ISSX President’s Message · 2019-12-09 · This book is one of a series entitled “Advances in . Pharmaceutical Technology,” in which other related titles include: “Novel Delivery

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 expert and from her long and active involvement with ISSX through our meetings, conference organization, and Society leadership. With support 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 very successful year in 2019, the premier event being the 12th

International ISSX Meeting in Portland, OR during late July. According to Society policy, only one meeting is held every 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 forward 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 very busy year for ISSX, since we will be co-hosting two important meetings. The first with the European

Association for Clinical Pharmacology and Therapeutics (EACPT) in Geneva, Switzerland, from June 7–10, 2020 (information is 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 Resort on the Big Island of Hawaii from October 4–8, 2020. Both meetings feature exciting scientific programs and will be held in very 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

Book Review

2019 ISSX Workshop Disposition of Biologics

Renew Your ISSX Membership for 2020

Enroll in the ISSX Mentorship Program

15th European ISSX and EACPT Joint Meeting

23rd North American ISSX Meeting & 35th JSSX Meeting

4th Annual Conference of SSX-India

Changes to the ISSX Council

Welcome New Members

ISSX Focus Groups

IN THIS ISSUE

3

4

2

6

7

5 8

1114

ISSX President’s MessageBy Thomas Baillie, ISSX President

Thomas Baillie, Ph.D.ISSX President.

Continued on page 10

14

Volume 42 Issue 4, 2019

IN VITRO DRUG RELEASE TESTING OF SPECIAL DOSAGE FORMSEditors; Nikoletta Fotaki, Sandra Klein.John Wiley and Sons312 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 particular 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 properties 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.

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 Delivery Systems,” “Rectal Dosage Forms,” and “Ophthalmic Dosage Forms.” The final segment is concerned with regulatory 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 Delivery Systems for Transdermal and Intradermal Delivery Systems (2015),” “Pulmonary Drug Delivery: Advances and Challenges (2015),” and “Drug Delivery Strategies for Poorly Water-Soluble Drugs (2012).” The relevant section of the Wiley website (www.wiley.com/en-us) is well worth a perusal if individuals are interested in this aspect of pharmaceutics or missed these previous volumes, which are still available.

Notified bySteve MitchellImperial College London, UK

Book Ordering InformationJohn Wiley and SonsCorporate Headquarters111 River StreetHoboken, NJ 07030-5774United States of AmericaTelephone: (201) 748-6011Facsimile: (201)748-6088Email: [email protected]

The AtriumSouthern Gate, ChichesterWest Sussex PO19 8SQEnglandTelephone: (44) 1243-779777Facsimile: (44) 1243-775878Email: [email protected]

Book Review

2 /

ISS

X N

ewsl

ette

r /

Issu

e 4, 2019

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 January 2020. This will include overview 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 pertinent digests will be available online and as a printed version (www.tandfonline.com/loi/ixen20).

Schedule at a Glance

THURSDAY, DECEMBER 12, 2019

Basic Determinants for the Disposition/ADME of Protein TherapeuticsJoseph Balthasar, SUNY Buffalo, Buffalo, NY, USA

Clinical Examples to Showcase the Disposition Properties of BiologicsBernd Meibohm, University of Tennessee Health Science Center, Memphis, TN, USA

Overview - Bioanalytical Methods used to Assess the Disposition of BiologicsRenuka Pillutla, BMS, Princeton, NJ, USA

Assessing Whole-body Disposition of Biologics (Preclinical and Clinical) Using Imaging MethodAndrew 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 PopulationHonghui Zhou, Janssen, Spring House, PA, USA

Quantitative Characterization and Prediction of the Disposition of BiologicsDhaval Shah, SUNY Buffalo, Buffalo, NY, USA

Employing the Knowledge about the Disposition of Biologics to Support Discovery, Development, and Clinical TranslationWeirong Wang, Janssen, Spring House, PA, USA

FRIDAY, DECEMBER 13, 2019

Case Study 1: Understanding the Disposition of Biologics to Treat Neurodegenerative DiseasesDrew MacCannell, Biogen, Boston, MA, USA

Case Study 2: Understanding the Disposition VedolizumabMaria Rosario, MA, USA

Case Study 3: Understanding the Disposition DaratumumabThomas Puchalski, Spring House, PA, USA

Disposition of Protein Therapeutics in Human Tissues and TumorsNeeta Pandit, Memorial Sloan Kettering Cancer Center, New York, NY, USA

