ISSX Newsletter | Issue 3, 2017

Volume 40

Issue 3, 2017

ISSX President’s Message

By Geoff Tucker, ISSX President The 14th European ISSX Meeting in Cologne, Germany held at the end of June was ver y successful. There were about 470 par ticipants from 28 nations. Congratulations to Uwe Fuhr and the Meeting Organizing Committee on the excellent venue selection and arrangements and the well-balanced program.

While in Cologne, ISSX met with members of the leadership of the European Association of Clinical Pharmacology and Therapeutics (EACPT) where it was agreed that the next European gathering of ISSX in 2020 will be held jointly with the EACPT in Geneva, Switzerland. We are ver y much looking for ward to this combined meeting.

ISSX also looks for ward eagerly to the 21st Nor th American Meeting in Providence, Rhode Island from September 24 - 28. Jash Unadkat, Allan Rettie, and the other members of the organizing committee have put together an outstanding series of presentations. Congratulations are due to Kathy Giacomini, 2017 recipient of the ISSX Scientific Achievement Award in Honor of Ronald W. Estabrook, and to Namandjé Bumpus, winner of the 2017 Nor th American New Investigator Award in Honor of James R. Gillette. Both Kathy and Namandje will be present to receive their awards and to deliver their award lectures in Providence. It is not too late to make plans to attend and, if you need any assistance or

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information, please contact the ISSX staff.

In this issue of the ISSX Newsletter you will see statements from Geoff Tucker, Ph.D. the chairs and ISSX President. co-chairs of the three ISSX Focus Groups.

Par ticipation in ISSX Focus Groups is included with the standard annual dues assessment and members may choose to join one or more groups.

See page 3 for more information and descriptions about each Focus Group.

Continued on next page

For me, ISSX meetings are an excellent forum to learn new information and to recharge my professional batteries.

—Recent Past ISSX Meeting Attendee

It’s not too late to make plans to join hundreds of other scientists in Providence, Rhode Island in pursuit of deeper knowledge of drug metabolism and pharmacokinetics and related areas. Gain new insight from important scientific and educational sessions on drug metabolism, drug transport, small and large molecules, toxicology, pharmacology, molecular biology, and related topics while engaging with others working on drug/xenobiotic research in diverse areas

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including basic and clinical pharmacology and therapeutics, toxicology, oncology, endocrinology, physiology, biochemistry, molecular and structural biology, and more. We look forward to enjoying this charming part of New England while renewing past acquaintances and meeting new colleagues at the 21st North American ISSX Meeting and we hope you will join us! Details available at issx2017na.com.

President’s Message Continued from previous page Associating and actively par ticipating in a Focus Group can significantly enhance the exchange of the most current scientific research information and open doors to endless oppor tunities for collaboration and career advancement. We hope that active par ticipation provides personal growth and professional development to ISSX members. Align yourself with one, two, or each of the ISSX Focus Groups now. Simply go to issx.org/focusgroups to register.

Finally, it is my pleasure to announce the results of the recent election. ISSX members were asked to select the new President-Elect/Secretar y, TreasurerElect, four members of Council, and three members of the Nomination Committee. Each of the selected individuals have confirmed their willingness to ser ve.

Their terms will commence on Januar y 1, 2018.

President-Elect/Secretary: Ann K. Daly, Newcastle University Treasurer-Elect: Erin K. Schuetz, St. Jude Children’s Research Hospital

ISSX Council: Emily Scott, University of Michigan William Griffith Humphreys, Bristol-Meyers Squibb Mike Zientek, Takeda Lei Zhang, U.S. Food and Drug Administration Nomination Committee: Sandy Pang, University of Toronto Charles Crespi, Corning Life Sciences Tommy B. Andersson, AstraZeneca Many thanks to Nomination Committee Chair John Miners and the entire Nomination Committee in developing a fine slate of candidates for office.

Watch for your membership dues renewal in the coming months and be sure to renew regardless of whether you plan to join us in Montreal for our 22nd Nor th American Meeting in July. Your sustained membership with ISSX is ver y impor tant to us and is greatly appreciated.

