Volume 42
Issue 4, 2019
ISSX President’s Message By Thomas Baillie, ISSX President This President’s Message, appearing as it does in the final issue of the ISSX Newsletter for 2019, is my last as President of the Society since my two-year term expires at the end of December. Professor Ann Daly from the University of Newcastle in England will succeed me in the role of ISSX President for 2020–2021. I extend a warm welcome to her in this new position. Many of you know Ann from her extensive research in the area of drug pharmacogenetics, a field in which she is an internationally recognized exper t and from her long and active involvement with ISSX through our meetings, conference organization, and Society leadership. With suppor t from the newly elected and returning members of Council, the future of ISSX in the next two years is in good hands, indeed! Looking back, ISSX had a ver y successful year in 2019, the premier event being the 12th
International ISSX Meeting in Por tland, OR during late July. According to Society policy, only one meeting is held ever y third year when the international meeting takes place, as was the case in 2019. However, based on the success of our past workshops, we aim to hold workshops focused on specific topics on a regular basis, and we look for ward to the upcoming workshop, “Disposition of Biologics,” organized jointly by Dhaval Shah and Honghui Zhou, at the Merck facility in Boston, MA (December 12–13, 2019). If you have not yet registered for this workshop, the program for which is posted at issx.org/2019workshop, please register soon since space is limited due to the size of the auditorium. As I mentioned in the last Newsletter, 2020 will be a ver y busy year for ISSX, since we will be co-hosting two impor tant meetings. The first with the European
Association for Clinical Pharmacology and Therapeutics (EACPT) in Geneva, Switzerland, from June 7–10, 2020 Thomas Baillie, Ph.D. (information is ISSX President. available at www. issxeacpt2020.org), and the second with colleagues from the Japanese Society for the Study of Xenobiotics (JSSX) at the Hilton Waikoloa Village Resor t on the Big Island of Hawaii from October 4–8, 2020. Both meetings feature exciting scientific programs and will be held in ver y attractive locations, so they are cer tain to be well attended! Additionally, by popular demand, we are re-instituting our ISSX webinar series. The first of these, dealing with OATP1B1-mediated drug-drug interactions and delivered Continued on page 10
IN THIS ISSUE 2 3
Book Review
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Renew Your ISSX Membership for 2020
2019 ISSX Workshop Disposition of Biologics
5
Enroll in the ISSX Mentorship Program
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15th European ISSX and EACPT Joint Meeting
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23rd North American ISSX Meeting & 35th JSSX Meeting
8 4th Annual Conference of SSX-India 11 Changes to the ISSX Council 14 Welcome New Members 14 ISSX Focus Groups
Book Review IN VITRO DRUG RELEASE TESTING OF SPECIAL DOSAGE FORMS Editors; Nikoletta Fotaki, Sandra Klein. John Wiley and Sons 312 pp. ISBN: 978-1-118-67583-0. 2019/2020 This interesting book collects aspects of diverse methodologies that can be, and are, employed to assess the per formance of various special dosage forms in one volume. Unless one is working in this par ticular area, it is easy to dismiss formulations simply as an oral tablet or capsule and an injectable solution, but there are many others designed for specific use. The ability to predict the in vivo per formance and proper ties of a specific formulation from the results of in vitro testing with a reasonable degree of cer tainty is paramount to the design and construction of these specialized dosage forms.
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More than twenty authors constructed a comprehensive tome. Differing dosage forms are covered extensively in nine chapters, including: “Lipid-based Oral Formulations,” “Chewable Oral Drug Products,” “Injectables,” “Drug-eluting Stents,” “in vitro Dissolution for Inhalation Products,” “Topicals and Transdermals,” “Vaginal and Intrauterine Deliver y Systems,” “Rectal Dosage Forms,” and “Ophthalmic Dosage Forms.” The final segment is concerned with regulator y considerations. The chapters are divided into many sub-sections, which makes navigation of the material easy. References at the end of each ar ticle enable specific points made within the text to be examined in more detail if the reader so desires. The chapters, which are well laid out, are pleasing to the eye and the copious inclusion of tables, graphs, schematics, and color photographs enhance the text.
This book is one of a series entitled “Advances in Pharmaceutical Technology,” in which other related titles include: “Novel Deliver y Systems for Transdermal and Intradermal Deliver y Systems (2015),” “Pulmonar y Drug Deliver y: Advances and Challenges (2015),” and “Drug Deliver y Strategies for Poorly Water-Soluble Drugs (2012).” The relevant section of the Wiley website (www.wiley.com/en-us) is well wor th a perusal if individuals are interested in this aspect of pharmaceutics or missed these previous volumes, which are still available.
Notified by
Steve Mitchell Imperial College London, UK
Book Ordering Information John Wiley and Sons Corporate Headquar ters 111 River Street Hoboken, NJ 07030-5774 United States of America Telephone: (201) 748-6011 Facsimile: (201)748-6088 Email: info@wiley.com
The Atrium
Southern Gate, Chichester West Sussex PO19 8SQ England Telephone: (44) 1243-779777 Facsimile: (44) 1243-775878 Email: customer@wiley.com
SPECIAL ISSUE OF XENOBIOTICA: PHARMACOGENETICS OF DRUG METABOLISM An upcoming special issue of the journal, Xenobiotica, entitled, “Pharmacogenetics of Drug Metabolism,” will be published in Januar y 2020. This will include over view ar ticles on the drug metabolizing enzymes that exhibit polymorphic activity in man. In addition to summarizing the current position, it will provide an assessment of the impact, or not, of this knowledge and its practical application within the clinical arena. This collection of timely and per tinent digests will be available online and as a printed version (www.tandfonline.com/loi/ixen20).
