Volume 47
Issue 3, 2023
ISSX President’s Message By Scott Obach, ISSX President Greetings Fellow ISSX Members– This will be the last president’s message from me as my term ends at the end of 2023, and I hand the reins over to Aleksandra Galetin. Over the past two years I’ve had the pleasure of working with Alex, as she has been taking an increasing lead in the deliberations of Council, in preparation for her role as president in full. We will be in excellent hands!! I’m pleased to announce a new change to the ISSX meeting policies. Over the past several years, we have witnessed a backlash against progress made across the world regarding honoring the rights of groups that have been marginalized based on sex, race, gender, sexual orientation, and other characteristics. While we are first and foremost a science society, we are also a society comprised
of fellow human beings, and the Council felt it appropriate to take an official stand against prejudice, discrimination, and hate. The ISSX Council has composed and approved a position statement, which was communicated at the opening of the 25th North American ISSX Meeting in Boston.
“As a scientific society, the ultimate goal of ISSX is to promote science that will improve the health and welfare of humankind. Humankind encompasses everyone regardless of race, ethnicity, sex, gender identity, sexual orientation, age, religion, and ability, and all are deserving of respect and care. ISSX hosts various conferences and events in locations around the world. All participants are welcome to these events in a safe and healthy environment. In this spirit, our policy is to preferentially consider venues that foster
acceptance and basic human rights.” This was greeted with spontaneous applause. I am so proud of us for this. Granted, Scott Obach we’re a small ISSX President society and our act of choosing to avoid having conferences in locales that have espoused discriminatory practices may go unnoticed, but every bit counts. If you happen to reside in one of these locations, please do your best to make your local officials aware of our position. We all share responsibility in making the world a better place.
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IN THIS ISSUE 2 Changes on the ISSX Council 6 Book Review 7 Multidisiplinary View of Modeling and Simulation 8 Renew Your ISSX Membership the Date: The 26th North American 10 Save ISSX Meeting and JSSX Meeting
11 ISSX Webinar Series 14 ISSX Focus Group 15 25th North American ISSX Meeting in Review 18 Welcome New Members 21 2023 ISSX Award Recipients 24 ISSX 2023 Featured Jobs Guide
Changes on the ISSX Council As 2023 comes to a close, we welcome the newest Council members, Michael A. Zientek, Albert P. Li, Yuji Ishii, Amin Rostami, and Valerie Kramlinger to the ISSX Council. Michael, Albert, Amin, and Valerie begin their two-year terms of service on Council on January 1, 2024. Michael will serve as the President-Elect/Secretary. Albert will serve as the Treasurer-Elect. Yuji represents the Asia Pacific region, and Valerie represents the North American region. Amin represents the European region.
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Michael A. Zientek (Mike) is a U.S. Citizen and received his B.S. from Purdue University and MPH from the University of Michigan. Mike has over 29 years of experience in drug metabolism and pharmacokinetics working in industry for both Pfizer Worldwide Research and Development and Takeda Pharmaceuticals. Mike has served in many roles throughout his career including Head of DMPK Takeda San Diego, and a neuroscience research project leader. He is currently a senior director and global head of ADME sciences at Takeda where he and his group provide mechanistic ADME, biotransformation, isotope chemistry, biodistribution and DMPK guidance to advance molecules through design efforts in discovery, optimizing and predicting human pharmacokinetic properties, preparing molecules for regulatory submission, and progressing compounds through clinical proof of concept. Mike served on the Council of ISSX from 2016–2020, the Nomination Committee from 2022 to present, and the Scientific Advisory Committee from 2020–2022. Recently, he co-chaired the 2022 ISSX/MDO conference in Seattle, WA. He has also served on the steering committee of the Southern California Drug Discussion Group for the past 10 years and he has been both Chair and Vice-Chair of the Gordon Research Conference (GRC) on Drug Metabolism.
Dr. Li is currently Chief Scientific Officer, Pharmacology and Toxicology, Discovery Life Sciences. He was the President, CEO and co-founder of In Vitro ADMET Laboratories LLC, Columbia, MD and Malden, MA which was acquired by Discovery Life Sciences in November, 2021. Previously, Dr. Li was President and CEO of Phase 1 Molecular Toxicology, Inc. in Santa Fe, New Mexico, U. S. A. (2002–2003), Chief Scientific Officer of In Vitro Technologies, Inc., Baltimore, Maryland, U.S.A. (1995–2002); Research Professor and Director of the Surgical Research Institute, Department of Surgery, St. Louis University Medical School (1993–1995); Senior Fellow and Director, Liver Biology Department, Monsanto Company (1982–1993); Group Leader, Cellular and Genetic Toxicology, Lovelace Inhalation Toxicology Research Institute (1979–1982); Assistant Professor and Research Scientist, Cancer Research and Treatment Center and Department of Radiology, University of New Mexico (1976–1979). Dr. Li obtained his B. Sc. (1972, Chemistry) from the University of Wisconsin, Stevens Point, Ph. D. (1976, Biomedical Sciences) from the University of Tennessee, Oakridge Graduate School of Biomedical Sciences. His received his doctoral training and performed his dissertation research under Professor Abraham Hsie in the Biology Division of Oak Ridge National Laboratory, Oak Ridge, Tennessee, and MBA (2002) from the University of Maryland University College. Dr. Li has devoted his scientific career to the development and advancement of scientific concepts and in vitro technologies to accurately predict human drug properties including metabolic fate, drug-drug interaction potential, and organ-specific toxicity. He is one of the pioneers in the cryopreservation of human hepatocytes which are now universally regarded as the gold standard for in vitro evaluation of human drug properties including metabolic fates, drug-drug interactions, and hepatotoxicity. Dr. Li has published 188 scientific papers/book chapters and edited 6 books in drug metabolism, drug-drug interactions, and
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toxicology. He serves as Section Editor of Pharmacology of Drug Metabolism Letters; Associate Editor of Predictive Toxicology, Frontiers in Pharmacology; as well as a member of the editorial board for various scientific journals. He is a member of the Industrial Advisory Board, Washington State University, Spokane and a committee member of several work groups of the Health and Environmental Science Institute.
Valerie earned her BS and Ph.D. at the University of Minnesota in chemistry and biochemistry, respectively. Her thesis research focused on inhibition and inactivation of the Cytochrome P450 2A enzymes with tobacco-specific nitrosamine and the subsequent impact on nicotine metabolism. She carried out postdoctoral research in the laboratory of Fred Guengerich at Vanderbilt University focusing on cytochrome P450mediated metabolism of endogenous substrates and extrahepatic metabolism. With her background in mechanistic small-molecule metabolism and active role in drug discovery and development, Valerie’s research interests include applying mechanistic drug metabolism concepts to solve drug discovery challenges, particularly in reactive metabolite identification, extrahepatic drug metabolism and human PK prediction.
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Yuji Ishii served on the Editorial Board of the official journal of ISSX, Drug Metabolism Reviews from 2014– present and Xenobiotica from 2020-present. He served as Guest Associate Editor of DMPK from 2015–16. Yuji Ishii served as a committee member of General Affairs
Valerie Kramlinger is a research professor in the department of Pharmacology at Vanderbilt University, serving as director of DMPK within the Warren Center for Neuroscience Drug Discovery. Her primary responsibility is to lead the DMPK characterization (in vitro ADME, biotransformation, and in vivo PK) of small molecules to support strategy on programs in the hit-to lead, lead optimization, and candidate selection stages of drug discovery. She also teaches graduate level drug discovery and DMPK within the Pharmacology and Quantitative Chemical Biology departments. Prior to this role, she spent seven years working in the pharmaceutical industry focusing on small-molecule ADME, including biotransformation, to support drug discovery and development.
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Yuji Ishii is a citizen of Japan who received a B.A. degree from the Faculty of Pharmaceutical Sciences, Fukuoka University and Master and Ph.D. degrees from the Graduate School of Pharmaceutical Sciences, Kyushu University. He was appointed as an instructor, Faculty of Pharmaceutical Sciences, Kyushu University in 1993. While in this position, he was a visiting Postdoctoral Fellow in the Department of Clinical Pharmacology at Flinders University of South Australia from 1997 to 1998. During this visit, he was supported by funding for overseas study from the Japan Research Foundation for Clinical Pharmacology and awarded a visiting Scientist Bilateral Joint Research Project between JSPS and the Australian Academy of Science. In 2001, Yuji Ishii was appointed as Lecturer of the Institute of Community Medicine, University of Tsukuba, Ibaraki, Japan and in 2003 returned to Kyushu University as Associate Professor. Since 2003 Yuji Ishii has been Associate Professor of the Laboratory of Molecular Life Sciences which, in 2019, was merged into the Division of Pharmaceutical Cell Biology, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan. Yuji Ishii’s research has focused on functional protein-protein interactions of UDP-glucuronosyltransferases and cytochromes P450 and more recently, on the mechanism of toxicity of maternally exposed 2,3,7,8-tetrachlorodibenzo-p-dioxin to next generations and on finding biomarkers of response to synthetic cannabinoids. He has authored over 120 publications.
of JSSX from 2019–present, Membership Activation JSSX from 2012–15 and DIS (director-initiative session)drug metabolizing enzymes from 2012–15. Yuji Ishii gave invited lectures in ISSX-Asia Pacific (2012), MDO (2014), ICCP450 (2015), International ISSX (2016), MDO (2016), and ISSX-MDO (2022) conferences. He co-chaired symposium sessions in ICCP450 (2015), MDO (2016), CSPS-PSJ-joint symposium (2021) and ISSX-MDO (2022). He also was a member of the Organizing Committee for the International Workshop on Conjugation 2016 in Vancouver, Canada.
