2015 - American College of Clinical Pharmacology

Transcription

2015 Annual Meeting
American College of Clinical Pharmacology
Clinical Pharmacology in the Development
& Use of Biologics & Small Molecules
September 27 – 29, 2015 • Westin St Francis • San Francisco, CA
FINAL PROGRAM
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Co-chairs: John Davis,
PhD and Michael Neely, MD, MSc
Join Us for the
2016 ACCP
Annual Meeting!
Clinical
Pharmacology:
Discovery and
Application
in the Era of
Precision Medicine
September 25 – 27, 2016
Bethesda N Marriott Hotel &
Conference Center, Bethesda, MD
FUTURE MEETINGS:
2017 Annual Meeting
September 15 – 17, 2017
Hilton San Diego Resort & Spa
San Diego, CA
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2018 Annual Meeting
September 23 – 25, 2018
Bethesda N Marriott Hotel & Conference Center
Bethesda, MD
Did You Know?
ACCP has expanded its Continuing Education
Program!
An accredited provider of Continuing Medical Education (CME) and
Continuing Pharmacy Education (CPE), ACCP continues to expand
its Continuing Education Program. New this year are ACCP’s Virtual
Journal Club and its Fundamentals Tutorials series. The ACCP Virtual
Journal Club provides readers of The
Journal of Clinical Pharmacology with
the chance to talk with the author of
a recently-published article. Previous
ACCP Virtual Journal Club events
“Clinical Drug-Drug Interaction Assessment of Ivacaftor as a Potential
Inhibitor of Cytochrome P450 and P-glycoprotein” and “Emerging Areas
of Research in the Assessment of PK in Patients with Chronic Kidney
Disease” are now available online. The ACCP Virtual Journal Club is
free for Members and Non-members. ACCP’s Fundamentals Tutorials
series is designed to provide a “not too technical” overview of clinical
pharmacology. Each webinar features a presentation by a subject matter
expert followed by questions and discussion. These one-hour events are
offered live and then as online activities. Currently available online are
“Pharma & Biotech Outlook & Challenges” and “Introduction to Clinical
Trials and Drug Development.” Coming in October: “Regulatory Affairs.”
The Fundamentals Tutorial series is free for ACCP Members and $35 for
Non-members. For more information see page 13.
Publish Your Manuscript in The Journal of
Clinical Pharmacology
ACCP invites you to submit your manuscript for publication in The
Journal of Clinical Pharmacology (JCP). When you publish in the JCP,
you get:
• No page charges;
• Time to first decision to author of 22 days;
• Increased page numbers, allowing authors more words,
tables, figures and references;
• Online publication of accepted articles within 7 days and
online publication of final article proofs within 30 days of
acceptance;
• Critically-evaluated clinical pharmacology-based reviews
are considered for publication.
JCP offers CE credit for physicians and pharmacists each month.
JCP is always looking for qualified reviewers. Potential reviewers should
send their CV to elizabeth.marshall@kwfco.com which will then be
forwarded to the Editor-in-Chief for review.
http://mc.manuscriptcentral.com/jocp
Submit Your Next Paper to Clinical
Pharmacology in Drug Development
Clinical Pharmacology in Drug Development (CPDD) is a wellrespected, peer-reviewed medical and scientific journal with a renowned
international editorial board. CPDD serves as a forum for publication of
high-quality scientific manuscripts reporting on clinical studies done as
part of the process of drug development. Scientific merit, rather than
global clinical impact, is the principal criteria for acceptance. CPDD
understands that the outcome of descriptive and “negative” studies
provides important information that guides therapeutic decisions. CPDD
is now broadening the scope of scholarly activities to include the following
types of manuscripts:
• Review articles on topics related to drug development and clinical
pharmacology (2,500–3,000 words);
• Brief opinion or commentary articles, serving as balanced editorial type evaluations of contemporary or controversial topics (1,000–1,500
words);
• Key teaching points, dealing with factual or methodologic issues in
need of clarification or emphasis (500–1,500 words). Areas of focus
could include: drug metabolism, pharmacokinetics, product labeling,
adverse drug reactions, etc.
CPDD features:
• Growing international readership: full text article downloads
increased by >160% in 2014;
• Quick and easy online submission and review process;
• Rapid publication: articles are available online weeks ahead of
issue publication;
• Open access options available for authors who wish to make their
article free for all to access online;
• Immediate international exposure with Web of Science: Science
Citation Index Expanded (SCIE), Scopus, Chemical Abstracts,
Embase and Google Scholar indexation.
http://mc.manuscriptcentral.com/cpd
Attending the Meeting as a Student or Trainee?
ACCP has planned a series of events specifically to benefit Students &
Trainees! See page 35 for details.
Interested in joining ACCP?
Stop by the ACCP Registration Desk for complete information or to
complete a profile and pay 2016 Dues entitling you to ACCP Member
Benefits.
Take Time to Visit Our Exhibitors!
Exhibitor support is critical to the success of the ACCP Annual Meeting.
We encourage you to visit our Exhibitors during breakfast, breaks and the
evening receptions to learn about new technologies and service offerings.
These exceptional Exhibitors are the leaders in their fields and are
anxious to share with you the latest information on how they can help you
meet your goals! Please take a moment to thank them for their support.
“Like” ACCP and add to “My Page’s Favorites” on
Facebook
or join our
network for
regular updates.
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Table of Contents
American College of
Clinical Pharmacology
2015 Program Committee
John Davis, PhD, Co-chair
Invitation to 2016 ACCP Annual Meeting. . ....................... 2
Did You Know?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Letter of Welcome from President
& Program Co-chairs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Program at a Glance. . ............................................. 6
Michael Neely, MD, MSc, Co-chair
Keynote Speaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Lawrence Cohen, PharmD (ex officio)
2015 ACCP Recognition Award Winners. . . . . . . . . . . . . . . . . . . . . . . 9
Daniel Gonzalez, PharmD, PhD
Walter K. Kraft, MD, MS
Educational Accreditation.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Anne Paccaly, PharmD, PhD
Educational Activities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Natella Rakhmanina, MD, PhD
2015 Disclosure Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Michael Reed, RPh, PharmD
Catherine Sherwin, PhD, MS
Laurent Vernillet, PharmD, PhD
Honghui Zhou, PhD
Pre-meeting Workshops. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Symposia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Faculty... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Why Join ACCP?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Students & Trainees. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Sponsors.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Exhibitors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Poster Sessions.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
ACCP Officers, Regents, Vision & Mission. . . . . . . . . . . . . . . . . . . 50
New Members: August 1, 2014 – July 31, 2015. . . . . . . . . . . . . . 51
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Letter of Welcome from
President & Program Co-chairs
Welcome to the 2015 ACCP Annual Meeting!
Clinical Pharmacology in the Development & Use of Biologics & Small Molecules
Dear Colleague:
It is our pleasure to welcome you to the 2015 Annual Meeting of
the American College of Clinical Pharmacology (ACCP), Clinical
Pharmacology in the Development & Use of Biologics & Small
Molecules. The 2015 Annual Meeting Program Committee, co-chaired
by Drs. John Davis and Michael Neely, has developed a varied and
exceptional program adhering to ACCP’s commitment to excellence in
science and education. Speakers include globally-recognized experts in the
field of clinical pharmacology representing academia, industry, regulatory
and clinical entities. The Workshops and Symposia are an exciting mix of
current topics that balance laboratory and clinical pharmacologic science
and include a special focus on biologics as a rapidly expanding therapeutic
area. Organizing the meeting into topic tracks allows attendees to match
content to their individual interests. The program includes analysis
of pharmacokinetic data using R, microdosing in drug development,
return on investment on the utilization of systems pharmacology and
pharmacometrics in drug development for rare diseases, applying new
PK/PD strategies to old antibiotics, novel approaches to first-in-human
studies, what there is left to know about vancomycin, abuse liability
evaluation of new chemical entities, trends in HIV drug development,
Bayesian adaptive designs in early development studies, clinical
significance of food effect confrontation, clinical pharmacology of nucleic
acid therapeutics, oncology immunotherapy, creatinine-drug interactions
involving renal transporters, cancer cachexia and effect of disease state
on the PK/PD of drugs and therapeutic proteins.
Bernd Meibohm, PhD
ACCP President
We invite you to socialize and network during twice-daily tea/coffee breaks,
lunch provided on Monday and Tuesday and evening catered receptions.
Poster Sessions, held Sunday and Monday, will highlight new findings and
preliminary data, and will stimulate discussion and hypothesis generation
in a relaxed atmosphere. Of particular interest to Students & Trainees is a
series of events focused on their unique needs and designed to broaden
their exposure to cutting-edge science and career development.
ACCP has a rich history of providing healthcare professionals and
scientists with a forum to exchange knowledge and ideas, and continually
responds to the evolving needs of its Members and Annual Meeting
attendees. ACCP is committed to promoting and expanding the value of
clinical pharmacology in healthcare, as recently highlighted in President
Obama’s Precision Medicine Initiative.
ACCP also remains committed to offering Continuing Medical Education
(CME) and Continuing Pharmacy Education (CPE) credits for our
educational events, provided to meeting attendees at no additional cost.
All of the educational sessions, social events and networking will be held
at the Westin St Francis, facilitating the ease with which meeting attendees
can participate in events.
We welcome you to an outstanding 2015 ACCP Annual Meeting and look
forward to your feedback!
John Davis, PhD
Program Co-chair
Michael Neely, MD, MSc
Program Co-chair
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Program at a Glance
The 2015 ACCP Annual Meeting is supported in part by an Educational Grant from Pfizer Inc
FRIDAY, SEPTEMBER 25, 2015
ACCP Registration Desk Open
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4:00 – 6:00 pm
Executive Committee Meeting
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6:00 – 9:00 pm
Continental Breakfast
Registration Area, Mezzanine
Bristol, Second Floor
SATURDAY, SEPTEMBER 26, 2015
Board of Regents Meeting
Elizabethan D, Second Floor
Pre-meeting Workshop 1
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7:00 am – 5:30 pm
8:00 am – 1:00 pm
8:00 am – 5:30 pm
Introduction to R for Pharmacokinetic Data Analysis
CHAIR: Michael Neely, MD, MSc
Essex, Second Floor
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1:30 – 5:30 pm
CO-CHAIRS: Tal Burt, MD and Saskia N. de Wildt, MD, PhD
Georgian, Mezzanine
Italian, Mezzanine
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6:30 am – 7:00 pm
7:00 – 8:00 am
Welcome and Opening Remarks by President
7:45 – 8:00 am
Colonial, Mezzanine
Symposium 1
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8:00 am – 12:00 pm
Reviving Old Antibiotics: Applying New PK/PD Strategies
CO-CHAIRS: Hartmut Derendorf, PhD and Ursula Theuretzbacher, PhD
Colonial, Mezzanine
Symposium 2
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8:00 am – 12:00 pm
Applications of Bayesian Adaptive Designs in Early
(Non-oncology) Development Studies
CO-CHAIRS: Patricia Sanwald Ducray, PharmD, PhD and David Guede, MSc
Microdosing in Drug Development: A Range of Clinical Trial
Designs and Applications
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1:30 – 5:30 pm
Return on Investment on the Utilization of Systems
Pharmacology and Pharmacometrics in Drug Development
for Rare Diseases: Challenges and Opportunities
CO-CHAIRS: Nitin Mehrotra, PhD and Jeffrey Barrett, PhD
California East & West, Second Floor
Honors & Awards Committee Meeting
12:00 – 1:30 pm
Sussex, Second Floor
2015 – 2016 Program Committee Meeting
Olympic, Second Floor
Public Policy Committee Meeting
Mayfair, Second Floor
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12:00 – 1:30 pm
12:00 – 1:30 pm
Elizabethan D, Second Floor
Symposium 3
Student Panel Discussion and Career Guidance
2:00 – 3:30 pm
CO-CHAIRS: Marc H. Scheetz, PharmD, MSc, BCPS AQ-ID and Thomas
Lodise, PharmD, PhD
Finance Committee Meeting
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Student Podium Presentations
Student Networking Reception
3:00 – 5:00 pm
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3:30 – 4:30 pm
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4:30 – 5:30 pm
Regents & Awards Reception (invitation only)
6:00 – 7:00 pm
St Francis Suite Library
Regents & Awards Dinner (invitation only)
7:00 – 9:00 pm
St Francis Suite East Room
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SUNDAY, SEPTEMBER 27, 2015
1:30 – 5:30 pm
Vancomycin: Is There Anything Left to Know?
Colonial, Mezzanine
Symposium 4
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1:30 – 5:30 pm
Innovation in Study Approach: Abuse Liability Evaluation of
New Chemical Entities
CHAIR: Lorraine Rusch, PhD
Opening Reception, Poster Session 1 & Exhibits
5:30 – 7:30 pm
Grand Ballroom & Italian, Mezzanine
Students Meet at ACCP Registration Desk for Poster
Tour
5:45 pm
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Program at a Glance
TUESDAY, SEPTEMBER 29, 2015
MONDAY, SEPTEMBER 28, 2015
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7:00 am – 7:00 pm
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Exhibit Hall Open
7:00 – 10:00 am
Colonial, Mezzanine
Symposium 5
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Colonial, Mezzanine
12:00 – 1:30 pm
1:30 – 5:30 pm
Food Effect Confrontation: Exploring Clinical Significance
CO-CHAIRS: Jing-He Yan, PhD and Jun Yang, PhD
Colonial, Mezzanine
Symposium 8
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1:30 – 5:30 pm
Considerations for the Clinical Pharmacology of Nucleic Acid
Therapeutics
CO-CHAIRS: Zhaoyang (Megan) Li, PhD and Monette M. Cotreau, PhD
Exhibit Hall Open
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8:00 am – 12:00 pm
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8:00 am – 12:00 pm
CO-CHAIRS: Xinning Yang, PhD and Arik Zur, PhD
Lunch & Awards Session
Grand Ballroom, Mezzanine
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12:00 – 1:30 pm
Student & Trainee Abstract Awards
Wayne A. Colburn Memorial Award
New Member Abstract Award
Member-Get-a-Member Award
Bristol-Myers Squibb Mentorship Award
Keynote Presentation: “Drugs That Forestall Aging – Extending
Healthspan” Brian K. Kennedy, PhD, President & CEO, Buck Inst
for Research on Aging
Symposium 11
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1:30 – 5:30 pm
Current and Emerging Therapies for the Treatment for Cancer
Cachexia
Colonial, Mezzanine
Evening Reception and Poster Session 2
Oxford, Second Floor
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7:00 – 8:00 am
CO-CHAIRS: Eric Roeland, MD and Joseph Ma, PharmD
3:00 – 8:00 pm
Editorial Board Dinner (invitation only)
Symposium 9
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Creatinine-Drug Interactions Involving Renal Transporters:
Current Status and Implications for Drug Development
Distinguished Investigator Award
Honorary Fellowship Award
Nathaniel T. Kwit Memorial Distinguished Service Award
McKeen Cattell Memorial Award
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Symposium 10
Symposium 7
Publications Committee Meeting
7:00 – 8:00 am
Colonial, Mezzanine
CHAIR: John Davis, PhD
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CO-CHAIRS: Manish Gupta, PhD and Indrajeet Singh, PhD
8:00 am – 12:00 pm
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7:00 – 10:00 am
Oncology Immunotherapy: The Next Era of Treating Cancer
Novel Approaches to First-in-Human Studies
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8:00 am – 12:00 pm
Lunch & Awards Session
7:00 – 8:00 am
Education Committee Meeting
7:15 – 8:00 am
CO-CHAIRS: Islam R. Younis, PhD and Sam Harirforoosh, PharmD, PhD
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7:00 am – 5:30 pm
An Update on HIV Treatment, Prevention and Drug Development
Symposium 6
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Annual Business Meeting
7:00 – 8:00 am
Exhibit Hall Open
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5:30 – 7:30 pm
7:30 – 9:30 pm
Symposium 12
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1:30 – 5:30 pm
Effect of Disease State on the PK/PD of Drugs and Therapeutic
Proteins: Implications in Drug Development and Clinical Practice
CO-CHAIRS: Manish Gupta, PhD and Arnab Mukherjee, PhD
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Keynote Speaker
Tuesday, September 29, 2015 | 1:00 – 1:30 pm | Grand Ballroom, Mezzanine
Brian K. Kennedy, PhD
President & CEO, Buck Inst for Research on Aging
Presentation Title:
Drugs That Forestall Aging – Extending Healthspan
Dr. Brian Kennedy is President & CEO of the Buck Inst for Research on Aging. He is
internationally recognized for his research in the basic biology of aging and as a visionary
committed to translating research discoveries into new ways of delaying, detecting,
preventing and treating age-related conditions. Dr. Kennedy leads a team of 23 Principal
Investigators at the Buck Inst for Research on Aging – all of whom are involved in
interdisciplinary research aimed at extending healthspan, the healthy years of life.