Seats available at the 2019 ISSX Workshop, Disposition of Biologics Schedule at a Glance
FRIDAY, DECEMBER 13, 2019
THURSDAY, DECEMBER 12, 2019
Case Study 1: Understanding the Disposition of Biologics to Treat Neurodegenerative Diseases Drew MacCannell, Biogen, Boston, MA, USA
Basic Determinants for the Disposition/ADME of Protein Therapeutics Joseph Balthasar, SUNY Buffalo, Buffalo, NY, USA Clinical Examples to Showcase the Disposition Properties of Biologics Bernd Meibohm, University of Tennessee Health Science Center, Memphis, TN, USA Overview - Bioanalytical Methods used to Assess the Disposition of Biologics Renuka Pillutla, BMS, Princeton, NJ, USA Assessing Whole-body Disposition of Biologics (Preclinical and Clinical) Using Imaging Method Andrew Boswell, Genentech, San Francisco, CA, USA Factors Affecting Disposition of Biologics (e.g. TMDD/ Immunogenicity/Physicochemical Properties) Edit Tarcsa, Abbvie, Boston, MA, USA DDI Potential of Biologics and Disposition in Special Population Honghui Zhou, Janssen, Spring House, PA, USA Quantitative Characterization and Prediction of the Disposition of Biologics Dhaval Shah, SUNY Buffalo, Buffalo, NY, USA
Case Study 3: Understanding the Disposition Daratumumab Thomas Puchalski, Spring House, PA, USA Disposition of Protein Therapeutics in Human Tissues and Tumors Neeta Pandit, Memorial Sloan Kettering Cancer Center, New York, NY, USA Tissue Metabolism as a New Perspective in Discovery of Biologics Donglu Zhang, Genentech, San Francisco, CA, USA Novel in vitro Techniques to Predict the Disposition of Biologics Dan Rock, Amgen, San Francisco, CA, USA Quantitative Characterization of the Disposition of CAR-T Xu Zhu, Novar tis, MA, USA Understanding the Disposition of Oligonucleotides/ SiRNA Diane Ramsden, Alnylam, Boston, MA, USA Understanding the Disposition of Gene Therapy Vectors (e.g. AAV) Nagendra Chemuturi, Novar tis, Seattle, WA, USA
Register Today: www.issx.org/2019workshop
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Whole-body Disposition/Tropism of AAVs in Human Miguel Esteves, University of Massachusetts, Worcester, MA, USA
Issue 4, 2019
Employing the Knowledge about the Disposition of Biologics to Support Discovery, Development, and Clinical Translation Weirong Wang, Janssen, Spring House, PA, USA
Case Study 2: Understanding the Disposition Vedolizumab Maria Rosario, MA, USA
Renew Your ISSX Membership for 2020 Thank you for your membership and suppor t this year! Don’t forget to renew your membership for 2020 to stay connected to the Society and your fellow members. Please renew by December 31, 2019 to remain active. Renewing your ISSX membership is easy! Simply follow the steps below to complete your renewal: 1. Visit issx.org/renew. 2. O n the right-hand side of the page, log in with your ISSX username and password. If you do not know your username or password, you may re-set it by visiting issx.org/password. 3. C lick RENEW YOUR MEMBERSHIP NOW in the blue box at the top of your profile page. 4. O n the next screen, review and update your contact information to ensure uninterrupted communication from ISSX.
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5. O nce you verify your contact information, you will be directed to the payment screen, where you may view your renewal options, including instant payment online via credit card. • I f you would like to pay by check, select "Bill Me" under Payment. You can access your invoice on the subsequent page and it will be automatically sent to you via email. Please print the invoice and submit it with your check to: ISSX 8652 Solution Center Chicago, IL 60677-8006 ISSX members have access to a variety of exclusive benefits including: • Free Enrollment into the ISSX Mentorship Program that pairs young investigators with senior scientists with related interests; • ISSX Focus Group Membership to connect with scientists in your research areas; • Reduced registration fees for all ISSX meetings and workshops;
•O nline learning opportunities such as the ISSX Webinar Series, which feature world-renowned speakers and cutting-edge science; •A subscription to the ISSX Newsletter that highlights Society news, member spotlights, late-breaking scientific news, and much more; •T he opportunity to submit and present scientific abstracts at ISSX meetings; •E ligibility to apply for and receive travel grants to attend ISSX meetings; •A nd the chance to hold office, serve on a committee, and vote in ISSX elections. Your membership indicates suppor t of our mission to advance research and education on the interplay of living systems with medicines and chemicals for the benefit of society worldwide and helps sustain our program of operations. Visit issx.org/renew today! If you have questions about renewing your membership or membership benefits, please contact ISSX by phone at +1-202-367-1160 or by email at information@issx.org. Donations ISSX relies on assistance from members and other individuals as well as corporate entities to advance our mission. If you would like to make a gift to ISSX, please visit www.issx.org/donations to learn about the various funds you can suppor t. ISSX is a 501 (c)(3) organization incorporated in the United States. As such, your contribution may qualify for a tax deduction. Consult your tax advisor for full information. Our federal tax identification number is 22-243-2063. If you need a copy of our federal W-9 form, simply email information@issx.org and we will promptly reply.
