Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Final Program - American College of Clinical Pharmacology
Document related concepts
Medical research wikipedia , lookup
Harm reduction wikipedia , lookup
Clinical trial wikipedia , lookup
Nanomedicine wikipedia , lookup
Pharmacognosy wikipedia , lookup
Prescription costs wikipedia , lookup
Theralizumab wikipedia , lookup
Drug discovery wikipedia , lookup
Transcript
Clinical Pharmacology Innovations: Population-based Drug Development to Patient-centered Care September 14 – 16, 2014 Westin Peachtree Plaza and AmericasMart, Atlanta, GA Co-chairs: Ayyappa Chaturvedula, PhD and Walter K. Kraft, MD Final Program JOIN US FOR THE 2015 ACCP ANNUAL MEETING! Clinical Pharmacology in the Development and Use of Biologics and Small Molecules Sept 27 – 29, 2015 • Westin St Francis • San Francisco, CA ACCP is a proud provider of Continuing Medical Education (CME) & Continuing Pharmacy Education (CPE) Future Meeting 2 2016 Annual Meeting Sept 25 – 27, 2016 Bethesda North Marriott Hotel & Conference Center Bethesda, MD Did You Know? Continuing Education Program from ACCP and technical soundness rather than perceived importance of the presented results. Thus, negative study results are explicitly not an obstacle for positive acceptance decisions. Only original research papers can be submitted in unsolicited form to CPDD. Editorials and reviews are considered by invitation only. Submit a manuscript to: http://mc.manuscriptcentral.com/cpd ACCP is proud to offer both Continuing Medical Education (CME) and Continuing Pharmacy Education (CPE) credits for its educational events. • 2014 Annual Meeting Events – To obtain credits for events at the 2014 Annual Meeting and print your CME or CPE certificates: 1. Go to: https://accp1.inreachce.com/ 2. Log in. If you don’t know your login credentials, please email [email protected] 3. Click on the activity you attended and complete the post-event test. You must receive a 75% or better score to print your certificate. Contact [email protected] if you have any questions. Attending the Meeting as a Student or Trainee? ACCP has planned a series of events specifically to benefit Students & Trainees! See page 33 for details. Interested in Joining ACCP? Stop by the Registration Desk in the Foyer for complete information or to complete a profile and pay 2015 Dues entitling you to ACCP Member Benefits. • Select Courses Available Post-meeting – ACCP will be making select events from the 2014 ACCP Annual Meeting available as online activities. Email notifications will be sent when the events are available online. 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 or 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. • Webinars – In August, 2014, ACCP hosted a webinar on “Utilizing Comparative Effectiveness and/or Patientcentered Outcomes Research (CER/PCOR) on the Effects of Healthcare Interventions,” the first of a series of planned webinars. The next webinar is planned for October 8th, 2:00 – 3:30 pm ET on reducing medication errors. Visit ACCP1.org for updates and new event listings. “Like” ACCP and add to “My Page’s Favorites” on Facebook or join our network for regular updates. Do You Want to Get Your Manuscript Published In The Journal of Clinical Pharmacology (JCP) or Clinical Pharmacology in Drug Development (CPDD)? ACCP Registration Desk Hours / Foyer For more than fifty years, medical professionals have relied on The Journal of Clinical Pharmacology (JCP) for original research, special reviews, commentaries and case reports on all phases of drug development from absorption, disposition, metabolism, excretion interactions, and preferred uses through post-marketing evaluations. Join the ranks of the premier clinical pharmacology professionals who have published in the JCP by submitting a manuscript to: http://mc.manuscriptcentral.com/jocp 4:00 – 6:00 pm Friday, September 12th Saturday, September 13th 7:00 am – 5:00 pm Sunday, September 14 th 6:30 am – 7:00 pm Monday, September 15th 7:00 am – 7:00 pm Tuesday, September 16th 7:00 am – 5:00 pm Lost & Found Clinical Pharmacology in Drug Development (CPDD) is an international, peer-reviewed, online-only journal focused on publishing high-quality clinical pharmacology studies in drug development which are primarily (but not exclusively) performed in early development phases in healthy subjects. Acceptance of a manuscript in CPDD will be determined by scientific rigor Persons wishing to retrieve or submit a lost item should contact ACCP Staff at the ACCP Registration Desk in the Foyer. 3 Table of Contents Invitation to 2015 Annual Meeting.. ....................................... 2 American College of Clinical Pharmacology 2014 Program Committee Did You Know?............................................................. 3 Letter of Welcome from President & President-elect..................... 5 Program at a Glance...................................................... 6 Ayyappa Chaturvedula, PhD, Co-chair Keynote Speakers......................................................... 8 Walter K. Kraft, MD, Co-chair 2014 ACCP Recognition Award Winners. ................................ 9 Daniel Gonzalez, PharmD, PhD Nilima Kshirsagar, MD, PhD Educational Accreditation. ............................................... 11 Michael Neely, MD 2014 Disclosure Information............................................. 12 Deven V. Parmar, MBBS, MD Pre-meeting Workshops. . ................................................ 13 Lorraine M. Rusch, PhD Sreedharan Sabarinath, PhD Islam R. Younis, PhD Symposia.................................................................. 17 Faculty. ................................................................... 29 Why Join ACCP?......................................................... 32 Students & Trainees. ..................................................... 33 Sponsors.................................................................. 34 Exhibitors.................................................................. 35 Poster Sessions. ......................................................... 38 ACCP Officers, Regents, Vision & Mission. ............................. 49 New Members: Sept 1, 2013 – Aug 1, 2014. ........................... 