Volume 42
Issue 3, 2019
ISSX President’s Message By Thomas Baillie, ISSX President Our Society’s premier event of the year, the 12th International ISSX Meeting, held in Por tland, OR, from July 28–31, proved to be a great succes and more than 700 delegates from 24 countries around the world attended. Thanks to the effor ts of the meeting co-chairs, Aleksandra Galetin, Deepak Dalvie, and Hiroyuki Kushahara, members of the Meeting Organizing Committee, and the ISSX administrative staff, the event provided a stimulating scientific forum with one keynote lecture, three plenar y lectures, 11 scientific symposia, one awards session, one new investigator session, three focus group discussions, 268 poster presentations, and two industr ysponsored symposia. Coupled with an enjoyable social program, and blessed with beautiful summer weather typical for the Pacific NW, the conference seemed to meet—or exceed—ever yone’s expectations. A new feature on the program was a
general membership meeting, at which updates from members of Council were presented on the state of the Society and many excellent suggestions regarding our activities were made by members in attendance. There was considerable discussion around the timing of our annual Nor th American conference, held in the summer last year (in Montreal) as well as this year when it took the form of the triannual International Meeting. Due to conflicts with summer vacations and other factors, we will be moving this event back to the fall, with the meeting next year (a joint meeting with our Japanese colleagues, JSSX) taking place in Hawaii (October 4–8, 2020) and the following year’s event being held in Boston, MA (September 12–16, 2021). Hopefully, this scheduling change will facilitate greater attendance by all segments of our membership. On the subject of future ISSX events, the upcoming workshop.
“Disposition of Biologics,” jointly organized by Dhaval Shah and Honghui Zhou, will take place at Merck Research Laboratories Thomas Baillie, Ph.D. in Boston, MA, ISSX President. December 12–13, 2019. Registration is now open on the ISSX website. Next year promises to be a busy one for ISSX since, in addition to the Hawaii meeting, we are co-sponsoring a conference with the European Association for Clinical Pharmacology and Therapeutics (EACPT) in Geneva, Switzerland, from June 7–11, 2020, and plans are under way for a workshop on in vitro technologies to be held towards year-end—stay tuned for more details! Continued on page 8
IN THIS ISSUE 2
Book Review
4
12th International ISSX Meeting in Review
3
In Memoriam: Joyce Allene Goldstein
9
ISSX 2019 Workshop
11 Welcome New Members
Book Review DRUG METABOLISM, PHARMACOKINETICS AND BIOANALYSIS Editors: Lee HS, Liu KH. Multidisciplinar y Publishing Institute (MDPI) 232 pp. ISBN 978-3-03897-916-6 (Pkb); ISBN 978-3-03897-917-3 (PDF). 2019
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This book, available both as a printed work and online (pdf), is a reprint of ar ticles from the special issue entitled, Drug Metabolism, Pharmacokinetics and Bioanalysis that was published in the journal, Pharmaceutics (2018, volume 10). The chapters, or more correctly, papers, contained are multifarious and have the titles as given below. “Dr ying technologies for the stability and bioavailability of biopharmaceuticals,” “Pharmacokinetic proper ties of acetyl tributyl citrate, a pharmaceutical excipient,” “Pharmacokinetics and anti-gastric ulceration activity of oral administration of aceclofenac and esomeprazole in rats,” “Simultaneous determination of chlorogenic acid isomers and metabolites in rat plasma using LC-MS/MS and its application to a pharmacokinetic study following oral administration of Stauntonia Hexaphylla leaf extract (YRA-1909) to rats,” “Characterization of CYPs and UGTs involved in human liver microsomal metabolism of osthenol,” “Pharmacokinetics and brain distribution of the active components of DA-9805, saikosaponin A, paeonol and imperatorin in rats,” “Pharmacokinetic drug-drug interaction and responsible mechanism between memantine and cimetidine,” “Exploring the metabolism of loxoprofen in liver microsomes: The role of cytochrome P450 and UDP-glucuronosyltransferase in its biotransformation,” “A simple and sensitive liquid chromatography with tandem mass spectrometric method for the simultaneous determination of anthraquinone glycosides and their aglycones in rat plasma: Application to a pharmacokinetic study of Rumex acetosa extract,” “Bioavailability of eur ycomanone in its pure form and in a standardised Eur ycoma longifolia water extract,” “Development of a column-switching HPLC-MS/MS method and clinical application for determination of ethyl glucuronide in hair in conjunction with AUDIT for detecting high-risk alcohol consumption,” “Effect of red ginseng extract on the pharmacokinetics and efficacy of metformin in streptozotocin-induced diabetic rats,” “Simultaneous