I hope to see you at an ISSX meeting soon!

Promoting the Science Around the World In May, ISSX suppor ted the Chinese Society for the Study of Xenobiotics in the organization of a workshop entitled Pharmacokinetics Evaluation & Review for Suppor ting IND/NDA – Case Studies. The workshop was held May 20 – 21 in Beijing, China and included sessions on CYP450 Induction, Transpor ter-based DDI, Radioisotope DMPK, Silicon Prediction, Herb-Drug Interactions and Bioequivalence. The workshop was attended by more than 100 par ticipants including a large number of students.

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Special thanks for their contributions in making this workshop a success go to: Zhuohan Hu Takashi Izumi Sonia de Morais Jas Sahi Chuang Lu Dennis Bashaw Raju Subramanian

Free to ISSX Members Register with an ISSX Focus Group Today!

One outcome of the strategic planning meeting held in 2015 was the development of Focus Groups to provide oppor tunities for members to engage in concentrated dialog with others and to impact content at future ISSX meetings. While the long-term objectives of each group may evolve, the initial purposes include: •E ncouraging the involvement of members in ISSX affairs; •S timulating communication between ISSX members from around the world; • Generating new membership in the Society; •E nabling members to provide specific input into meeting program planning and on-line education initiatives; •E nhancing interaction and collaboration with other societies interested in the interplay of living systems with medicines and chemicals.

We have made plans to convene our Focus Groups at the 22nd Nor th American Meeting in Montreal. While the exact form of each session is in the planning stage, please know that we welcome you to special sessions at this meeting to help with planning. Here is more about each of the three Focus Groups: Biotransformation Mechanisms & Pathways Chair: Amit Kalgutkar (Pfizer) Co-Chair: Barr y Jones (AstraZeneca)

Modelling & Simulation Chair: Har tmut Derendor f (University of Florida) Co-Chair: Yusuke Tanigawara (Keio University, Tokyo) The emphasis of this group is to focus on the role of modeling and simulation in drug development in all stages. Examples include translational extrapolations from preclinical data to clinical expectations, drug-drug interactions, extrapolations of PK/PD data to special populations, early dose optimization and selection of doses for clinical testing, physiologically based pharmacokinetics, population pharmacokinetics and many others. Beyond being a forum for discussion, this group will strive to generate and publish position papers on the role of modeling and simulation for good decision making in drug development and regulator y decisions. The focus group will also maintain an active role at ISSX meetings, where members can meet and connect regularly to discuss progress and to recruit new members. The group will also aim to have targeted sessions at ISSX meetings that highlight new and exciting science within our focus area. Fur thermore, the focus group will reach out to other societies (ASCPT, ACCP, AAPS, ISOP, FIP) to join forces and interact closely on modeling and simulation topics.

The aims of this focus group are (a) to promote stateof-the-ar t analytical technologies to solve challenging issues faced in ADME studies and bioanalysis, (b) to enable industrial scientists to actively contribute to Continued on next page

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Bioanalysis in ADME Science Chair: Mingshe Zhu (MassDefect Technologies) Co-Chair: Kevin Bateman (Merck)

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The emphasis of this group is to focus on various aspects of metabolic biotransformation pathways associated with small molecule drugs and xenobiotics.

This is a relatively broad topic for both academic and industrial research but some of the initial points for discussion will include: (a) metabolism-directed drug design (e.g., incorporation of D to reduce metabolic liability), (b) mechanisms underlying biotransformations that yield “unusual” metabolites and characterization of the metabolizing enzymes responsible for their formation, and (c) idiosyncratic immune-mediated toxicity via metabolism (e.g., reactive metabolites).

The list of topics extends way beyond these examples,

spreading into drug design, drug-drug interactions and drug safety to name a few areas of interest. Beyond being a discussion forum, this group will aim to generate and publish position papers on new vistas in biotransformation science in relation to drug discover y/ development. The focus group will also maintain an active role at drug metabolism-centered (e.g., ISSX) meetings where members can meet/connect regularly to discuss progress and to recruit new members. The group will also aim to have targeted sessions at ISSX meetings that highlight new and exciting science within our focus area.

