug Metabolism and Transport Using Primary Human Hepatocytes Hongbing Wang

Ballroom DE This lecture will provide researchers information on how human hepatocytes are uniquely capable of answering important ADME questions in the most accurate and predictive manner. It will highlight human primary hepatocytes as a physiologically relevant in vitro model for investigation of drug metabolism and transport.

Lack of metabolic competence is a major limitation for the majority of current cell-based assays used for evaluation of drug efficacy and toxicity. Many promising medications identified using these methods have failed in clinical trials due to either unexpected human toxicity or lack of efficacy.

Properly cultured human primary hepatocytes (HPH) retaining physiologically relevant expression and function of major drug-metabolizing enzymes and transporters have been well-accepted as in vitro models for testing drug metabolism and transport. Our presentation will describe the molecular basis of metabolism-mediated conversion of PK11195 from an antagonist to an agonist of the constitutive androstane receptor in HPH. Utilizing metformin as a model compound, we will also provide experimental evidence to show that repression of BSEP expression in HPH may contribute to clinically observed drug-induced cholestasis.

The BioreclamationIVT sponsored symposium will focus on in vitro application of HPH models for ADME assays to provide the attendees with a better understanding of metabolism-mediated pharmacodynamics changes of drug actions, as well as the role of BSEP repression in druginduced cholestasis. The presentation is intended to stimulate awareness of the importance of metabolic capacity in in vitro cell-based drug evaluation.

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TUESDAY, SEPTEMBER 26 7:45 am - 8:45 am Presented by Lonza

Direct and Quantitative Evaluation of CYP450 Contribution (fm) to Drug Clearance Using the in vitro Model Silensomes™ Ashwani Sharma

Ballroom DE The purpose of this presentation is to understand the role of the Silensomes™ to evaluate in vitro the fraction of the drug metabolized (fm) by each CYP in order to predict DDI. Regulators, including the U.S. Food and Drug Administration (FDA) have taken a prospective approach to the problem of drug interactions by assessing the interaction potential at an early stage of drug development. As a result, prediction of metabolically-based DDIs from in vitro and in vivo data has become a need in drug development. However, the accuracy of predicted results depends on the quality of the input dataset. In addition it is crucial that the complexities of the DDI process, as much as possible, are modeled in a welldefined algorithm based on fully reliable data.

In vitro identification and measurement of the contribution (fm) of the major cytochrome P450 enzymes (CYP450s) involved in the metabolism of a new drug candidate, also called “CYP450 phenotyping”, helps to predict the impact of other co-administered drugs (perpetrators) on the pharmacokinetics of the new chemical entity (NCE = victim).

Today, a battery of in vitro tests (recommended by the regulatory agencies) is required for CYP450 phenotyping, each of which has a number of limitations.

A new in vitro model, called Silensomes™, has been developed to address the disadvantages of the current methodologies.

SilensomesTM are human pooled HLM chemically and irreversibly inactivated for one specific CYP450 activity (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4) using a mechanism based inhibitor (MBI). Examples of fm evaluation for NCE metabolized by one or several CYPs will be shown.

Correlation between in vitro and in vivo fm evaluation will be demonstrated Learning objectives of this session include evaluation of fm for the DDI prediction using a new in vitro tool, Silensomes™.

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

Exhibitor Directory 908 DEVICES ANALIZA, INC. BOOTH 504 BOOTH 215 908 Devices ZipChip™ is radically improving process efficiencies for automated sample analysis of small and large molecules across the biopharma industry. This innovative CE platform provides high-quality separations as a front-end for mass spectrometry (MS). Using integrated microfluidic technology, ZipChip prepares, separates and electrosprays biological samples directly into MS instruments.

ABSORPTION SYSTEMS BOOTH 329

Absorption Systems supports pharmaceutical and medical device companies in identifying and overcoming ADMET barriers in development of drugs and medical devices. The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur.

Visit www.absorption.com to view our comprehensive contract services and applied research programs.

AGILENT TECHNOLOGIES BOOTH 211

Agilent is a leader in life science research tools, providing analytical instruments, software, consumables and services for research laboratories worldwide. Agilent products including Seahorse, iLab, Dako, SureSelect, and mass spec are used in phenotyping, metabolomics, cell metabolism, and mitochondrial toxicity assays; as well as immunotherapy, cancer, and metabolic disease research.