determination of five cytochrome P450 probe substrates and their metabolites and organic anion transpor ting polypeptide probe substrate in human plasma using liquid chromatography-tandem mass spectrometr y,” “A liquid chromatography-quadrupole-time- of-flight mass spectrometric assay for the quantification of Fabr y disease biomarker globotriaosylceramide (GB3) in Fabr y model mouse,” “Qualification and application of a liquid chromatography-quadrupole time-of-flight mass spectrometric method for the determination of adalimumab in rat plasma,” and “Simultaneous determination of procainamide and N-acetylprocainamide in rat plasma by ultra-high-pressure liquid chromatography coupled with a diode array detector and Its application to a pharmacokinetic study in rats.” This is quite an eclectic mix of papers and covers a wide range of interests under the groupings of drug metabolism, pharmacokinetics, drug interactions, and bioanalysis. The volume has a reasonable layout enhanced by many tables, schematics, diagrams, mass spectra, histograms, graphs, chemical formulae, metabolic pathways, and photographs. Five hundred and seventy per tinent references are given, but with a collective work of this type, there is no index. It is well wor th a look if one of the chapter titles stirs special interest.
Reviewed by
Steve Mitchell Faculty of Medicine Imperial College London London SW7 2AZ, UK
Book Ordering Information MDPI (Multidisciplinar y Publishing Institute) St Alban-Anlage 66 4052 Basel Switzerland Tel. +41 61 683 77 34 Fax +41 61 302 89 18 www.mdpi.com Pharmaceutics Editorial Office E-mail: pharmaceutics@mdpi.com www.mdpi.com/journal/pharmaceutics
In Memoriam: Joyce Allene Goldstein March 8, 1941–August 6, 2019 Joyce Allene Goldstein was born March 8, 1941, to Herma Mae Cotton Winfrey and Clarence Winfrey in Whittier, California. The family moved to Camden County, Missouri in 1948 and Joyce graduated from Stoutland High School in Stoutland, Missouri in 1959. She attended Southwest Missouri State University in Springfield, Missouri and graduated with a bachelor’s degree in 1962. She attended graduate school at Florida State University in Tallahassee, Florida for one year and then transferred to the University of Texas Southwestern Medical School in Dallas, Texas, where she received a doctorate degree in Pharmacology and Biochemistr y in 1968. Joyce was an outstanding scientist and made major contributions to the fields of drug metabolism, pharmacogenetics, gene regulation and toxicology. As a pioneering researcher in the fields of drug metabolism and pharmacogenetics, Joyce’s strong publication record and long histor y of impact to this field of science was profoundly impactful. Her most impor tant discover y was in the field of pharmacogenetics to explain interindividual variations in drug disposition with the discover y of major genetic polymorphisms in the CYP2C19 and CYP2C9 genes. These discoveries were the foundation for fur ther work, by her and others within the field, and enabled a clearer understanding of the genetic variation for widely-prescribed drugs.
Throughout her career, Joyce valued the impor tance of collaborations. She was driven and determined to work with the best in the field around the world, and to forge impactful research. She also fostered a spirit of camaraderie with her laborator y staff. Many of the friendships that star ted many years ago, are still strong to this date. She took pride in making the best scientific decisions, even though, at times, it was a daunting challenge; or it was unconventional relative to the current thinking within the field. In a global race with top researchers to identify the gene responsible for the polymorphism, Joyce relied on her collaborative work with top international scientists to sequence DNA from phenotypic poor metabolizers, which eventually unraveled the myster y. The life of a scientist is defined by the knowledge they create, the par tnerships they forge, and the legacy they leave behind. Joyce left an indubitable legacy of novel discoveries and inspiration to her apprentices, who went on to lead their own successful scientific careers. In a time when there were few women in the high ranks of drug metabolism and toxicology, Joyce’s contributions will last for generations to come. In 2018, Joyce was recognized by the International Society for the Study of Xenobiotics with the Nor th American Scientific Achievement Award. Even with her handicapped status due to MS, she travelled to Montreal to attend the society’s international meeting to give a lecture and receive the award.
