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Source: https://issx.site-ym.com/resource/rss/news.rss

<rss version="2.0" xmlns:atom="http://www.w3.org/2005/Atom">
<channel>
<title>ISSX News</title>
<link>https://www.issx.org/news/</link>
<description><![CDATA[ ]]></description>
<lastBuildDate>Sat, 27 Apr 2024 07:56:48 GMT</lastBuildDate>
<pubDate>Tue, 23 Apr 2024 13:29:00 GMT</pubDate>
<copyright>Copyright © 2024 International Society for the Study of Xenobiotics</copyright>
<atom:link href="http://www.issx.org/resource/rss/news.rss" rel="self" type="application/rss+xml"></atom:link>
<item>
<title>April 23, 2024 ISSX President's Message</title>
<link>https://www.issx.org/news/670714/</link>
<guid>https://www.issx.org/news/670714/</guid>
<description><![CDATA[Dear ISSX fellow members, A very warm welcome with this first message as your new ISSX President. Before looking into 2024, I would like to thank Scott Obach for leading the Society over the past two years. During that time, ISSX re-started in-person meetings, continued a very successful webinar series, and instigated some new initiatives to address challenges of diversity and inclusion. My thanks also extend to the outgoing members of the Council (Nina Isoherranen, Ylva Terelius, Uwe Fuhr, Kiyomi Ito, and Sandy Pang), and Zoë Fuller and her team for their support and service in helping out with any ISSX-related matters. Many congratulations to newly elected members of the ISSX Council, including Mike Zientek who is our President-Elect for 2024-25, together with Valerie Kramlinger, Albert Li, Yuji Ishii, and Amin Rostami. We had an exciting start to 2024 with <a href="https://learn.issx.org/products/bringing-practical-applications-of-endogenous-biomarkers-for-drug-transporters-a-step-closer-current-status-and-future-perspectives-an-issx-2024-virtual-workshop-event" target="_blank">the virtual workshop</a> dedicated to endogenous biomarkers for drug transporters in late February, proposed by Transporter Focus Group and co-chaired by Bhagwat Prasad and Xinning Yang. The workshop topics ranged from discovery of new biomarkers, in vitro characterization, bioanalytical challenges all the way to clinical study design, modelling, and regulatory implications. It was delightful to see the audience engaging in multiple panel discussions during the workshop! If you have missed any of the sessions or the whole workshop, there is still an opportunity to catch up via our <a href="https://learn.issx.org/events">ISSX Learning Center</a>. I fully recommend it; you are in for a treat! Going forward, ISSX is considering opportunities to have smaller meetings for a specific target audience, in addition to our standard large meetings. One illustration of that concept is our <a href="https://www.issx2024.org/issx-workshop-overview-june2024">upcoming Proteomics workshop</a> which will take place on June 27-28th in Sheffield, UK at the Certara UK Offices. In parallel, we are continuing with our monthly Tuesday webinars. The series also includes webinars from scientists discussing their research in Africa, as part of our ISSX Africa initiative. If you have an idea for a webinar/ speaker or would like an opportunity to share your research with the ISSX community, <a href="https://www.issx.org/general/custom.asp?page=WebinarSubmission">please get in touch</a>, we always welcome new and great ideas! And of course, we are very much looking forward to our joint I<a href="https://www.issx2024.org/issxjssx/invitation">SSX/JSSX Meeting in Honolulu, Hawaii</a> from September 15-18th. First call for abstracts for this meeting has just closed and I can tell you that the abstract reviewing committee will be very busy in the coming days, with a staggering 300 abstract submissions to go through! Rest assured that a lot of planning is already happening for 2025, including the first ISSX Africa workshop in the early part of 2025 and 14th International ISSX Meeting (September 21-24th, 2025 in Chicago); more information to follow soon. Details of all exciting programs in 2024 are available on our website; hopefully you will be able to register and join us for as many of these events as possible. Speaking of the ISSX website, we are currently in the process of refreshing the website (long overdue, last round was in 2019!). ISSX Council members suggested various ideas to make the website easier to navigate, and to bring more of a community feel to it, with highlighted photos from our past events. Watch this space for updates. I had a fair share of meetings since January to meet most of the ISSX committees, discuss current activities (and challenges), but also new ideas. Many thanks to all of you who have volunteered their time and effort to these activities to support our Society. It was great to see increasing involvement of early career scientists in the ISSX, either through the New Investigator Forum, as volunteers in some of the committees, or as a member of the biomarker workshop organizing committee. We ended 2023 with fantastic 1,132 members and welcomed some new members since the start of 2024. There are plenty of activities and opportunities for education, training, and professional development to entice you to renew your membership 😊. These opportunities heavily rely on our ISSX Learning Center and we are on our way to make it an even better learning tool for our members. In the last year, Scott Obach has asked for volunteers to develop ideas and recommendations for the Learning Center. Thank you to those who offered their support. We now have a small team who will work on those changes and develop strategies, in conjunction with the Continuing Education Committee who will be reviewing/ removing some of the outdated materials. In addition, Council members will be reviewing existing ISSX bylaws, and mission and vision of our Society, and I will update you on those activities in the coming months. Hopefully, you would have all seen and enjoyed the new format of our newsletter that launched recently (hence my delayed welcome message). We have called the new newsletter XenoXpress. It will come out bi-weekly, with a mix of ISSX related news and featured articles, celebrating some of the latest research advances and innovative work. We are exploring options for a real-time feedback mechanism, but until then, please contact the ISSX team or myself with any ideas or feedback, all are very welcome! Looking forward to the exciting year ahead. With best wishes, Alex ]]></description>
<category>General</category>
<pubDate>Tue, 23 Apr 2024 14:29:00 GMT</pubDate>
</item>
<item>
<title>ISSX 2024 Workshop Virtual Transporters Workshop in Review</title>
<link>https://www.issx.org/news/667360/</link>
<guid>https://www.issx.org/news/667360/</guid>
<description><![CDATA[ ISSX 2024 Workshop: Bringing Practical
Application of Endogenous Biomarkers for Drug Transporters a Step Closer:
Current Status and Future Perspectives
 
The ISSX 2024
Workshop, Bringing Practical Application of Endogenous Biomarkers for Drug Transporters
a Step Closer: Current Status and Future Perspectives, was held virtually February
28-March 1, 2024. The workshop, co-chaired by Xinning Yang, USA FDA and Bhagwat
Prasad, Washington State University, created a virtual space for attendees and
speakers to learn and connect.
The three-day workshop
brought 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. Some of the exciting topics to be covered were: the
application of transporter biomarkers in drug development; understanding
transporter function changes in specific populations facilitated by biomarker
assessment; methods to identify transporter biomarkers; and emerging biomarkers
of efflux transporters. Each session of this workshop featured expert speakers,
and a panel discussion, with special case studies and lightning abstract
presentations; the latter of which was selected from a pool of abstracts from
the students and industry attendees. The presentations, slides, panel
discussions, and Q&A have been made available to attendees to review at
their leisure and are also now available on the <a href="https://learn.issx.org/products/bringing-practical-applications-of-endogenous-biomarkers-for-drug-transporters-a-step-closer-current-status-and-future-perspectives-an-issx-2024-virtual-workshop-event#tab-product_tab_overview">ISSX Learning Center</a> for those who were unable to attend
live.
The workshop
began on Wednesday, February 28 with Session One, entitled “Application of
Transporter Biomarker Studies in Drug Development: Study Design, Case Studies,
and Regulatory Perspectives” and presenters included Kenta Yoshida, Bridget L.
Morse, Fenglei Huang, Xiaoxing Wang, Mikko Niemi, Tomoki Koishikawa, and
Xinning Yang.
Session Two,
“Novel Tools to Improve Understanding of Modulation in Transporter Function in
Specific Populations,” continued on Thursday, February 29, and speakers
included Manthena Varma, Aleksandra Galetin, Bhagwat Prasad, and selected
abstract speakers. 
On the final
day of the workshop, Session Three, “Methods for Transporter Biomarker
Identification, Liquid Biopsy, and Emerging Biomarkers of Efflux Transporters,”
concluded the workshop. Speakers in this session included Martin Fromm, Brahim
Achour, Xiaoyan Chu, Hong Shen, and Kathleen Giacomini. 
At the end of
each daily session, the speakers engaged in a roundtable discussion, answering
questions from the attendees. The session co-chairs moderated the roundtable
discussions, allowing for productive conversations and questions. Both the
presentations and roundtable discussions were recorded and may be viewed after
the fact. 
ISSX
appreciates the commitment and efforts of the Workshop Organizing Committee,
speakers, abstract presenters, and attendees who made this a successful
workshop. 
ISSX would also
like to offer special thanks to LabCorp for its sponsorship of the workshop. 
For anyone who
was unable to register and attend the workshop, the recordings and speaker
slides are accessible in the <a href="https://learn.issx.org/products/bringing-practical-applications-of-endogenous-biomarkers-for-drug-transporters-a-step-closer-current-status-and-future-perspectives-an-issx-2024-virtual-workshop-event#tab-product_tab_content">ISSX Learning Center</a>.]]></description>
<category>General</category>
<pubDate>Wed, 13 Mar 2024 22:23:00 GMT</pubDate>
</item>
<item>
<title>Welcome New ISSX Members!</title>
<link>https://www.issx.org/news/667354/</link>
<guid>https://www.issx.org/news/667354/</guid>
<description><![CDATA[<h1>We are excited to welcome our newest members!</h1><h6>Thank you for joining the ISSX Community!</h6>Eun-Young Ahn, SPMED, Pusan, BukGu, South Korea Daisuke Aibara, Fukuoka University, Fukuoka, Japan Anoud Ailabouni, Washington State University, Spokane, Washington, United States Athbah AlOwaifeer, Pittsburgh, Pennsylvania, United States Nicole Anders, Takeda, San Diego, California, United States Beshoy Armanios Mina Azimi, Cytokinetics, Inc., Dublin, California, United States Agnes Badu-Mensah, Eli Lilly, Indiana, United States Todd Baughman, SpringWorks Therapeutics, Durham, North Carolina, United States Yamini Bobde, Nagpur, Kalmeshwar, India Erica Bradshaw, Biomosaic Consulting, LLC, Carlsbad, California, United States Jose F. Catala Torres, Baltimore, Maryland, United States Winny Chan, Taiho Oncology, Pleasanton, California, United States Jaimin Chaudhari, Zydus Lifesciences ltd, Ahmedabad, Gujarat, India Taylor Choi, Bridge Bio, San Diego, California, United States Ton Dang, Septerna Inc., South San Francisco, California, United States Prashant Desai, Genentech, South San Francisco, California, United States Julian Dopstadt, Novartis, Basel, Switzerland Melanie Felmlee, University of the Pacific, Stockton, California, United States Raeanne Geffert, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States Arthur Germakovski Mark Grainger, LabLogic Systems Ltd, Sheffield, United Kingdom, United Kingdom Elizabeth Hayden Pin Jiang, Medicilon, Pudong New Area, Shanghai, China Eugene Kadar, Pfizer, Groton, Connecticut, United States Yuvaneshwari Kanagasabapathy, Galenicum Health India Pvt., Ltd., Hyderabad, Telangana, India Haribhau Kangne, The University of Manchester, Manchester, United Kingdom Phisit Khema, Mahidol University, Bang Phli, Samutprakarn, Thailand Jiyoung Kim, Seoul National University Sarah Kim, University of Washington Gabriel Knudsen, RTI, International, Durham, North Carolina, United States Nathan Kozon, Gilead Sciences Inc., Foster City, California, United States Kamil Kus, Ryvu Therapeutics, Krakow, Poland Sarina Kyburz, Maisprach, Switzerland Ajay Lale, Zydus Lifesciences ltd, Ahmedabad, India Mitchell Lavarias, Nurix Therapeutics, San Francisco, California, United States Xiuli Li, Roche R&D China, Shanghai, China Jennifer Liem Annamaria Marra, Nerviano Medical Sciences, Nerviano, Lombardia, Italy Melanie Melanie, Merck Helathcare KGaA, Darmstadt, Hessen, Germany Nicola Melillo, Nerviano Medical Sciences, Nerviano, Lombardia, Italy Vijaya Saradhi Mettu, Johns Hopkins Medical Institute, Baltimore, Maryland, United States Chandrasekhar Natarajan, ViNa Pharma Consultants LLC, Cambridge, Massachusetts, United States Le Tra Giang Nguyen, University of Connecticut, Storrs, Connecticut, United States Rune Norgaard, Novo Nordisk AS, Malov, Denmark Dolapo Odujinrin, King's College London, United Kingdom Eimear O'Mahony, University of Washington School of Pharmacy Shambhavi Parab, University of Pittsburgh Purvi Patel, RTI International, Durham, North Carolina, United States Nicholas Patino, Vertex, Boston, Massachusetts, United States David Paul, NIPER-Kolkata, Kolkata, India Ryan Paulukinas, Johnson & Johnson Innovative Medicine, Malvern, Pennsylvania, United States Jorge Pineda Garcia, Kyushu University, Fukuoka, Kyushu, Japan Noah Post, Ionis Pharmaceuticals, Carlsbad, California, United States Leila Potzel, Biopharmacy Department Pharmaceutical Sciences University of Basel, Basel, Switzerland Julie Price, Thermofisher Scientific, Abingdon, United Kingdom Alessandra Pugliano Rana Rais, Johns Hopkins University, Baltimore, Maryland, United States Ravindra Reddy, Syngeneinternational ltf, Bangalore, Bommasandra, India David Reynolds, BioCrsyt Pharmaceuticals, Chapel Hill, North Carolina, United States Maria Rincon Nigro, Karuna Therapeutics, St Louis, Missouri, United States Michael Scherz, Arphamid Therapeutics, Basel, Switzerland Abdul Shaik, Texas Tech University, HSC, Lubbock, Texas, United States Yufei Shi, Fudan University, Shanghai, China Youjun Suh, University of Washington, Seattle, Washington, United States Austin Sun, Morphic Therapeutic, Waltham, Massachusetts, United States Sasikala Talari, NIPER Hyderabad, Hyderabad, India Hanlin Tao, WuXi App Tec, Cranbury, New Jersey, United States Ravi Trivedi, Zydus Life Sciences Ltd, Ahmedabad, India Shirley Tsunoda, UCSD, La Jolla, California, United States Meijuan Tu, UC Davis, Sacramento, California, United States Ugbedeojo Uwodi, Solina Center for International Development and Research, Abuja, Nigeria Yimei Wang Yue Wen, University of Washington, Seattle, Washington, United States Jing Wu, Boehringer Ingelheim Pharm, Ridgefield, Connecticut, United States Bufan Yao Shekhar Yeshwante, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States Aiming Yu, UC Davis School of Medicine, Sacramento, California, United States Mengqi Zhao, Washington State University Spokane, Spokane, Washington, United States Xiaohua Zhu, Nimbus Therapeutics, Boston, Massachusetts, United States]]></description>