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Amin Rostami was listed as one of the world's most highly cited researchers (under 'Pharmacology & Toxicology) in 2017 by the Institute of Scientific Information. Amin is also at 0.05% top rank of the Highly Cited Researchers List by Elsevier for pharmacology (2021). He has published over 300 peer reviewed highly influential scientific articles (>22,000 citations, h-index = 80). The work of Professor Rostami covers wide areas of drug development over the last 30 years, ranging from pharmaceutics (e.g. bioavailability and bioequivalence) to clinical pharmacology (e.g. mixture pharmacology of drug/metabolites), translational and systems pharmacology (e.g. quantitative proteomics of enzymes and transporter for in vitro to in vivo (IVIVE) scaling).
throughout his service as President and on Council, providing valuable input to ISSX. In addition to his time on the ISSX Council, he co-organized the ISSX North American Meeting in Providence, RI in 2003 and has served on advisory boards for several other ISSX meetings. He also served on the ISSX Scientific Advisory Board. Dr. Obach is a Vice President of Scientific Research in the Medicinal Sciences Group at Pfizer in Groton, CT. He earned his Ph.D. in biochemistry from Brandeis University in 1990, followed by a postdoctoral fellowship in 1990–1992 at the New York State Department of Health Research Laboratories with Dr. Laurence Kaminsky. In 1992, Scott joined the Drug Metabolism Department at Pfizer Inc. as a Research Scientist. His work experiences have included serving on multidisciplinary research and development project teams, and he has been involved in the development of Chantix and Geodon.
Amin was co-founder of two spin-off companies from the University of Sheffield (Simcyp Limited and Diurnal PLC). As a leader in the field of physiologically-based pharmacokinetics (PBPK) and quantitative systems pharmacology (QSP), he is internationally recognized for his expertise in IVIVE to predict the behavior of drugs in the human body and understanding the associated inter-individual variabilities. He was one of the founding editors of Pharmacometrics and System Pharmacology, and serves on the Editorial Boards of several other journals. As the Senior Vice President of Research & Development (SVP) and Chief Scientific Officer at Certara, he facilitates the incorporation and integration of the latest advances in translational modelling to biosimulation platforms offered by Certara to its clients, with the aim of accelerating the development and regulatory approval of safer drug products and bringing them to the patients.
K. Sandy Pang’s term as ISSX Treasurer comes to a close at the end of 2023. While serving as treasurer, Sandy has diligently reviewed ISSX financials and served on the ISSX Finance Committee. Dr. Pang is a Professor of Pharmacy and Pharmacology, Faculties of Pharmacy and Medicine at the University of Toronto. She received her Ph.D. from UCSF and post-doctoral training at the National Institutes of Health. Dr. Pang’s work spans the fields of pharmacokinetics, enzymes and transporters, and their regulation, and metabolite kinetics. She uses mechanistic-based approaches to explain drugs and metabolite handling within the eliminating organs upon inclusion of transport and metabolic processes into physiologically-based pharmacokinetic models. Recent work focuses on targets for the vitamin D receptor, VDR, and processing of calcitriol, active VDR ligand, on the regulation of transporters and enzymes and dynamics in the brain and kidney. She has served on various committees for NIH ASPET, AAPS, ISSX, and AAAS and is presently the Treasurer of ISSX. She is the editor-inchief of Biopharmaceutics and Drug Disposition and member of the editorial review boards of Drug Metabolism and Disposition and Xenobiotica. She was the recipient of various awards and was honored recently with the Gary Levy Lectureship at University of Buffalo.
ISSX also wishes to extend our thanks and appreciation for the work of our outgoing Council members, R. Scott Obach, K. Sandy Pang, Uwe Fuhr, Kiyomi Ito, and Nina Isoherranen. R. Scott Obach is completing his second term, and presidency, on the ISSX Council. Scott has been instrumental to the governance of the Society
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Uwe Fuhr finishes his term on the ISSX Council at the end of 2023. Along with his time on the ISSX Council, Uwe served on the ISSX Finance Committee from 2005 to 2007, and served on the Membership Affairs Committee. Additionally, he served as the chair of the Meeting Organizing Committee for the 14th European ISSX meeting in 2017. Dr. Fuhr is a citizen of Germany and attended Johann Wolfgang Goethe University in Frankfurt am Main, Germany, as an undergraduate in Medicine to obtain state registration as a physician and the degree of “Dr. med.” After residency training in Clinical Pharmacology at the Johann Wolfgang Goethe University, he was a Postdoctoral Fellow in the Institute of Biomedical and Pharmaceutical Research in Nürnberg, Germany. In 1996, Uwe Fuhr was appointed as Associate Professor and head of the Clinical Pharmacology group in the Department of Pharmacology at Medical Faculty, University of Cologne, where he is also Acting Chairman of the Center of Pharmacology since 2015. In parallel, in 2006 he co-founded the full service contract research organization “ITECRA” (Institute for Tailored Early Clinical Research and Advice GmbH & Co. KG), where he acted as the scientific advisor until 2012. Kiyomi Ito’s second term on the ISSX Council concludes in December 2023. Kiyomi currently serves as the co-chair of the ISSX/JSSX Meeting occurring in Hawaii in September of 2024. She is a Professor of Research Institute of Pharmaceutical Sciences at Musashino University, Tokyo, Japan. She received her B.S. (1989) and M.S. (1991) in Pharmaceutical Sciences from the University of Tokyo, and then worked as a research associate in the Department of Pharmacy, the University of Tokyo Hospital (under Prof. Tatsuji Iga) and in the Faculty of Pharmaceutical Sciences, the University of Tokyo (under Prof. Yuichi Sugiyama). She received her Ph.D. degree in 1996 from the University of Tokyo. In 1998, she moved to the School of Pharmaceutical
Sciences, Kitasato University as an assistant professor. From 2001 until 2003 she worked at the Centre for Applied Pharmacokinetic Research (CAPKR), the University of Manchester, as a postdoctoral research associate under Prof. J. Brian Houston. She then moved to the Department of Clinical Pharmacokinetics, Hoshi University in 2003 as an associate professor and to the Research Institute of Pharmaceutical Sciences, Musashino University in 2009 as a full professor. Nina Isoherranen’s second term concludes in December 2023. In additional to her service on the ISSX Council, Dr. Isoherranen has served as a member of the ISSX Membership Affairs Committee. Nina Isoherranen received her B.S. and M.S. in Analytical Chemistry from the Faculty of Science, University of Helsinki, Finland and her Ph.D. in Pharmaceutical Sciences from the School of Medicine, Hebrew University of Jerusalem, Israel. In 2004 she joined the faculty of the Department of Pharmaceutics at UW as an Acting Assistant Professor. She was promoted to a full professor with tenure at the UW in 2017 and she is currently the Associate Chair of the Department of Pharmaceutics, UW. In addition, she is a member of American Society of Pharmacology and Therapeutics (ASPET), American Chemical Society (ACS), and American Society of Clinical Pharmacology and Therapeutics (ASCPT). She has held leadership positions in professional societies including being the chair of the Drug Metabolism and Disposition division of ASPET. She is an Associate Editor of Drug Metabolism and Disposition, Clinical and Translational Science, Pharmacology & Therapeutics and an Editorial board member for Scientific Reports. She frequently serves as a grant reviewer for the NIH and other national and international funding agencies. ISSX is grateful to Scott, Sandy, Uwe, Kiyomi, and Nina for their service and commitment to ISSX.
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Book Review RECENT ADVANCES IN NANOCARRIERS FOR PANCREATIC CANCER THERAPY. Editors; P Kesharwani, N Gupta Academic Press, Elsevier 500pp. ISBN; 978-0-443-19142-8. (2023)
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The above book is divided into three parts; (A) ‘Overview, molecular pathways and conventional therapy of pancreatic cancer,’ (B) ‘Application of various nanocarriers for the management of pancreatic cancer,’ and (C) ‘Recent advances and future prospects for pancreatic cancer.’ Although of undoubted relevance and importance to those concentrating on this particular field, the information contained especially within the second section will be of a broader interest to many other workers. As stated in the accompanying literature, the book thoroughly describes, ‘the most recent developments in emerging modern drug delivery systems focused on, and derived from, nanotechnology.’ If nanotechnology can aid in providing a means by which therapeutic concentrations of an agent may be specifically delivered to the required physical location or particular cell type whilst minimizing, or hopefully completely avoiding, any off-target ramifications, then the quest for perfectly effective and entirely safe drug therapy may edge closer to reality. Within this second section, twelve chapters cover the potential drug delivery aspects of hydrogel-based systems, nanoemulsions, liposomes and noisomes, micelles, theranostic nanoparticles, polymeric nanoparticles, metallic nanoparticles, solid lipid nanoparticles, dendrimers and carbon nanotubes. The material within is pertinent not only to the particular ailment discussed by the present book, but also to the general field of drug delivery and therapeutic targeting, BIOMARKERS IN TOXICOLOGY Editors; VB Patel, VR Preedy, R Rajendram Springer Cham (Springer Nature Switzerland) 1188pp. ISBN: 978-3-031-07391-5. (2023). This reference volume is part of the book series published over the last 10 years, entitled, ‘Biomarkers in Disease: Methods, Discoveries and Applications.’ The accompanying literature quotes that this work, ‘provides a thorough overview on biomarkers in toxicology’ and is ‘a unique, comprehensive guide for methods for detecting toxicity in the human body’ being, ‘written for biomedical researchers, clinicians, forensic scientists and pharmacologists’ and the preface makes especial mention of ‘academicians and students at an advanced level.’