ALLIANCE PHARMA BOOTH 413

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.

ALTURAS ANALYTICS, INC. BOOTH 312

Alturas Analytics delivers bioanalytical 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 through a focused emphasis on teamwork, communication, and exceptional science. We are the MS/MS experts.

Analiza, Inc. is a leading US-based provider of complete analytical services supporting drug discovery. We offer expertise from physicochemical and ADME property screening to fully customized HPLC and LC-MS based analytical studies. We deliver quality data with the fastest turn-around time, smallest sample requirement, and lowest cost in the industry.

BIOMERE BOOTH 415

Biomere is a preclinical CRO located in Worcester, MA. Founded in 1996, our scientific expertise in metabolic and autoimmune disease has since expanded to a comprehensive profile of various therapeutic areas. With colonies of rodents to NHPs, we are the number one choice for CROs for all your discovery needs.

BIORECLAMATIONIVT BOOTH 410

BioreclamationIVT is a worldwide provider of biological and in vitro products to pharmaceutical and biotechnology organizations. Our company specializes in animal, human and disease state human biological matrices for use in drug discovery along with LiverPool and cryoplateable hepatocyte, microsome and media products used in the preclinical industry.

CELL RESOURCE CORE, MASSACHUSETTS GENERAL HOSPITAL BOOTH 225

The Cell Resource Core specializes in hepatocyte isolations, whole liver perfusion studies and cell culture products. Our core’s uniquely broad proprietary technologies and products is the result of over 30 years of medical, scientific and engineering collaborations at Massachusetts General Hospital.

CORNING LIFE SCIENCES BOOTH 401

.

Corning is the industry leader in the development of tools and solutions for ADME/Tox testing.

Corning offerings include hepatic cell-based models, tissue fractions, recombinant enzymes, Transwell® Permeable Supports, as well as Contract Services for drug metabolism/transport/ toxicity studies. In addition, Corning continues to be the industry’s most reliable source of beginning-to-end cell culture solutions with trusted brands, such as Falcon® products, Matrigel® matrix, and cell culture media.

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Exhibitor Directory CURACHEM, INC. BOOTH 305

Custom Synthesis of Radiolabeling with 14C and/or 3H • Carbon-14 radiolabeled small molecules for pre-clinical study and clinical trials • H-3 radiolabeled compounds • Stable isotope labeling • Non-labeled Synthesis of Metabolites, Impurities and Reference Standards • Peptide, Protein, Antibody, Recommbinant protein (intact or modified) • Nucleic acid • Antibody Drug Conjugate • Saccharide • PEG polymer

CYPEX, LTD. BOOTH 325

Cypex specialises 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 and metabolite generation. All products and services are covered by Cypex’s ISO9001:2008 accredited QA system.

CYPROTEX BOOTH 516

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 the US. In 2016, Cyprotex was acquired by Evotec AG, enabling the company to offer both integrated and standalone drug discovery services.

ENVIGO BOOTH 311

Envigo provides essential research services, models and products for biopharmaceutical, crop protection, and chemical companies as well as universities, governments, and other research organizations. Our business is founded on a dedication to customer service and the expertise and experience of our 3,800 people. Read more at envigo.com.

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EUROFINS PHARMA DISCOVERY SERVICES BOOTH 303

Eurofins Pharma Discovery Services has been supporting Drug Discovery research for >40 years. Through the combined expertise of Eurofins Discovery Services, Cerep, Panlabs & Villapharma we offer a broad portfolio of products and services including; in vitro pharmacology, cell-based phenotypic assays, chemistry services, ADME-Tox, in vivo drug safety & efficacy, custom proteins and assay development services.

GENOMEMBRANE CO., LTD. BOOTH 512

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.

HERA BIOLABS BOOTH 402

Hera BioLabs is focused on providing services with precisely gene-edited models to produce high-confidence and translational data. Our diverse capabilities include custom model creation, HepG2-CYP cell panel, huMDCK cells for transporter assays, and our SRG rat model for xenografts and humanization of the liver and humanization of the immune system.

HUREL CORPORATION BOOTH 231

HuREL® develops and sells primary hepatic co-cultures in a variety of species and formats. HuREL’s robust co-cultures offer superior metabolic functionality helping researchers produce more relevant data. Focusing on commercial practicality and convenience, HuREL delivers its products ready to use, including all necessary media; saving valuable time and money.