His own research has led to the discovery of Sirtuins and the mTOR pathway as key
regulators of aging, with current studies seeking to move discoveries from simple organisms
into mammalian animal models as quickly as possible in order to develop new approaches to
alleviate age-associated diseases in humans.
The inventor on several patents, Dr. Kennedy is co-founder of two US companies aimed
at developing treatments for age-related chronic disease. He is actively involved in aging
research in the Pacific Rim, which features the largest elderly population in the world. He is
a visiting professor at the Aging Research Inst at Guangdong Medical Coll in China. In the
past year he lectured in Korea, Russia, China, Chile, Austria, Italy and the United Kingdom.
In conjunction with the Univ of Southern California, he also launched the nation’s first PhD
program in the Biology of Aging.
Dr. Kennedy has published more than 100 manuscripts in prestigious journals, including
Science and Nature, and has been quoted in The Wall Street Journal, The New York Times
and The Boston Globe, among others. He is Co-Editor-in-Chief of Aging Cell and serves as
a consultant for biotech and pharmaceutical companies.
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2015 ACCP Recognition
Award Winners
Distinguished Investigator Award
Monday, September 28, 2015 | 12:00 – 1:30 pm | Grand Ballroom, Mezzanine
Presentation Title:
Precision Medicine: Progress and Problems
Joseph R. Bertino, MD – American Cancer Society Professor, Chief Scientific
Officer, Rutgers Cancer Inst of New Jersey, Univ Professor of Medicine &
Pharmacology, Rutgers – Robert Wood Johnson Medical School, Rutgers, The
State Univ of New Jersey
The Distinguished Investigator Award is given annually and is intended to recognize superior
scientific expertise and accomplishments by a senior investigator, usually involving a distinct area
of research in basic or clinical pharmacology, for which the individual is internationally known. The
candidate need not be a Member or Fellow of the College.
Dr. Bertino’s seminal work in the area of drug resistance in cancer, his paradigm-shifting studies
that led to the use of methotrexate in cancer therapy and his lifelong contributions to the field of
clinical pharmacology and oncology make him a worthy candidate of the 2015 ACCP Distinguished
Investigator Award.
Honorary Fellowship Award
Presentation Title:
Integrated Drug-Disease Modeling Approach for Optimizing Drug
Development
Roberto Gomeni, PhD, HDR – President of Pharmacometrica & Adjunct Professor,
Pharmacotherapy and Experimental Therapeutics, Univ of North Carolina at Chapel
Hill, Eshelman School of Pharmacy
The Honorary Fellowship Award is given annually to a Non-member of the College and is meant
to recognize primary activities within the immediate domain of clinical pharmacology. The award
recognizes overall contributions to the field, rather than any particular scientific work, by a senior
investigator or authority having a national or international reputation in the scientific, public service,
legislative, governmental or other area of endeavor impacting the field.
Dr. Gomeni’s influence on population PK/PD analysis and mathematical modeling in drug
discovery and preclinical and clinical pharmacology is internationally recognized, making him a
fitting candidate for the 2015 ACCP Honorary Fellowship Award.
Vera Donnenberg, PhD • Claude Abdallah, MD, MSc Pharm • April Barbour, PhD
Steven Crosby, BS • Navin Goyal, PhD • Howard Greenberg, MD, MSE, MBA
Honors &
Abstract
Manoj Jadhav, PhD • Jatinder Mukker, PhD • Eric Olson, PhD
Awards
Reviewers
Committee
Laurent Vernillet, PharmD, PhD • Peter Wiernik, MD
2015
2015
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Award Winners
Nathaniel T. Kwit Memorial Distinguished Service Award
Presentation Title:
Clinical Pharmacology Now: A Time of Feast and Famine
Lisa L. von Moltke, MD, FCP – Vice President, Clinical Pharmacology &
Translational Medicine, Alkermes Inc
The Nathaniel T. Kwit Memorial Distinguished Service Award is given in memory of the late
Nathaniel T. Kwit, MD, FCP, a founding Fellow of the College, who served as a Regent for 5 years
and as Treasurer for 20 years. The primary intent of this award is to recognize accomplishments
of a general nature which benefit the field of clinical pharmacology. These may be in the area
of teaching, administration, service with ACCP or long-term and wide-ranging scientific studies
having practical importance and other service-related functions. It is differentiated from the
Distinguished Investigator Award in that it is not intended to recognize any distinct area of scientific
investigation, but rather an overall contribution to the field. The candidate need not be an ACCP
Member or Fellow.
Dr. von Moltke is receiving this award for her overall contribution to the field of clinical
pharmacology and her exceptional devotion to ACCP.
Bristol-Myers Squibb Mentorship Award
Tuesday, September 29, 2015 | 12:00 – 1:30 pm | Grand Ballroom, Mezzanine
Presentation Title:
Global Gator Pharmacy
Hartmut Derendorf, PhD, FCP – Chairman, Distinguished Professor of
Pharmaceutics, V. Ravi Chandran Professor in Pharmaceutical Sciences,
Univ of Florida
The Bristol-Myers Squibb Mentorship Award is given annually and the awardee should
demonstrate exemplary promotion of clinical pharmacology, with emphasis on training/
guidance of junior scientists and/or colleagues.
Dr. Derendorf is receiving this award for his leadership in the discipline of clinical
pharmacology and also for his extraordinary academic and mentorship accomplishments
working with the current and future generation of clinical pharmacologists.
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Award Winners
McKeen Cattell Memorial Award
Peiying Zuo, PhD – Clinical Pharmacokineticist, PAREXEL (previously affiliated
with GlaxoSmithKline)
The McKeen Cattell Memorial Award is made in memory of the late McKeen Cattell, MD, PhD,
FCP, the first editor of The Journal of Clinical Pharmacology and co-founder of the College. This
award is made annually, recognizing an outstanding research paper published in the JCP during
the preceding year. The award is typically presented to the first author of the paper.
Journal Article: “Integration of Modeling and Simulation to Support Changes to Ondansetron
Dosing Following A Randomized, Double-blind, Placebo- and Active-controlled Thorough
QT Study” Authors: Peiying Zuo, PhD, Lynda J. Haberer, PhD, Lei Fang, MSc, Thomas L. Hunt,
MD, PhD, Derry Ridgway, MD and Mark W. Russo, MD, PhD. Published in The Journal of Clinical
Pharmacology Volume 54, Issue 11, pages 1221–1229, November 2014.
Tuesday, September 29, 2015
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12:00 – 1:30 pm
Student & Trainee Abstract Award Winners
Eight Student & Trainee Abstract Awards are given for the best
abstracts submitted by Students & Trainees for presentation at each
year’s Annual Meeting.
Wayne A. Colburn Memorial Award
The Wayne A. Colburn Memorial Award honors the memory of the
late Wayne A. Colburn, former ACCP President, and will be given for
the best paper among the eight Student & Trainee Award Winners, as
judged by the Program Committee during the Poster Sessions at the
Annual Meeting. At the time the award is given, the author will give a
short talk outlining the findings of the study.
New Member Abstract Award
The New Member Abstract Award is given for the best abstract
submitted by a New Member of the College for presentation at the
Annual Meeting. Abstracts submitted by New Members will be judged
during the Poster Sessions. A short talk outlining the summary of the
findings of the study will be presented by the recipient.
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2015 Student & Trainee Abstract Award Winners
Student Award Winners will present their posters at both Poster Sessions.
• Jonathan Constance (Poster #074) Univ of Utah, Salt Lake City, UT
• Jiexin Deng (Poster #009) Univ of Florida Coll of Pharmacy,
Orlando, FL
• Cheng-Hui Hsiao (Poster #034) Texas Southern Univ/Univ of
Houston, Houston, TX
• Jatinder K. Mukker (Poster #020) Univ of Florida, Gainesville, FL
• Snehal Samant (Poster #023) Univ of Florida, Orlando, FL
• Mohamed H. Solayman (Poster #104) Univ of Florida Coll of
Pharmacy, Gainesville, FL
• Christian Wagner (Poster #024) Merck & Co Inc, Darmstadt,
Germany, formerly US Food & Drug Administration, Silver Spring, MD
• Lei Wu (Poster #045) Univ of Houston, Houston, TX
• Daping Zhang (Poster #083) Univ of Houston, Houston, TX
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Educational Accreditation
Accreditation Statements
The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a
provider of continuing pharmacy education.
The ACPE universal program numbers assigned and hours of credit are noted within each segment of the program for a maximum
of 24.5 Contact Hours. All CPE activities are application-based.
The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education
(ACCME) to provide continuing medical education for physicians.
Designation Statement
The American College of Clinical Pharmacology designates this live educational activity for a maximum of 24.5 AMA PRA Category 1 Credits™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Symposium 1: Reviving Old Antibiotics: Applying New PK/PD Strategies has been planned and implemented in accordance with the accreditation
requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American College
of Clinical Pharmacology and the International Society of Anti-Infective Pharmacology (ISAP). The American College of Clinical Pharmacology
is accredited by the ACCME to provide continuing medical education for physicians.
Continuing Education Process for 2015
What is CPE Monitor?
Attendees interested in earning continuing education credit should have
specifically requested that when they registered for the 2015 Annual
Meeting. Attendees who indicated they want to obtain continuing education
credit will be provided with access to post-event tests related to the
courses they attend. Completion of the post-event tests is required to earn
the credit and to print continuing education credit certificates. Post-event
tests require a 75% passing score.
CPE Monitor is a national, collaborative effort by
ACPE and the National Association of Boards
of Pharmacy (NABP) to provide an electronic
system for pharmacists/pharmacy technicians
to track their completed Continuing Pharmacy
Education (CPE) credits. It also offers state boards
of pharmacy the opportunity to electronically authenticate the CPE units
completed by their licensees, rather than requiring pharmacists/pharmacy
technicians to submit proof of completion statements upon request or for
random audits.
Attendees seeking CPE credit should, if they have not already done so,
provide ACCP with their NABP Profile Number and the month and date
of their birthday via email at CE@ACCP1.org. The profile number and
birthday information is used when ACCP sends CPE credit information
to the National Association of Boards of Pharmacy (NABP) using CPE
Monitor. Pharmacists/pharmacy technicians are asked to obtain their
NABP e-Profile ID by contacting the National Association of Boards
of Pharmacy or by contacting NABP Customer Service at 847-391-4406.
Please note: If pharmacists/pharmacy technicians fail to set up their
NABP e-Profile Identification Number, ACCP will not be able to provide
the ACPE/NABP with the information which will allow pharmacists/
pharmacy technicians to track completed continuing pharmacy education
credit(s). ACCP cannot be responsible for individuals who have not taken
the necessary steps to obtain their NABP e-Profile Identification Number
and who have not provided this to ACCP prior to CPE post-event testing.
For more information, or for answers to Frequently Asked Questions
regarding CPE Monitor, please visit Accreditation Council for Pharmacy
Education.
12
Educational Activities
Spend an hour each month with ACCP
to stay in the forefront of your field!
Over the next year, ACCP will offer 12 new Journal CE activities based on articles in The Journal of Clinical Pharmacology,
four Fundamentals Tutorials (live and on demand) and four ACCP Virtual Journal Club webinars (live and on demand).
Recorded events from the 2015 Annual Meeting will be available later this year. These activities are each planned to offer CME
and CPE credit.
October CE activities include:
• October 6, 2015 JCP Journal CE article on “Antiretroviral
Therapy-induced Toxicity Is Associated With Increased mRNA
Expression of Telomerase”
• October 13, 2015 Fundamentals Tutorial “Regulatory Affairs”
webinar with Laurie Strawn, Senior Director, Oncology Regulatory,
Pfizer Inc. Obtaining regulatory approval on an investigational
drug is an immense task. Expertise in global regulatory approvals
is invaluable in the pharmaceutical/biotech industry. The purpose
of this webinar is to highlight regulatory initiatives and
requirements on a global basis.
Additional Fundamentals Tutorials are scheduled for February,
April and July 2016. The tutorials will cover:
• Model-based Drug Development: Including Population PK Modeling 101, Exposure-Response/Dose-Response
Modeling and How Modeling & Simulation Assist/Inform Key Decisions During Drug Development
•Pharmacogenomics
•Pharmacovigilance
ACCP Virtual Journal Club webinars are scheduled for December 2015 and March, June
and September 2016. The ACCP Virtual Journal Club discussions are based on a recent
article in The Journal of Clinical Pharmacology. An author of the article is invited to give a
short presentation, followed by the opportunity for webinar attendees to ask questions.
Watch your email for details on how to register for these events.
Log onto ACCP’s Learning Management System at https://accp1.inreachce.com for a listing of ACCP’s upcoming educational
activities and on demand materials.
In addition to these new activities, 2014 Annual Meeting Recorded Events, “Poster Presentation Skills” and “Utilizing CER/PCOR
on the Effects of Health Care Interventions” are available online.
13
2015 Disclosure
Information
The following Faculty participants have indicated they have a disclosure related to the content of
their presentation.