ISSX Focus Group Continued from previous page and par ticipate at ISSX meetings and associated activities, and (d) to enhance synergy between industrial scientists and academic researchers. Activities of this group include organizing ADME and bioanalysis-related sessions, workshops and discussion forums at ISSX meetings, to generate and publish position papers on emerging analytical technologies and approaches faced in drug discover y and development, and to collaborate with other organizations to discuss regulator y aspects of ADME and bioanalysis. In the next two years, this group will focus on the following topics: •M ethods of analysis of biologics and data interpretation in drug discover y and development.

•N ew technology and approaches for the bioanalysis of intact protein therapeutics.

•S trategies for early assessment of metabolite safety issues in drug development.

• I dentification of new analytical tools for improving in vitro models.

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•D MPK approaches to optimizing exposures with limited resources.

•S trategies and methods for early identification of issues associated with potentially toxic metabolites in drug discover y.

Par ticipation in ISSX Focus Groups is included with the standard annual dues assessment and members may choose to join one or more groups.

Aligning with one or more ISSX Focus Groups is easy.

Simply go to issx.org/focusgroups to sign up. Once we have a body of members aligned with each our chairs will use the forums to generate discussion and stimulate ideas for content at future ISSX meetings.

Routine interactions through the forums will enable members to post questions, comments, materials, and links to interesting and relevant online resources, and more.

Associating and actively par ticipating in a Focus Group can significantly enhance the exchange of the most current scientific research information and open doors to endless oppor tunities for collaboration and career advancement. We hope that active par ticipation provides personal growth and professional development to ISSX members.

Scenes from Cologne If you attended the 14th European Meeting of ISSX in Cologne this past June, we thank you and hope you enjoyed the experience. If you could not join us, here are some scenes from this excellent meeting.

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ISSX Names 2017 North American Award Winners North American Scientific Achievement Award in Honor of Ronald Estabrook

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The Nor th American Scientific Achievement Award is named in honor of Ronald W. Estabrook and is presented to an ISSX member who has made major scientific contributions to the field.

The focus of the award is the individual’s scientific accomplishments and it is intended to recognize the best in the field within Kathy Giacomini, Ph.D. Nor th America. The 2017 recipient is Kathy Giacomini, Ph.D, Professor, University of California San Francisco School of Pharmacy and Co-Director of the UCSF-Stanford Center of Excellence in Regulator y Sciences and Innovation.

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

At the University of California, San Francisco, Dr. Giacomini is a Professor and Co-Chair of the Depar tment of Bioengineering and Therapeutic Sciences. She is also a professor in the university's Depar tments of Pharmaceutical Chemistr y and Cellular and Molecular Pharmacology.

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

Dr. Giacomini has co-authored more than 200 manuscripts in peer-reviewed journals and has received many awards for her research including the Dawson Award of the American Association of Colleges of Pharmacy, the Rawls Palmer Award of the American Society for Clinical Pharmacology and Therapeutics, and the Scheele Award from the Swedish Academy of Pharmaceutical Scientists. It is in addition to these that ISSX bestows her with our highest award for scientific achievements in Nor th America. The award presentation and Dr. Giacomini’s lecture, Discovering the Endogenous Roles of Drug Transpor ters Through Genetic Studies, will take place on Wednesday, September 27 at 10:15 a.m.

North American New Investigator Award in Honor of James R. Gillette Presented to ISSX members who have made significant contributions to the field during their early career years (normally within 10 years from the time of receiving his/her highest earned degree), the Nor th American New Investigator Award encourages and recognizes developing scientists in the region.

The Nor th American Namandjé Bumpus, Ph.D. New Investigator Award is named in honor of James R. Gillette and is awarded this year to Namandjé Bumpus, Ph.D. Dr. Bumpus is an assistant professor of pharmacology and molecular sciences at the Johns Hopkins University School of Medicine. She holds a secondar y appointment in the Division of Pharmacology within the Depar tment of Medicine.

