19th North American ISSX / 29th JSSX Meeting Program

We elcom me to o San Francisco o!

Dearr Colleagues,

behalf of the e Meeting Orrganizing Committee, it is our sincerre pleasure tto welcome you to the 1 19th North On b th Ameerican ISSX and 29 JSSX X Annual Mee eting – a join nt scientific meeting ded dicated to Professor Yuichi Sugiyama.

Our Meeting Orgganizing Com mmittee, alo ong with the symposia chhairs and invvited speakeers, have all worked diligeently to makke this an ou utstanding sccientific mee eting for youu.

This meeting builds on the sscientifically informative and sociallyy rewarding joint meetin ng organized d by JSSX and d ISSX in Maui, Hawaii in 2005 5. This third jjoint meetin ng between oour two sociieties is a wo onderful opp portunity forr researchers to share cuttingg‐edge inform mation in xenobiotic meetabolism an nd transport as well as pharrmacokineticcs and pharm macodynamics togetherr with chronoopharmacology, systems pharmacology, antib body engineering, and b biomarker discovery.

The meeting beggins with sho ort courses o on DDI prediction and reegulatory recommendattions for asseessments, d NMR quanttitation, non n‐CYP metabbolism in dru ug discovery, and miningg public metaabolite biosyynthesis and databases duringg clinical dru ug developm ment. The short courses w will be follow wed by the o opening plenary lectures and a welcome rreception for all attende ees and regisstered guestts. The core of the meetting featuress fourteen scien ntific symposia encompaassing a broaad spectrum m of topics im mportant in tthe field. Ad dditionally, the meeting will ffeature the p presentation n of the ISSX X North Ame erican Scienttific Achievem ment and Neew Investigaator Awards with their accom mpanying lecctures as well as the JSSX X Award andd Young Inveestigator Aw ward and lecttures. A Poster Awards C Competition will be held with the winners to be announced on Wednesday at 5:00 p.m. We hop pe that you will atte end all of the awards sessions to sho ow your suppport and to help celebrate with thee award pients. recip The premier social event of the meetingg is a dinner cruise on thhe yacht “San n Francisco SSpirit” on W Wednesday even ning. Join uss to view the e city lights aand architectture as we ccruise the baay of San Fraancisco. Takee photographs of th he famous Alcatraz Island with its former federaal penitentia ry, the magn nificent Gold den Gate Briidge, the art deco o Coit Towerr, the iconic TTransamericca Building aand much moore while en njoying an op pen bar and dinner bufffet on th he yacht. Ticckets may still be availab ble. Please in nquire at thee meeting reegistration desk.

In yo our free time e, consider e exploring som me of the many sights a nd outstand ding dining aand nightlife for which Sa an Francisco is know wn. We also hope that yyou will rene ew past acquuaintances aand meet new friends while learning g with us at this be eautiful city by the Bay. Enjoy the m meeting!

With h best regard ds,

Tetsuya Terasakki, Ph.D. and d Eric Johnso on, Ph.D. Meeeting Organizzing Committtee Co‐Chaiirs

Meetin ng Dedicattion The 19th North A American ISSX / 29th JSSXX Meeting iss dedicated tto Dr. Yuichii Sugiyama to ackknowledge h his outstandiing scientificc contributio ons to the arrea of xenob biotic disposition, which h are second d to none. D r. Sugiyama was born in n Kochi‐city in 1947, and receivved a Ph.D. ffrom Universsity of Tokyoo, School of Pharmacy in n 1978. He started his acade emic career iin 1974 as a Research Asssociate of tthe Universitty of Tokyo. He was promoted to the rank of Asso ociate Professsor in 1989 and of Proffessor in 199 91. Dr. niversity of TTokyo in 20112 and has continued hiss studies as Sugiyaama retired from the Un head of the Sugiyyama Laboratory at the R RIKEN Innovvation Center.

Dr. SSugiyama is aacknowledged as a world‐leader in tthe fields of physiologically based pharmacokinetics and mem mbrane transsporters. Hiss work on ph hysiologicallyy based pha rmacokinetiics has been pivotal for q quantitative in vittro – in vivo extrapolatio on, especially the develo opment of m models for th he prediction n of drug cleearance and the m magnitude o of inhibitory drug‐drug in nteractions iin humans. FFurther, Dr. Sugiyama’s studies on m membrane transsporters, wh hich encomp pass molecullar cloning, ffunctional annd kinetic ch haracterizatiion, and the impact of geneetic variation n, have been n fundamenttal to our un nderstandingg of the role of transportters in drug disposition.

Dr. SSugiyama’s w work has truly been influ uential in settting the direection of dru ug dispositio on research over the lastt threee decades. H His research is notable fo or its qualityy, rigor, innoovation and p productivityy, and these have all conttributed to itts impact. Drr. Sugiyama’’s passion, enthusiasm aand commitm ment to reseearch and to o the study of xeenobiotic me etabolism an nd dispositio on more generally are reemarkable.

Overrall, Dr. Sugiyyama has prroduced a re emarkable bo ody of scien tific work. H He is the author of 642 o original articcles, 63 revie ew articles, aand 29 book chapters. He was recoggnized by ISI in 2007 as aa top scientisst in the field of “Pharmaacology and TToxicology” for the num mber of citatiions his publications recceived in thee preceding 10 yeears. Dr. Suggiyama has b been the reccipient of maany prestigioous awards, including th he AAPS Awaard in 2003, PSW WC Research Achievemen nt Award in 2 2007, ISSX A Asia Pacific S cientific Ach hievement A Award in 200 08, FIP Host‐ Mad dsen Gold Medal in 2009 9, Medal with Purple Rib bbon given bby Governmeent of Japan in 2010, BB B Brodie Award from ASP PET in 2012, Rawls‐Palme er Progress in Medicine Award from m ASCPT in 2 2014, and thee RT Williams Distinguished Scien ntific Achieve ement Awarrd from ISSXX in 2013. In addition to his scientificc work, Dr. Sugiyyama has he eld leadership positions in several sccientific orgaanizations. In n particular,, he has servved as President of ISSX X and JSSX and has stron ngly promote ed xenobiot ic metabolissm and dispo osition reseaarch worldwide. His m many friendss and colleaggues in ISSX and JSSX exxtend their b best wishes ffor all of his ffuture endeeavors.

dent Kan Chiba, Ph.D.., JSSX Presid

John n Miners, Ph..D., ISSX Pressident

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Schedule Overview Saturday, October 18, 2014 1:00 p.m. – 7:00 p.m.

Meeting Registration Open 4:00 p.m. – 6:00 p.m.

Japanese Society for the Study of Xenobiotics President’s Lecture and Awards Ceremony 6:00 p.m. – 8:00 p.m.

JSSX Reception

Sunday, October 19, 2014 8:00 a.m. – 7:00 p.m.

8:00 a.m. – 5:00 p.m.

8:00 a.m. – 9:00 a.m.

9:00 a.m. – 12:00 p.m.

12:00 p.m. 1:00 p.m.

1:00 p.m. – 4:00 p.m.

4:15 p.m. – 4:45 p.m.

4:45 p.m. – 6:45 p.m.

7:00 p.m. – 9:00 p.m.

Meeting Registration Open Exhibitor Set‐Up Breakfast for Morning Short Course Registrants Short Course 1 and Short Course 2 Lunch for Afternoon Short Course Registrants Short Course 3 and Short Course 4 Opening Session Opening Plenary Lectures Opening Welcome Reception/Meet the Exhibitors

Monday, October 20, 2014 7:30 a.m. – 5:00 p.m.

7:45 a.m. – 8:45 a.m.

9:00 a.m. – 11:30 a.m.

11:30 a.m. – 2:00 p.m.

11:30 a.m. – 12:30 p.m.

12:30 p.m. – 2:00 p.m.

2:00 p.m. – 4:30 p.m.

4:30 p.m. – 6:00 p.m.

6:00 p.m. – 8:00 p.m.

7:00 p.m. – 9:00 p.m.

Meeting Registration Open Industry‐Sponsored Symposia Concurrent Symposia 1 and 2 Meet with Exhibitors / Lunch on Own

Finalist Authors of Posters A1 through A6 Attend and Present Posters Authors of Posters P1 through P104 Attend and Present Posters Concurrent Symposia 3 and 4 Authors of Posters P105 through P215 Attend and Present Posters New Investigator’s Reception JSSX and ISSX Presidents’ Reception (by invitation)

Tuesday, October 21, 2014 7:30 a.m. – 5:00 p.m.

7:45 a.m. – 8:45 a.m.

9:00 a.m. – 11:30 a.m.

11:30 a.m. – 2:00 p.m.

11:30 a.m. – 12:30 p.m.

12:30 p.m. – 2:00 p.m.

2:00 p.m. – 3:00 p.m.

3:00 p.m. – 5:30 p.m.

5:30 p.m. – 7:00 p.m.

Meeting Registration Open Industry‐Sponsored Symposia Concurrent Symposia 5 and 6 Meet with Exhibitors / Lunch on Own Finalist Authors of Posters A7 through A12 Attend and Present Posters Authors of Posters P216 through P318 Attend and Present Posters ISSX Awards Session Concurrent Symposia 7 and 8 Authors of Posters P319 through P429 Attend and Present Posters

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Schedule Overview Wednesday, October 22, 2014 7:30 a.m. – 5:00 p.m.

7:45 a.m. – 8:45 a.m.

9:00 a.m. – 11:30 a.m.

11:30 a.m. – 2:00 p.m.

12:30 p.m. – 2:00 p.m.

2:00 p.m. – 4:00 p.m.

4:00 p.m. – 5:00 p.m.

5:00 p.m. – 5:15 p.m.

6:00 p.m. – 10:00 p.m.

Meeting Registration Open Industry‐Sponsored Symposia Concurrent Symposia 9 and 10 Meet with Exhibitors / Lunch on Own Authors of Posters P430 through P543 Attend and Present Posters JSSX Awards Session Poster Awards Competition Finalists Short Oral Presentations Presentation of Poster Awards Competition Awards Dinner Cruise on San Francisco Bay

Thursday, October 23, 2014 7:30 a.m. – 3:30 p.m.

7:45 a.m. – 8:45 a.m.

9:00 a.m. – 11:30 a.m.

11:30 a.m. – 12:30 p.m.

12:30 p.m. – 3:00 p.m.

3:00 p.m. – 3:30 p.m.

Meeting Registration Open Industry‐Sponsored Symposia Concurrent Symposia 11 and 12 Lunch on Own Concurrent Symposia 13 and 14 Closing Session / Meeting Adjourns

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Meeting Organizing Committee Meeting Organizing Committee Chairs:  

Tetsuya Terasaki, PhD, Tohoku University Eric Johnson, PhD, The Scripps Research Institute

Meeting Organizing Committee:              

Kan Chiba, PhD, Chiba University Frank Gonzalez, PhD, National Cancer Institute Natalie Hosea, PhD, Pfizer Inc. Takashi Izumi, PhD, Daiichi Sankyo Co., Ltd. R. Scott Obach, PhD, Pfizer Inc. Paul Ortiz de Montellano, PhD, University of California, San Francisco Bill Smith, PhD, Gilead Sciences Hiroshi Suzuki, PhD, The University of Tokyo Hospital Peter W. Swaan, PhD, University of Maryland Mikihisa Takano, PhD, Hiroshima University Ikumi Tamai, PhD, Kanazawa University Toshio Teramura, PhD, Astellas Pharma, Inc. Hiroshi Yamazaki, PhD, Showa Pharmaceutical University Xiao‐bo Zhong, PhD, University of Connecticut School of Pharmacy

Poster Awards Competition Committee          

Kan Chiba, PhD, Chiba University Maria Almira Correia, PhD, University of California, San Francisco Natalie Hosea, PhD, Pfizer Inc. Takashi Izumi, PhD, Daiichi Sankyo Co., Ltd. R. Scott Obach, PhD, Pfizer Inc. Paul Ortiz de Montellano, PhD, University of California, San Francisco Peter W. Swaan, PhD, University of Maryland Ikumi Tamai, PhD, Kanazawa University Hiroshi Yamazaki, PhD, Showa Pharmaceutical University Xiao‐bo Zhong, PhD, University of Connecticut School of Pharmacy

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JSSX Council President

Toshiyuki Kume Mitsubishi Tanabe Pharma Corporation

Kan Chiba Graduate School of Pharmaceutical Sciences Chiba University

Yoshiro Saito National Institute of Health Sciences

President‐Elect

Mikihisa Takano Department of Pharmaceutics and Therapeutics Graduate School of Biomedical & Health Sciences, Hiroshima University

Shigeru Ohmori Shinshu University Hospital

Directors

Tetsuya Terasaki Division of Membrane Transport and Drug Targeting Graduate School of Pharmaceutical Sciences, Tohoku University

Ichiro Ieiri Department of Clinical Pharmacokinetics Graduate School of Pharmaceutical Sciences Kyushu University

Toshio Teramura Astellas Pharma, Inc.

Takashi Izumi Daiichi Sankyo Co., Ltd

Eiichi Fuse Kyowa Hakko Kirin Co., Ltd

Shogo Ozawa Pharmacodynamics and Molecular Genetics School of Pharmacy, Iwate Medical University

Toshiya Moriwaki Takeda Pharmaceutical Co., Ltd

Eiji Kashiyama Otsuka Pharmaceutical Co., Ltd.

Hiroshi Yamazaki Showa Pharmaceutical University

Yukio Kato Faculty of Pharmacy Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University

Tsuyoshi Yokoi Department of Drug Safety Sciences Nagoya University Graduate School of Medicine

Hiroyuki Kusuhara Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo

Yasuo Ohno National Institute of Health Sciences

JSSX Auditors

Takahiko Baba Shionogi & Co., Ltd.

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ISSX Council President

Lawrence Marnett Vanderbilt University School of Medicine Nashville, Tennessee, USA

John Miners Department of Clinical Pharmacology Flinders University School of Medicine Adelaide, Australia

Paul Ortiz de Montellano University of California ‐ San Francisco San Francisco, California, USA

President‐Elect/Secretary

Hiroshi Yamazaki Showa Pharmaceutical University Machida, Tokyo, Japan

Geoff Tucker Simcyp Ltd Sheffield, England, UK

Allan Rettie University of Washington Department of Medicinal Chemistry Seattle, Washington, United States

Treasurer Andrew Parkinson XPD Consulting Shawnee, Kansas, USA

ISSX Staff

Treasurer‐Elect

Steven Kemp, CAE Executive Director

James Halpert University of California San Diego La Jolla, California, USA

Zoë Fuller Sr. Coordinator

Members of Council

Sarah Langan Coordinator

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

Diana DiAntonio Sr. Associate Ashley Pencak Meeting Manager

Maria Almira Correia University of California San Francisco, California, USA

David Merli Exhibits and Sponsorship Sales Manager

Ann Daly Newcastle University Institute of Cellular Medicine Newcastle Upon Tyne, UK

Brittany Jackson Exhibits Coordinator Sarah Alcock Accountant

Richard Kim University of Western Ontario Department of Medicine London, Ontario, Canada

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Up pcom ming JJSSX M Meetiings 29tth Worksh hop of JSS SX Mayy 14 ‐15, 2015 Hitottsubashi Halll, Gakujutsu u Sogo Cente er, Tokyo, Japan Meeeting Chair: Eiji Kajiyamaa, Ph.D.

9th h Short Co ourse of JS SSX Mayy 14, 2015 Hitottsubashi Halll, Gakujutsu u Sogo Cente er, Tokyo, Japan Meeeting Chair: M Masashi Yabuki, Ph.D.

30tth JSSX An nnual Mee eting Nov..12 ‐ 14, 201 15 Tower Hall Funabori, Tokyo,, Japan Meeeting Chair: TTsuyoshi Yokkoi, Ph.D.

31sst JSSX An nnual Mee eting Oct.1 18 ‐ 20, 2016 6 Tower Hall Funabori, Tokyo,, Japan Meeeting Chair: SShigeru Ohm mori, Ph.D.