Karim Azer: employee (salary) – Sanofi Pharmaceuticals
Diane Mould: employee (salary) – Projections Research Inc
Jeffrey Barrett: employee (salary) – Sanofi Pharmaceuticals
Arnab Mukherjee: employee (salary) – Pfizer Inc
Leslie Z. Benet: corporate & scientific advisory boards – Hurel Corp,
Impax Laboratories Inc, Kinex Pharmaceuticals, Medicines360, Optivia
Biotechnology Inc, Prolynx LLC, Viral Genetics Inc; consultancies, expert
witness & confidentiality agreements – Allergan plc, Apotex, Baxalta Inc,
Boehringer Ingelheim, Forest Laboratories LLC, Genentech Inc, Jazz
Pharmaceuticals plc, Johnson & Johnson, Lifemax Laboratories Inc, Merck
& Co Inc, Novartis Pharma AG, Oriel Therapeutics Inc, Principia Biopharma
Inc, Reiley Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, Vanguard
Therapeutics Inc
Markus Niggli: employee (salary) – F Hoffmann-La Roche
Monette M. Cotreau: former employee (salary/stock) – Alnylam
Pharmaceuticals Inc; employee (salary) – ImmunoGen Inc
John Davis: employee (salary/stock) – Regeneron Pharmaceuticals Inc;
former employee (salary/stock) – Genentech Inc
William S. Denney: employee (salary/stock) – Pfizer Inc
Megan Gibbs: employee (salary/stock) – Amgen Inc
C.J. Godfrey: consulting (fees) – Bristol-Myers Squibb, Alexion
Pharmaceuticals Inc; stock – Vertex Pharmaceuticals
Manish Gupta: employee (salary/stock) – Bristol-Myers Squibb
*Craig Hendrix: honorarium & research grant support – GlaxoSmithKline
*Laura Kovanda: employee (salary) – Astellas Pharma Global
Development Inc
*Joseph Kuti: spouse employed by Boehringer Ingelheim; speaker
– Actavis plc, Pfizer Inc; research funding – Actavis plc, Cubist
Pharmaceuticals, Merck & Co Inc, The Medicines Co, Theravance
Biopharma US Inc; advisory board – Theravance Biopharma US Inc
* Eve-Irene Lepist: employee (salary) – Gilead Sciences; contract studies
– Optivia Biotechnology Inc, Solvo Biotechnology
Lawrence J. Lesko: consulting (fees) – Alexion Pharmaceuticals Inc,
Biogen
Zhaoyang (Megan) Li: employee (salary) – Genzyme, a Sanofi Co
*Thomas Lodise: consulting (honorarium) – Cubist Pharmaceuticals,
Actavis plc, Theravance Biopharma US Inc, The Medicines Co; grants
& other support – Achaogen Inc, Paratek Pharmaceuticals Inc, Forest
Laboratories LLC, Pfizer Inc, Merck & Co Inc
Bernd Meibohm: consulting (fees) – AstraZeneca, Biogen, Merck & Co Inc,
Novartis Inst for Biomedical Research
Xiaopeng Miao: employee (salary) – Biogen
14
*Kavitha Ramchandran: advisory board – Clovis Oncology, GTX Inc
Mark Ratain: consulting (fees) – Genentech Inc
Sue Richards: employee (salary/stock) – Sanofi Global R&D
*Eric Roeland: consulting (fees) – Teva Pharmaceuticals, Eisai Co Ltd,
Eli Lilly and Co; honorarium – Eisai Co Ltd
*Jon L. Ruckle: employee Pacific Pharma Group LLC, consulting (fees) –
DART NeuroScience LLC, Cardax, Arena Pharmaceuticals, KemPharm Inc
Lorraine Rusch: spouse is employed by Acorda Therapeutics; spouse has
stock in Cara Therapeutics
*Michael J. Rybak: research support & honoraria – Actavis plc, Forest
Laboratories LLC, The Medicines Co, Cubist Pharmaceuticals; honorarium
– Sunovian Pharmaceuticals Inc
Patricia Sanwald Ducray: employee (salary/stock) – F Hoffmann-La Roche
*Marc H. Scheetz: research grant – Cubist Pharmaceuticals
Megan J. Shram: employee (salary) – Altreos Research Partners Inc
Wen Chyi Shyu: employee (salary) – Takeda Pharmaceuticals USA Inc
Indrajeet Singh: former employee (salary) – Amgen Inc; employee (salary)
– Janssen Pharmaceuticals Inc
Jingli Song: employee (salary/stock) – Bristol-Myers Squibb
*Yuichi Sugiyama: lab receives support from Astellas Pharma US Inc,
Eisai Co Ltd, Kyorin Pharmaceutical Co Ltd, Kowa Co Ltd, JCL Bioassay
Corp, GenoMembrane Co Ltd, Shimadzu Corp, Taisho Pharmaceutical
Co Ltd, Mitsubishi Tanabe Pharma Corp, Chugai Pharmaceutical Co Ltd,
Teikoku Seiyaku Co Ltd, Fujitsu Kyushu Systems Ltd, Fujifilm Holding Corp,
Meiji Seika Pharma Co Ltd, Daichi Sankyo Co Ltd
*Vijay V. Upreti: employee (salary) – Amgen Inc
Le Thuy Vuong: honorarium – BioCore Co Ltd
Colin Walsh: employee (salary/ownership interest) – Precision
NanoSystems Inc; employee (salary) – NanoDimension
Jing-He Yan: employee (salary/stock) – Novartis Inst for Biomedical
Research
*Arik Zur: scholarship – Pfizer Inc
continued on next page
Letter of2015
Invitation
Disclosure
from
President & Program
Information
Co-chairs
The following Faculty have indicated they have
no disclosures related to their presentation:
The following activity planners have indicated
they have disclosures:
Vikram Arya*
Jonathan P. Moorman*
Vickie Baracos*
Michael Neely*
Lawrence Cohen: consulting (fees) – PharMerica Corp, Otsuka America
Pharmaceutical Inc
Jay Bartroff
Robert J. Noveck*
Melanie Blank*
Amit P. Pai*
Tal Burt*
Lakshmi Putcha*
Saskia N. de Wildt*
Judith Quinlan
Hartmut Derendorf*
Beatriz Rocha
Neville Ford
Alex Sparreboom*
Anne Paccaly: former employee (salary) – Amgen Inc; employee (salary) –
Regeneron Pharmaceuticals Inc
Jeanne Fourie Zirkelbach
Randall Stoltz
Laurent Vernillet: employee (salary) – Boehringer Ingelheim
David Guede
Kimberly Struble*
Honghui Zhou: employee (salary/stock) – Johnson & Johnson
Sam Harirforoosh*
Vincent Tam*
Christy S. John*
Ursula Theuretzbacher*
Bharat Joshi
Wouter H.J. Vaes*
The following planners have indicated they have
no disclosures:
Mary Jeanne Kallman
Jian Wang
Francis Achike
Senthil Rajasekaran
Manoj Khurana
Jun Yang
Steven Crosby
Natella Rakhmanina
Joseph Ma*
Xinning Yang*
Brian Decker
Arun Ram
Islam R. Younis*
Vineet Goti
Michael Reed
Nitin Mehrotra
Elisha Injeti
Sreedharan Sabarinath
*This disclosure list includes all 2015 Annual Meeting Faculty. Continuing
education credit is offered for seven of the 16 available Workshops and
Symposia. The Faculty participating in Workshops and Symposia offering
CE credit are noted with an asterisk.
Otito Iwuchukwu
Catherine Sherwin
Karthika Natarajan
Jian Wang
Conan MacDougall*
Daniel Gonzalez: consulting (fees) – Applied Research Associates Inc,
Jacobus Pharmaceutical Co Inc
David Kisor: royalty – Jones and Bartlett Learning
Walter K. Kraft: research support to university employer – Merck & Co Inc,
Bristol-Myers Squibb
15
Pre-meeting Workshops
l Pre-meeting Workshop 1 l 8:00 am – 5:30 pm
Introduction to R for Pharmacokinetic
Data Analysis
ESSEX, SECOND FLOOR
Offers both CME and CPE Credit
UAN #: 0238-0000-15-006-L01-P
ACPE – 7.0 CONTACT HOURS/APPLICATION-BASED
CHAIR:
Michael Neely, MD, MSc, Associate Professor of Pediatrics, Univ of
Southern California
Participants need to bring their laptops, and they need to have R and
RStudio installed. Windows and Mac laptops will be supported.
PLEASE NOTE THAT NO ONSITE TECHNICAL SUPPORT WILL BE AVAILABLE.
TARGET AUDIENCE:
This Workshop will be useful for researchers in any branch of clinical
pharmacology, both young and experienced, who are interested in learning
how to analyze and plot data with R.
BACKGROUND REQUIREMENTS:
A knowledge of R is not required, but comfort with computers and general
basic programming concepts will be helpful.
GOALS AND OBJECTIVES:
The goal of this course is to introduce R, the statistical programming
language and environment, and to discuss how it can be used for
pharmacometric data analysis and plots. Following completion of this
course, the participant will be able to:
1. Create data objects in R, using pharmacokinetic data as an example
framework;
2. Manipulate data in R;
3. Generate plots of pharmacokinetic data in R;
4. Compare some pharmacokinetic resources available in R.
8:00 – 8:30 am
10:00 – 11:00 am
Subsetting R Data
Michael Neely, MD, MSc, Associate Professor of Pediatrics, Univ
of Southern California and Laura Kovanda, BA, Director, Global
Development Project Leader, Infectious Diseases, Astellas
Pharma Global Development Inc
11:00 am – 12:00 pm
Making and Using R Functions
12:00 – 1:30 pm / Break
1:30 – 2:00 pm
Making and Using R Functions (cont)
2:00 – 3:00 pm
Read/Write External Files
3:00 – 3:30 pm / Break
Introduction to RStudio, R Scripts and the
Console
3:30 – 5:00 pm
8:30 – 9:30 am
5:00 – 5:30 pm
Development Project Leader, Infectious Diseases, Astellas Pharma
Global Development Inc
R Data Objects
16
9:30 – 10:00 am / Break
Development Project Leader, Infectious Diseases, Astellas Pharma
Global Development Inc
Plots in R
Pharmacology Resources in R
l Pre-meeting Workshop 3 l 1:30 – 5:30 pm
Microdosing in Drug Development:
A Range of Clinical Trial Designs
and Applications
GEORGIAN, MEZZANINE
UAN #: 0238-0000-15-007-L01-P
2:20 – 2:40 pm
Microdosing Trials in Vulnerable Populations
and Extreme Environments
Saskia N. de Wildt, MD, PhD, Pediatric Intensivist-Clinical
Pharmacologist, Erasmus MC Sophia Children’s Hosp and
Lakshmi Putcha, PhD, Chief Pharmacologist/Technical Manager,
NASA Johnson Space Ctr
2:40 – 3:00 pm
CO-CHAIRS:
Intra-arterial Microdosing: A Novel Drug
Development Approach
Tal Burt, MD, Assistant Professor, Dept of Psychiatry and Behavioral
Sciences, Duke Univ School of Medicine
Saskia N. de Wildt, MD, PhD, Pediatric Intensivist-Clinical Pharmacologist,
Erasmus MC Sophia Children’s Hosp
Tal Burt, MD, Assistant Professor, Dept of Psychiatry and
Behavioral Sciences, Duke Univ School of Medicine
3:00 – 3:30 pm / Break
TARGET AUDIENCE:
3:30 – 4:00 pm
The target audience for this Workshop is drug developers in both academia
and industry, clinical pharmacologists, pharmacists, regulators, educators,
statisticians and analytics experts interested in microdosing.
None
Cassette Microdosing Design to Identify
Optimal Pharmacokinetic Properties
Yuichi Sugiyama, PhD, Head of Sugiyama Laboratory, RIKEN
Innovation Ctr
4:00 – 4:20 pm
Following completion of this course, the participant will be able to:
1. Identify recent challenges in translational drug development and
recognize the role and promise of microdosing in accelerating drug
development;
2. Employ microdosing principles in the design and conduct of First-in Human clinical trials;
3. Match drug development needs with recent microdosing innovations:
intra-arterial microdosing, cassette microdosing, cocktail microdosing
and PET-microdosing;
4. Apply microdosing methodology to the development of drugs for
vulnerable populations and conditions (pediatric patients, pregnant
women, hepatically/renally-impaired, frail elderly, co-morbidities,
polypharmacy, extreme environments) with a special focus on pediatric
drug development.
1:30 – 1:50 pm
Microdosing: The Regulatory Perspective
Christy S. John, PhD, Senior Clinical Pharmacology Reviewer,
Office of Clinical Pharmacology, US Food & Drug Administration
1:50 – 2:20 pm
Pharmaceutical Industry Clinical
Pharmacology Perspective on Microdosing
Vijay V. Upreti, PhD, Principal Scientist, Clinical Pharmacology,
Modeling & Simulation, Amgen Inc and Le Thuy Vuong, MBA, PhD,
Senior Clinical Advisor, BioCore Co Ltd
Microdosing Study Designs
Jon L. Ruckle, MD, CPI, Principal, Pacific Pharma Group LLC
4:20 – 4:40 pm
Microdose/Phase-1 Combination Using
Adaptive Design
Wouter H.J. Vaes, PhD, Senior Scientist, Netherlands
Organisation for Applied Scientific Research
4:40 – 5:00 pm
Design Your Own Microdosing Study: Choose
from Five Scenarios
Robert J. Noveck, MD, PhD, Associate Professor of Medicine/
Medical Director, Duke Univ School of Medicine/Duke Clinical
Research Unit and Le Thuy Vuong, MBA, PhD, Senior Clinical
Advisor, BioCore Co Ltd
5:00 – 5:30 pm
Panel Discussion and Q&A: Addressing
the Challenges to Realize the Potential of
Microdosing in Drug Development
Saskia N. de Wildt, MD, PhD, Pediatric Intensivist-Clinical
Pharmacologist, Erasmus MC Sophia Children’s Hosp and
Lakshmi Putcha, PhD, Chief Pharmacologist/Technical Manager,
NASA Johnson Space Ctr
17
l Pre-meeting Workshop 4 l 1:30 – 5:30 pm
Return on Investment on the
Utilization of Systems Pharmacology
and Pharmacometrics in Drug
Development for Rare Diseases:
Challenges and Opportunities
ELIZABETHAN D, SECOND FLOOR
CO-CHAIRS:
Nitin Mehrotra, PhD, Team Leader, Office of Clinical Pharmacology, US
Food & Drug Administration
Jeffrey Barrett, PhD, Vice President, Interdisciplinary Pharmacometrics,
Sanofi Pharmaceuticals
TARGET AUDIENCE:
This Workshop will be useful for clinical pharmacologists from both the
pharmaceutical industry and regulatory agencies, pharmacometricians,
clinical researchers and drug development scientists who have an interest
in applying and/or currently apply principles of systems pharmacology and
pharmacometrics to innovate and accelerate drug development in the area
of rare diseases.
None
1:40 – 2:20 pm
Clinical Pharmacology Evidence Supporting
the Approval and Labeling of Orphan Drugs
for Rare Diseases
Lawrence J. Lesko, PhD, Clinical Professor and Director, Ctr for
Pharmacometrics and Systems Pharmacology, Univ of Florida
Coll of Pharmacy
2:20 – 3:00 pm
Modeling & Simulation: Filling the
Knowledge Gap in Ultra-rare Diseases
C.J. Godfrey, PhD, Principal Scientist II, Director, MetroBoston,
Metrum Research Group LLC
3:00 – 3:30 pm / Break
3:30 – 4:10 pm
Enabling Drug Development for Rare
Diseases Through Systems Pharmacology
Approaches
Karim Azer, PhD, Senior Director and US Head, Systems
Pharmacology, Sanofi Pharmaceuticals
4:10 – 4:50 pm
1. Understand the challenges and opportunities in drug development for
rare diseases from a clinical and clinical pharmacology perspective;
2. Analyze and understand the value of pharmacometrics and systems
pharmacology in drug development for rare diseases;
3. Describe real case studies where pharmacometrics and systems
pharmacology approaches played a significant role in drug
development or regulatory decisions.
Application of Pharmacometrics and
Systems Pharmacology in Drug Development
and Regulatory Decisions for Drugs to Treat
Rare Diseases: Are We Doing Enough?
A Regulatory Perspective
Manoj Khurana, PhD, Acting Team Leader, Office of Clinical
Pharmacology, US Food & Drug Administration
4:50 – 5:30 pm
Panel Discussion
1:30 – 1:40 pm
Introduction
Nitin Mehrotra, PhD, Team Leader, Office of Clinical
Pharmacology, US Food & Drug Administration and Jeffrey
Barrett, PhD, Vice President, Interdisciplinary Pharmacometrics,
Sanofi Pharmaceuticals
18
Symposia
l Symposium 1 l 8:00 am – 12:00 pm
Reviving Old Antibiotics: Applying
New PK/PD Strategies
COLONIAL, MEZZANINE
APPLICATION TRACK
UAN #: 0238-9999-15-008-L01-P
This activity has been planned and implemented in accordance with the
accreditation requirements and policies of the Accreditation Council for
Continuing Medical Education (ACCME) through the joint providership
of the American College of Clinical Pharmacology and the International
Society of Anti-Infective Pharmacology (ISAP). The American College of
Clinical Pharmacology is accredited by the ACCME to provide continuing
medical education for physicians.
This Symposium is supported by an Educational Grant from Merck & Co Inc
CO-CHAIRS:
Hartmut Derendorf, PhD, Chairman, Distinguished Professor of
Pharmaceutics, V. Ravi Chandran Professor in Pharmaceutical Sciences,
Univ of Florida
Ursula Theuretzbacher, PhD, President, International Society of AntiInfective Pharmacology and the European Society of Clinical Microbiology
and Infectious Diseases PK/PD Study Group
TARGET AUDIENCE:
The target audience for this Symposium is clinical pharmacists,
pharmacologists, infectious disease specialists, microbiologists,
regulatory agency representatives and drug developers interested in the
pharmacokinetics/pharmacodynamics (PK/PD) of antibiotics.
None
1. Apply PK/PD principles to clinical practice when choosing dosing
regimens;
2. Summarize strategies to update knowledge of old antibiotics;
3. Analyze critical PK/PD factors to reduce the risk of emergence of
resistance;
4. Describe the relevance of infection site pharmacokinetics.
8:00 – 8:10 am
Introduction
Pharmaceutics, V. Ravi Chandran Professor in Pharmaceutical
Sciences, Univ of Florida
8:10 – 8:50 am
How Do You “Re-develop” an Old Antibiotic?