Dr. Bumpus received her Ph.D. in pharmacology at the University of Michigan-Ann Arbor and per formed thesis research in the laborator y of Dr. Paul F. Hollenberg where she investigated the effect of a naturally occurring cytochrome P450 (CYP) 2B6 mutation on the ability of the enzyme to become inactivated by known inactivators of the wild-type enzyme. As Continued on next page

North American Award Winners Continued from previous page a postdoctoral fellow with Dr. Eric F. Johnson at The Scripps Research Institute, Dr. Bumpus studied the regulation of CYP4A and CYP4F genes in mice.

Her research program is focused on defining the contribution of drug metabolism to the pharmacology and toxicology of drugs used to treat and prevent HIV infection.

Dr. Bumpus has authored or co-authored numerous peer-reviewed publications, ser ves on the editorial board of the journal Drug Metabolism and Disposition,

and is a regular member of the National Institutes of Health (NIH) Xenobiotic and Nutrient Disposition and Action study section. In 2013, she was honored with the prestigious Tanabe Young Investigator Award from the American College of Clinical Pharmacology. ISSX will honor her with the Nor th American New Investigator Award in Honor of James R. Gillette on Wednesday, September 27 when she will deliver her award lecture, Metabolism of Anti-HIV Drugs: A Quest to Personalize HIV Treatment and Prevention.

Advance Your Knowledge–Attend an ISSX Meeting The scientific meetings organized by ISSX provide exceptional oppor tunities for members of the scientific community to exchange ideas and exper tise, to develop a common vision, and to create and nur ture collaborations in fields related to the study of chemicals that are foreign to the human body.

We offer the chance to present your research via multiple formats at our meetings that we hold in Nor th America, Asia, and in Europe.

Shor t courses at our meetings on a variety of impor tant topics are a popular way to gain invaluable training. Scientific symposia tracks offer a multitude of options and forums for attendees to learn the most recent developments incorporating the newest 21st North American ISSX Meeting Rhode Island Convention Center Providence, Rhode Island, USA September 24–28, 2017 Meeting Chairs: Jashvant Unadkat, Ph.D. & Allan Rettie, Ph.D.

ideas and the most current evidence. The chance to view the latest product lines and learn about the ser vices of the companies par ticipating in the trade exhibitions drive even more value to your investment. Moreover, the people that you will meet at our meetings are extraordinar y. They are contributing to the expanding base of knowledge crucial to broadening the understanding of the effects of drugs, the mechanism of their actions, and the movement of drugs throughout organisms.

Please be sure to include funds in your training budget for you as well as your scientific team and par ticipate in our ver y high quality meetings that are organized by teams of leading educators and investigators worldwide:

6th Asia Pacific ISSX Meeting Zhejiang University Hangzhou, China May 11–15, 2018 Meeting Chairs: Su Zeng, Ph.D., and Jasminder Sahi, Ph.D.

Committee via ISSX Headquar ters at least 4–5 years in advance of the contemplated date of the meeting.

For more information, go to issx.org/submit.

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ISSX seeks proposals from members who may wish to organize scientific meetings. Individuals who wish to organize an ISSX meeting are welcome to submit a proposal and contact the Scientific Affairs

23rd ISSX North American and 35th JSSX Meeting Hilton Waikoloa Village Waikoloa, Hawaii, USA October 4–8, 2020 Meeting Chairs: Allen Rettie, Ph.D. and Hiroshi Yamazaki, Ph.D

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12th International ISSX Meeting Por tland Convention Center Por tland, Oregon, USA July 29–August 1, 2019 Meeting Chairs: Aleksandra Galetin, Ph.D., Hiroyuki Kusuhara, Ph.D., and Deepak Dalvi, Ph.D.

22nd North American ISSX Meeting Palais des congrès de Montréal Montreal, QC Canada July 15–19, 2018 Meeting Chair: Jack Uetrecht, M.D., Ph.D.

ISSX Welcomes New Members

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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.

