20th North American ISSX Meeting Registration Brochure

October 18 - 22, 2015 Hilton Orlando Bonnet Creek Resort

Orlando, Florida

ŠDisney

Register before Friday, July 31 for the limited-time early discount incentive! www.issx.org/20NA/register Reserve your hotel room by Monday, September 21! www.issx.org/20NA/hotel

INVITATION TO ATTEND Dear colleagues and friends, On behalf of the Meeting Organizing Committee, it is our pleasure to welcome you to participate in the 20th North American ISSX Meeting that will be held October 18 - 22, 2015 in Orlando, Florida.

The Meeting Organizing Committee and symposia chairs designed a stimulating program in a venue that is sure to foster scientific exchange, networking, and collaborative discovery.

In addition to the symposia and podium sessions, the 20th North American ISSX Meeting features state-of-the-art exhibits and interactive poster sessions to optimize discussion and exchange ideas. We encourage you to submit your research abstract for presentation. Many of the most interesting and stimulating abstract submissions will be selected for oral presentation in podium sessions. However, many past meeting participants prefer presentations at poster sessions where discussion among a few researchers can bring fresh insights.

There are compelling reasons to attend the 20th North American ISSX Meeting at the Hilton Bonnet Creek Resort this October.

• Participate in important scientific and educational sessions on drug metabolism, toxicology, pharmacology, molecular biology and related topics.

• Hear from leading experts who will present cutting-edge research findings.

• Gain recognition for presenting your work.

• Engage in networking and collegial interaction with others working on drug/xenobiotic research in diverse areas including basic and clinical pharmacology and therapeutics, toxicology, oncology, endocrinology, physiology, biochemistry, molecular and structural biology, and genetics!

Last, but not to be forgotten, is the beautiful venue surrounded by the Walt Disney World Resort®. Enjoy a little of Florida while renewing past acquaintances and meeting new colleagues at this premier entertainment attraction destination.

We look forward to welcoming you in Orlando!

Sincerely,

Hartmut Derendorf, Ph.D. and Stephan Schmidt, Ph.D. 20th North American ISSX Meeting Co-Chairs

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20th North American ISSX Meeting • October 18-22, 2015

WHY ATTEND? If you work in the fields of toxicology, pharmacology, and molecular biology or if you research xenobiotics, you can’t afford to miss the 20th North American ISSX meeting: • Learn the latest information in this dynamic and specialized field through broad-based and informative short courses.

• Expand your knowledge of xenobiotics by learning from top experts lecturing in ten symposia, three plenary lectures, and two plenary sessions.

• Join new investigators for a panel discussion on career and leadership development hosted by senior scientists.

• Meet the rising stars in the field through posters presented for the predoctoral and postdoctoral poster awards competition.

• Gain recognition by presenting an abstract or poster to colleagues.

• Network with other researchers and exhibitors.

• Meet with top suppliers at the Sunday evening Welcome Reception.

• Enjoy a free afternoon with family or friends in Orlando to visit the parks and attractions!

Meeting Organizing Committee Hartmut Derendorf (Co-Chair) University of Florida, Gainesville, Florida, USA

Reggie Frye University of Florida, Gainesville, Florida, USA

Amin Rostami University of Manchester, Manchester, UK

Stephan Schmidt (Co-Chair) University of Florida, Orlando, Florida, USA

Margaret James University of Florida, Gainesville, Florida, USA

Mirjam Trame University of Florida, Orlando, Florida, USA

Vikram Arya U.S. Food and Drug Administration, Silver Spring, Maryland, USA

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

Geoff Tucker Simcyp Ltd., Sheffield, United Kingdom

Andrew Parkinson XPD Consulting, Shawnee, Kansas, USA

TABLE OF CONTENTS Important Dates.............................. 4

Registration Information................... 14

About ISSX..................................... 4

Exhibitor Registration....................... 15

Short Course Program...................... 5

Attendee Programs.......................... 16

Program At-a-Glance........................ 6

Abstract and Poster Information........ 16

Be a Part of the Program.................. 8

Social Program................................ 17

Scientific Program........................... 9

General Information......................... 18

Register today at www.issx.org/20NA/register

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IMPORTANT DATES July 10, 2015..............Abstract Submission Deadline July 10, 2015..............Deadline for Travel Grant Applications July 17, 2015 .............Deadline for Receipt of Exhibitor Cancellation (in writing) July 24, 2015..............Notification of Travel Grant Acceptance July 27, 2015..............Notification of Abstract Acceptance July 27, 2015..............Notification to Finalists of Poster Awards Competition July 31, 2015..............Deadline for Reduced Pre-registration for Meeting and Short Courses August 17, 2015..........Nomination Deadline for ISSX Awards September 4, 2015...... Deadline for Receipt of Meeting and Short Course Cancellation (in writing) September 7, 2015......Deadline for Hotel Registrations (subject to availability) October 12, 2015........ Deadline for Pre-registration for Meeting and Short Courses (on-site fees will increase)

ABOUT ISSX What is ISSX? ISSX is an international association of scientists that promotes the understanding of the interactions of medicines and chemicals with living systems.