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Upcom U ming g ISSX X Mee etingss 13tth Europe ean Meeting Junee 22 ‐ 25, 201 15 The University o of Strathclyde e Glasggow, Scotlan nd, UK Meeeting Chairs: Roland Wolf, Ph.D. & A Ann Daly, Ph.D.

20tth North A American Meeting Octo ober 18 ‐ 22, 2015 Hilto on Orlando B Bonnet Creek Orlando, Florida, USA Meeeting Chairs: Hartmut De erendorf, Ph h.D. & Stephan Schmidt, Ph.D.

11tth Interna ational ISS SX Meetin ng Junee 12 ‐ 16, 201 16 Busaan Exhibition n and Convention Center Busaan, Korea Meeeting Chair: JJae‐Gook Sh hin, Ph.D.

21stt North Am merican M Meeting Septtember 24 ‐ 28, 2017 Rhod de Island Convention Ce enter Provvidence, Rho ode Island Meeeting Chair: JJashvant Unadkat, Ph.D.

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JS SSX Aw wards The e Japanese Society for the Sttudy of Xe enobioticcs Award 2014 The Japaanese Society for the Stu udy of Xenobbiotics (JSSXX) Award is presented to a JSSX memberr who has made substan ntial and sem minal scientiffic contributtions to the ffield of drug metabolism and phaarmacokinettics. The foccus of this aw ward is the in ndividual's sscientific ntended to recognize thee best in thee field. The 2 2014 recipieent is accomplishments, in or Hiroshi Yamazaki, Ph.D D., Laboratoory of Drug M Metabolism aand Pharmaacokinetics, Professo Showa P Pharmaceutical Universitty, Tokyo, Jaapan.

Hiroshi YYamazaki has served as P Professor off Laboratory of Drug Metabolism and Pharrmacokineticcs, Showa Pharmaceuticcal Universitty, Tokyo, Ja pan since 20005. After rreceiving hiss BS and MS degrrees from Gifu Pharmace eutical Unive ersity and hiis PhD in Phaarmaceuticaal Sciences frrom Osaka U University in Japan, he trained d as a post‐d doctoral fello ow at Vande erbilt Univerrsity School o of Medicine, Nashville, TTN, USA in 1994 4. He was re ecruited as aan Associate Professor att Kanazawa University from Osaka P Prefectural Institute of Public Health in 1998 and m moved to a po ost as Associate Professoor of Hokkaiido University Graduatee School of Pharrmaceutical Sciences in 2 2001.

Profeessor Yamazzaki’s research has focussed on polym morphic cytoochrome P4550 and flavin n‐containingg mon nooxygenase e, which are major catalyysts involved d in drug meetabolism in toxicology aand pharmaccology in hum mans. He hass authored o over 280 pub blications and is recognizzed as a ‘Higghly Cited Reesearcher’ in n Pharrmacology by Thomson Reuters. Pro ofessor Yamazaki has beeen the recip pient of young scientist awards from m the P Pharmaceutical Society o of Japan (20 000) and the Japanese Soociety for th he Study of X Xenobiotics ((JSSX, 2005),, and in 2008 he w was named aa JSSX Fellow w.

Profeessor Yamazzaki has been actively involved in professional oorganizationss for several decades: Bo oard Mem mber of JSSX X (2000 ‐ pressent), Associate Editor (Drug Metabbolism and PPharmacokin netics (DMPK K), 2006‐ 2009 9), Editor‐in‐‐Chief of DM MPK Newslettter (2006 ‐ 2 2009), Counccil member ((2010 ‐ 2017 7), and Edito or‐in‐Chief off DMP PK (2014 ‐ 20 017). He serrved as a Councilor of ISSX from 20111 – 2014. PProfessor Yam mazaki also serves as an n Edito orial Advisorry Board member for Bio ochemical Ph harmacologyy, British Jouurnal of Cliniical Pharmacology, and Chem mical Researrch in Toxico ology. Professsor Yamazaaki was a meember of thee Local Organ nizing Comm mittee for the 1 13th North A American ISSSX/20th JSSX X Meeting in n Maui, Hawaaii, USA in 2005 and is o on the Meetiing Orgaanizing Comm mittee for 19 9th North American ISSX X/29th JSSX Meeting.

d celebrate P Professor Yaamazaki’s sciientific cont ributions to the field of xenobiotic m metabolism To reecognize and span nning three d decades, he is honored w with the JSSX X Award in 22014. He wiill present hiis talk entitleed “Metabolic Activvation and Fate of Xenob biotics Determined by PPolymorphic Drug‐metab bolizing Enzyymes”.

The JSSX X Awards Sesssion is scheeduled for W Wednesday, October 22 ffrom 2:00 p.m. to 4:00 p.m m. in the Con tinental Balllroom

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JSS SX Aw wardss The e JSSX Aw ward for Young Scie entists The JJSSX Award ffor Young Sccientists is presented to JSSX membeers who havve made sign nificant contrributions to the ffield during ttheir early ca areer years.

The 2014 recipie ents of this a award are D Dr. Hiroshi W Watanabe, Kumamoto U University an nd Dr. Satom mi Onoue, an.

Univversity of Shizuoka, Japa

Dr. Hiroshi W Watanabe obtained his b bachelor’s ddegree in Phaarmaceuticaal Sciences frrom Kumamoto University in n 1996 and ccontinued too pursue his MSc and PhD degrees u under the supervision of Professorr Masaki Otaagiri at the B Biopharmaceeutics Laboraatory, investtigating the drug bindingg sites on hu uman albumin using sitee‐directed mutagenesis aand spectrosscopic techniques. t After obtain ning his PhD degree in 2 001, he joined Kumamo oto Universitty Hospital as a hospital pharmacistt, and was appointed as Assistant Prrofessor of tthe Hospital Pharmacy Depaartment heaaded by Proff. Hideyuki Saito in 2005. He was ressearching on n personalizeed medicine and mem mbrane transsport of chemotherapeu utic agents. IIn 2006, Dr. Watanabe joined the Deepartment o of Clinical Pharrmaceutical Sciences heaaded by Professor Toru Maruyama, Kumamoto University. In 2007 ‐ 20 008, he was a a postdoctoral visiting scientisst researchin ng on cholessterol traffickking at Prof. Ta Yuan Chang’s Laboraatory, Depaartment of B Biochemistryy, Dartmouth h Medical Scchool, USA. IIn 2011, he w was promotted to the cu urrent Asso ociate Professsor position n of Biopharm maceutics Laaboratory. D Dr. Watanabe’s current m main researcch focus is chro onic kidney d disease, with h special inte erests on mo olecular mecchanism of o oxidative streess‐induced tissue damage, biomarrkers identifiication and n novel therap peutics deveelopment. Hee has publish hed more th han 70 original research h papers and d was awarded “The PSJ Kyushu Bra nch Award ffor Young Sccientists” in 2 2012.

Dr. Satomi Onoue is currently a Full Professor iin the Deparrtment of Ph harmacokineetics and Pharmacod dynamics, Scchool of Pharrmaceutical Sciences, University of Shizuoka, Jaapan. He received his BS and MSS from the O Okayama Uniiversity (Japaan), and PhD D from the U University of Shizuoka (Japan). He w was in charge e of pharmacceutical reseearch and deevelopment at Pfizer Global Rese earch and De evelopmentt with intern ational projeect team ressponsibility. His recent studies havve focused on (1) nano‐D DDS for pharrmacokineticc control of BCS class II//IV drugs; (2)) powder inhaalation system to de‐riskk new drug candidates; aand (3) prediction tools for phototoxxic potential dry p of drrugs, that waas successfully adopted by ICH (ICH S10 guidelinne “Photosaffety Evaluation of Pharrmaceuticalss”). In 2007, Dr. Onoue rreceived the Pfizer Globaal Research & Developm ment Excellence Award; in 20 011, the Pharmaceutical Society of Japan (PSJ) in n Tokai Brannch Award fo or Young Scientists; in 20 012, the Acad demy of Pharmaceutical Science and d Technologyy, Japan (APPSTJ) Award for Young Sccientists; in 2012, the Japanese Peptide Society (JP PS) Award fo or Young Scie entists; and in 2013, he was awardeed the Japan nese Society of To oxicology (JSSOT) Science e and Techno ology Prize. H He has publiished 118 peeer‐reviewed papers in ttop rated scien ntific journals, and he re eceived 26 paatents on ne ew drug can didates, DDSS, and reseaarch tools.

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JS SSX Aw wards The e JSSX Aw ward for Young Indu ustrial Sccientists The JJSSX Award ffor Young In ndustrial Scieentist is pressented to JSSSX members who have m made significcant conttributions to the field durring their ea arly career yeears as an inndustrial scieentist.

The 2014 recipie ents of this aaward are Sh hintaro Nakaayama, Daiicchi Sankyo Co., Ltd., Hiro oshi Kodaira,, Kyowa Hakkko n Co., Ltd. an nd Takafumi Akabane, Asstellas Pharm ma Inc. Kirin

Shintaro Nakayama, Ph..D. is an Asso ociate Senioor Researcheer in the Drug Metabolism and Pharmacokinetics Reseaarch Laborattories in the R&D divisio on of Daiichi Sankyo Co, Ltd. Dr. earned his B.S. and Ph.D. in Pharmacceutical Scieence at Chibaa University. After Nakayama e graduation, he Joined Saankyo Co., Ltd. in 2001 w where he plaanned and m monitored cllinical ogy studies in n their drug developmennt departmeent. He then moved to th he DMPK pharmacolo Reseearch Laboraatory in 2003 3 where he h has continue ed to perform m a range off DMPK activvities around d drug metaabolism, phaarmacokinettics and mod deling & simulation. In hhis current ro ole, he is rep presenting D DMPK on vario ous drug disccovery team ms and is resp ponsible for providing P K/PD support for translaational reseaarch from precclinical to clin nical. His ressearch interests include drug metabbolism, reacttive metabolites, drug in nduced liver injurry, and idiosyyncratic drug toxicity. In n addition, he currently ffocuses on ssystems pharmacology aand systems toxiccology. Dr. N Nakayama is the recipien nt of the JSSX X Best Posteer Award (20013).

Hiroshi Koda H aira is curren ntly a researcch scientist iin the research and dep partment divvision at Kyowa Hakko K o Kirin Co., LLtd. He has b been supporrting projectt teams for d disorders of nephrology, oncology, im o mmunology aand allergy, aand CNS on PK in the preclinical and d clinical devvelopment. H He earned his B e .S. degree frrom the Osaka Universitty and his Ph h.D. degree ffrom the Un niversity of Tokyo in pha T armaceutical sciences. H He started his career in tthe pharmacceutical indu ustry in 1999 9 by jo oining the re esearch laboratory of Kyo owa Hakko K Kogyo, Co., LLtd., which w was merged with Kirin P Pharma Co., Ltd. in 2008. He e has experie ence as an ADME/PK scie entist on varrious drug discovery pro ograms including CNS drug disco overy. From 2007 to 201 11, he has co onducted cooperative reesearch with h the Universsity of Tokyo o (Prof.

Sugiyyama’s Lab.)) on develop pment of me ethodology tto predict th e drug concentrations in n the brain interstitial spacce at the drug discovery stage of CNSS drugs. At p present, his rresearch interests includ de the studyy of drug transsporters in d drug absorpttion, disposition, and elimination at the preclinical and clinical stages in n drug deveelopment.

Takafumi Akaabane earned his Ph.D. in Pharmaceeutical Sciencces at Chiba University aand received d his undergrad duate degree in Pharmaceutical Scieences at Meiji Pharmaceeutical Univeersity. Dr. Akabane beg A an his professional career at Astellaas Pharma In nc. (Formerlyy, Yamanoucchi Pharmaceuticcal Co., Ltd.)) in 2002, and he had beeen responsible for geneeration, interrpretation and re ecording of A ADME data ffor projects and developpment of strrategies for A ADME assessment of Ne ew Chem mical Entitie es in Analysiss & Pharmaccokinetics Re esearch Labss. Dr. Akaban ne had also been engageed in researcch activvities such ass species diffferences in iintestinal me etabolism beetween hum mans and mo onkeys and eevaluation systeems for alde ehyde oxidasse (AO) metaabolism in humans. In 20009, Dr. Akaabane transferred deparrtments to jo oin Astellas Research Institute o of America LLC where he e had develooped novel aapproach to hepatic cleaarance diction for AO O‐cleared co ompounds using pooled cryopreservved hepatoccytes for two o years. After returning tto pred Japan, Dr. Akabaane had expaanded his exxpertise in PKPD modeli ng and simu ulation and p played important role in 013, Dr. Akaabane had taaken an assisstant directo or position aat OSI transslational ressearch for prrojects. In 20 Pharrmaceuticalss, Inc. and m managed junior scientistss within the ddepartmentt. More recently, Dr. Akaabane has been n on loan to Institute forr Health Economics and Policy, a nonn‐profit orgaanization ap pproved by the Ministry of Heallth, Labour aand Welfare,, where he h has been involved in inveestigative reesearch on H Health Econo omics.

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ISS SX Aw wardss Norrth Ameriican Scien ntific Achiievementt Award in n Honor o of Ron nald W. Esstabrook,, Sponsorred by Xen noTech The North h American SScientific Achievement A Award in Honor of Ronald W. Estabrrook, Sponsored d by XenoTe ech, is presented to an ISSSX memberr who has m made major sscientific contributiions to the ffield within tthe North Am merica regio on. The purpose of this aaward is to recognize e meritoriouss contributio ons by senio r or mid‐carreer scientistts that have had a majorr impact on n research in n the field. TThe 2014 re cipient is Th homas A. Baiillie, Ph.D.,D.Sc. of the Universityy of Washinggton.

Dr. B Baillie has made major contributionss to our understanding oof the metab bolism of xeno‐ and end dobiotics and d is intternationallyy recognized d for seminal contributio ons in this fieeld. Dr. Bailllie’s early co ontributions include studies of the fo ormation of rreactive mettabolites of xxenobiotics and drugs su uch as phencyclidine, allyliisopropylace etamide, valproic acid, N N‐methylform mamide, andd acetamino ophen. His in nvestigation of the desaaturation of vvalproic acid d provides an example o of his elegantt use of isotope effects and mass sp pectrometry to ch haracterize aa novel, mecchanistically important function of c ytochrome p‐450 enzym mes. His stu udies of the bioactivation of acetaminop phen and its involvement in protein alkylation caame at an eaarly stage an nd helped to o establish what h has become tthe paradigm m for the rellationship beetween drugg activation, glutathionee depletion, on, and toxicity. Dr. Bailliie has played d a major roole in elucidaation of the mechanism of the protein alkylatio coen nzyme A‐dep pendent mettabolic chiraal inversion o observed witth agents su uch as ibupro ofen. This reecord of creative drug me etabolism re esearch has rresulted in m more than 2000 original rresearch pap pers in addition to manyy revieews and boo ok chapters.

Dr. B Baillie is Proffessor of Me edicinal Chem mistry and D Dean of the SSchool of Ph harmacy at th he Universitty of Washington in Seattle, Wash hington. He trained in Scotland annd Sweden and began his academic career at University off London. In n 1978, Dr. B Baillie took u up a researchh appointmeent at the Un niversity of C California the U Berkkeley, and latter joined th he faculty at the Universsity of Califorrnia at San FFrancisco. H He next spent fourteen yearrs at the Univversity of Washington Scchool of Phaarmacy before joining M Merck as head of their glo obal drug metaabolism dep partment. In n 2008, Dr. Baillie returned to the Unniversity of W Washington as Dean of tthe School of Ph harmacy.

To reecognize and d celebrate D Dr. Baillie’s ssubstantial ccontributionns to the field d of xenobio otic disposition including g his service on the leadership p of ISSX and d other scien ntific societiees, we proud dly award him the 2014 North Ameerican Scienttific Achievem ment Award d in Honor off Ronald W. Estabrook.