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Joyce was preceded in death by her parents and two brothers, Lyle Keith Winfrey and Gerald Wayne Winfrey. She is sur vived by her husband of fifty-five years, Rober t J. Goldstein, a brother, Clyde Winfrey of Richland, Missouri and a sister, Jeane Arlene Winfrey of Jefferson City, Missouri. Joyce will also be mourned by her large professional family of colleagues, post-doctoral fellows, and research technicians.
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Joyce was admired by most of her peers in the field. From the earliest years, she stood shoulder-toshoulder with many of the giants in the field of drug metabolism research, something few other women can claim even today. Her scientific publication record was exemplar y with more than 163 peer reviewed papers, and 25 book chapters/review ar ticles. Her two most prominent publications on the CYP2C19 gene have together received more than 2000 citations by others. She was given the ISI Highly Cited Author in
Pharmacology Award in 2006. Her career at NIH/NIEHS culminated at the Senior Biomedical Research Ser vice (SBRS) level, which designates the best class of NIH. Joyce’s last role was as a Scientist Emeritus at the National Institute of Environmental Health Sciences at the Research Triangle Park in Nor th Carolina.
12th International ISSX Meeting in Review Seven hundred scientists, students, and exhibitors convened at the Oregon Convention Center in Por tland, Oregon, USA this July 28–31 for ISSX2019: The 12th International ISSX Meeting. The meeting was co-chaired by Deepak Dalvie of Celgene, Aleksandra Galetin of the University of Manchester, and Hiroyuki Kusuhara of the University of Tokyo. The Meeting Organizing Committee and the Scientific Affairs Committee created a rich scientific program that showcased a broad range of shor t courses, symposia, and lectures designed to ser ve the interests of scientists from around the world.
View all of the ISSX2019 Meeting Photos
12th International ISSX Meeting Organizing Committee Co-Chairs, Deepak Dalvie, Aleksandra Galetin, and Hiroyuki Kusuhara.
at ISSX.SMUGMUG.COM The meeting was preceded by four shor t courses attended by nearly 200 meeting registrants. The courses covered Advances in the Role of Transpor ters in Drug Development; Non-P450 Enzymes in ADMET for Drug Discover y and Development; State of the Ar t PKPD and QSP Modeling; and Idiosyncratic Drug-induced Liver Injur y.
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The meeting began with an Opening Welcome Reception for attendees to view posters, network, and visit with the 50 exhibiting companies to view their products and ser vices at the meeting. This year, attendees par ticipated in a “Taste of Por tland” to sample regional wines and beers during the reception. Poster networking and presentation sessions were held throughout the meeting and provided more than 250 authors
Keynote Speaker, Larry Lesko, presents Model-Informed Precision Dosing at the Bedside: Scientific Challenges and Opportunities.