Who is ISSX? Members include academic and industry groups and consist primarily of research scientists and future scientists in toxicology, pharmacology, molecular biology, and other disciplines related to the study of xenobiotics.

ISSX has a strong international base of members from more than 50 countries.

JOIN ISSX Visit us at

Join ISSX Become part of the premier international association representing the interests of researchers and educators in the field of xenobiotics. The Society is engaged in multiple activities to support, promote, and advance the profession on a global scale.

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Membership dues are a great value at only $135 USD for Regular Membership or the Student Membership price of $25 USD for graduate and postgraduate students as well as postdoctoral scientists in training. We also proudly support scientists in designated countries with extremely discounted membership dues. ISSX Members also receive steep discounts on meeting registration.

www.issx.org/membership to submit your membership application online.

20th North American ISSX Meeting • October 18-22, 2015

SHORT COURSE PROGRAM SHORT COURSE 1: Maximizing the Predictability of PBPK Models Using Topdown Approach Chair: Ping Zhao, FDA, Silver Spring, Maryland, USA The objectives of this short course are to 1) update the current status of applying PBPK to support decision-making in drug development; 2) “demystify” misconception that PBPK is a bottom-up approach and articulate the importance of using clinical data to maximize the utility and predictability of PBPK models in drug development; and 3) demonstrate how various top-down methods can be used to enhance our understanding of human physiology and drug behavior based on clinically observed data.

SHORT COURSE 2: Introduction to Pharmacometric and Regulatory Aspects Pertaining Special Populations Chair: Jeff Barrett, Sanofi Pharmaceuticals, Bridgewater, New Jersey, USA The objectives of this short course include the following: 1) provide an overview of populations defined as “special” and describe the discriminating features which define them as such along with current practices that govern their clinical evaluation; 2) examine case studies where pharmacometric approaches have been used by industrial sponsors to evaluate the extent to which these populations vary from the otherwise mainstream population and provide meaningful dosing guidance in the labeling; and 3) provide a regulatory view of the extent to which these approaches provide a defendable rationale for dose selection and dosing guidance in general for special populations.

SHORT COURSE 3: Methodological Aspects of Transporter Measurements Chair: Per Artursson, Uppsala University, Uppsala, Sweden Drug transporting proteins influence the ADME profiles and target access of many drugs. When correctly performed, transporter measurements provide better ADME profiling in vitro and improved predictions of drug fate in vivo. In this short course, the principles and caveats of different transporter methodologies will first be presented. Transport measurements in cell culture and vesicle-based assays will be covered. Basic concepts of transport processes will be used to put the methodological considerations into perspective. Then, supporting methodologies for quantitative assessment of transporter impact will be presented. Methodologies for measurement of transporter abundance and intracellular free concentrations will be covered and combined with transporter kinetics for more quantitative predictions of transporter contribution to drug fluxes, intracellular drug exposure and drug-drug interactions. Finally, techniques for applying transporter data for improved in vitro-in vivo extrapolations will be in focus. Real-world examples of how transporter data influences predictions of drug pharmacokinetics, pharmacodynamics, and drug-drug interactions will be provided.

SHORT COURSE 4: Introduction to PK/ PD of Proteins, Antibodies and Protein Conjugates Chair: Bernd Meibohm, University of Tennessee Health Science Center, Memphis, Tennessee, USA The objective of this short course is to introduce attendees to 1) drug disposition of therapeutic proteins and protein constructs including antibody-drug conjugates and 2) to exemplify the opportunities and challenges in using PK/PD assessments throughout the drug development process for this class of compounds.

Register today at www.issx.org/20NA/register

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PROGRAM AT-A-GLANCE SUNDAY, OCTOBER 18, 2015 8:00 a.m. – 7:00 p.m.

Meeting Registration Open

9:00 a.m. – 12:15 p.m.

Concurrent Morning Short Courses SHORT COURSE 1: Maximizing the Predictability of PBPK Models Using Top-down Approach

12:15 p.m. – 1:30 p.m.

Short Course Attendee Lunch

1:30 p.m. – 4:45 p.m.

Concurrent Afternoon Short Courses SHORT COURSE 3: Methodological Aspects of Transporter Measurements

SHORT COURSE 2: Introduction to Pharmacometric and Regulatory Aspects Pertaining Special Populations

SHORT COURSE 4: Introduction to PK/PD of Proteins, Antibodies and Protein Conjugates

6:00 p.m. – 6:15 p.m.

Opening Welcome Remarks

6:15 p.m. – 7:00 p.m.

OPENING KEYNOTE LECTURE: Personalized Medicine – Myth or Reality

7:00 p.m. – 9:00 p.m.

Opening Welcome Reception with Exhibitors

MONDAY, OCTOBER 19, 2015 7:30 a.m. – 5:00 p.m.

Meeting Registration Open

7:30 a.m. – 8:45 a.m.

Industry-Sponsored Symposia

9:00 a.m. – 11:00 a.m.

PLENARY SESSION 1: Sources of Variability in PK and PD

11:00 a.m. – 11:30 a.m.