Enroll in the ISSX Mentorship Program! The ISSX Mentorship Program pairs young investigators with senior scientists within and across fields and industries to discuss career options, review competencies for success, consider challenges and problems, and receive practical advice from experienced scientists. This program is an exclusive member benefit that has seen great success since its inception. The 2020 cycle will run for 12 months and ISSX will begin making matches in January 2020. The program matches mentors and mentees based on an award-winning algorithm. From there, the pairs have the flexibility to define their conversation topics to best suit the needs of their relationship. Past par ticipants noted their focus was individual and career development, collaboration, and leadership. Milestones are set along the way for par ticipants to review their desired outcomes of the mentorship, set goals, and provide progress updates. What do participants say? “I was at a cross section of taking two complete different career paths when I star ted the program. My mentor helped me to navigate through this process with thorough introspection and strength identification. Not only did I find my career direction but also who I am. She boosted my confidence and inspired me to reach my greatest potential. I feel so lucky to be her mentee!�
Enroll Today! If you are interested in joining as a mentor or a mentee, please visit www.issx.org/Mentorship to learn more. ISSX will provide resources to help you launch and sustain effective mentoring relationships. Mentoring is a personal and professional development experience that challenges one to reflect on their own actions and behaviors over time. For those who have benefited from a helpful mentor in their lives or careers, there is often a strong drive to pay this for ward to others by ser ving in the same role. Finding a true mentor is not always easy. The ISSX Mentorship Program can help and we are proud to offer this valuable resource and oppor tunity for new relationships, skills, and conversations to develop.
Did you miss a recent webinar? Sign into your ISSX membership account and view all past webinars. www.issx.org/pastwebinars
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ISSX Webinar Series Recordings Available Online
Issue 4, 2019
"I always look for ward to chatting with my mentor. I find her ver y approachable and easygoing. Additionally she has great advice to give when I present her with something I am struggling with. It is not always easy to find a mentor you feel comfor table with; however, I think this match is great. I look for ward to our next few months in the mentorship program!"
ISSX thanks past par ticipants for their work and dedication to this initiative and we invite you to re-enroll in the program so that you may continue growing personally and professionally.
Join us in Geneva for the 15th European ISSX and EACPT Joint Meeting June 7–10, 2020
The 15th European ISSX (International Society for the Study of Xenobiotics) and EACPT (European Association for Clinical Pharmacology and Therapeutics) joint meeting is to be held in beautiful Geneva, Switzerland. This joint meeting—under the overarching theme “Precision Medicine from Bench to Bedside”—will bring together researchers from experimental and clinical disciplines engaged in drug research, drug development, drug use, and clinical practice. Members from the two scientific societies will have the oppor tunity to exchange ideas and exper tise, develop a common vision, and create and nur ture collaborations in different fields of the study of medicines.
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The meeting will star t with shor t courses on options for the development of patient population specific PBPK models and basic aspects, applications, and methodologies of major omics technologies in the context of precision medicine. Following the shor t courses, the opening keynote lecture will discuss regulator y aspects of precision medicine, after which attendees and registered guests may attend the welcome reception to enjoy refreshments and meet with exhibiting companies. State-of-the-ar t plenar y and lectures and Fifteen scientific symposia will encompass a broad spectrum of topics impor tant in the field. In addition, there will be poster sessions, a trade exhibition, and industr y-sponsored symposia. On the social side, we are planning an enjoyable banquet dinner for the oppor tunity to expand your network. Geneva is the second largest city in Switzerland and known for its humanitarian tradition and cosmopolitan flair, hosting numerous international organizations. Embedded between nearby alpine peaks and the hilly terrain of the Jura, the French-speaking city of Geneva grows from the shores of Lake Geneva into the surrounding countr y. We suggest that you bring your family and extend your stay to make this a unique summer holiday.
HOTELS ISSX has secured special rates for meeting attendees at area hotels. Review the options and make your reser vation via the meeting website. Reser ve a room by April 21 to secure the ISSX/EACPT rates. MEETING ORGANIZING COMMITTEE Meeting President Jules Desmeules Meeting Chairs Caroline Samer Christoph Funk Organizing Committee Janne Backman Jamie Coleman Ann Daly Patrick Dansette Dieter Lang Arantxa Sancho Nico Vermeulen Markus Zeitlinger PROGRAM AT A GLANCE The meeting program is currently in development. Session topics are outlined below and details will be added to the meeting website as they become available. PLENARY SESSIONS Four general sessions will be presented: •P ast, Present and Future Development in Pharmacogenomics • The Need for Complex Cellular Models • Nanotechnologies Enabling Drug Deliver y • Predictive Risk Scores: Patient Empowerment Continued on next page
15th European ISSX and EACPT Join Meeting Continued from previous page •C hallenges in Today's Drug Research and Development—The Regulator's View PARALLEL SESSIONS • Implementation of Pharmacogenomic Testing
•M icrophysiological Systems: Current Status and Applications
•S tem Cell-based in vitro Systems to Assess Drug Safety, Drug Discover y and Development
•C urrent Approaches and Limitations in the Assessment of Drug-induced Liver Injur y (DILI)
•N ew Developments in Therapeutic Drug Monitoring (TDM)
• Drivers of Modern Drug Development
• T he Use of Ar tificial Intelligence and Machine Learning in Drug Discover y and Development
OPTIONAL SHORT COURSES Shor t courses are scheduled for Sunday, June 7 and may be added to attendee registrations for an additional fee. Course attendees will receive digital access to course materials and lunch is to all course registrants.