50 4 Letter of Welcome President & President-elect Welcome to the 2014 ACCP Annual Meeting! Clinical Pharmacology Innovations: Population-based Drug Development to Patient-centered Care Dear Colleague: It is our pleasure to welcome you to the 2014 Annual Meeting of the American College of Clinical Pharmacology (ACCP)! In planning the meeting, Clinical Pharmacology Innovations: Population-based Drug Development to Patient-centered Care, the 2014 Annual Meeting Program Committee, co-chaired by Drs. Walter K. Kraft and Ayyappa Chaturvedula, worked to develop a program focused on prominent global issues where clinical pharmacology can have an impact, resulting in a series of Workshops and Symposia that are timely and will critically challenge current and future practice and professional activity paradigms, while encouraging audience interaction. Topics include opportunities and challenges in antimicrobial & antibiotic development; real-world, large-scale implementation of pharmacogenetic-guided drug dosing; genderspecific pharmacokinetics/pharmacodynamics (PK/PD) of hypnotic drugs; integrated development for pediatric drug use; cardiovascular disease and associated risk assessment during drug development; immunogenicity risk of biosimilars and clinical pharmacology challenges of biotherapeutics with novel protein scaffolds. These educational events will be of interest to clinical pharmacologists and a broad range of healthcare professionals in academia, industry, government and clinical practice. new and exciting programs intended to broaden their exposure to cutting-edge science and provide career guidance. In addition to the educational events, Poster Sessions will be held daily that highlight new findings and preliminary data and stimulate discussion and hypothesis generation in a relaxed atmosphere. Of particular interest to Students & Trainees are We welcome you to an outstanding 2014 ACCP Annual Meeting where you can learn, network and be part of a progressive ACCP! Lisa L. von Moltke, MD, FCP President ACCP offers CME and CPE credits for Pre-meeting Workshops and Symposia, a particular value for pharmacists, physicians and other healthcare professional attendees. Building on its rich history, ACCP continues to be an organization focused on meeting the needs of its Members and Annual Meeting attendees. With a vision of the value that clinical pharmacology brings to the future of healthcare, ACCP strives to provide healthcare professionals and scientists with a forum for the exchange of knowledge. Despite the global nature of the audience, the ACCP Annual Meeting remains an intimate gathering of pharmacologists, physicians, pharmacists, pharmacometricians and clinical scientists from academia, industry, government and clinical settings who understand the important contributions that clinical pharmacology can make to the future of healthcare. The meeting offers an opportunity to network and to discover new techniques that you can immediately apply to your work, be it drug development or patient-care related. Bernd Meibohm, PhD, FCP President-elect 5 Program at a Glance The 2014 ACCP Annual Meeting is supported in part by Educational Grants from Pfizer Inc and Projections Research Inc All events are at the AmericasMart, Bldg 2, 4th Floor unless specified otherwise. FRIDAY, SEPTEMBER 12, 2014 l ACCP Registration Desk Open Foyer l Executive Committee Meeting Westin, Level 6, Chastain B Continental Breakfast Hallway 4:00 – 6:00 pm Room H – J 6:00 – 9:00 pm SATURDAY, SEPTEMBER 13, 2014 l Foyer Pre-meeting Workshop 1 Room E l 7:00 am – 5:00 pm 8:00 am – 5:00 pm CHAIR: Joga Gobburu, PhD, MBA Room F l 8:00 am – 12:00 pm CHAIR: Walter K. Kraft, MD Board of Regents Meeting Westin, Level 6, Chastain G Room G l l 12:30 – 5:00 pm 1:00 – 5:00 pm CHAIR: Islam R. Younis, PhD Room F l Systems Approaches in Drug Development: Detailed Systems Descriptions Bring New Information to Light CO-CHAIRS: Rebecca N. Burns, PharmD, PhD and Jeffry Florian, PhD l Finance Committee Meeting Room H – J Regents & Awards Reception Westin, Level 6, Chastain 2 Regents & Awards Dinner Westin, Level 6, Chastain 1 l 3:00 – 5:00 pm l 5:30 – 6:30 pm 6:30 – 8:30 pm SUNDAY, SEPTEMBER 14, 2014 ACCP Registration Desk Open Foyer l 7:30 – 7:45 am 8:00 am – 12:00 pm CO-CHAIRS: Jesse T. Jacob, MD and Steve Mok, PharmD Symposium 2 l 8:00 am – 12:00 pm Real-world, Large-scale Implementation of Pharmacogeneticguided Drug Dosing CHAIR: Walter K. Kraft, MD l 12:00 – 1:15 pm Room H – J • Distinguished Investigator Award • Nathaniel T. Kwit Memorial Distinguished Service Award KEYNOTE SPEAKER: RICHARD WENDER, MD, Chief Cancer Control Officer, American Cancer Society Inc, “The 10 Trends and Issues that will Determine the Future of Cancer in the World” Room F – G l 1:30 – 5:30 pm Opportunities and Challenges in New Antibiotic Development: A Multidisciplinary Perspective CO-CHAIRS: Jesse T. Jacob, MD and David M. Tenero, PharmD Symposium 4 1:00 – 5:00 pm l Opportunities in Antimicrobial Development: Clinical Cases to Close the Research Gap Symposium 3 Modes of Drug Development and the US Food & Drug Administration Pre-meeting Workshop 4 l Lunch & Awards Session Opioid Prescribing: Reducing the Risks Pre-meeting Workshop 3 Symposium 1 Room D – E Dose-Response Trials: Overview and Adaptive Designs Pre-meeting Workshop 2 7:00 – 8:00 am Welcome and Opening Remarks Room F – G ACCP Registration Desk Open l Room D – E l 1:30 – 5:00 pm Gender-specific Pharmacokinetics/Pharmacodynamics (PK/PD) of Hypnotic Drugs CO-CHAIRS: Angela Yuxin Men, MD, PhD and Jagan Mohan Parepally, PhD Education Committee Meeting Room L l Publications Committee Meeting Room H – J 5:30 – 6:30 pm l 5:30 – 6:30 pm Student Outreach Reception & Panel Room D – E l 5:30 – 6:30 pm Opening Reception, Poster Session 1 & Exhibits 6:00 – 8:00 pm Room A – C 6:30 am – 7:00 pm 6 Program at a Glance MONDAY, SEPTEMBER 15, 2014 Annual Business Meeting Room H – J l Foyer Room A – C Exhibit Hall Open Room A – C Symposium 5 Room F – G l l l Foyer 7:00 – 7:45 am ACCP Registration Desk Open Continental Breakfast Students Meet at ACCP Registration Desk for Posters Tour 5:45 pm l Poster Session 2 & Reception Room A – C 7:00 am – 7:00 pm Editorial Board Dinner Westin, Level 6, Chastain 2 7:00 – 8:00 am l ACCP Registration Desk Open Public Policy Committee Meeting Room L Exhibit Hall Open Room A – C CO-CHAIRS: Suraj G. Bhansali, PhD and Shefali Kakar, PhD Symposium 9 12:00 – 1:00 pm Room F – G Room H – J • Tanabe Young Investigator Award KEYNOTE SPEAKER: DEBORAH DOWELL, MD, MPH, LCDR, USPHS, Team Lead, Prescription Drug Overdose Team, Div of Unintentional Injury Prevention, Ctrs for Disease Control and Prevention, “Prescription Drug Overdose Prevention: The CDC’s Perspective” Symposium 7 Room F – G l l Symposium 10 Room D – E CHAIR: Honghui Zhou, PhD 3:00 – 8:00 pm Podium Presentations Room D – E l Room H – J l Room F – G 8:00 am – 12:00 pm l 12:00 – 1:30 pm l 1:30 – 5:30 pm Many Features of an Integrated Development for Pediatric Drug Use CO-CHAIRS: Jing-He Yan, PhD and Jun Yang, PhD 5:30 - 6:30 pm 2014 and 2015 Program Committee Meeting Room L l Room H – J • Honorary Fellowship Award • McKeen Cattell Memorial Award • Student & Trainee Abstract Awards • Wayne A. Colburn Memorial Award • New Member Abstract Award Symposium 11 5:00 – 6:00 pm Honors & Awards Committee Meeting 8:00 – 11:30 am Lunch & Awards Session 1:00 – 5:00 pm l 7:00 – 11:00 am CO-CHAIRS: Nilima Kshirsagar, MD, PhD and Hartmut Derendorf, PhD Biotherapeutics with Novel Protein Scaffolds: How Translational Research Helps Turn Creative Concepts into a Reality Room A – C 7:00 – 8:00 am Is Rational Use of Medicines Guided by Laboratory Tests, Cost, Quality or Ethics? 