Refreshment Break in Exhibit Hall

11:30 a.m. – 12:30 p.m.

ISSX Awards Presentations and Lectures

12:30 p.m. – 2:00 p.m.

Lunch on Own / Visit Exhibitors / View Posters

2:00 p.m. – 4:00 p.m.

Concurrent Symposia PARALLEL SYMPOSIUM 1: New Developments in Transporters

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PARALLEL SYMPOSIUM 2: Preclinical Applications of Systems Pharmacology in Drug Development

4:00 p.m. – 4:30 p.m.

Refreshment Break in Exhibit Hall

4:30 p.m. – 6:30 p.m.

Oral Presentations of Selected Abstracts from New Investigators

7:00 p.m. – 9:00 p.m.

THE NEW INVESTIGATORS FORUM: Career and Leadership Development

20th North American ISSX Meeting • October 18-22, 2015

PROGRAM AT-A-GLANCE TUESDAY, OCTOBER 20, 2015 7:30 a.m. – 1:30 p.m.

Meeting Registration Open

7:30 a.m. – 8:45 a.m.

Industry-Sponsored Symposia

9:00 a.m. – 9:45 a.m.

PLENARY LECTURE 1: Significance of Uptake and Efflux Transporters in the Liver

9:45 a.m. – 10:15 a.m.

Refreshment Break in Exhibit Hall

10:15 a.m. – 12:15 p.m.

Concurrent Symposia PARALLEL SYMPOSIUM 3: Adverse Outcome Pathways: From Research to Regulation

PARALLEL SYMPOSIUM 4: Retrometabolic Drug Design

12:15 p.m. – 1:30 p.m.

Lunch on Own / Visit Exhibitors / View Posters

1:30 p.m. – 5:00 p.m.

Free Afternoon to Visit Local Parks and Attractions

WEDNESDAY, OCTOBER 21, 2015 7:30 a.m. – 6:00 p.m.

Meeting Registration Open

7:30 a.m. – 8:45 a.m.

Industry-Sponsored Symposia

9:00 a.m. – 9:45 a.m.

PLENARY LECTURE 2: Understanding Idiosyncratic Hepatoxicity: From Cage to Clinic

9:45 a.m. – 10:15 a.m.

Refreshment Break in Exhibit Hall

10:15 a.m. – 12:15 p.m.

Concurrent Symposia PARALLEL SYMPOSIUM 5: Transporters and Biomarkers in Kidney and Liver: Implications for Drug Development

PARALLEL SYMPOSIUM 6: Preclinical Applied Pharmacometrics in Drug Development

12:15 p.m. – 1:30 p.m.

Lunch on Own / Visit Exhibitors / View Posters

1:30 p.m. – 3:30 p.m.

Plenary Session 2: Regulatory Requirements for Drug-Drug Interaction Studies – A Comparison around the World

3:30 p.m. – 4:00 p.m.

Refreshment Break in Exhibit Hall

4:00 p.m. – 6:00 p.m.

Concurrent Symposia PARALLEL SYMPOSIUM 7: Phase II Metabolism and Relevance for Drug Safety Parallel

PARALLEL SYMPOSIUM 8: Pharmaceuticals and Personal Care Products in the Environment

Register today at www.issx.org/20NA/register

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PROGRAM AT-A-GLANCE THURSDAY, OCTOBER 22, 2015 7:30 a.m. – 2:00 p.m.

Meeting Registration Open

7:30 a.m. – 8:45 a.m.

Industry-Sponsored Symposia

9:00 a.m. – 9:45 a.m.

PLENARY LECTURE 3: Preclinical Development of Biologics

9:45 a.m. – 10:15 a.m.

Poster Awards Competition Awards Presentation

10:15 a.m. – 10:30 a.m.

Refreshment Break

10:30 a.m. – 12:30 p.m.

Concurrent Symposia PARALLEL SYMPOSIUM 9: Determining CYP Activity in vivo - A Challenge for the Implementation of Personalized Drug Dosage

12:30 p.m. – 12:45 p.m.

PARALLEL SYMPOSIUM 10: Lab on a Chip

Meeting Closing

BE A PART OF THE PROGRAM: SUBMIT AN ABSTRACT A highlight of every ISSX meeting is the showcase of investigators presenting cuttingedge research on the latest advances in topics related to drug metabolism and pharmacokinetics during abstract poster sessions. Investigators have the opportunity to share important findings with colleagues and interact with global leaders in the field.

Benefits of presenting a poster at the 20th North American ISSX Meeting include: •P ublication – Accepted abstracts of original work are published in a topranked journal, Drug Metabolism Reviews (with a 5-year Impact Factor of 6.218).

•V isibility and Feedback – Global experts in the field of xenobiotic research will see your work and dedicated viewing times create opportunities for one-on-one discussion with faculty and attendees.

Presenters benefit from this interaction by gaining feedback on current and future projects, while also discovering the latest research results and advances in DMPK. 8

•A cknowledgement of Exceptional Research – Investigators meeting certain criteria are eligible to participate in the Poster Awards Competition.