<category>General</category>
<pubDate>Wed, 13 Mar 2024 21:17:00 GMT</pubDate>
</item>
<item>
<title>Prequel to ISSX</title>
<link>https://www.issx.org/news/661902/</link>
<guid>https://www.issx.org/news/661902/</guid>
<description><![CDATA[<h3 style="text-align: center;">Prequel to ISSX</h3><h6 style="text-align: center;">Written by Bruce H. Migdalof, Ph.D.</h6>The Prequel to ISSX was originally presented at the 25th North American ISSX Meeting in September 2023, by Dr. Margaret O. James, a charter member of ISSX, on behalf of Bruce Migdalof.For the many of you who are not familiar with me, let me introduce myself. I am Bruce Migdalof, one of the four founders of ISSX, and sadly, the only surviving founder, hence the uniqueness of my knowledge of how it all began.  <table align="center" cellspacing="5" cellpadding="5"><tbody><tr><td colspan="4" style="text-align: center;"><h6> ISSX Founders</h6></td></tr><tr><td> <img src="https://www.issx.org/resource/resmgr/issx_history/bruce_migdalof.jpg" alt="Bruce H. Migdalof" style="width: 200px; height: 267px;" /></td><td><img alt="" src="https://www.issx.org/resource/resmgr/issx_history/fred_dicarlo.jpg" style="width: 200px; height: 267px;" /> </td><td> <img alt="" src="https://www.issx.org/resource/resmgr/issx_history/john_baer.jpg" style="width: 200px; height: 258px;" /></td><td> <img alt="" src="https://www.issx.org/resource/resmgr/issx_history/ina_snow.jpg" style="width: 200px; height: 324px;" /></td></tr><tr><td> Bruce H. Migdalof</td><td> Fred DiCarlo</td><td> John Baer</td><td> Ina Snow</td></tr></tbody></table> The founders of the ISSX were Fred DiCarlo, John Baer, Ina Snow and myself, and the year it was founded was 1981. I will share with you today, from my personal perspective, an overview of some of the individuals involved, and the historical sequence of events that resulted in the formation of both the Delaware Valley DMDG and the International Society for the Study of Xenobiotics, because the two are intertwined. The time interval I will focus on spans the years from mid-1972 to early 1984. This period will begin with my first attendance at a Gordon Conference in Drug Metabolism and end shortly after the first North American ISSX Meeting at the end of October in 1983. In this multiyear journey, I could have started this presentation at a much earlier year, but I will spare you a longer journey. I will note that when I was in the fourth grade in 1950, I had this great idea to organize our class’s outdoor recess activities by creating what I called the “Playground Association”. Dues were to be ten cents a week. Not one classmate was interested, so that was my first try at organizing and it was an abysmal and total failure. Interest in a national drug metabolism society dates back to at least 1970. However, there was no discussion of, or effort to, form a local group in the Delaware Valley until 1975. As mentioned, the nexus for each was a Gordon Research Conferences in Drug Metabolism. The DMDG was founded in 1975 without problems. ISSX was founded in 1981, after a very thorny problem was solved. My roles in both will be explained a bit later.1972 Gordon Research Conference in Drug Metabolism The Gordon Research Conference (GRC) in Drug Metabolism in 1972 was the first scientific meeting I attended that gave me that feeling that I felt at home, not a well treated visitor in a pharmacology society, a toxicology society, a chemical society or a pharmacy society. That meeting showed me the need for more drug metabolism meetings: open meetings, larger meetings, and perhaps some held at more accessible venues. That was what I hoped to see, and which I was willing to work toward. At the time of the 1972 GRC in Drug Metabolism, I was barely 31 years old and had only three years experience in drug metabolism. I was thrilled that I, a young newcomer to the field, had my application accepted by the conference chair, Carl Smith. When it came time to travel to the conference I was faced with the reality that it was not easy to travel to the site of the meeting, the Holderness School in rural New Hampshire. In fact, it was a six-hour drive from my home. This need to travel far was not unusual. Other attendees travelled from all over the United States, and from several foreign countries, so lengthy travel times and long distances were common. In those pre-laptop and pre-cellphone days, it would be fair to say attendees were well isolated from distractions at the GRC in Drug Metabolism. Most attendees stayed at the school, which contained housing, meeting rooms and dining facilities, all within waking distances. There were no telephones in the dormitories and no televisions. The only telephones on site outside of the school offices in Livermore Hall were several payphones on a wall in the basement of the Weld Dining Hall, the building where we took our meals. The basement of Weld Dining Hall also contained the Snack Bar, where many conference attendees enjoyed late night libations and conversations. There were, however, a variety of outdoor activities available to attendees, and since meeting sessions were held in the morning and in the evening after dinner, every afternoon was free time to enjoy the available outdoor activities or to sleep, read, or enjoy informal discussions. <img alt="" src="https://www.issx.org/resource/resmgr/issx_history/grc.jpg" style="width: 200px; height: 267px;" />The beginning of friendships and relationships that were essential to the formation of both the DMDG and ISSX actually began at that Gordon Conference in the summer of 1972. Let me now expound a bit on the Gordon Research conferences. The Gordon Research Conferences organization is a prestigious worldwide nonprofit scientific organization dedicated to fostering scientific meetings that advance the frontiers of science. The Gordon Research Conference in Drug Metabolism, first held in July of 1971, is one of many Gordon Research Conferences held annually around the globe. The fact that, at that time, the drug metabolism meeting attendance was limited to only about 120 scientists fostered meeting fellow attendees and having frequent informal gatherings of small groups throughout the week. The remote location of the GRC in Drug Metabolism served as an incubator for the birth of new ideas. DMDG Now let me describe how the DMDG began. At my first Gordon Research Conference in Drug Metabolism, as I met many of the attendees I was of course impressed by them, but I also became aware that a number of us were from the greater Philadelphia area. Somewhat surprisingly to me, was the fact that we had to travel to a remote rural site in New Hampshire to meet each other or have discussions on topics of common interest. I continued to attend the annual GRC in Drug Metabolism meetings regularly. In 1975, I came to the conclusion that local drug metabolism meetings in the greater Philadelphia area would be greatly appreciated and well attended, a far more favorable circumstance than my playground efforts 25 years prior.During the 1975 meeting, I conceived the idea of starting a drug metabolism discussion group in the greater Philadelphia area, so that scientists in our discipline, at all levels, not just PhD’s, could gather several times a year. By that time, I knew John Baer well enough that I felt comfortable approaching him on the subject. If he, the most well-known and respected elder statesman in our field in the Northeast, endorsed the idea and let his support be known, the proposed discussion group was going to happen. Upon hearing my plan, John immediately and enthusiastically endorsed the idea and urged me to go forward with forming the group. But to start the group I also needed support from company where I was employed. In 1975, I was only recently promoted to Group Leader of Drug Metabolism at McNeil Laboratories in Ft. Washington, Pennsylvania. When I returned to work after the conference, I reported my plan to start a local drug metabolism discussion group to my boss, John Plostnieks, who was Director of the Biology Department. When he learned that John Baer supported my idea he readily agreed to the starting of the DMDG. For political reasons he decided that he, a Department Director, would lead the Steering Committee the first year, which he did. The next year, I was able to take on the role of Chairman of the DMDG Steering Committee, which I chaired Committee for the next two years, and I was a member of the Steering Committee for many years.During those early years, I used what influence I had to keep the name as the DMDG rather than adding a geographical linkage to the Delaware Valley. My reluctance, then, to limit the DMDG to the Delaware Valley was because during the 1970s there was a growing movement across the country to start a national drug metabolism society, but certain factors were keeping that from becoming a reality The reason I wanted the name of the DMDG to be unrestricted geographically was because I though the DMDG could expand over time and go national if no other option reached fruition. When ISSX was founded, there was no longer any reason to restrict name of the discussion group to the DMDG, and the name was formally changed to the Delaware Valley DMDG, as it is currently known.Let me now share with you who Bob Rozman was and why he was honored by later having the annual DMDG symposium named in his honor. I met Bob Rozman at an early Gordon Research conference in Drug Metabolism, and we became close friends. He was active in the DMDG and was a terrific supporter of ISSX and a member of the Organizing Committee. Bob wore heavy braces on both legs and walked with the aid of crutches. Bob rose above his physical limitations and was an excellent scientist who conducted research on a cure for malaria at Walter Reed Army Research Hospital in Bethesda, Maryland. When the DMDG was formed, not only did Bob actively support it, he drove all the way from the Bethesda, Maryland area to the DMDG meetings, held at a hotel north of Philadelphia. And he usually convinced a few of his fellow researchers from Walter Reed to join him in the long drive to and from the meetings. After years of supporting the DMDG and working in the Organizing Committee in the early days of ISSX, he received very bad news. Bob was diagnosed with late stage terminal liver cancer, and had little time remaining. On learning of that, I thought of a fitting honor for him in the DMDG and suggested to the DMDG Steering Committee that the annual DMDG symposium be named in Bob’s honor, and they readily concurred.   Formation of ISSX - ISSX Cofounders Let me now focus on the formation of ISSX, a much larger project, in which I played a role. My esteemed cofounders were John Baer, Fred DiCarlo and Ina Snow. They were all my elders, all my mentors, and all were my good friends. They were the wind beneath my wings and worked very hard to keep me in flight. I fear I will not do them full justice in the limited time I have in trying to share with you who they were, their scientific achievements, their skills in interpersonal relations, their extraordinary energy and enthusiasm for founding the society and their tireless efforts to do the work necessary to bring to fruition the society to which we were so deeply committed.  It is time for me to provide a brief profile of each of my cofounders.  I met them all in 1972 at the second Gordon Research Conference In Drug Metabolism.Fred DiCarlo The first cofounder-to-be that I met was Fred DiCarlo. In fact, Fred was literally the first person I met at a Gordon Conference. He was slim, but athletic, impeccably attired in casual clothes, and exuded self-confidence. With his full head of prematurely white hair, he was a distinguished and imposing figure. Fred was originally from New York, and exhibited what some described on their first impression of him as a “New York edge”. In truth, he was one of the most friendly and social people I ever met. Over his career, his experience spanned employment in industry, consulting and government. In 1972, he had just started, and was the Executive Editor of, the quarterly journal, “ Drug Metabolism Reviews”. In his last position, he joined the EPA as a Senior Scientist at the EPA’s Office of Pollution Prevention and Toxics where he led their program in establishing ways to establish the safety of chemical entities introduced into the environment. Even when working in Washington, DC, Fred maintained his permanent home in Mountain Lakes, New Jersey, a fact of great relevance in the founding of ISSX. Fred had also developed an incredible flair for managing scientific and social events, and he excelled at setting up and running large scientific meetings in venues that attracted many attendees John Baer Now let me introduce you to John Baer. John was tall and broad shouldered with a full head of white hair, and, when I met him, he presented a calm and dignified image consistent with his many years of experience. First and foremost, John was an icon in drug metabolism. As one of the original leaders in industrial drug metabolism research, John was a well-established, highly esteemed, and widely respected scientist when I met him. In 1972 he held the title of Director of Drug Metabolism at Merck Sharpe & Dohme.  John was one of the most accessible and helpful individual in the field I ever met. When approached, John projected a humility and gentleness that put anyone who met him at ease, and he was quick to flash a boyish grin. John’s extensive involvement in ASPET and his great ability to modulate discussions to avoid confrontations was of incalculable value in wooing many of his ASPET colleagues into accepting and supporting ISSX in 1981. Ina Snow Last, but definitely not least of the other three founders, let me tell you a little about Ina Snow. Ina was an amazing person. At a time when the field of scientific studies of xenobiotics was a male-dominated field, Ina Snow’s research flourished at Smith Kline and French in Philadelphia. That was all the more remarkable because Ina did not have a PhD, but was conducting PhD-level research. One example of her research was that she pioneered studies, conducted in dogs, that demonstrated that reabsorption of drugs could occur in the bladder. Ina was in the midst of almost every discussion I was in at the Gordon Conferences and played a major role in the early years of the Delaware Valley DMDG. For example, in 1981 she was Chairperson of the Drug Metabolism Discussion Group, and she chaired the group’s Fourth Annual Symposium, “Interesting Topics in Drug Metabolism” that year. The presentations from that meeting were edited by Bob Rozman and published in Drug Metabolism Reviews that year. I will have more to say about Bob Rozman later.  