Tissue Metabolism as a New Perspective in Discovery of BiologicsDonglu Zhang, Genentech, San Francisco, CA, USA

Novel in vitro Techniques to Predict the Disposition of BiologicsDan Rock, Amgen, San Francisco, CA, USA

Quantitative Characterization of the Disposition of CAR-TXu Zhu, Novartis, MA, USA

Understanding the Disposition of Oligonucleotides/ SiRNADiane Ramsden, Alnylam, Boston, MA, USA

Understanding the Disposition of Gene Therapy Vectors (e.g. AAV)Nagendra Chemuturi, Novartis, Seattle, WA, USA

Whole-body Disposition/Tropism of AAVs in HumanMiguel Esteves, University of Massachusetts, Worcester, MA, USA

Seats available at the 2019 ISSX Workshop, Disposition of Biologics

Issue 4, 2

019 /

ISS

X New

sletter / 3

Register Today: www.issx.org/2019workshop

Thank you for your membership and support 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. On the right-hand side of the page, log in with your ISSX username and password. If you do not know your username or password, you may re-set it by visiting issx.org/password.

3. Click RENEW YOUR MEMBERSHIP NOW in the blue box at the top of your profile page.

4. On the next screen, review and update your contact information to ensure uninterrupted communication from ISSX.

5. Once 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.

• If 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;

• Online 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;

• The opportunity to submit and present scientific abstracts at ISSX meetings;

• Eligibility to apply for and receive travel grants to attend ISSX meetings;

• And the chance to hold office, serve on a committee, and vote in ISSX elections.

Your membership indicates support 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 [email protected].

DonationsISSX relies on assistance from members and other individuals as well as corporate entities to advance our mission. If you would like to make a gift to ISSX, please visit www.issx.org/donations to learn about the various funds you can support.

ISSX is a 501 (c)(3) organization incorporated in the United States. As such, your contribution may qualify for a tax deduction. Consult your tax advisor for full information. Our federal tax identification number is 22-243-2063. If you need a copy of our federal W-9 form, simply email [email protected] and we will promptly reply.

Renew Your ISSX Membership for 2020

4 /

ISS

X N

ewsl

ette

r /

Issu

e 4, 2019

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 participants 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!”

"I always look forward to chatting with my mentor. I find her very 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 comfortable with; however, I think this match is great. I look forward to our next few months in the mentorship program!"

ISSX thanks past participants 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.

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 forward to others by serving 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 opportunity for new relationships, skills, and conversations to develop.

Enroll in the ISSX Mentorship Program!

Issue 4, 2

019 /

ISS

X New

sletter / 5

ISSX Webinar Series Recordings Available Online

Did you miss a recent webinar? Sign into your ISSX membership account and view all past webinars.

www.issx.org/pastwebinars

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 opportunity to exchange ideas and expertise, develop a common vision, and create and nurture collaborations in different fields of the study of medicines.

The meeting will star t with short 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 short courses, the opening keynote lecture will discuss regulatory 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 plenary and lectures and Fifteen scientific symposia will encompass a broad spectrum of topics important in the field. In addition, there will be poster sessions, a trade exhibition, and industry-sponsored symposia. On the social side, we are planning an enjoyable banquet dinner for the opportunity 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 country. We suggest that you bring your family and extend your stay to make this a unique summer holiday.

HOTELSISSX has secured special rates for meeting attendees at area hotels. Review the options and make your reservation via the meeting website.

Reserve a room by April 21 to secure the ISSX/EACPT rates.

MEETING ORGANIZING COMMITTEE

Meeting PresidentJules Desmeules

Meeting ChairsCaroline SamerChristoph Funk

Organizing CommitteeJanne BackmanJamie ColemanAnn DalyPatrick DansetteDieter LangArantxa SanchoNico VermeulenMarkus Zeitlinger

PROGRAM AT A GLANCEThe 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 SESSIONSFour general sessions will be presented:

• Past, Present and Future Development in Pharmacogenomics

• The Need for Complex Cellular Models

• Nanotechnologies Enabling Drug Delivery

• Predictive Risk Scores: Patient Empowerment

Join us in Geneva for the 15th European ISSX and EACPT Joint Meeting June 7–10, 2020