Encompassing a category for graduate students and another for postdocs, this competition is available for poster authors to compete for cash prizes and awards.

• I nternational Recognition – The winners of the Poster Awards Competition as well as all authors presenting posters at the meeting will present their research on the international stage and may include their presentation on their CV. Be an active part of the 20th North American Meeting by submitting an abstract by Friday, July 10 and presenting a poster this October. View more information about the poster awards and general poster presentations on page 16 of this booklet and by visiting www.issx.org/20NA/abstracts.

20th North American ISSX Meeting • October 18-22, 2015

PRELIMINARY SCIENTIFIC PROGRAM Sunday, October 18, 2015 SHORT COURSE 1: Maximizing the Predictability of PBPK Models Using Topdown Approach Chair: Ping Zhao, FDA, Silver Spring, Maryland, USA Strategies, Techniques, Applications of Combining Top-down and Bottom-up Approaches in PBPK Models Ping Zhao, FDA, Silver Spring, Maryland, USA Parameterization of Physiology Model Based on Clinical PK Data Joerg Lippert, Bayer, Wuppertal, Germany Parameterization of Drug Models Based on Clinical PK Data Jan Snoeys, Janssen, Beerse, Belgium SHORT COURSE 2: Introduction to Pharmacometric and Regulatory Aspects Pertaining Special Populations Chair: Jeff Barrett, Sanofi Pharmaceuticals, Bridgewater, New Jersey, USA

Program subject to change.

SHORT COURSE 3: Methodological Aspects of Transporter Measurements Chair: Per Artursson, Uppsala University, Uppsala, Sweden Transport Assays: Principles, Methodologies and Caveats Bruno Stieger, University Hospital Zurich, Zurich, Switzerland New Cell Based Approaches for Better Predictions of Drug Transport and Cellular Drug Exposure Per Artursson, Uppsala University, Uppsala, Sweden Translating Transporter Data: in vitro – in vivo Extrapolation to Assess Pharmacokinetics, Pharmacodynamics and Drug-drug Interactions Sybille Neuhoff, Simcyp (a Certara company), Sheffield, United Kingdom SHORT COURSE 4: Introduction to PK/ PD of Proteins, Antibodies and Protein Conjugates Chair: Bernd Meibohm, University of Tennessee Health Science Center, Memphis, Tennessee, USA

Special Populations: Who are They and Why are Pharmacometric Approaches Beneficial for Their Investigation Jeff Barrett, Sanofi Pharmaceuticals, Bridgewater, New Jersey, USA

Therapeutic Protein Disposition: An Old Dog with New Tricks Bernd Meibohm, University of Tennessee Health Science Center, Memphis, Tennessee, USA

Pharmacometric Approaches to Evaluating Special Populations Michael Fossler, GSK, Philadelphia, Pennsylvania, USA

PK/PD Challenges in the Development of Monoclonal Antibodies: From Dose Finding to Regulatory Submission Manish Gupta, Bristol-Myers Squibb, Princeton, New Jersey, USA

Dose Justification for Special Population: Regulatory Perspective Yaning Wang, FDA, Silver Spring, Maryland, USA

Antibody-Drug Conjugates: Combining Two Worlds of PK/PD Assessments Frank-Peter Theil, UCB, Braine, Belgium OPENING KEYNOTE LECTURE: Personalized Medicine – Myth or Reality Larry Lesko, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida, USA

Register today at www.issx.org/20NA/register

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Monday, October 19, 2015 PLENARY SESSION 1: Sources of Variability in PK and PD Chair: Amin Rostami, University of Manchester, Manchester, United Kingdom Variability in Pharmacodynamics and Its Sources Alan Forrest, University of Buffalo, Buffalo, New York, USA Variability in Pharmacokinetics and Its Sources Amin Rostami, University of Manchester, Manchester, United Kingdom Dealing with Variability in a Patient Setting Jeff Barrett, Sanofi Pharmaceuticals, Bridgewater, New Jersey, USA PARALLEL SYMPOSIUM 1: New Developments in Transporters Co-Chairs: Andrew Parkinson, XPD Consulting, Shawnee, Kansas, USA and Jashvant Unadkat, University of Washington, Seattle, Washington, USA Predicting Transporter-based Drug Disposition Using Quantitative Proteomics and PET Imaging Jashvant Unadkat, University of Washington, Seattle, Washington, USA

PARALLEL SYMPOSIUM 2: Preclinical Applications of Systems Pharmacology in Drug Development Chair: Mirjam Trame, University of Florida, Orlando, Florida, USA Translational Modeling for Cardiovascular Safety Assessment Jay Mettetal, Astra Zeneca, Waltham, Massachusetts, USA Quantitative Systems Pharmacology at Pfizer: A Paradigm Shift to Improve the Probability of Successful Proof of Concept Studies R&D Cynthia Musante, Pfizer, Inc., Cambridge, Massachusetts, USA Translational PKPD Modeling and Systems Pharmacology to Drug Discovery at Merck: Implementation, Impact, and Challenges Tjerk Bueters, Merck & Co., Westpoint, Pennsylvania, USA Oral Presentations of Selected Abstracts from New Investigators THE NEW INVESTIGATORS FORUM: Career and Leadership Development Co-Chairs: Tom Baillie, University of Washington, Seattle, Washington, USA and Andrew Parkinson, XPD Consulting, Shawnee, Kansas, USA