Experience from the Publicly-funded
Multinational Project AIDA
Ursula Theuretzbacher, PhD, President, International Society of
Anti-Infective Pharmacology and the European Society of Clinical
Microbiology and Infectious Diseases PK/PD Study Group
8:50 – 9:30 am
Optimization and Individualization of
Antibacterial Drug Dosages
Joseph Kuti, PharmD, Associate Director of Clinical and Economic
Studies, Ctr for Anti-Infective Research and Development,
Hartford Hosp
9:30 – 10:00 am / Break
10:00 – 10:40 am
Considering Target Site Concentrations When
Choosing a Dosing Regimen
Pharmaceutics, V. Ravi Chandran Professor in Pharmaceutical
Sciences, Univ of Florida
10:40 – 11:20 am
Dosing Strategies to Reduce the Risk of
Emergence of Resistance
Vincent Tam, PharmD, Professor, Univ of Houston Coll of
Pharmacy
11:20 am – 12:00 pm
Panel Discussion
19
Symposia
Applications of Bayesian Adaptive
Designs in Early (Non-oncology)
Development Studies
CALIFORNIA EAST & WEST, SECOND FLOOR
8:50 – 9:30 am
Bayesian Adaptive Designs: Phase 1 Case
Studies
Markus Niggli, PhD, Senior Statistical Scientist, F Hoffmann-La
Roche
DISCOVERY TRACK
CO-CHAIRS:
Patricia Sanwald Ducray, PharmD, PhD, Senior Principal Clinical
Pharmacologist, F Hoffmann-La Roche
David Guede, MSc, Expert Biostatistician, Laboratoire de Statistique
Théorique et Appliquée, Univ Pierre et Marie Curie, Paris VI and ClinBay
TARGET AUDIENCE:
This Symposium will be useful for clinical pharmacologists, translational
medicine leaders, medical monitors, biostatisticians, principal investigators
and subinvestigators, clinical research associates and coordinators working
in industry, regulatory agencies or academia who have an interest in trial
design innovation and its application to early development.
General knowledge of drug development would be useful.
The goal of this course is to introduce and discuss how Bayesian statistics
and adaptive designs can be applied and impact early drug development.
1. Describe the basic principles of Bayesian methods;
2. Discuss the opportunities, benefits and challenges of applying Bayesian
Adaptive Designs in early (non-oncology) development phases;
3. Apply/implement the approach/methodology prospectively in
development programs/protocols.
8:00 – 8:10 am
Introduction
Patricia Sanwald Ducray, PharmD, PhD, Senior Principal Clinical
Pharmacologist, F Hoffmann-La Roche
8:10 – 8:50 am
Basic Principles of Bayesian Methods and
Their Benefits in Phase 1
David Guede, MSc, Expert Biostatistician, Laboratoire de
Statistique Théorique et Appliquée, Univ Pierre et Marie Curie,
Paris VI and ClinBay
20
9:30 – 10:00 am / Break
10:00 – 10:40 am
A Bayesian Adaptive, Utility-based Design of
a Neuropathic Pain Dose-ranging Study
Xiaopeng Miao, PhD, Senior Biostatistician, Biogen
10:40 – 11:20 am
Folk Law, Myths and Perception About
Adaptive Trial Execution
Judith Quinlan, MSc, Senior Vice President, Trial Design &
Implementation, ICON plc
11:20 am – 12:00 pm
Panel Discussion
Symposia
l Symposium 3 l 1:30 – 5:30 pm
Vancomycin: Is There Anything Left
to Know?
COLONIAL, MEZZANINE
APPLICATION TRACK
UAN #: 0238-0000-15-009-L01-P
2:20 – 3:00 pm
Vancomycin PK/PD Toxicity: A Focus on
Nephrotoxicity
Marc H. Scheetz, PharmD, MSc, BCPS AQ-ID, Associate
Professor of Pharmacy Practice, Midwestern Univ Chicago Coll of
Pharmacy
3:00 – 3:30 pm / Break
CO-CHAIRS:
Marc H. Scheetz, PharmD, MSc, BCPS AQ-ID, Associate Professor of
Pharmacy Practice, Midwestern Univ Chicago Coll of Pharmacy
Thomas Lodise, PharmD, PhD, Associate Professor, Dept of Pharmacy
Practice, Albany Coll of Pharmacy and Health Sciences
TARGET AUDIENCE:
The target audience for this Symposium is clinical pharmacists, clinical
physicians, researchers, pharmacometricians and outcomes-based
researchers interested in vancomycin best practices.
None
1. Define patient populations and infections that benefit from vancomycin
therapy and those that require alternative Gram positive antimicrobial
therapy;
2. Identify best practice dosing strategies to maximize efficacy and
minimize toxicity of vancomycin;
3. Describe metrics that allow prediction of clinical efficacy and toxicity with
vancomycin;
4. Distinguish population subgroups requiring alternate vancomycin
dosing schemes.
1:30 – 1:40 pm
Introduction
Marc H. Scheetz, PharmD, MSc, BCPS AQ-ID, Associate Professor
of Pharmacy Practice, Midwestern Univ Chicago Coll of Pharmacy
and Thomas Lodise, PharmD, PhD, Associate Professor, Dept of
Pharmacy Practice, Albany Coll of Pharmacy and Health Sciences
1:40 – 2:20 pm
3:30 – 4:00 pm
Vancomycin Dosing Across the Body Size
Spectrum: Is Weight the Best Body Size
Parameter?
Amit P. Pai, PharmD, Professor, Dept of Pharmacy Practice,
Albany Coll of Pharmacy and Health Sciences
4:00 – 4:25 pm
Vancomycin is Clinically Dead
Michael J. Rybak, PharmD, MPH, Professor, Dept of Pharmacy
Practice, Wayne State Univ
4:25 – 4:50 pm
Vancomycin is Clinically Alive and Well
Conan MacDougall, PharmD, Associate Professor of Clinical
Pharmacy, Univ of California, San Francisco
4:50 – 4:55 pm
Rebuttal
Michael J. Rybak, PharmD, MPH, Professor, Dept of Pharmacy
Practice, Wayne State Univ
4:55 – 5:00 pm
Rebuttal
Conan MacDougall, PharmD, Associate Professor of Clinical
Pharmacy, Univ of California, San Francisco
5:00 – 5:30 pm
Panel Discussion
Vancomycin PK/PD Efficacy
Thomas Lodise, PharmD, PhD, Associate Professor, Dept of
Pharmacy Practice, Albany Coll of Pharmacy and Health Sciences
21
Symposia
Innovation in Study Approach: Abuse
Liability Evaluation of New Chemical
Entities
2:20 – 3:00 pm
Preclinical Assessment of Abuse Potential:
Models and Regulatory Implications
Mary Jeanne Kallman, PhD, CEO, Kallman Preclinical Consulting
LCC
DISCOVERY TRACK
CHAIR:
Lorraine Rusch, PhD, Vice President, Business Development, Vince &
Associates Clinical Research Inc
TARGET AUDIENCE:
The target audience for this Symposium includes regulatory professionals
developing a comprehensive assessment of abuse potential of central
nervous system (CNS)-active new chemical entities (NCEs) to support new
drug application (NDA) filing, clinical pharmacologists involved in the clinical
development of CNS-active drugs and preclinical scientists evaluating the
abuse potential of NCEs.
None
1. Demonstrate how preclinical and clinical data together inform on the
human abuse potential of CNS-active compounds;
2. Identify key principles of the assessment of abuse potential and their
role in supporting schedule recommendations;
3. Evaluate and understand critical components of human abuse liability
(HAL) study designs.
1:30 – 1:40 pm
Introduction
Lorraine Rusch, PhD, Vice President, Business Development,
Vince & Associates Clinical Research Inc
1:40 – 2:20 pm
Strategy for the Assessment of Abuse
Potential of Development Compounds
Beatriz Rocha, MD, PhD, Head, Clinical Global Regulatory
Strategy, Covance Inc
22
3:00 – 3:30 pm / Break
3:30 – 4:10 pm
Understanding the Clinical Assessment
of Abuse Potential During CNS Drug
Development
Megan J. Shram, PhD, Director, Altreos Research Partners Inc
4:10 – 4:50 pm
Recruitment and Medical Management of
Subjects Participating in HAL Clinical Studies
Lorraine Rusch, PhD, Vice President, Business Development,
Vince & Associates Clinical Research Inc
4:50 – 5:30 pm
Panel Discussion
Symposia
An Update on HIV Treatment,
Prevention and Drug Development
COLONIAL, MEZZANINE
APPLICATION TRACK
UAN #: 0238-0000-15-010-L02-P
This Symposium is supported by an Educational Grant from Gilead Sciences
CO-CHAIRS:
Islam R. Younis, PhD, Team Leader, Office of Clinical Pharmacology,
US Food & Drug Administration
Sam Harirforoosh, PharmD, PhD, Associate Professor, Dept of
Pharmaceutical Sciences, Gatton Coll of Pharmacy, East Tennessee
State Univ
TARGET AUDIENCE:
The target audience for this Symposium includes clinical pharmacologists,
scientists, pharmacists and other healthcare professionals with an interest
in HIV clinical management and drug development.
None
8:50 – 9:30 am
Pharmacogenomics of HIV Medications
Sam Harirforoosh, PharmD, PhD, Associate Professor, Dept
of Pharmaceutical Sciences, Gatton Coll of Pharmacy, East
Tennessee State Univ
9:30 – 10:00 am / Break
10:00 – 10:40 am
HIV Prevention and Development of
Microbicides
Craig Hendrix, MD, Professor, Medicine, Pharmacology, Molecular
Sciences and Epidemiology, Johns Hopkins Univ
10:40 – 11:20 am
Regulatory Perspective on Developing HIV
Infection Medications
Kimberly Struble, PharmD, Team Leader, Div of Antiviral Products,
11:20 am – 12:00 pm
Panel Discussion
1. Understand current treatments of HIV infection;
2. Demonstrate the role of genetics in HIV infection treatment;
3. Understand strategies for the prevention of HIV infection;
4. Discuss the regulatory requirements for developing HIV infection
medications.
8:00 – 8:10 am
Introduction
Islam R. Younis, PhD, Team Leader, Office of Clinical
8:10 – 8:50 am
Current Trends in Treatment of HIV Infection
Jonathan P. Moorman, MD, PhD, Div Chief, Infectious Diseases,
Vice Chair for Research and Scholarship, Quillen Coll of
Medicine, East Tennessee State Univ
23
Symposia
Novel Approaches to First-in-Human
Studies
9:00 – 9:30 am
DISCOVERY TRACK
William S. Denney, PhD, Director, Biotherapeutics Clinical
Pharmacology, Pfizer Inc
CHAIR:
John Davis, PhD, Head, Clinical Pharmacology, Regeneron
Pharmaceuticals Inc
TARGET AUDIENCE:
The target audience for this Symposium is drug developers in both
academia and industry, clinical pharmacologists, regulators, educators,
statisticians and other healthcare scientists interested in early-phase clinical
studies.
None
1. Describe a rational approach to the design of early-phase clinical
studies;
2. Identify clinical study design options and settings which favor one option
vs another;
3. Describe the value of safety/toleration data collected in early-phase
studies;
4. Describe the settings which justify the use of placebo controls and/or
blinding.
Big and Little Data to Design and Understand
First-in-Human Studies
9:30 – 10:00 am / Break
10:00 – 10:30 am
When are Randomization and Blinding Useful
in Phase 1 Studies? A Perspective from an
Academic Clinician
Mark Ratain, MD, Director, Ctr for Personalized Therapeutics,
The Univ of Chicago
10:30 – 11:00 am
Inclusion of Placebos and Blinding for
First-in-Human and Other Underpowered
Phase 1 Studies Has Not Been Justified
and, on Balance, is Not Useful
Leslie Z. Benet, PhD, Professor, Dept of Bioengineering and
Therapeutic Sciences, Univ of California, San Francisco
11:00 – 11:30 am
Why Do We Need Novel Approaches to Firstin-Human Studies
Neville Ford, MD, PhD, Principal, Woodfield Clinical Consulting
LLC
8:00 – 8:05 am
Introduction
John Davis, PhD, Head, Clinical Pharmacology, Regeneron
Pharmaceuticals Inc
8:05 – 8:35 am
Novel Dose-escalation Designs for First-inHuman Studies
Jay Bartroff, PhD, Associate Professor, Univ of Southern California
8:35 – 9:00 am
Perspective from the Bedside of Healthy
Subjects
Randall Stoltz, MD, CPI, Medical Director, Covance Inc
24
11:30 am – 12:00 pm
Panel Discussion
Symposia
Food Effect Confrontation: Exploring
Clinical Significance
2:20 – 3:00 pm
APPLICATION TRACK
Jeanne Fourie Zirkelbach, PhD, Senior Reviewer, Office of
Clinical Pharmacology, US Food & Drug Administration
COLONIAL, MEZZANINE
CO-CHAIRS:
Jing-He Yan, PhD, Senior Investigator, Clinical PK/PD, Novartis Inst for
Biomedical Research
Jun Yang, PhD, Senior Reviewer, Office of Clinical Pharmacology, US
TARGET AUDIENCE:
A Regulator’s Insight on Food Effect: Are We
Missing Any Opportunities?
3:00 – 3:30 pm / Break
3:30 – 4:10 pm
Preclinical Prediction and Role of
Formulation: Where is the Focus?
The target audience for this Symposium is specialty physicians, clinical
pharmacologists and clinical research associates interested in food effect.
Wen Chyi Shyu, PhD, Vice President, Head of Global DMPK,
Takeda Pharmaceuticals Intl Co
4:10 – 4:50 pm
None
1. Articulate the overall description of food effect;
2. Describe the regulatory perspectives on food effect;
3. Be familiar with preclinical prediction tools and formulation rules;
4. Apply pharmacokinetic/pharmacodynamic (PK/PD) knowledge to
assess the clinical impact of food effect;
5. Differentiate clinically-relevant and irrelevant food effect.
Clinical Impact on PK/PD: How Relevant
Could It Be?
Mark Ratain, MD, Director, Ctr for Personalized Therapeutics,
The Univ of Chicago
4:50 – 5:30 pm
Panel Discussion
1:30 – 1:40 pm
Introduction
Jing-He Yan, PhD, Senior Investigator, Clinical PK/PD, Novartis
Inst for Biomedical Research and Jun Yang, PhD, Senior Reviewer,
Office of Clinical Pharmacology, US Food & Drug Administration
1:40 – 2:20 pm
What is Food Effect? An Overview
Jing-He Yan, PhD, Senior Investigator, Clinical PK/PD, Novartis Inst
for Biomedical Research
25
Symposia
Considerations for the Clinical
Pharmacology of Nucleic Acid
Therapeutics
DISCOVERY TRACK
CO-CHAIRS:
Zhaoyang (Megan) Li, PhD, Director, Clinical & Exploratory Pharmacology,
Genzyme, a Sanofi Co
Monette M. Cotreau, PhD, Executive Director, Head of Clinical
Pharmacology, ImmunoGen Inc
TARGET AUDIENCE:
The target audience for this Symposium is clinical pharmacologists,
physicians of various specialties, basic scientists, pharmacists, regulatory
scientists and drug developers interested in nucleic acid therapeutics.
None
1. Understand the unique aspects of developing nucleic acid therapies;
2. Demonstrate a general understanding of the ADME properties of nucleic
acid therapies;
3. Compare differences and similarities in the clinical pharmacology
development program for nucleic acid agents vs other types of
therapeutic modalities;
4. Demonstrate a basic knowledge of the mechanism of action of various
types of nucleic acid-based therapies;
5. Encourage collaborative efforts in the biopharmaceutical industry, as
well as in academia, to build the knowledge base.