with the oppor tunity to present their research on an international stage. This meeting featured the presentation of three prestigious Society awards. The R.T. Williams Distinguished Scientific Achievement Award, sponsored by Charles Crespi and Family, was awarded to C. Roland Wolf, OBE, FRSE, FMedSci, FRSA, FBTS of the University of Dundee, Medical Research Institute. The Frederick J. Di Carlo Distinguished Ser vice Award was awarded to Charles Crespi, Ph.D. A new award, the Distinguished Accomplishments in Drug Discover y and Development Award was presented to Raymond Evers, Ph.D., Director, Transpor ters and In Vitro Technologies, Drug Metabolism and Pharmacokinetics, Merck and Co. Learn more about these award winners on pp. 6–8. The ISSX New Investigator Group hosted a breakfast session on Monday, July 29. Bhagwat Prasad of Washington State University chaired the session and welcomed more than 50 par ticipants. All investigators within their first ten years of receiving their highest earned degree were invited to attend and par ticipate in this session. Senior scientists in academia, industr y, and government met with attendees to review topic areas and questions such as 1) What current trends do you see in your area of work/research that may affect the job oppor tunities or research directions in the next 2–5 years? 2) How should a young investigator make his/herself stand out among their peers during the Continued on next page
12th International ISSX Meeting Continued from previous page application or inter view process? 3) What are the factors to consider when selecting to pursue a position/career in industr y, academia, or government/ regulator y? The ISSX Focus Groups held open sessions throughout the meeting to invite feedback and par ticipation in the three focus areas of Bioanalysis in ADME Science, Biotransformation Mechanisms and Pathways, and Modeling & Simulation. The ISSX Focus Groups were first developed in 2016 as an extension of the ISSX Strategic Plan and became an active forum for discussion in 2017. Membership in the ISSX Focus Groups is an exclusive benefit of ISSX membership. ISSX Focus Groups are designed to allow members to network with colleagues, while discussing topics relevant to the day. If you have not yet joined one or more groups, please visit issx.org/focusgroups to sign up today and learn more.
New Investigators enjoy breakfast and career conversations with senior scientists.
The Society is grateful to the meeting co-chairs, the organizing committees, session chairs, speakers, exhibitors, sponsors, and attendees who made this meeting possible.
Graduate/Predoctoral Awards • FIRST PLACE: Haeyoung Zhang of the University of Washington in Seattle, Washington, USA for the poster A1 entitled “IS URINARY TESTOSTERONE GLUCURONIDE A POTENTIAL BIOMARKER FOR UGT2B17 ONTOGENY IN AGES 7 TO 18 YEARS?” • SECOND PLACE: Revathi Chapa of the University of Washington in Seattle, Washington, USA for the poster A6 entitled “INVESTIGATING THE ROLE OF DRUG TRANSPORTERS IN FUROSEMIDE ABSORPTION, FOOD— EFFECT AND ELIMINATION USING A PROTEOMICS INFORMED—MECHANISTIC PBPK MODELING APPROACH.” • THIRD PLACE: Jasleen Sodhi of the University of California San Francisco, San Francisco, California, USA for the poster A5 entitled “THE EFFECT OF CHANGES IN PHARMACOKINETICS OF TRANSPORTER SUBSTRATES ON PBPK MODELING APPROACHES.” Postdoctoral Awards • FIRST PLACE: Naveen Neradugomma and Abdul Basit of the University of Washington in Seattle, Washington, USA for the poster A10 entitled “CHARACTERIZATION OF DIFFERENTIAL TISSUE ABUNDANCE OF MAJOR NON– CYP ENZYMES IN HUMAN.” Continued on next page
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Were you unable to join ISSX in Por tland? Make plans to attend the ISSX 2019 Workshop: Disposition of Biologics this December 12 & 13 in Boston, Massachusetts. This two-day workshop features well-known speakers from industr y, academia, and regulator y agencies and will address critical challenges in predicting human clearance and pharmacokinetics. Learn more about this workshop on pp. 9–10.
ISSX encourages high-quality research and recognizes distinguished poster presentations by young scientists in both the graduate/predoctoral and postdoctoral categories during the meeting. All posters accepted as finalists in the competition were reviewed and rated by the Poster Awards Committee on the basis of Significance of the Research Problem; Experimental Approach; Soundness of Conclusions; and Clarity of Presentation. The award recipients were:
Issue 3, 2019
You Can Still Attend an ISSX Event this December!
12th International ISSX Meeting Poster Award Winners.
12th International ISSX Meeting Continued from previous page
Top left: Attendees visit the exhibit hall to attend Sunday’s Opening Welcome Reception. Top right: Attendees learn from one another during a poster networking session at the meeting. Left: Attendees enjoyed arcade games, craft beers, and cocktails at the Spirit of 77 Networking Happy Hour, sponsored by Frontage.