HYPHA DISCOVERY BOOTH 310

Hypha Discovery make drug metabolites for clients using proven microbial and mammalian biotransformation 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.

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Exhibitor Directory IMABIOTECH

LONZA

Localized in USA, Europe and Asia, ImaBiotech is a Contract Research Organization (CRO) company which supports pharmaceutical compagnies with innovative services from preclinical to clinical stages. ImaBiotech is specialized in a new technology called Mass Spectrometry Imaging which improves Target Engagement, Pharmacokinetics, pharmacodynamics and support of toxicology studies.

Lonza Bioscience Solutions provides instruments, research tools and software throughout the entire pharmaceutical value chain, from drug discovery, ADME/Tox to Quality Control. Our integrated portfolio of transfection instruments and primary cells, now including hepatocytes, allows seamless screening of CRISPR libraries for phenotypic screening as well as early ADME/Tox investigations.

IN VITRO ADMET LABORATORIES INC. (IVAL)

BOOTH 229

BOOTH 403

BOOTH 404 Premiere provider of in vitro drug metabolism and toxicology products and contract research services. IVAL provides comprehensive in vitro ADMET contract research services including metabolic stability, metabolite profiling, P450 inhibition and induction, transporter inhibition, and in vitro toxicity. Products include cryopreserved primary hepatocytes and primary cryopreserved enterocytes.

INTERVIVO SOLUTIONS BOOTH 428

InterVivo Solutions is a preclinical in vivo CRO providing research services using translational animal models for efficacy, pharmacokinetics, safety and toxicology, including studies with the PXB Humanized Liver Mouse ® and Horizon/SAGE ® Knockout Rats. InterVivo specializes in CNS drug discovery and is unique in its offering of translational models and multidomain services to improve the clinical success of NCEs.

LABLOGIC SYSTEMS, INC. BOOTH 300

LabLogic Systems is a worldwide market leader in the supply of LIMS and chromatography data systems to pharmaceutical, academic, nuclear medicine and research laboratories. Our products include LIMS for ADME studies and PET production, radiochromatography detectors and software for HPLC and TLC, liquid scintillation and gamma counters.

LHASA LIMITED BOOTH 316

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.

BOOTH 500

MICROCONSTANTS MicroConstants is a GLP-compliant Contract Research Organization focused on performing bioanalysis, drug metabolism, and pharmacokinetic analysis in support of new therapeutic development programs. We specialize in method development, validation, and sample analysis for small molecules and macromolecules using LC/MS/MS, HPLC/UV, and immunoassay techniques.

MILLIPORESIGMA BOOTH 324

For ADME/Tox and DMPK scientists performing Tier1/Tier2 safety testing assays, MilliporeSigma provides more predictive in vitro model systems for intestine, liver, and kidney with primary, wild type, and engineered cell lines. These systems, listed in FDA and EMA preclinical guidance documents, address transporters and nuclear receptors related to cyp induction.

MIMETAS BV BOOTH 524

MIMETAS develops better predictive human tissue and disease models using organ-on-a-chip technology. Her coreproduct, the OrganoPlate®, allows perfused 3D cell culture, membrane free co-culture and culture of tubules and vessels.

MIMETAS works for nearly all major pharmaceutical companies worldwide on a variety of models for compound screening and toxicity testing.

NEXCELOM BIOSCIENCE BOOTH 427

Nexcelom’s Cellometer and Celigo image cytometry products are designed for cell analysis in life science and biomedical research. The Cellometer instruments cover basic cell counting, viability and cell-based assays with 20uL of sample. The Celigo is a high throughput micro-well image cytometer. Products are placed in thousands of laboratories globally.

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Exhibitor Directory OMNI INTERNATIONAL

PHARMARON

Omni International’s homogenizers have been a laboratory staple for over 60 years. Omni sets the industry standard with a commitment to outstanding design, performance and a uniquely diversified solution-based product line. We offer a complete portfolio of homogenizers and reagents for sample preparation in pharmaceutical, life science, biotechnology, agricultural, microbiology and chemical research laboratories.