Aw ward Presenttation and Leecture: Tuessday, Octobeer 21, 2014 || 2:00 p.m. –– 3:00 p.m. | Continenta al Ballroom

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IS SSX Aw ward ds Norrth Ameriican New Investiga ator Awarrd in Honor of Jam mes R. Gille ette The 2014 North Amerrican New In nvestigator A Award in Hon nor of Jamess R. Gillette is presented d to an ISSX X member who has made e significant contributions to the fieeld during their early career yeaars. The purrpose of thiss award is to encourage and recognize a develop ping scientist w who is active e in the field in North Am merica.

Dr. Isoherrranen has established a solid researrch program m that is focu used primarily on the interaction of xenobio otics with (le ess well know wn) enzymee systems succh as CYP26 and ALDH H1A2 that m modulate retinoic acid ho omeostasis aand thereby influence a variety of pharmacologgical proccesses. This w work has inccluded studie es on potenttial agents foor male conttraception, d drug candidaates for the treattment of Alzzheimer’s dissease, and aspects of drug dispositioon during prregnancy, all of which arre influenced by CYYP26 and/or ALDH1A2 sttatus. Dr. Iso oherranen a lso has deveeloped an intterest in thee role of inhib bitory drug m metabolites as mediatorrs of complex, clinically rrelevant dru ug‐drug interractions, succh as those caussed by the sttereoselectivve inhibition of CYPs 2C1 19 and 3A4 bby fluoxetinee and norfluoxetine. Dr. Isoheerranen ’s productivity iin each of th hese areas is reflected byy her impresssive list of p publications in the peer‐‐ revieewed literature, which n now numberrs almost 70 full papers, and by her success in atttracting fed deral research supporrt as Principaal Investigato or on NIH grrants.

Dr. Issoherranen earned a Ph h.D. in pharm maceutical scciences at thhe Hebrew U University off Jerusalem, Israel and completed postd doctoral traiining at the U University of Washingtoon School of Pharmacy in n the Departtment of Pharrmaceutical Sciences. Sh he was prom moted to faculty in 2006 and achieveed the positiion of Associate Profeessor with te enure in 201 12. During this time, Dr.. Isoherrane n has becom me recognizeed in the fiellds of drug metaabolism and pharmacokkinetics throu ugh the estaablishment oof a diverse aand producttive research h proggram. The ovverall theme e of Dr. Isohe erranen’s re esearch has bbeen the application of in‐vitro enzyymology and d enzyyme kinetics knowledge to clinical ph harmacokine etics problem ms.

In reecognition off her original and significcant scientiffic contributiions as well as future strrong potential in the field of foreign ccompound m metabolism aand dispositiion, ISSX prooudly bestow ws the 2014 North Amerrican New Investigator Awaard in Honorr of James R. Gillette on Nina Isoherrranen.

Aw ward Presenttation and Leecture: Tuessday, Octobeer 21, 2014 || 2:00 p.m. –– 3:00 p.m. | Continenta al Ballroom 13th EEUROPEAN ISSX MEETIN NG AWARDSS www.issx.org//awards/nominations Th he 2015 European Scientiffic Achievem ment Award aand the 20155 European N New Investigaator Award, iin Honor of Karll J. Netter, will be presented at the 13 3th European ISSX Meetinng in June 20115 in Glasgow w, Scotland. The awards will include travel suppo ort to the meeting. Nomi nate a deserrving membeer today!

The ssubmission d deadline is Appril 10, 20155.

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G Generral In nform mation n Mee eting Ven nue Hilto on San Franccisco Union SSquare Hote el 333 O’Farrell Strreet San Francisco, California 941 102 USA Telephone: + 1 4 415 771‐140 00

Asb btracts Meeeting abstraccts are availaable for revie ew in the abstract book prrovided to atttendees at check‐in and on the meetting app. All abstracts accepted for this meeting will be publishe ed in a special suppleme ent edition oof Drug Metaabolism Reviiews.

Exh hibitor Ch heck‐Off C Card Each h meeting attendee rece eived an Exhibitor Checkk‐Off Card in their meeting materialss. Please vissit our exhibitors and ask for a reprresentative tto initial their booth spaace on the caard. Attendeees who visit with exhibitors and obtain a minimum of 20 vvalid exhibitting companny representaatives to inittial their corrresponding bootth spaces will be entered d into a draw wing for prizzes on Wednnesday, Octo ober 22 at 1:30 p.m. in th he Exhibit Hall.

Info ormation for Invite ed Speake ers An audio‐visual ttechnician w will be available to assistt speakers w with loading ttheir presentations. Speeakers should d bringg their prese entations on a USB flash drive to the eir assigned meeting roo om no less th han 30 minu utes prior to the b beginning off the session n.

ISSX X Awardss Session The ISSX Awardss Session is sscheduled fo or Tuesday, O October 21 ffrom 2:00 p.m. to 3:00 p p.m. in the C Continental Ballrroom. The So ociety’s high hest awards presented in n the North American Reegion will bee bestowed to the award d winn ners who willl then delive er their awards lectures. We greatlyy appreciatee all meetingg attendees tto be presen nt at th his important session and to show th heir support of this yearr’s celebrated awardees..

JSSX X Awardss Session The JJSSX Awardss Session is sscheduled fo or Wednesdaay, October 22 from 2:000 p.m. to 4:0 00 p.m. in th he Imperial Ballrroom. The Jaapanese Society for the SStudy of Xen nobiotics Aw ward lecture,, the JSSX Aw ward for You ung Scientistts lectu ure, and the JSSX Award for Young In ndustrial Scientists lectuure will be deelivered. Ap pplaud this yyear’s hono orees by atte ending this ssignificant re ecognition event.

Nam me Badge es and Eve ent Ticketts Nam me badges arre required ffor admission to the mee eting sessionns, the Exhib bit Hall, and social functions. Badgess help facilitate ne etworking an nd communiication with your fellow attendees. If you lose yyour name badge you may eck‐in station ns or you maay ask the m meeting regisstrar for assistance. printt another at the self‐che Adm mission to the e Opening W Welcome Recception is inccluded in th e full‐meetin ng registration fee. Atteendees will need d their name e badges in o order to be aadmitted to this receptioon. Each reggistrant and paid guest w will receive two beverage ticckets upon e entering the reception fo or complimeentary beverrages duringg the Openin ng Welcome Receeption. Unre egistered guests or single day registrants may p urchase an aadmission ticket for $50 0 for the reception at the meeting reggistration de esk.

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General Information Opening Welcome Reception Fully‐registered attendees and registered guests are invited to attend the Opening welcome Reception on Sunday, October 19 from 7:00 p.m. to 9:00 p.m. in the Exhibit Hall (Grand Ballroom A/B). Our exhibitors will be on‐hand to meet you and share information about their latest products and services. Hors d’oeuvres will be offered and each attendee will receive two beverage tickets. Name badges are required for entrance.

Premier Social Event – Dinner Cruise on San Francisco Bay Tickets may still be available for this scenic and enjoyable cruise on the yacht San Francisco Spirit on Wednesday, October 22.

Enjoy a delicious buffet and open bar as you view the city lights and architecture of San Francisco. Attendees will see the infamous Alcatraz Island with its former federal penitentiary, the magnificent Golden Gate Bridge, the art deco Coit Tower, the iconic Transamerica Building and more while relaxing with friends and making new acquaintances. The yacht features three decks with heated indoor and outdoor areas, two marble dance floors, three bars, and plenty of windows to afford attendees with spectacular views. Motor coaches will depart the Taylor Street exit of the hotel beginning promptly at 6:15 p.m. to transport guests to Pier 3. Tickets will be collected at the entrance of the yacht. The event will last three hours and motor coaches will return guests back to the Hilton Hotel.

Poster Awards Competition and Short Oral Presentations of Finalists The awards for best predoctoral and postdoctoral poster presentations will be held on Wednesday, October 22 at 5:00 p.m. in the Continental Ballroom. Meeting attendees may view the 12 finalist poster presentations which will be located in the foyer area of the Continental Ballroom throughout the meeting.

While not a part of the competition, poster awards finalists have been invited to deliver short oral presentations. This special session will be held immediately prior to the awards session from 4:00 p.m. to 5:00 p.m. Predoctoral poster awards competition finalists will be in the Continental Ballroom. Postdoctoral poster awards competition finalists will be in the Imperial Ballroom.

New Investigator’s Reception All graduate and postgraduate students as well as postdoctoral scientists still in training who are fully registered for this meeting are cordially invited to attend a special networking reception on Monday, October 20 from 6:00 p.m. to 8:00 p.m. in the Vista Lounge. Attendees will receive one drink ticket and may purchase additional drinks with cash. A light buffet will be provided. Make sure to attend this event to make new friends and learn about each other’s research interests.

Meeting Registration Hours

Exhibit Hall Hours

Saturday, October 18 | 1:00 p.m. – 7:00 p.m.

Sunday, October 19 | 7:00 p.m. – 9:00 p.m.

Sunday, October 19 | 8:00 a.m. – 7:00 p.m.

Monday, October 20 | 11:30 a.m. – 6:00 p.m.

Monday, October 20 | 7:30 a.m. – 5:00 p.m.

Tuesday, October 21 | 11:30 a.m. – 4:30 p.m.

Tuesday, October 21 | 7:30 a.m. – 5:00 p.m.

Wednesday, October 22 | 11:30 a.m. – 2:00 p.m.

Wednesday, October 22 | 7:30 a.m. – 5:00 p.m.

Thursday, October 23 | 7:30 a.m. – 3:30 p.m.

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Meetting S Space e Map p Â

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Scientific Program Saturday, October 18, 2014

9:00 a.m. – 12:00 p.m. | Yosemite Ballroom Short Course II: Metabolite Biosynthesis and Quantitation by NMR Spectroscopy Co‐Chairs: R. Scott Obach, Pfizer Global Research and Development, Groton, CT, USA and Swapan Chowdhury, Takeda Pharmaceutical Co., International, Cambridge, MA, USA

1:00 p.m. – 6:30 p.m. | West Lounge Meeting Registration Open 4:00 p.m. – 4:30 p.m. | Imperial Ballroom JSSX Council Meeting 4:30 p.m. – 5:45 p.m. | Imperial Ballroom JSSX General Session and Awards Session

9:00 – 9:35 | SC2.1 | PART 1: AN INTRODUCTION TO MIST CONCEPTS AND THE IMPORTANCE OF DRUG METABOLITES Swapan Chowdhury, Takeda Pharmaceutical Company, International, Cambridge, MA, USA

6:00 p.m. – 8:00 p.m. | CityScape Room, 46th Floor JSSX Reception

9:35 – 10:10 | SC2.2 | PART 2: BIOSYNTHESIS OF METABOLITES USING MAMMALIAN IN VITRO SYSTEMS AND TECHNICAL TRICKS IN ISOLATION R. Scott Obach, Pfizer Inc., Groton, CT, USA

Sunday, October 19, 2014 8:00 a.m. – 7:00 p.m. | West Lounge Meeting Registration Open

10:10 – 10:45 | SC2.3 | PART 3: USE OF MICROBIAL SYSTEMS TO BIOSYNTHESIZE METABOLITES Jonathan Steele, Hypha Discovery Ltd., Middlesex, UK

8:00 a.m. – 9:00 a.m. | Imperial and Yosemite Breakfast for Morning Short Course Registrants

10:45 – 11:20 | SC2.4 | PART 4: AN INTRODUCTION TO NMR SPECTROSCOPY AS APPLIED TO DRUG METABOLITES Gregory Walker, Pfizer, Groton, CT, USA

9:00 a.m. – 12:00 p.m. | Imperial Ballroom Short Course I: Prediction of Drug‐drug Interactions and Regulatory Recommendations for Assessment Co‐Chairs: Shiew‐Mei Huang, Food and Drug Administration (FDA), Silver Spring, MD, USA and Takashi Izumi, Daiichi‐Sankyo Co. Ltd., Tokyo, Japan

11:20 – 12:00 | SC2.5 | PART 5: QUANTITATIVE NMR SPECTROSCOPY – PRINCIPLES AND PRACTICE Gregory Walker, Pfizer Inc., Groton, CT, USA

12:00 p.m. – 1:00 p.m. | Imperial and Yosemite Lunch for Afternoon Short Course Registrants 1:00 p.m. – 4:00 p.m. | Imperial Ballroom Short Course III: Non‐CYP Metabolism in Drug Discovery Co‐Chairs: Jeff Jones, Washington State University, Pullman, WA, USA and Teruko Imai, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan

9:00 – 9:40 | SC1.1 | SYSTEMATIC CLASSIFICATION OF DRUGS INVOLVED IN DRUG‐DRUG INTERACTIONS TO SEAMLESSLY AVOID SERIOUS EVENTS Akihiro Hisaka, Chiba University, Chiba, Japan 9:40 – 10:20 | SC1.2 | UTILITY AND IMPACT OF PHYSIOLOGICALLY‐BASED PHARMACOKINETIC MODELING TO PREDICT AND INTERPRET DRUG‐DRUG INTERACTIONS: CASES OF ASTELLAS PHARMA INC. Tsuyoshi Minematsu, Astellas Pharma Inc., Osaka, Japan

1:00 – 1:45 | SC3.1 | NEW STRATEGY TO IDENTIFY UNKNOWN DRUG‐METABOLIZING ENZYMES BY PROTEOMICS Kazuishi Kubota, Daiichi Sankyo RD Novare Co., Ltd., Tokyo, Japan

10:20 – 11:00 | SC1.3 | CLINICAL IMPACT OF DURG‐DRUG INTERACTIONS: CONSIDERATION OF ETHNIC AND OTHER PATIENT FACTORS Shiew‐Mei Huang, Food and Drug Administration (FDA), Silver Spring, MD, USA

1:45 – 2:30 | SC3.2 | INVESTIGATION OF DRUG METABOLISM

BY NON‐CYTOCHROME P450 ENZYMES (11Β‐ HYDROXYSTEROID DEHYDROGENASE/UGT2B15) AND ITS CLINICAL RELEVANCE Mitsuhiro Nishihara, Takeda Pharmaceutical Company Ltd., Fujisawa, Japan

11:00 – 11:40 | SC1.4 | COMPARISON OF THE EMA, FDA AND PMDA DRUG INTERACTION GUIDANCES Eva Gil Berglund, Medical Products Agency, Uppsala, Sweden 11:40 – 12:00 | PANEL DISCUSSION

2:30 – 3:15 | SC3.3 | DETERMINING THE ROLE OF MOLYBDENUM OXIDASES IN DRUG METABOLISM Jeff Jones, Washington State University, Pullman, WA, USA

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Scientific Program 3:15 – 4:00 | SC3.4 | THE IMPACT OF CHEMISTRY ON THE ADME OF ANTIBODY DRUG CONJUGATES Dan Rock, Amgen Inc., Seattle, WA, USA

7:00 p.m. – 9:00 p.m. | Grand Ballroom AB Opening Welcome Reception/Meet the Exhibitors

Monday, October 20, 2014

1:00 p.m. – 4:00 p.m. | Yosemite Ballroom Short Course IV: How to Maximize the Use of DMPK and Drug‐Drug Interaction Data Available in the Literature and Regulatory Reviews During Clinical Development of New Chemical Entities Co‐Chairs: Nina Isoherranen, University of Washington, Seattle, WA, USA and Yoshiyuki Shirasaka, Kanazawa University, Kanazawa, Japan

7:30 a.m. – 5:00 p.m. | West Lounge Meeting Registration Open 9:00 a.m. – 11:30 a.m. | Continental Ballroom Symposium 1: Humanized and Knockout Animal Models in PK Studies Co‐Chairs: Hiroshi Yamazaki, Showa Pharmaceutical University, Tokyo, Japan and Robert Tukey, University of California, San Diego, La Jolla, CA, USA

1:00 – 1:45 | SC4.1 | QUANTITATIVE PREDICTIONS AND PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING OF DRUG‐DRUG INTERACTIONS BASED ON RETROSPECTIVE LITERATURE DATA Ping Zhao, Food and Drug Administration (FDA), Silver Spring, MD, USA