Bruce Migdalof By now, some of you may be wondering what my contributions were to the formation of ISSX. Let me begin by stating that, as was the case for my cofounders, I grew into the role. My relevant skills include the ability to innovate, to problem solve effectively, to chair meetings of small groups, and to wordsmith skillfully in the preparation of written documents including letters, agendas, and organizational constitutions and bylaws. I also became comfortable being highly visible in scientific meetings, including the DMDG, and leading them. And yes, by 1980 I had sound scientific credentials in drug metabolism research.In the summer of 1980, at the end of the Gordon Conference, my three cofounders bestowed upon me a great honor, and placed upon me a great burden, in encouraging me to take the lead in our efforts to launch the international society. I hosted the original meetings of the four of us, chaired the Organizing Committee, and later chaired the Membership Committee.  Returning now to my first meeting with Fred DiCarlo in 1972, as I was approaching the entrance to the Gordon Conference site, the Holderness School, on foot, Fred saw me and walked toward me smiling. As he approached, Fred extended a welcoming hand and introduced himself. After the introduction, he escorted me around to meet many of the other attendees, where I was also warmly greeted. From those first encounters, I knew that the Gordon Research Conference in Drug Metabolism was the first scientific meeting where I, as a drug metabolism scientist, felt fully at home Formation of ISSX - from 'ISEX' to 'ISSX' Now it is time to delve into the events that led to the formation of ISSX. By 1980, one of the frequent discussion topics on those warm July afternoons at the Gordon Conferences revolved about the desire to form a national, I repeat, a national, drug metabolism society. A major barrier was that many of the well-established drug metabolism scientists were long-time, well-entrenched, members of ASPET, the national pharmacology society. In 1973 ASPET had created a Division of Drug Metabolism, and there were serious concerns among drug metabolism scientists that creation of a national drug metabolism society would result in unwelcome interference with ASPET that might involve their having to choose one or the other society.By July of 1980, at the GRC in Drug metabolism, it was abundantly clear that many attendees had strong feelings about the need for a national drug metabolism society, but efforts to form a national drug metabolism society were stymied by probable negative interactions with ASPET.As early as 1975, John Baer had known of my strong desire, which he shared, for drug metabolism scientists to have our own national “home” society in the United States. So, around that time, he gave me some sound advice. “Before you risk antagonizing ASPET”, he advised, “join the society, so you would not be an outsider stirring things up”. I followed his advice. I took the time to have two scientific articles published in refereed journals, and had two ASPET members submit letters of recommendation when I applied. I had no trouble being accepted into ASPET. My acceptance as an ASPET member would result in a serendipitous event that unlocked the door barring formation of a drug metabolism society. Let me now invoke those two magic words “serendipity” and “epiphany”. By choice, I attended the annual ASPET meeting in the spring of 1980.  By chance, while attending that meeting, I wandered into an open meeting of the ASPET Council. I sat and watched as the council vigorously deliberated whether to go international or not. The decision was emphatically to remain strictly an American society. That decision would resonate in me at the Gordon Conference in July that year.On Monday, July 21, 1980 after the evening scientific session at the Schoolhouse was over, I had been among many attendees who migrated to the makeshift BYOB bar in the Snack Bar in Weld Dining Hall. I quietly left, alone, sometime after midnight. It was in that early morning hour, as I slowly walked alone across the dark quiet quadrangle toward the dormitories, I had an epiphany. Efforts to start a national drug metabolism society would result in major interaction problems, and that was holding us back. I remembered the fact that ASPET had recently firmly committed to remaining strictly an American society. And there it was, my epiphany! Why not break with tradition and move directly to form an INTERNATIONAL drug metabolism society. The next day I sprang my innovative idea on as many of the attendees as I could find, and the word spread. The initial reaction I received when I proposed an international society and skipping a national society was, ”Can we do that?” Then came the realization, “Yes, we can!”Later in the week, on Thursday afternoon, August 4th, ten of the conference attendees participated in an important informal meeting about starting the new society. That was the beginning of serious discussions among more than the founding four to start the new society. Of course, Fred DiCarlo, John Baer, Ina Snow and I were present. But it was noteworthy that there were four attendees present who were from outside the United States: Mitch Cayen from Canada, and John Caldwell, Bob Smith and Peter Johnson from England. We had gone international!  <img alt="" src="https://www.issx.org/resource/resmgr/issx_history/formation_of_issx.jpg" />ISSX Founders Back Row: Bob Smith, John Caldwell, Ina Snow, Mitch Cayen, John Baer, Peter Johnson, Bruce Migdalof; Front Row: Fred DiCarlo, Gaylord (Guy) Paulson; Not Shown: Zafar Israili (Photographer) <div>The attendees of that informal meeting were captured in the photo, which is now posted online in the ISSX History section. The photo shows nine people, but there was a tenth who took the photo. I firmly believe the tenth attendee was Zafar Israili, who was a Professor at Emory University and an avid amateur photographer. Zafar was a frequent attendee at GRC Gordon Conferences and would later be a member of the ISSX Organizing Committee. </div>By the end of that Gordon Conference, it had become the opinion of many attendees that yes, we could and should start as an international drug metabolism society. The door to an international drug metabolism society had swung open. Following the GRC in Drug Metabolism meeting in July of 1980, the four founders met in early September to establish the groundwork for the organization that would spell out the goals of the society and the requirements for membership. For the meeting of the four of us on Saturday, September 6th, it was decided to meet at my home because it was centrally located, within no more than a ninety-minute drive, for the other three. And here is the explanation as to why Fred maintaining his main address in New Jersey was important. If he lived in Washington, D.C. he could not have been able to meet with us. My home was in Robbinsville, New Jersey our meeting place, which became the first address for ISSX; 156 Richardson Rd, Robbinsville, NJ 08691.The format of the meeting on September 6th was that we convened at my house in the early afternoon, held our discussions on the scheduled agenda on the large open back porch of my house, and stopped at about 6:00 pm. My wife had dinner ready for us by then, and after dinner the others left for home.During our meeting, the four of us never argued, but we had some great discussions. John, Fred and I were members of societies with restricted membership, including ASPET. My concept for the new society was to have no formal requirements for membership other than supporting the goals of the society and paying the annual dues. On that Ina and I agreed. John was neutral but Fred had concerns. At one point, after lengthy discussions on the topic, Fred asked me what would happen if, for example, a shoe salesman wanted to join. My response, which probably surprised him, was that if the shoe salesman acknowledged his support for the goals of the society and paid his dues I would say to him, “Hi. Welcome to our society”. At that point there was no further opposition to an open society. <img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_applicaion_form.jpg" style="width: 750px; height: 312px;" /> An application for membership a few years later clearly shows the only requirements to join are supporting the goals of the society, and paying the annual dues.A critical next step was for the four of us to identify other potential members of an Organizing Committee, contact them, see if they agreed to participate, and establish where we would meet. With much thought and effort we identified the most promising other attendees, and contacted them by phone as to their potential interest. Fred and John provided most of the names of individuals and made the initial phone contacts. Once contacted scientists agreed to participate, I sent out letters and supporting documents via mail and airmail to the identified individuals inviting them to a formal organizing committee meeting for the new international society. Along with each invitation letter, was an agenda and the proposed constitution and bylaws.  <table cellspacing="5" cellpadding="5"><tbody><tr><td colspan="3">Organizing Committee Documents</td><td> </td></tr><tr><td><img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_organizing_committee.jpg" style="width: 200px; height: 268px;" /></td><td><img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_organizing_committee_1.jpg" style="width: 200px; height: 268px;" /> </td><td><img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_organizing_committee_2.jpg" style="width: 200px; height: 267px;" /></td><td><img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_organizing_committee_me.jpg" style="width: 200px; height: 271px;" /></td></tr><tr><td>Organizing Committee Meeting Highlights</td><td colspan="2"> Organizing Committee Members</td><td>Organizing Committee Agenda</td></tr></tbody></table>The letterhead for the minutes of the September 6th meeting of the four founders and the documents for the October 30th meeting of the Organizing Committee in Arlington identified the society not as ISSX, but as the International Society for Experimental Xenobiology (ISEX). The name “ISEX” had the appearance of paying homage to the name of the national pharmacology society, ASPET, but there is more to the story of the origin and purpose of the proposed name ISEX and how the name became ISSX. In 1980, a scientific society whose name was pronounced, “ I-SEX” would have been, to put it mildly, highly controversial.The choice of the name of the society for the presentation to the Organizing Committee was mine. So let me explain why I proposed a controversial name. Going into the meeting in Arlington, the support from some of the attendees was felt to be marginal, and we four founders were not at all sure the outcome of the meeting would be to move forward expeditiously. I thought a diversionary tactic might be of value.  I decided that if I proposed to use the name ISEX for the international society, this might divert attention from the question “Should we move forward with the society? ” to the question  “What should the name of the society be? I did not share my motives for proposing the controversial name ISEX to my cofounders because I wanted them to be free to spontaneously voice their own reservations about the choice of the name at the upcoming Organizing Committee meeting.  When I first proposed the name on September 6th to Fred, John and Ina at the informal meetings at my home, eyebrows went up. Fred, John and Ina were not happy but, after some discussion, they did ultimately support me and agreed to go forward with that name. So I had their full, if not enthusiastic, support when I sent out the invitation letters for the meeting in Arlington. At that September 6th meeting, the four founders agreed unanimously that a new international drug metabolism named the International Society of Experimental Xenobiology had been formed. So ISEX was actually the prequel to ISSX! That critical organizational meeting was held at the Twin Bridges Marriot U.S. 1 in in Arlington, Virginia, a suburb of Washington D.C., on Thursday October 30, 1980. With full support from Fred, John and Ina, I chaired the meeting. The event was attended by sixteen scientists who had agreed to participate as members of the Organizing Committee of the new society. Of the sixteen scientists who attended the meeting, fourteen attendees were from the United States and two attendees were from outside the United State. Mitch Cayen came from Canada, and Peter Johnson came from England, so we had some international representation. Ina attended, of course, but was not the lone female attendance. The very well respected Marjory Horning, from Baylor College of Medicine, also attended. It is noteworthy that Marjory agreed to participate in the meeting, since she was an officer in ASPET at the time, and would go on to become the first woman president of ASPET in 1984. The attendees included scientists from industry, academia and government. When the attendees entered the conference room in the hotel where our meeting was to be held, they found on the table at each seat a notebook labeled in gold “THE INTERNATIONAL SOCIETY FOR EXPERIMENTAL XENOBIOTICS”. In the notebook, under the ISEX banner, were an agenda and a draft constitution and bylaws. Once the meeting began, the planned agenda was not followed. As no surprise to me, early in the meeting a somewhat heated exchange took place about the name of the society. After much discussion, a committee to select several alternative names, not including ISEX, was established. From there on, the meeting proceeded well, and it was decided to expand the Organizing Committee to as many members as possible. At the end of the meeting Fred came up to me and paid me one of the highest compliments I have ever received. He told me he felt that no one else he knew could have run that meeting better than I did. Within a few weeks after the meeting, the committee on naming the society had selected three choices for the name of the society, and forward the list to me at Squibb. Ballots were prepared and sent to the members of the Organizing Committee with directions for completing the ballots. The results were close, but ISSX was the clear winner. And that is how ISSX got its name.<table cellspacing="5" cellpadding="5"><tbody><tr><td> <img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_vote_to_name_society.jpg" style="width: 750px; height: 293px;" /></td></tr><tr><td>Results of the Organizing Committee Vote to Name the New International Society (January 28, 2981) </td></tr></tbody></table> Of course, there is more to starting a society than merely voting it into existence. After the meeting in Arlington, committees that were formed there carried out a variety of functions including preparing options for the name of the society, finance, meeting planning and establishing relations with existing journals. The goals were to expand the size of the organizing committee, with more countries represented, and to enroll as many charter members as possible. As of September 1, 1981 the Organizing Committee had grown to 60 members from all over the world! The Charter Membership drive, which ended November 1, 1981, resulted in charter membership for 529 members. ISSX was strong and definitely international. The Membership Committee was formed and continued to seek out prospective new  members of ISSX.Simultaneously, intense planning was in process beginning late 1980, to organize the first ISSX Meeting, which was the first North American ISSX meeting, to be held in late 1983. Arrangements for that critical meeting were the responsibility of Fred DiCarlo, who had been appointed the Meeting Manager. That Fred was able to arrange a very successful meeting within those time limits was extraordinary. The scientific core of the meeting was an outstanding program arranged by the Scientific Program Chairman, John Caldwell, a dynamic and well-respected drug metabolism scientist from St. Mary’s Hospital in London, England.<img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_seal.jpg" style="width: 200px; height: 111px;" />   ISSX Seal The registration of ISSX as a corporate entity in the state of New Jersey was achieved on March 20, 1981, however establishing its certification to hiring staff (Employer Identification Number) was not received until February 23, 1983. Acknowledgement from the IRS that ISSX qualified as a tax-exempt organization did not occur until April 3, 1984.<img alt="" src="https://www.issx.org/resource/resmgr/issx_history/issx_logo-original.jpg" style="width: 200px; height: 268px;" /> ISSX Original LogoIt is noteworthy that five names, not four, are on the incorporation document filed in 1981. In addition to the four founders, Bob Rozman’s name is there.  His dedication to ISSX was intense, and had it been possible for Bob to meet in person with Fred, John, Ina and myself at my home after the 1980 Gordon Conference, their might have been a fifth founder.In 1981, John Baer took his rightful and long overdue place as President of ISSX. He was then formally elected to a two-year term for 1982 and 1983. The international nature of ISSX was visibly represented by the fact that the second ISSX President was Robert Smith from England, and the third was Ryuchi Kato from Japan.]]></description>