Building Confidence Towards Quantitative Prediction of Transporter-based Hepatic and Renal Drug-drug Interactions Manthena V. Varma, Pfizer, Inc., Groton, Connecticut, USA Role of NTCP in the Hepatic Uptake of Hepatitis B and D Viruses Stephan Urban, University of Heidelberg, Heidelberg, Germany

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20th North American ISSX Meeting • October 18-22, 2015

Tuesday, October 20, 2015

Wednesday, October 21, 2015

PLENARY LECTURE 1: Significance of Uptake and Efflux Transporters in the Liver Yuichi Sugiyama, RIKEN, Tokyo, Japan

PLENARY LECTURE 2: Understanding Idiosyncratic Hepatoxicity: From Cage to Clinic Paul Watkins, University of North Carolina, Chapel Hill, North Carolina, USA

PARALLEL SYMPOSIUM 3: Adverse Outcome Pathways: From Research to Regulation Chair: Charlene McQueen, US Environmental Protection Agency, Research Triangle Park, North Carolina, USA Using Kinetic Data to Explain Atrazine’s AOP Sue Yi, Syngenta Crop Protection, Greensboro, North Carolina, USA Applying the Skin Sensitization AOP to Human Health Gavin Maxwell, Unilever, Bedfordshire, United Kingdom Computationally-Predicted AOPs and Systems Toxicology Stephen Edwards, US Environmental Protection Agency, Raleigh/Durham, North Carolina, USA PARALLEL SYMPOSIUM 4: Retrometabolic Drug Design Chair: Erik Bodor, Bodor Labs, Miami, Florida, USA Soft Drugs: A Brief Review of Notable “Accidental” Soft Drugs and Recent Rational Designs Peter Buchwald, University of Miami, Miami, Florida, USA Second Generation of Soft Steroids Nicholas Bodor, University of Florida, Bodor Labs, Gainesville, Florida, USA Rational Anesthetic Drug Design: Rapidly Metabolized Analogues of Etomidate Douglas Raines, Harvard University, Cambridge, Massachusetts, USA

PARALLEL SYMPOSIUM 5: Transporters and Biomarkers in Kidney and Liver: Implications for Drug Development Co-Chairs: Vikram Arya, FDA, Silver Spring, Maryland, USA and Lei Zhang, FDA, Silver Spring, Maryland, USA Hepatic Biomarkers and the Transformation of Liver Risk Assessment Paul Watkins, University of North Carolina, Research Triangle Park, North Carolina, USA Renal Biomarkers Melanie Blank, FDA, Silver Spring, Maryland, USA Renal Transporters Vikram Arya, FDA, Silver Spring, Maryland, USA PARALLEL SYMPOSIUM 6: Preclinical Applied Pharmacometrics in Drug Development Chair: Stephan Schmidt, University of Florida, Orlando, Florida, USA Evaluating Antiviral Pharmacodynamics: An Experimental Approach Ashley Brown, University of Florida, Orlando, Florida, USA Translation from Bench to Bedside in Infectious Diseases: An Example from the ICU George Drusano, Institute for Therapeutic Innovation, University of Florida, Lake Nona, Florida, USA Relevance of Infection Site Concentrations for PK/PD Modeling of Antimicrobials Teresa Dalla Costa, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil

Register today at www.issx.org/20NA/register

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PLENARY SESSION 2: Regulatory Requirements for Drug-drug Interaction Studies—A Comparison around the World Chair: Hartmut Derendorf, University of Florida, Gainesville, Florida, USA Regulatory View of DDI Studies from the FDA Lei Zhang, FDA, Silver Spring, Maryland, USA Regulatory View of DDI Studies in Europe Anna Nordmark, Medical Products Agency, Uppsala, Sweden Regulatory View of DDI Studies in Japan Masanobu Sato, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan PARALLEL SYMPOSIUM 7: Phase II Metabolism and Relevance for Drug Safety Chair: Michael Zientek, Pfizer, Inc., San Diego, California, USA Uncovering Genetic and Epigenetic Mechanisms of UGTs which Contribute to Acetaminophen Hepatoxicity Michael Court, Washington State University, Pullman, Washington, USA

PARALLEL SYMPOSIUM 8: Pharmaceuticals and Personal Care Products in the Environment Chair: Margaret James, University of Florida, Gainesville, Florida, USA Human Exposure to Chemicals Present in Personal Care Products in the U.S. Sherry (Xiaoyun) Ye, Centers for Disease Control and Prevention, Atlanta, Georgia, USA Pathways for Environmental Exposure of People to Pharmaceuticals and Personal Care Products Arjun K. Venkatesan, Arizona State University, Tempe, Arizona, USA Environmental Exposure and Effects of Pharmaceuticals and Personal Care Products in Aquatic Species Duane Huggett, Waterborne Environmental, Inc., Leesburg, Virginia, USA