Pharmaron is a premier R&D service provider. Founded in 2003, Pharmaron has 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

BOOTH 302

OPTIBRIUM, LTD. BOOTH 304

Optibrium creates elegant software solutions for small molecule design, optimisation and data analysis, including: StarDropTM, a comprehensive environment that guides the design and selection of high quality compounds; SentiraTM, a powerful and easy-to-use desktop tool for chemistry data visualisation; and Asteris, an iPadTM app for creative compound exploration and design.

OPTIVIA BIOTECHNOLOGY BOOTH 514

Optivia Biotechnology is a leading contract research organization (CRO) that offers drug transporter research services, products, and customized solutions for DDI, DMPK, safety, and pharmacology. Our award-winning transporter assay services provide high-quality, comprehensive FDA/EMA/ PMDA-compliant transporter inhibition and substrate assays, serving over 300 biotechnology, pharmaceutical and academic organizations worldwide.

PEAK SCIENTIFIC BOOTH 213

Peak Scientific produces market-leading nitrogen, hydrogen and zero air systems mainly for the fields of LC-MS (Liquid Chromatography-Mass Spectrometry) and GC (Gas Chromatography). What differentiates us is our world-class technical support and ongoing service care throughout the generator’s lifespan, wherever you may be in the world.

BOOTH 425

AMS technology. www.pharmaron.com.

PHOENIXBIO USA CORPORATION BOOTH 411

PhoenixBio produces the PXB-Mouse®, the world’s most widely used humanized liver chimeric mouse model for drug discovery and development. With a liver consisting of up to 98% human hepatocytes, the in vivo PXB-Mouse® model optimizes pre-clinical drug development with accurate human translatability for DMPK/Tox, NASH/NAFLD, Oligonucleotide Therapeutics and HBV/HCV fields.

PROTEA BIOSCIENCES BOOTH 430

Protea Biosciences provides services and consumables for mass spectrometry imaging (MSI), proteomics, protein characterization, and small molecule analysis. Protea’s innovative mass spectrometry technology featured in our service laboratory include the LAESI DP-1000 Direct Ionization System for ambient pressure, matrix-free applications, MALDITOF tissue imaging workflows, and high resolution, accurate mass bioanalytical LC-MS capabilities. Our interdisciplinary team offers the expertise to support researchers’ projects and help accelerate drug discovery and characterization. Learn how Protea Biosciences can enhance the quality of your research and reduce your time to market.

Q2 SOLUTIONS BOOTH 330

Launched in 2015, Q2 Solutions is a global clinical trials laboratory services organization that helps biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions offers complete bioanalytical and ADME solutions for testing across the product development spectrum.

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Exhibitor Directory QPS, LLC

SEKISUI XENOTECH

QPS is a GLP/GCP-compliant CRO that supports discovery, preclinical, and clinical drug development. We provide quality services in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, and Clinical Development to pharmaceutical and biotech clients worldwide. Our regional laboratories, clinical facilities and offices are located in North America, Europe, India and Asia. For more information, visit https://www.qps.com.

Sekisui XenoTech is a global Contract Research Organization with unparalleled experience and proven expertise from discovery through clinical support, providing cell and tissuebased products, screening, radiolabeling, API manufacturing, in vitro ADMET and pharmacology, in vivo ADMET and QWBA, metabolite ID and production, bioanalytical services and consulting. Learn more at www.xenotech.com.

QUALYST TRANSPORTER SOLUTIONS, LLC

SEVENTH WAVE LABORATORIES

Qualyst provides in vitro hepatic models to predict the effect of compounds on the human liver. Qualyst’s models integrate hepatic uptake, metabolism, regulation, and efflux and demonstrate superior in vitro-in vivo correlation compared to conventional systems. The model data informs drug R&D decisions and is used to address regulatory concerns.

Seventh Wave represents a unique alternative to traditional contract research. We integrate nonclinical disciplines in pharmacology, drug metabolism & pharmacokinetics, toxicology and pathology to provide robust nonclinical evaluations of drug efficacy, safety, systemic exposure and metabolism. With a consultative, flexible, integrated and multi-disciplinary approach, we offer the advice, analysis and answers necessary to bring your drug to market.

BOOTH 203

BOOTH 510

QUOTIENT CLINICAL BOOTH 405

Quotient Clinical is a world leading provider of human ADME studies to the pharmaceutical industry generating data to support global regulatory submissions. Our integrated GMP manufacturing and GCP clinical facility with dedicated capability for the conduct of conventional and tracer radiolabelled studies offers a unique solution for pharmaceutical companies needing to generate human metabolism and pharmacokinetic data to support drug development and registration.