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<pubDate>Mon, 8 Jan 2024 20:43:00 GMT</pubDate>
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<title>ISSX Newsletter | Issue 3, 2023</title>
<link>https://www.issx.org/news/658701/</link>
<guid>https://www.issx.org/news/658701/</guid>
<description><![CDATA[<div style="position:relative;padding-top:max(60%,326px);height:0;width:100%"><iframe allow="clipboard-write" sandbox="allow-top-navigation allow-top-navigation-by-user-activation allow-downloads allow-scripts allow-same-origin allow-popups allow-modals allow-popups-to-escape-sandbox allow-forms" allowfullscreen="true" style="position:absolute;border:none;width:100%;height:100%;left:0;right:0;top:0;bottom:0;" src="https://e.issuu.com/embed.html?d=issx_newsletter_issue3_2023_final&u=issx"></iframe></div>]]></description>
<category>General</category>
<pubDate>Mon, 20 Nov 2023 21:15:00 GMT</pubDate>
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<title>ISSX Newsletter | Issue 2, 2023</title>
<link>https://www.issx.org/news/649127/</link>
<guid>https://www.issx.org/news/649127/</guid>
<description><![CDATA[<div style="position:relative;padding-top:max(60%,326px);height:0;width:100%"><iframe allow="clipboard-write" sandbox="allow-top-navigation allow-top-navigation-by-user-activation allow-downloads allow-scripts allow-same-origin allow-popups allow-modals allow-popups-to-escape-sandbox allow-forms" allowfullscreen="true" style="position:absolute;border:none;width:100%;height:100%;left:0;right:0;top:0;bottom:0;" src="https://e.issuu.com/embed.html?d=issx_newsletter_issue2_2023_final&u=issx"></iframe></div>]]></description>
<category>General</category>
<pubDate>Wed, 16 Aug 2023 19:58:00 GMT</pubDate>
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<title>ISSX Newsletter | Issue 1, 2023</title>
<link>https://www.issx.org/news/633346/</link>
<guid>https://www.issx.org/news/633346/</guid>
<description><![CDATA[<div style="position:relative;padding-top:max(60%,326px);height:0;width:100%;"><iframe allow="clipboard-write" sandbox="allow-top-navigation allow-top-navigation-by-user-activation allow-downloads allow-scripts allow-same-origin allow-popups allow-modals allow-popups-to-escape-sandbox allow-forms" allowfullscreen="true" style="position:absolute;border:none;width:100%;height:100%;left:0;right:0;top:0;bottom:0;" src="https://e.issuu.com/embed.html?d=issx_newsletter_issue1_2023&u=issx"></iframe></div>]]></description>
<category>General</category>
<pubDate>Mon, 27 Feb 2023 22:33:00 GMT</pubDate>
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<title>ISSX Newsletter | Issue 3, 2022</title>
<link>https://www.issx.org/news/626614/</link>
<guid>https://www.issx.org/news/626614/</guid>
<description><![CDATA[<div style="position:relative;padding-top:max(60%,326px);height:0;width:100%"><iframe allow="clipboard-write" sandbox="allow-top-navigation allow-top-navigation-by-user-activation allow-downloads allow-scripts allow-same-origin allow-popups allow-modals allow-popups-to-escape-sandbox allow-forms" allowfullscreen="true" style="position:absolute;border:none;width:100%;height:100%;left:0;right:0;top:0;bottom:0;"
src="https://e.issuu.com/embed.html?d=issx_newsletter_issue3_2022_final&u=issx"></iframe></div>]]></description>
<category>General</category>
<pubDate>Wed, 21 Dec 2022 15:53:00 GMT</pubDate>
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<title>ISSX Newsletter | Issue 2, 2022</title>
<link>https://www.issx.org/news/615347/</link>
<guid>https://www.issx.org/news/615347/</guid>
<description><![CDATA[<h4 style="box-sizing: border-box; line-height: 1<h4 style=;"><a href="https://issuu.com/issx/docs/issx_newsletter_issue1_2022_final" style="box-sizing: border-box; background-color: transparent; color: #222222; text-decoration-line: none; outline: 0px;">View the latest issue of the ISSX Newsletter online now!</a></h4> 
Click <a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_newsletter_issue2_2022_.pdf" style="box-sizing: border-box; background-color: transparent; text-decoration-line: none;" target="_blank">here for a PDF</a> or
click the image below for online viewing.
 
<div style="position:relative;padding-top:max(60%,326px);height:0;width:100%;"><iframe allow="clipboard-write" sandbox="allow-top-navigation allow-top-navigation-by-user-activation allow-downloads allow-scripts allow-same-origin allow-popups allow-modals allow-popups-to-escape-sandbox" allowfullscreen="true" style="position:absolute;border:none;width:100%;height:100%;left:0;right:0;top:0;bottom:0;" src="https://e.issuu.com/embed.html?d=issx_newsletter_issue2_2022_final&u=issx"></iframe></div>]]></description>
<category>General</category>
<pubDate>Tue, 23 Aug 2022 21:54:00 GMT</pubDate>
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<title>ISSX Newsletter | Issue 1, 2022</title>
<link>https://www.issx.org/news/599497/</link>
<guid>https://www.issx.org/news/599497/</guid>
<description><![CDATA[<h4 style="box-sizing: border-box; line-height: 1.1; background-color: #ffffff;"><a href="https://issuu.com/issx/docs/issx_newsletter_issue1_2022_final" style="box-sizing: border-box; background-color: transparent; color: #222222; text-decoration-line: none; outline: 0px;">View the latest issue of the ISSX Newsletter online now!</a></h4><br
style="box-sizing: border-box; background-color: #ffffff;" />
Click <a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_newsletter_issue1_2022_.pdf" style="box-sizing: border-box; background-color: transparent; text-decoration-line: none;" target="_blank">here for a PDF</a> or
click the image below for online viewing.
 
<div style="position:relative;padding-top:max(60%,326px);height:0;width:100%"><iframe sandbox="allow-top-navigation allow-top-navigation-by-user-activation allow-downloads allow-scripts allow-same-origin allow-popups allow-modals allow-popups-to-escape-sandbox" allowfullscreen="true" style="position:absolute;border:none;width:100%;height:100%;left:0;right:0;top:0;bottom:0;"
src="https://e.issuu.com/embed.html?d=issx_newsletter_issue1_2022_final&hideIssuuLogo=true&u=issx"></iframe></div>]]></description>
<category>General</category>
<pubDate>Fri, 18 Mar 2022 14:10:00 GMT</pubDate>
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<title>ISSX Newsletter | Issue 3, 2021</title>
<link>https://www.issx.org/news/590992/</link>
<guid>https://www.issx.org/news/590992/</guid>
<description><![CDATA[<h4 style="box-sizing: border-box; line-height: 1.1; background-color: #ffffff;"><a href="https://issuu.com/issx/docs/issx_newsletter_issue2_2021_final" style="box-sizing: border-box; background-color: transparent; color: #222222; text-decoration-line: none; outline: 0px;">View the latest issue of the ISSX Newsletter online now!</a></h4> 
Click <a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_newsletter_issue3_2021_.pdf" style="box-sizing: border-box; background-color: transparent; text-decoration-line: none;" target="_blank">here for a PDF</a> or
click the image below for online viewing.
 
<div style="position:relative;padding-top:max(60%,326px);height:0;width:100%;"><iframe sandbox="allow-top-navigation allow-top-navigation-by-user-activation allow-downloads allow-scripts allow-same-origin allow-popups allow-modals allow-popups-to-escape-sandbox" allowfullscreen="true" style="position:absolute;border:none;width:100%;height:100%;left:0;right:0;top:0;bottom:0;" src="https://e.issuu.com/embed.html?d=issx_newsletter_issue3_2021_final&u=issx"></iframe></div>]]></description>
<category>General</category>
<pubDate>Mon, 20 Dec 2021 14:56:05 GMT</pubDate>
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<title>5th Annual Virtual Conference of Indian Society for the Study of Xenobiotics (SSX-2021)</title>
<link>https://www.issx.org/news/589832/</link>
<guid>https://www.issx.org/news/589832/</guid>
<description><![CDATA[<h3>5th Annual Conference of India (SSX-2021)</h3>Indian Society for the Study of Xenobiotics (SSX-India) organized 5th Annual conference virtually, from 14th to 17th July 2021 with the theme of “Emerging trends in ADMET science in drug discovery and development”.  SSX India is growing each year and has been a great success for the last six years. Each year number of participants has been increasing and this year, 452 participants attended the conference, especially with an increased participation from academia.    The key features of the conference were four keynote talks; poster sessions; oral presentations by young investigators and mentorship programme. There were twenty scientific talks by speakers from academia and industry of different countries; five sponsors’ talk and six presentations from young investigators. Day -1 (14th July, 2021): The main conference day started with the opening remarks by Dr. T. Thanga Mariappan, President, SSX, explaining the vision of SSX and major aspects of SSX-2021. He made delegates familiar with the history of SSX from 2009 to 2021 and gave his remarks on the theme of the conference. He also explained details about other initiatives of SSX, such as certificate course on DMPK for the students. He also announced that 7th Asia Pacific ISSX will be hosted by SSX-India at Bangalore in 1Q, 2023.  The conference was inaugurated by Prof. Ann Daly (President, ISSX), Dr. Kenneth Barr (Senior Vice President, Syngene international Ltd.) and Dr. Yuchi Sugiyama (Professor Emeritus, Josai International University, Japan) and Dr. T. Thanga Mariappan (Scientific Director, Bristol Myers Squibb India and President of SSX India). The first scientific session “Drug metabolism and transporters, In vitro and In vivo tools to predict DDI” was moderated by Dr. Prakash Vachaspati, Associate Research Director, Biocon Bristol-Myers Squibb Research Center, Syngene International Ltd., India and Dr. Anandi Karumbati, Team Lead, Center for Chemical Biology and Therapeutics, inStem, India.  The scientific session started with a keynote lecture, “Use of endogenous biomarkers for quantitatively predicting transporter-mediated drug interactions; Importance of using PBPK modeling,” by Professor Yuichi Sugiyama. Dr. Sugiyama explained that the endogenous compounds that may be used as biomarkers for assessing DDI risk coupled with the use of PBPK modelling prior to conducting a clinical trial. This lecture was followed by Dr. Vinay H. K., Lead Investigator, Biocon Bristol Myers Squibb Research & Development Center (BBRC), India, who continued the notion of using endogenous markers like coproporphyrin with this talk on “Can biomarkers be utilized to simplify DDI studies? Role of coproporphyrin in assessment of OATP1B1 and -1B3 hepatic transporter inhibition” The session continued with talks by Dr. Manthena Verma, Pfizer Global Research and Development, USA on ‘Transporter-based drug-drug interaction risk assessment in early drug development”.  He discussed the utility of static models and mechanistic PBPK models in quantitative assessment of transporter-mediated DDIs.  He spoke on DDI involving intestinal transporters (BCRP) hepatic transporters (OATP/BCRP) and renal transporters (OATs and OCT2/MATEs). The next talk on “Protein effect on the hepatic uptake and the improvement of IVIVE in a PBPK model” was by Dr.Yurong Lai,  Director of Drug Metabolism at Gilead Sciences, USA. He discussed on the development of an improved IVIVE describing recent advances in a PBPK model for human PK prediction by incorporating protein binding data.   The first day sessions concluded with a talk by Dr. Deepak Dalvie, Scientific Executive Director at Bristol Myers Squibb, USA, who emphasized the different ways of drug metabolism with his talk on “Role of non-CYP mediated pathways in drug metabolism and disposition”.  He specifically spoke about the metabolism of ozanimod in humans and the involvement of monoamine oxidase in its metabolism. Day -2 (15th July, 2021): The theme of the day 2 session was on "ADME/PK driven case studies and learnings" and was co-chaired by Dr. Deepika Dhaware, Senior Scientist, Orion Corporation, Finland and Prof. S. Bharath, Dean, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, India. This session was made up of a series of talks on data driven methods used for de-risking strategies of drugs like compounds to progress potential molecules with significant mechanistic understanding.  