1:30 – 1:40 pm
Introduction
Zhaoyang (Megan) Li, PhD, Director, Clinical & Exploratory
Pharmacology, Genzyme, a Sanofi Co
1:40 – 2:20 pm
Nucleic Acid Therapeutics: Opportunities and
Challenges of an Emerging Drug Modality
Colin Walsh, PhD, Alliance Manager and Technical Liaison,
Precision NanoSystems Inc
26
2:20 – 3:00 pm
Absorption, Distribution, Metabolism and
Elimination of Nucleic Acid Therapeutics
Monette M. Cotreau, PhD, Executive Director, Head of Clinical
Pharmacology, ImmunoGen Inc
3:00 – 3:30 pm / Break
3:30 – 4:10 pm
Immunogenicity and Safety Implications of
Nucleic Acid Therapeutics
Sue Richards, PhD, Global Deputy, Immunology & Biomarkers,
PSI and Vice President, Clinical Laboratory Sciences, DSAR,
Sanofi Global R&D
4:10 – 4:50 pm
Oligonucleotide-based Drug Development:
Considerations for Clinical Pharmacology
Jian Wang, PhD, Senior Clinical Pharmacologist, US Food & Drug
Administration
4:50 – 5:30 pm
Panel Discussion
Symposia
Oncology Immunotherapy: The Next
Era of Treating Cancer
COLONIAL, MEZZANINE
APPLICATION TRACK
CO-CHAIRS:
Manish Gupta, PhD, Director, Clinical Pharmacology and
Pharmacometrics, Bristol-Myers Squibb
Indrajeet Singh, PhD, Principal Scientist, Biologics Clinical Pharmacology,
Janssen Pharmaceuticals Inc
TARGET AUDIENCE:
The target audience for this Symposium includes clinical pharmacologists,
scientists, modeling and simulation scientists, pharmacists and other
healthcare professionals with an interest in immunotherapy, pharmacology
and pharmacokinetics/pharmacodynamics (PK/PD) to model drug kinetics
and response.
None
1. Describe the unique aspect of clinical pharmacology of combining
immunotherapy agents;
2. Work within the regulatory framework for immunotherapy-based
development and combination therapy;
3. Incorporate novel clinical trial designs and statistical considerations for
studying immunotherapy agents.
8:50 – 9:30 am
Statistical Issues and Challenges for
Development of Immunotherapy Agents in
Oncology
Jingli Song, PhD, Director, Dept of Global Biometric Sciences,
Bristol-Myers Squibb
9:30 – 10:00 am / Break
10:00 – 10:40 am
Clinical Pharmacology of Novel Agents in
Oncology Immunotherapy
Megan Gibbs, BSc Pharm, PhD, Executive Director, Global Head
of Clinical Pharmacology, Modeling & Simulation, Amgen Inc
10:40 – 11:20 am
Regulatory Perspectives for Immunotherapy
in Oncology
Bharat Joshi, PhD, Chemist, Office of Cellular, Tissue and Gene
Therapies, US Food & Drug Administration
11:20 am – 12:00 pm
Panel Discussion
8:00 – 8:10 am
Introduction
Indrajeet Singh, PhD, Principal Scientist, Biologics Clinical
Pharmacology, Janssen Pharmaceuticals Inc
8:10 – 8:50 am
Novel Immunotherapy Agents and Their Role
in Oncology Treatment
27
Symposia
Creatinine-Drug Interactions
Involving Renal Transporters: Current
Status and Implications for Drug
Development
8:10 – 8:50 am
Creatinine-Drug Interactions Involving Renal
Transporters
Alex Sparreboom, PhD, Professor, Div of Pharmaceutics and
Pharmaceutical Chemistry, The Ohio State Univ
DISCOVERY TRACK
UAN #: 0238-0000-15-011-L01-P
This Symposium is supported by an Educational Grant from AbbVie Inc
CO-CHAIRS:
Xinning Yang, PhD, Senior Clinical Pharmacology Reviewer, Office of
Clinical Pharmacology, US Food & Drug Administration
Arik Zur, PhD, Postdoctoral Scholar, Univ of California, San Francisco
TARGET AUDIENCE:
The target audience for this Symposium includes physicians, clinicians
involved in drug development and trial design, clinical pharmacologists and
preclinical scientists, academic research scientists, pharmacists and other
healthcare professionals interested in creatinine-drug interactions involving
renal transporters.
None
1. Describe potential sources of observed serum creatinine increase and
determine the clinical implications of the elevation;
2. Create a framework (in vitro and clinical approaches) for efficient clinical
evaluation of an increase in serum creatinine in the future;
3. Discuss potential alternative renal function biomarkers other than
creatinine to aid in drug development.
8:00 – 8:10 am
Introduction
Xinning Yang, PhD, Senior Clinical Pharmacology Reviewer, Office
of Clinical Pharmacology, US Food & Drug Administration
28
8:50 – 9:30 am
Emerging Role of Renal Transporters in
Creatinine-Drug Interactions: An Industry
Perspective
Eve-Irene Lepist, PhD, Senior Research Scientist, Gilead
Sciences
9:30 – 10:00 am / Break
10:00 – 10:40 am
Regulatory Implications of An Increase
in Serum Creatinine Mediated by Renal
Transporters
Vikram Arya, PhD, Senior Staff Fellow, Office of Clinical
10:40 – 11:20 am
Translational Renal Safety Biomarkers:
Current Status and Future Perspectives
Melanie Blank, MD, Medical Officer, Office of New Drugs, US
11:20 am – 12:00 pm
Panel Discussion
Symposia
Current and Emerging Therapies for
the Treatment for Cancer Cachexia
2:20 – 3:00 pm
APPLICATION TRACK
Joseph Ma, PharmD, Associate Professor, Univ of California, San
Diego
COLONIAL, MEZZANINE
UAN #: 0238-0000-15-012-L01-P
CO-CHAIRS:
Eric Roeland, MD, Assistant Clinical Professor, Univ of California, San
Diego
Joseph Ma, PharmD, Associate Professor, Univ of California, San Diego
TARGET AUDIENCE:
Current Therapies and Investigational Agents
for Cancer Cachexia
3:00 – 3:30 pm / Break
3:30 – 4:10 pm
Analyzing Body Composition in Cancer
Cachexia
Eric Roeland, MD, Assistant Clinical Professor, Univ of California,
San Diego
The target audience for this Symposium is multidisciplinary healthcare
professionals who care for cancer patients, as well as basic and clinical
researchers focused on cancer cachexia.
4:10 – 4:50 pm
Vickie Baracos, PhD, Professor and Alberta Cancer Foundation
Chair in Palliative Medicine, Univ of Alberta
None
1. Describe the limitations of current definitions of cancer cachexia and
propose a clinically-relevant definition;
2. Discuss current pharmacological approaches in the treatment of cancer
cachexia;
3. Apply novel study methods to evaluate cancer cachexia.
Lean Body Mass as a Biomarker of Toxicity
4:50 – 5:30 pm
Panel Discussion
1:30 – 1:40 pm
Introduction
Eric Roeland, MD, Assistant Clinical Professor, Univ of California,
San Diego and Joseph Ma, PharmD, Associate Professor, Univ of
California, San Diego
1:40 – 2:20 pm
Pathophysiology of Cancer Cachexia and
Impact on Quality of Life
Kavitha Ramchandran, MD, Clinical Assistant Professor, Stanford
Univ
29
Symposia
Effect of Disease State on the PK/PD
of Drugs and Therapeutic Proteins:
Implications in Drug Development
and Clinical Practice
1:40 – 2:20 pm
Effect of Disease State on the PK/PD of
Therapeutic Proteins and its Implications on
Clinical Practice
Diane Mould, PhD, President, Projections Research Inc
DISCOVERY TRACK
CO-CHAIRS:
Arnab Mukherjee, PhD, Director, Clinical Pharmacology, Pfizer Inc
TARGET AUDIENCE:
The target audience for this Symposium is clinical pharmacologists,
scientists, modeling and simulation scientists, pharmacists and other
healthcare professionals with an interest in the effect of disease state on
the pharmacokinetics/pharmacodynamics (PK/PD) of drugs and therapeutic
proteins.
None
1. Describe the effect of disease state on the PK/PD of small molecules
and therapeutic proteins;
2. Discuss the implications of the variability in pharmacokinetic exposure
due to disease state and immunogenicity in clinical practice;
3. Implement drug development strategies to manage the variability in
pharmacokinetic (PK) exposure due to disease state and
immunogenicity.
2:20 – 3:00 pm
Confounding Effect of Disease State on the
Pharmacokinetics and Efficacy of Oncology
Drugs
Bernd Meibohm, PhD, Professor of Pharmaceutical Sciences,
Associate Dean for Research and Graduate Programs, Coll of
Pharmacy, The Univ of Tennessee Health Science Ctr
3:00 – 3:30 pm / Break
3:30 – 4:10 pm
The Effect of Disease State on PK and
Efficacy of Small Molecule Therapeutics in
Inflammatory Conditions and Implications in
Drug Development
Arnab Mukherjee, PhD, Director, Clinical Pharmacology, Pfizer Inc
4:10 – 4:50 pm
Drug Development Strategies to Evaluate the
Effect of Disease State on Clinical Outcomes
in Oncology and Immunology Indications
4:50 – 5:30 pm
1:30 – 1:40 pm
Introduction
Pharmacometrics, Bristol-Myers Squibb and Arnab Mukherjee,
PhD, Director, Clinical Pharmacology, Pfizer Inc
30
Panel Discussion
Faculty
Last Name
First Name
Activity
Affiliation
Arya
Vikram
Symposium 10
Azer
Karim
Baracos
Vickie
Barrett
Jeffrey
Bartroff
Jay
Symposium 6
Associate Professor, Univ of Southern California
Benet
Leslie Z.
Symposium 6
Professor, Dept of Bioengineering and Therapeutic Sciences, Univ of California, San
Francisco
Blank
Melanie
Symposium 10
Medical Officer, Office of New Drugs, US Food & Drug Administration
Burt
Tal
Cotreau
Monette M.
Symposium 8
Executive Director, Head of Clinical Pharmacology, ImmunoGen Inc
Davis
John
Symposium 6
Head, Clinical Pharmacology, Regeneron Pharmaceuticals Inc
de Wildt
Saskia N.
Denney
William S.
Symposium 6
Director, Biotherapeutics Clinical Pharmacology, Pfizer Inc
Derendorf
Hartmut
Symposium 1
Chairman, Distinguished Professor of Pharmaceutics, V. Ravi Chandran Professor in
Pharmaceutical Sciences, Univ of Florida
Senior Staff Fellow, Office of Clinical Pharmacology, US Food & Drug Administration
Pre-meeting Workshop 4 Senior Director and US Head, Systems Pharmacology, Sanofi Pharmaceuticals
Symposium 11
Professor and Alberta Cancer Foundation Chair in Palliative Medicine, Univ of Alberta
Pre-meeting Workshop 4 Vice President, Interdisciplinary Pharmacometrics, Sanofi Pharmaceuticals
Assistant Professor, Dept of Psychiatry and Behavioral Sciences, Duke Univ School of
Medicine
Pre-meeting Workshop 3 Pediatric Intensivist-Clinical Pharmacologist, Erasmus MC Sophia Children's Hosp
Ford
Neville
Symposium 6
Principal, Woodfield Clinical Consulting LLC
Fourie
Zirkelbach
Jeanne
Symposium 7
Senior Reviewer, Office of Clinical Pharmacology, US Food & Drug Administration
Gibbs
Megan
Symposium 9
Executive Director, Global Head of Clinical Pharmacology, Modeling & Simulation, Amgen Inc
Godfrey
C.J.
Guede
David
Symposium 2
Gupta
Manish
Symposium 9 &
Symposium 12
Harirforoosh
Sam
Symposium 5
Associate Professor, Dept of Pharmaceutical Sciences, Gatton Coll of Pharmacy, East
Tennessee State Univ
Hendrix
Craig
Symposium 5
Professor, Medicine, Pharmacology, Molecular Sciences and Epidemiology, Johns Hopkins
Univ
John
Christy S.
Senior Clinical Pharmacology Reviewer, Office of Clinical Pharmacology, US Food & Drug
Administration
Joshi
Bharat
Symposium 9
Chemist, Office of Cellular, Tissue and Gene Therapies, US Food & Drug Administration
Kallman
Mary Jeanne
Symposium 4
CEO, Kallman Preclinical Consulting LCC
Pre-meeting Workshop 4 Principal Scientist II, Director, MetroBoston, Metrum Research Group LLC
Expert Biostatistician, Laboratoire de Statistique Théorique et Appliquée, Univ Pierre et
Marie Curie, Paris VI and ClinBay
Director, Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb
31
Table of Contents
Faculty
Last Name
First Name
Khurana
Manoj
Pre-meeting Workshop 4 Acting Team Leader, Office of Clinical Pharmacology, US Food & Drug Administration
Kovanda
Laura
Kuti
Joseph
Symposium 1
Associate Director of Clinical and Economic Studies, Ctr for Anti-Infective Research and
Development, Hartford Hosp
Lepist
Eve-Irene
Symposium 10
Senior Research Scientist, Gilead Sciences
Lesko
Lawrence J.
Li
Zhaoyang
(Megan)
Symposium 8
Director, Clinical & Exploratory Pharmacology, Genzyme, a Sanofi Co
Lodise
Thomas
Symposium 3
Associate Professor, Dept of Pharmacy Practice, Albany Coll of Pharmacy and Health
Sciences
Ma
Joseph
Symposium 11
Associate Professor, Univ of California, San Diego
MacDougall
Conan
Symposium 3
Associate Professor of Clinical Pharmacy, Univ of California, San Francisco Mehrotra
Nitin
Meibohm
Bernd
Symposium 12
Professor of Pharmaceutical Sciences, Associate Dean for Research and Graduate
Programs, Coll of Pharmacy, The Univ of Tennessee Health Science Ctr
Miao
Xiaopeng
Symposium 2
Senior Biostatistician, Biogen
Moorman
Jonathan P.
Symposium 5
Div Chief, Infectious Diseases, Vice Chair for Research and Scholarship, Quillen Coll of
Medicine, East Tennessee State Univ Mould
Diane
Symposium 12
President, Projections Research Inc
Mukherjee
Arnab
Symposium 12
Director, Clinical Pharmacology, Pfizer Inc
Neely
Michael
Niggli
Markus
Symposium 2
Noveck
Robert J.
Associate Professor of Medicine/Medical Director, Duke Univ School of Medicine/Duke
Clinical Research Unit
Pai
Amit P.
Symposium 3
Professor, Dept of Pharmacy Practice, Albany Coll of Pharmacy and Health Sciences
Putcha
Lakshmi
Quinlan
Judith
Ramchandran
32
Activity
Affiliation
Director, Global Development Project Leader, Infectious Diseases, Astellas Pharma Global
Development Inc
Clinical Professor and Director, Ctr for Pharmacometrics and Systems Pharmacology, Univ
of Florida Coll of Pharmacy
Pre-meeting Workshop 4 Team Leader, Office of Clinical Pharmacology, US Food & Drug Administration
Pre-meeting Workshop 1 Associate Professor of Pediatrics, Univ of Southern California
Senior Statistical Scientist, F Hoffmann-La Roche
Pre-meeting Workshop 3 Chief Pharmacologist/Technical Manager, NASA Johnson Space Ctr
Symposium 2
Senior Vice President, Trial Design & Implementation, ICON plc
Kavitha
Symposium 11
Clinical Assistant Professor, Stanford Univ
Ratain
Mark
Symposium 6 &
Symposium 7
Director, Ctr for Personalized Therapeutics, The Univ of Chicago
Richards
Sue
Symposium 8
Global Deputy, Immunology & Biomarkers, PSI and Vice President, Clinical Laboratory
Sciences, DSAR, Sanofi Global R&D
Faculty
Last Name
First Name
Activity
Affiliation
Rocha
Beatriz
Symposium 4
Head, Clinical Global Regulatory Strategy, Covance Inc
Roeland
Eric
Symposium 11
Assistant Clinical Professor, Univ of California, San Diego
Ruckle
Jon L.
Rusch
Lorraine
Symposium 4
Vice President, Business Development, Vince & Associates Clinical Research Inc
Rybak
Michael J.
Symposium 3
Professor, Dept of Pharmacy Practice, Wayne State Univ
Sanwald
Ducray
Patricia
Symposium 2
Senior Principal Clinical Pharmacologist, F Hoffmann-La Roche
Scheetz
Marc H.
Symposium 3
Associate Professor of Pharmacy Practice, Midwestern Univ Chicago Coll of Pharmacy
Shram
Megan J.