1:00 – 5:00 pm Exhibit Hall Open 7:00 – 8:00 am CHAIR: Lorraine M. Rusch, PhD CO-CHAIRS: Gangadhar Sunkara, PhD and Manoj Jadhav, PhD Room D – E l l l l Key Considerations for Efficient Study Designs in Early Stage Clinical Development and Proof-of-Concept Studies Cardiovascular Diseases: Drug Discovery to Recovery Symposium 8 7:00 am – 5:00 pm Room A – C Elephant in the Room: Immunogenicity Potential of Biosimilars l l Continental Breakfast & Poster Session 3 8:00 am – 12:00 pm Lunch & Awards Session 6:00 – 8:00 pm 8:00 – 10:00 pm Foyer 8:00 am – 12:00 pm CO-CHAIRS: Damayanthi Devineni, PhD and Anne Chain, PhD Room D – E l l TUESDAY, SEPTEMBER 16, 2014 7:00 – 11:00 am Pragmatic Assessment of Pro-arrhythmic Risk During Drug Development Symposium 6 l Symposium 12 l Room D – E l 1:30 – 5:00 pm Bench to Market: REMS at the Crossroads 5:30 – 6:30 pm CHAIR: Deven V. Parmar, MBBS, MD 7 Keynote Speakers Monday, September 15, 2014 12:30 – 1:00 pm | Room H – J Sunday, September 14, 2014 12:45 – 1:15 pm | Room H – J Deborah Dowell, MD, MPH, LCDR, USPHS, Team Lead, Prescription Drug Overdose Team, Div of Unintentional Injury Prevention, Ctrs for Disease Control and Prevention Richard Wender, MD Chief Cancer Control Officer, American Cancer Society Inc Presentation Title: The 10 Trends and Issues that will Determine the Future of Cancer in the World Dr. Richard Wender is the Chief Cancer Control Officer of the American Cancer Society Inc (ACS), a position he assumed in November, 2013. This is a newly created position charged with providing oversight and guidance for the national and global cancer control programs of ACS, including cancer screening, tobacco control, access to care and quality of life, in addition to providing high level oversight for ACS’s global cancer control efforts. Dr. Wender has received numerous awards and honors, including the Laurel for Cancer Prevention Leadership from the Prevent Cancer Foundation and the St George Medal from the American Cancer Society. In 2006, Dr. Wender was elected as the national President of the American Cancer Society, becoming the first primary care physician to serve in this capacity. While his new position will allow him to have a greater impact on the cancer burden around the world, his roots remain grounded in primary care, and he continues to provide primary care to patients at Thomas Jefferson Univ. Through advocacy and through constructing lasting partnerships, Dr. Wender remains committed to building bridges between public health, community medicine and primary care. Presentation Title: Prescription Drug Overdose Prevention: The CDC’s Perspective Dr. Deborah Dowell is Team Lead for the Prescription Drug Overdose Team at the Ctrs for Disease Control and Prevention (CDC). She previously served as an advisor to Health Commissioner Thomas Farley at the New York City Dept of Health and Mental Hygiene where she led and collaborated on several New York City initiatives related to prevention of prescription drug overdoses, including development of opioid prescribing guidelines for general practice and for emergency medicine. Dr. Dowell received her undergraduate and medical degrees from Columbia Univ and her master of public health degree from the Johns Hopkins Bloomberg School of Public Health. She completed her residency and chief residency in Primary Care Internal Medicine at New York Univ/Bellevue Hosp Ctr and is Board Certified in Internal Medicine. She practiced general medicine at Gouverneur Healthcare Services and is a clinical assistant professor at the New York Univ School of Medicine, where she has taught epidemiology, health policy and clinical medicine. 8 2014 ACCP Recognition Award Winners Distinguished Investigator Award Sunday, September 14, 2014 | 12:00 – 1:15 pm | Room H – J Presentation Title: “Research at the Interfaces of Clinical Pharmacology” Kathleen M. Giacomini, PhD – Professor, Dept of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, Univ of California, San Francisco 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. Giacomini is receiving this award for her seminal work in the area of transporter polymorphisms. She represents the best of the translational, laboratory-based approach to the discipline of clinical pharmacology. Her work is well recognized, and she has risen quickly through the academic ranks. Nathaniel T. Kwit Memorial Distinguished Service Award Sunday, September 14, 2014 | 12:00 – 1:15 pm | Room H – J Presentation Title: “Clinical Pharmacology is the Core Science of Drug Development and Regulation” Carl Peck, MD, Dr hc – Adjunct Professor, Dept of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, Univ of California, San Francisco, Ctr for Drug Development Science, UC – Washington, Washington, DC and Chairman and Co-founder, NDA Partners LLC 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. Peck is receiving this award for his contributions to academia, regulatory sciences and pharmaceutical drug development. Tanabe Young Investigator Award Monday, September 15, 2014 | 12:00 – 1:00 pm | Room H – J Presentation Title: “Impact of CYP3A5 Genotype on Maraviroc Metabolism” Namandjé N. Bumpus, PhD – Dept of Pharmacology & Molecular Sciences, Johns Hopkins Univ School of Medicine The Tanabe Young Investigator Award is given on a biannual basis (on even numbered years), and is funded by a grant from Tanabe Research Labs USA. The award recognizes the significant contributions of an investigator who has made unusual strides in research related to clinical pharmacology and whose career shows promise of outstanding achievements at a relatively early stage, typically 10 – 12 years post-research degree. The candidate need not be a Member or Fellow of ACCP. Dr. Bumpus is receiving this award for her work in drug metabolism and clinical pharmacology. She has had an extraordinary track record of external research funding, published work and academic achievements since joining the faculty at the Johns Hopkins Univ, Div of Clinical Pharmacology. 