The keynote talk by Dr. Krishna Iyer addressed the CYP450 mediated metabolism of xenobiotics. Dr. Iyer described various metabolism pathways of xenobiotics via CYPs with particular focus on the halocarbons and their toxicological and ecological impacts. The discussion also included circumventing strategies that serves as initial drug metabolism informed strategies for compound synthesis with reduced reactive metabolite liabilities. The reactive metabolite related risks and metabolite mediated CYP induction can lead to several adverse effects in the organ where these metabolites are formed. A significant amount of metabolism of the xenobiotics is carried out in the liver and therefore the most important organ for toxicology studies. The adverse effects in the liver of rodents used as toxicological models are usually identified based on increase in liver weight, hepatocellular hypertrophy, cell proliferation and hepatocarcinogenesis. There are several challenges within the toxicology assessments due to the inherent differences in the liver anatomy within the rodent species. This also evokes questions related to the translatability of these adverse effects in higher species. The liver related adverse effects are seldom a rodent species related issue only. However, care must be taken to tease this from other factors that may cause adverse effects in higher species liver. Dr. Venkatesh Udupa brought forward a case study where the toxicological findings were associated with CYP induction, hepatocellular hypertrophy and thyroid follicular hypertrophy. The talk also measured the strategies employed to study the toxicology profile in rodents and predictions of translation of these adverse effects in humans and early clinical outcomes using a case example.  With improved awareness around drug metabolism, increasingly lower clearance compounds are being synthesized. The limitation of the current enzyme models for in-vitro assessments of these new low clearance modalities makes it further challenging to understand the metabolism and subsequent drug-drug interaction predictions. Thus, less confidence in the predicted outcomes of human clinical trials in terms of clinical efficacy and toxicity. It is also increasingly challenging to conduct the in vitro to in vivo correlations requiring newer strategies to develop understanding with existing in-vitro systems. Dr. Ravi Talluri provided several such considerations as a lead compound, its selectivity and progress towards the clinic. To conclude, the PK/PD correlation based on PK and in-vitro data should be refined in conjunction with efficacy outcomes from animal studies to predict the likely doses and efficacy response in human. The identified lead molecules with optimized target engagement are fast progressed towards the clinic. However, the desired pharmacodynamics responses at low doses are mostly sought for the identified candidates. Several screening strategies are employed to evaluate key endpoints from various assays such as in-silico, in-vitro and in-vivo including the early relative human dose projection. Dr. Elizabeth Joshi’s presented strategies that utilized the relationship between lipophilic ligand efficiency and relative dose predictions for speeding up the compound nomination for advanced testing. This was supported with case studies that highlighted the simplicity of these approaches towards minimizing the efforts on poor quality molecules. The expectation is that such approaches would help accelerate drug discovery and evolve the way candidate progression to be carried out in conventional DMPK laboratories.The general recommendation of the regulatory authorities for drug-drug interaction (DDI) studies employ traditional in-vitro systems which in some cases do not capture the clinical outcomes. These unconventional cases are usually the ones where the interplay between several clearance pathways is observed for example interplay between induction of metabolic enzymes and uptake transporters, etc. Dr. Niresh Hariparsad, highlighted the limitations of the standard in-vitro approaches for the assessment of the DDI risks. He also shared a case study where the DDI predictions were particularly challenging due to the interplay between uptake transporters, CYP450 induction as well as non-CYP metabolism via aldehyde oxidase. Future opportunities for development of next generation systems for ADMET studies were also discussed. A brief introduction of the IQ Induction WG and the resource material were also shared.  The need for improvised in-vitro systems was recognized and well established during Dr. Niresh’s talk It is imperative to explore and optimize in-vitro systems that would allow assessments of complex interactions between several clearance pathways with minimalistic variability. These manifold challenges that crop up in late candidate selection necessitate the need for long term viability cells for further assessments. Therefore, the need for consistent quality hepatocytes for the studies on transporters and metabolism is also deemed essential. Towards this, Dr. Li presented some in-vitro models for hepatic and enteric metabolism using the human hepatic and enteric cells. The application of the plateable human hepatocytes were demonstrated in uptake transport, P450 induction, hepatotoxicity, gene therapy and fatty liver disease. In addition to other scientific talks, AB Sciex presented the key highlights of the new LC-MS/MS technology and troubleshooting for new drug modalities including the oligonucleotides etc.  Day -3 (16th July, 2021): Day 3 session was co-chaired by Dr. Vinay H.K., BBRC, Bangalore and Dr. Arti Thakkar, Amity University, Noida. The theme of the session was ADME Tox Perspectives on New Modalities and Technologies. Session was begun with introductory remarks and first speaker of the day Dr. Vishwottam Kandikere, from Syngene International Ltd., Bangalore, India spoke on “ADME strategies for PROTAC Druggability”. Dr. Kandikere discussed the major issues associated with PROTAC compounds such as low solubility, low permeability, high LogD values, high binding to plasma proteins, CYP mediated metabolism. Also, routine in-vitro ADME studies doesn’t help in evaluating PROTACs. Thus, to address ADME and PK issues, the Syngene DMPK group has developed modified Caco-2 conditions and bio-relevant thermodynamic solubility assessments to select compounds for oral PK studies.  This session was followed by Dr. Vamsi Madgula, In Vitro ADME Services, Syngene International Ltd., Bangalore, who spoke on “Harmonisation of Wave 1 ADME assays- A CRO perspective” Dr. Madgula shared that there are multiple variables in the conduct of Wave-1 ADME assays (like DMSO solubility/ kinetic solubility, plasma protein binding, intrinsic clearance in liver microsomes/ hepatocytes) in different labs and there is an opportunity and need for harmonization.  He suggested that we should setup a core team across industry, academia and CRO to discuss and publish outcomes as white papers / present in global conferences for harmonization. This was followed by a session on Acknowledgment of Sponsors. All sponsors were thanked with a certificate and SSX memento for their involvement, support and belief in SSX team.  Next presentation was by Dr. Nagendra Chemuturi, Takeda, Massachusetts, USA. He spoke on “Gene Therapies: A new paradigm in the treatment of rare diseases”. Dr. Chemuturi discussed that approximately 7000 known rare diseases with more than 85% are due to genetic mutation for which very few treatments with poor prognosis are available which is not viable commercially. Dr.  Chemuturi further discussed that Gene Therapy products (mainly viral vector therapies) can supply the functional copy of the gene which can give a sustained therapeutic effect with single administration. He elaborated various viral vectors – specifically Adeno Associated Virus (AAV) which differ in DNA loading capacity, tropism, species specificity (infectivity or cross reactivity), mechanism of gene delivery, etc. He gave a case study of Luxturna™ (AAV2) for treating Leber’s Congenital Amaurosis and Zolgensma ® (AAV9) approved for treating Spinal Muscular Atrophy.  The next talk was on “3D Human Liver Spheroids: Moving Towards Meaningful In Vitro Assays” by Dr. Feng Li from Corning Life Sciences. He shared some of their data with 3D spheroid qualified primary human hepatocytes. Corning Elplasia plates can be used to grow large number of spheroids. Each well on Elplasia plates can give rise to about 500 spheroids. These systems can be used for the assessment of drug induced liver injury. Data suggest that primary human hepatocyte (PHH) liver spheroids have superior sensitivity of 2-3 folds in in vitro hepatotoxicity assays in comparison to the conventional 2D PHH monolayer cultures.  The next talk was on “Strategies to Optimize Your Drug-Drug Interaction Program” which was delivered by Mr. Daniel Albaugh, Dr. Andreas Reichl and Dr. Brandon Gufford from Covance, Greater Madison, USA. They discussed that over 2 million ADRs occur each year and most of them are due to potential drug-drug interactions. They discussed various strategies such as Static DDI models, Preclinical in vitro studies, PBPK modeling, clinical DDI studies and Population PK modeling to assess the potential drug-drug interactions. The last presentation of the day was from Dr. Prasoon Chaturvedi from C4 Therapeutics, USA on “ADME Properties of Bifunctional Degradation Activating Compounds (BiDACs)”. He explained that with their TORPEDOTM platform, they were able to design potent, selective and orally bioavailable monofunctional (MonoDAC) and heterobifunctional (BiDAC) targeted protein degrading compounds. TORPEDO is primarily focused on Cereblon E3 ligase, the only clinically validated ligase for targeted protein degradation. He showed data on several compounds with respect to Caco-2 permeability and its relation to bioavailability. Even though BiDACs fall under beyond Rule of 5 category, they were able to design compounds in such a way that they were able to get >50% bioavailability in mouse. Day -4 (17th July, 2021): Dr. Surulivel Rajan, Manipal College of Pharmaceutical Sciences, India, and Dr. Manasa Deepa R, East West College of Pharmacy, Bangalore, co-chaired the session 4 with the theme of PK/PD Modeling and Simulations and Translational Sciences.  The session instigated with keynote lecture by Dr. Bhagwat Prasad, Associate Professor in the Department of Pharmaceutical Sciences, Washington State University (WSU), Spokane, WA, Dr. Bhagwat delivered the keynote talk on “Whether glucuronidation really a drug elimination pathway? Implications in PBPK modelling. Dr. Bhagwat explained glucuronidation interplay with drug transporters and gut microbiome. Dr. Bhagwat also covered importance of glucuronidation in distribution and its importance in drug half-life when the compounds are reabsorbed post cleavage into parent compounds by the UGT enzymes. Dr. Jaydeep Sinha, School of Medicine, University of North Carolina at Chapel Hill, USA, delivered the second talk on “Application of Physiology-Based Pharmacokinetic Modeling in Understanding Drug-Drug Interaction. He emphasized more about the drug-drug interaction of oxcarbazepine in epilepsy treatment. He also focused about model-informed drug discovery and development, both in industry and in academia.  Dr. Rajbharan Yadav, Genentech, South San Francisco, California, USA, presented “Design and Development of a Potency-Reduced Immunocytokine in Cancer Therapy.” His talk emphasized about how the engineered IL15/IL15 Rα-Fc binds to IL2/ IL15 Rβγ subunits on NK cells and T lymphocyte and significant role of XmAb24306 to target the cancer cells pave the way to improve efficacy in cancer chemotherapy. Professor Dr. Vikram Gota, clinical pharmacology, ACTREC, Tata Memorial Centre, India, presented “Population PK studies on the influence of ADME gene polymorphisms on the pharmacokinetics of anticancer drugs” in his presentation; he specified the role of drug efflux pump ABCB1 gene on the PK of imatinib, along with albumin and WBC. Pre-emptive pharmacogenetic guided dose individualization could prove beneficial in this population. The scientific session concluded with Dr. Rama Sivasubramanian presentation on “Pediatric drug development”.  Dr. Rama explained about special attention requirements in Pediatric drug development to dose identification in the pediatric population. She also stressed about Modeling & simulations and in silico approaches have been successfully applied to various aspects of pediatric drug development including dose identification. She highlighted both efficacy and safety for the pediatric development need to be carefully evaluated. Poster session:  There has been a huge interest for submission of abstracts for poster presentation. Totally 102 abstracts were finally selected after screening by the scientific committee members. The abstracts were categorized into various topics related to drug discovery and development, viz., 19 abstracts in ADME; 34 abstracts in formulation development; 28 abstracts in pharmacology and toxicology and 18 abstracts from other interdisciplinary studies. A panel of adjudicators from industry and academia evaluated the posters and selected four best e-posters with certificates and cash prizes. Below is the list of best posters.<ul><li>Mr. Amol Bisen, CSIR-CDRI, Lucknow India<ul><li>Development of sustained release liposomal formulation of amphotericin B against invasive fungal keratitis and its PK-PD analysis</li></ul></li><li>Ms. Anusha Saraswathi D S, M.S. Ramaiah University, Bangalore<ul><li>“Preparation, characterization and in-vitro cell viability assay of ginsenoside nanoformulation”.  </li></ul></li><li>Mr. Deepak Ahire, College of Pharmacy and Pharmaceutical Sciences, Washington State University (WSU), Spokane, WA<ul><li>Human liver microsomes data overpredict interindividual variability in drug-metabolizing enzymes: Implications for PBPK modelling”.</li></ul></li><li>Mr. Gautam Vijaywargi, NIPER, Mohali<ul><li>Studying the effect of genetic polymorphism on the pharmacokinetics of cyp2d6 substrate propafenone using PBPK modelling”. </li></ul></li></ul>Young Investigator Presentation:  Six best abstracts were selected for the oral presentation by the students. Ms. Abira Dey (Annotation Analytics Pvt. Ltd, Haryana, India); Mr. Bhim Bahadur Chaudhari (Manipal College of Pharmaceutical Sciences, India); Ms. Priya Sharma (Amity University, Noida, India); Mr. Ansari Mohd Faraz Zubair Md Mukhtar Ahmed (M.S. Ramaiah University of Applied Sciences, India) ; Dr. Manisha Bhateria  (CSIR, IITR Lucknow) and Ms. Varsha S R (M.S.Ramaiah University of Applied Sciences, India) have presented their research to a diverse audience and received constructive feedback to help better their research careers. Juries assessed the six presentations and awarded a certificate and cash prize to the two best presenters. The following were the winners for oral presentation: <ul><li>Dr. Manisha Bhateria, from CSIR, IITR Lucknow for her presentation on “Predicting the in vivo developmental toxicity of fenarimol in rats and humans from in vitro toxicity assay using PB/TK modelling facilitated reverse dosimetry approach” </li><li>Mr. Bhim Bahadur Chaudhari from Manipal College of Pharmacy, India presented Development of a DBS based analytical method for quantification of Cefotaxime: Applicable for pharmacokinetic evaluation in neonates”. Both poster session and young scientists’ presentations were effectively coordinated by Drs. Sachin Tulsankar, Anoop Kumar and Amol Raje. </li></ul>Mentorship program: Mentorship programme was conducted to help students to get started with research career in the ADME-Tox sciences. Students registered in the mentorship programme based on the research interest were paired with mentors who are either renowned conference speakers or senior scientists from industry or academia. The agenda was coordinated by Mr. Shashyendra Singh Gautam.  Raffle card lucky draw and Vote of thanks: Delegates were encouraged to drop the raffle card along with their feedback about the conference. At the end of 4th day Session, two raffle cards were picked up from the participants randomly. Winners of the raffle card lucky draw has announced and bestowed with their amazon voucher Rs 5,000 each. This was followed by vote of thanks presentation by Dr Vamsi Madgula and he announced the forthcoming certificate course on DMPK to the delegates. Meeting Chair: T. Thanga Mariappan, Ph.D.,  President, SSX, India Scientific Director,  Bristol Myers Squibb India, Bangalore, India. Meeting Organizing committee: Deepika Dhaware  Vamsi Madgula  Vinay HK Amol Raje Anoop Kumar  Sachin Tulsankar  S. Bharath  Shashyendra Singh  Nilesh Gaud  Eljo J. Jose  Meeting Sponsors/Collaborators: Corning AB Sciex Syngene International Ltd. Vivo Bio Bugworks, Bangalore Orchid Scientific & Innovative India Pvt. Ltd. Labcorp Bristol-Myers Squibb GenoMembrane Orchid Scientific & Innovative India Pvt. Ltd. Intra Globus Biosystems-Hamilton IVAL Ongoing and Future Events of SSX-India: <ul><li>Certification Course of DMPK, August to December, 2021: To provide basic understanding of DMPK concepts, techniques and applications of preclinical to clinical translation; Webinar based training programme for 40 hours over 5 months </li><li>Asia Pacific ISSX Meeting, 1Q, 2023: 7th AP-ISSX has been scheduled at Bangalore, India </li></ul><div> </div>]]></description>