9:00 – 9:30 | S3 | REACTIVE METABOLITE FORMATION OF DRUGS BY HUMAN P450S IN CHIMERIC MICE WITH HUMANIZED LIVER Hiroshi Yamazaki, Showa Pharmaceutical University, Tokyo, Japan

1:45 – 2:30 | SC4.2 | CLINICAL IMPORTANCE OF TRANSPORTER‐MEDIATED DRUG‐DRUG INTERACTIONS: BASICS AND APPLICATIONS OF EVIDENCE‐BASED DECISION MAKING Kazuya Maeda, The University of Tokyo, Tokyo, Japan

9:30 – 10:00 | S4 | HUMANIZED MODELS IN MICE/RATS THAT EXPRESS DRUG‐METABOLIZING ENZYMES VIA CHROMOSOME ENGINEERING TECHNOLOGY Yasuhiro Kazuki, Tottori University, Tottori, Japan

2:30 – 3:15 | SC4.3 | CO‐MEDICATION CONSIDERATIONS TO RATIONALIZE DRUG INTERACTION STRATEGIES Jackie Bloomer, GlaxoSmithKline, Ware, UK

10:00 – 10:30 | S5 | APPLICATION OF MOUSE MODELS TARGETING P450 REDUCTASE AND THE CYP2ABFGS GENE CLUSTER Xinxin Ding, SUNY College of Nanoscale Science & Engineering, Albany, NY, USA

3:15 – 4:00 | SC4.4 | STRATEGIES AND RETROSPECTIVE DATA ANALYSIS IN HEPATIC IMPAIRMENT STUDIES Rob Foti, Amgen Inc., Seattle, WA, USA

4:15 p.m. – 4:45 p.m. | Continental Ballroom Opening Session Kan Chiba, President, Japanese Society for the Study of Xenobiotics and John Miners, President, International Society for the Study of Xenbobiotics Meeting Co‐Chairs: Tetsuya Terasaki and Eric Johnson Meeting Dedicatee: Yuichi Sugiyama

10:30 – 11:00 | S6 | IMPORTANCE OF INTESTINAL GLUCURONIDATION IN BILIRUBIN METABOLISM. USE OF HUMANIZED AND TARGETED GENE KNOCKOUT MOUSE MODELS Robert Tukey, University of California, San Diego, La Jolla, CA, USA

4:45 p.m. – 6:45 p.m. | Continental Ballroom Opening Plenary Lectures

11:15 – 11:30 | P428 | PRELIMINARY CHARACTERIZATION OF A SUITE OF NUCLEAR RECEPTOR KNOCKOUT RATS Kevin P. Forbes, Sage Labs, Inc., Saint Louis, MO, USA

11:00 – 11:15 | P99 | IS THE CHIMERIC HUMANIZED LIVER MOUSE MODEL READY TO PREDICT HUMAN DRUG METABOLISM IN VIVO? Edwin C.Y. Chow, University of Toronto, Toronto, Canada

4:45 – 5:45 | S1 | MECHANISTIC MODELING OF BILE ACID‐ MEDIATED DRUG‐INDUCED LIVER INJURY Kim Brouwer, University of North Carolina, Chapel Hill, NC, USA 5:45 – 6:45 | S2 | CONTRIBUTIONS OF THE HUMAN GUT MICROBIOME TO DRUG METABOLISM Peter Turnbaugh, University of California San Francisco, San Francisco, CA, USA

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Scientific Program 2:00 p.m. – 4:30 p.m. | Continental Ballroom Symposium 3: Chronopharmacological Strategy for Drug Discovery and Evolution Co‐Chairs: Shigehiro Ohdo, Kyushu University, Fukuoka, Japan and Damjana Rozman, Centre for Functional Genomics and Bio‐Chips, Ljubljana, Slovenia

9:00 a.m. – 11:30 a.m. | Imperial Ballroom Symposium 2: Cancer Biomarker Discovery Co‐Chairs: Sumio Ohtsuki, Kumamoto University, Kumamoto, Japan and Frank J. Gonzalez, National Cancer Institute, Bethesda, MD, USA 9:00 – 9:30 | S7 | QUANTITATIVE PROTEOMICS FOR ACCELERATING CANCER BIOMARKER RESEARCH Sumio Ohtsuki, Kumamoto University, Kumamoto, Japan 9:30 – 10:00 | S8 | COLON AND LUNG CANCER BIOMARKERS Frank J. Gonzalez, National Cancer Institute, Bethesda, MD, USA

2:00 – 2:30 | S11 | CHRONO‐DRUG AND DELIVERY SYSTEM: RHYTHM MONITORING, DISRUPTION AND MANIPULATION Shigehiro Ohdo, Kyushu University, Fukuoka, Japan 2:30 – 3:00 | S12 | MOLECULAR CLOCK MECHANISMS UNDERLYING CIRCADIAN RHYTHM OF TRANSPORTERS AND/OR CYPS Satoru Koyanagi, Kyushu University, Fukuoka, Japan

10:00 – 10:30 | S9 | DISCOVERY AND VALIDATION OF AN EARLY‐DIAGNOSTIC LUNG CANCER MARKER IN BLOOD PLASMA BY METABOLOMICS Oliver Fiehn, University of California, Davis, Davis, CA, USA

3:00 – 3:30 | S13 | COMMON TRANSCRIPTIONAL NODES OF CHOLESTEROL HOMEOSTASIS, DRUG METABOLISM AND THE LIVER CLOCK Damjana Rozman, Centre for Functional Genomics and Bio‐ Chips, Ljubljana, Slovenia

10:30 – 11:00 | S10 | METABOLOMICS ANALYSIS FOR MEDICAL RESEARCH Masaru Yoshida, Kobe University, Kobe, Japan 11:00 – 11:15 | P256 | MALDI‐MS/MS‐BASED HIGH‐ THROUGHPUT BIOMARKER PROTEIN QUANTIFICATION WITH A NEW INTERNAL STANDARD METHOD Toshihiro Yoneyama, Tohoku University, Sendai, Japan

3:30 – 4:00 | S14 | REGULATION OF CIRCADIAN BEHAVIOR AND METABOLISM BY SYNTHEIC REV‐ERB AGONISTS Chris Bradfield, University of Wisconsin‐Madison, Madison, WI, USA

11:15 – 11:30 | P231 | STABLE ISOTOPE RESOLVED METABOLOMICS OF ERLOTINIB AND GEFITINIB RESISTANT NON SMALL‐CELL LUNG CANCER (NSCLC) CELL LINES Walter Jaeger, University of Vienna, Vienna, Austria

4:00 – 4:15 | P308| IMPACT OF GENDER, AGE AND FED/FASTED STATE OF RATS ON THEIR SERUM HYDROPHILIC METABOLITES Keiko Maekawa, National Institute of Health Sciences, Tokyo, Japan

11:30 a.m. – 2:00 p.m. | Grand Ballroom AB Meet with Exhibitors / Lunch on Own

4:15 – 4:30 | P103| AGE‐RELATED CHANGES IN EXPRESSION AND ACTIVITY OF HUMAN MITOCHONDRIAL GLUTATHIONE TRANSFERASE ZETA1 Guo Zhong, University of Florida, Gainesville, FL, USA

11:30 a.m. – 12:30 p.m. | East Lounge Graduate/Pre‐Doctoral Poster Finalist Poster Presentations A1 – A6 Poster Presentations

2:00 p.m. – 4:30 p.m. | Imperial Ballroom Symposium 4: Metabolomics in Drug Development and Drug Safety Co‐Chairs: Yoshiro Saito, National Institute of Health Sciences, Tokyo, Japan and Xiaochao Ma, University of Pittsburgh, Pittsburgh, PA, USA

12:30 p.m. – 2:00 p.m. | Grand Ballroom Poster Session 1: Analytical – Differences in Metabolism P1 – P104 Poster Presentations 12:30 – 1:15 | Odd Numbered Posters 1:15 – 2:00 | Even Numbered Posters

2:00 – 2:30 | S15 | METABOLOMICS – QUALITY ASSURANCE AND PATHWAY IDENTIFICATION FOR THE HUMAN TOXOME PROJECT Thomas Hartung, The Johns Hopkins University, Baltimore, MD, USA 2:30 – 3:00 | S16 | METABOLOMICS‐BASED ANALYSES ON DILATED CARDIOMYOPATHY AND ALZHEIMER'S DISEASE Yoshiro Saito, National Institute of Health Sciences, Tokyo, Japan

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Scientific Program 3:00 – 3:30 | S17 | THE OPPORTUNITIES AND CHALLENGES OF METABOLOMICS IN DRUG SAFETY EVALUATION Xiaochao Ma, University of Pittsburgh, Pittsburgh, PA, USA

10:00 – 10:30 | S21 | TEMPORAL AND DOSE‐RESPONSE PATHWAY ANALYSIS FOR PREDICTING CHRONIC CHEMICAL TOXICITY Russell S. Thomas, US Environmental Protection Agency, Research Triangle Park, NC, USA

3:30 – 4:00 | S18 | METABOLOMICS/LIPIDOMICS FOR DRUG DEVELOPMENT IN A PHARMACEUTICAL COMPANY Yoshinori Satomi, Takeda Pharmaceutical Company, Kanagawa, Japan

10:30 – 11:00 | S22 | SYSTEMS BIOLOGY ANALYSIS OF GENETIC AND ENVIRONMENTAL DETERMINANTS OF TOXICITY Ivan Rusyn, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

4:00 – 4:15 | P249 | COMPARATIVE ANALYSIS OF HUMAN FETAL AND ADULT HEPATOCYTES BY METABOLOMICS AND GENOMICS Seiichi Ishida, National Institute of Health Sciences, Tokyo, Japan

11:00 – 11:15 | A12 | QUANTIFICATION OF HEPATOBILIARY TRANSPORTER EXPRESSION IN HUMAN, RAT, DOG, AND MONKEY BY LC‐MS/MS USING SURROGATE PEPTIDES Li Wang, University of Washington, Seattle, WA

4:15 – 4:30 | P230 | COMPARISON OF PLASMA LIPIDOMIC PROFILE OF HUMANS WITH PRECLINICAL ANIMALS Kosuke Saito, National Institute of Health Sciences, Tokyo, Japan

11:15 – 11:30 | P226 | LC‐MS/MS‐BASED TARGETED PROTEOMICS ASSAY TO DETERMINE THE ABSOLUTE PROTEIN EXPRESSION OF CLINICALLY RELEVANT PHASE I & II ENZYMES Stefan Oswald, University of Greifswald, Greifswald, Germany

4:30 p.m. – 6:00 p.m. | Grand Ballroom Poster Session 2: Disposition – Extrahepatic Metabolism P105 – P215 Poster Presentations 4:30 – 5:15 | Odd Numbered Posters 5:15 – 6:00 | Even Numbered Posters

9:00 a.m. – 11:30 a.m. | Imperial Ballroom Symposium 6: From Understanding to Prediction: Opportunities and Challenges in Modeling Xenobiotic Metabolism and Disposition Co‐Chairs: Yasushi Yamazoe, Food Safety Commission, Cabinet Office, Government of Japan, Tokyo, Japan and Paul Ortiz de Montellano, University of California‐San Francisco, San Francisco, CA, USA

6:00 p.m. – 8:00 p.m. | Vista Lounge New Investigator’s Reception 7:00 p.m. – 9:00 p.m. | Kuleto’s JSSX and ISSX Presidents’ Reception (by invitation)

9:00 – 9:30 | S23 | PREDICTIVE SAR OF CYP1A2 ENZYME Yasushi Yamazoe, Food Safety Commission, Cabinet Office, Government of Japan, Tokyo, Japan

Tuesday, October 21, 2014

9:30 – 10:00 | S24 | BIOMOLECULAR SIMULATIONS OF CYTOCHROME P450 ENZYMES Chris Oostenbrink, University of Natural Resources and Life Sciences, Vienna, Austria

7:30 a.m. – 5:00 p.m. | West Lounge Meeting Registration Open

10:00 – 10:30 | S25 | BRIDGING ADME AND PK MODELING FOR XENOBIOTICS: TOWARDS A MULTI‐SCALE MODEL OF THE BLOOD‐BRAIN BARRIER Matthew Jacobson, University of California San Francisco, San Francisco, CA, USA

9:00 a.m. – 11:30 a.m. | Continental Ballroom Symposium 5: Is Systems Biology a Powerful Tool to Explore/Understand the Mechanism of Action, Especially for Toxicity?

Co‐Chairs: Hiroshi Suzuki, The University of Tokyo, Tokyo, Japan and Ivan Rusyn, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

10:30 – 11:00 | S26 | LIGAND DISCOVERY FOR MEMBRANE TRANSPORTERS Andrej Sali, University of California San Francisco, San Francisco, CA, USA

9:00 – 9:30 | S19 | MECHANISM OF ACTION‐BASED PREDICTIVE MODELING OF POTENTIAL ADVERSE EFFECTS OF DRUGS USING A LARGE‐SCALE TOXICOGENOMICS DATABASE Takeki Uehara, Shionogi & Co., Ltd., Osaka, Japan

11:00 – 11:15 | P258| MODELING THE REACTIVITY OF DRUG METABOLITES S. Joshua Swamidass, Washington University in Saint Louis, Saint Louis, MO, USA

9:30 – 10:00 | S20 | UTILIZATION OF SYSTEMS‐BIOLOGY IN ANALYZING AND PREDICTING THE TOXICITY OF MOLECULAR TARGET DRUGS Hiroshi Suzuki, The University of Tokyo Hospital, Tokyo, Japan

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Scientific Program 11:15 – 11:30 | P361 | INHIBITION OF ALDEHYDE OXIDASE ACTIVITY BY NATURAL PRODUCT CONSTITUENTS: ASSESSING CLINICAL RELEVANCE AND IDENTIFYING KEY ENZYME‐LIGAND INTERACTIONS John T. Barr, Washington State University, Spokane, WA, USA

4:00 – 4:30 | S29 | DRUG DELIVERY FACTORS THAT INFLUENCE THE TREATMENT OF PRIMARY AND SECONDARY BRAIN TUMORS William F. Elmquist, University of Minnesota, Minneapolis MN, USA

11:30 a.m. – 2:00 p.m. | Grand Ballroom AB Meet with Exhibitors / Lunch on Own

4:30 – 5:00 | S30 | PROGRESS IN ASSESSING BBB IN DRUG DISCOVERY AND DEVELOPMENT Xingrong Liu, Genentech, Inc., South San Francisco, CA, USA

11:30 a.m. – 12:30 p.m. | East Lounge Post‐Doctoral Poster Finalist Poster Presentations A7 – A12 Poster Presentations

5:00 – 5:15 | P526 | IN VIVO AND IN VITRO TRANSPORT OF APOMORPHINE ENANTIOMERS ACROSS THE BLOOD‐BRAIN BARRIER Takashi Okura, Teikyo University, Tokyo, Japan 5:15 – 5:30 | P461 | IMPACT OF SATURATION OF EFFLUX TRANSPORTERS AT THE BBB AND IMPLICATIONS FOR DRUG DISCOVERY Jamie Henshall, UCB, Slough, UK

12:30 p.m. – 2:00 p.m. | Grand Ballroom Poster Session 3: Gene Expression and Regulation – Metabolic Profiling P216 – P318 Poster Presentations 12:30 – 1:15 | Odd Numbered Posters 1:15 – 2:00 | Even Numbered Posters

3:00 p.m. – 5:30 p.m. | Imperial Ballroom Symposium 8: Solving ADME/Tox Challenges in Drug Discovery Co‐Chairs: Toshiya Moriwaki, Takeda Pharmaceutical Company Limited, Kanagawa, Japan and Cyrus Khojasteh, Genentech, Inc., South San Francisco, CA, USA

2:00 p.m. – 3:00 p.m. | Continental Ballroom ISSX Awards Session Chair: Geoff Tucker, ISSX President‐Elect/Secretary and ISSX Awards Committee Chair