9 2014 ACCP Recognition Award Winners Honorary Fellowship Award Tuesday, September 16, 2014 | 12:00 – 1:30 pm | Room H – J Presentation Title: “Hypertension Pharmacogenomics: Discoveries and Opportunities” Julie A. Johnson, PharmD, FCCP, BCPS – Dean and Distinguished Professor, Coll of Pharmacy, Univ of Florida 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. Johnson is receiving this award for her contributions to clinical pharmacology, including her numerous leadership roles in national and international organizations, as well as her research, which focuses on the sources of inter-patient variability in drug response, particularly cardiovascular drug pharmacogenomics, and the influence of race and ethnicity on drug response and pharmacogenomics. McKeen Cattell Memorial Award Tuesday, September 16, 2014 | 12:00 – 1:30 pm | Room H – J Alexander K. Berg, PharmD, PhD – Senior Clinical Research Scientist, Clinical Pharmacology Group, Upsher-Smith Laboratories Inc 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: “Population Pharmacokinetic Model for Cancer Chemoprevention With Sulindac in Healthy Subjects” Authors: Alexander K. Berg, Sumithra J. Mandrekar, Katie L. Allen Ziegler, Elsa C. Carlson, Eva Szabo, Mathew M. Ames, Daniel Boring, Paul J. Limburg, Joel M. Reid, J Clin Pharmacol. 2013; April; Volume 53, Issue 4, pages 403 – 412. Tuesday, September 16, 2014 Lunch & Awards Session l 12:00 – 1:30 pm l Room H – J 2014 Student & Trainee Abstract Award Winners Student & Trainee Abstract Award Winners Student Award Winners will present their posters at all three Poster Sessions. Eight Student & Trainee Abstract Awards are given for the best abstracts submitted by Students & Trainees for presentation at each year’s Annual Meeting. • Puneet Gaitonde (Abstract 2-82-2000395) Univ of Florida, Orlando, FL • Jennifer E. Hibma (Abstract 2-63-1999997) Univ of California San Francisco, San Francisco, CA 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 presented, the author will give a short talk outlining the findings of the study. • Kumpal Madrasi (Abstract 2-84-2000366) Mercer Univ, Atlanta, GA • Nivea Maria Simoes Falcao (Abstract 3-104-1957990) Univ of Florida, Gainesville, FL • Ravi Shankar P. Singh (Abstract 2-83-2000544) Univ of Florida, Gainesville, FL New Member Abstract Award • Amit Somani (Abstract 1-36-1996711) Univ of Florida, Orlando, FL 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, and the award winner will be announced following the last Poster Session. A short talk outlining the summary of the findings of the study will be presented by the recipient. • Lei Wu (Abstract 2-79-1997622) Univ of Houston, Houston, TX • Fausto Zaruma-Torres (Abstract 1-29-1983392) National Polytechnic Inst of Mexico, Durango, Mexico 10 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 28 Contact Hours (2.8 CEUs). 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 28 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Continuing Education Process for 2014 What is CPE Monitor? Attendees interested in earning continuing education credit should have specifically requested that when they registered for the 2014 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 and course evaluations 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 via e-mail at [email protected]. The profile number 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: 847-391-4406. Please note: If a pharmacist/pharmacy technician fails 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. 11 2014 Disclosure Information The following Faculty participants have indicated they have a disclosure related to the content of their presentation. Balaji Agoram: employee MedImmune David M. Tenero: employee, stock GlaxoSmithKline Suraj G. Bhansali: employee, stock Novartis Pharmaceuticals Corp Alexander A. Vinks: royalty AssureRx Health Anne Chain: employee Merck Lynn Webster: consultant Acura Pharmaceuticals Inc, AstraZeneca, BioDelivery Sciences Intl, CVS Caremark, Mallinckrodt Pharmaceuticals, Medtronic Inc, Neura Therapeutik LLC, Nevro Corp, Quintiles, Shionogi Pharma Inc; advisory board AcelRx Pharmaceuticals Inc, Collegium Pharmaceuticals Inc, Inspirion Pharmaceuticals, Insys Therapeutics Inc, Mallinckrodt Pharmacueticals, Nektar Therapeutics, Orexo Pharmaceuticals, Teva Pharmaceutical Industries Ltd; travel expenses QRx Pharma Ltd Mark Chiu: employee Janssen Biotechnology Ctr of Excellence Bruce Damiano: employee Janssen Research & Development LLC; spouse is employee LipoScience Damayanthi Devineni: employee Janssen Research & Development LLC David A. Flockhart: honoraria Quest Diagnostics Inc and Clinical Equilibrium Consulting LLC Sheila Weiss: employee DrugLogic Michael J. Fossler, Jr.: employee, stock GlaxoSmithKline Gillian Woollett: employee Avalere Health Christine Garnett: employee Certara, Pharsight Consulting Svcs Jing-He Yan: employee, stock Novartis Inst of BioMedical Research Elizabeth E. Garrard: employee United Therapeutics Corp Jing Yang: employee Seattle Genetics Inc Vanthida Huang: speaker Forest Pharmaceuticals Inc Honghui Zhou: employee, stock Janssen Research & Development LLC Venkateswar Jarugula: employee, stock Novartis Inst of BioMedical Research The remaining Faculty participants (see pages 29 – 31) have no disclosures. Judith K. Jones: consultant Takeda, Bayer Health Products, Boehringer Ingelheim Pharmaceuticals; analyst Sanofi, Teva Pharmaceutical Industries Ltd, AbbVie Inc, Pfizer Inc, Genentech-Roche, Boehringer Ingelheim Pharmaceuticals Shefali Kakar: employee Novartis Pharmaceuticals Corp Kenneth Levy: consultant Siloam Biosciences Bernd Meibohm: consultant AstraZeneca, Biogen Idec, Janssen Research & Development LLC, MedImmune, Merck Serono, Pieris AG, Roche, Teva Pharmaceutical Industries Ltd Kathryn M. Momary: speaker Sanofi-Aventis; investigator-initiated grant Merck Dharani Gokul Munirathinam: employee Synowledge LLC Michael Neely: co-founder Applied Pharmacometrics Inc Deven V. Parmar: employee Prolong Pharmaceuticals LLC Luana Pesco Koplowitz: employee DUCK FLATS Pharma LLC Nikhil Phadke: employee, stock GenePath Dx (Causeway Healthcare) Michael Poirier: employee Biogen Idec Hayden A. Rhudy: employee AbbVie Inc Brooke Rock: employee Amgen Inc Lorraine M. Rusch: employee Vince & Associates Clinical Research Inc; employee, stock Cara Therapeutics; spouse is employee, stock Acorda Therapeutics Philip Sager: consultant iCardiac Technologies Inc and Biomedical Systems Gopi Shankar: employee Janssen Research & Development LLC Lakshmi Sivaraman: employee Bristol-Myers Squibb Gangadhar Sunkara: employee Novartis Inst of BioMedical Research The following activity planners have indicated they have disclosures: Lawrence Cohen: consultant PharMerica; consultant, speaker Sunovion Pharmaceuticals Inc; speaker Otsuka America Pharmaceutical Inc/Lundbeck Nancy Lass: consultant Kyowa Kirin Pharma Inc Michael Neely: co-founder Applied Pharmacometrics Inc Deven V. Parmar: employee Prolong Pharmaceuticals LLC Lorraine M. Rusch: employee Vince & Associates Clinical Research Inc; employee, stock Cara Therapeutics; spouse is employee, stock Acorda Therapeutics Lisa L. von Moltke: employee, stock Genzyme, a Sanofi company The following activity planners have no disclosures: Francis Achike Ayyappa Chaturvedula Daniel Gonzalez Christine Hon Otito Iwuchukwu Manoj Jadhav Walter K. Kraft Nilima Kshirsager Senthil Rajasekaran Arun Ram Sreedharan Sabarinath Catherine M. Sherwin Islam R. Younis 12 Pre-meeting Workshops SATURDAY, SEPTEMBER 13, 2014 l Pre-meeting Workshop 1 l 8:00 am – 5:00 pm Room E Dose-Response Trials: Overview and Adaptive Designs 10:00 – 10:30 am / Break 10:30 am – 12:00 pm Offers both CPE and CME Credit UAN #: 0238-0000-14-004-L01-P ACPE - 7.0 CONTACT HOURS / APPLICATION-BASED Dose-Response Trial Designs Joga Gobburu, PhD, MBA, Professor, School of Pharmacy, Univ of Maryland CHAIR: Joga Gobburu, PhD, MBA, Professor, School of Pharmacy, Univ of Maryland 12:00 – 1:00 pm / Break TARGET AUDIENCE: 1:00 – 2:00 pm The target audience is clinical pharmacologists, clinical researchers, statisticians, pharmacometricians, physician scientists, pharmacists and drug development scientists. Adaptive Designs Mathangi Gopalakrishnan, PhD, Research Assistant Professor, Univ of Maryland BACKGROUND REQUIREMENT: Basic knowledge of PK/PD, biostatistics and clinical pharmacology. 2:00 – 3:00 pm Conditional Power Estimation, Exercise GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Understand evidence of effectiveness; 2. Set up analysis hypothesis; 3. Describe dose-response trial designs; 4. Understand adaptive designs; 5. Overcome some of the logistical and technical challenges involved in adaptive clinical trials. Mathangi Gopalakrishnan, PhD, Research Assistant Professor, Univ of Maryland 3:00 – 3:30 pm / Break 3:30 – 4:15 pm Dose-Response: US Food & Drug Administration Expectations Vikram Sinha, PhD, Director, Div of Pharmacometrics, Ctr for Drug Evaluation and Research, US Food & Drug Administration 8:00 – 9:00 am Efficacy Evidentiary Standards Joga Gobburu, PhD, MBA, Professor, School of Pharmacy, Univ of Maryland 4:15 – 5:00 pm / Panel Discussion 9:00 – 10:00 am Hypothesis, ITT, PP, Missingness Joga Gobburu, PhD, MBA, Professor, School of Pharmacy, Univ of Maryland 13 Pre-meeting Workshops SATURDAY, SEPTEMBER 13, 2014 l Pre-meeting Workshop 2 l 8:00 am – 12:00 pm Room F Opioid Prescribing: Reducing the Risks 8:05 – 8:45 am An Approach to Pain Management Lynn Webster, MD, Vice President of Scientific Affairs, PRA Health Sciences Offers both CPE and CME Credit UAN #: 0238-0000-14-005-L05-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 8:45 – 9:25 am This Workshop is supported by an Educational Grant from Purdue Pharma LP Pharmacology and Pharmacogenetics of Opioids, Variability of Responses and Susceptibility to Opioid Adverse Effects and Dependence CHAIR: Walter K. Kraft, MD, Associate Professor of Pharmacology and Therapeutics, Thomas Jefferson Univ Senthilkumar Sadhasivam, MD, MPH, Professor of Anesthesia and Pediatrics, Director of Perioperative Pain Svc, Cincinnati Children’s Hosp Medical Ctr TARGET AUDIENCE: The target audience is physicians, nurse practitioners and pharmacists who care for patients who are prescribed opioids. 9:25 – 10:05 am Scope of the Problem and the CDC Response BACKGROUND REQUIREMENT: None GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Understand how to assess patients for treatment with ER/LA opioid analgesics; 2. Be familiar with how to initiate therapy, modify dose and discontinue use of ER/LA opioid analgesics; 3. Be knowledgeable about how to manage ongoing therapy with ER/LA opioid analgesics; 4. Formulate a strategy to manage pain using non-opioid medications; 5. Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics. David E. Sugerman, MD, MPH, Team Lead, Prescription Drug Overdose (PDO) Health System and State Intervention Team, Div of Unintentional Injury Prevention, Ctrs for Disease Control and Prevention 10:05 – 10:30 am / Break 10:30 – 11:10 am Opioid Patient-Prescriber Agreements: Person-centered Care Through Risk Mitigation Frederick A. Curro, DMD, PhD, Director, PEARL PracticeBased Translational Network, New York Univ 8:00 – 8:05 am Introduction 11:10 am – 12:00 pm / Panel Discussion Walter K. Kraft, MD, Associate Professor of Pharmacology and Therapeutics, Thomas Jefferson Univ 14 Pre-meeting Workshops SATURDAY, SEPTEMBER 13, 2014 l Pre-meeting Workshop 3 l 1:00 – 5:00 pm Room G Modes of Drug Development and the US Food & Drug Administration 1:40 – 2:20 pm Offers CPE Credit UAN #: 0238-0000-14-006-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED Hayden A. Rhudy, Director, Therapeutic Area Strategies, Government Affairs, AbbVie Inc US Food & Drug Administration Breakthrough Designation Program CHAIR: 2:20 – 3:00 pm Islam R. Younis, PhD, Team Leader, Office of Clinical Pharmacology, Ctr for Drug Evaluation and Research, US Food & Drug Administration The Role of Clinical Pharmacology in Supporting Different Regulatory Approval Pathways TARGET AUDIENCE: Vikram Sinha, PhD, Director, Div of Pharmacometrics, Ctr for Drug Evaluation and Research, US Food & Drug Administration The target audience is scientists (particularly clinical pharmacologists and regulatory scientists), physicians and pharmacists from the pharmaceutical industry, regulatory agencies, academia and hospitals who are engaged in drug development. 