•P harmacogenomics, Drug Development and Regulator y Aspects •N ovel, Human in vitro Models to Study Diseases and Mechanisms •E merging Topics in the Field of Drug Transpor ters • I mpact of New Drug Deliver y Methodologies on ADME and Safety • T ranspor ter-mediated Drug-drug Interactions and Translation from in vitro to Clinics • New Modalities—New Challenges • Drug-drug Interactions from the Model to the Clinic
ABSTRACT SUBMISSIONS NOW OPEN ISSX and EACPT members are invited to submit an abstract for poster presentation or for the student poster awards competition. Poster presentations are a highlight of ever y ISSX meeting. Visit the meeting website to submit your research before first call closes on March 1, 2020. Visit issxeacpt2020.org to learn more about the meeting, submit an abstract, and register.
Save the Date!
23rd North American ISSX Meeting & 35th JSSX Meeting October 4–8, 2020 in Waikoloa Village, Hawaii Attendees will stay at Hilton Waikoloa Village, a beautiful oceanfront resor t on the Big Island.
Organizing Committee Mike Zientek Natalie Hosea Sonia de Morais Ann Daly
Ryan Takahashi Kiyomi Ito Kevin Bateman Nagasaka Yasuhisa
PROGRAM, REGISTRATIONS, AND ABSTRACT SUBMISSIONS Watch for more information coming soon!
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Kenji Tabata Hideki Hirabayashi Yoshiro Saito Miki Nakajima Kouichi Yoshinari
Issue 4, 2019
MEETING ORGANIZING COMMITTEE Meeting Chairs Hiroshi Yamazaki • Allan Rettie
4th Annual Conference of SSX–India (SSX–2019) Indian Society for the Study of Xenobiotics (SSX-India) organized the 4th Annual Conference at J.N. Tata Auditorium, Indian Institute of Science (IISc), Bangalore, from September 18–21, 2019, with the theme “Exploring Impact of ADMET and Modelling Science and Technology on Drug Discover y and Development.” SSX India is consistently growing and has had great success in the last four years. The number of par ticipants increased from previous years, with 356 par ticipants this year. It was a balanced blend of delegates from academia and industr y. Key features of the conference included: pre-conference workshops and shor t-courses, main conference with two plenar y lectures and seven sessions across three days, panel discussion for students, poster sessions, oral presentations by young investigators, a cultural program, a mentorship program, and travel grants to national and international students. There were 20 scientific talks by speakers from academia and industr y, five sponsor talks, and young investigator presentations from the top five abstracts. Pre-conference workshop and short-course: Three parallel sessions: 1. S hor t-course: Drug Metabolism, Transpor ters and Toxicology
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2. H ands-on Workshop: Pharmaceutical Modelling and Simulation (PuMAS) Software 3. M icro Sampling and Mass Spectrometr y Workshop Main objectives of the pre-conference workshop/ shot-course were:
a) t o provide basic knowledge of ADMET concepts to the students/young scientists to prepare them for better understanding of the content of the main conference and b) t o provide hands-on experience with PuMAS software and mass spectrometer and their utility One-hundred and twenty delegates par ticipated in the pre-conference workshop and shor t-course. Main conference (19th–21st September 2019) The main conference day star ted with opening remarks by Dr. T. Thanga Mariappan, SSX President, explaining the vision of SSX and reflecting on SSX 2019. He spoke about the histor y of SSX and the theme of the conference. Dr. Mariappan explained two new, studentfocused initiatives of SSX, which include the cer tificate course on DMPK for students and the hands-on workshop on PuMAS software that will be held in Bangalore, Delhi, and Hyderabad during Februar y and March of 2020. He announced that the 7th Asia Pacific ISSX Meeting will be hosted in Bangalore, Februar y 21–24, 2021. Conference Inauguration with Indian Rituals Dr. Lois-LehmanMcKeeman, Prof. Yuichi Sugiyama, Dr. Bill Smith, Dr. Jasminder Sahi, and Dr. T. Thanga Mariappan inaugurated the conference with the traditional lamp lighting ceremony. All ceremonial dignitaries wore traditional attire to give it an Indian touch.
Review summaries of the shor t courses, plenar y lectures, parallel sessions, and poster presentations on the ISSX website at www.issx.org/ssxindia19.
Continued on next page
4th Annual Conference of SSX–India (SSX–2019) Continued from previous page MEETING CHAIR T. Thanga Mariappan, Ph.D., President, SSX, India Senior Lead Investigator, Biocon–BMS R&D Centre (BBRC), Syngene International Ltd., Bangalore, India.