• SECOND PLACE: Daniel Scotcher from the University of Manchester, Manchester, United Kingdom for the poster A12 entitled “MECHANISTIC KIDNEY MODELS FOR CREATININE: RELEVANCE OF OCT2 TRANSPORT DRIVING FORCE TO PREDICTION OF CREATININE‒DRUG INTERACTIONS.”
• THIRD PLACE: Ryota Shizu of the School of Pharmaceutical Sciences, University of Shizuoka, Japan for the poster A7 entitled “INTERACTION WITH YAP IS A POSSIBLE UNDERLYING MECHANISM FOR CAR-DEPENDENT HEPATOCARCINOGENESIS.” Congratulations to all of the graduate/predoctoral and postdoctoral award finalists and winners.
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2019 ISSX Awards The 12th International ISSX Meeting featured an awards ceremony commemorating the achievements of these distinguished scientists. R.T. Williams Distinguished Scientific Achievement Award, Sponsored by Charles Crespi and Family C. Roland Wolf, Ph.D. Charles Crespi presents the award to C. Roland Wolf.
The R.T. Williams Distinguished Scientific
Achievement Award is presented to an ISSX member from any region who has made substantial and seminal scientific contributions to the field over a sustained period and celebrates the individual's scientific accomplishment. This award recognizes the best in the field on international level. The 2019 recipient is C. Roland Wolf, OBE, FRSE, FMedSci, FRSA, FBTS, University of Dundee, Medical Research Institute. Roland Wolf graduated from the University of Surrey in 1972 with a BSc Honors in Chemistr y followed by a PhD in Biochemistr y. Until recently, he held position of Research Director at the University of Dundee Medical Research Institute and was Honorar y Director at the Cancer Research UK Molecular Pharmacology Unit. Continued on next page
12th International ISSX Meeting Continued from previous page In addition, he was a founder and the Scientific Director of CXR Biosciences (now Concept Life Sciences), based in Dundee, UK. Currently, he is Professor of Molecular Pharmacology at Dundee University. Professor Wolf’s primar y research interests are understanding the pathways that determine the sensitivity of cells to drugs, environmental agents, and chemical toxins, par ticularly molecular and genetic studies on how chemical agents interact with cells, how this influences their therapeutic and toxicological proper ties, and how genetic polymorphisms in the genes involved relate to disease susceptibility, adverse drug pharmacology and toxicology. Specific, current projects focus on preclinical drug development, the personalized treatment of cancer and the development of novel transgenic models to study drug pharmacology, disease etiology, and the mechanisms that underlie the deleterious effects of environmental pollution. Professor Wolf has published 533 papers in peerreviewed scientific journals, cited more than 28,000 times, and has an H index of 86. He has been a member of numerous national and international committees and advisor y panels in academia, government, and industr y.
metabolism and safety. Areas of long-term research focus of Dr. Crespi include: the development of mammalian cells which are competent for the metabolism and transpor t of xenobiotics, the overexpression of xenobiotic metabolizing enzymes and transpor ters in various host systems, and the development of novel applications of these systems to the discover y, development, and safety assessment of new chemical entities. A distinguished scientists and entrepreneur, Dr. Crespi has been a member of the International Society for the Study of Xenobiotics (ISSX) since the early 1990s. He ser ved the Society in a variety of roles including poster awards committee, meeting organizing committees, as a member of the Finance Committee from 2006–2009, and as Treasurer for two years, from 2010–2011. Dr. Crespi and his family generously endowed the R.T. Williams Distinguished Scientific Achievement Award. For his active involvement, leadership, exper tise, contributions, and commitment, ISSX is proud to honor Charles Crespi with the 2019 Frederick J. Di Carlo Distinguished Ser vice Award. Distinguished Accomplishments in Drug Discovery and Development
To recognize and celebrate Dr. Wolf’s substantial and sustained scientific contributions to the field of xenobiotic disposition spanning nearly five decades, he was awarded the 2019 R.T. Williams Distinguished Scientific Achievement Award. The Frederick J. Di Carlo Distinguished Service Award Charles Crespi, Ph.D.