3:00 – 3:30 pm / Break BACKGROUND REQUIREMENT: None 3:30 – 4:10 pm GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Understand the various US Food & Drug Administration drug approval pathways; 2. Understand the requirements, benefits and utility of the newly- launched US Food & Drug Administration breakthrough therapy designation program; 3. Gain knowledge on the role of clinical pharmacology in drug development through the various regulatory approval pathways; 4. Gain an industry and regulatory insight on maximizing the benefit and utility of the available approval pathways toward improving the efficiency of drug development. 1:00 – 1:40 pm Overview of the US Food & Drug Administration Drug Approval Pathways Islam R. Younis, PhD, Team Leader, Office of Clinical Pharmacology, Ctr for Drug Evaluation and Research, US Food & Drug Administration 15 The Utility of US Food & Drug Administration Approval Pathways in Drug Development: An Industry Perspective Michael Poirier, MS, Vice President, Biogen Idec 4:10 – 5:00 pm / Panel Discussion Pre-meeting Workshops SATURDAY, SEPTEMBER 13, 2014 l Pre-meeting Workshop 4 l 1:00 – 5:00 pm Room F Systems Approaches in Drug Development: Detailed Systems Descriptions Bring New Information to Light 1:10 – 1:50 pm Computational Systems Biology and the Drug Development Pipeline Eberhard O. Voit, PhD, Professor and David D. Flanagan Chair in Biological Systems, Georgia Inst of Technology Offers CPE Credit UAN #: 0238-0000-14-007-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 1:50 – 2:30 pm Systems Pharmacology Models for Antiviral Drug Development Joga Gobburu, PhD, MBA, Professor, School of Pharmacy, Univ of Maryland This Workshop is supported by an Educational Grant from AbbVie Inc CO-CHAIRS: 2:30 – 3:10 pm Rebecca N. Burns, PharmD, PhD, Assistant Professor, Mercer Univ Jeffry Florian, PhD, Pharmacometrics Reviewer, Ctr for Drug Evaluation and Research, US Food & Drug Administration Use of Systems Modeling for Decision Making During Pharmaceutical R&D Balaji Agoram, PhD, Director, MedImmune TARGET AUDIENCE: This session will be useful for pharmacists, clinical pharmacologists, basic scientists, modeling and simulation scientists and other healthcare professionals with an interest in utilizing the biology, pharmacology and pharmacokinetics/dynamics to model drug kinetics and effects. 3:10 – 3:30 pm / Break 3:30 – 4:10 pm Use of Systems Pharmacology Tools in Post-marketing Safety BACKGROUND REQUIREMENT: A basic biology, statistics and pharmacology background would be beneficial. Keith Burkhart, MD, Senior Advisor for Medical Toxicology, Ctr for Drug Evaluation and Research, US Food & Drug Administration GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Understand the utility of a systems biology approach; 2. Describe the systems pharmacology approach; 3. Understand the relevance of systems approaches in drug development, including its use in regulatory evaluation. 4:10 – 5:00 pm / Panel Discussion 1:00 – 1:10 pm Introduction Rebecca N. Burns, PharmD, PhD, Assistant Professor, Mercer Univ Jeffry Florian, PhD, Pharmacometrics Reviewer, Ctr for Drug Evaluation and Research, US Food & Drug Administration 16 Symposia SUNDAY, SEPTEMBER 14, 2014 l Symposium 1 l 8:00 am – 12:00 pm Room F–G Opportunities in Antimicrobial Development: Clinical Cases to Close the Research Gap 8:00 – 8:05 am Introduction Jesse T. Jacob, MD, Assistant Professor of Medicine, Div of Infectious Diseases, Emory Univ School of Medicine (Plan to attend Symposium 3 for more information on this topic) Offers both CPE and CME Credit UAN #: 0238-0000-14-008-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 8:05 – 8:45 am The Challenge of MRSA Infections in the Era of Multidrug Resistance Vanthida Huang, PharmD, BSPHM, Associate Professor, Midwestern Univ Coll of Pharmacy-Glendale This Symposium is supported by an Educational Grant from Cubist Pharmaceuticals Inc CO-CHAIRS: 8:45 – 9:25 am Jesse T. Jacob, MD, Assistant Professor of Medicine, Div of Infectious Diseases, Emory Univ School of Medicine Steve Mok, PharmD, Antimicrobial Stewardship Pharmacist, Emory Healthcare The Future of Vancomycin Dosing: Pharmacometrics and AUCs Michael Neely, MD, Associate Professor of Pediatrics, Univ of Southern California TARGET AUDIENCE: The target audience is healthcare professionals, including physicians and pharmacists, who have an interest in pharmacokinetics, pharmacodynamics, drug development, clinical trials and clinical pharmacology as they relate to infectious diseases. 9:25 – 10:05 am The Goldilocks Dilemma: Finding That “Just Right” Dose Steve Mok, PharmD, Antimicrobial Stewardship Pharmacist, Emory Healthcare BACKGROUND REQUIREMENT: None 10:05 – 10:30 am / Break GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Discuss the various therapeutic strategies for treatment of these infections, including in complex patients, and identify gaps in current evidence and research needs; 2. Identify patient populations who need dose adjustments that are different than the FDA-labeled doses; 3. Discuss the various methods of dosing vancomycin and the relationship between TDM and patient outcomes; 4. Determine the appropriate use (based on current literature) of the newer MRSA agents in endocarditis, meningitis and osteomyelitis; 5. Demonstrate the use of specific, clinically-oriented pharmacometric tools for AUC-guided vancomycin dosing; 6. Apply current evidence to treat multidrug-resistant gram negative bacilli. 17 10:30 – 11:10 am Gram Negative Gap: Approaches to Pharmacotherapy Jesse T. Jacob, MD, Assistant Professor of Medicine, Div of Infectious Diseases, Emory Univ School of Medicine 11:10 am – 12:00 pm / Panel Discussion Symposia SUNDAY, SEPTEMBER 14, 2014 l Symposium 2 l 8:00 am – 12:00 pm Room D–E Real-world, Large-scale Implementation of Pharmacogenetic-guided Drug Dosing 8:05 – 8:45 am CPIC and eMERGE: Translating Genomic Research into Therapeutic Recommendations Dan M. Roden, MD, Assistant Vice Chancellor for Personalized Medicine, Vanderbilt Univ School of Medicine Offers both CPE and CME Credit UAN #: 0238-0000-14-009-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 8:45 – 9:25 am CHAIR: Regulatory Approaches to Evaluate and Communicate PG Testing Recommendations Walter K. Kraft, MD, Associate Professor of Pharmacology and Therapeutics, Thomas Jefferson Univ Michael A. Pacanowski, PharmD, MPH, Associate Director for Genomics and Targeted Therapy, Ctr for Drug Evaluation and Research, US Food & Drug Administration TARGET AUDIENCE: The target audience is physicians, pharmacists, researchers and regulators who are seeking to understand the evaluation of pharmacogenetic research, how it is communicated to practitioners and how end users are trained. The goal is to provide models for implementation of pharmacogenetic data into clinical practice. 