3:00 – 3:30 | S31 | EARLY ESTIMATION OF HUMAN EFFECTIVE AND MAXIMUM TOLERATED DOSE FROM PRECLINICAL RESULTS IN ONCOLOGY DRUG DEVELOPMENT: APPLICATION TO COMPOUND PROGRESSION AND RISK ASSESSMENTS Robert J Griffin, Takeda Pharmaceuticals International Company Ltd., Cambridge, MA, USA

METABOLIC ACTIVATION AND DRUG‐INDUCED TOXICITY – WHERE DO WE GO FROM HERE Thomas A. Baillie, North American Scientific Achievement Award in Honor of Ronald Estabrook, Sponsored by XenoTech VITAMIN A AND RETINOIC ACID HOMEOSTASIS IN HEALTH AND DISEASE: THE ROLE OF ALDH1A AND CYP26 ENZYMES Nina Isoherranen, North American New Investigator Award in Honor of James R. Gillette

3:30 – 4:00 | S32 | CHALLENGES FOR OVERCOMING ADMET ISSUES IN A DRUG DISCOVERY PROGRAM; THE USE OF SANDWICH‐CULTURED HEPATOCYTES Kazuhiro Tetsuka, Astellas Pharma Inc, Ibaraki, Japan

3:00 p.m. – 5:30 p.m. | Continental Ballroom Symposium 7: New Strategies in the Human CNS Barriers Research: The Development of New CNS Drugs and Therapies for the CNS Disorders Co‐Chairs: Hiroyuki Kusuhara, The University of Tokyo, Tokyo, Japan and Xingrong Liu, Genentech, Inc., South San Francisco, CA, USA

4:00 – 4:30 | S33 | OVERLAP BETWEEN DRUG AND ENDOGENOUS SUBSTRATES OF CYTOCHROME P450 ENZYMES F. Peter Guengerich, Vanderbilt University, Nashville, TN, USA 4:30 – 5:00 | S34 | BEYOND STRUCTURAL ALERTS: IDENTIFICATION OF AN UNANTICIPATED BIOACTIVATION PATHWAY ON ARYLOXYPIPERIDINE MOTIF IN A CARDIOVASCULAR DRUG CANDIDATE Amit S. Kalgutkar, Pfizer Inc., Cambridge, MA, USA

3:00 – 3:30 | S27 | PLASTICITY AND ROBUSTNESS OF THE BLOOD‐BRAIN BARRIER TRANSPORTERS, CHANNELS, AND RECEPTORS: A STUDY OF ADVANCED QUANTITATIVE TARGETED PROTEOMICS Tachikawa Masanori, Tohoku University, Sendai, Japan

5:00 – 5:15 | P432 | MODULATING THE STRENGTH OF HYDROGEN‐BOND ACCEPTORS TO ACHIEVE LOW CACO2 EFFLUX FOR ORAL BIOAVAILABILITY OF POTENT PARP6 INHIBITORS Chungang Gu, AstraZeneca Pharmaceuticals, Waltham, MA, USA

3:30 – 4:00 | S28 | QUANTITATIVE ANALYSIS OF THE RECEPTOR OCCUPANCY BY CNS ACTING DRUGS IN HUMAN BRAIN Hiroyuki Kusuhara, The University of Tokyo, Tokyo, Japan

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Scientific Program 5:15 – 5:30 | P29 | DEVELOPMENT OF A RELAY ASSAY WITH PLATED HUMAN HEPATOCYTES FOR THE EVALUATION OF SLOWLY METABOLIZED COMPOUNDS Utkarsh Doshi, In Vitro ADMET, Columbia, MD, USA

9:00 a.m. – 11:30 a.m. | Imperial Ballroom Symposium 10: Translational PKPD Modeling & Simulation in Front Line of Drug Development Co‐Chairs: Koji Chiba, Yokohama College of Pharmacy, Kanagawa, Japan and Shinji Yamazaki, Pfizer Inc., San Diego, CA, USA

5:30 p.m. – 7:00 p.m. | Grand Ballroom AB Poster Session 4: Metabolism ‐ Receptors/nuclear Receptors P319 – P429 Poster Presentations 5:30 – 6:15 | Odd Numbered Posters 6:15 – 7:00 | Even Numbered Posters

9:00 – 9:30 | S39 | PROJECTION OF EFFICACIOUS CONCENTRATIONS FOR ANTICANCER DRUGS BY PHARMACOKINETIC‐PHARMACODYNAMIC MODELING: A CASE STUDY OF MULTIPLE TYROSINE KINASE INHIBITOR, CRIZOTINIB Shinji Yamazaki, Pfizer Inc., San Diego, CA, USA

Wednesday, October 22, 2014

9:30 – 10:00 | S40 | TRANSLATIONAL PHARMACOKINETIC‐ PHARMACODYNAMIC MODELING OF RITUXIMAB AND OFATUMUMAB IN CHRONIC LYMPHOCYTIC LEUKEMIA Takashi Ito, Daiichi Sankyo Co., Ltd., Tokyo, Japan

7:30 a.m. – 5:00 p.m. | West Lounge Meeting Registration Open

10:00 – 10:30 | S41 | IN VITRO ‐ IN VIVO EXTRAPOLATION FOR DRUGS’ PRO‐ARRHYTHMIC POTENCY ASSESSMENT WITH USE OF MODELLING AND SIMULATION APPROACH Sebastian Polak, Simcyp Limited (a Certara Company), Sheffield, UK

9:00 a.m. – 11:30 a.m. | Continental Ballroom Symposium 9: Drug‐drug Interactions: Novel Mechanisms and Advances in Prediction Co‐Chairs: Ikumi Tamai, Kanazawa University, Kanazawa, Japan and Jane Kenny, Genentech Inc., South San Francisco, CA, USA

10:30 – 11:00 | S42 | THE APPLICATION OF QUANTITATIVE SYSTEM PHARMACOLOGY MODELING TO TRANSLATIONAL RESEARCH Ananth Kadambi, Rosa & Co, LLC, San Mateo, CA, USA

9:00 – 9:30 | S35 | CHALLENGES AND ADVANCES IN PREDICTING CYTOCHROME P450 MEDIATED DRUG‐DRUG INTERACTIONS IN PHARMACEUTICAL RESEARCH AND DEVELOPMENT R. Scott Obach, Pfizer Inc., Groton, CT, USA

11:00 – 11:15 | P406 | PRECLINICAL TO CLINICAL PKPD TRANSLATION OF LYMPHOCYTE CIRCULATION INHIBITION BY ABT‐413, A S1P1 INHIBITOR Ting Ting Zhang, AbbVie, North Chicago, IL, USA

9:30 – 10:00 | S36 | MULTIPLE MECHANISMS OF JUICE EFFECT ON INTESTINAL UPTAKE TRANSPORTERS Ikumi Tamai, Kanazawa University, Kanazawa, Japan

11:15 – 11:30 | P396 | A CLINICAL PK/PD ANALYSIS OF VX‐ 770 (KALYDECOTM) AND ITS ACTIVE METABOLITE M1 Jason LaButti, Pfizer, Inc., Cambridge, MA, USA

10:00 – 10:30 | S37 | EARLY RISK ASSESSMENT: INVESTIGATION OF ENDOGENOUS PROBE FOR RENAL TRANSPORTER‐RELATED DDI Yuichiro Imamura, Daiichi‐Sankyo, Co. Ltd., San Diego, CA, USA

11:30 a.m. – 2:00 p.m. | Grand Ballroom AB Meet with Exhibitors / Lunch on Own 12:30 p.m. – 2:00 p.m. | Grand Ballroom AB Poster Session 5: Transporters P430 – P543 Poster Presentations 12:30 – 1:15 | Odd Numbered Posters 1:15 – 2:00 | Even Numbered Posters

10:30 – 11:00 | S38 | TRANSLATIONAL MODELING OF METABOLISM‐TRANSPORTER INTERPLAY AND DRUG‐DRUG INTERACTIONS Aleksandra Galetin, The University of Manchester, Manchester, UK 11:00 – 11:15 | P162 | A ‘HUMAN FIRST' APPROACH TO ASSESS FRACTION METABOLISED (FM) AND INFORM VICTIM DRUG INTERACTIONS Jackie Bloomer, GlaxoSmithKline, Ware, UK 11:15 – 11:30 | P287 | IMPACT OF CYP3A5 GENETIC POLYMORPHISM ON MECHANISM‐BASED INACTIVATION BY LAPATINIB James Chun Yip Chan, National University of Singapore, Singapore

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Scientific Program 4:00 p.m. – 5:00 p.m. | Continental Ballroom Graduate/Pre‐Doctoral Poster Awards Competition Finalists Short Oral Presentations

2:00 p.m. – 4:00 p.m. | Continental Ballroom JSSX Awards Session 2:00 – 3:00 | 2014 JSSX Award Hiroshi Yamazaki, Showa Pharmaceutical University METABOLIC ACTIVATION AND FATE OF XENOBIOTICS DETERMINED BY POLYMORPHIC DRUG‐METABOLIZING ENZYMES

4:00 – 4:10 | A1 | SUPPRESSION OF CYTOCHROME P450 3A4 ACTIVITY BY UDP‐GLUCURONOSYLTRANSFERASE (UGT) 2B7: THE ROLE OF CHARGED RESIDUE(S) IN THE CYTOSOLIC TAIL OF UGT2B7 Yuu Miyauchi, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan

Chair: Kan Chiba, Chiba University 3:00 – 3:20 | 2014 JSSX Award for Young Industrial Scientists

4:10 – 4:20 | A2 | HIGHER CYP2C19 FUNCTIONAL ACTIVITY IN CHILDREN IS NOT ENTIRELY EXPLAINED BY HIGHER GENE OR PROTEIN EXPRESSION Nicole R. Zane, UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA

Shintaro Nakayama, Daiichi Sankyo Co., Ltd. RISK ASSESSMENT OF THE CHEMICALLY REACTIVE METABOLITES AND IDIOSYNCRATIC DRUG TOXICITY IN DRUG DEVELOPMENT

4:20 – 4:30 | A3 | ALTERED HNF4α ACTIVITY CONTRIBUTES TO CYP2D40 INDUCTION DURING PREGNANCY IN MICE Miaoran Ning, University of Illinois at Chicago, Chicago, IL, USA

Chair: Takashi Izumi, Daiichi Sankyo Co., Ltd. 3:20 – 3:40 | 2014 JSSX Award for Young Scientists Hiroshi Watanabe, Kumamoto University MOLECULAR PHARMACOKINETIC MECHANISMS OF OXIDATIVE STRESS‐INDUCED TISSUE DAMAGE IN CHRONIC KIDNEY DISEASE FOR MEDICAL DEVELOPMENT AND THERAPEUTIC APPLICATION

4:30 – 4:40 | A4 | PROTEIN GLUTATHIONYLATION: THE HIDDEN HAND IN ACETAMINOPHEN TOXICITY James Chun Yip Chan, National University of Singapore, Singapore 4:40 – 4:50 | A5 | THE GUT MICROBIOME: IMPLICATIONS IN TACRINE‐INDUCED TRANSAMINITIS Lian Yee Yip, National University of Singapore, Singapore

Chair: Masaki Otagiri, Sojo University 3:40 – 4:00 | 2014 JSSX Award for Young Scientists

4:50 – 5:00 | A6 | HEPATIC ORGATIC CATION TRANSPORTER 1 (OCT1) REGULATES THE HEPATIC CLEARANCE OF TRIPTANS, BUT NOT BETA‐BLOCKERS Xuan Zhang, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan

Satomi Onoue, University of Shizuoka STRATEGIC DEVELOPMENT OF NANO‐DRUG DELIVERY SYSTEM FOR PHARMACOKINETIC CONTROL

Chair: Shizuo Yamada, University of Shizuoka 2014 JSSX Award for Young Industrial Scientists

4:00 p.m. – 5:00 p.m. | Imperial Ballroom Post‐Doctoral Poster Awards Competition Finalists Short Oral Presentations

Hiroshi Kodaira, Kyowa Hakko Kirin Co., Ltd. DEVELOPMENT OF PREDICTIVE METHOD OF UNBOUND BRAIN CONCENTRATION OF CENTRAL NERVOUS SYSTEM DRUGS FOR DRUG DISCOVERY Please note: This lecture was cancelled and will be available for review at JSSX web site in the member’s account on October 22.

4:00 – 4:10 | A7 | THE MECHANISM OF THE CARBON‐ CARBON BOND CLEAVAGE STEP OF THE CYTOCHROME P450 19A1 AROMATASE REACTION Francis Yoshimoto, Vanderbilt University School of Medicine, Nashville, TN, USA

2014 JSSX Award for Young Industrial Scientists

4:10 – 4:20 | A8 | IMPACT OF NEONATAL DRUG EXPOSURE ON INTERINDIVIDUAL VARIATIONS OF P450‐MEDIATED DRUG METABOLISM Yun‐Chen Tien, School of Pharmacy, University of Connecticut, Storrs, CT, USA

Takafumi Akabane, Astellas Pharma Inc. WHAT I LEARNED FROM DRUG DISCOVERY ADME RESEARCH Please note: This lecture was cancelled and will be available for review at JSSX web site in the member’s account on October 22.

4:20 – 4:30 | A9 | KINETIC ANALYSIS OF STEROID 21‐ HYDROXYLASE IN HUMAN CYTOCHROME P450 21A2 FUNCTIONAL VARIANTS Chunxue Wang, Vanderbilt University, Nashville, TN, USA

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Scientific Program 4:30 – 4:40 | A10 | CARBON MONOXIDE BOUND RED BLOOD CELLS PROTECT THE FUNCTION OF HEPATIC CYTOCHROME P450 AFTER RESUSCITATION FROM HEMORRHAGIC SHOCK VIA SUPRESSION OF TOLL‐LIKE RECEPTOR‐4 EXPRESSION ON THE KUPFFER CELLS Shigeru Ogaki, Graduate School of Pharmaceutical Sciences Kumamoto University, Kumamoto, Japan

10:30 – 11:00 | S46 | GENOMIC CHARACTERIZATION OF PHARMACOGENE REGULATORY ELEMENTS Nadav Ahituv, University of California San Francisco, San Francisco, CA, USA 11:00 – 11:15 | P371 | GENES ASSOCIATED WITH PLASMA ANASTROZOLE, AN AROMATASE INHIBITOR, AND HYDROXYANASTROZOLE GLUCORONIDE CONCENTRATIONS IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE (ER+) BREAST CANCER Tanda M. Dudenkov, Mayo Clinic, Rochester, MN, USA

4:40 – 4:50 | A11 | 'MATE1 TRANSPORTER CONTRIBUTES TO LAMIVUDINE ELIMINATION AND INDINAVIR ALTERS THE PHARMACOKINETICS OF LAMIVUDINE Qing Li, School of Pharmacy, University of Maryland, Baltimore, MD, USA

11:15 – 11:30 | P96 | EFFECT OF AGE AND GENOTYPE ON CYP2D6 ACTIVITY IN CHILDREN AND ADOLESCENTS Andrea Gaedigk, Children's Mercy Hospital, Kansas City, MO, USA

4:50 – 5:00 | A12 | QUANTIFICATION OF HEPATOBILIARY TRANSPORTER EXPRESSION IN HUMAN, RAT, DOG, AND MONKEY BY LC‐MS/MS USING SURROGATE PEPTIDES Li Wang, Department of Pharmaceutics, University of Washington, Seattle, WA, USA

9:00 a.m. – 11:30 a.m. | Imperial Ballroom Symposium 12: Frontier of Antibody Engineering for Next‐generation Therapeutics, Including ADCs: Opportunities and Challenges Co‐Chairs: Masaki Ishigai, Chugai Pharmaceutical Co., Ltd., Shizuoka, Japan and Mauricio Leal, Pfizer, Pearl River, NY, USA

5:00 p.m. – 5:15 p.m. | Continental Ballroom Presentation of Poster Awards Competition Awards 6:00 p.m. – 10:00 p.m.

Dinner Cruise on San Francisco Bay This is a ticketed event.