MEETING CO-CHAIR Vinay H.K., Ph.D. Secretar y, SSX, India Lead Investigator, Biocon–BMS R&D Center (BBRC), Syngene International Ltd., Bangalore, India.
MEETING ORGANIZING COMMITTEE Deepika Dhaware (BBRC/Syngene) Vamsi Madgula (Syngene) Jasminder Sahi (Sanofi, China) Bhagwat Prasad (Univ. Washington) Sandhya Mandlekar (BMS, India) Amarjeet G (BBRC/Syngene) Anoop Kumar (BBRC/Syngene) Ar ti Thakkar (Amity University Anandi Karumbati (CCBT, InStem) Sankar Sivaprasad (BBRC/Syngene) Shashyendra Singh (BBRC/Syngene) Vishwanath Kurawattimath (BBRC/Syngene) Sagnik Chatterjee (BBRC/Syngene) Priyadeep Bhutani (BBRC/Syngene) Uday Agar wal (BBRC/Syngene) Manasa Deepa (East West College of Pharmacy)
Nilesh Gaud (BBRC/Syngene) Sachin Tulsankar (BBRC/Syngene) Anup Deshpande (BBRC/Syngene) Sandhya Subash (BBRC/Syngene) Satheesh Kumar (NIPER, Hyderabad) S. Bharath (M.S. Ramaiah University) Eljo Jose (BBRC/Syngene) Ashwani Sharma (Biopredic) Hari Kangne (BBRC/Syngene) Mallikarjuna Rao (IISc) Ramasivasubramanian (Novar tis, Hyderabad) Ravindra Reddy (BBRc/Syngene) Sachin Tulsankar (BBRC/Syngene) Safala Malvankar (BBRC/Syngene) Sakthi Devan (BBRC/Syngene)
MEETING SPONSORS/COLLABORATORS Bristol-Myers Squibb GVK Bio GenoMembrane Amgen Syngene Solvo AB Sciex Biopredic-Advancells Corning
Gilead Samitek Instruments ATNT Bugworks, Bangalore In vitro ADMET Allied biosystems Nanotemper Tech Vishnu Traders Wipro GE Healthcare Pvt. Ltd.
•P uMAS Workshops, February and March, 2020: Hands-on workshop on PuMAS software in different cities of India (Amity University-Delhi; Manipal University-Manipal; M.S. Ramaiah University of Applied Sciences-Bangalore and NIPER-Hyderabad) •A sia Pacific ISSX Meeting, 21st–24th February, 2021: The 7th AP-ISSX Meeting has been scheduled in Februar y 2021 in Bangalore, India
Continued on next page
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•W orkshop on Physiology based Pharmacokinetic (PBPK) Models for Drug Development and Therapeutics: Jointly organized with Manipal College of Pharmaceutical Sciences
on 21st and 22nd November, 2019 at Manipal Academy of Higher Education Issue 4, 2019
ONGOING AND FUTURE EVENTS OF SSX-INDIA •C ertification Course of DMPK, August to December, 2019: To provide basic understanding of DMPK concepts, techniques and applications of preclinical to clinical translation; Webinar based training programme for 36 hours over five months in five premium pharmaceutical institutions
Association of Pharmaceutical Teachers of India Orchid Scientific & Innovative India Pvt. Ltd. East West College of Pharmacy Indian Institute of Science M.S. Ramaiah University of Applied Sciences
President’s Message Continued from page 1 by Professor Yuichi Sugiyama (RIKEN, Tokyo), was held on November 18, 2019. The second webinar, scheduled for December 2, 2019, and entitled “The next frontier in ADME research: predicting tissue drug concentrations,” featured Professor Jashvant Unadkat (University of Washington). As these events will have taken place by the time you read this Newsletter, please be sure to visit the ISSX website to access the slides and recordings. Additional webinars are currently being planned for 2020. We will also be offering a third cycle of the ISSX Mentorship Program, a free benefit to new investigators and longtime members of the Society. Finally, I am ver y pleased to announce that ISSX has now added a four th Focus Group—dealing with drug transpor ters—to our list of member interest groups. The Transpor ter Focus Group will be led by Xiaoyan Chu (Merck) and Xinning Yang (FDA) and plans to hold its first meeting in conjunction with next year’s conference
in Hawaii. This addition complements nicely our existing focus groups on modeling & simulation, biotransformation mechanisms, and bioanalysis in ADME science, and it provides discussion forums that cover a broad spectrum of our members’ interests. In closing, I would like to acknowledge the effor ts of all those who have generously given of their time and effor t this past year to fur ther the goals and activities of ISSX, namely members of Council, regular committee members and their chairs, meeting organizing committees and their chairs, and leaders of the focus groups. In par ticular, I would like to thank Steve Kemp, Zoë Fuller, and their staff at SmithBucklin for their continued outstanding administrative suppor t of ISSX. With the Holiday Season almost upon us, I would like to wish all ISSX members a happy and relaxing year-end and much success in 2020!