<category>General</category>
<pubDate>Thu, 30 Sep 2021 05:00:00 GMT</pubDate>
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<title>Results of ISSX 2021 Election and Bylaws Vote</title>
<link>https://www.issx.org/news/581391/</link>
<guid>https://www.issx.org/news/581391/</guid>
<description><![CDATA[Thank you to all members who participated in the recent Society election and vote. Voting is an important right of membership in ISSX and it is your opportunity to help determine the future leadership of our Society. In this year's election, members of ISSX voted to elect a President-Elect/Secretary, a Treasurer-Elect, three members of Council, and three members of the Nomination Committee. Additionally, ISSX members voted on an update to the ISSX Bylaws.   <h3>ISSX Election for Officers-Elect, Council, and Nomination Committee Members</h3>ISSX Officers-Elect: President-Elect/Secretary: Aleksandra Galetin, University of Manchester, United Kingdom Treasurer-Elect: Mary Paine, Washington State University, USA   Council Members: Asia Pacific: Kiyomi Ito, Musashino University, Japan (second term) Europe: Uwe Fuhr, University Hospital of Cologne, Germany (second term) North America: Nina Isoherranen, University of Washington, USA (second term) Nomination Committee Members: Deepak Dalvie, Bristol Myers Squibb, USA Elizabeth Gillam, The University of Queensland, Australia Amin Rostami-Hodjegan, University of Manchester, United Kingdom On January 1, 2022 when these newly-elected officials join the slate of officers, Council and Nomination Committee members will be: Officers: President: Scott Obach, Pfizer Inc., USA President-Elect/Secretary: Aleksandra Galetin, University of Manchester, United Kingdom Treasurer: K. Sandy Pang, University of Toronto, Canada Treasurer-Elect: Mary Paine, Washington State University, USA Council Members: Uwe Fuhr, University Hospital of Cologne, Germany  Kiyomi Ito, Musashino University, Japan  Nina Isoherranen, University of Washington, USA Simone Schadt, F. Hoffmann-La Roche Ltd, Switzerland Jashvant Unadkat, University of Washington, USA Kouichi Yoshinari, University of Shizuoka, Japan Ylva Terelius, Scientific Affairs Committee (SAC) Chair, Ex Officio to Council, ADMEYT AB, Sweden Nomination Committee:  Ann Daly, Newcastle University, United Kingdom Deepak Dalvie, Bristol Myers Squibb, USA Elizabeth Gillam, The University of Queensland, Australia Amit Kalgutkar, Pfizer Inc., USA Peter Mackenzie, Flinders University, Australia Amin Rostami-Hodjegan, University of Manchester, United Kingdom Michael Zientek, Takeda, USA The Society is grateful to all candidates who agreed to serve in the election as well as to the following members of the Nomination Committee who were responsible for assembling the slate of candidates: Thomas Baillie, Chair and Immediate Past President, University of Washington, USA Constanze Hilgendorf, AstraZeneca R&D, Sweden Amit Kalgutkar, Pfizer Inc., USA Peter Mackenzie, Flinders University, Australia Miki Nakajima, Kanazawa University, Japan K. Sandy Pang, University of Toronto, Canada Michael Zientek, Takeda, USA <h3>Bylaws Vote</h3>Bylaws are the rules that govern the internal management of an organization. They are written by the organization's founders or directors and cover, at a minimum, topics such as how directors are elected, how meetings of directors are conducted, and what officers the organization will have, and what their duties may include.  In April 2021, the ISSX Council met to review and discuss changes to the ISSX Bylaws which will increase the flexibility with which ISSX can appoint members to the Scientific Affairs Committee.  In the 2021 Election, members voted to pass the changes to the ISSX Bylaws as outlined below: Article and Section: Article V, Section 3 Previous Language: Scientific Affairs Committee:  The Scientific Affairs Committee will consist of thirteen (13) members: four (4) from the Americas region, four (4) from the Asia/Pacific region, four (4) from the European region, and the President-elect as an ex-officio member, with half the members rotating off every two years. The President may consider appointing organizers of recent Society meetings as committee members. Its function is to oversee the planning, development and content of the scientific programs of meetings of the Society. New Language: Scientific Affairs Committee:  The Scientific Affairs Committee will consist of thirteen (13) members: three (3) from the Americas region, three (3) from the Asia/Pacific region, three (3) from the European region, three (3) members representing any region and the President-elect as an ex-officio member, with half the members rotating off every two years. The President may consider appointing organizers of recent Society meetings as committee members. Its function is to oversee the planning, development and content of the scientific programs of meetings of the Society. Once Adopted: Removes restrictions on filling the committee roster.  Increases flexibility of President to appoint members to the committee. ]]></description>
<category>General</category>
<pubDate>Fri, 10 Sep 2021 15:55:36 GMT</pubDate>
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<title>David Rodrigues Named ISSX 2021 North American Drug Discovery Award Winner</title>
<link>https://www.issx.org/news/578705/</link>
<guid>https://www.issx.org/news/578705/</guid>
<description><![CDATA[ ISSX congratulates Dr. A. David Rodrigues for being named the recipient of the 2021 North American Distinguished Accomplishments in Drug Discovery and Development Award.<table><tbody><tr><td style="text-align: center; vertical-align: top;"><img alt="" src="https://www.issx.org/resource/resmgr/awards_related/rodrigues.png" /></td><td style="vertical-align: top;">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 on the basis of a single high impact scientific accomplishment that dramatically changed practices in the ADME characterization of drugs or drug candidates or a sustained body of scientific work that shows high impact on the ADME characterization of drugs. The 2021 recipient is A. David Rodrigues, Ph.D., Senior Scientific Director and Head of the Transporter Sciences Group at Pfizer Global Research and Development. Dr. Rodrigues continues to drive innovation in the study of xenobiotic metabolism and clearance. During his 30-year career in the pharmaceutical industry he has had significant influence on the scientific direction in several areas of DMPK science and since joining Pfizer he has continued to expand his scope of influence into the areas of drug transporter sciences and ADME biomarkers.  Notable Contributions to the Field: A Pioneer of In Vitro Drug Metabolism Applied to Drug Discovery and Development: In the 1990s, the field of drug metabolism evolved from one that was merely descriptive of the metabolites if drugs in the drug development phase to one that was predictive of the total disposition of new drug candidates in humans. Dr. Rodrigues was one of the leaders in this arena, leveraging newly available in vitro reagents such as human liver microsomes and heterologously expressed drug metabolizing enzymes, as well as human hepatocytes. This allowed us to understand drug metabolism, metabolic clearance, interindividual variability, and drug-drug interactions at the molecular level. Dr. Rodrigues published multiple early papers describing the use of these new reagents that built the foundations for what are now standard activities in drug metabolism laboratories across the pharmaceutical industry and contract research organizations. These include in vitro P450 inhibition assays, induction assays, and reaction phenotyping studies, among others. Incorporation of high-throughput (HT) methodologies enabled a paradigm shift from uncovering DM issues (e.g. high CL, DDI) in development to identifying and dialing out these concerns early on in discovery. Mechanistically, his research efforts led to a deeper understanding of enzyme kinetics of cytochrome (CYP) P450-mediated reactions; predictive utility of the pregnane X receptor transactivation assay for CYP3A induction; impact of incorporating albumin in metabolic rate assays; comparative utility of liver microsomes versus rhCYPs for CYP phenotyping, among others. The impact of these changes was demonstrated and review articles describing the approaches in vitro metabolism, DDI, HT screening and CYP reaction phenotyping have appeared throughout his career. PK/DDI Predictions: The utilization of in vitro approaches to informing drug discovery teams has expanded in scope and demanded improvements in prediction accuracy. Since joining Pfizer in 2014 as the head of its global drug transporter group, he has led a team of scientists to innovative advances in transporter-mediated PK and DDI assays and predictions; identification of biomarkers for early clinical evaluation; and characterization of new transporters. The group has developed and implemented IVIVE of hepatic uptake CL involving hepatic SLCs, based on both relative activity and relative protein expression by targeted protein quantification using liquid chromatography-tandem mass spectrometry with stable isotope-labeled standards; and optimized experimental methods using plated hepatocytes or individually transfected HEK cells and the impact of incorporating plasma or albumin to the media.  Endogenous Biomarkers: With the established utility of selective substrates for various CYP isoforms and drug transporters in clinical DDI studies, scientists have further sought to employ endogenous biomarkers as indicators of drug-induced inhibition and induction. At both BMS and Pfizer, this reflects his most active area of research, one which have saved millions by eliminating separate clinical studies when combined within the SAD/MAD Phase 1 program. Due to the high percentage of drugs metabolized by CYP3A, it has historically been of greatest interest. Dr. Rodrigues contributed to the evaluation and establishment of robust bioanalytical methods and led research activities within Pfizer to identify endogenous compounds dependent of transporter-mediated clearance to serve as indicators of drug transporter-mediated DDI.  Dr. Rodrigues’s sustained impactful contribution as a leading industry researcher is clearly demonstrated through his strong links with the broader scientific community. Dr. Rodrigues has authored more than a dozen book chapters and >170 peer‐reviewed manuscripts, and through presentations at more than 80 scientific meetings.  Dr. Rodrigues holds positions on editorial boards for multiple Q1 international DMPK‐related journals including Current Drug Metabolism, Drug Metabolism Letters, and Drug Metabolism & Disposition. In 2009, Dr. Rodrigues’s outstanding contributions to the pharmaceutical sector were acknowledged through his induction as a Fellow of The American Association of Pharmaceutical Scientists (AAPS). Dr. Rodrigues also has a long standing affiliation with the International Society for the Study of Xenobiotics as a member and through his service to the society on the Scientific Affairs Committee from 2006 to 2011. The quality and impact of the work that Dr. Rodrigues has lead and the clarity of his vision is exemplified through his leadership of two publications in Clinical Pharmacology and Therapeutics and role as a senior author on a 2019 British Journal of Clinical Pharmacology Best Manuscript award. In addition to his many scientific accomplishments, he actively works across diverse scientific disciplines and as such has developed a wide network of active collaborators. In January 2022, Dr. Rodrigues presented an award webinar, Leveraging a Global Network of Colleagues to Drive Cutting Edge PK-ADME Science. <a href="https://www.issx.org/page/ISSXWebinar01252022">View the webinar recording and details here.</a></td></tr></tbody></table> ]]></description>
<category>General</category>
<pubDate>Wed, 1 Sep 2021 21:03:00 GMT</pubDate>
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<title>Rachel Tyndale Named ISSX 2021 North American Scientific Achievement Award Winner</title>
<link>https://www.issx.org/news/578703/</link>
<guid>https://www.issx.org/news/578703/</guid>