BOOTH 424

BOOTH 328

SIMULATIONS PLUS BOOTH 201

Simulations Plus is the premier developer of modeling & simulation solutions supporting drug discovery and development. With subsidiary companies Cognigen & DILIsym, we provide easy-to-use software (including GastroPlus™, ADMET Predictor™, KIWI™, and DILIsym®) and PBPK modeling, pharmacometrics, and systems toxicology/ pharmacology consulting to assist with safety risk assessment and preclinical/clinical development.

SAI LIFE SCIENCES BOOTH 429

Sai Life Sciences provides services to our pharma innovator partners, which accelerate the discovery, development and manufacture of complex small molecules. Our clients gain clear competitive advantages through shorter time to market and risk minimization using our integrated and high-quality scientific services. Through our comprehensive discovery groups, Sai provides high-value integrated services in pharmacology, DMPK, toxicology and formulation development to better support the increasing needs of our customers.

SOLVO BIOTECHNOLOGY US BOOTH 205 Drug Transporter Services and Products from the Expert!

SOLVO Biotechnology is the leading provider of transporter assays Worldwide, since 1999.

With over 100 solutions, we support your in-house or outsourced projects with high quality products or services, including FDA-, EMA, PMDA-ready reports.

Please visit our booth #205 and www.solvo.com!

21ST NORTH AMERICAN ISSX MEETING | PROVIDENCE, RHODE ISLAND, USA | SEPTEMBER 24 - 28, 2017

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Exhibitor Directory SUVEN LIFE SCIENCES, LTD.

WATERS CORPORATION

Suven Discovery has 15 years experience in discovery and development of several small molecules to clinic in CNS. Suven offers Medicinal-Chemistry, Analytical-Chemistry, ImpuritiesMetabolite Synthesis; ADME assays (Metabolic stability, Reaction phenotyping, Met ID, DDI- Inhibition & induction assays, Transporter assays, rodent and non-rodent PK and CNS penetration), Microdialysis; Receptor-Occupancy; In-vivo Pharmacology; Toxicology and Bioanalysis.

Waters Corporation creates business advantages for laboratory-dependent organizations by delivering scientific innovation to enable customers to make significant advancements. Waters helps customers make profound discoveries, optimize laboratory operations, deliver product performance, and ensure regulatory compliance with a connected portfolio of separations and analytical science, laboratory informatics, mass spectrometry, as well as thermal analysis.

BOOTH 217

THERMO FISHER SCIENTIFIC

BOOTH 313

BOOTH 526

WUXI APPTEC

The GibcoTM brand by Thermo Fisher Scientific provides cellbased products to accelerate the development of effective drugs. Our comprehensive portfolio of primary hepatocytes, media, and supplements to provide the stable foundation you need to confidently screen compounds for potential effects on liver function; our team of hepatic scientists will help you integrate these powerful tools.

WuXi AppTec Laboratory Testing Division (LTD) provides a comprehensive and integrated testing platform for drug development. LTD provides services and solutions in analytical chemistry, in vivo pharmacology, full-scale in vitro ADME and in vivo PK, bioanalysis, toxicology, clinical testing and customized antibody and reagent preparation in both China and the U.S.

BOOTH 314

UNIVERSITY OF WASHINGTON, DRUG INTERACTION DATABASE PROGRAM BOOTH 417

The Metabolism & Transport Drug Interaction Program (www. druginteractioninfo.org) maintains web-based research applications (DIDB, e-PKGene) for pharmaceutical scientists and clinicians working in drug metabolism, drug transport, and drug-drug interactions. The platform contains preclinical and clinical drug interaction, organ impairment, and pharmacogenetic studies from the Literature and from recent NDA reviews.

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Exhibit Hall CD Floor Plan

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Quality, reliability & cost effectiveness Enzymes, Substrates, Metabolites, Inhibitors, Antibodies, Purified CYPs, Custom aliquotted enzymes.

Pig CYPs recently released.

Contract CYP inhibition screening Contract protein expression

www.cypex.co.uk

t: (+44) (0) 1382 562391 e: info@cypex.co.uk Cypex Ltd is an ISO 9001 accredited company