4th Annual Conference of SSX-India (SSX–2019) Continued from previous page
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ORGANIZING COMMITTEE
CONFERENCE PARTICIPANTS
Changes to the ISSX Council As we approach the end of 2019, we will see five long-ser ving members complete their terms of ser vice with ISSX. Dr. Thomas A. Baillie is Professor of Medicinal Chemistr y and Dean Emeritus of the School of Pharmacy at the University of Washington in Seattle, WA, where he also ser ved as Vice Provost for Strategic Initiatives. He was born in Scotland and educated at the University of Glasgow, where he earned B.Sc. (Hons) and Ph.D. degrees in Chemistr y in 1970 and 1973, respectively. He also holds an M.Sc. degree in Biochemistr y from the University of London (1978) and was awarded the degree of D.Sc. in Chemistr y from the University of Glasgow in 1992. Following postdoctoral research at the Karolinska Institute in Stockholm, Sweden (1973–75), Dr. Baillie held successive faculty positions at the University of London (1975–78), University of California San Francisco (1978–81), and University of Washington (1981–94). He then joined Merck Research Laboratories in West Point, PA, where he was Global Vice President of Drug Metabolism & Pharmacokinetics until 2008, at which point he returned to the University of Washington.
Dr. Sonia de Morais has BS and MS degrees in Pharmacy from the University of Sao Paulo, Brazil, and Ph.D. in Pharmacy from the University of Toronto, Canada. Her postdoctoral research focused on the Ah receptor while at the Depar tment of Pharmacology, University of Toronto; followed by research on the identification of genetic polymorphisms in the CYP2C19 gene at the NIEHS, in the Research Triangle Park, NC. The NIH patented this discover y in 1994. Dr. de Morais joined the pharmaceutical industr y in 1995, initially at Boehringer Ingelheim in Ridgefield, where she was a Group Leader of Drug Metabolism. She joined Pfizer in 1999, and led the development of in vitro technologies to understand drug transpor ters and other ADMET processes, as well as being responsible for the suppor t of Hit-to-Lead Discover y project teams. She received the National Hispanic Corporate Achievers award from Pfizer in 2007. Continued on next page
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Dr. Baillie was Chair of the 1994 Gordon Conference on Drug Metabolism, and he has ser ved on the International Advisor y Committee for the Symposia on Microsomes and Drug Oxidations and on the Organizing Committees for the ISSX conferences in Orlando, FL (2002), Noordwijk, Netherlands (2012), and Busan, Korea (2016). He has been an active member of ISSX since 1988, and has held office as ISSX Councilor (1991–93 and 2012–15), Secretar y Elect and Secretar y (1996–99), and President Elect and President (2016–2019).
During his tenure as President of ISSX, Dr. Baillie continued to promote broadly the study of foreign compounds in living systems through the organization of high quality regional and international scientific meetings and workshops aimed at integrating basic research with applied science. In par ticular, he emphasized the need for the Society to focus on the needs of both new investigators and established researchers from academia, industr y, and regulator y agencies in being the premier international organization for the advancement of xenobiotic science.
Issue 4, 2019
Dr. Baillie’s research interests center on the application of mass spectrometr y and allied techniques to mechanistic studies of the metabolism of foreign compounds, with par ticular emphasis on the generation of chemically reactive, potentially toxic products of biotransformation. He has co-authored over 250 peerreviewed publications, ser ves on the Advisor y Boards of a number of scientific journals and academic/ government research centers, and acts as a consultant to several companies in the pharmaceutical and biotechnology industries.
Dr. Baillie was awarded a Fogar ty Senior International Fellowship from the NIH in 1988, was the recipient of the James R. Gillette Award from the American Society for Pharmacology & Experimental Therapeutics (2001), and received the Lifetime Achievement Award from the International Isotope Society (2009). In 2010, he was elected as a Fellow of the Royal Society of Chemistr y and a Fellow of the Japanese Society for the Study of Xenobiotics. In 2011, Dr. Baillie became a Fellow of the American Chemical Society, and he received the Founder’s Award from the ACS Division of Chemical Toxicology in 2012. In 2014, he was the recipient of the Nor th American Scientific Achievement Award from ISSX.
Changes to the ISSX Council Continued from previous page
Dr. de Morais has an extensive scientific publication record, and has been invited to present and chair sessions at multiple international conferences on the areas of drug transpor ters, enzyme induction, ADMET screening, Hit-to-Lead, and discover y suppor t. Dr. de Morais obtained an Executive MBA from Rensselaer Polytechnic Institute in 2003. The concepts of Finance, Organizational Behavior, and other business relevant topics were instrumental to her career progression in management in the pharmaceutical industr y. Dr. de Morais joined Abbott Laboratories in Chicago in December 2008. The Pharmaceutical Division of Abbott separated from the parent company and became AbbVie Inc. in 2013. She was Director of Drug Metabolism and Pharmacokinetics at AbbVie Inc., and her depar tment had about 65 scientists responsible for scientific studies from early Discover y to NDA, for both small molecules and antibody-drug-conjugates. Dr. de Morais currently owns SdM BioPharma Consultants LLC, and works from her home in Florida.