6 /

ISS

X N

ewsl

ette

r /

Issu

e 4, 2019

Continued on next page

PARALLEL SESSIONS• Implementation of Pharmacogenomic Testing

• Stem Cell-based in vitro Systems to Assess Drug Safety, Drug Discovery and Development

• New Developments in Therapeutic Drug Monitoring (TDM)

• The Use of Ar tificial Intelligence and Machine Learning in Drug Discovery and Development

• Pharmacogenomics, Drug Development and Regulatory Aspects

• Novel, Human in vitro Models to Study Diseases and Mechanisms

• Emerging Topics in the Field of Drug Transporters

• Impact of New Drug Delivery Methodologies on ADME and Safety

• Transporter-mediated Drug-drug Interactions and Translation from in vitro to Clinics

• New Modalities—New Challenges

• Drug-drug Interactions from the Model to the Clinic

• Challenges in Today's Drug Research and Development—The Regulator's View

• Microphysiological Systems: Current Status and Applications

• Current Approaches and Limitations in the Assessment of Drug-induced Liver Injury (DILI)

• Drivers of Modern Drug Development

OPTIONAL SHORT COURSESShort 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.

ABSTRACT SUBMISSIONS NOW OPENISSX 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 every 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.

Attendees will stay at Hilton Waikoloa Village, a beautiful oceanfront resort on the Big Island.

MEETING ORGANIZING COMMITTEEMeeting Chairs

Hiroshi Yamazaki • Allan Rettie

Organizing Committee

Save the Date!23rd North American ISSX Meeting & 35th JSSX MeetingOctober 4–8, 2020 in Waikoloa Village, Hawaii

PROGRAM, REGISTRATIONS, AND ABSTRACT SUBMISSIONSWatch for more information coming soon!

15th European ISSX and EACPT Join MeetingContinued from previous page

Issue 4, 2

019 /

ISS

X New

sletter / 7

Kenji Tabata Hideki Hirabayashi

Yoshiro Saito Miki Nakajima

Kouichi Yoshinari

Mike ZientekNatalie Hosea

Sonia de MoraisAnn Daly

Ryan Takahashi Kiyomi Ito

Kevin Bateman Nagasaka Yasuhisa

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 Discovery 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 participants this year. It was a balanced blend of delegates from academia and industry.

Key features of the conference included: pre-conference workshops and short-courses, main conference with two plenary 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 industry, five sponsor talks, and young investigator presentations from the top five abstracts.

Pre-conference workshop and short-course:Three parallel sessions:

1. Short-course: Drug Metabolism, Transporters and Toxicology

2. Hands-on Workshop: Pharmaceutical Modelling and Simulation (PuMAS) Software

3. Micro Sampling and Mass Spectrometry Workshop

Main objectives of the pre-conference workshop/shot-course were:

a) to 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) to provide hands-on experience with PuMAS software and mass spectrometer and their utility

One-hundred and twenty delegates participated in the pre-conference workshop and short-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 history of SSX and the theme of the conference. Dr. Mariappan explained two new, student-focused 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 February and March of 2020. He announced that the 7th Asia Pacific ISSX Meeting will be hosted in Bangalore, February 21–24, 2021.

Conference Inauguration with Indian RitualsDr. Lois-Lehman-McKeeman, 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.

4th Annual Conference of SSX–India (SSX–2019)

8 /

ISS

X N

ewsl

ette

r /

Issu

e 4, 2019

Continued on next page

Review summaries of the short courses, plenary lectures, parallel sessions, and poster presentations on the ISSX website at www.issx.org/ssxindia19.

4th Annual Conference of SSX–India (SSX–2019)Continued from previous page

MEETING CHAIRT. Thanga Mariappan, Ph.D., President, SSX, IndiaSenior Lead Investigator, Biocon–BMS R&D Centre (BBRC), Syngene International Ltd., Bangalore, India.

MEETING CO-CHAIR Vinay H.K., Ph.D. Secretary, SSX, IndiaLead Investigator, Biocon–BMS R&D Center (BBRC),Syngene International Ltd., Bangalore, India.

MEETING ORGANIZING COMMITTEE

MEETING SPONSORS/COLLABORATORS

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 Agarwal (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 (Novartis, Hyderabad)Ravindra Reddy (BBRc/Syngene)Sachin Tulsankar (BBRC/Syngene)Safala Malvankar (BBRC/Syngene)Sakthi Devan (BBRC/Syngene)

Bristol-Myers SquibbGVK Bio GenoMembraneAmgenSyngeneSolvoAB SciexBiopredic-AdvancellsCorning

GileadSamitek InstrumentsATNTBugworks, BangaloreIn vitro ADMETAllied biosystemsNanotemper TechVishnu TradersWipro GE Healthcare Pvt. Ltd.