The inaugural recipient of this award is Raymond Evers, Director, Transpor ters and In Vitro Technologies, Drug Metabolism and Pharmacokinetics, Merck and Co. He is receiving this award for his significant and sustained contributions to the field of drug transpor ter science and enzymology that have had tremendous impact on Continued on next page
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Charles Crespi received his PhD in toxicology from the Massachusetts Institute of Technology. In the early 1980s, Dr. Crespi and associates founded GENTEST Corporation, a company that became a leader in developing in vitro systems for the study of drug
The Distinguished Accomplishments in Drug Discover y and Development Award was created in 2018 to honor an individual or a team employed in an Ann Daly presents the organization involved in award to Raymond Evers. drug discover y and/or drug development. The award is bestowed on the basis of a single, high impact scientific accomplishment that dramatically changed practices in the ADME characterization of drugs or drug candidates or a sustained body of scientific work that shows high impact on the ADME characterization of drugs.
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Ann Daly presents the award to Charles Crespi.
The 2016 Frederick J. Di Carlo Distinguished Ser vice Award is presented to an ISSX member from any region with an illustrious record of impor tant ser vice to the Society and its goals. The 2019 recipient is Charles Crespi.
Raymond Evers, Ph.D.
President’s Message Continued from page 1 One sad piece of news to repor t is the recent death at age 78 of Dr. Joyce Goldstein, a long-time ISSX member and true pioneer in the field of cytochrome P-450 biology and pharmacogenetics, notably of the CYP2C9 and 2C19 genes. Many of you will recall that Joyce received the ISSX Nor th American Scientific Achievement Award in 2018, and we were most gratified that she was able to travel to the Montreal meeting to accept the award despite her declining health. A shor t tribute to Joyce is included elsewhere in this newsletter. On a happier note, I am pleased to repor t that membership in the Society is strong, and our initiatives on suppor ting new investigators have been well received. For example, the ISSX mentorship program, a free benefit to our younger members, has just concluded its second 6-month cycle, and more than 50 mentees have “graduated” thus far. Based on its popularity, we will be recruiting a third cohor t of par ticipants in the near future—if you are
interested in becoming either a mentor or mentee, please visit the membership section of the website to learn more and sign up. Finally, I note that all three of the ISSX Focus Groups (Modeling & Simulation, Bioanalysis in ADME Science, and Biotransformation) held meetings at the Por tland meeting that were well attended and hopefully will ser ve as the basis for ongoing interactions between members with similar interests. Going for ward, plans are being made to include representation from these FGs in the organizing committees of future ISSX meetings so that programming will include more “grassroots” input from the general membership. So, there’s lots going on, and much to look for ward to—thanks for your membership and continued suppor t of ISSX! Tom Baillie
12th International ISSX Meeting Continued from previous page
his company’s por tfolio and on the broader, scientific and regulator y field.
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Dr. Evers has had a tremendous impact with Merck and in the broader scientific community in the field of drug transpor ters and enzymology. His leadership and research have helped to improve the quality of the small molecule and peptide por tfolio in discover y and development and have contributed to the approval of many registered drugs. Dr. Evers has continued to
advance the discipline of drug transpor ters, drug-drug interactions, and DMPK in general, as evidenced by a strong and impactful record of publications and significant involvement in scientific societies. For his high impact scientific accomplishments advancing the ADME characterization of drugs and drug candidates, Dr. Evers was awarded the ISSX Distinguished Accomplishments in Drug Discover y and Development Award.