This lengthy text is divided into seven parts each containing several chapters. The collective section headings are; ‘Single components (8 chapters),’ ‘Panels and arrays (7),’ ‘Genetic, cellular and histological variables (7),’ ‘Functional and physiological variables and platforms (8),’ ‘Biomarkers in specific conditions and scenarios (16),’ ‘Biomarkers in models and modelling toxicity (3),’ and ‘Resources (1).’ This is certainly an all-embracing text with its 50 chapters, 79 tables, 175 illustrations of which 140 of them are in color and brought to a close with a 20 page index. A stand-alone volume, complementing the more specific previous tomes regarding biomarkers for particular disease states. As mentioned in the preface and accompanying literature, the, ‘handbook is a must have for researchers in toxicology and biomedicine who analzye the effects of drugs and various other substances in the human body and in model organisms.’ It is surely worthwhile to acquire this reference book if your profession or field of work involves or impinges the realm of biomarker technology.
Books alerts notified by Steve Mitchell Imperial College London, UK
Book Ordering Information
Academic Press, Elsevier Inc. (S&T Books and Cell Press) 50 & 60 Hampshire Street, 5th Floor Cambridge, MA 02139, US Elsevier Ltd (Corporate Office) 125 London Wall London EC2Y 5AS, UK http://store.elsevier.com/Academic-Press https://www.elsevier.com/books-and-journals Springer Nature One New York Plaza, Suite 4600 New York, NY 10004-1562, USA Springer Nature London The Campus, 4 Crinan Street London Ni 9XW, UK http://www.springernature.com/gp
Multidisciplinary View of Modeling and Simulation: Fundamentals, Case Examples, and Future Directions An ISSX Virtual Short Course • November 30–December 1, 2023 INVITATION TO ATTEND Please join us for an exciting virtual short course, “Multidisciplinary View of Modeling and Simulation: Fundamentals, Case Examples, and Future Directions” on November 30 and December 1, 2023 from 11:00 am–1:00 pm ET. The course will be recorded and attendees will receive access to recordings and slides. ABOUT THE SHORT COURSE This course was developed by the ISSX Modeling and Simulation Focus Group and will be moderated by Maria Posada, Ph.D., Eli Lilly and Company, USA, Oliver Hatley, Ph.D., Certara UK, United Kingdom, and Jaydeep Yadav, Ph.D., Merck, USA. This short course will focus on the fundamentals of modeling and simulation, spanning several modeling disciplines, including PBPK, QSP, PopPK and Biopharmaceutics, (small molecules, peptides, proteins, or new modalities). The course will include the fundamentals for beginners, advancement, and application, as well as case examples. SHORT COURSE REGISTRATION FEES ISSX Member Nonmember Student/Postdoc Member
Registration Fees $150 $200 $50
11:00 am–11:05 am | Welcome and Introduction 11:05 am–11:45 am | Principles of Population PKPD Modeling Stacey Tannenbaum, Ph.D., Metrum Research Group, USA 11:45 am–12:30 pm | Informing Drug Discovery and Development using Quantitative Systems Pharmacology Approaches Jason Chan, Ph.D., Eli Lilly and Company, USA 12:30 pm–1:00 pm | Roundtable Panel Discussion with Speakers Friday, December 1, 2023 | 11:00 am–1:00 pm ET (US) Session 2 11:00 am–11:05 am | Welcome and Introduction 11:05 am–11:45 am | PBPK Modelling of Drug-Drug Interactions – Challenges and Opportunities Aleksandra Galetin, Ph.D., University of Manchester, United Kingdom 11:45 am–12:30 pm | Physiologically Based Mechanistic Oral Absorption Modeling Kazuko Sagawa, Ph.D., Pfizer, USA 12:30 pm–1:00 pm | Roundtable Panel Discussion with Speakers
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Register today!
SHORT COURSE PROGRAM Thursday, November 30, 2023 | 11:00 am–1:00 pm ET (US) Session 1
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Renew Your ISSX Membership for 2024 Thank you for your membership and support of ISSX! If you haven’t yet renewed, we urge you to remain a part of the premier international association that advances research and education on the interplay of living systems with medicines and chemicals for the benefit of society worldwide by renewing your ISSX membership today. The ISSX Webinar Series is one of our most popular benefits of membership and provides members with the opportunity to learn about a variety of topics presented by leaders in the field. The ISSX Focus Groups provide an excellent forum for scientific discourse and members are encouraged to join one or all four groups. In addition, the New Investigators Group is very active and this group provides an excellent way to connect with fellow early career scientists to share experiences and tips. Another point of connection for members is the ISSX Mentorship Program, which links early career scientists with experienced colleagues to provide career advice and discuss career options. Finally, ISSX members benefit from steep discounts to our highlyrated scientific meetings where they learn about the latest research developments, network with leaders in the field, and present their research in multiple forums. Please make plans to join ISSX in person at the jointly hosted 26th North American ISSX and JSSX Meeting at the Hilton Hawaiian Village Resort in Honolulu, Hawaii, USA this September 15–18, 2024.
Natalie Hosea and Kiyomi Ito. This is a members-only event. • November 30 & December 1: This exciting virtual course, “Multidisciplinary View of Modeling and Simulation: Fundamentals, Case Examples, and Future Directions” will be held on November 30 and December 1, 2023. Registration is now open and the program is available on the short course webpage!
UPCOMING TRANSPORTERS WORKSHOP February 28–March 1, 2024: This virtual workshop will bring together scientists from academia, industry, and regulatory agencies to share their research findings, experience, and expert views on endogenous biomarkers for drug transporters, an active research area with rapid advances in recent years. Registration is now open and the program is available on the workshop webpage.
• September 15-18: ISSX is hosting the 26th North American ISSX and JSSX Meeting in Honolulu, Hawaii. Additional details to be announced. More information about these events will be shared soon. Be sure to renew your membership to access the ISSX member discounts to attend!
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Mark Your Calendar for These Upcoming Events 2024 will be an exciting year to expand your connections. We look forward to greeting you at our virtual and in-person educational events. ISSX members enjoy steeply discounted registration for workshops and meetings. Please save the dates and make plans to join us! • November 29: The 2023 ISSX Member Meeting will be held online on Wednesday, November 29, 2023. Join the meeting to hear important updates from ISSX President, Scott Obach, ISSX President-Elect, Aleksandra Galetin, ISSX Treasurer, Sandy Pang, ISSX Membership Affairs Committee Chair, Marcel Hop, ISSX Transporters Focus Group Chair, Xinning Yang, and the Co-Chairs of the ISSX/JSSX 2024 Meeting,
Please follow the steps below to complete your renewal: 1. Visit issx.org/renew. 2. On the right-hand side of the page, log in with your ISSX username and password. If you do not know your username or password, you may re-set it by visiting issx.org/password. 3. Click “RENEW YOUR MEMBERSHIP NOW” in the blue box at the top of your profile page. 4. On the next screen, review and update your contact information to ensure uninterrupted communication from ISSX.