9:25 – 10:05 am Clinical Implementation of Pharmacogenetics: The Cincinnati Experience BACKGROUND REQUIREMENT: None Alexander A. Vinks, PharmD, PhD, Professor, Pediatrics & Pharmacology, Director, Div of Clinical Pharmacology, Cincinnati Children’s Hosp Medical Ctr GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Explain how drug dosing based upon pharmacogenetic discovery is validated; 2. Educate other caregivers regarding the limits and strengths of the technology; 3. Overcome logistical and ethical challenges associated with implementation. 10:05 – 10:30 am / Break 10:30 – 11:10 am How Much Do Practitioners Need to Know and How to Train Them Kristin Weitzel, PharmD, Associate Director, Clinical Associate Professor, Univ of Florida Health Personalized Medicine 8:00 – 8:05 am Introduction Walter K. Kraft, MD, Associate Professor of Pharmacology and Therapeutics, Thomas Jefferson Univ 11:10 am – 12:00 pm / Panel Discussion 18 Symposia SUNDAY, SEPTEMBER 14, 2014 l Symposium 3 l 1:30 – 5:30 pm Room F–G Opportunities and Challenges in New Antibiotic Development: A Multidisciplinary Perspective 1:35 – 2:20 pm The Current Challenge of Antibiotic Resistance to US Healthcare Arjun Srinivasan, MD, Associate Director for Healthcare Associated Infection Prevention Programs, Div of Healthcare Quality Promotion, Ctrs for Disease Control and Prevention (Plan to attend Symposium 1 for more information on this topic) Offers both CPE and CME Credit UAN #: 0238-0000-14-010-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 2:20 – 3:05 pm Antibiotic Development: The Regulatory Perspective This Symposium is supported by an Educational Grant from Cubist Pharmaceuticals Inc CO-CHAIRS: Jesse T. Jacob, MD, Assistant Professor of Medicine, Div of Infectious Diseases, Emory Univ School of Medicine David M. Tenero, PharmD, Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline TARGET AUDIENCE: David Ross, MD, PhD, MBI, Director, HIV, Hepatitis and Public Health Pathogens Programs, Dept of Veterans Affairs, Associate Clinical Professor, George Washington Univ School of Medicine 3:05 – 3:30 pm / Break 3:30 – 4:15 pm The target audience is healthcare professionals, including physicians and pharmacists, who have an interest in pharmacokinetics, pharmacodynamics, drug development, clinical trials and clinical pharmacology as they relate to infectious diseases. Advancing Study Design in Infectious Diseases: Scientifically Valid Approaches John H. Powers, MD, Associate Clinical Professor of Medicine, George Washington Univ School of Medicine BACKGROUND REQUIREMENT: Basic understanding of pharmacological study design for drug approval. GOALS AND OBJECTIVES: 4:15 – 5:00 pm MICs vs Time-Kill Curves: Which is the Better PK/PD Approach? Following completion of this activity, the learner will be able to: 1. Discuss the current state of antimicrobial resistance and identify the greatest need for new drug development; 2. Best design studies that fit within regulatory mechanisms; 3. Understand the issues that influence the development pathway for an antibiotic; Hartmut Derendorf, PhD, Distinguished Professor and Chairman, Dept of Pharmaceutics, Univ of Florida 5:00 – 5:30 pm / Q&A Session 4. Understand the in vitro time-kill PK/PD approach for antibiotics. 1:30 – 1:35 pm Introduction Jesse T. Jacob, MD, Assistant Professor of Medicine, Div of Infectious Diseases, Emory Univ School of Medicine David M. Tenero, PharmD, Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline 19 Symposia SUNDAY, SEPTEMBER 14, 2014 l Symposium 4 l 1:30 – 5:00 pm Room D–E Gender-specific Pharmacokinetics/ Pharmacodynamics (PK/PD) of Hypnotic Drugs 2:00 – 2:35 pm The Effect of Intrinsic Factors on Pharmacokinetics/Pharmacodynamics (PK/PD) of Hypnotic Drugs Jagan Mohan Parepally, PhD, Senior Clinical Pharmacologist, Ctr for Drug Evaluation and Research, US Food & Drug Administration Offers both CPE and CME Credit UAN #: 0238-0000-14-011-L01-P ACPE - 3 CONTACT HOURS / APPLICATION-BASED CO-CHAIRS: 2:35 – 3:10 pm Angela Yuxin Men, MD, PhD, Neurology Team Leader, Ctr for Drug Evaluation and Research, US Food & Drug Administration Jagan Mohan Parepally, PhD, Senior Clinical Pharmacologist, Ctr for Drug Evaluation and Research, US Food & Drug Administration Gender Differences in the Pharmacokinetics and Pharmacodynamics of Zolpidem: In vitro vs In vivo Findings David J. Greenblatt, MD, Professor of Pharmacology and Experimental Therapeutics, Tufts Univ School of Medicine TARGET AUDIENCE: The target audience is individuals involved in the development of hypnotic drugs, those that use hypnotic drugs in the clinical setting, including pharmacists and physicians, and scientists that conduct research on hypnotic drugs. 3:10 – 3:30 pm / Break 3:30 – 4:05 pm BACKGROUND REQUIREMENT: Driving Performance After Administration of Sleep Medication: Human Factors None Matthew Rizzo, MD, Frances and Edgar Reynolds Professor & Chair, Dept Neurological Sciences, Univ of Nebraska Coll of Medicine GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Identify the safety and efficacy of various hypnotic drugs; 2. Discuss the US Food & Drug Administration’s perspectives on the clinical pharmacology basis for the dosing recommendations; 3. Adjust dosing recommendations based on gender; 4. Overcome some of the challenges related to evaluating next day residual effects. 4:05 – 4:40 pm Safety and Efficacy of Hypnotic Drugs: Dosing Recommendations for Women Ronald Farkas, MD, PhD, Clinical Team Leader, Div of Neurology Products, Ctr for Drug Evaluation and Research, US Food & Drug Administration 1:30 – 2:00 pm Introduction: Why Does it Matter? Intrinsic Factors on Pharmacokinetics/ Pharmacodynamics (PK/PD) 4:40 – 5:00 pm / Panel Discussion Angela Yuxin Men, MD, PhD, Neurology Team Leader, Ctr for Drug Evaluation and Research, US Food & Drug Administration 20 Symposia MONDAY, SEPTEMBER 15, 2014 l Symposium 5 l 8:00 am – 12:00 pm Room F–G Pragmatic Assessment of Pro-arrhythmic Risk During Drug Development 8:40 – 9:15 am Pro-arrhythmic Assessment of Drugs: The Need for a New Paradigm Philip Sager, MD, Chair, Scientific Programs Committee, Cardiac Safety Consortium, Consulting Professor, Stanford Medical School (Plan to attend Symposium 7 for more information on this topic) Offers both CPE and CME Credit UAN #: 0238-0000-14-012-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 9:15 – 9:50 am Pro-arrhythmic Potential and Drug Development Decision Making: Current Practices and Future Directions This Symposium is supported by an Educational Grant from Bristol-Myers Squibb and Pfizer Inc Norman Stockbridge, MD, PhD, Director, Div of Cardiovascular and Renal Products, Ctr for Drug Evaluation and Research, US Food & Drug Administration CO-CHAIRS: Damayanthi Devineni, PhD, Director, Clinical Pharmacology, Janssen Research & Development LLC Anne Chain, PhD, Associate Principal Scientist, Merck 9:50 – 10:05 am / Q&A Session TARGET AUDIENCE: The target audience is clinical pharmacologists, pharmacists, specialty physicians, clinical research associates and basic scientists with an interest in drug development. 