Mechanisms of UGT Regulation and How Regulation Translates to Clinical Relevance Robyn Meech, Flinders University, Adelaide, Australia Implications of UGT Bioactivation of Clopidogrel on Drug Safety: in vitro to the Clinic Janne Backman, University of Helsinki, Helsinki, Finland

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20th North American ISSX Meeting • October 18-22, 2015

Thursday, October 22, 2015 PLENARY LECTURE 3: Preclinical Development of Biologics Douglas Leipold, Genentech, South San Francisco, California, USA PARALLEL SYMPOSIUM 9: Determining CYP Activity in vivo - A Challenge for the Implementation of Personalized Drug Dosage Chair: Geoff Tucker, University of Sheffield, Sheffield, United Kingdom The Specificity of Metabolic Ratios Re-visited Geoff Tucker, University of Sheffield, Sheffield, United Kingdom Prospects for the Identification of Informative CYP3A4 Genotypes Wolfgang Sadee, The Ohio State University, Columbus, Ohio, USA

PARALLEL SYMPOSIUM 10: Lab on a Chip Chair: Edward Kelly, University of Washington, Seattle, Washington, USA Human Kidney Microphysiological System for Drug and Xenobiotic Toxicity Testing Edward Kelly, University of Washington, Seattle, Washington, USA Development of an Integrated Liver Microphysiological System Lawrence Vernetti, University of Pittsburgh, Pittsburgh, Pennsylvania, USA Pharmaceutical Industry Perspective on MPS Technologies for Drug Development Jinping Gan, Bristol-Myers Squibb R&D, Princeton, New Jersey, USA

The Utility of Drug Microdosing for Marking CYP Activity Gerd Mikus, University of Heidelberg, Heidelberg, Germany

REGISTER TODAY REGISTRATION: Register before Friday, July 31 to receive the early registration discount! www.issx.org/20NA/register

HOTEL: Reserve your hotel room by Monday, September 21! www.issx.org/20NA/hotel

Register today at www.issx.org/20NA/register

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REGISTRATION INFORMATION The 20th North American ISSX Meeting features: • • • • • • • • •

Short Courses* Scientific Symposia and Plenary Sessions Keynote and Plenary Lectures Presentation of the North American Scientific Achievement Award in honor of Ronald W. Estabrook and sponsored by XenoTech Presentation of the North American New Investigator Award in honor of James R. Gillette Poster Presentations Competition and Awards for Best Presentations by Predoctoral and Postdoctoral Researchers Commercial Exhibition Sunday Evening Welcome Reception

*The short courses are separately ticketed offerings and may be added to a registration at an additional fee.

Meeting Registration Hours Sunday, October 18, 2015

8:00 a.m. – 7:00 p.m.

Monday, October 19, 2015

7:30 a.m. – 5:00 p.m.

Tuesday, October 20, 2015

7:30 a.m. – 1:30 p.m.

Wednesday, October 21, 2015

7:30 a.m. – 6:00 p.m.

Thursday, October 22, 2015

7:30 a.m. – 2:00 p.m.

Registration hours are subject to change.

Meeting Registration Fees The meeting registration fee includes admittance to the keynote and plenary lectures, plenary sessions, symposia sessions, poster sessions, the commercial exhibition, entrance to the welcome reception, and refreshment breaks. Attendees receive a meeting tote bag, a copy of the meeting abstracts, and a conference program.

The guest registration fee includes entry to the welcome reception and commercial exhibition.

Guests are welcome to partake in all refreshment breaks. Guest registration does not include admittance to the scientific sessions.

Please note: The meeting registration fee does not include access to the Sunday, October 18 short courses. A nominal separate fee applies.

Meeting Cancellation Policy Registration fees for the meeting and for short courses, less an administrative processing fee of $100, will be refunded if a written/emailed request is received on or before Friday, September 4, 2015. No refunds can be issued past this date as ISSX is required to provide guarantees and pay deposits for various meeting services based on anticipated attendance.

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20th North American ISSX Meeting • October 18-22, 2015

Registration Fees

SHORT COURSES

Early

Regular On-Site

May 1 – July 31

August 1 – October 12

After October 12

ISSX Member

$175

$225

$250

Non-Member

$225

$275 $325

ISSX Student Member

$100

$125

$150

Student Non-Member

$125

$150

$175

MEETING REGISTRATION

Early

Regular On-Site

May 1 – July 31

August 1 – October 12

After October 12

ISSX Member

$625

$725

$795

Non-Member

$835

$935 $1,005

ISSX Student Member

$250

$275

$300

Student Non-Member

$285

$315

$340

$75

$75

$75

Guest Registration

EXHIBITOR REGISTRATION Exhibitors are encouraged to register as early as possible in order to secure their preferred booth selection. Visit the meeting website to download the prospectus, view the exhibit hall floor plan, and complete the exhibitor application: www.issx.org/20NA/exhibit.

Exhibition Hours Sunday, October 18, 2015 Exhibitor Registration and Move-In......................................... 8:00 a.m. – 5:00 p.m.