Symposium 4
Director, Altreos Research Partners Inc
Shyu
Wen Chyi
Symposium 7
Vice President, Head of Global DMPK, Takeda Pharmaceuticals Intl Co
Singh
Indrajeet
Symposium 9
Principal Scientist, Biologics Clinical Pharmacology, Janssen Pharmaceuticals Inc
Song
Jingli
Symposium 9
Director, Dept of Global Biometric Sciences, Bristol-Myers Squibb
Sparreboom
Alex
Symposium 10
Professor, Div of Pharmaceutics and Pharmaceutical Chemistry, The Ohio State Univ
Stoltz
Randall
Symposium 6
Medical Director, Covance Inc
Struble
Kimberly
Symposium 5
Team Leader, Div of Antiviral Products, US Food & Drug Administration
Sugiyama
Yuichi
Tam
Vincent
Symposium 1
Professor, Univ of Houston Coll of Pharmacy
Theuretzbacher
Ursula
Symposium 1
President, International Society of Anti-infective Pharmacology and the European Society of
Clinical Microbiology and Infectious Diseases PK/PD Study Group
Upreti
Vijay V.
Vaes
Wouter H.J.
Vuong
Le Thuy
Walsh
Colin
Symposium 8
Alliance Manager and Technical Liaison, Precision NanoSystems Inc
Wang
Jian
Symposium 8
Senior Clinical Pharmacologist, US Food & Drug Administration
Yan
Jing-He
Symposium 7
Senior Investigator, Clinical PK/PD, Novartis Inst for Biomedical Research
Yang
Jun
Symposium 7
Senior Reviewer, Office of Clinical Pharmacology, US Food & Drug Administration
Yang
Xinning
Symposium 10
Senior Clinical Pharmacology Reviewer, Office of Clinical Pharmacology, US Food & Drug
Administration
Younis
Islam R.
Symposium 5
Team Leader, Office of Clinical Pharmacology, US Food & Drug Administration
Zur
Arik
Symposium 10
Postdoctoral Scholar, Univ of California, San Francisco
Pre-meeting Workshop 3 Principal, Pacific Pharma Group LLC
Pre-meeting Workshop 3 Head of Sugiyama Laboratory, RIKEN Innovation Ctr
Pre-meeting Workshop 3 Principal Scientist, Clinical Pharmacology, Modeling & Simulation, Amgen Inc
Pre-meeting Workshop 3 Senior Scientist, Netherlands Organisation for Applied Scientific Research
Pre-meeting Workshop 3 Senior Clinical Advisor, BioCore Co Ltd
33
Why Join ACCP?
The American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing
exceptional interprofessional, accredited Continuing Education programs, publications, networking and other career-enhancing
opportunities to a wide spectrum of healthcare professionals using clinical pharmacology in disciplines from research to patient care.
Membership includes MDs, PharmDs, PhDs, post-doctoral candidates, students and others from academia, industry, regulatory and clinical
entities who are seeking to advance their career through the Member Benefits offered by ACCP.
Why Should You Join the American College of
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Your membership in ACCP now gets you more and is your way
to stay at the top of your professional game!
• Confidently achieve a high level of professional performance
by staying on the cutting edge of clinical pharmacology
developments;
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goals and objectives;
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ACCP Member Benefits get you there!
• Free access to the latest scientific research. Members have free online access to ACCP’s high quality publications, The
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Students & Trainees, access to Mentors.
34
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option. Please note that the “Half-year” option is only available the
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BEFORE YOU APPLY FOR MEMBERSHIP, PLEASE NOTE IF ANY
OF THE FOLLOWING APPLIES TO YOU:
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Please contact KLevy@ACCP1.org for existing profile and login
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Students & Trainees
Annual Meeting Events for Students &
Trainees
Student & Trainee membership and participation in ACCP’s
Annual Meeting are strongly encouraged and are beneficial
on several levels:
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Student & Trainee-specific Events
Panel Discussion, Podium Presentations and Student
Networking Reception
On Saturday, September 26th, the following events will be
hosted in the Olympic Room:
• Panel Discussion on Career Guidance (2:00 – 3:30 pm)
– A select group of ACCP Mentors whose careers have
spanned various settings and disciplines within the field of
clinical pharmacology will share their experiences and answer your questions in a relaxed, intimate atmosphere. If you are considering a career that includes any combination of academia, industry, regulatory or clinical roles, don’t miss this opportunity to hear what the experts have to say about how their own career paths progressed and what guidance they can provide to ensure your personal success!
• Podium Presentations (3:30 – 4:30 pm) – Immediately
following the Panel Discussion, a select number of Student
Abstract Award winners will present their research in a
Podium Presentation. Support your colleagues by being part
of this important event.
• Student Networking Reception (4:30 – 5:30 pm) – After
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Schools represented by groups of six or more Students &
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All Student & Trainee attendees were encouraged to provide
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Join, Get Involved and Enjoy the Benefits of
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Visit us at
The Student Outreach Committee, co-chaired by Amelia N.
Deitchman, PharmD and Daniel Gonzalez, PharmD, PhD, is
critical in providing guidance regarding Student & Trainee needs
and ensuring that those needs are consistently met by ACCP.
The committee is comprised of Student Members, Members
and Fellows, and it focuses on student-related activities at the
Annual Meeting and provides guidance on programs, new and
old, required to effectively support Students & Trainees. Have a
great idea? Please share it with us at SOC@ACCP1.org.
Poster Tours
On Sunday, September 27th, 6:00 – 7:00 pm, small groups of
Students & Trainees will be hosted by an ACCP Fellow or senior
Member to tour the poster area and discuss preselected posters
that provide exceptional educational content or presentation.
Meet at the ACCP Registration Desk at 5:45 pm to participate
in this event.
Amelia N. Deitchman, PharmD
Co-chair, SOC
Daniel Gonzalez, PharmD, PhD
Co-chair, SOC
35
Sponsors
ACCP gratefully acknowledges
Sponsors of the 2015 Annual Meeting:
GOLD
LEVEL SPONSOR
BRONZE
36
LEVEL SPONSOR
Exhibitors
ACCP gratefully acknowledges 2015 Exhibitors
BioPharma Services Inc is a leading, full-service Contract Research
Organization specializing in Phase I/IIa, as well as Bioequivalence clinical
trials, in healthy volunteers and patient populations. Founded in 2006,
BioPharma is a physician-owned and physician-run, US FDA, Health Canada,
UK MHRA-inspected CRO, with state-of-the-art clinical facilities in Toronto,
Canada and Columbia, Missouri. BioPharma also offers in-house GLP
preclinical and clinical bioanalytical laboratory services, featuring LC-MS/MS
technology, at its Toronto facility. We proudly offer a one-stop shop solution for
early-stage clinical trials and are dedicated to building and maintaining longlasting relationships with our Global clients by providing superior quality service
and timely and reliable research results.
www.biopharmaservices.com
Certara, the leading biosimulation company, provides technology-enabled
solutions to the global biopharmaceutical industry. We have brought together
the leaders in biosimulation and regulatory writing – Pharsight, Simcyp,
Tripos, Synchrogenix and ClinGenuity – to create an integrated solution to
quantitatively inform drug development.
www.certara.com
Clinical Pharmacology of Miami Inc is a private pharmaceutical research
organization dedicated to the conduct of clinical trials (Phase I-IV) in the
South Florida area. Kenneth C. Lasseter, MD, Stacy C. Dilzer, RN, BSN
and E. Cooper Shamblen are the principals who make up our experienced
management team. We have the experience, expertise and facility to conduct
safe, well-controlled clinical research with new and existing drugs. Our
research facility is state-of-the-art and fully equipped with 120 beds. Our local
subject population includes healthy males and females, Hepatically impaired,
Renal insufficiency, Hypertensive, Geriatric, Diabetic and Obese volunteers.
www.clinpharmmiami.com
37
Exhibitors
Cognigen and Simulations Plus provide modeling & simulation software
and consulting services from discovery through clinical development. Our
GastroPlus™ platform is the leading PBPK modeling solution for prediction
of absorption/DDI/population outcomes in humans and animals. This is
complemented by our KIWI™ platform and our pharmacometric modeling and
simulation services and clinical pharmacology support.
www.cognigencorp.com
Compass Research, a multi-therapeutic clinical research company,
conducts all phases of research and has worked with some of the world’s
largest pharmaceutical companies completing over a thousand clinical trials.
With its experienced board-certified physicians & support staff, Compass is
known for its commitment to advancing medicine for a broad range of health
conditions.
www.CompassResearch.com
GVK Biosciences Pvt Ltd’s Informatics & Analytics division is widely
popular for manual data curation from scientific literature. Our customdeveloped Clinical Trial Outcomes Databases are a gold standard in the
industry for performing MBMA and informed decision making in clinical
development. Apart from database development services, GVK also provides
Pharmacometrics services like popPK, PK-PD and PBPK analysis.
www.gvkbio.com/products-services/informatics-analytics
Inflamax Research Inc is a global, full-service CRO with clinics in Canada
and the US. Inflamax offers both Early-Phase Clinical Pharmacology and
Late-Phase Research Services towards pharma, biotech, generic and medical
device product developments. Inflamax has unique, high-capacity, singlecenter capabilities. Our experience runs the gamut from proof-of-concept
studies to large, multi-center/multi-national trials with a successful track record
of over 800 studies completed.
www.inflamaxresearch.com
38
Exhibitors
The Medpace Clinical Pharmacology Unit (MCPU) is an early-phase
clinical pharmacology unit, conducting studies in normal healthy volunteers,
special populations and patient populations over a spectrum of diseases.
Medpace CPU is owned by Medpace Inc. MCPU features a 96-bed, stateof-the-art facility housed on the Medpace clinical research campus which is
centrally located in Cincinnati, Ohio.
www.medpace.com
NOCCR and VRG are privately-owned, multispecialty clinical research groups
conducting over 2,000 clinical trials in the last 30 years. With combined space
exceeding 24,500 sq ft, full-time MDs, Nurse Practitioners, Nurse/Coordinators,
EMTs, nursing assistants and separate regulatory, data and recruiting
departments, we have earned a reputation for excellence and consistently
exceeding enrollment goals. NOCCR-Knoxville is primarily a Phase I unit with
up to 50 beds. It is particularly well suited for conducting First-in-Human trials
as it is situated within the Univ of Tennessee Medical Ctr, with code team
and 24-hour critical care coverage. This Unit is widely known for its ability to
conduct procedurally difficult trials and to recruit special populations, including
volunteers with renal and hepatic insufficiency, elderly, postmenopausal, heart
failure, hypertension and normal healthy volunteers. VRG and NOCCR New
Orleans are primarily focused on conducting later phase studies in a broad
array of therapeutic areas.
www.noccr.com
PRA Health Sciences’ early-phase professionals live and breathe clinical
pharmacology. As the most comprehensive high-end Phase I CRO in the world,
PRA Early Development Services provides a unique scientific environment
required for complex compound development in both healthy volunteers and
special patient populations. Committed to the highest standards of clinical
excellence and scientific expertise, we operate state-of-the-art facilities in The
Netherlands and North America, as well as an innovative patient pharmacology
model in Central and Eastern Europe. Our fully-harmonized, GLP-compliant
laboratories are located close to our clinical units, enabling us to quickly analyze
time-critical samples.
www.PRAHS.com
39
Exhibitors
Vince & Associates Clinical Research has been providing clinical
research services to the global biopharmaceutical industry for 15 years.
We offer full-service clinical pharmacology expertise to guide and support
development plans when entering into clinical trials, especially complex clinical
pharmacology trials in healthy normal volunteers and patient populations.
www.vinceandassociates.com
Wiley is a global provider of knowledge and knowledge-enabled services that
improve outcomes in areas of research, professional practice and education.
Through the Research segment, the Company provides digital and print
scientific, technical, medical and scholarly journals, reference works, books,
database services and advertising. The Professional Development segment
provides digital and print books, online assessment and training services and
test prep and certification. In Education, Wiley provides education solutions
including online program management services for higher education institutions
and course management tools for instructors and students, as well as print and
digital content.