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Dr. de Morais has served on the ISSX Scientific Advisory Council, and she was a member of the organizing committee of the 18th North American Regional meeting in Dallas in 2012. She is currently a member of the organizing committee of the 23rd ISSX North American and 35th JSSX meeting. She was elected in 2015 and has served on the ISSX Council as Treasurer since 2017. Dr. William Griffith (Griff) Humphreys is currently principal with Aranmore Pharma Consulting. Prior to that, he spent 26 years at Bristol-Myers Squibb Pharmaceutical Company, with the last 12 years leading the Biotransformation Depar tment. He received his graduate training at the University of Virginia in chemistr y and completed a post-doctoral fellowship at Vanderbilt University in the Center in Molecular Toxicology. Dr. Humphreys' interests include the consequences of reactive metabolite formation, development of new analytical methodologies for metabolite detection, reaction phenotyping of CYP and UGT catalyzed biotransformations, predictive metabolism and toxicology models, in vitro-in vivo correlations, and strategies for candidate optimization. He has
co-authored more than 130 refereed manuscripts, numerous reviews, and book chapters. Dr. Humphreys is a member of the ISSX and the ACS Chemical Toxicology Division (TOXI). He is on the Editorial Advisor y Boards of Drug Metabolism and Disposition and ser ves as reviewer for multiple additional journals. He ser ved on the Executive Committee of TOXI from 2008–2017 and was TOXI Program Chair for the 2013–2014 National meetings. Griff was on the ISSX Council from 2016-2019 and was a member of the Meeting Organizing Committee for the 22nd NA ISSX Meeting. He was Meeting Chair for the 2019 Drug Metabolism Gordon Research Conference. Dr. Lei Zhang is currently Deputy Director of Office of Research and Standards (ORS), Office of Generic Drugs (OGD), at the Center for Drug Evaluation and Research (CDER), the U.S. Food and Drug Administration (FDA). ORS implements the Generic Drug User Fee Amendments (GDUFA) science and research commitments to ensure the therapeutic equivalence of generic drug products. She was Senior Advisor for Regulator y Programs and Policy and Managing Director of the OCP Guidance Modernization Initiative, in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), CDER, FDA. She is an accomplished professional with more than 21 years of combined experiences in the areas of drug research, development and regulator y review and approval. She received her Ph.D. in Biopharmaceutical Sciences from the University of California, San Francisco (UCSF). She worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader before she joined the FDA in 2002. At the FDA, apar t from regulator y review, Dr. Zhang is involved in several regulator y science initiatives and has been a principal investigator or collaborator on numerous regulator y research projects and mentors scientific interest group members, reviewers, and fellows. Dr. Zhang has contributed to regulator y guidance development and revision including guidance on drug interactions, bioavailability studies submitted in NDAs or INDs, pharmacokinetics (PK) studies in renal impairment patients, clinical pharmacogenomics, clinical pharmacology data to Continued on next page
Changes to the ISSX Council Continued from previous page
suppor t biosimilarity determination, clinical pharmacology labeling, and bioequivalence studies with PK endpoints for drug products submitted in ANDA. Her research focuses on the science-based regulator y decision-making and applying clinical pharmacology principles through drug development and regulator y approval, in par ticular drug interactions, drug transpor ters, pharmacogenomics, specific populations, and PBPK modeling. Dr. Zhang has been a member of ISSX since 1999. She was a member of the ISSX’s Committee on Regulator y Affairs 2012–2017. The Committee has organized symposia/workshops at both Nor th American and other Regional and International ISSX meetings. She was elected as an ISSX Council Member and has ser ved on the Council since Januar y 2018. She is a frequently invited speaker at the ISSX meetings and shor t courses, and also par ticipated in the meetings/ workshop co-organized by ISSX and the Chinese Society for the Study of Xenobiotics (CSSX). She ser ved on the Meeting Organization Committee for the 12th International ISSX Meeting in Por tland, Oregon.
He has ser ved on the steering committee of the Southern California Drug Discussion Group for the past 9 years, is currently an ISSX council member, and has been both Chair and Vice-Chair of the Gordon Research Conference (GRC) on Drug Metabolism. He has been an invited speaker or discussion leader at the GRC, American Association of Pharmaceutical Sciences (AAPS), ISSX, and is a member of several professional societies. He is currently ser ving on the Drug Metabolism and Disposition Editorial Board and has been a peer reviewer for Drug Metabolism and Disposition, Clinical Pharmacokinetics, Exper t Opinion in Drug Metabolism and Toxicology, and many others. His goal as an ISSX council member has been to increase the impact and value of ISSX scientific meetings and workshops for its members, while ever increasing the international diversity of its membership and leadership which has helped to promote collaboration among academic, industr y, and regulator y agencies to speed advancements in our sciences and xenobiotic discover y. He will continue to contribute to the society on the nominations committee and hopes to continue promoting diversity and topnotch scientific talent to the ISSX leadership. ISSX is thankful to each of these individuals for their ser vice and commitment to the Society.
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Michael (Mike) A. Zientek is a U.S. Citizen and received his B.S. from Purdue University and MPH from the University of Michigan. He has 25 years of experience in drug metabolism and pharmacokinetics working in industr y for both
His research activities have been and continue to be devoted to investigation of drug metabolizing enzymes, polymorphisms, drug-drug interactions, and human ADME of new and established xenobiotics. He has authored >30 publications in this area ranging from new tools for ADME investigations to characterization of targeted therapies.