9:00 – 9:30 | S47 | DISCOVERY OF NOVEL ANTIBODY DRUG CONJUGATE TECHNOLOGY Yuki Abe, Daiichi Sankyo Co., Ltd., Tokyo, Japan

Thursday, October 23, 2014

9:30 – 10:00 | S48 | ENGINEERED ANTIBODY TO SWEEP ANTIGEN BY PH‐DEPENDENT ANTIGEN BINDING AND INCREASED FCRN BINDING Tatsuhiko Tachibana, Chugai Pharmaceutical Co., Ltd, Singapore

7:30 a.m. – 3:30 p.m. | West Lounge Meeting Registration Open

10:00 – 10:30 | S49 | ADME OF ANTIBODY‐AURISTATIN CONJUGATES FOR CANCER THERAPY Steve Alley, Seattle Genetics, Bothell, WA, USA

9:00 a.m. – 11:30 a.m. | Continental Ballroom Symposium 11: Personalized Drug Therapy: Promise and Challenge of a Genomics Approach Co‐Chairs: Miki Nakajima, Kanazawa University, Kanazawa, Japan and Wolfgang Sadee, The Ohio State University, Columbus, OH, USA

10:30 – 11:00 | S50 | PRECLINICAL/CLINICAL MAB IMAGING IN SUPPORT OF ADC BIOLOGY Simon Williams, Genentech Inc., South San Francisco, CA, USA 11:00 – 11:15 | P313 | IN VITRO METABOLISM OF THE MAYTANSINOID PAYLOADS USED FOR ANTIBODY DRUG CONJUGATES John A. Davis, Amgen Inc., Seattle, WA, USA

9:00 – 9:30 | S43 | CURRENT STATUS AND PERSPECTIVE OF PERSONALIZED MEDICINE IN DRUG DEVELOPMENT Akira Nagumo, Merck Sharp and Dohme, Tokyo, Japan

11:15 – 11:30 | P321 | THE USE OF RADIOLABELS IN STUDYING ADME PROPERTIES OF BIOTHERAPEUTIC PROTEINS: EFFECT OF LABELLING ON PHYSICAL PROPERTIES OF PROTEINS Andrew McEwen, Quotient Bioresearch Limited, Rushden, UK

9:30 – 10:00 | S44 | MICRORNA‐RELATED POLYMORPHISMS TO PREDICT DRUG RESPONSE Miki Nakajima, Kanazawa University, Kanazawa, Japan 10:00 – 10:30 | S45 | GENETICS OF GENE EXPRESSION AND RNA BIOLOGY IN DRUG METABOLISM AND DISPOSITION Wolfgang Sadee, The Ohio State University, Columbus, OH, USA

11:30 a.m. – 12:30 p.m.

Lunch on Own

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Scientific Program 1:30 – 2:00 | S57 | TRANSCRIPTIONAL REGULATION OF DRUG METABOLIZING ENZYMES BY NUCLEAR RECEPTORS Thomas Kocarek, Wayne State University, Detroit, MI, USA

12:30 p.m. – 3:00 p.m. | Continental Ballroom Symposium 13: Advances in PBPK Modeling and Simulation for Special Populations Co‐Chairs: Shinichi Inoue, Daiichi Sankyo Co., Ltd., Tokyo, Japan and Steve Leeder, Children's Mercy Hospital and Clinics, Kansas City, MO, USA

2:00 – 2:30 | S58 | REGULATION OF TRANSPORTERS IN THE CNS AND KIDNEY Joanne Wang, University of Washington, Seattle, WA, USA 2:30 – 2:45 | P54 | ROLE OF MICRORNA IN SPECIES‐SPECIFIC INDUCTION OF CYP2B Lyudmila F. Gulyaeva, Institute of MolBiol and Bioph SB RAMS, Novosibirsk, Russia

12:30 – 1:00 | S51 | MODELING & SIMULATION FOR CLINICAL DEVELOPMENT OF NEW DRUGS Takahiko Tanigawa, Bayer Pharma AG, Berlin, Germany

2:45 – 3:00 | P444 | ROLE OF N‐TERMINAL MOTIS OF ORGANIC ANION TRANSPORTING POLYPEPTIDE 1B3 (OATP1B3) IN REGULATING ITS EXPRESSION LEVELS AND SURFACE MEMBRANE TRAFFICKING Nilay Thakkar, University of Kentucky, Lexington, KY, USA

1:00 – 1:30 | S52 | POPULATION PHYSIOLOGICALLY‐BASED PHARMACOKINETIC MODELING AND SIMULATION OF INTERETHNIC DIFFERENCES IN PHARMACOKINETICS Shinichi Inoue, Daiichi Sankyo Co., Ltd., Tokyo, Japan 1:30 – 2:00 | S53 | INCORPORATING CYP2D6 PHARMACOGENETICS INTO PEDIATRIC PBPK MODELS Nina Isoherranen, University of Washington, Seattle, WA, USA and Steve Leeder, Children's Mercy Hospital and Clinics, Kansas City, MO, USA

3:00 p.m. – 3:30 p.m. | Imperial Ballroom Closing Session / Meeting Adjourns

2:00 – 2:30 | S54 | DEVELOPMENT AND APPLICATION OF PBPK MODELS OF DRUG DISPOSITION DURING PREGNANCY Jashvant Unadkat, University of Washington, Seattle, WA, USA 2:30 – 2:45 | P380 | APPLICATION OF ANTIBIOTIC PHARMACOKINETIC MODELS CONSTRUCTED FOR CAUCASIANS TO A JAPANESE POPULATION Koji Chiba, Yokohama College of Pharmacy, Kanagawa, Japan 2:45 – 3:00 | P389 | DEVELOPMENT AND QUALIFICATION OF A PHYSIOLOGY‐BASED PHARMACOKINETIC (PBPK) MODEL OF THE INVESTIGATIONAL AURORA A KINASE INHIBITOR ALISERTIB: PREDICTION OF PEDIATRIC PK AND DRUG‐DRUG INTERACTIONS (DDI) Chirag G. Patel, Takeda Pharmaceuticals International Co., Cambridge, MA, USA

12:30 p.m. – 3:00 p.m. | Imperial Ballroom Symposium 14: Post‐Translational and Transcriptional Regulation of Transporters and Metabolism Co‐Chairs: Ichiro Ieiri, Kyushu University, Fukuoka, Japan and Xiaobo Zhong, University of Connecticut School of Pharmacy, Storrs, CT, USA 12:30 – 1:00 | S55 | miRNA‐328 ON BCRP EXPRESSION – TRANSCRIPTIONAL REGULATION AND CLINICAL APPLICATION Takeshi Hirota, Kyushu University, Fukuoka, Japan 1:00 – 1:30 | S56 | UTILITY OF iPS CELLS FOR DRUG METABOLIZING ENZYME EXPRESSION: HISTONE DEACETYLASE INHIBITOR PROMOTES THE DIFFERENTIATION OF HUMAN INDUCED PLURIPOTENT STEM CELLS INTO HEPATOCYTE‐LIKE CELLS Tamihide Matsunaga, Nagoya City University, Nagoya, Japan

26

Poster Information Poster Awards Competition | Poster and Podium Presentations Poster Session

Graduate / Pre‐Doctoral Posters A1 – A6 Post‐Doctoral Posters A7 – A12

Poster Set-Up

Poster Tear-Down

All Finalist Posters

All Finalist Posters

Monday, October 20

Thursday, October 23

7:30 a.m. – 9:00 a.m.

11:30 a.m. – 12:30 p.m.

Poster Presentation Session Location, Date, and Times

Podium Presentation Session Location, Date, and Time

East Lounge Monday, October 20 11:30 a.m. – 12:30 p.m.

Continental Ballroom Wednesday, October 22 4:00 p.m. – 5:00 p.m.

East Lounge Tuesday, October 21 11:30 a.m. – 12:30 p.m.

Imperial Ballroom Wednesday, October 22 4:00 p.m. – 5:00 p.m.

General Poster Abstracts Presentations | Grand Ballroom AB All posters must be removed by 6:30 p.m. on Wednesday, October 22. Posters not removed by this time will be discarded.

Poster Set-Up

Poster Session

Poster Tear-Down

Poster Presentation Dates and Times

Session 1

Monday, October 20 | 12:30 p.m. – 2:00 p.m.

12:30 – 1:15 | Odd Numbers 1:15 – 2:00 | Even Numbers

Analytical – Differences in Metabolism Posters P1 – P104

Session 2

Monday, October 20 | 4:30 p.m. – 6:00 p.m.

4:30 – 5:15 | Odd Numbers 5:15 – 6:00 | Even Numbers

Disposition – Extrahepatic Metabolism Posters P105 – P215

Session 3

All General Posters

All General Posters

Monday, Wednesday, Gene Expression and Regulation – Metabolic October 20 October 22 Profiling 7:30 a.m. – 5:15 p.m. – Posters P216 – P318 9:00 a.m.

6:30 p.m.

Session 4 Metabolism – Receptors / Nuclear Receptors Posters P319 – P429

Tuesday, October 21 | 12:30 p.m. – 2:00 p.m.

12:30 – 1:15 | Odd Numbers 1:15 – 2:00 | Even Numbers

Tuesday, October 21 | 5:30 p.m. – 7:00 p.m.

5:30 – 6:15 | Odd Numbers 6:15 – 7:00 | Even Numbers Wednesday, October 22 | 12:30 p.m. – 2:00 p.m.

12:30 – 1:15 | Odd Numbers 1:15 – 2:00 | Even Numbers

Session 5 Transporters Posters P430 – P543

View the poster numbering scheme on the following page.

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Poster Information Poster Number Quick Guide: Finalists in the Graduate / Pre‐doctoral Poster Awards Competition

A1 – A6

Finalists in the Postdoctoral Poster Awards Competition

A7 – A12

Analytical

Bioavailability

Clearance Prediction

Conjugation Reactions and Enzymes

Cytochrome P450

Differences in Metabolism (species, gender, age, diseases) Disposition

Drug Discovery and Development

Drug Interaction

Enzyme Induction

Enzyme Inhibition/Inactivation

Extrahepatic Metabolism

Gene Expression and Regulation

Genomics / Metabolomics / Proteomics

Hepatocytes

High‐throughput Techniques

in silico

in vitro Techniques

Mechanisms of Xenobiotic Toxicities

Metabolic Profiling

Metabolism

Non‐P450 Phase I Enzymes

Pharmacogenetics

Pharmacokinetics and Pharmacodynamics

Receptors / Nuclear Receptors

Transporters

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P1 – P9 P10 – P19 P20 – P33 P34 – P46 P47 – P82 P83 – P104 P105 – P116 P117 – P146 P147 – P180 P181 – P196 P197 – P206 P207 – P215 P216 – P223 P224 – P231 P232 – P252 P253 – P256 P257 – P261 P262 – P283 P284 – P306 P307 – P318 P319 – P356 P357 – P370 P371 – P377 P378 – P425 P426 – P429 P430 – P543

Industry‐Sponsored Symposia Industry‐Sponsored Symposia (ISS) are commercially‐supported educational sessions held in conjunction with the 19th North American ISSX and 29th JSSX Annual Meeting. Although not part of the official ISSX / JSSX scientific program, these symposia have been approved for presentation at our meeting. We invite all attendees to enjoy a light breakfast and the education that these sessions provide.

Monday, October 20, 2014 7:45 a.m. – 8:45 a.m. | Continental Ballroom Presented by Thermo Scientific Metabolite Profiling and Identification Using Thermo Scientific Compound Discoverer Software Jonathan N. Bauman, Senior Scientist, Biotransformation and Environmental Sciences, PDM‐NCE Pfizer Worldwide Research & Development, Groton, CT, USA High Resolution Mass Spectrometry (HRMS) in concert with Ultra Performance Liquid Chromatography (UPLC) has improved the quality and throughput of metabolite profiling and structure elucidation data. The synergies of these two technologies results in several challenges to the biotransformation scientist including a significant amount of rich and complex data sets. An additional challenge is collating, correlating, summarizing and reporting data within a project across several biological matrices. Compound Discoverer (Thermo Scientific) is a software solution that enables the scientist to mine and manage these complex parallel data sets in a more efficiently fashion then previously possible.                                

7:45 a.m. – 8:45 a.m. | Imperial Ballroom Presented by Bioreclamation IVT Extreme Donor Variability in Human Aldehyde Oxidase Activity: Pharmacogenomics and In Vitro Solutions J. Matthew Hutzler, Ph.D. Prediction of metabolic clearance in humans by AO has proven especially difficult, due to profound species differences in activity, as well as high variability between human donors in part due to pharmacogenetics, which has likely contributed to under‐predicting clearance in vivo. This seminar will highlight the background relevance for AO, as well as the recent findings as it relates to AO activity and pharmacogenetics across a large pool of donors. In addition, in vitro approaches for the prediction of AO‐mediated metabolic clearance will be highlighted, including custom pools of human liver cytosol and/or cryopreserved human hepatocytes with high AO activity.

Tuesday, October 21, 2014 7:45 a.m. – 8:45 a.m. | Continental Ballroom Presented by Hepregen Corporation Cross‐Species Comparison of Metabolite Profiles Using HepatoPac R. Scott Obach, Ph.D., Pfizer, Inc. Laboratory animal models are the industry standard for use in preclinical risk assessments for drug candidates.

Thus, it is important that these species possess profiles of drug metabolites that are similar to that anticipated in human, since metabolites could also be responsible for biological activities or unanticipated toxicity. Under most circumstances, preclinical species reflect human in vivo metabolites well, however, there have been several notable exceptions, and understanding and predicting these exceptions with an in vitro system would be very useful. Human micropatterned co‐cultured (MPCC) hepatocytes have been shown to recapitulate human in vivo qualitative metabolic profiles but its application to preclinical species and toxicity species

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Industry‐Sponsored Symposia selection has not been evaluated. In this study, we investigated several compounds that are known to produce human unique metabolites through CYP2C9, UGT1A4, or aldehyde oxidase (AO) that were poorly covered or not detected at all in the selected preclinical species. To perform our investigation we used 24‐well MPCC hepatocyte plates having three individual human donors, monkey, dog and rat to study drug metabolism at four time points per species. Through the use of the multispecies MPCC system, the metabolite profiles of the selected compounds with human donors effectively captured the qualitative in vivo metabolite profile with respect to the human metabolite of interest. Human unique metabolites that were not detected in vivo in certain preclinical species (normally dog and rat) were also not generated in the corresponding species in vitro confirming that the MPCC hepatocytes can provide an assessment of preclinical species metabolism.

From these results, we conclude that MPCC hepatocytes plates could be used as an effective in vitro tool for understanding preclinical species metabolism relative to humans and aid in choosing the appropriate preclinical models.                                

7:45 a.m. – 8:45 a.m. | Imperial Ballroom HTG Molecular Diagnostics Fully Automated and Easy to Use Solution for your Cytochrome P450 Gene Expression Testing Jason DeLoach, Ph.D., Senior Manager and Mark Schwartz, Ph.D., Lab Manager Drug metabolizing enzymes and transporter induction can result in clinically meaningful drug interactions. Therefore, it is important to identify potential drug interactions early in the drug development process. Measuring gene expression has traditionally relied upon RNA extraction from treated hepatocytes followed by RT‐qPCR. An alternative, potentially more efficient method for measuring gene induction is the multiplex HTG Edge quantitative nuclease protection assay (HTG Edge chemistry).