www.wiley.com
Worldwide Clinical Trials provides full-service drug development services
to the pharmaceutical industry. We can support you in your pre-registration
through peri-approval studies, but also specialize in bioanalytical and earlyphase development. This powerful combination of services ensures that you
are working with a global CRO that can understand and meet the needs of your
entire drug development program
www.wwctrials.com
40
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41
Table
Contents
PosterofSession
1
Sunday, September 27, 2015 / 5:30 – 7:30 pm, Grand Ballroom & Italian, Mezzanine
Drug Interactions
Poster
Title
Type
Authors
001
OATP1B1 Inhibition Potential of Eluxadoline Assessed Through
Rosuvastatin Pharmacokinetics in Healthy Volunteers
J. Michael Davenport, Thomas Hunt, Leonard S. Dove,
Paul Covington
002
A Drug-Drug Interaction Study of Eluxadoline, Norethindrone and Ethinyl
Estradiol
J. Michael Davenport, Bradley Vince, Leonard S. Dove,
Paul Covington
003
NM
Clinical Investigation of the Effect of the Cyclophilin Inhibitor, Alisporivir, on
the Calcium Channel Blocker, Isradipine, in Healthy Subjects
June Ke, Kristina Dabovic, Yi Cheng, Sree Anumolu, Jie
Zhang, Daniel S. Stein, Haiying Sun, Steven J. Kovacs
004
NM
Clinical Investigation of the Effect of the Cyclophilin Inhibitor Alisporivir on
the Non-benzodiazepine Hypnotics Zolpidem and Eszopiclone in Healthy
Subjects
June Ke, Kristina Dabovic, Yi Cheng, Sree Anumolu, Jie
Zhang, Daniel S. Stein, Haiying Sun, Steven J. Kovacs
005
Effect of Alisporivir on the Pharmacokinetics of EDP239 (an HCV-specific
NS5A Inhibitor) in Healthy Adult Subjects – A Mechanistic Population
Pharmacokinetic Approach
Xuemin Jiang, June Ke, Richard Colvin,
Steven J. Kovacs, Venkateswar Jarugula, Haiying Sun
006
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of
Retosiban Coadministered With Efavirenz
Brendt Stier, Stephen Caltabiano, Michael Fossler,
Feng Liu, Stewart W. McCallum
007
Omarigliptin, a Once-weekly Dipeptidyl Peptidase-4 Inhibitor, Has No
Meaningful Drug-Drug Interaction With Metformin, Ethinyl Estradiol/
Levonorgestrel or Atorvastatin
Eunkyung A. Kauh, Nadia Cardillo Marricco,
Marieve Dupuis, Xiaoli Shirley Glasgow, Angela Mirzac,
Henry Davis, Laura George, Mike Di Spirito,
Michael Gartner, Mark J. Allison, Daniel Tatosian
008
Evaluation of the Effects of the Weak CYP3A4 Inhibitors Atorvastatin and
E, NM Ethinyl Estradiol/Norgestimate on Lomitapide Pharmacokinetics in Healthy
Subjects
Gina Patel, Alex King, Santanu Dutta, Sarah Korb,
Janet Wade, Pamela Foulds, Mark Sumeray
009
E, S, Can Drug-Drug Interactions Be Used to Inform Gene-Drug Interactions and
SA Vice Versa? Jiexin Deng, Chakradhar Lagishetty,
Lawrence J. Lesko, Hobart Rogers,
Michael Pacanowski, Stephan Schmidt
011
Pharmacokinetic Interaction of Para-aminosalicylic Acid and Efavirenz in
E, NM HIV-uninfected and HIV-coinfected Tuberculosis Patients Managed for
Multidrug-resistant and Extensively Drug-resistant Tuberculosis
Sherwin K. Sy, Lizanne de Kock, Bernd Rosenkranz,
Andreas Diacon, Kenneth Hernandez, Peter Donald,
Hartmut Derendorf
012
NM
Effects of Lemborexant, a Dual Orexin Receptor Antagonist, on CYP3A and
CYP2B6 Activity in Healthy Volunteers LEGEND:
E = Encore Presentation
NM = New Member (Dues paid August 1, 2014 – July 31, 2015)
P = Podium Presentation
S = Student Abstract
SA = Student Award Winner
Gina Pastino, Nancy Hall, Jagadeesh Aluri, Bhaskar
Rege, Patricia Murphy, Margaret Moline, Jim Ferry
Please visit www.ACCP1.org for updates on the Abstract
Submission process and deadlines for the 2016 Annual Meeting
Francis Achike, MD, PhD, MEd • Gaurav Bajaj, PhD • Ayyappa Chaturvedula, PhD • Lawrence Cohen, PharmD
Steven Crosby, MA, BSP • Brian Decker, MD, PharmD • Vineet Goti, BPharm • Elisha Injeti, PhD
David Kisor, PharmD • Joseph Kitzmiller, MD, PhD • Walter K. Kraft, MD • Karthika Natarajan, BPharm, PhD
Abstract
Anne Paccaly, PharmD, PhD • Natella Rakhmanina, MD, PhD • Arun Ram, MD • Michael Reed, RPh, PharmD
Sreedharan Sabarinath, PhD • Catherine Sherwin, PhD • Laurent Vernillet, PharmD, PhD • Jian Wang, PhD
Reviewers
Honghui Zhou, PhD
2015
42
Letter of Invitation from
President & Program
Co-chairs
Poster Session
1
Applications of Modeling and Simulation
Poster
Type
013
NM
Title
Authors
Lemborexant Does Not Affect QT Interval: High-precision Analysis from
Early Clinical Studies
Gina Pastino, Patricia Murphy, Jim Ferry, Nancy Hall,
Jagadeesh Aluri, Bhaskar Rege, Margaret Moline
014
Modeling of the Time Course of Encenicline Exposure-Response in
Schizophrenia Subjects Receiving Atypical Antipsychotics
H. Steve Kuan, Gordon Loewen, Dana C. Hilt
015
A Model-based Approach for Informing Early Anti-nicotine Vaccine
Development Decisions
Kai H. Liao, Michael J. McCluskie, Heather L. Davis,
Gilbert Wong, Roberto Bugarini, Xu Meng
016
Physiologically-based Pharmacokinetic Modeling to Determine the DrugDrug Interaction Potential for CYP3A Perpetrators During Ibrutinib Therapy
Loeckie de Zwart, Jan Snoeys, Jan de Jong, Juthamas
Sukbuntherng, Eric Mannaert, Mario Monshouwer
017
Utility of a Quantitative Systems Pharmacology Model in Regulatory Decision Manoj Khurana, Immo Zadezensky, Liang Li,
Making: Assessing the Dosage Regimen of Recombinant Human Parathyroid Naomi Lowy, Dragos Roman, Jean Marc Guettier,
Hormone for Hypoparathyroidism
Chandrahas Sahajwalla, Vikram Sinha, Nitin Mehrotra
018
E
Optimal Phase 2 Dose Selection Based on the Relationship Between
Exposure and Target Occupancy
Mona Alameddine, Christophe Boetsch, Ronan Carnac,
Nicolas Frey, Patricia Sanwald Ducray
Systems Model for Ursodeoxycholic Acid Metabolism in Healthy and Primary Peiying Zuo, Robert Dobbins,
Biliary Cirrhosis Patients
Robin O’Connor-Semmes, Malcolm Young
019
Physiologically-based Pharmacokinetic Modeling as a Tool for In Silico
Bioequivalence Predictions: A Case of Telmisartan
Jatinder K. Mukker, Ravi S. Singh, Michaela K. Wimmer,
Rajendra P. Singh, Hartmut Derendorf
021
Population Pharmacokinetics of High-dose Methotrexate in Primary Central
Nervous System Lymphoma Rebecca N. Burns, Sarah Wheeler, Trevor McKibbin
022
Population Pharmacokinetic/Pharmacodynamic Analysis of a Novel
Formulation of Methylphenidate
Timothy Nicholas, Bharat Damle, Kenneth Albert,
Richat Abbas
020
P, S
SA
023
A Physiologically-based Pharmacokinetic/Pharmacodynamic Model for
S, SA Evaluating Clinically-important Drug-Drug Interactions and Genetic
Polymorphisms: A Clopidogrel Case Study 024
S, SA
Predicting the Effect of Intrinsic and Extrinsic Factors on the Exposure of
Antiretroviral Medications
Christian Wagner, Ping Zhao, Vikram Arya,
Charu Mullick, Kimberly Struble, Stanley Au
025
S
Population Pharmacokinetic Modeling for Vancomycin from Routinelycollected Therapeutic Drug Monitoring Data, Including Dialysis Patients
Vineet Goti, Ayyappa Chaturvedula, Michael Fossler,
Steve Mok, Jesse Jacob
026
S
A Semi-mechanistic Model for Predicting the Nasal and Plasma
Pharmacokinetics of Intranasal Corticosteroids
Uta Schilling, Tobias Miesler, Benjamin Weber,
Guenther Hochhaus
027
S
An Open-source, User-friendly Simulation Tool to Predict the
Pharmacokinetics of Inhaled Corticosteroids
Uta Schilling, Tobias Miesler, Benjamin Weber,
Guenther Hochhaus
028
Snehal Samant, Xiling Jiang, Richard B. Horenstein,
Alen R. Shuldiner, Laura M. Yerges-Armstrong,
Lambertus Peletier, Lawrence J. Lesko, Stephan Schmidt
Modeling and Simulation to Support Clinical Development of Eslicarbazepine Soujanya Sunkaraneni, Elizabeth Ludwig,
Acetate in Partial-onset Epilepsy
Julie Passarell, David Blum, Jill Fiedler-Kelly
LEGEND:
43
Table
Contents
PosterofSession
1
Clinical Pharmacokinetics and Pharmacodynamics
Title
Authors
Poster
Type
029
E
Eslicarbazepine Acetate Monotherapy: A Population Pharmacokinetic
Analysis
Bassel Abou-Khalil, Imran Ali, Aashit Shah,
Jill Fiedler-Kelly, Elizabeth Ludwig,
Soujanya Sunkaraneni, David Blum
030
E
Relationship Between Exposure and Efficacy of Eslicarbazepine Acetate
Monotherapy
Joanne Rogin, Andrew Cole, Laura Strom,
Julie Passarell, Jill Fiedler-Kelly, Elizabeth Ludwig,
David Blum, Soujanya Sunkaraneni
031
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of the
Novel, Dual GIP/GLP-1 Agonist (RG7697) After Single, Subcutaneous
Administration in Healthy Subjects
Agnes Portron, Shirin Jadidi, Neena Sarkar, Jonathan
Hauptman, Christophe Schmitt
032
Safety, Pharmacokinetics and Pharmacodynamics of Multiple, Ascending
Christophe Schmitt, Agnes Portron, Shirin Jadidi,
Doses of the Novel, Dual GIP/GLP-1 Agonist RG7697 in Patients with Type 2
Neena Sarkar, Jonathan Hauptman
Diabetes Mellitus
033
NM, S
Characterizing Serotonin Receptor Expression and Density on Platelets in
Healthy Volunteers
Blair Curless, Kathryn Momary
034
S, SA
Fat Percentage as an Important Covariate on Propofol Pharmacokinetics in
the Pediatric Obese Population
Cheng-Hui Hsiao, Olutoyin A. Olutoye, David A. Lazar,
Lei Wu, Dong Liang, Diana Chow
036
Comparison of Atrasentan Pharmacokinetics in Japanese and Western
Subjects
Dipak S. Pisal, Chih Wei Lin, Cheri E. Klein,
Nael Mostafa
038
Oral Pharmacokinetics of Cetirizine in Mexicans: Evidence for Interethnic
Variability
Francisco J. Flores-Murrieta,
Miriam D. Carrasco-Portugal
039
Pharmacokinetics and Bioavailability of a Novel, Highly-specific Oxytocin
Receptor Agonist Håkan Olsson, Rikard Sandström, Vivian Kristoffersson,
Yu Bagger
040
Single-dose, Multiple-dose and Population Pharmacokinetics of SUN13837
Injection, a Basic Fibroblast Growth Factor Mimic in Healthy Subjects
Bharti Shah, Inger Darling, Elizabeth Ludwig,
Hamim Zahir, Kenneth Duchin
041
Further Evidence for Interethnic Differences in the Oral Pharmacokinetics
NM, S of Some Drugs Metabolized by CYP3A4 in Mexican Healthy Volunteers:
Evaluation of the Possible Influence of CYP3A4*1B Polymorphism Juthamas Sukbuntherng, Harisha Atluri, Purvi Jejurkar,
Elizabeth Bilotti, Thorsten Graef, Ravi Vij,
Paul Richardson
042
Pharmacokinetics of Ibrutinib With Concomitant Use of Dexamethasone in
Patients With Multiple Myeloma
043
Global Population Pharmacokinetics of Investigational Aurora A Kinase
Karthik Venkatakrishnan, Xiaofei Zhou,
Inhibitor Alisertib (MLN8237) in Cancer Patients: Rationale for Lower Dosage Takatoshi Takubo, Claudio Dansky Ullmann,
in Asia Diane R. Mould, Ashley Milton
044
Pharmacokinetic and Pharmacodynamic Correlates for Tissue-central
Compartments Using Muscle Biopsy Techniques
LEGEND:
44
José C. Aguilar-Carrasco, Hugo Antonio HernándezPérez, Samuel Canizales-Quinteros, Miriam D.
Carrasco-Portugal, Francisco J. Flores-Murrieta
Kelly Whitehurst, Randall Stoltz,
Rogelio Mosqueda-Garcia
President & Program
Co-chairs
Poster Session
1
Clinical Pharmacokinetics and Pharmacodynamics (cont)
Poster
Title
Type
045
Assessment of Bioequivalence of Intranasal Scopolamine Using Population
S, SA Analysis in Human Subjects Exposed to a Simulated Microgravity
Environment
046
NM, S
Authors
Lei Wu, Lakshmi Putcha, Diana Chow
Evaluation of Omeprazole Limited-sampling Strategy to Estimate
Cytochrome P450 (CYP) 2C19 Activity in Healthy Adults
Lisa H. Lam, Alessandro Allegrini, Muhammad
Hammami, Ju-Seop Kang, Daniele Pavone,
Yoo-Sin Park, Ophelia Q. Yin, Joseph Ma
047
Effect of Food on the Plasma Pharmacokinetics of the Smoothened Inhibitor
Glasdegib (PF-04449913)
Nagdeep Giri, Lisa H. Lam, Robert LaBadie, Yali Liang,
M. Naveed Shaik
048
Schwartz Creatinine Clearance is Not the Best Descriptor of Infant
Gentamicin Elimination
Michael Neely, Ronald Floyd
049
Evaluation of Side Effects of Sertraline in Healthy Volunteers Enrolled in a
Bioequivalence Study
Miriam D. Carrasco-Portugal,
Francisco J. Flores-Murrieta
Comparing the Effect of Tampering on the Oral Pharmacokinetic Profile
of Two Extended-release Oxycodone Formulations With Abuse-deterrent
Properties
Naama Levy-Cooperman, Jeff Gudin,
Ernest A. Kopecky, Alison B. Fleming
Genetics and Drug Response: Study on the Influence of Genetics in
Individual Variations in Response to Ibuprofen Use
Natasha Anand, Bilikis Akindele, Brian Meshkin,
Daniel Schwarz, Tobore Onojighofia, May Hafez
052
Tiotropium Pharmacokinetics in Patients With Asthma – A Pooled Analysis
Ashish Sharma, Benjamin Weber, Peter Stopfer,
Marion Schmid, Barbara Rapp, Jens Borghardt,
Christoph Hallmann, Petra Moroni-Zentgraf
053
Relative Bioavailability of Empagliflozin 25 mg/Linagliptin 5 mg
Fixed-dose Combination Tablet vs the Mono Components, a Second
Fixed-dose Combination Formulation and in Fed vs Fasted Conditions Stephan Glund, Michaela Mattheus, Lois Rowland,
Frank Runge, Christian Friedrich, Peter Rose
Moxifloxacin and Pyrazinamide Dose Optimization for Multidrug-resistant
and Extensively Drug-resistant Tuberculosis
Tobias Heinrichs, Robert May, Russell Kempker,
Judith Johnson, Charles Peloquin, Hartmut Derendorf
Confirmation of the Cardiac Safety of Rupatadine in a Single Ascending
Dose and Multiple Ascending Dose Study in Japanese Healthy Subjects
Using Intensive ECG Assessments Jörg Täubel, Georg Ferber, Iñaki Izquierdo
Pharmacokinetics and Pharmacodynamics of VX-509 (Decernotinib) in
Healthy Subjects
Jiayin Huang, Xia Luo, Matt Harding, Thomas Hoock,
Nils Kinnman, Jinshan Shen
057
The Effect of Food on the Pharmacokinetics of Eluxadoline in Healthy
Volunteers
J. Michael Davenport, Thomas Hunt, Leonard S. Dove,
Paul Covington
058
Eluxadoline Single- and Repeat-dose Pharmacokinetics in Healthy
Volunteers
J. Michael Davenport, Leonard S. Dove, Paul Covington
050
E
051
NM
054
NM, S
055
056
NM
LEGEND:
45
Table
Contents
PosterofSession
2
Monday, September 28, 2015 / 5:30 – 7:30 pm, Grand Ballroom & Italian, Mezzanine
Clinical Pharmacology Education
Poster
Type
059
S
Title
Authors
Using Clinical Trial Simulations to Teach Pharmacy Students About the Drug Kacey Anderson, Hari V. Kalluri,
Development Process
Lawrence R. Kobulinsky, Randall B. Smith
Clinical Trials and Human Pharmacology
Title
Authors
Poster
Type
060
E
Metabolic Tolerability Profile of Brexpiprazole in Acute Schizophrenia
Catherine Weiss, Aleksandar Skuban, Mary Hobart,
Peter Zhang, Emmanuelle Weiller