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Now on to other society happenings…. The 25th North American ISSX Meeting in Boston was a big success, with some very engaging plenary and symposium sessions. I observed the poster and exhibitor hall was continuously vibrant with conversation. As always, I enjoyed the interactions with poster authors, but this time I had several good conversations with exhibitors too. I haven’t always met with exhibitors at previous meetings, but having been engaged in this role with ISSX I understand how important our exhibitors are to the financial success of our meetings. It is important that they know that renting exhibit space at an ISSX meeting is financially valuable for their companies. Finally, while I enjoyed all the sessions I attended, the final plenary session that was led by Dr. Sandy Pang and the very esteemed Professor Malcolm Rowland was particularly noteworthy. Often meeting attendance starts to wane by last session, but not this time. Intense discussion ensued after the initial presentations made by Malcolm and Sandy; immediately followed by a discussion (yet again!) landing on the role of plasma protein binding in defining hepatic clearance among other esteemed long-time leaders in our field–Drs. Bill Jusko, Yuichi Sugiyama, and Marcel Hop. I left this meeting simultaneously energized and exhausted. Congratulations to Jash Unadkat as recipient of the ISSX Achievement Award--well deserved for many years of outstanding research that has cast light on our knowledge of drug distribution, among many of his other accomplishments. More progress has been made toward improving our ISSX Learning Center. A small team reviewed the Learning Center, providing feedback on content and cost so that we can continue to build the Learning Center for the benefit of ISSX members and the Society. There was a
desire for an organized library of basic learning content modules that are affordable and can be delivered in smaller pieces than a standard-length lecture or short course. Now the task at hand is to lay out the specifics and topics for such modules and start enlisting volunteers to create these. We have also made progress in identifying an affiliated journal where ISSX members can submit original research papers. I am pleased to share that the journal Drug Metabolism and Pharmacokinetics, which is the official journal of JSSX will also now be an official journal of ISSX. We are in the process of working out details such as increasing editorial board membership from outside Japan and how we will develop the relationship between the journal and ISSX. I encourage you to consider submitting your next research paper to DMPK. Many thanks go to Dr. Hiroshi Yamazaki for championing this effort. Progress continues in our endeavor to expand ISSX into Africa. Currently we are aiming to have our first ISSX affiliated workshop in South Africa in early 2025. As of now, we are thinking that the topic will be on pharmacogenetics and individualized therapy, with more details to be announced. Our series of webinars from African xenobiotic researchers will continue into 2024, with an expectation that we will have three more next year. I will close by extending my heartfelt gratitude for all the help that I have received from Council members, our president-elect Alex, and of course Zoë, Katherine, and the ISSX staff these past two years. And thank you, ISSX members, for this opportunity to serve you in this role. I look forward to continued interaction with you in advancing and promoting our important and very special area of science for the benefit of humankind. All the best, Scott
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Save the Date: The 26th North American ISSX Meeting and JSSX Meeting The Hilton Hawaiian Village Waikiki Beach Resort • Honolulu, Hawaii, USA September 15–18, 2024 On behalf of the Meeting Organizing Committee, it is our pleasure to invite you to the 26th North American ISSX and JSSX Meeting. This meeting will convene at the Hilton Hawaiian Village Waikiki Beach Resort September 15–18, 2024. The meeting provides an exceptional opportunity for researchers, from academia and industry alike, to gather, network, and exchange ideas. In addition to an outstanding scientific program, the meeting provides you with access to state-of-the-art exhibits, ample opportunities to socialize and collaborate with friends and colleagues, and to present your research during our poster presentation sessions. Meeting Chairs Natalie Hosea, Bristol Myers Squibb, USA and Kiyomi Ito, Musashino University, Japan
Meeting Organizing Committee Deepak Dalvie, Crinetics, USA Aleksandra Galetin, University of Manchester, UK Sarah Glass, Janssen, USA Kenta Haraya, Chugai, Japan Hideki Hirabayashi, Takeda, Japan Kazuya Maeda, Kitasato University, Japan Tadahaya Mizuno, Tokyo University, Japan Mary Paine, Washington State University, USA Yoshiyuki Shirasaka, Kanazawa University, Japan Fumiyoshi Yamashita, Kyoto University, Japan Hiroshi Yamazaki, Showa Pharmaceutical University, Japan Xinning Yang, FDA, USA Program, Registration, and Abstract Submission details to be announced in December 2023!
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Watch for more information coming soon!
The ISSX Webinar Series ABOUT THE ISSX WEBINAR SERIES The ISSX Webinar Series is an engaging and innovative way to hear from and interact with speakers from around the world on a range of topics related to the metabolism and disposition of xenobiotics. Members can participate for free. Participate in regularly scheduled live webinars with an exciting range of speakers, as well as watch previous webinars on your own schedule. ISSX webinars are presented by internationally recognized scientists on a variety of subjects relevant to the field. The ISSX Continuing Education Committee is charged with the responsibility for reviewing these educational offerings and setting the webinar schedule. Mark Your Calendar for these Upcoming ISSX Webinars November 2023 November 29, 2023 at 9:00 AM ET US (14:00 UTC) 2023 ISSX Member Meeting Summary: The 2023 ISSX Member Meeting will be held online on Wednesday, November 29, 2023. Join the meeting to hear important updates from ISSX President, Scott Obach, ISSX President-Elect, Aleksandra Galetin, ISSX Treasurer, Sandy Pang, ISSX Membership Affairs Committee Chair, Marcel Hop, ISSX Transporters Focus Group Chair, Xinning Yang, and the Co-Chairs of the ISSX/JSSX 2024 Meeting, Natalie Hosea and Kiyomi Ito. December 2023 December 5, 2023 at 11:00 AM ET US (16:00 UTC)
Presented by Drs. Chris Mathes, Ph.D. and Shiny Rajan, Ph.D.
Abstract: Join us Tuesday, December 5, for a ISSX educational webinar presented by Dr. Chris Mathes, Chief Commercial Officer at AnaBios, and Dr. Shiny Rajan, Director of Tissue Development at Javelin. Together, they will explore the transformative potential of utilizing human primary hepatocytes and liver sinus
As Chief Commercial Officer (CCO) of AnaBios, Dr. Chris Mathes provides leadership in business development activities and contributes to the strategic direction of the company. Previously, Mathes acted as the CCO of the early drug discovery company, Icagen. Prior to Icagen, Dr. Mathes led North American business development efforts for Discovery services at Charles River Laboratories. Dr. Mathes was CCO at ChanTest (acquired by Charles River in 2014), a market leader in ion channel drug discovery and associated in vitro safety testing. Prior to ChanTest, he established and managed all aspects of the U.S. subsidiary of Sophion Bioscience A/S (Denmark) as Vice President & General Manager. Mathes has over 25 years of experience in the ion channel field and contributed to the early development and marketing strategy of automated patch clamp systems. He earned a B.S. in Biology from Stanford University (with departmental honors). He received his Ph.D. in Neuroscience from the University of California, Los Angeles in 1995. In 2009, Mathes earned an Executive M.B.A. degree
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This webinar is sponsored by AnaBios and Javelin
About the Speakers: Shiny Rajan is the Director of Tissue Engineering for Javelin Biotech where she leads the Tissue Engineering team in the development and characterization of single- and multi-organ tissue chip platforms for preclinical drug discovery and development. Her group’s recent focus has been highly functionalized liver, kidney, and muscle tissues for individual and integrated microphysiological systems (MPS), and developing those products for use in ADME, drug safety and toxicology (druginduced liver injury), and pharmacodynamic disease modeling applications. Shiny joined Javelin Bio from Virginia Tech-Wake Forest University, where she earned her MBA and her doctoral research focused on complex human microphysiological systems.
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The Significance of Primary Human Hepatic Cells in Drug Development Research and its utilization in Predictive Applications using the Millifluidic Liver Tissue Chips
endothelial cells (LSEC) for revolutionizing drug development processes. They will discuss how liver tissue chips address the limitations of conventional microfluidic-based tissue chips, offering a physiologically relevant platform for better predict pharmacokinetic endpoints and improve the drug optimization process. Users will learn how Liver Tissue Chips enhance safety assessment and the implications for predicting drug-drug interactions (DDI) and drug-induced liver injury (DILI).
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from Rutgers University. He established Candidate Biopharma Advisors in January 2018. December 7, 2023 at 11:00 AM ET US (16:00 UTC) We Are Not "DON" YET: Discovery of Tumor Targeted Glutamine Antagonists Through Prodrug Strategy
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Presented by Dr. Rana Rais, Ph.D. Abstract: Many cancers change their energy metabolic requirements and become "glutamine addicted" for their growth and survival. The glutamine antagonist 6-diazo-5-oxo-l-norleucine (DON) has shown robust efficacy in both preclinical animal models and exploratory clinical studies. Although promising, clinical studies with DON were halted due to its marked dose-limiting toxicities, which were mainly gastrointestinal (GI)-related, as the GI system is highly dependent on glutamine utilization. To overcome these toxicity issues, we sought to develop a DON prodrug that could selectively deliver DON to tumor tissues while sparing normal glutaminedependent tissues like the GI tract. We designed over 100 prodrugs by installing dual promoeities on DON that can be dislodged by the enriched milieu of esterase and protease enzymes in tumor. Using iterative chemistry and pharmacokinetic efforts, we identified various promising DON prodrugs that showed preferential tumor bioactivation and delivery. Of these, our best DON prodrug, DRP-104 is bioactivated in the tumor while bio-inactivated in gastrointestinal (GI) tissues resulting in 11-fold higher glutamine antagonist delivery to the tumor (target site) versus GI (toxicity site) resulting in robust anti-cancer activity with minimal GI-toxicities. DRP-104, is now being evaluated in Ph1/2a clinical trials in cancer patients (ClinicalTrials.gov Identifier: NCT04471415). References: Leone et al., Science 366, 1013-1021 (2019) Rais et al., Sci. Adv. 8, eabq5925 (2022) About the Speaker: Dr. Rana Rais, Ph.D. is an Associate Professor of Neurology (Primary) and Pharmacology and Director of the drug metabolism, pharmacokinetics (DMPK) at Johns Hopkins. Dr. Rais received her Ph.D. in Pharmaceutical Sciences with substantial experience in biopharmaceutics, drug permeability, drug transport, drug metabolism, pharmacokinetics, and drug delivery including prodrug design and characterization. Her lab has expertise in in vitro and in vivo ADME as well as in novel drug delivery
approaches specifically intranasal delivery and prodrug approaches for successfully enhancing bioavailability, brain delivery and targeted delivery of compounds with poor physicochemical properties. She has impacted drug discovery projects in Oncology, NeuroAIDS, Neuropathic pain, Inflammatory bowel disease, multiple sclerosis and Alzheimer’s disease. She is a co-inventor of over 15 JHU patents; and has published over 100 coauthored manuscripts including recent ones in Science, PNAS, Science Advances and Science Translational medicine. She has also co-founded two JHU start-up companies, which have amassed over $40M in external funding. December 12, 2023 at 11:00 AM ET US (16:00 UTC) Clofazimine Pharmacokinetics in HIV-Infected Adults with Diarrhea: Implications of Diarrheal Disease on Absorption of Orally Administered Therapeutics Presented by Dr. Samuel Arnold, Ph.D. Abstract: Oral drug absorption is a complex process involving the interplay between physicochemical characteristics of the drug and physiological conditions in the gastrointestinal tract. Diarrhea, a condition common to numerous diseases impacting many worldwide, is associated with physiological changes in many processes critical to oral drug absorption. Oral drug absorption kinetics are usually established in populations with a properly functioning gastrointestinal tract. However, many diseases and therapeutics can alter gastrointestinal physiology and cause diarrhea. The extent of diarrhea-associated impact on drug pharmacokinetics has not been quantitatively described. To address this knowledge gap, we used a population pharmacokinetic modeling approach with data collected in a phase 2a study of matched HIV-infected adults with/without cryptosporidiosis and diarrhea to examine diarrheaassociated impact on oral clofazimine pharmacokinetics. Covariates describing cryptosporidiosis-associated diarrhea severity (e.g., number of diarrhea episodes, diarrhea grade, etc.) or HIV infection (e.g., viral load, CD4 cell count) were evaluated. In conclusion, the maximum diarrhea grade of a study participant was associated with a significant reduction in clofazimine bioavailability. Our results highlight the importance of studying disease impacts on oral therapeutic pharmacokinetics to inform dose optimization and maximize the chance of treatment success.