Wednesday, October 22, 2014 7:45 a.m. – 8:45 a.m. | Continental Ballroom Presented by Corning Incorporated Corning® TransportoCells™ and Corning HepatoCells Na Li, Ph.D., Staff Scientist, Development and Rongjun Zuo, Staff Scientist, Development The workshop will introduce newly developed cell‐based models to support drug ADME studies. It is recommended that the attendees have a basic understanding of concepts of drug ADME/Tox studies. First, the workshop will introduce Corning HepatoCells for ADME/Tox study. Derived from primary human hepatocytes, Corning HepatoCells are a renewable source of hepatocyte‐like cells, which retain most of the physiological properties of their parental hepatocytes, show mature hepatocyte‐like morphology, and have been characterized for CYP3A4, 1A2, and 2B6 induction response to prototypical inducers. An overview of the characterization of Corning HepatoCells for ADME/Tox studies will be presented, along with using the model system for prediction of clinical CYP induction. The attendees will gain an understanding of the capability of Corning HepatoCells for drug ADME/Tox study. Second, the workshop will introduce a new cell‐based SLC transporter model system for studying regulatory agency recommended SLC transporters. The system provides a convenient “thaw and go”, high performing mammalian cell model which supports regulatory agency recommendations for evaluating transporter mediated drug‐drug interactions in vitro. A general overview of the currently used in vitro transporter models will be presented, along with a new single‐use cryopreserved SLC drug transporter model. The attendees will gain an understanding of current drug transporter available and the performance application of the new SLC transporter system.

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Industry‐Sponsored Symposia 7:45 a.m. – 8:45 a.m. | Imperial Ballroom Presented by Life Technologies New Advances in Organotypic Models for ADME/Tox Applications The current “state of the art” cell culture technology for in vitro liver drug metabolism and pharmacokinetic (DMPK) studies is the hepatocyte two‐dimensional sandwich monoculture. This model has been successfully used in predictions of the metabolic properties and short term cytotoxicity assessment of new chemical and pharmaceutical compounds. While this system has been extensively used in the field for those applications, the drawback of this type of monoculture is that there is limited utility in performing more physiologically relevant metabolic and cytotoxic studies that require modeling of specific liver metabolic states. As such, there is a need for more advanced, organotypic cultures that are able to more accurately mimic various liver physiology such as inflammation, cholestasis, or liver regeneration. This necessitates use of more complex co‐ culture systems that require proper understanding of their use and their limitation. In this presentation, we will provide an overview of current advanced hepatic systems with inclusion of skin and cornea models to show their advantages and disadvantages, and what is necessary to use them effectively in drug metabolism and toxicity, pharmacokinetics and drug discovery studies.

Thursday, October 23, 2014 7:45 a.m. – 8:45 a.m. | Continental Ballroom Presented by Quotient Bioresearch Japanese Latest Guidelines on Drug‐Drug Interactions (DDI) Guy Webber, Ph.D., Chief Scientist In Vitro With the 3rd major global regulatory authority (Japanese Ministry of Health, Labour and Welfare; JMHLW) releasing a guideline on drug‐drug interactions (DDI) within the last 12 months, this symposium will present the key elements of the guideline and will compare these to the earlier guidelines published by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Participants will learn the requirements for DDI data submission in each of the regulatory regions, the basic experimental elements of the studies, how to interpret and process the results and when the data are required by the regulatory authorities.                                

7:45 a.m. – 8:45 a.m. | Imperial Ballroom Presented by Quotient Clinical Defining a “Gold Standard” for Establishing Intravenous Pharmacokinetics, Human Mass Balance and Metabolism Data from a Single Integrated Study and a Single Regulatory Submission Iain Shaw, Ph.D. Although the human mass balance and metabolism (14C‐ADME) study is a core component of any drug development plan, it is also a study that is not performed frequently.

Development teams are often required to conduct traditional 14C‐ADME alongside newer AMS based studies with little real or recent experience of the detailed requirements to ensure delivery of a study that will generate all the regulatory data necessary to support new drug applications.

This session is intended for all those involved in the establishment, delivery and conduct of human 14C‐enabled metabolism and pharmacokinetic studies intended to support drug registration.

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Meeting Sponsors We wish to thank and recognize corporate sponsors of the meeting:

Gold Gilead Triangle Research Labs XenoTech, LLC

Silver Sigma Life Science

Bronze Affymetrix, Inc. InSphero, Inc. Life Technologies Microconstants Optivia Biotechnology Quintiles Sekisui Medical Co., Ltd. Solvo Biotechnology Waters Corporation

New Investigator’s Reception Genentech

Name Badge Lanyards Corning

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Corrporate Do onors JSSSX and ISSX X thank the ffollowing fo or their geneerous donatiions in supp port of the th

th

29 JSSSX and 19 IISSX Joint An nnual Meetiing: Asahi Kassei Pharma a Corporation

CHUGAI P PHARMACEU UTICAL CO., LTD.

0tsukka Pharmaceeutical Factory, Incc.

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Ex xhibittor D Directtory With hout questio on, the supp port of the m many vendorrs participatting in our m meeting exhiibition signifficantly help p us to o organize and host lead ding scientiffic meetings. We hope tthat you willl spend time with each h company with h us in the exxhibit hall to o learn how their produ ucts and servvices can heelp you with your researrch.

A Affymetrix, Inc Booth 205 5

Affym metrix enable es the most co omprehensive e path for the e study of Xennobiotics with tools to invvestigate the D DNA, mRNA and P Protein. Takin ng a systems aapproach allo ows researche ers to make m more informeed decisions, w which stream mlines the drug development process and d overall time e to market.

Agilent Technologies 7 Booth 507

ogies is a leading provid der of GC, LC, L MS and Spectroscop py instrumen nts, technolo ogies, related d Agileent Technolo consumables, sup pport, services, and workfllow solutionss that enable labs to analyyze, confirm aand quantify substances o of interest with confidence while e maintainingg the most stringent s labooratory practtices, from saample preparration to fina al

report. Learn morre at www.agilent.com.

Agilux Labs Booth 414 4

uilding the ind dustry’s leadiing Drug Metabolism and Pharmacokin netics CRO. W We’ve built a tteam of over At Aggilux we’re bu 100 d drawn from le eading compaanies in the B Boston and Caambridge phaarmaceutical and biotechn nology hub. W We’ve built an n infrastructure dessigned to deriive the highesst quality data as quickly aas possible. M Most importantly, we’ve nurtured a cultu ure where eve ery team mem mber is deeply committed to high servi ce and open communicatiion. Our com mprehensive services include: Discovery (No on‐GLP) Bioanalysis; In Vivvo (PK) Pharm macokinetics; In Vivo Pharm macology; In Vitro ADMET T; Biom marker Assays; GLP Bioanallysis.

a Alliance Pharma Booth 103 3

Allian nce Pharma sspecializes in GLP and non‐‐GLP bioanalyytical servicess and DMPK ssupport for bo oth small and d large moleecules. We serve preclinicaal and clinical programs with LC‐MS/MSS bioanalysis, metabolism,, PK, biomarker and agrocchemicals anaalysis for smaall molecule; iimmunoassayys for PK or im mmunogeniciity studies and biomarker analysis, cell based assays for b biologics.

Altu uras Analytics 4 Booth 604

ntract researcch organizatioon (CRO) speccializing in reggulated LC‐M MS/MS & GC‐ Alturras Analytics iis a research‐intensive con MS/M MS bioanalysis of small and large moleccules. Service es include Biooanalytical Meethod Develo opment and V Validation, Routine Quantitattive Analysis o of Preclinical//Clinical Samp ples, GLP/No n‐GLP. Alturaas is a leader in antibody d drug ugate and bio omarker analyysis using LC‐MS/MS & GC C‐MS/MS. conju

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E Exhib bitor Direcctory y BioreeclamationIVT T Booth 301 1

BioreeclamationIVTT is a worldwide provider o of biological aand in vitro pproducts to ph harmaceuticaal and biotech hnology organ nizations. Our company sp pecializes in ccontrol animal, normal hum man and disease state hum man biologicaal matrices for use in drug discovvery along witth hepatocyte e and microso ome productss used in the preclinical industry.

uker Daltonics Bru Booth 307 7

Brukeer is a leadingg provider of Chromatograaphy and Masss Spectromeetry instruments and solutions for the A Analytical Scien nces. Our innovative and e easy‐to‐use p product families (ESI‐QTOFF, Ion Trap, FTTMS, MALDI‐TTOF, LC‐Triplee Quads and GC‐TTriple Quads) provide the h highest performance, rugggedness and vvalue for a wide range of aapplications in n the food, envirronmental, fo orensic, industrial, bio/phaarmaceutical aand life scien ce research m markets.

Charles River Booth 508 8

Charles River provvides productts and service es to help glob bal pharmaceeutical and biotechnology companies, ggovernment agencies and acad demic instituttions acceleraate their research and drugg development. Our dediccated employyees focus on n with exactly w what they nee ed to improve e and expeditte the discoveery, early‐stagge development and safe proviiding clients w manu ufacture of ne ew therapies for patients w who need the em. Visit ww ww.criver.com m.

Corning g Booth 502 2

Corning Incorporaated offers in ntegrated solutions to sup pport life scieences and acccelerate drug discovery w with products and C Contract Rese earch Service es for the in vvitro analysis of xenobioti c metabolism m and drug trransport. Pro oducts include e Corning® Gentestt™ Hepatocyttes, Tissue Frractions, Tran nsporter Systtems, Corningg Supersomees™ Enzymes,, and Corning g Genttest Contract Research Serrvices.

Cypex x Booth 612 2

Cypeex manufactures high quality recombinaant CYPs from m a range of sspecies along with other enzymes such as AOX, ALDH H, GSTs and SULTs as well as offering an ntibodies, purrified CYPs, suubstrates and d inhibitors. SServices inclu ude CYP inhib bition screenin ng, protein exxpression and d metabolite generation. PProducts and services are ccovered by an ISO90 001:2008 acccredited qualiity assurance system.

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Ex xhibittor D Directtory Cyprotex x Booth 302 2

Cypro otex is an AIM M‐listed comp pany (CRX) he eadquartered d in Macclesfi eld, UK with laboratories iin Watertown n, MA and Kalam mazoo, MI (CeeTox). The ccompany is th he leader in p predictive toxxicology and A ADME researcch, offers sevveral proprietary technologies (CellC Ciphr®, Cloe®PK, eCiphrCardio and eCipphrNeuro) and d prides itselff on custom aassay deveelopment and fast turnarou und times.

FFrontage Labs 2 Booth 212

Fronttage Laborato ories helps biopharmaceuttical organizaations advancce early‐phasee research an nd developmeent with full service offerings– – including bio oanalysis, pre eclinical and cclinical studiess, analytical ttesting, produ uct developm ment and manu ufacturing support– that sspan drug disccovery througgh late phasee studies. Fron ntage also pro ovides product deveelopment, bioequivalence aand analyticaal services to ggeneric pharm maceutical co ompanies to ssupport ANDA A subm missions.

Fujitssu Kyusha Sysstems Limited d Booth 606 6

ADM MEWORKS is a high‐speed vvirtual screening system in ntended for e valuation of A ADMET propeerties and a ttool for build ding models u using various cchemical properties. DDI Simulator qu antitatively p predicts the extent of drugg‐drug interactions usingg PBPK models. ADMEDattabase provid des most com prehensive d data on interaactions of sub bstances with Drugg Metabolizingg Enzymes an nd Transporte ers.

GenoMemb brane Co., Ltd d Booth 614 4

Geno oMembrane C Co., Ltd specializes in the rresearch and developmentt of drug tran nsporters. We provide transporter‐ related products aand research services. In o order to contrribute to pharrmacokineticc study, we haave also involved in the busin ness cooperattion with ove erseas firm an nd introduced d research reaagents for phaarmacokinetiics and in vitrro biliary excreetion technologies.

n Hepregen Booth 101 1

Heprregen offers aa range of DM MPK/Tox serviices using novvel in vitro livver platforms:: HepatoPac® ® and HepatoM Mune™ (a Ku upffer‐cell‐enhanced sisterr product). Th hese tools, uttilizing patentted micro‐arcchitecture, produce resultss far more predictive of in vivvo outcomes than conventtional modelss. Their longeevity and intact hepatocytee biology makke them an ideal solution for time‐dependent readoutss.

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E Exhib bitor Direcctory y

Hitachi A Aloka Medica al Booth 503 3

Hitacchi Aloka Med dical has been n a long‐stand ding manufaccturer of liquiid scintillation n counters (LSSC) since we ffirst launched d thosee to the scien ntific world in 1962. Our qu ualified produ ucts make acaademic/reseaarch users sattisfied with ad dvanced featu ures. It is our greatest pleaasure to support radio isotope tracer teest in pharmacokinetics.

H HTG Moleculaar Diagnostics Booth 200 0

Head dquartered in Tucson, Arizona, HTG Mo olecular Diagn nostics’ comm mercialized itss HTG Edge syystem in 2013 3 and a portffolio of mRNA A and miRNA assays that le everage HTG’s proprietaryy nuclease pro otection chem mistry. HTG Edge system capabilities have b been expande ed to fully automate samp ple and libraryy preparation n for targeted d next‐generaation sequencing.

Hureel Corporation n Booth 309 9

es, develops, and commercializes produ ucts and serviices based on n its patent‐pending three‐dimensional HµREEL® researche (“3D””) cell‐based tissue constructs. Currenttly, Hurel offe ers hepatic coo‐culture mod dels of the hu uman, non‐hu uman primate, dog and rat species in n almost any fformat; The C Company’s Hµ µRELflowTM multi‐tissue m microfluidic p platform is curreently in beta‐ttest stage.

Hypha D Discovery LTD D Booth 505 5

Hyph ha Discovery m manufacturess microbial an nd mammaliaan metabolitees for pharmaaceutical and agrochemicaal partners world dwide. We arre experts in m mg to gram sccale production of metaboolites derived d from CYP an nd non‐CYP prrocesses, as well as conjugatess such as gluccuronides. Ap pplication of o our microbiall technology aalso delivers polar analogu ues for lead optim misation proje ects.

o ADMET Laboratories, LLC C In Vitro Booth 313 3

In Vittro ADMET Laaboratories, Inc. (IVAL) pro oducts and se ervices repressent three decades of expeertise in reseaarch and innovvation toward d evaluating d drug absorptiion, metabolism, drug‐druug interaction ns, drug transporters, and ttoxicity. For consistently high‐functioning h hepatocytes, reliable in vitro services, aand cutting ed dge hepatocyyte technologies, IVAL is the C Complete Hep patocyte Solu utions provide er.

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Ex xhibittor D Directtory IInSphero, Incc.

Booth 514 4

InSph hero is the leaading provide er of 3D InSight™ Microtisssues and screeening servicees to the pharmaceutical, cosmetics & chem mical industryy. Our organottypic 3D InSigght™ Liver Miicrotissues (h uman, rat, HeepG2, dog, m minipig) featurre long‐lived, induccible CYP expression and ffunctional bile e canaliculi, e enabling moree biologically relevant & predictive in vitro toxicity and D DMPK analysiis.

InterVivo SSolutions, Incc.

Booth 509 9

InterrVivo Solution ns, a Canadian n CRO providiing pre‐clinicaal services foccusing on translational mo odels, offers ccore expertise in drug d discovery/optimization inccluding CNS e efficacy, phar macokineticss, bioanalysis,, safety and im maging services. Of signifficance is a naaturally aged canine mode el of human ddiseases which allows the eevaluation off NCEs for on and osteoaarthritis.

Alzheeimer’s Disease progressio

JCL Bioasssay USA, Incc.

Booth 515 5

ed and respon nsive bioanalyytical Contracct Research O Organization ((CRO) for preclinical and JCL iss an international dedicate cliniccal bioanalysiss. With JCL, yyou can trust that you will receive relia ble and timelly assay results so you can n make inforrmed drug development de ecisions. In aanyone else’s hands, the reesults would not be the saame.

d Lablogic Sysstems Limited Booth 300 0 LabLo ogic Systems Limited, is a worldwide m market leaderr in the supplly of LIMS and chromatoggraphy data systems to the e pharmaceutical, agrochemical a and nuclearr/PET industrries. We also design, man nufacture, sell and servicee instruments used in the measu urement of lo ow‐level radio oactivity.

Lhasa Limited d Booth 500 0

Educcational charitty and active research organisation with an enviablee reputation ffor collaborattive work with hin different indusstry sectors; LLhasa Limited d is a developer of prediction software and chemicall databases.