<description><![CDATA[ISSX congratulates Dr. Rachel F. Tyndale for being named the recipient of the 2021 North American Scientific Achievement Award.<table><tbody><tr><td style="text-align: center; vertical-align: top;"><img alt="" src="https://www.issx.org/resource/resmgr/awards_related/tyndale.png" /></td><td style="vertical-align: top;">The North 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 North America.  The 2021 recipient is Rachel F. Tyndale, Ph.D., Professor, Pharmacology & Toxicology; Psychiatry, Endowed Chair in Addictions, Head Pharmacogenetics, Centre for Addiction and Mental Health at the University of Toronto. Dr. Tyndale is recognized for this award because of her distinguished scientific career and especially her multiple contributions to our understanding of the important role of drug metabolizing enzymes in the brain—as well their genetic variation.  Dr. Tyndale’s career has been spent almost entirely at the University of Toronto where she was initially a graduate student, receiving both M.Sc. and Ph.D. degrees, followed Post-Doctoral work at UCLA, and then a return to the University of Toronto for the remainder of her career. Throughout her career at the University of Toronto, her goal has been to better understand the mechanisms involved with drug abuse and optimize treatment approaches. Dr. Tyndale has studied the important role of cytochromes P-450, especially CYP2D6, CYP2A6 and CYP2B6, in the brain—and particularly their role in the biotransformation and effects of addictive substances such as nicotine. Dr. Tyndale’s scientific research is well-recognized in the realm of pharmacogenomics and in particular, the genetics of nicotine addiction. Her published research is highly cited with over 1,200 citations in 2020 and an H-index of 64. Notably, nine of her manuscripts have been cited over 200 times. Dr. Tyndale has produced 344 peer-reviewed publications and 95 book chapters and reviews. Dr. Tyndale’s work has had a significant impact in merging pharmacogenomics with addiction science and the influence of her work on the health of patients suffering from nicotine addiction.  Dr. Tyndale has served as a regular member on a number of funding agencies and scientific journals. She has made outstanding contributions in her professional services, including those toward ISSX by consistently providing leadership on the Council, Membership and Scientific Affairs Committees, on the Meeting Organizing Committee for the 2013 International Meeting, and as a symposium chair and speaker at several other ISSX meetings. Her scientific honors and recognition are extensive. She has received over 50 awards spanning clinical and basic pharmacology, neuroscience and genetics, including the following recent honors: elected a fellow of the AAAS (2020), was the Wiersma Visiting Professor of Neurobiology at CalTech (2018), received the Faculty of Medicine Graduate teaching award (2017), the Canada Research Chair in Pharmacogenomics (2016-2023) and was the Endowed Chair in Addictions (2013-2016). Dr. Tyndale was also previously awarded the 2005 ISSX North American New Investigator Award. Seminal Contributions to the Field of Nicotine Metabolism and Addiction:Nicotine Metabolism in Humans: Here, Dr. Tyndale has made important contributions to understanding the enzymes involved in the metabolism of nicotine. In particular, she and her colleagues discovered that CYP2A6 is responsible for the oxidation of nicotine to cotinine, the major route of metabolism of nicotine. This work challenged previous perceptions of enzymes responsible for nicotine metabolism and set the stage for genetic studies focused on polymorphisms of CYP2A6 as well as of biomarker studies of the enzyme activity. The manuscript by Messina ES et al, published in 1997 in the Journal of Pharmacology and Experimental Therapeutics, has been cited over 300 times. Genetics of Nicotine Addiction: In an elegant and highly cited manuscript, published in Nature in 1998, Dr. Tyndale and her colleagues showed that individuals harboring reduced function alleles of CYP2A6 were protected from becoming smokers, as they required fewer cigarettes per day than individuals with normal alleles of the enzyme. This research was precedent setting and for the first time, showed the scientific and clinical communities that polymorphisms in enzymes influence addictive behavior. This novel research at the interface of drug metabolism and addiction represents the type of research that has characterized Dr. Tyndale’s scientific career. The manuscript has been cited over 300 times. Nicotine Metabolic Ratios as Biomarkers of CYP2A6 Activity: In a novel clinical study, Dr. Tyndale and her colleagues showed that the ratio of trans-3’-hydroxycotinine/cotinine in smokers served as a biomarker of CYP2A6 activity as well as a biomarker of nicotine clearance and by extrapolation smoking behavior. The manuscript, published in Clinical Pharmacology and Therapeutics in 2004, has been cited about 300 times and was groundbreaking in terms of exploring biomarkers not only for enzyme activity but for smoking and addiction behavior. More recently, Dr. Tyndale and her colleagues have extended this work from populations of European ancestry to populations from Africa (Clinical Pharmacology and Therapeutics, January 2021). Collectively, her research allows the use of the metabolic ratio biomarkers for not only European and African populations but for the highly admixed populations of North America.  Dr. Tyndale also has an extraordinary record of accomplishment as a teacher. She has trained more than 40 doctoral students and 40 postdoctoral fellows and visiting scientists, and numerous undergraduate students. In recognition of her teaching, Dr. Tyndale was recently awarded the 2017 Faculty of Medicine Graduate Teaching Award for Sustained Excellence in Graduate Teaching and Mentorship at the University of Toronto. Collectively, Dr. Tyndale’s research accomplishments over several decades represent an enormous achievement and an outstanding contributions to the field of drug metabolism and the genetics of addiction. She is clearly a world leader in drug metabolism and the study of xenobiotics. She brings a unique aspect to the field of pharmacogenetics and pharmacology, and drug metabolism at the interface of behavior. In March 2022, Dr. Tyndale presented an award webinar, Smoking, it’s in your Genes: Risk, Cessation, Brain Imaging and Disease. <a href="https://www.issx.org/page/ISSXWebinar03082022">View the webinar recording and details here</a>.</td></tr></tbody></table> ]]></description>
<category>General</category>
<pubDate>Wed, 1 Sep 2021 20:55:00 GMT</pubDate>
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<item>
<title>ISSX Newsletter | Issue 2, 2021</title>
<link>https://www.issx.org/news/578961/</link>
<guid>https://www.issx.org/news/578961/</guid>
<description><![CDATA[<h4 style="box-sizing: border-box; line-height: 1.1; background-color: #ffffff;"><a href="https://issuu.com/issx/docs/issx_newsletter_issue2_2021_final" style="box-sizing: border-box; background-color: transparent; color: #222222; text-decoration-line: none; outline: 0px;">View the latest issue of the ISSX Newsletter online now!</a></h4><br
style="box-sizing: border-box; background-color: #ffffff;" />
Click <a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_newsletter_issue2_2021_.pdf" style="box-sizing: border-box; background-color: transparent; text-decoration-line: none;">here for a PDF</a> or
click the image below for online viewing.

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<category>General</category>
<pubDate>Wed, 1 Sep 2021 20:39:54 GMT</pubDate>
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<item>
<title>ISSX BMP Focus Group August 2021Newsletter</title>
<link>https://www.issx.org/news/577940/</link>
<guid>https://www.issx.org/news/577940/</guid>
<description><![CDATA[Review the latest news from the ISSX Biotransformations, Mechanisms, and Pathways Focus Group in their August 2021 newsletter.<a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/issx_focus_groups/issx_bmpfg_08.2021_news.pdf"><img alt="" src="https://www.issx.org/resource/resmgr/issx_focus_groups/issx_bmpfg_08.2021_newscover.jpg" style="border:1px solid #000000;width: 300px; height: 389px;" /></a>]]></description>
<category>General</category>
<pubDate>Wed, 25 Aug 2021 19:18:09 GMT</pubDate>
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<item>
<title> ISSX Newsletter | Issue 1, 2021</title>
<link>https://www.issx.org/news/559114/</link>
<guid>https://www.issx.org/news/559114/</guid>
<description><![CDATA[<h4 style="box-sizing: border-box; line-height: 1.1; background-color: #ffffff;"><a href="https://issuu.com/issx/docs/issx_newsletter_issue1_2020_final" style="box-sizing: border-box; background-color: transparent; color: #222222; text-decoration-line: none; outline: 0px;">View the latest issue of the ISSX Newsletter online now!</a></h4> 
Click <a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_nl_issue1_2021.pdf" style="box-sizing: border-box; background-color: transparent; text-decoration-line: none;">here for a PDF</a> or
click the image below for online viewing. 
<iframe allowfullscreen="true" style="border:none;width:100%;height:326px;" src="https://www.issx.org//e.issuu.com/embed.html?d=issx_newsletter_issue1_2021_final&u=issx"></iframe>]]></description>
<category>General</category>
<pubDate>Thu, 1 Apr 2021 20:16:24 GMT</pubDate>
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<item>
<title>In Memoriam, Laurence Samuel Kaminsky</title>
<link>https://www.issx.org/news/545995/</link>
<guid>https://www.issx.org/news/545995/</guid>
<description><![CDATA[In Memoriam, Dr. Laurence Samuel Kaminsky (1940-2020)The drug/xenobiotic metabolism research community is saddened to learn of the recent passing of Dr. Laurence Samuel (Larry) Kaminsky at the age of 80.  Larry was born in Cape Town, South Africa, in 1940.<img alt="" src="https://www.issx.org/resource/resmgr/images/kaminsky.jpg" style="width: 171px; height: 221px; float: right;" />He was trained in organic chemistry at the University of Cape Town, receiving his Ph.D in 1966. Following post-doctoral training at Yale and State University of New York at Albany, he became a faculty member in the Physiology and Medical Biochemistry Department at University of Cape Town (1968-1975). In 1975, Larry immigrated to the United States with his wife Sylvia, son Philip, and daughter Rena, and joined the Wadsworth Center of New York State Department of Health as a Senior Research Scientist. Larry spent more than 30 years at the Wadsworth Center, taking on various leadership positions, including Director of Biochemical Toxicology, Chief of Laboratory of Human Toxicology and Molecular Epidemiology, Deputy Director of the Division of Environmental Disease Prevention, Professor and Chair of the Department of Environmental Health Sciences, and Director of the Office of Environmental Research Development. In the past 14 years, Larry served as the Associate Chief of Staff for Research and Development at the Stratton VA Medical Center in Albany.Larry was an active researcher for nearly 60 years.  In his early work, Larry published a number of important studies on the biochemistry of cytochrome c. His work on cytochrome c and redox enzymes led him to cytochrome P450, on which his first studies were published in 1975. His most well-known research focused on cytochrome P450 and the metabolism of the anticoagulant warfarin. An early adopter of HPLC, his lab was able to separate multiple metabolites of the stereoisomers of warfarin and leverage this in probing the activities of rat and human P450 enzymes, since multiple enzymes yield different profiles of warfarin metabolites.  This resulted in a multitude of important scientific papers on P450 enzymes, frequently in collaboration with noted P450 scientists, such as Fred Guengerich, Joyce Goldstein, and Jim Halpert. His further work on P450 enzymes included characterization of intestinal P450s and the metabolism of various drugs, such as theophylline and tolbutamide. As a researcher in a state public health research organization, Larry also carried out research of interest to public health, such as the biochemical toxicology of fluorocarbons and metals. Career-wise, Larry was the author or co-author of more than 170 original research papers and review articles, many of which were highly cited. One of his papers received the Frank R. Blood Award from the Society of Toxicology in 1991. Larry provided important service and leadership to the drug/xenobiotic metabolism research community. He served as an Associate Editor for Drug Metabolism and Disposition (2000-2017) and Pharmacology and Therapeutics (2004-2008) and was a Guest Editor for Molecular Pharmacology (1992). He was elected Chair of the Drug Metabolism division of ASPET (2005), and Councilor (1994-1997) and Treasurer (2005-2009) of ISSX. He chaired two major scientific meetings in our field for ISSX (1992) and Microsomes and Drug Oxidations (2008).  He was a member of the standing International Advisory Committee for Microsomes and Drug Oxidations. Larry mentored eight Ph.D students and numerous postdoctoral scientists and junior faculty members. His scientific legacy continues to be realized in the research carried out in the academic and private sectors by those scientists he trained. After joining the VA, Larry changed his focus to translational research, mentoring many physician scientists and significantly expanding both basic and clinical research at the Albany VA Medical Center. Our research community extends its condolences to Larry’s family. Larry enjoyed life as much as he enjoyed research. He liked many things in life: music, food, wine, art, and travel. He was well known for his knowledge in wine tasting. He was a role model for balancing life and career. Larry will be remembered as a passionate researcher, a good friend, a great mentor, an inspiring leader, and a dedicated public servant. By Xinxin Ding and Scott Obach ]]></description>
<category>General</category>
<pubDate>Tue, 5 Jan 2021 14:23:06 GMT</pubDate>
</item>
<item>
<title> ISSX Newsletter | Issue 3, 2020</title>
<link>https://www.issx.org/news/544885/</link>
<guid>https://www.issx.org/news/544885/</guid>
<description><![CDATA[<a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_nl_3_2020.pdf">View the latest issue of the ISSX Newsletter online now!</a><img alt="" src="https://cdn.ymaws.com/issx.site-ym.com/resource/resmgr/newsletter/issx_nl_3_2020_cover.jpg" style="border:1px solid #000000;width: 170px; height: 221px;" usemap="#rade_img_map_1608583818468" />In this Issue:<ul><li style="text-align: left;">Book Review</li><li style="text-align: left;">2020 North American Awards</li><li style="text-align: left;">Translation of in vitro ADMET Science to in vivo: Current Perspectives and Challenges scheduled for March 2-5</li><li style="text-align: left;">Renew Your ISSX Membership</li><li style="text-align: left;">The ISSX Mentorship Program</li><li style="text-align: left;">ISSX Webinar Series</li><li style="text-align: left;">Changes to the ISSX Council</li><li style="text-align: left;">Save the Date: 24th North American ISSX Meeting</li><li style="text-align: left;">Welcome New Members</li></ul>Click <a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_nl_3_2020.pdf" style="box-sizing: border-box; background-color: transparent; text-decoration-line: none;" target="_self">here for a PDF</a> or click the image above for online viewing.<map id="rade_img_map_1608583818468" name="rade_img_map_1608583818468"><area shape="RECT" coords="0,0,174,225" href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/newsletter/issx_nl_3_2020.pdf" /></map>]]></description>
<category>General</category>
<pubDate>Mon, 21 Dec 2020 20:43:16 GMT</pubDate>
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<item>
<title>ISSX Transporters Focus Group December 2020 Newsletter</title>
<link>https://www.issx.org/news/544647/</link>
<guid>https://www.issx.org/news/544647/</guid>
<description><![CDATA[Review the latest news from the ISSX Transporters Focus Group in their December 2020 newsletter.<a href="https://cdn.ymaws.com/www.issx.org/resource/resmgr/issx_focus_groups/issx_tfg_newslttr_dec_2020.pdf"><img alt="" src="https://cdn.ymaws.com/issx.site-ym.com/resource/resmgr/issx_focus_groups/issx_tfg_newsc_dec_2020.jpg" style="border:1px solid #000000;width: 300px; height: 389px;" /></a>]]></description>
<category>General</category>
<pubDate>Fri, 18 Dec 2020 18:36:36 GMT</pubDate>
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<item>
<title>Edna Choo Named ISSX 2020 North American Drug Discovery Award Winner</title>
<link>https://www.issx.org/news/538165/</link>