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About the Speaker: Dr. Samuel Arnold joined the Department of Pharmaceutics at the University of Washington as an Assistant Professor in 2023, and his research predominantly focuses on drug development for enteric infections. While there has been a substantial reduction in diarrhea associated mortality over the past decade, diarrheal diseases continue to be a major global health concern (second leading cause of death in children < 5 years old). The remarkable reduction in disease burden can be attributed to many factors, and this includes vaccine rollout for rotavirus. However, with a reduction in rotavirus infections, there has been a concurrent increase in the proportion of diarrheal diseases attributed to other etiological agents of disease (e.g., Cryptosporidium and Shigella). Dr. Arnold’s work includes the development of in vitro and in vivo models for cryptosporidiosis and shigellosis. As a member of the Bill & Melinda Gates Foundation Cryptosporidium Drug Accelerator (CryptoDA), Dr. Arnold led a successful effort to identify pharmacokinetic/pharmacodynamic (PK/PD) relationships for anti-cryptosporidiosis drugs. Due to the gastrointestinal localization of the pathogen, this work required a non-traditional experimental approach to identify exposure-response relationships. In addition, Dr. Arnold provided clinical pharmacology support for an anti-cryptosporidiosis clinical trial in Malawi (Clinicaltrials.gov #NCT03341767) that investigated clofazimine as a potential anticryptosporidiosis treatment. Subsequent analysis of the data from this trial has demonstrated that a participant’s diarrheal status is associated with therapeutic exposure. Based on these results, the Arnold lab is working on the development of pharmacokinetic models that can predict the impact of diarrhea on drug exposure prior to human dosing.
January 2024 January 16, 2024 at 11:00 AM ET US (16:00 UTC) Highlights of the in vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance Presented by Dr. Brian Ogilvie, Ph.D.
This webinar is sponsored by BioIVT. Abstract: In June 2022, the ICH released the first draft of its harmonized Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies' guidelines to create a single guideline that will be used across all member countries. After a review period, the guideline will be adopted in early 2024. This presentation will offer perspectives on the differences between current in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan drug development strategies to meet the ICH M12 guideline. About the Speaker: Brian Ogilvie, PhD, is the VP of Scientific Consulting at BioIVT, where he leads a team that advises clients on in vitro drug-drug interaction studies and program strategy. He received a PhD in toxicology from the University of Kansas Medical Center. He has published various research articles and book chapters. Additionally, he has been an invited speaker at numerous drug development conferences. Additional webinars will be announced soon! Check the ISSX webinar schedule to stay in the know on upcoming scientific lectures and discussions.
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Do you have an idea for a webinar? Submit a Proposal to Present for the ISSX Webinar Series We want to hear from you! Complete a brief form online to submit your proposal today. The information presented in the ISSX Webinar must be balanced and provide the attendee with an objective viewpoint. Proposals for the ISSX Webinar will be evaluated for the ability to provide educational content to ISSX members. The scientific content (merit) of the webinar is subject to review and prior approval by the ISSX Continuing Education Committee (CEC) is needed before proceeding.
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Did you miss a recent webinar? Sign into your ISSX membership account and view all past webinars here.
ISSX Focus Groups ISSX Focus Groups provide ISSX members with a great opportunity to network with your colleagues while discussing topics relevant to the day. Your participation in the ISSX Focus Groups help us to enhance the exchange of the most current scientific research information and open doors to endless opportunities for collaboration and career advancement. View the latest from the ISSX Focus Groups and join today! BIOANALYSIS IN ADME SCIENCE Chair: Matthew Albertolle, Takeda Development Center Americas (TDCA) Co-Chair: Bingming Chen, Merck The aims of this group include: (a) to promote stateof-the-art analytical technologies to solve challenging issues faced in ADME studies and bioanalysis, (b) to enable industrial scientists to actively contribute to and participate at ISSX meetings and associated activities, and (c) to enhance synergy between industrial scientists and academic researchers. BIOTRANSFORMATION, MECHANISMS, AND PATHWAYS Chair: Valerie Kramlinger, Vanderbilt University Co-Chair: Aaron Teitelbaum, Boehringer Ingelheim Points for discussion 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).
MODELING AND SIMULATION Chair: Yuan Chen, Genentech Co-Chair: Maria Posada, Lilly This group focuses on the role of modeling and simulation in drug development in all stages, including topics such as (a) translational extrapolations from preclinical data to clinical expectations, (b) drugdrug interactions, (c) extrapolations of PK/PD data to special populations, (d) early dose optimization, and (e) selection of doses for clinical testing. TRANSPORTERS Chair: Xinning Yang, FDA Co-Chair: Bhagwat Prasad, Washington State University The goals of this focus group are to disseminate and promote state-of-the-art research and foster collaborations among ISSX members on the role of transporters in drug disposition, drug interactions, efficacy, and toxicity, and their impact on drug discovery, development, and regulatory decision making.
DON'T MISS THIS UPCOMING EVENT!
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Modeling and Simulation Focus Group Virtual Short Course: Multidisciplinary View of Modeling and Simulation: Fundamentals, Case Examples, and Future Directions November 30, 2023–December 1, 2023 | 11:00 AM–1:00 PM
25th North American ISSX Meeting in Review Over six hundred scientists, students, and exhibitors convened in Boston, Massachusetts in the United States, this September 10-13 for the 25th North American Meeting. The meeting was co-chaired by Amit Kalgutkar of Pfizer and Fatemeh Akhlaghi of Pfizer. The Meeting Organizing Committee and the Scientific Affairs Committee created a rich scientific program that showcased a broad range of short courses, symposia, and lectures designed to serve the interests of scientists from around the world. The meeting was preceded by four short courses. The courses covered Best Practices for In Vitro enzyme (CYP, UGTs) and Clinical Study Design (encompasses PBPK) to Support DDI Studies & Product Labeling, State-ofthe-art on the ADME of Protein Therapeutics, Strategies That Enable Successful FIH and Beyond, and Transporter Substrate/Inhibition/Induction, DDI. The meeting began with a keynote lecture given by F. Peter Guengerich of Vanderbilt University School of Medicine. Following the keynote lecture, the Opening Welcome Reception provided attendees and exhibitors an opportunity to network and engage with each other. Poster networking and presentation sessions were held throughout the meeting and provided 180 authors with the opportunity to present their research on an international stage.
This meeting featured the presentation of two prestigious Society awards. The ISSX North American Scientific Achievement Award was presented to Jashvant Unadkat of the University of Washington. The ISSX Distinguished Accomplishments in Drug Discovery and Development was presented to the Pfizer Paxlovid Team. Meeting attendees also had the opportunity to network with each other at the networking reception on Tuesday, September 12 at the Westin Pavilion. This special event allowed attendees to interact with each other while enjoying live music. POSTER AWARDS COMPETITION 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 of the basis of Significance of the Research Problem; Experimental Approach; Soundness of Conclusions; and Clarity of Presentation. The award recipients were: GRADUATE/PREDOCTORAL AWARDS • FIRST PLACE: Aarzoo Thakur for the poster A6 entitled NOVEL METABOLOMICS APPROACH TO IDENTIFY BIOMARKERS OF ORGANIC ANION RENAL TRANSPORTERS.
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Attendees enjoyed drinks and live music during the special networking event.
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•S ECOND PLACE: Sherouk Tawfik for the poster A2 entitled, UNVEILING THE INTRACELLULAR JOURNEY: GOLGA8N-MEDIATED SUBCELLULAR TRAFFICKING OF SIRNA DRUGS AND ITS IMPLICATIONS ON SILENCING EFFICACY.
• SECOND PLACE: Sandhya Subash for the poster A12 entitled, RELATIVE EXPRESSION VERSUS ACTIVITY FACTOR (REF VS. RAF) TO ESTIMATE FRACTIONAL CONTRIBUTION OF INDIVIDUAL UGT ISOFORMS (FGLUC) IN DRUG GLUCURONIDATION.