Derek Nexus: Toxicity predictio on; Meteor Nexus: Metabo olic fate pred iction; Sarah Nexus: Toxiccity prediction n; Vitic Nexus: Chem mical database; Zeneth: Ch hemical degraadation prediction

Life Technologies 1 Booth 401

Life TTechnologiess™ products harness the power of sccience to tra nsform lives. As a memb ber of the TThermo Fisher Scien ntific family of o brands, our instrumen nts, everydayy tools, and services offeer high‐qualitty, innovative life science e soluttions for every lab and app plication. Go tto lifetechnologies.com too learn more.

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E Exhib bitor Direcctory y MiicroConstants Booth 403 3

Micro oConstants iss a GLP‐compliant Contract Research Organization foocused on peerforming regulated bioanaalysis, drug metaabolism and p pharmacokine etic analysis in n support of d discovery, preeclinical and clinical drug d developmentt studies.

Micro oConstants p performs indu ustry‐standard d assays, custtom drug mettabolism reseearch, and IND D‐enabling sttudies to assesss drug‐drug iinteraction po otential, metabolic stabilitty, metabolitee profiling, an nd protein bin nding.

Nexcelo om Bioscience e Booth 314 4

meter line of simple‐to‐use e cell counterrs automate m manual cell counting procedures by ob btaining Nexccelom’s Cellom accurrate counts, vviability, and cell sizes in le ess than 30 se econds & onlyy 20uL of sam mple. Fluoresccence detectiion capabilities enable e fast & simple determination of GFP trransfection raates, PI‐viabillity, & direct ccounting of W WBCs withoutt lysingg.

O Optibrium Ltd d Booth 409 9

oftware helps guide decisio ons to select aand design hiigh quality co ompounds witth a good balance of Our SStarDrop™ so properties. StarDrrop combiness predictive A ADME, toxicityy and P450 m metabolism models and auttomatic QSAR R model build ding with uniq que approaches including tthe Glowing M Molecule™ annd Probabilisttic Scoring to o intuitively in ntegrate predicted and exp perimental daata.

Optivia B Biotechnology y Booth 204 4

Optivvia Biotechno ology, Inc. is aa leader in transporter biollogy researchh and transpo orter research h services. Op ptivia providess an arrray of transp porter assays based on its p proven Opti‐EExpression™ ttechnology and offers com mprehensive databases and m models to help in the disco overy and devvelopment off drugs with i mproved safeety and efficaacy.

Organiization for To ottori Industrial Promotion n Booth 304 4

We, TTottori Bio‐Frrontier Organ nization for Industrial Prom motion in Totttori prefecturre, are focusin ng on developing new chrom mosome engineering tech hnologies for vvarious pharm maceutical usses. We suppo ort the development of model mice, rats aand cells whicch show humanized drug m metabolism. YYou’re welco me to talk ab bout collaboraative research h, business,

etc. u using these m models.

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Ex xhibittor D Directtory Oxxford Biomed dical Research h Booth 306 6

Oxford Biomedicaal Research prrovides innovvative tools fo or studies of XXenobiotic Metabolism, in ncluding recom mbinant humaan Glutathion ne S‐transferaases, and antiibodies to GSST isoforms. O Our NEW CypExpress™ technology provvides human P450 0 & oxidoredu uctase coexprression in high hly stable perrmeabilized yyeast “shells” that retain G G6PDH — exceellent for robust metabolite e identificatio on, and large sscale producttion of metabbolites.

Paaraza Pharma a Booth 406 6

discovery servvice provider with deep exxpertise in Meedicinal Chem mistry, Custom m Synthesis aand DMPK (in A preemium drug d vitro//in vivo). Enttirely based in n North Amerrica (Montreaal) in a state oof the art buillding with higghly experiencced staff from large compaanies. Establisshed track record of succe ess and unparralleled cost eefficiency.

oenixBIO USA A Corporation n Pho Booth 512 2

PhoeenixBio produ uces the PXB‐Mouse® and high quality p pre‐clinical coontract researrch services. TThe PXB‐Mou use® is the world d's most wide ely used human liver chimeric mouse fo or predicting human respo onses in DMP PK/Toxicologyy and Hepaatitis B & C research fields,, providing more accurate and relevantt pre‐clinical d data for drug discovery and deveelopment.

n Promegaa Corporation Booth 501 1

Prom mega is a leader in providin ng innovative solutions and d technical suupport to thee life sciences industry. Pro omega Corporation’s ADM ME/Tox product line includ des our P450‐Glo assays foor measuringg inhibition/in nduction of a wide variety of cytochrome P4 450s as well ass our industryy leading cell viability reaggents for stud dying cellular toxicity.

Proteeomedix Fron ntiers Co., Ltd d Booth 405 5

ntiers holds an exclusive liccense to use SSilico‐peptidee selection method for pro otein quantification by LC‐ Proteeomedix Fron MS/M MS. We offer On‐Demand Protein Quan ntification Me ethod for druug metabolizin ng enzymes, ttransporters, receptors and cchannel prote eins in any an nimals. Our m method may be used to hel p in developm ment of biom marker protein ns for perso onalized med dicine.

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E Exhib bitor Direcctory y Puracyp p Booth 315 5

Pu uracyp is the w world’s leade er in transcrip ptional analys is of ADME geenes. Our neewest panel aassays meet all th man CYP1A2, he regulatory challenges asssociated with induction guidelines. Paanel screens tto predict ind duction of hum CYP22B6, CYP3A4 aand CYP4 are available. Asssays to predict induction in various animal models are also availlable.

C QPS, LLC 3 Booth 203

drug develop RO that supports discoveryy, preclinical,, and clinical d pment. We provide quality QPS is a GLP/GCP‐‐compliant CR services in CNS Ph harmacology, DMPK, Toxiccology, Bioanaalysis, Translaational Mediccine, and Early Stage & Phaase II ‐ IV A, Netherlandss, Austria, Cliniccal Research tto clients worrldwide. Our regional facilities and officces are locateed in the USA ny and the Un Taiwan, India, China, Czech Republic, Croatiia, Slovenia, SSerbia, Bosniaa, Hungary, Spain, German nited dom.

Kingd

Qualyst TTransporter SSolutions, LLC C 3 Booth 213

ducts and con Qualyst Transportter Solutions is the world'ss exclusive provider of heppatic drug transporter prod ntract B‐CLEAR® technology, thatt support drug discovery aand developm reseaarch services,, utilizing the proprietary B ment. Our integgrated hepaticc model can investigate: in ntracellular co oncentration,, transporter uptake and eefflux mechan nisms of clearrance, drug trransporter intteractions related to inducction and inhiibition, and hepatic‐related toxicities su uch as choleestasis and hyyperbilirubine emia.

Quintiles 5 Booth 415

ADME Labs, Q Quintiles offerrs 20+ years oof scientific leeadership with expertise and resources Through its Bioanalytical and A otechnology ccompanies identify and adddress compleex issues. Wee provide a range of in to heelp pharmaceutical and bio olite identificaation servicess in support oof drug discovvery and ADM ME regulatoryy filings. vitro ADME assays and metabo

Quotien h nt Bioresearch 8 Booth 608

O providing e Quottient Bioreseaarch is a leadiing global CRO early stage annd specialist ddrug developm ment servicess to clients ed and integraated solutionss for pharmacceutical, biotechnology an world dwide. We prrovide tailore nd agrochemical clients, ogies underpinned by unpaaralleled scienntific, medicaal, chemical and biological expertise. usingg state‐of‐the e‐art technolo ormation contact us at info o@quotientb For aadditional info bioresearch.coom.

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Ex xhibittor D Directtory Quo otient Clinica al Booth 312 2

Quottient Clinical iintegrates all the scientificc and operatio onal componeents required d to design an nd deliver a human ADME programme for re egulatory submission, inclu uding recent cchanges in reequirements rregarding thee generation o of absolute bioavvailability datta. We have e extensive experience in human ADME pprogrammes ffor drugs adm ministered thrrough all routees of delivery.

ReproCelll Booth 506 6

ReproCELL develo ops diverse prroducts, with an underlying theme of sttem cell technology, to address the neeeds of reseaarchers and clinicians. Human iPSC‐derrived hepatoccytes, cardiom urons; Suppo myocytes, neu ort matrices fo or 3D culture of ceells; Research reagents for human ES/iP PS culture; Dissease model ccell generatio on using human iPS cell tecchnologies.

SAGE Labs 3 Booth 513

SAGEE Labs specializes in the cu ustom design,, developmen nt and charactterization of unique, next‐‐generation aanimal reseaarch models ffeaturing specific gene deletions, inserttions and moddifications. W We also provid de extensive support services for researchers workin ng with animaal research m models.

Medical Co, Ltd d Sekisui M Booth 400 0

ADME CRO in JJapan since 11971. We con nduct various in vivo and in n vitro studiess Sekissui Medical (SSMD) has been a leading A such as QWBA, traansporter asssays or ADMEE studies usingg chimeric m ice with humanized liver. SMD, togetheer with our group company Xenotech, we offer overall contract servvices for ADM ME.

Sigm ma Life Science e Booth 308 8 Sigma® Life Sciencce offers a wide portfolio o of innovative technologiess to further reesearch in preeclinical drugg metabolism and ssafety testingg. Using our exclusive CompoZr® Zinc Finger Nucleasse technologyy we have devveloped noveel genetically‐ modiified cell base ed assays to in ncrease predictability and improve druug developmeent success.

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E Exhib bitor Direcctory y Simulations Plus, Incc.

Booth 413 3

mans and animals plus GastrroPlus™ sets the standard for PBPK/PD D modeling for different addministration routes in hum popu ulation simulaations and DD DI capabilities. DDDPlus™ aand MembrannePlus™ offerr simulations of in vitro disssolution and d perm meability expe MET Design SSuite™ mines compound libbraries, desiggns new moleecules, and virrtually eriments. ADM screeens structuress for >140 AD DMET propertties.

SNBL USA Ltd d Booth 305 5

m preclinical through Phasse IIa clinical sservices, SNBLL offers a full range of drugg developmen nt capabilitiess ranging from enced staff, addvanced bioaanalytical equ including premierr bioanalytical services. With its experie uipment and aa broad range e ervices in multiple test sysstems, SNBL ccan support your preclinicaal and clinical bioanalysis se of RI‐‐labeled and non‐labeled b studiies.

Solvo B Biotechnology y Booth 602 2

nd 450 custom VO Biotechnoology is the leading provideer of With 15 years of e experience an mers in 40 countries, SOLV ucts. Leveraging our expertise in efflux and uptake transporters, w we generate quality transsporter servicces and produ reports for submission to the FFDA and the EEMA. From sm mall moleculees to protein therapeuticss, SOLVO can test all your transsporter needss!

Taconic Booth 206 6

Taconic is a global provider of genetically m modified rodent models, seelected in vitrro tools and services. As a full‐service ounded in 195 indusstry leader, fo 52, Taconic helps clients acquire, test, ddevelop, breeed, cryopreseerve, prepare, and ngineered, hu distriibute highly rrelevant reseaarch lines worldwide. Whe ether you reqquire custom ggenetically en umanized or reseaarch‐ready models or hepaatocytes, Taconic's scientissts will partneer with you to o rapidly and efficiently ob h btain the high discovery or p ded for your d preclinical pro ograms. qualiity tools need

Takara B Bio Europe AB B Booth 109 9 Cellartis™ Enhancced hiPS‐HEP represents a reliable sourcce of functionnal human plu uripotent steem cell (hPSC)) derived e. The compaany also offerrs a robust Heepatocyte Diffferentiation SService from hepaatocytes, provvided by Takaara Bio Europe AB was formed d in Septemb hPSC. Takara Bio Europe A on of Cellectis AB, formerlly Cellartis ber 2014 thro ugh acquisitio any h

by Takara Bio Inc. AB, b

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Ex xhibittor D Directtory Tandem Labs 2 Booth 412 Tand dem Labs is a leading bioan nalytical serviice provider w with cutting‐eedge technolo ogy and services focused o on supporting g small and large‐m molecule development effo orts for discovvery, pre‐cliniical and cliniccal studies. W We strive to diffferentiate od developmeent, on‐time ourseelves with our scientific exxpertise, responsive projecct managemeent staff, strucctured metho metrrics, and stron ng regulatory history.

Therrmo Scientific 5 Booth 115

The TThermo Scien ntific brand re epresents The ermo Fisher SScientific’s brooad range of laboratory so olutions for th he life scien nces industrie es. Our product offerings in nclude chrom matography, m mass spectrom metry, and sp pectroscopy p products as well as guaranteed support to meet your an nalytical need ds. Whether yyour analysess are routine, investigativee, advanced reseaarch or process oriented, w we offer comprehensive so olutions for yyour applications. Our instruments and related techn nologies are u used throughout the chem mical, pharmaaceutical, bioppharmaceuticcal, proteomics, genomics,, ADM ME/DMPK, polymer, petrocchemical, environmental, aand food as w well as in goveernment and university lab boratories.

Thermo Scientific Pierce e

Booth 113 3

ntific Pierce RED Device forr Rapid Equilibrium Dialysiis provides an n easy‐to‐use, robust and reliable The TThermo Scien systeem for performing high‐thrroughput, auttomation‐com mpatible plassma protein‐b binding assayss. The Single‐‐Use RED Devicce consists off disposable in nserts preloaded into a baase plate form matted to a sttandard micro oplate footprint. For more e inforrmation visit B Booth 113 or visit thermosscientific.com m/RED.

Triangle R Research Labs Booth 207 7

Trian ngle Research Labs is a rapidly growing hepatocyte ccompany baseed out of Research Triangle Park, North h Carolina.

TRL is dedicated to revolutionizing the hepaatocyte experrience by con sistently exceeeding our cu ustomer's exp pectations quality produccts, superior customer serrvice and flexiibility, and un nbeatable value. with the highest q

of Washington n University o Booth 408 8

The M Metabolism & & Transport D Drug Interaction Knowledggebase (www .druginteracttioninfo.org) iis a web‐baseed research tool ffor pharmace eutical scientiists and clinicians working in the field oof drug metab bolism, drug ttransport, and d drug‐drug interactions. The platform conttains preclinical and clinicaal drug interaaction, organ impairment, and pharmaccogenetic studiies from the LLiterature and d from recentt NDA Review ws.

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E Exhib bitor Direcctory y Wako o Pure Chemiical Industries Booth 107 7

nd addressingg next generaation needs At Pu ure Chemical Industries, Lttd. We believe in supportin ng your R&D endeavors an throu ugh continued excellence in technologyy and quality.

Waters Corporation n 7 Booth 407

Wateers Corporattion creates business ad dvantages for laboratory ‐dependent organizations by deliverring scientific make profound discoveriess, innovvation to enaable customerrs to make siggnificant advaancements. W Waters helps customers m d ory operation optim ns, deliver product perfo ormance, andd ensure reggulatory compliance with a connected mize laborato portffolio of separations and an nalytical scien nce, laboratorry informaticss, mass spectrometry, as w well as thermal analysis.

Xenobioticc Laboratories 0 Booth 600

o nical ADME, P Xeno PK/TK, in vitro oBiotic Laboraatories, Inc. iss a leading contract laboratory specializzing in non‐clinical and clin drug interaction, ttransporters and metaboliism, bioanalyytical method developmen nt/validation aand clinical saample DA and USDA analyysis. XBL is FD ear Princeton , NJ. XBL‐Chin na is located in Nanjing. B Both facilities nd located ne A registered an edited. are A AAALAC accre

C X XenoTech, LLC 0 Booth 400

bal CRO with expertise in e Xeno oTech is a glob evaluating drug candidatees, nutraceuticals, cosmetics, food addittives and other compoundss, substrates, inhibitors and inducers off cytochrome P450, UGT, d drug transporrters and otheer drug mpany offerss a variety of iin vitro and inn vivo safety aassessment studies, as weell as an metaabolizing enzyymes. The com earch. nsive selectio on of productss for drug meetabolism rese exten

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Ex xhibitt Halll Floo or Pla an Grand Ballroo om AB

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