Welcome Reception.............................................................. 7:00 p.m. – 9:00 p.m.

Monday, October 19, 2015 Exhibits Open....................................................................... 11:30 a.m. – 4:30 p.m.

Tuesday, October 20, 2015 Exhibits Open....................................................................... 9:45 a.m. – 1:30 p.m.

Wednesday, October 21, 2015 Exhibits Open....................................................................... 9:45 a.m. – 4:00 p.m.

Exhibitor Move-out................................................................ 4:00 p.m. – 6:00 p.m.

Exhibition Cancellation Policy Notification of cancellation must be made in writing to meetings@issx.org. If space is cancelled prior to Friday, July 17, 2015, a refund of the amount paid, less 50% (USD), will be issued. No refunds will be issued after July 17, 2015. All sales made after July 17, 2015 are final and non-refundable.

Register today at www.issx.org/20NA/register

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ATTENDEE PROGRAMS Abstract and Poster Information Abstracts The abstract submission deadline for the 20th North American ISSX Meeting is Friday, July 10, 2015. To submit an abstract for the meeting, please visit www.issx.org/20NA/ abstracts. Abstracts submitted after the July 10 deadline may be considered for a poster presentation; however, location with other posters of the same topic cannot be guaranteed.

Predoctoral & Postdoctoral Poster Awards The Poster Awards Committee reviews abstracts entered into the competition for best presentations by predoctoral and postdoctoral researchers and identifies finalists prior to the meeting. Finalists’ posters will be in place for the entire meeting. The Poster Awards Committee will visit the posters of finalists and interview authors. Based on these interviews, the committee will select winners in each category (predoctoral and postdoctoral research). Awards will be presented on Thursday, October 22, 2015 during the Poster Awards session. Prizes will consist of engraved plaques and cash awards.

Poster Schedule

Monday, October 19

Tuesday, October 20

Wednesday, October 21

Set-Up Time

8:00 a.m. – 9:00 a.m.

8:00 a.m. – 9:00 a.m.

8:00 a.m. – 9:00 a.m.

Poster Viewing

9:00 a.m. – 7:00 p.m.

9:00 a.m. – 1:30 p.m.

9:00 a.m. – 6:00 p.m.

Authors Present

12:30 p.m. – 2:00 p.m.

12:15 p.m. – 1:30 p.m. 12:15 p.m. – 1:30 p.m.

Dismantle Time

6:30 p.m. – 7:00 p.m.

1:30 p.m. – 2:00 p.m.

6:00 p.m. – 6:30 p.m.

New Investigator Programs Oral Presentations of Selected Abstracts from New Investigators This year, new investigator attendees have the opportunity to present their work at a special symposium of selected abstracts to be held on Monday, October 19 from 4:30 p.m. – 6:30 p.m.

ISSX New Investigators Forum: Career and Leadership Development New investigators are also invited to attend a special session on Monday, October 19 from 7:00 p.m. – 9:00 p.m. The goal of this forum is to provide new investigators with an insight into career opportunities in different segments of the pharmaceutical sciences (academia, “big pharma,” biotech, and government), with an emphasis on both making oneself more “marketable” to potential employers and acquiring critical leadership skills for a successful career. Topics that will be addressed include employers’ expectations at the time of hiring, and the necessary skill sets for career advancement and leadership development. The forum will take the form of a panel discussion with senior scientists representing each of the above career paths, followed by a Q&A session. This event will be of particular interest to graduate students, postdoctoral fellows, and investigators in the early stages of their careers.

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20th North American ISSX Meeting • October 18-22, 2015

SOCIAL PROGRAM Opening Welcome Reception All registered attendees and registered guests are invited to join us for the opening welcome reception on Sunday, October 18, 2015 from 7:00 p.m. – 9:00 p.m. in the exhibition hall. Meet with the exhibitors, make new acquaintances, and catch up with old friends while you enjoy hors d’oeuvres and drinks with your fellow attendees.

Explore Orlando – Free Afternoon on October 20, 2015 Make plans to enjoy Florida’s world famous theme parks and many other attractions in Orlando with your family, friends, and fellow meeting attendees. The meeting organizers have programmed in a free afternoon on Tuesday, October 20 to provide attendees the opportunity for hours of fun at their choice of attractions. If rides and attractions aren’t your style, consider relaxing at the hotel spa or enjoy the resort’s beautiful pools or threeacre lazy river while you soak up the Florida sun!

Things to Do The beautiful Hilton Orlando Bonnet Creek Resort offers a convenient location near a variety of activities in Orlando—only two-and-a-half miles from the Downtown Disney® Area, two miles from Epcot®, and just minutes from Magic Kingdom® Park. Guests at the Hilton Orlando Bonnet Creek can also enjoy complimentary motor coach transportation to and from all Walt Disney World® theme parks.

Complimentary Shuttle to Walt Disney World® Theme Parks The hotel’s complimentary shuttle picks up at the hotel and takes ISSX meeting attendees directly to Walt Disney World® Theme Parks and back. Shuttles are scheduled seasonally and run approximately every half hour. Please visit the hotel front desk for the current schedule or telephone the hotel at +1 (407) 597-3600.