Derek Angus, Cyprotex Lena Anoshchenko, University of Washington Benjamin Barlock Abdul Basit, University of Washington Gregory Boyce, Protea Biosciences Hon Chan, Allergan Sunny Chen, SPARCBIO LLC Liming Chen, UCONN Harry Chobanian, Merck and Co. Inc Nelson Cornwell, toXcel, LLC Li Di, Pfizer Inc. Vaishali Suresh Dixit, Eisai Sara Eyal, The Hebrew University of Jerusalem Laura Furge, Kalamazoo College Deepak Gupta, Vishnu Traders Allyson Hamlin, Johns Hopkins Medical Institute Matthew Hartog, SUNY Polytechnic Institute Angela Hayes, The Institute of Cancer Research Xiaowei He, Eisai Inc. Karen Houseknecht, University of New England Liyue Huang, Epizyme Masaru Iwasaki, Daiichi Sankyo RD Novare Co., Ltd. Rohitash Jamwal, University of Rhode Island Licong Jiang, Ver tex Amin Kamel, Takeda Kishore Katyayan, Eli Lilly and Company Lloyd King, UCB Mika Kosaka, Genentech, Inc. Adrien Labriet Rui Li, Pfizer Inc. Jian Lin, Pfizer Inc. Bo Lin, Nexcelom Bioscience Pingrong Liu, Boehringer Ingelheim

Ying Liu Bin Ma, University of Minnesota Fabrice Muller Neha Maharao, University of Washington Enrique Martinez, Oxford Biomedical Research Sumathy Mathialagan, Pfizer Inc. Takanobu Matsuzaki, University of Manchester David Mertz, Georgia Institute of Technology Anthony Midey, Waters Corp.

Yoshihisa Mimura, Nagoya City University Gordon Murray, Waters Corp.

Mika Nagai, Kaken Pharmaceutical Co. LTD. Olivier Nicolas, Sanofi Daichi Onozato, Nagoya City University Christine Orozco, Pfizer Inc. Xin-Ru Pan-Zhou, Retrophin Gabby Patilea-Vrana, University of Washington Stephanie Piekos, University of Connecticut Sylvie Pilote, CRIUCPQ Lisa Rahbaek, Inception Sciences Florence Raynaud, The Institute of Cancer Research Keith Riccardi, Pfizer Inc. Sophie Rose, IRSET Christopher Rowbottom, Biogen Frank Runge, Boehringer Ingelheim Pharma GmbH & Co. KG Sangwoo Ryu, Pfizer Inc. Armin Sadighi Yoko Sakai, Aichi Gakuin University Mitesh Sanghvi, Xceleron Inc. Rachel Sanig, Waters Corporation Herana Seneviratne, Johns Hopkins University

Mohammad Shadid, Biogen Peter Shaw, Merck & Co. Mai Shimizu, Japan Tobacco Inc. Matt Soars, Bristol-Myers Squibb Sam Sperry, Effector Therapeutics Marianna Stamou Kefeng Sun, Eli Lilly and Company Wei Sun, Sanofi Risa Takenaka Aaron Teitelbaum, Boehringer Ingelheim Wei Tong, Boehringer Ingelheim Animal Health Leon van Haandel, Childrens Mercy Hospital Anna Maria Vildhede, Pfizer Inc. Stella Vincent, Merck Marc Vrana Paul Vulto, Mimetas David Wagner, University of Washington Gregory Walker, Pfizer Inc. Stephen Wang, Pfizer Inc. Takao Watanabe, Sumitomo Dainippon Pharma Co., Ltd. Jeff Weber, Q2 Solutions Andrea Whitcher-Johnstone, Boehringer Ingelheim Beth Williamson, Evotec Francesca Wood, The Institute of Cancer Research Ryan Wulf, EUROFINS Takahiro Yamashiro, Nagoya City University Bingfang Yan, University of Rhode Island Xin Yang, Pfizer Inc. Honglu Zhang, Merck Research Laborator y Jingyu Zhang, Gilead Sciences, Inc. Sucha Zhang, Enanta Pharmaceuticals, Inc.