• T HIRD PLACE: Aurora Authement for the poster A4 entitled, PHARMACOKINETICS AND PHARMACODYNAMICS OF ENDOGENOUS AND EXOGENOUS CORTISOL IN PREMENOPAUSAL, HEALTHY WOMEN.
• THIRD PLACE: Ankit Balhara for the poster A10 entitled, PREDICTION AND VALIDATION OF FETAL EXPOSURE TO DUAL BCRP/P-GP DRUG SUBSTRATES USING THE PROTEOMICS INFORMED EFFLUX RATIORELATIVE EXPRESSION FACTOR (ER-REF) APPROACH AND PBPK MODELING AND SIMULATION.
POSTDOCTORAL AWARDS • F IRST PLACE: Juhee Oh for the poster A8 entitled, METHOD DEVELOPMENT TO CORRECT TISSUE CONCENTRATIONS FOR RESIDUAL BLOOD: APPLICATION TO DRUG DISTRIBUTION IN BRAIN TUMORS.
Congratulations to all of the graduate/predoctoral and postdoctoral award finalists and winners.
ATTEND THE 26TH NORTH AMERICAN MEETING AND 39TH JSSX MEETING
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Were you unable to join ISSX in Boston? Make plans to the 26th North American ISSX Meeting and 39th JSSX Meeting in Honolulu, Hawaii September 15-18, 2024.
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ISSX THANKS OUR SPONSORS: GOLD SPONSORS
SILVER SPONSORS
BRONZE SPONSORS
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Welcome New Members The International Society for the Study of Xenobiotics proudly welcomes the following new members. We greatly appreciate their support and hope that each remains aligned and affiliated with ISSX for many years to come.
2022 NEW MEMBERS Munira Abdullahi, Nigerian Natural Medicine Development Agency, Lagos, Nigeria
Ananthsrinivas Rao Chakilam, Cerevel Therapeutics, Cambridge, Massachusetts, United States
Garrett Ainslie, AbbVie Inc, Sandyhook, Connecticut, United States
Bhim Chaudhari, Manipal College of Pharmaceutical Sciences, Udupi, Karnataka, India
Wendell Akers, Lipscomb University, Nashville, Tennessee, United States
Tae Hyun Choi, KIRAMS, Seoul, South Korea
Davoud Asgari, chemQ bioscience LLC, Research Triangle Park, North Carolina, United States
Dillon Clemmer
Satish Kumar Bedada, Siddhartha Institute of Pharmacy, Hyderabad, India Leena Bhave, Merck & Co., Boston, Massachusetts, United States Maria João Bonifácio, BIAL, Coronado (S Romao e S Mamede), Portugal
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Alexander Burns, Johnson and Johnson, San Diego, California, United States
Matthew Crouthamel, Takeda Pharmaceuticals, Chelmsford, Massachusetts, United States Lina Dahabiyeh, The University of Jordan, Amman, Jordan Lu Dai, University of Houston, Houston, Texas, United States Nathan Delvaux, Labcorp Early Development Labs, Madison, Wisconsin, United States Ryan Dick, Maze Therapeutics, South San Francisco, California, United States
Robert Busby, Busby Pharma Consulting, LLC, Hingham, Massachusetts, United States
Alicia Yinghua Du, Frontage Labs, La Jolla, California, United States
Hongliang Cai, Sumitomo Pharma America, Marlborough, Massachusetts, United States
Peter Dugan, Pete Dugan, Oceanport, New Jersey, United States
Luca Campisi, Pisa, Italy
Lars Erik Andreas Ehnbom, IU School of Medicine, Greenfield, Indiana, United States
Samantha Carreiro, Nimbus Tx, Reading, Massachusetts, United States
Eman El-Khateeb, Certara, Sheffield, UK, United Kingdom
Adam Elliott, Mirati Therapeutics, San Diego, California, United States Ili Erdemir, Merck, West Point, Pennsylvania, United States Darin Evans, Labcorp Drug Development, Madison, Wisconsin, United States Jinshu Fang, Circle Pharma Inc., South San Francisco, California, United States Sarah Favara, Labcorp Drug Development, Fishers, New Jersey, United States Griffin Ferrara, Visikol, Inc., Hampton, New Jersey, United States Guanfa Gan, Boehringer Ingelheim, Ridgefield, Connecticut, United States Shashyendra Gautam, Biocon Bristol Myers Squibb R&D Centre, Bangalore, India Mark Grillo, Cytokinetics, South San Francisco, California, United States Jaime Hagen, Loxo@Lilly, Louisville, Colorado, United States Robin Haid, ETH Zurich, Zurich, Switzerland Peter Haroldsen, Exelixis Inc., Alameda, California, United States Rose Hayeshi, North-West University, Potchefstroom, South Africa
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Sofie Heylen
Yoongqin Li
Ming Hu, University of Houston, Houston, Texas, United States
Chun Li, Chun ADME-PKPD Consulting LLC, San Diego, California, United States
Avinash Jadhav, Syngene International Limited, Bangalore, India Anandi Karumbati, Institute for Stem Cell Science and Regenerative Medicine, Bangalore, India
Kevin Litwiler, OnKure Inc., Boulder, Colorado, United States Cong Liu, Certara UK Simcyp Division, Sheffield, United Kingdom
Emma Perry, Alexion, New Haven, Connecticut, United States Nav Phulara, Baltimore, Maryland, United States Haili Ping, Clinical Pharmacology, Lexington, Massachusetts, United States Chitra Rajagopal, GSK, Wayland, Massachusetts, United States
Shuhan Liu, University of Michigan Dan Kelly, Alexion, New Haven, Connecticut, United States Hailey Kilian, Loxo Oncology at Lilly, Louisville, Colorado, United States Jonghan Kim, University of Massachusetts Lowell, Lowell, Massachusetts, United States John Klecker, Karuna Therapeutics, Melrose, Massachusetts, United States Vishwanath KM, Jubilant Biosys Limited, Bangalore, Karnataka, India Prashant Kole, Syngene International Limited, Bangalore, Jigani, India Sneha Kumar, Biocon Bristol Myers Squibb R&D Centre, Bangalore, Karnataka, India Sarah Lee, SMPA, Brisbane, California, United States
Ruisi Leng
Shanghao Li, WuXi AppTec, East Windsor, New Jersey, United States
Vaibhav Maheshwari, Takeda Pharmaceuticals, Cambridge, Massachusetts, United States
Vincent Ramirez, Astex Pharmaceuticals, Pleasanton, California, United States
Christian Martin, Nuvalent Inc, Cambridge, Massachusetts, United States
Arina Ranjit, Baltimore, Maryland, United States
Takatoshi Matsuzawa, ASKA Pharmaceutical, Fujisawa, Kanagawa, Japan Michael McCoy, Takeda, Cambridge, Massachusetts, United States Igor Mezine, Pharmaron US Lab Services, Exton, Pennsylvania, United States Ginger Milne, Vanderbilt University Medical Center, Nashville, Tennessee, United States Rajeev Mudakavi, Colorado School of Mines, Golden, Colorado, United States Smita Pattanaik, Post Graduate Institute of Medical Education and Reseach, Chandigarh, India Ruisong Pei, Labcorp Drug Development, Madison, Wisconsin, United States
David Reynolds, BioCryst, Chapel Hill, North Carolina, United States Abdul-Rahim Sanogo, Providence, Rhode Island, United States Emma Sevigny, Precision Biosciences, Durham, North Carolina, United States David Shackleford, CDCO, Monash University, Parkville, Victoria, Australia Abdul Basit Shaikh, Charles River Laboratories, Worcester, Massachusetts, United States Jackie Shang, Janssen, Spring House, Pennsylvania, United States Ankita Sharma, Crinetics Pharmaceuticals, San Diego, California, United States Honglue Shen, Merck, Boston, Massachusetts, United States
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Yong Li, Sanofi, Boston, Massachusetts, United States
Prabhakar Rajanna, Syngene International Ltd (BBRC), Bengaluru, Jigani, India
Issue 3, 2023
Min Seo Lee, Bucheon-si, Gyeonggi-do, South Korea
Mukesh Lulla, Biogen, Lexington, Massachusetts, United States
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Lei Shi, Sumitomo Pharma America, Inc., Marlborough, Massachusetts, United States
Yuki Ujihira, The University of Manchester, Manchester, England, United Kingdom
Luisa Shin Ogawa, Black Diamond Therapeutics, Cambridge, Massachusetts, United States
Ogochukwu Ume, Igbinedion University Okada, Benin City, Edo, Nigeria
Francine Celise Siqueira Cesar Carnevale, University of Florida, Redwood City, California, United States
Stephan Walch, CVUA Karlsruhe, Karlsruhe, BadenWeißenburger, Germany
Glyn Steventon, Defence, Science and Technology Laboratory, Sailsbury, Wiltshire, United Kingdom Ashish Thakur, PTC Therapeutics, Inc., Bridgewater, New Jersey, United States
Kelly Wang, Gilead Sciences, Inc., Foster City, California United States Stephen Wang, Novartis, Cambridge, Massachusetts, United States Rita West, Loxo Oncology at Lilly, Lousiville, Colorado, United States
Shengjie Xu Tingting Yan, National Cancer Institute, Bethesda, Maryland, United States Xinxin Yang, ChemPartner, Palo Alto, California, United States Indy Zang, Enanta Pharmaceuticals, Inc, Watertown, Massachusetts, United States Zhoupeng Zhang, AstraZeneca, Cambridge, Massachusetts, United States Jennifer Zimmer, Alturas Analytics, Inc., Moscow, Idaho, United States
Vesna Tumbas Saponjac, University of Houston, Houston, Texas, United States
Renew Your ISSX Membership for 2024
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5. O nce you verify your contact information, you will be directed to the payment screen, where you may view your renewal options, including instant payment online via credit card. • I f you would like to pay by check, select "Bill Me" under Payment. You can access your invoice on the subsequent page and it will be automatically sent to you via email. Please print the invoice and submit it with your check to: ISSX 8652 Solution Center Chicago, IL 60677-8006 If you have questions about renewing your membership or membership benefits, please contact ISSX by phone at +1-202-367-1160 or by email at information@issx.org.