Issue 4, 2019
Dr. Zhang is also a member of the American Association of Pharmaceutical Sciences (AAPS), American College of Clinical Pharmacology (ACCP), and the American Society for Clinical Pharmacology and Therapeutics (ASCPT). She is a Board Member of ASCPT and ser ves on the Clinical Pharmacology and Therapeutics Editorial Board. Dr. Zhang was named AAPS Fellow in 2013. Dr. Zhang is a member of the International Transpor ter Consor tium (ITC) that published a transpor ter whitepaper in 2010 and several whitepapers/position papers in 2013 and 2018. She is an Adjunct Professor in the Depar tment of Bioengineering and Therapeutic Sciences, UCSF Schools of Pharmacy and Medicine. Dr. Zhang has authored and co-authored more than 100 papers and book chapters. Dr. Zhang has received many awards, including FDA Outstanding Achievement Award, FDA Scientific Achievement Award, and CDER Special Recognition Awards.
Pfizer Worldwide Research and Development and Takeda Pharmaceuticals. He is currently a director of DMPK at Takeda California, where he and his group provide bioanalytical and mechanistic DMPK guidance to advance molecules through design effor ts in discover y, optimizing and predicting human pharmacokinetic and pharmacodynamic proper ties, preparing molecules for regulator y submission, and progressing compounds through clinical proof of concept. Additionally, he also ser ves as a research project lead to deliver neuroscience candidate drugs to patients.
Welcome New Members The International Society for the Study of Xenobiotics proudly welcomes the following new members. We greatly appreciate their suppor t and hope that each remains aligned and affiliated with ISSX for many years to come.
Alex Byer-Alcorace, Boehringer Ingelheim, Ridgefield, CT, United States
Inyoung Hwang, Seoul National University College of Medicine and Hospital, Seoul, South Korea
Ming Cheng, Boehringer Ingelheim, Ridgefield, CT, United States
Sohee Im, Daewoong Pharmaceutical Company, Yongin-si, South Korea
James Chien, Abbvie, Menlo Park, CA, United States Caitlin Dunning, Waters Corporation, Milford, MA, United States Peter Eddershaw, Ver tex Pharmaceuticals Ltd, Abingdon, United Kingdom
Mariia Kliachyna, Bienta Enamine Biology Ser vices, Kyiv, Ukraine Thomas Larson, Mayo Clinic, Rochester, MN, United States Alix Leblanc, Abbvie, Chicago, IL, United States
Chris Edwards, GlaxoSmithKline, Stevenage, United Kingdom Eman El-Khateeb, University of Manchester, Manchester, United Kingdom
Madhan Masilamani, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, United States Marion Rossmann, CRO, Grafing bei München, Germany
Michael Gerisch, Bayer AG, Wupper tal, Germany
Hong Shen, Bristol-Myers Squibb, Lawrenceville, NJ, United States
Odaine Gordon, Pharmacyclics, Sunnyvale, CA, United States
Bhargavi Srija Ramisetty, University of Kansas, Lawrence, KS, United States
Will Tao, Takeda California Inc., San Diego, CA, United States Toshiaki Tsuchitani, Faculty of Pharmacy, Keio University, Minato-ku, Japan Madelé van Dyk, Flinders University, Henley Beach, Australia Areti-Maria Vasilogianni, University of Manchester, Manchester, United Kingdom Guanyu Wang, Ver tex Pharmaceuticals, Boston, MA, United States Jaap Wieling, BiosanaPharma, Leiden, Netherlands Mengyue Yin, University of Washington, Seattle, WA, United States Yueping Zhang, BristolMyers Squibb, Lawrenceville, NJ, United States
ISSX FOCUS GROUPS
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/ISSX Newsletter / Issue 4, 2019
Biotransformation Mechanisms and Pathways Chair: Amit Kalgutkar, Pfizer • Co-Chair: Valerie Kramlinger, Amgen Bioanalysis in ADME Science Chair: Kevin Bateman, Merck • Co-Chair: Jens Sydor, Abbvie Modeling and Simulation Chair: Har tmut Derendor f, University of Florida • Co-Chair: Ping Zhao, Bill and Melinda Gates Foundation New in 2020: Transporter Focus Group Chair: Xiaoyan Chu • Co-Chair: Xinning Yang The goals of this focus group are to disseminate and promote state-of-the-ar t research and foster collaborations among ISSX members on the role of transpor ters in drug disposition, drug interactions, efficacy, and toxicity, and their impact on drug discover y, development, and regulator y decision making. Sign up at www.issx.org/FocusGroups
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Editor Dr. Allen Cato, III Cato Research, LTD 6480 Weathers Place, Suite 104 San Diego, California 92121 USA Telephone: +1-858-452-7271 Fax: +1-858-452-7784 E-mail: jcato@cato.com
Change of Address If your mailing address, telephone, fax number, or e-mail has changed or will change, please let us know as soon as possible. You may update your contact information at any time using the online membership director y, which you can access in the Member Only section of the website. If you have forgotten your username and/or password, please contact information@issx.org.
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The quarterly ISSX Newsletter is an online publication featuring Society updates, scientific articles of interest, book reviews, summaries of ISSX meeting proceedings, and more. This publication is designed to update the ISSX membership on the activities and events of the organization and to provide an information forum. Not only is the ISSX Newsletter promoted directly to all ISSX members, it is also available to anyone who visits the ISSX website. Visit issx.org/advertising or contact Scott Narug at snarug@issx.org.