<guid>https://www.issx.org/news/538165/</guid>
<description><![CDATA[ ISSX congratulates Dr. Edna Choo for being named the recipient of the 2020 North American Distinguished Accomplishments in Drug Discovery and Development Award.<table><tbody><tr><td style="text-align: center; vertical-align: top;"><img alt="" src="https://www.issx.org/resource/resmgr/webinars/headshots/edna_choo.png" /></td><td style="vertical-align: top;">Dr. Edna Choo has a sustained body of scientific work in the ADME characterization, both non-clinical and clinical, across multiple projects and therapeutic areas. She has undertaken a sustained body of scientific work in the ADME characterization, both non-clinical and clinical, across multiple projects and therapeutic areas.Dr. Choo earned her PhD in pharmacokinetics from Monash University and completed a post-doctoral Fellowship in Clinical Pharmacology at Vanderbilt University. She joined Genentech after working at Pfizer in Groton, CT as principal scientist supporting multiple projects pre-IND to Phase 2. She joined Genentech in 2005 where, over time, she was appointed Associate Director in 2019. The group led by Dr. Choo (six PhD and five BS/MS) has responsibility for about half of the Genentech small molecule portfolio – both discovery and development.Dr. Choo was a key contributor to the development of cobimetinib. She was Pharmacology Subteam Leader for this project, which handles all aspects during development related to DMPK, clinical pharmacology and nonclinical safety. As leader of this team, she played a key role in the development of this drug and the subsequent regulatory filings, including the ultimate NDA, and responses to questions from regulatory agencies. On the scientific front, her main contribution has been to integrate data from both preclinical and clinical studies to enhance our understanding of the cobimetinib pharmacokinetics, in particular the contribution of intestinal metabolism. Her data indicate that there is substantial contribution from intestinal metabolism for cobimetinib and this has also implications for drug-drug interactions. She confirmed the human finding with detailed studies with transgenic mice. This work and other cobimetinib related work has been published in several well-known journals including Drug Metabolism and Disposition, Molecular Pharmaceutics and Cancer Chemotherapy Pharmacology. The second project that benefited in a major way from the contributions of Dr. Choo is venetoclax. In this collaboration with Abbvie, Dr. Choo focused on the absorption issues for venetoclax. Venetoclax is a BCS class IV compound, but absorption is still quite reasonable – both in preclinical species and in humans. Edna showed that this is due to a significant extent of lymphatic absorption, the importance of which has been overlooked for many lipophilic drugs. Edna performed in vivo experiments to support this and it was published in Drug Metabolism and Disposition in 2014. Beyond her contributions to many discovery and development projects, Edna has achieved a reputation for sophisticated PK-PD modeling, including modeling of efficacy following combo treatment (e.g., combining a MEK and a PI3K inhibitor). As a scientist, Dr. Choo maintains and active presence in terms of publications and invited presentations. She is a strong proponent of the application of humanized animal models to address mechanistically DMPK-related questions at all stages of development. Her insight and approach are well described in her publication in Molecular Pharmaceutics (2014). Her work; provided a robust characterization of the extent of CNS penetration and the influence of drug transporters (Choo, 2015 Drug Metabolism Disposition). Dr. Choo is a frequent reviewer for ADME related scientific journals including Current Drug Metabolism, AAPS Journal, Journal of Medicinal Chemistry and Xenobiotics.Dr. Choo is a mentor and role model for multiple junior scientists and interns. She has built a broad and impactful career spanning the entire spectrum of drug discovery and development. She has made significant contributions to marketed products, discovery and development programs, ADME science, and the next generation of DMPK scientists through her work. ISSX congratulates Dr. Edna Choo on winning the 2020 Distinguished Accomplishments in Drug Discovery and Development Award.In April 2021, Dr. Choo presented an award webinar, A Tale of Two Drugs - A DMPK Scientist's Journey in Unraveling the Mysteries of Drug Disposition. <a href="https://www.issx.org/page/ISSXWebinar04062021">View the webinar recording and details here</a>.</td></tr></tbody></table> ]]></description>
<category>General</category>
<pubDate>Mon, 9 Nov 2020 18:35:33 GMT</pubDate>
</item>
<item>
<title>Dhaval K. Shah Named ISSX 2020 North American New Investigator Award Winner</title>
<link>https://www.issx.org/news/538157/</link>
<guid>https://www.issx.org/news/538157/</guid>
<description><![CDATA[ISSX congratulates Dr. Dhaval K. Shah for being named the recipient of the 2020 North American New Investigator Award.<table><tbody><tr><td style="text-align: center; vertical-align: top;"><img alt="" src="https://www.issx.org/resource/resmgr/webinars/12_15_2020shah/dhaval_shah.png" /></td><td style="vertical-align: top;">Dr. Dhaval K. Shah has been named the winner of the 2020 ISSX New Investigator Award in Honor of James R. Gillette.  Dr. Shah is Associate Professor at the Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences at the University of Buffalo.Formerly with Pfizer Inc., Dr. Shah started a research program at the University of Buffalo to transform the discovery, development, and preclinical-to-clinical translation of protein therapeutics. His goal is to develop a unique and impactful research program to train future scientists in the field of protein engineering, drug development, and pharmacokinetics (PK) and pharmacodynamics (PD). His group has performed several pioneering investigations, including the development of quantitative structure pharmacokinetics relationships (QSPKR) for protein therapeutics, invention of the biodistribution coefficient concept, development of first-ever brain microdialysis system for antibodies, development of a novel microscopic system to study protein therapeutics disposition in mouse eye, development of first de novo 2-pore PBPK model, and development of systems PK-PD models and translational framework for bench-to-bedside translation of antibody-drug conjugates.  He has published 50 research papers and several book chapters. His research work has significantly impacted the development of protein therapeutics and many scientific principles and mathematical models developed by his group are routinely used by pharmaceutical companies for drug development and regulatory submissions. His research work has been highlighted at prestigious venues including The National Academies of Sciences, Engineering, and Medicine. He is deeply dedicated to mentoring the next generation of scientists. To date, Dr. Shah has mentored more than 75 individuals.   With the advancing field of protein therapeutics Dr. Shah’s fundamental work on establishing the platform PBPK model for biologics and quantitative structure-PK relationship (QSPKR) for biologics is becoming increasingly significant. The premise for this work relies on the hypothesis that proteins with similar physicochemical properties demonstrate similar systemic and tissue disposition profiles, and the disposition profile of proteins in human can be predicted a priori based their PK in animals. Dr. Shah’s research has also contributed towards improving the discovery and development of ADCs, especially their preclinical-to-clinical translation. He has developed the first ever multi-scale systems PK/PD model for ADCs, which is able to integrate bio-measures and chemo-measures from all the stages of drug development to a priori predict preclinical and clinical PK of ADCs on cellular and tissue levels, and also predict the clinical responses of ADCs including their progression-free survival (PFS) and objective response rates (ORRs).  Recently, Dr. Shah has also made significant progress in understanding the disposition of protein therapeutics in anatomically peculiar tissues like brain, eye, and solid tumor. His group is the first one to use microdialysis technique to measure the distribution of antibody in different regions of brain. In addition, he has also developed an unprecedented systems PK model to characterize the disposition of protein therapeutics in the brain.  For his outstanding scientific contributions early in his career, ISSX awards the 2020 ISSX New Investigator Award in Honor of James R. Gillette to Dhaval K. Shah.<div>In February 2021, Dr. Shaw presented an award webinar, Towards Development of Translational Systems Pharmacokinetics Models for Protein Therapeutics. <a href="https://www.issx.org/page/ISSXWebinar02232021">View the webinar recording and details here</a>. </div><div> </div></td></tr></tbody></table> ]]></description>
<category>General</category>
<pubDate>Mon, 9 Nov 2020 18:12:24 GMT</pubDate>
</item>
<item>
<title>K. Sandy Pang Named ISSX 2020 North American Scientific Achievement Award Winner</title>
<link>https://www.issx.org/news/537979/</link>
<guid>https://www.issx.org/news/537979/</guid>
<description><![CDATA[ISSX congratulates Dr. K. Sandy Pang for being named the recipient of the 2020 North American Scientific Achievement Award.
<table>
<tbody>
<tr>
<td style="text-align: center; vertical-align: top;"><img alt="" src="https://www.issx.org/resource/resmgr/webinars/headshots/pang_headshot.png" /></td>
<td style="vertical-align: top;">
Dr. K. Sandy Pang, Professor, Leslie Dan Faculty of Pharmacy at the University of Toronto is the 2020 recipient of the ISSX North American Scientific Achievement Award in Honor of Ron Estabrook. Dr. Pang is an academic researcher with broad-reaching impact on both theoretical and experimental research, as well as mentoring scientists in her laboratory and in the field. Dr. Pang has made transformational contributions to the understanding of drug absorption, metabolism, and elimination and significantly advanced the field of physiologically based pharmacokinetic (PBPK) modeling. These advances are evident in the summary below, the bibliography of her highly cited publications, and the impact of her work as evidenced by the accompanying letters as well as the vast number of citations of her work across Pharmacokinetics textbooks and research articles. Her seminal contributions to pharmacokinetics include the following: Clearance Concepts: Dr. Pang has published on the fundamentals of drug clearance, a parameter critical to understanding drug disposition. Importantly, this work with Dr. Malcolm Rowland was seminal in establishing utility of the well-stirred model of the liver for predicting the hepatic clearance of drugs. Her experimental work in liver enzyme zonation and flow heterogeneity in this area have led to the development of other liver models. Much of the experimental and theoretical considerations have laid the foundations to Dr. Pang’s early discoveries and research on liver drug clearance.    Metabolite Pharmacokinetics: Dr. Pang has led the field in understanding and modeling the disposition of circulating drug metabolites and metabolite elimination. Her group has developed methods and models to correctly quantitate the complexities within this important pharmaceutical science area. She has published extensively in this area and her research includes study on the formation of metabolite within an organ, its sequential metabolism, and modeling elimination of all drug-related metabolites along with parent drug; different fates of formed vs. preformed metabolites due to enzyme zonation or permeability barriers; futile cycling kinetics; and transporter-enzyme interplay. Intestinal Drug Absorption and Metabolism: In addition to the transformational advances in improving our understanding of drug elimination in liver, Dr. Pang has contributed significantly to the area of drug absorption and intestinal metabolism. Dr. Pang modeled the intestine as a tissue receiving segregated blood flows to the enterocyte and serosal regions, namely the segregated flow model, SFM. This model has set the foundation for several key modeling frameworks widely used by modeling platforms today–specifically, the physiological framework for intestinal absorption and metabolism highlights a greater extent of intestinal removal for drugs given orally versus intravenously.Critical Issues with Humanized Mouse Liver Models: Dr. Pang has published important work clearly showing that chimeric (humanized) mouse liver models generate toxic liver models due to persistence of murine bile acids, miscommunication between the mouse intestine and humanized liver, and disruptive handling of bile acids. This work has highly significant implications in the development of chimeric animal models to study disposition, and the interpretation of results obtained from such animal models.   Kinetics of 1α,25-Dihydroxyvitamin D3 (Calcitriol): Dr. Pang utilized the PBPK-PD model to describe the kinetics of calcitriol, active vitamin D receptor ligand, by properly including  calcitriol-mediated CYP24A1 induction for calcitriol degradation and CYP27B1 inhibition for calcitriol synthesis.  Dr. Pang uncovered calcitriol-mediated inhibition of SHP (small heterodimer partner), which increased CYP7A1 towards cholesterol degradation. Dr. Pang predicted the dynamics of calcitriol-mediated induction of CYP7A1 in cholesterol metabolism and lowering, the calcium channel TRPV6 in calcium absorption and P-glycoprotein in brain and kidney efflux.  In recognition of her outstanding scientific contribution developed over the span of a productive and successful scientific career, including many fundamental concepts and investigative approaches that are now commonly used in contemporary pharmacology research and drug development, ISSX proudly bestows Dr. K. Sandy Pang  2020 North American Scientific Achievement Award in Honor of Ronald W. Estabrook. <div>In April 2021, Dr. Pang presented an award webinar, When Pharmacokinetics Meet Biology. <a href="https://www.issx.org/page/ISSXWebinar04132021">View the webinar recording and details here</a>. </div></td>
</tr>
</tbody>
</table> ]]></description>
<category>General</category>
<pubDate>Fri, 6 Nov 2020 20:40:47 GMT</pubDate>
</item>
<item>
<title>ISSX Newsletter | Issue 2, 2020</title>
<link>https://www.issx.org/news/524551/</link>
<guid>https://www.issx.org/news/524551/</guid>
<description><![CDATA[ 
<h4><a href="https://issuu.com/issx/docs/issx_newsletter_issue2_2020_final">View the latest issue of the ISSX Newsletter online now!</a></h4>
 
Click <a href="https://www.issx.org/resource/resmgr/newsletter/issx_newsletter_issue2_2020_.pdf">here for a PDF</a> or click the image below for online viewing.
 
<iframe allow="fullscreen" style="border:none;width:100%;height:326px;" src="https://www.issx.org//e.issuu.com/embed.html?d=issx_newsletter_issue2_2020_final&u=issx"></iframe>
 ]]></description>
<category>General</category>
<pubDate>Thu, 3 Sep 2020 14:09:51 GMT</pubDate>
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