Association of Pharmaceutical Teachers of India Orchid Scientific & Innovative India Pvt. Ltd.East West College of Pharmacy Indian Institute of ScienceM.S. Ramaiah University of Applied Sciences

ONGOING AND FUTURE EVENTS OF SSX-INDIA• Certification 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

• Workshop 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

• PuMAS 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)

• Asia Pacific ISSX Meeting, 21st–24th February, 2021: The 7th AP-ISSX Meeting has been scheduled in February 2021 in Bangalore, India

Issue 4, 2

019 /

ISS

X New

sletter / 9

Continued on next page

ORGANIZING COMMITTEE

4th Annual Conference of SSX-India (SSX–2019)Continued from previous page

CONFERENCE PARTICIPANTS

President’s MessageContinued 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 very pleased to announce that ISSX has now added a four th Focus Group—dealing with drug transporters—to our list of member interest groups. The Transporter 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 particular, I would like to thank Steve Kemp, Zoë Fuller, and their staff at SmithBucklin for their continued outstanding administrative support 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!

10 /

ISS

X N

ewsl

ette

r /

Issu

e 4, 2019

As we approach the end of 2019, we will see five long-serving members complete their terms of service with ISSX.

Dr. Thomas A. Baillie is Professor of Medicinal Chemistry and Dean Emeritus of the School of Pharmacy at the University of Washington in Seattle, WA, where he also served 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 Chemistry in 1970 and 1973, respectively. He also holds an M.Sc. degree in Biochemistry from the University of London (1978) and was awarded the degree of D.Sc. in Chemistry 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. Baillie’s research interests center on the application of mass spectrometry and allied techniques to mechanistic studies of the metabolism of foreign compounds, with particular emphasis on the generation of chemically reactive, potentially toxic products of biotransformation. He has co-authored over 250 peer-reviewed publications, serves on the Advisory 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 Chair of the 1994 Gordon Conference on Drug Metabolism, and he has served on the International Advisory 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), Secretary Elect and Secretary (1996–99), and President Elect and President (2016–2019).

Dr. Baillie was awarded a Fogarty 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 Chemistry 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 North American Scientific Achievement Award from ISSX.

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 particular, he emphasized the need for the Society to focus on the needs of both new investigators and established researchers from academia, industry, and regulatory agencies in being the premier international organization for the advancement of xenobiotic science.

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 Department 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 discovery in 1994.

Dr. de Morais joined the pharmaceutical industry 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 transporters and other ADMET processes, as well as being responsible for the support of Hit-to-Lead Discovery project teams. She received the National Hispanic Corporate Achievers award from Pfizer in 2007.

Changes to the ISSX Council

Issue 4, 2

019 /

ISS

X New

sletter / 1

1Continued on next page

Changes to the ISSX CouncilContinued 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 transporters, enzyme induction, ADMET screening, Hit-to-Lead, and discovery support.

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 industry.

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 department had about 65 scientists responsible for scientific studies from early Discovery 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.

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 (Grif f) 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 Department. He received his graduate training

at the University of Virginia in chemistry 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 Advisory Boards of Drug Metabolism and Disposition and serves as reviewer for multiple additional journals. He served on the Executive Committee of TOXI from 2008–2017 and was TOXI Program Chair for the 2013–2014 National meetings. Grif f 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 Regulatory 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 regulatory 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, apart from regulatory review, Dr. Zhang is involved in several regulatory science initiatives and has been a principal investigator or collaborator on numerous regulatory research projects and mentors scientific interest group members, reviewers, and fellows. Dr. Zhang has contributed to regulatory 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

12 /

ISS

X N

ewsl

ette

r /

Issu

e 4, 2019

Changes to the ISSX CouncilContinued from previous page

support biosimilarity determination, clinical pharmacology labeling, and bioequivalence studies with PK endpoints for drug products submitted in ANDA. Her research focuses on the science-based regulatory decision-making and applying clinical pharmacology principles through drug development and regulatory approval, in particular drug interactions, drug transporters, 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 Regulatory Affairs 2012–2017. The Committee has organized symposia/workshops at both North American and other Regional and International ISSX meetings. She was elected as an ISSX Council Member and has served on the Council since January 2018. She is a frequently invited speaker at the ISSX meetings and short courses, and also participated in the meetings/workshop co-organized by ISSX and the Chinese Society for the Study of Xenobiotics (CSSX). She served on the Meeting Organization Committee for the 12th International ISSX Meeting in Portland, Oregon.