Book Review HOW MEDICINES ARE BORN: The Imper fect Science of Drugs Authors: L. Vozza, M. D’Incalci (translated by A. Gescher) World Scientific Europe Ltd 188 pp, ISBN-13: 978-1-78634-297-3. 2017 This is an English translation of a book originally published in Italian (M D'Incalci & L Vozza, Come Nascono le Medicine; La scienza imper fetta dei farmaci. Bologna: Zanichelli, 2014). As is stated in the adver tising for this volume, it is “an excursion into the drug development process, from the initial conception in a chemical or molecular biology lab, via tests in isolated cells and animals, to the stage of clinical trials.” In other words, the journey from idea to practice. Perhaps often oversimplified and cer tainly understated, this journey is fraught with difficulties and forlorn hope. It is indeed an imper fect science, “which often exaggerates benefits and minimizes risks associated with the administration of new drugs” (page vi, foreword). The book maintains a careful balance between optimism and pessimism, attempting to express the complex situation from all angles.

The nine chapters are entitled – “To cure, heal or repair;” “Hunting for drugs;” “Laborator y stories;” “First time in humans;” “Only probabilities, never cer tainties;” “Approval or rejection;” “Vigilance, revision, new indications;” “Predicting the drugs of the future;” and “Not ever y pill is a proper drug.” There are also a few sections after the main texts expanding the general messages por trayed – “If you want to know more…;” "Myths to be dispelled;” “Did you know that…;” followed by an index. It is written in a ‘journalistic’ style but never theless contains per tinent information, not from an intense scientific position (appreciated only to

specialists in the field) but at a level understandable by and interesting to the educated layman. The suggested readership list includes, “undergraduate, post-graduate and researchers in basic biomedical, biological and chemical disciplines; physicians; health ser vice policymakers and members of the general public.” This book is available as a hardcover publication (ISBN: 978-178634-297-3), a paperback edition (ISBN: 978-1-78634298-0) and an electronic e-book version (ISBN: 978-178634-300-0). It is a thought-provoking read and a welcome refresher to those of us who are enmeshed in areas of this field and perhaps need to step back and not forget the “bigger picture.” Well wor th it.

Reviewed by

Steve Mitchell Faculty of Medicine Imperial College London London SW7 2AZ, UK

Book Ordering Information

World Scientific Publishing Ltd Head Office: 5 Toh Tuck Link, Singapore 596224 Tel: 65-6466-5775; Fax: 65-6467-7667; E-mail: wspc@wspc.com.sg US Office: 27 Warren Street, Suite 401-402, Hackensack, NJ 07601 Tel: 1-201-487-9655; Fax: 1-201-487-9656; E-mail: sales@wspc.com UK Office: 57 Shelton Street, Covent Garden, London WC2H 9HE Tel: 44-20-7836-0888; Fax: 44-20-7836-2020; E-mail: sales@wspc.co.uk

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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 Stephanie Young at styoung@issx.org.

Change of Address

If your mailing address, telephone, fax number, or e-mail has changed or will change, please let us know as soon as possible. You may update your contact information at any time using the online membership director y, which you can access in the Member Only section of the website. If you have forgotten your username and/or password, please contact information@issx.org.

Deadline for the submission of material to the ISSX Office: ISSUE

MATERIALS DEADLINE*

RELEASE DATE

Issue 4, 2017

November 3, 2017

December 2017

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Subject to change

Editor Dr. Allen Cato, III Cato Research, LTD 6480 Weathers Place, Suite 104 San Diego, California 92121 USA Telephone: +1-858-452-7271 Fax: +1-858-452-7784 E-mail: jcato@cato.com

ADVERTISE WITH ISSX The quarterly ISSX Newsletter is an online publication featuring Society updates, scientific articles of interest, book reviews, summaries of ISSX meeting proceedings, and more. This publication is designed to update the ISSX membership on the activities and events of the organization and to provide an information forum.

Not only is the ISSX Newsletter promoted directly to all ISSX members, it is also available to anyone who visits the ISSX website.

Visit issx.org/advertising or contact Stephanie Young at styoung@issx.org.

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