Transportation to Other Orlando Attractions Transportation to and from SeaWorld® Orlando and Universal Studios® is available and can be arranged through the hotel concierge for a fee payable to the hotel. Self-parking is also available (fees apply) at SeaWorld® Orlando and Universal Studios®. For more information, please telephone the Hilton Orlando Bonnet Creek at +1 (407) 597-3600.

Walt Disney World® Theme Parks and Water Parks: • • • • • •

Magic Kingdom® Park Disney’s Animal Kingdom® Theme Park Epcot® Disney Hollywood Studios™ Disney’s Blizzard Beach® Water Park Disney’s Typhoon Lagoon® Water Park

Other Attractions and Things to Do in Orlando, Florida: • Downtown Disney® Area • Universal Orlando® Resort • SeaWorld® Orlando • Premium & Prime Outlet Malls

Specially reduced priced tickets to several Orlando area attractions are available to ISSX meeting attendees. Visit www.issx.org/20NA/attractions.

Register today at www.issx.org/20NA/register

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GENERAL INFORMATION Meeting Location 20th North American ISSX Meeting October 18-22, 2015 Hilton Orlando Bonnet Creek Resort Orlando, Florida, USA

Hotel Information The 20th North American ISSX Meeting will be held from Sunday, October 18 to Thursday, October 22, 2015 at the Hilton Orlando Bonnet Creek located in Orlando, Florida, adjacent to Walt Disney World®. This beautiful resort property is considered one of the best hotels and meeting spaces in Orlando.

Features include: •1 ,001 guest rooms which all come with a sitting area, workspace, mini-refrigerator, and Hilton Signature Serenity beds.

•A three-acre water complex featuring a resort style pool with zero entry, a lazy river, and a water slide. It was named #1 by TripAdvisor’s “Top 10 Fantastic Pools.”

•T he hotel has twelve different restaurants and lounges featuring outstanding cuisine and quick bite options.

•L ocated next to a lush 482-acre nature preserve, it contains some of the most beautiful and unspoiled views in Orlando.

• Hotel guests also have access to the Waldorf Astoria which is connected to the conference center. The Waldorf Astoria features an award-winning spa and championship golf club.

•T he complex is in close proximity to Walt Disney World® and the hotel provides complimentary transportation to the Magic Kingdom®, Epcot®, Disney Hollywood Studios®, Animal Kingdom®, and Downtown Disney®.

The specially negotiated room rate available to all ISSX attendees is $239 exclusive of tax. Reservations made in the ISSX room block will receive a number of special benefits, including: • Discounted room rate.

• Waiver of the $25/night resort fee.

Reserve your accommodations now. The deadline for rooms in the ISSX block is Monday, September 21, 2015. For reservations, go to www.issx.org/20NA/hotel or telephone the hotel at +1 (888) 353-2013. Be sure to identify yourself as an ISSX meeting attendee in order to secure the special rate.

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20th North American ISSX Meeting • October 18-22, 2015

Awards Program Nominations are currently being accepted for the scientific achievement awards for established and new investigators to be presented at the 20th North American ISSX Meeting. Visit www.issx.org/awards for details and to submit a nomination. The nomination submission deadline is Monday, August 17, 2015.

Climate/Time Zone The month of October is characterized by gradually falling daily high temperatures, with daily highs around 87°F (30°C) throughout the month, at times exceeding 90°F (32°C).

The daily low temperature ranges from 63°F (17°C) to 70°F (21°C).

Orlando is located in the Eastern Time Zone of the USA and Daylight Savings Time will be observed at the time of the meeting.

Exhibit Hall Bring plenty of business cards to share with exhibitors. Top suppliers will be on-hand to share the latest products and services to help you advance your research.

Language The official language of the 20th North American ISSX Meeting is English. All abstracts and presentations will be in English. No simultaneous translation will be available.

Transportation and Car Rental Transportation options to and from the Orlando International Airport include: • Renting a car (fees apply and vary by car rental company) • Taking a taxi (fees apply–estimated at $55* USD/One Way), or •M EARS shuttle transportation (fees apply–estimated cost per adult is $22* USD/One Way or $36* USD/Round Trip). MEARS shuttles are shared riding services with pricing based on per person charges. Visit www.mearstransportation.com for more information. *These prices are estimated and may change.

Register today at www.issx.org/20NA/register

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20th North American ISSX Meeting • October 18-22, 2015

The International Society for the Study of Xenobiotics (ISSX) is the premier international scientific organization for researchers interested in the metabolism, disposition, and transport of xenobiotics and in other related disciplines. Our mission is to promote scientific development and to foster communication among researchers worldwide.

21st North American ISSX Meeting Providence, Rhode Island | September 24 - 28, 2017

11th International ISSX Meeting Busan, Korea | June 12 - 16, 2016

Visit www.issx.org for the latest information about upcoming ISSX meetings:

Orlando, Florida, USA | October 18 - 22, 2015

Visit www.issx.org/20NA/register to secure a seat at the 20th North American ISSX Meeting

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