061
E
The Metabolic Tolerability Profile of Adjunct Brexpiprazole in Major
Depressive Disorder
Craig Nelson, Aleksandar Skuban, Mary Hobart,
Peter Zhang, Catherine Weiss, Emmanuelle Weiller
062
E
Efficacy of Initiating Therapy With Amlodipine and Hydrochlorothiazide or
Their Combination in Hypertensive Nigerians
Godfrey Iyalomhe, Eric Omogbai, Ambrose Isah,
Osigbemhe Iyalomhe, Folorunso Dada,
Sarah Iyalomhe
063
E
Pharmacokinetics and Preliminary Safety of the HIV Integrase Strand
Transfer Inhibitor Elvitegravir in HIV-1-infected Pediatric Subjects
Joseph Custodio, Victor Musiime, Aditya Gaur,
Elizabeth McFarland, Wasana Prasitsuebsai,
Lize Hellstrom, Damian J. McColl, Xuelian Wei,
Rebecca Begley, Srinivasan Ramanathan,
Sean R. Bennett, David Piontkowsky
064
E
Efficacy of Brexpiprazole in Acute Schizophrenia: Results of Two Pooled,
Pivotal Studies
Ruth Duffy, Aleksandar Skuban, John Kane, John
Ouyang, Catherine Weiss, Emmanuelle Weiller,
Christoph U. Correll
065
NM, S
A Systematic Review of the Use of Deception as an Intervention in Clinical
Research
Sarika Paradkar, Mukta S. Kuyare, Anup Petare,
Nithya J. Gogtay, Urmila M. Thatte, Shyamal Sinha
Pharmacokinetics, Safety and Tolerability of Rupatadine in Healthy
Japanese Volunteers
Jörg Täubel, Eva Santamaria
066
Decision Making in Research and Development
Poster
Intra-arterial Microdosing: A Novel Drug Development Approach, Proof of
Concept in Rats
067
068
Title
Type
S
Tal Burt, Douglas Rouse, Kihak Lee, Huali Wu,
Thomas Hawk, Douglas Weitzel, Bennett Chin, Michael
Cohen-Wolkowiez, Shein-Chung Chow, Robert Noveck
Use of Physiologically-based Pharmacokinetic Modeling as a Computational
Tanay S. Samant, Stephan Schmidt, Lanyan Fang,
and Mathematical Tool to Evaluate the Switchability of Generic and Brand
Mirjam Trame, Lawrence J. Lesko
Name Products
LEGEND:
46
Authors
President & Program
Co-chairs
Poster Session
2
Disease Management
Poster
Type
Title
Authors
069
E
Efficacy Assessment of Combined Escitalopram and Sublingual Alprazolam
for Major Depression Associated With Insomnia
Daniel Goldenberg, Miguel Marquez, Norberto Caruso,
Eduardo De La Puente, Juan Carlos Groppa,
Rolando Kurz, Sergio Nunez
Experimental Pharmacology in In Vitro and In Vivo Studies
Poster
Type
070
NM
Title
Reduced SN38 Cmax After Etirinotecan Pegol (EP; NKTR-102) Attenuates
Neutropenia in the Presence of Increased SN38 AUC
Authors
Sherwin K. Sy, Theresa Sweeney, Chunmei Ji,
Ute Hoch, Michael Eldon
Special Populations, Including Women, Children, the Elderly and Obese Patients
Poster
Type
071
E, NM
Title
Authors
Application of a Physiologically-based Pharmacokinetic Model in Pediatric
Stavudine Dose Reduction
Sherwin K. Sy, Ruben Malmberg, Aoi Matsushima,
Eduardo Asin-Prieto, Bernd Rosenkranz,
Mark F. Cotton, Steve Innes, Hartmut Derendorf
072
Clinical Investigation of the Effect of End Stage Renal Disease on the
Pharmacokinetics of Alisporivir, a Drug Primarily Cleared Non-renally
Sree Anumolu, June Ke, Edward Wolfson, Jie Zhang,
Bin Yang, Janardhana Vemula, TsuHan Lin,
Sampath Kalluri, Haiying Sun, Steven J. Kovacs
073
Population Pharmacokinetic Modeling to Predict Exposure of a Novel
Adekemi Taylor, Colleen Burns, Terri Kim, Mark
Delayed-release Formulation of Metformin in Subjects with Renal Impairment Fineman
074
NM, P Nonsteroidal Anti-inflammatory Drug-associated Nephrotoxicity Among
S, SA Neonates Diagnosed With Patent Ductus Arteriosus
Jonathan Constance, Robert Ward, Catherine Sherwin,
E.K. Korgenski, Michael G. Spigarelli
075
Inclusion of Women and Sex Analyses in Clinical Trials of New Molecular
Entity Drugs and Biologics Approved by the US Food & Drug Administration
from 2013 to 2014
Emmanuel O. Fadiran, Hawi Itana, Merina Elahi,
Greg Soon, Alice Chen, Anne Pariser
076
Drug Utilization in Cancer Patients Receiving Radiation Therapy
Gerald H. Sokol, Loretta S. Loftus, Louis Cantilena
077
NM
078
S
Comparable Pharmacokinetics, Pharmacodynamics and Safety of Daclizumab Jonathan Q. Tran, Ahmed A. Othman, Devangi Mehta,
High-yield Process Between Healthy Japanese and Caucasian Subjects
Guolin Zhao, Gulden Ozen
Greater Reduction of CYP2D6 Activity than CYP3A in Renal Impairment
Kenta Yoshida, Bo Sun, Ping Zhao, Lei K. Zhang,
Shiew-Mei Huang
079
Pharmacokinetics and Dose Determination of Telaprevir in Combination with
Lakshmi Viswanathan, Joshua Henshaw, Jeysen
Peginterferon Alpha-2b and Ribavirin in Treatment-naïve Pediatric Subjects
Yogaratnam, Varun Garg
Infected with Genotype 1 Hepatitis C Virus
080
Evidence-based Guidance for Contraceptive Use in Phase 1 and Clinical
Pharmacology Trials Including Women of Child-bearing Potential
Rogelio Mosqueda-Garcia, Jeanelle Kam,
Matthew Medlock
081
Pharmacokinetics and Safety of Lorcaserin in Adolescents With Obesity
Ronald Christopher, Michael E. Morgan, Yong Tang,
Matilde Sanchez, Scott C. Stubbe, Cindy Turner,
William Shanahan
LEGEND:
47
Table
Contents
PosterofSession
2
Absorption, Distribution, Metabolism and Elimination
Poster
Title
Type
Authors
Assessment of Mass Balance of Eluxadoline in Humans
J. Michael Davenport, Matthew Medlock,
Leonard S. Dove, Paul Covington
Explaining Variability in Pharmacokinetics of Mycophenolic Acid in Pediatric
and Adult Patients with Hematopoietic Stem Cell Transplantation: From
Plasma Protein Binding and Metabolic Perspectives
Daping Zhang, Jamie L. Renbarger, Diana Chow
084
Allometric Scaling of Oritavancin Accurately Predicts Plasma Clearance in
Humans
Dario Lehoux, Brad Zerler, S. Eralp Bellibas
085
Various Vegetable Juices Inhibit CYP3A4 Activity in Recombinant CYP3A4
and LS180 Cells
Masayuki Tsujimoto, Tomoe Uchida, Hiroyuki Kozakai,
Saori Yamamoto, Tetsuya Minegaki, Kohshi Nishiguchi
086
Assessment of Relative Bioavailability of Diclofenac-loaded Poly
(Lactide-co-Glycolide) Nanoparticles After Oral Administration
Dustin Cooper, Angela Hanley, Kenny Bullins,
Greg Hanley, Jennifer Hoard, Jessica Coleman,
Sam Harirforoosh
082
083
P, S
SA
087
S
088
NM
Development and Optimization of an In Vitro Dissolution Test for Orallyinhaled Products
Pharmacokinetics, Metabolism, Elimination and Mass Balance of
14
C-VX-509 in Healthy Male Subjects
Sharvari Bhagwat, Hannah Kranich, Adriely Goes,
Sara Broenner, Martin Jetzer, Marc Rohrschneider,
Guenther Hochhaus
Jiayin Huang, Srinivas Chakilam, Shengkai Liao,
Lakshmi Viswanathan, Sanjeev Kumar, Nils Kinnman,
Jinshan Shen
Safety and Efficacy
Poster
Title
Type
VX-509 Did Not Prolong QTc Intervals in Healthy Subjects
Chonghua Li, Jiayin Huang, Lakshmi Viswanathan,
Yanqiong Zhang, Mohammed Asmal, Jinshan Shen
A Retrospective Study of Kidney Injury vs Vancomycin Use by Age
Alfred H. Balch, Jonathan Constance,
Michael G. Spigarelli, Catherine Sherwin
Evaluation of the Therapeutic Index of Sirolimus
Ho-Pi Lin, Xinyuan Zhang, Minori Kinjo, Lanyan Fang,
Wenlei Jiang, Robert Lionberger
092
Exposure-Response Analysis Facilitated Approval of Low-dose Naloxegol
for Opioid-induced Constipation
Justin C. Earp, Sandhya Apparaju, Sue Chih Lee, Aisha
P. Johnson, Anil Rajpal, Joyce Korvick, Nitin Mehrotra
093
A Model- and Systems-based Approach to Efficacy and Safety Questions
Related to Generic Substitution
Lawrence J. Lesko, Konstantinos Biliouris,
Tanay S. Samant, Francois Combes, Lanyan Fang,
Stephan Schmidt, Mirjam Trame
Integrated Data Mining and Systems Pharmacology to Explore the
Comparative Safety of Brand Name and Generic Drugs
Konstantinos Biliouris, Mirjam Trame,
Stephan Schmidt, Lanyan Fang, Lawrence J. Lesko
Therapeutic Drug Monitoring for Improved Celecoxib Therapy
Wen Wang, Anshuma Mehta, Larn Hwang
089
090
NM
091
S
094
S
096
NM
LEGEND:
48
Authors
President & Program
Co-chairs
Poster Session
2
Translational Medicine, Including Biomarkers and/or Imaging
Poster
Title
Type
097
Endothelin-1 Levels and Renal Function in Newborns
Authors
Anil Gulati, Gwendolyn Pais, Gospodin Stefanov,
Bhagya Puppala, Lorene Schweig
Experimental Pharmacology in In Vitro and In Vivo Studies
Poster
Endothelin B Receptor Agonist, IRL-1620, Provides Neuroprotection and
Enhances Angiogenesis in Diabetic Rats With Cerebral Ischemia
098
099
Title
Type
Pharmacological Characterization of Mechanisms Involved in the
NM, S Vasorelaxation Produced by Rosuvastatin in Aortic Rings from Rats with a
Cafeteria-style Diet
Authors
Anil Gulati, Monica Husby, Mary Leonard
José C. Aguilar-Carrasco, Jorge Skiold López-Canales,
Jair Lozano-Cuenca, Oscar Alberto López-Canales,
Lidia Aranda-Zepeda
100
Maternal Ethanol and Oxycodone Exposure Delay Central Nervous System Seema Briyal, Mary Leonard, Muhammad Ansari,
Development as Determined by Endothelin Receptor Expression in Neonatal Muralidhara Devarapalli, Lorene Schweig,
Rat Brains
Bhagya Puppala, Anil Gulati
101
The Apoptotic Pathway Mediates the Neuroprotective Effect of IRL-1620 in a Seema Briyal, Luu Thanh, Anupama Puppala,
Rat Model of Focal Cerebral Ischemia
Anil Gulati
102
Reversal of Naloxone-precipitated Opioid Withdrawal in Mice by Endothelin
ETA Receptor Antagonists
Shaifali Bhalla, Gwendolyn Pais, Anil Gulati
Pharmacoepidemiology / Pharmacogenomics
Poster
103
104
105
106
Title
Type
Patterns of Anti-epileptic Drug Use in Epileptic Pediatric Patients in Jordan
NM, P Association of Plasma MicroRNA with Anti-hypertensive Response to Beta
S, SA Blockers
NM
Authors
Abla Albsoul-Younes, Lubna Gharaibeh,
Abdel Kareem Qudah, Amer Murtaja
Mohamed H. Solayman, Taimour Langaee, Yan Gong,
Manal El-Hamamsy, Lamia El-Wakeel, Eric Boerwinkle,
Arlene Chapman, Stephen Turner, John Gums,
Amber Beitelshees, Rhonda Cooper-DeHoff,
Osama Badary, Julie Johnson
Genetics and Drug Response: Study on the Influence of Genetics in
Individual Variations in Response to Acetaminophen Use
Natasha Anand, Brian Meshkin, Tobore Onojighofia,
Bilikis Akindele, May Hafez, Daniel Schwarz
Association of Genetic Polymorphisms of CYP2C9 and VKORC1 With
Bleeding Due to Warfarin: An Audit
Siddharth P. Deshpande, Saket Thaker, Mansij Biswas,
D.V. Kulkarni, S.J. Bhatia, A.G. Rajadhyaksha,
Shital Bendkhale, Nithya J. Gogtay, Urmila M. Thatte
LEGEND:
49
VISION & MISSION
To improve health by optimizing therapeutics;
Provide innovative leadership and interdisciplinary
education that will enable the generation, integration
and translation of scientific knowledge to optimize
research, development and utilization of medication
for the benefit of all.
ACCP OFFICERS
ACCP REGENTS
PRESIDENT
Bernd Meibohm, PhD, FCP
Univ of Tennessee
Jeffrey S. Barrett, PhD, FCP
Sanofi
PRESIDENT ELECT
John van den Anker, MD, PhD, FCP
Children’s National Health System & Univ Children’s Hospital, Basel
SECRETARY
Vikram Arya, PhD, FCP
TREASURER
Michael W. Jann, PharmD, FCP
Univ of North Texas System
Coll of Pharmacy
IMMEDIATE PAST PRESIDENT
Lisa L. von Moltke, MD, FCP
Alkermes Inc
COUNCILOR
Lawrence J. Lesko, PhD, FCP
Univ of Florida Coll of Pharmacy
50
Megan A. Gibbs, BSc Pharm, PhD, FCP
Amgen Inc
Guenther Hochhaus, PhD, FCP
Univ of Florida
Nancy A. Lass, MD, FAAP, FCP, LLD
NL Specialty Consulting Inc
Donald E. Mager, PharmD, PhD, FCP
Univ of Buffalo, SUNY
Diane R. Mould, PhD, FCP
Projections Research Inc
Anne N. Nafzinger, MD, PhD
Bertino Consulting
Michael N. Neely, MD, MSc, FCP
Univ of Southern California Keck School of Medicine
Peter H. Wiernik, MD, FCP
Cancer Research Fdtn
New Members:
August 1, 2014 – July 31, 2015
Members Student Members Lubna Abuqayyas, PhD
Monika Agrawal, MBBS, MD
Mohammed E. Al Za’abi, MD, PhD
Saleh Almousa, PhD
Guohua An, PhD, MD
Natasha Anand, MS, BA
Alfred Balch, PhD
Kristin Bohnenberger, PharmD
Carol Braun, MD
Namandje Bumpus, PhD
David Burger, PhD, PharmD
Nadia Cardillo Marricco, MSc
Caly Chien, PhD
Emmanuel Chigutsa, PhD
Anjali Chudasama, MSc, MPH, CCRP
Vaishali Chudasama, PhD
Serge Cremers, PhD, PharmD
Elaine Dafnis, PharmD, MS
Vipin Dhote, PhD
Yves Donazzolo, MD
Noam Epstein, MD, MS
Tushar Garimella, PhD
Ronette Gehring, BVSc, M Med Vet
Mathangi Gopalakrishnan, PhD
Jason Gow, PhD
Kathleen Greene, PharmD
Anita Grover, PhD
Parthasarathi Gurumurthy, PhD
Jiale He, PhD, MD
Fareeda Hosein, MD, MBA
Jiayin Huang, PhD
Khaizar Husain, MClin Pharm
Andrew Huskey, PharmD
Paul James, PharmD
Jeanelle Kam, MD, CPI
June Ke, PhD
Farhan Khan, MBBS, MD
Aryun Kim, PharmD
Kenneth Levy, PhD, MBA
Yan Li, PhD
Jose Carlos Aguilar-Carrasco, MSc Pharm
Mohammed E. Anwar, BSc, MSc
Di Bei, BS Pharm, MS, MS
Guy Armel Bounda, PhD
Susan Calandra, BS
Mongjen Chen, PhD
Kit Wun Kathy Cheung, BS
Jonathan Constance, PhD
Blair Curless, BS
Zhongqi Dong, PhD
Asma El-Zailik, BS
Andy Eugene, MD
Stephen Greene, BS
Varun Gupta, MBBS, MD
Tobias Heinrichs, PharmD
Anjan Khadka, MBBS, MD
Abhaniv Kurumaddali, BS Pharm, M Pharm
Chakradhar Lagishetty, PhD
Lisa Lam, PharmD
Mersiha Mahmic-Kaknjo, MD
Josiah Makusa, MBChB, MSc
Marc Mazzuca, PhD
Rahul Mohan, MBBS, MD
Sarika Paradkar, MBBS
Yuli Qian, BS, MS
Jafar Sadik Shaik, PhD
Mohamed Solayman, BSc Pharm, MSc Pharm
Chris Stockman, BS
Timothy Tran, PhD
Yichao Yu, BS
Victoria Ziesenitz, MD
Xiaomei Liu, PharmD
Gail McIntyre, PhD, DABT
Jeffrey Ming, MD, PhD
Mukul Minocha, PhD
Renuka Munshi, MBBS, MD, DM
Hussam Murad, MD
Helen Ndagije, MSc, MBA
Korey Nevitt, BS
Phuong Nguyen, MD
Melanie Nicol, PharmD, PhD
Robert Nietupski, PharmD
Masahiro Nomoto, MD, PhD
Rajneet Oberoi, PhD
Catherine Ortemann-Renon, PharmD, PhD
Gina Pastino, PhD, DABT
Gina Patel, PhD
Natalia Penner, PhD
Meredith Petty, PharmD
Iris Rajman, MD, PhD
Atulkumar Ramaiya, PhD
Edgar Rayes Mayaute, MD
Joel Reid, PhD
Jennifer Sheng, PharmD, PhD
Susan Shoemaker, PhD
Rodney Siwale, PhD
Sarah Stapleton, BS
Vinita Stayavrat, MBBS, MD
Gangadar Sunkara, PhD
Howard Surks, MD
Sherwin Sy, PhD
Bani Tamraz, PharmD, PhD
Jonathan Tran, PharmD
Maia Tutberidze, MD
Harry Hao-Xiang Wang, PhD
Jian Wang, PhD, MSRS
Wen Wang, PhD
Carla Washington, PhD
Theodoros Xanthos, MD, MSc Med, PhD
Liming Zhang, PhD
51
Table of Contents
American College of Clinical Pharmacology
21750 Red Rum Dr, Suite 137, Ashburn, VA 20147
mailing address:
PO Box 1758, Ashburn, VA 20146
phone:
website:
2
571.291.3493
www.ACCP1.org

2015 - American College of Clinical Pharmacology

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