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 serves on the Clinical Pharmacology and Therapeutics Editorial Board. Dr. Zhang was named AAPS Fellow in 2013. Dr. Zhang is a member of the International Transporter Consortium (ITC) that published a transporter whitepaper in 2010 and several whitepapers/position papers in 2013 and 2018. She is an Adjunct Professor in the Department 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.

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 industry for both

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 discovery, optimizing and predicting human pharmacokinetic and pharmacodynamic properties, preparing molecules for regulatory submission, and progressing compounds through clinical proof of concept. Additionally, he also serves as a research project lead to deliver neuroscience candidate drugs to patients.

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.

He has served 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 serving on the Drug Metabolism and Disposition Editorial Board and has been a peer reviewer for Drug Metabolism and Disposition, Clinical Pharmacokinetics, Expert 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, industry, and regulatory agencies to speed advancements in our sciences and xenobiotic discovery. 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 service and commitment to the Society.

Issue 4, 2

019 /

ISS

X New

sletter / 1

3

Welcome New MembersThe International Society for the Study of Xenobiotics proudly welcomes the following new members. We greatly appreciate their support and hope that each remains aligned and affiliated with ISSX for many years to come.

14 /

ISS

X N

ewsl

ette

r /

Issu

e 4, 2019

Alex Byer-Alcorace, Boehringer Ingelheim, Ridgefield, CT, United States

Ming Cheng, Boehringer Ingelheim, Ridgefield, CT, United States

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

Chris Edwards, GlaxoSmithKline, Stevenage, United Kingdom

Eman El-Khateeb, University of Manchester, Manchester, United Kingdom

Michael Gerisch, Bayer AG, Wuppertal, Germany

Odaine Gordon, Pharmacyclics, Sunnyvale, CA, United States

Inyoung Hwang, Seoul National University College of Medicine and Hospital, Seoul, South Korea

Sohee Im, Daewoong Pharmaceutical Company, Yongin-si, South Korea

Mariia Kliachyna, Bienta Enamine Biology Services, Kyiv, Ukraine

Thomas Larson, Mayo Clinic, Rochester, MN, United States

Alix Leblanc, Abbvie, Chicago, IL, United States

Madhan Masilamani, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, United States

Marion Rossmann, CRO, Grafing bei München, Germany

Hong Shen, Bristol-Myers Squibb, Lawrenceville, NJ, 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, Bristol-Myers Squibb, Lawrenceville, NJ, United States

ISSX FOCUS GROUPS

Biotransformation Mechanisms and PathwaysChair: Amit Kalgutkar, Pfizer • Co-Chair: Valerie Kramlinger, Amgen

Bioanalysis in ADME ScienceChair: Kevin Bateman, Merck • Co-Chair: Jens Sydor, Abbvie

Modeling and SimulationChair: Har tmut Derendor f, University of Florida • Co-Chair: Ping Zhao, Bill and Melinda Gates Foundation

New in 2020: Transporter Focus GroupChair: 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 collaborationsamong 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

OLD

HeaderHeaderChange of AddressIf 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 directory, which you can access in the Member Only section of the website. If you have forgotten your username and/or password, please contact [email protected].

Editor Dr. Allen Cato, IIICato Research, LTD6480 Weathers Place, Suite 104San Diego, California 92121USATelephone: +1-858-452-7271Fax: +1-858-452-7784E-mail: [email protected]

ISSX Newsletter is published quarterly in the spring, summer, autumn, and winter. For information concerning advertising in this publication, including rates and specifications, please visit issx.org/advertising or contact Scott Narug at [email protected].

ADVERTISE WITH ISSX

The quarterly ISSX Newsletter is an online publication featuring Society updates, scientific articles of interest, book reviews, summaries of ISSX meeting proceedings,

and more. This publication is designed to update the ISSX membership on the activities and events of the organization

and to provide an information forum.

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

who visits the ISSX website.

Visit issx.org/advertising or contact Scott Narug at [email protected].