ISSX 2019 WORKSHOP:
Disposition of Biologics December 12–13, 2019 • Merck Research Laboratories, Boston, MA Who Should Attend? Biopharmaceutical scientists in industr y, academia, and non-profit organizations who are involved or interested in the discover y and development of novel biologics. They will learn: •W hat the key determinants responsible for whole-body and tissue-specific disposition of different biologics are •H ow biophysical characteristics like size, charge, and glycosylation affect disposition of biologics •E ffect of target engagement on the disposition and toxicity of biologics •H ow to determine optimal dosing regimen for biologics with nonlinear pharmacokinetics • I mpact of immunogenicity on the disposition, efficacy, and toxicity of biologics •D rug-interaction potential of biologics and assessment strategy •W hich biological modality to choose to maximize the probability of clinical success
Workshop Schedule-at-a-Glance Visit www.issx.org/workshopprogram to view the program and speaker details. THURSDAY, DECEMBER 12, 2019
By attending this workshop, scientists will: • L earn how to assess and characterize disposition profiles of biologics • Learn how to predict the disposition of biologics •E xamine how quantitative methods such as PK/PD Modeling and Simulation and Quantitative Systems Pharmacology are used to suppor t the discover y and development of biologics Get introduced to case-studies that can be leveraged to help ongoing or future projects in their organization •G ain insights into futuristic biologics that may become par t of their organization’s por tfolio going for ward •N etwork with other scientists and world-renowned exper ts who are working with similar biologics
10:45–11:30 AM Overview–Bioanalytical Methods used to Assess the Disposition of Biologics Renuka Pillutla, BMS, Princeton, NJ, USA 11:30–12:15 PM Assessing Whole-body Disposition of Biologics (Preclinical and Clinical) using Imaging Method Andrew Boswell, Genentech, San Francisco, CA, USA 12:15–1:30 PM Lunch Break 1:30–2:15 PM Factors Affecting Disposition of Biologics (e.g. TMDD/ Immunogenicity/Physicochemical Properties) Edit Tarcsa, Abbvie, Boston, MA, USA
10:30–10:45 AM Break Continued on next page
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9:45–10:30 AM Clinical Examples to Showcase the Disposition Properties of Biologics Bernd Meibohm, University of Tennessee Health Science Center, Memphis, TN, USA
How Will I Benefit from Attending?
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9:00–9:45 AM Overview—Basic Determinants for the Disposition/ ADME of Protein Therapeutics Joseph Balthasar, SUNY Buffalo, Buffalo, NY, USA
•H ow to employ the knowledge about disposition of biologics to suppor t the discover y, development, clinical translational, and regulator y filing of biologics
SSX 2019 Workshop Continued from previous page 2:15–3:00 PM DDI Potential of Biologics and Disposition in Special Population Honghui Zhou, Janssen, Princeton, NJ, USA 3:00–3:15 PM Break 3:15–4:00 PM Quantitative Characterization and Prediction of the Disposition of Biologics Dhaval Shah, SUNY Buffalo, Buffalo, NY, USA 4:00–4:45 PM Employing the Knowledge about the Disposition of Biologics to Support Discovery, Development, and Clinical Translation Weirong Wang, Janssen, Springhouse, PA, USA FRIDAY, DECEMBER 13, 2019 9:00–9:30 AM Case Study 1: Understanding the Disposition of Biologics to Treat Neurodegenerative Diseases Ivan Nestorov, Biogen, Boston, MA, USA 9:30–10:00 AM Case Study 2: Understanding the Disposition Secukinumab using Skin Microdialysis Studies 10:00–10:30 AM Case Study 3: Understanding the Disposition Daratumumab Thomas Puchalski, Janssen, Philadelphia, PA, USA
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10:30–10:45 AM Break 10:45–11:15 AM Case Sudy 4: Understanding the Disposition Vedolizumab Maria Rosario, Takeda, San Diego, CA, USA 11:15–11:45 AM Role of Biopsy and other Methods to Understand Clinical Disposition of Biologics 11:45–12:15 PM Novel in vitro Techniques to Predict the Disposition of Biologics Dan Rock, Amgen, San Francisco, CA, USA
12:15–1:30 PM Lunch Break 1:30–2:15 PM Understanding the Disposition of CAR-T and other Engineered Cells 2:15–3:00 PM Understanding the Disposition of Oligonucleotides/ SiRNA 3:00–3:15 PM Break 3:15–4:00 PM Understanding the Disposition of Gene Therapy Vectors (e.g. AAV) Nagendra Chemuturi, Novar tis, Seattle, WA, USA 4:00–4:45 PM Understanding the Novel Disposition of Novel Immunotherapy Like Oncolytic Virus
Visa Letters For many people, letters of invitation help smooth the visa process and we wish to suppor t international attendees in their effor ts to secure the needed travel documentation. However, in order to receive a letter of invitation, the workshop organizers must be assured that you intend to attend the workshop if your travel request is granted. Individuals that require an official letter of invitation in order to obtain a visa and authorization to attend the workshop must first register for the workshop and then request a Visa Letter of Invitation. We require that you provide your full name, address and email for us to process the official letter of invitation. The letter of invitation does not financially obligate the ISSX Workshop organizers in any way. All expenses incurred in relation to the workshop are the sole responsibility of the attendee. To request a letter of invitation, please email (indicate "invitation letter" in subject line) ISSX at information@issx.org. Register today at issx.org/2019workshop!