Donations ISSX relies on assistance from members and other individuals as well as corporate entities to advance our mission. If you would like to make a gift to ISSX, please visit www.issx.org/donations to learn about the various funds you can support. ISSX is a 501 (c)(3) organization incorporated in the United States. As such, your contribution may qualify for a tax deduction. Consult your tax advisor for full information. Our federal tax identification number is 22-2432063. If you need a copy of our federal W-9 form, simply email information@issx.org and we will promptly reply.
ISSX Congratulates 2023 ISSX Award Recipients 2023 Asia Pacific ISSX Awards Professor Baojian Wu, Ph.D., from Guangzhou University of Chinese Medicine is the recipient of the 2023 Asia Pacific New Investigator Award. Dr. Wu’s research focuses on the regulation of drug-metabolizing enzymes (DMEs) and transporters by the circadian clocks and the role of circadian pharmacokinetics in drug chronotoxicity and chronoefficacy. His lab has found that many DMEs display prominent diurnal rhythms in mice and in synchronized human cells. He also demonstrated that the expressions and activities of ABC transporters P-gp and MRP2 exhibit strong diurnal rhythms in the mouse intestine and liver. Dr. Wu’s lab went on to show that the diurnal rhythms of DMEs and transporters were transcriptionally controlled by the core clock genes, such as Bmal1, Clock, Npas2, Per2, and Rev-erbα. Dr. Wu has published 160 peer-reviewed research papers and review articles. He has been invited to present his work at over 40 international and national conferences and departmental seminars. Dr. Wu has been generous in his professional service. He serves as an editorial board member for Biochemical Pharmacology, Drug Metabolism and Disposition, Frontiers in Pharmacology (Associate Editor), Expert Opinion on Drug Metabolism & Toxicology, Acta Pharmaceutica Sinica B, Journal of Pharmacy and Pharmacology, Xenobiotica, and Current Drug Metabolism (co-Editor). Dr. Wu has served as ad hoc reviewer for over 30 scientific journals, such as Nature Communications, British Journal of Pharmacology, Communications Biology, Drug Metabolism & Disposition, and Biochemical Pharmacology.
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Professor Hiroshi Yamazaki, Ph.D., of the Showa Pharmaceutical University Laboratory of Drug Metabolism and Pharmacokinetics is the 2023 recipient of the ISSX Asia Pacific Scientific Achievement Award. Dr. Yamazaki has been working in the field of cytochrome P450 and xenobiotic metabolism for 40 years and has published more than 510 refereed (original) articles and 68 reviews and book chapters. His work is highly cited with an h index of 67 (Scopus). His work has ranged from very basic to highly practical in our field. The research began in 1984 with studies on nitrosamine metabolism and genotoxicity. Some of his work has involved basic mechanisms of P450 reactions, including some very important work with apo-cytochrome b5 that rules out an electron transfer requirement with many P450s. His P450 work has also dealt with assignments of individual P450s in reactions involving drugs, chemical carcinogens, and other xenobiotics. Other work has dealt with the effects of single nucleotide variants and molecular docking of substrates as a means of understanding structure-activity relationships. In addition to his work on P450s, he has also published considerably on flavin-containing monooxygenases (FMOs) and other enzymes involved in drug metabolism. He has also been heavily involved in the development of humanized rodent models and their pharmacokinetic comparisons to humans (and wildtype animals). He was Editor-in-Chief of Drug Metabolism and Pharmacokinetics (DMPK) from 2014–2017. Dr. Yamazaki was JSSX President from 2017–2019. He has also served two terms on the ISSX Council, as well as in numerous other society roles. He has served on numerous editorial boards, and he has also edited books—including the very recent one related to the 60th anniversary of the discovery of cytochrome P450.
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2023 European ISSX Awards Professor Amin Rostami-Hodjegan, Ph.D., is the Director of Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester and Certara Chief Scientific Officer and the recipient of the 2023 European ISSX Scientific Achievement Award. Dr. Rostami distinguished himself as a major contributor to the advancement of the science of xenobiotics with particular emphasis on the development and application of physiologically-based pharmacokinetic (PBPK) modelling tools and techniques that have emerged as a critically important approach to the study of drugs and the discovery and development of new therapeutics. Publication records of Dr. Rostami (>300 peer reviewed papers, >21,000 citation, h Index of 78) show many seminal pieces of novel research, many are influential in the field. Among these, reports on translation aspect of clearance with associated scaling factors, ability to extend these to young children using ontogeny models and creation of models to assess gut wall metabolism (so called “Qgut Model”) and ability to do in vitro to in vivo extrapolation (IVIVE) when assessing metabolic drug interactions, are just a subset of his widely recognized contributions. The extension of Dr. Rostami’s IVIVE modelling approach to population of patients was facilitated by engineering of a large public-private partnership, Simcyp Consortium, and the ease of technology transfer to practical use via associated software and databases. Hence the second period wider applications of these systems models are related to ‘stratified medicine’ particularly in pediatrics, pregnant women and obese patients undergoing bariatric surgery which have been very informative and led to actionable changes in drug development and patient care. In addition, Dr. Rostami has had connections to the Office of Generic Drugs (OGD) in CDER. His great contribution in the past years in the wider applications of PBPK models in pharmaceutics and designing and testing dosage forms has grown in parallel to applications in clinical pharmacology that warranted his contribution to over five OGD workshops in the last six years.
Professor Volker M. Lauschke, Ph.D., is the recipient of the 2023 European ISSX New Investigator Award–in honor of Karl. J. Netter. Dr. Lauschke is Full Professor in Translational Pharmacology at Karolinska Institutet, Stockholm, Sweden and has published 138 different papers during his time at Karolinska Institutet, most of them in journals in the fields of cell biology, hepatology, pharmacology and toxicology. Many of these are classified as “highly cited” and others are among the top journal downloads. Among his publications, he is first and co-first author in 20, last and co-final author in 58 and corresponding author in 65. His major achievements include the development of an in vitro model to study liver regeneration, liver physiology and pathophysiology, and the identification of new important genetic factors determining drug response and toxicity, including extrapolation of pharmacogenomics to the pharmacodynamic domain. He has demonstrated the importance of rare mutations for optimizing drug therapy, laying the foundation for true individualized therapy. He has developed novel algorithms for translating whole genome sequences into the identification of critical genetic variants of importance for drug selection and dosing. He is now integrating data from current population-based next-generation sequencing (NGS) projects to quantify the extent of genetic variability in pharmacogenes at the population level and, using an arsenal of in silico techniques, to quantify the impact on hepatic metabolism and pharmacokinetics and dynamics. Dr Lauschke and his team attach great importance to disseminating their discoveries to make innovations accessible to the public. To this end, they founded HepaPredict AB, a contract research organization (CRO) that has been accepted into the Karolinska Innovations DRIVE program.
Dr. Rostami and his team consistently made invaluable input to our regulatory science research.
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ISSX Congratulates 2023 ISSX Award Recipients Continued from previous page
2023 North American ISSX Awards
The Distinguished Accomplishments in Drug Discovery and Development Award was created in 2018 to honor an individual or a team employed in an organization involved in drug discovery and/or drug development. The award is bestowed based on 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. The 2023 recipients of the award are members of the Pfizer Paxlovid Team: Amit S. Kalgutkar, M.Sc., Ph.D., Heather S. (Eng) Wintrob, Li Di, Ph.D., R. Scott Obach, Ph.D., Eugene P. Kadar, Alyssa Dantonio, and Gregory S. Walker. This team was recognized for their work on the oral SARS-CoV-2 inhibitor Nirmatrelvir, designed to covalently target the Main Protease (Mpro) enzyme of SARS-CoV-2 for the treatment of COVID-19, for overcoming numerous DMPK challenges in extraordinary timelines, an unprecedented use of quantitative 19F NMR spectroscopy as a tool to characterize human ADME at an early stage of development, demonstrating the team's ability to innovate and adapt with Ritonavir boosting, and the completion of a human [14C]ADME study in time for regulatory submission for Emergency Use Authorization. The workings of the Paxlovid team are a great example of attitude, insight, teamwork, collaboration, excellent communication, and ability to see through problems by application of basic concepts and new technologies in ADME problem solving, not to mention, doing all this in a record time.