Welcome New Members The International Society for the Study of Xenobiotics proudly welcomes the following new members. We greatly appreciate their suppor t and hope that each remains aligned and affiliated with ISSX for many years to come.
Lavanya Bolla, National Institute of Pharmaceutical Education and Research-Hyderabad, India Karissa Cottier, BioIVT, United States
Ariane Leconte, Technologie Ser vier, France
David Steen, Biopredic, United States
Gregor y Loewen, Sekisui XenoTech, LLC, United States
Hao Sun, Seattle Genetics, United States
Maria Madeira, Merck, United States
Mengbi Yang, The Chinese University of Hong Kong, Hong Kong
Ji Eun Park, Sanofi, Japan Bo Feng, Ver tex, United States
Collen Masimirembwa, Aibst, Zimbabwe
Roslyn Thelingwani, Aibst, Zimbabwe
Joanna Gillette, University of Washington, United States
Mark McConnell, Celgene Corporation, United States
Mallor y Little, University of Washington, United States
Hugh Giovinazzo, Theravance Biopharma, United States
Gershon Mensah, University of Georgia, United States
Zeyuan Wang, Temple University, United States
Justin Hare, Novo Nordisk, United States
Narayana Narasimhan, Verastem Oncology, United States
Cozette Cuppett, Waters Corporation, United States
Shane Hendrickson, Wenatchee Valley College, United States
Joergen Olsen, Novo Nordisk Research Center, United States
Elijah Weber, Gilead Sciences, Inc., United States
Weize Huang, University of Washington Depar tment of Pharmaceutics, United States
Monica Maier, Oregon State University, United States
Alan Wong, Linus Pauling Institute, United States
Amit Patil, Tata Consultancy Ser vices, Ltd., India
Deok Yong Yoon, Seoul National University College of Medicine and Hospital, South Korea
Paul Jochems, Utrecht University, the Netherlands Abdul Karim Zulkarnain, Universitas Gadjah Mada, Indonesia
Jean Pineault, Pyxant Labs, Inc., United States
Chungping Yu, Supernus Pharmaceuticals, United States
Henr y Shin, KRCC, South Korea Molly Karlinsey, GlaxoSmithKline, United States
Angela Zhang, University of Washington, United States Mingyan Zhou, Purdue Pharma, United States
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Soo Kyung Bae, The Catholic University of Korea, South Korea
Byoung Soo Kim, Korea Institute of Radiological and Medical Sciences, South Korea
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it ng ee M
n PT a e C d p A n o E r la r u d e 0 E z n H t 2 T i a w 20 S 15 SX , , 0 a IS v -1 e 7 n Ge une J
MEETING PRESIDENT
Jules Desmeules
Hôpitaux Universitaires de Genève
MEETING CHAIRS
Caroline Samer
Hôpitaux Universitaires de Genève
Christoph Funk
ISSX/EACPT Roche Pharmaceutical Research and Early Development
Precision Medicine from Bench to Bedside
23RD ISSX NORTH AMERICAN AND 35TH JSSX MEETING A 2020 Vision for Biotransformation Research
October 4 - 8, 2020 Hilton Waikoloa Village Waikoloa, Hawaii, USA
MEETING CHAIRS: Allan Rettie, University of Washington Hiroshi Yamazaki, Showa Pharmaceutical University
Header ISSX Newsletter is published quar terly in the spring, summer, autumn, and winter. For information concerning adver tising in this publication, including rates and specifications, please visit issx.org/advertising or contact Scott Narug at snarug@issx.org.
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