Issue 3, 2023
Professor Jashvant Unadkat, Ph.D., of the School of Pharmacy at the University of Washington is the 2023 recipient of the ISSX North American Scientific Achievement Award in honor of Ronald W. Estabrook. Dr. Unadkat has produced over 240 peer-reviewed papers and has more than 15,000 citations (h-index of 73 and an i10-index of 22). His laboratory is recognized for using innovative DMPK tools to translate research from the bench to the bedside and vice versa. His pivotal work on transporters started when he characterized the role of nucleoside transporters in the human intestine in transporting endogenous nucleosides and exogenous nucleoside drugs (e.g. ribavirin). Dr. Unadkat has continued his research in DMPK changes in pregnancy through phenotyping studies where he reported that renal P-glycoprotein and hepatic CYP3A activity is significantly induced during human pregnancy. Since studying maternal-fetal disposition of all drugs taken by pregnant people is logistically and ethically not possible (especially in the 1st and 2nd trimester), he developed the first PBPK model to predict maternalfetal exposure to drugs throughout pregnancy. Additionally, he has extended the above work and used the REF/QTP approach to predict transporter-based tissue drug concentrations such as the human brain and liver. To validate his predictions, he has pioneered the use of PET imaging to non-invasively determine tissue drug concentrations in humans. His laboratory was the first to image P-glycoprotein (P-gp) activity at the human BBB using 11C- verapamil. In addition to his scientific research, Dr. Unadkat has provided leadership to the DMPK community through service on the ISSX Council, co-chairing the 21st North American ISSX Meeting, and initiating a biannual drug transporter conference with AAPS. Dr. Unadkat has also mentored 85 masters, doctoral, and post-doctoral students.
Pfizer Paxlovid Team
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Featured Jobs Guide
On behalf of the International Society for the Study of Xenobiotics, the ISSX Career Center, and all the participating organizations, welcome to the ISSX 2023 Featured Jobs Guide! ISSX maintains a strong focus on career development for all members. As you navigate your path in this field, this year’s ISSX Jobs Guide provides you with the opportunity to make connections and find resources to take you to the next step of your career. This guide contains special information on the organizations looking to recruit YOU today! Learn more about what organizations are looking for in their candidates, current career opportunities, and company culture and benefits. Don’t forget to visit the ISSX Career Center to create your job seeker profile, upload your resume, and view more information about how you can use the ISSX Career Center to achieve your goals year-round. We look forward to helping you connect with top employers and moving ahead in your career! Best wishes, The International Society for the Study of Xenobiotics (ISSX)
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ISSX 2023 Featured Jobs Guide
DIRECTORY 11 Common Resume Errors
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26th North American ISSX and JSSX Meeting
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Boehringer Ingelheim
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Cogent Biosciences
INOTIV, INC.
ISSX Career Center
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ISSX Learning Center
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ISSX Membership
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ISSX 2023 Featured Jobs Guide
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ISSX 2023 Featured Jobs Guide
APPLY NOW! ISSX 2023 Featured Jobs Guide
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ISSX 2023 Featured Jobs Guide
It’s Almost Time to Renew Your ISSX Membership for 2024! Dear ISSX Members, Thank you for your membership and support of ISSX! We hope you will choose to remain an integral part of the premier international association that advances research and education on the interplay of living systems with medicines and chemicals for the benefit of society worldwide, by renewing your ISSX membership today.
Connect with the Benefits of Membership • • • • •
The ISSX Webinar Series is one of our most popular benefits of membership and provides members with the opportunity to learn about a variety of topics presented by leaders in the field. The ISSX Focus Groups provide an excellent forum for scientific discourse and members are encouraged to join one or all four groups. In addition, the New Investigators Group is very active and this group provides an excellent way to connect with fellow early career scientists to share experiences and tips. Another point of connection for members is the ISSX Mentorship Program, which links early career scientists with experienced colleagues to provide career advice and discuss career options. Finally, ISSX members benefit from steep discounts to our highlyrated scientific meetings where they learn about the latest research developments, network with leaders in the field, and present their research in multiple forums.
Join Us Online and In-Person 2024 programming includes a February virtual workshop presented by the ISSX Transporters Focus Group that will focus on endogenous biomarkers. Additionally, the much-anticipated joint ISSX and JSSX Meeting which is themed, The Future of Translational Xenobiotic Research, will be held in Honolulu, Hawaii September 15-18. Be sure to join ISSX to expand your connections and learning. We look forward to greeting you online in the ISSX Learning Center for our webinars and recorded short courses and workshops. Be sure to renew your membership for 2024 beginning October 1, 2023 to retain access to all the benefits of membership with ISSX in the year ahead! Visit www.issx.org/renew today!
ISSX 2023 Featured Jobs Guide
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Join us on the ISSX Learning Center ISSX provides numerous virtual educational offerings for members and non-members alike. Visit the ISSX Learning Center, a virtual learning experience, and access all ISSX webinars, recorded workshops, and short courses. Getting started with the ISSX Learning Center is easy. ISSX members can log in using their ISSX username and password, with no need to remember another password. After logging in, members can update their profile to receive recommended webinars based on their interest in our top five interest categories. Members can also update their time zone to ensure that future live webinars offerings will be shown in their time zone. To register for an offering listed in the ISSX Learning Center, members simply select the “Register” button for the product. Members can then choose to continue adding additional offerings to their cart, or finish the registration immediately. As a reminder, all ISSX members receive access to webinars free of charge! All registered products appear in the Dashboard section of the member’s account. Here, members can easily filter by the type of product they would like to view or filter by completion status to view educational offerings that have not yet been viewed. All of the products also include access to speaker slides, along with the recordings. Additionally, the ISSX Learning Center includes a robust Frequently Asked Questions section and a quick video tutorial to assist with registering for a product, logging in, or other questions. The ISSX Learning Center can help you to be up to date on research in numerous topics, and new webinars are added regularly to access live or as a recording. Visit www.learn.issx.org to log in today!
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ISSX 2023 Featured Jobs Guide
SAVE THE DATE THE FUTURE OF
Translational Xenobiotic Research
ISSX 2023 Featured Jobs Guide
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11 COMMON RÉSUMÉ ERRORS By Jordan Warshafsky, Partner, Ashton Tweed Don’t fall victim to these top eleven résumé errors. The job market for the life sciences is so competitive that one can’t risk making these common mistakes, for they might lead to your immediate elimination as a potential job candidate. Go through this checklist before submitting your résumé: 1. Typos: There is NO excuse for errors, grammatical or other errors. Proofread and then proofread again. Have a third party read the résumé, not for content, but for mistakes. 2. No focus: Write a professional summary of what you have to offer rather than a professional objective statement. A summary gives a focus to you and your career experience, while an objective is vague and uninformative. Remember, that many readers never get beyond the introductory summary paragraph. So make it impactful. 3. Lacking keywords: Your résumé should be specific to each job opportunity. It’s a critical mistake to send out a one-size fits-all résumé. Use keywords from the job description. 4. Missing relevant accomplishments: Don’t be modest in your résumé. In order to market your skills and personality, make sure to list notable activities, awards, and accomplishments. Be as quantitative as you possibly can. 5. Too long or too short: Be selective. Don’t list irrelevant or obvious skills. However, don’t sacrifice notable details to keep your résumé under a certain length. 6. Lengthy Lists: For each career experience, focus on specifying your accomplishments rather than listing lengthy job responsibilities. Answer what did you complete and how successful was it? 7. Visually unappealing: Be careful not to have inconsistent formatting; your résumé should be uniform. Be wary of too many fonts and colors and keep an eye out for large blocks of text or blank space. A bullet point format is easiest to use and read. 8. Point of View: Your résumé can be written in 1st or 3rd Just make sure to drop the pronoun in your sentences and phrases. EX: Write “Managed the business development initiative” rather than “I managed the business development initiative.” 9. Fluff phrases: Use action verbs and strong words to depict your experiences. Avoid overused phrases and words because they will not help you stand out from other candidates. 10. Email choice: You don’t want to use your past or current work email, but that doesn’t mean it’s appropriate to use an unprofessional email. Use a simple personal email that easily identifies you. EX: Use JPeterson@email.com instead of KoolKat79@email.com. 11. Out of date: You MUST keep your résumé up-to-date. Add current and relevant information and cut out anything that is no longer applicable. And remember, a résumé must be totally honest and true. 10
ISSX 2023 Featured Jobs Guide
CAREER CENTER The premier resource for pharmacology and toxicology professionals looking to plan or advance their careers.
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Upload your resumes so employers can find you. Sign up for the monthly “New DMPK Jobs” email and receive top open positions sent right to your inbox. Set custom alerts for when positions that meet your criteria are posted. Bookmark your top jobs using the star icon and apply when you are ready. Access valuable resources, including career insights as well as helpful resume reviews and interview tips.
Visit issx-jobs.careerwebsite.com to get started!
ISSX 2023 Featured Jobs Guide
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Header ISSX Newsletter is published quarterly in the spring, summer, autumn, and winter. For information concerning advertising in this publication, including rates and specifications, please visit issx.org/advertising or contact Scott Narug at snarug@issx.org.
Editor Dr. Allen Cato, III Vistagen Therapeutics 343 Allerton Avenue South San Francisco, CA 94080 USA Telephone: +1-650-577-3698 E-mail: jcato@vistagen.com
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