10:05 – 10:30 am / Break 10:30 – 10:35 am BACKGROUND REQUIREMENT: Introduction (after break) None Anne Chain, PhD, Associate Principal Scientist, Merck GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Describe the pros and cons of new and innovative approaches to better manage pro-arrhythmic risk during drug development; 2. Understand decision algorithms incorporating early markers of risk; 3. Generate a roadmap for pro-arrhythmic risk assessment during different stages of drug development. 10:35 – 11:10 am Developments in Nonclinical Approaches to Pro-arrhythmic Risk Assessment Bruce Damiano, PhD, Scientific Director and Fellow, Preclinical Development and Safety, Discovery Sciences, Janssen Research & Development LLC 8:00 – 8:05 am 11:10 – 11:45 am Introduction Role of Translational Approaches to Predict Pro-arrhythmic Risk in Clinic Based on Nonclinical Assays Damayanthi Devineni, PhD, Director, Clinical Pharmacology, Janssen Research & Development LLC Anne Chain, PhD, Associate Principal Scientist, Merck 8:05 – 8:40 am 11:45 am – 12:00 pm / Panel Discussion New Quantitative Approaches to Assess Pro-arrhythmic Risk Christine Garnett, PharmD, Vice President, Lead Scientist, Certara, Pharsight Consulting Svcs 21 Symposia MONDAY, SEPTEMBER 15, 2014 l Symposium 6 l 8:00 am – 12:00 pm Room D–E Elephant in the Room: Immunogenicity Potential of Biosimilars 8:05 – 8:40 am Introduction to Biosimilars Gillian Woollett, MA, DPhil, Senior Vice President, Avalere Health Offers both CPE and CME Credit UAN #: 0238-0000-14-013-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 8:40 – 9:15 am Immunogenicity of Biosimilars: Scientific and Regulatory Considerations This Symposium is supported by an Educational Grant from Amgen Inc Suraj G. Bhansali, PhD, Manager, Clinical Pharmacology, Novartis Pharmaceuticals Corp CO-CHAIRS: Suraj G. Bhansali, PhD, Manager, Clinical Pharmacology, Novartis Pharmaceuticals Corp Shefali Kakar, PhD, Senior Director, Clinical Pharmacology, Novartis Pharmaceuticals Corp 9:15 – 9:50 am Bio-analytical Assessment of Immunogenicity: Assay Formats and Impact on Comparability TARGET AUDIENCE: The target audience is the national and international scientific community in academia, pharma/biotechnology industry and regulatory agencies associated with drug development. Gopi Shankar, PhD, MBA, Senior Director, Janssen Research & Development LLC BACKGROUND REQUIREMENT: 9:50 – 10:05 am / Q&A Session None GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Introduce immunogenicity in the context of biosimilars (e.g. interchangeability, risk-based assessment, assay considerations, etc.); 2. Provide an overview of global regulatory biosimilars guidances; 3. Apply analytical methods to assess immunogenicity and explore emerging technologies to predict immunogenicity of biosimilars; 4. Develop strategies for clinical interpretation and implications of immunogenicity data – correlation with PK, safety and efficacy. 10:05 – 10:30 am / Break 10:30 – 11:05 am Clinical Development of Biosimilars: Addressing Immunogenicity and Interchangeability Shefali Kakar, PhD, Senior Director, Clinical Pharmacology, Novartis Pharmaceuticals Corp 11:05 – 11:40 am 8:00 – 8:05 am The Clinical Pharmacology Perspectives for Assessing Immunogenicity of Biologics: How Are We Doing? What Lies Ahead? Introduction Suraj G. Bhansali, PhD, Manager, Clinical Pharmacology, Novartis Pharmaceuticals Corp Shefali Kakar, PhD, Senior Director, Clinical Pharmacology, Novartis Pharmaceuticals Corp Yow-Ming C. Wang, PhD, Clinical Pharmacology Biologics Team Leader, Ctr for Drug Evaluation and Research, US Food & Drug Administration 11:40 am – 12:00 pm / Panel Discussion 22 Symposia MONDAY, SEPTEMBER 15, 2014 l Symposium 7 l 1:00 – 5:00 pm Room F–G Cardiovascular Diseases: Drug Discovery to Recovery 1:30 – 1:55 pm Angiotensin Converting Enzyme2: Recent Advances and Our Experiences (Plan to attend Symposium 5 for more information on this topic) Vinayak Shenoy, PhD, Assistant Research Scientist, Univ of Florida Offers both CPE and CME Credit UAN #: 0238-0000-14-014-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 1:55 – 2:20 pm Resistant Hypertension: New Therapeutic Considerations This Symposium is supported by an Educational Grant from Bristol-Myers Squibb and Pfizer Inc Jasenka Zubcevic, PhD, Research Assistant Professor, Univ of Florida CO-CHAIRS: Gangadhar Sunkara, PhD, Executive Director, Novartis Inst of BioMedical Research Manoj Jadhav, PhD, Post-doctoral Research Associate, Div of Cardiology, Coll of Medicine, Univ of Florida 2:20 – 2:45 pm Clinical Studies with Cardiovascular Diseases: Overview TARGET AUDIENCE: Deven V. Parmar, MBBS, MD, Director, Clinical Development, Prolong Pharmaceuticals LLC The target audience is healthcare professionals, including pharmacists, clinical pharmacologists and basic scientists who are involved in drug development and research on cardiovascular disease. The course is also applicable to students pursuing their MD, PhD or PharmD. 2:45 – 3:10 pm The Patient Experience with Anticoagulants and Antiplatelets BACKGROUND REQUIREMENT: None Kathryn M. Momary, PharmD, Associate Professor, Mercer Univ Coll of Pharmacy GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Understand recent advances in research and treatment for cardiovascular diseases; 2. Implement recent advances related to research and treatment for cardiovascular diseases as appropriate. 3:10 – 3:30 pm / Break 3:30 – 3:55 pm Balancing Sensitivity and Specificity in Assessment of Cardiovascular Safety of Drugs 1:00 – 1:05 pm Introduction Manoj Jadhav, PhD, Post-doctoral Research Associate, Div of Cardiology, Coll of Medicine, Univ of Florida Norman Stockbridge, MD, PhD, Director, Div of Cardiovascular and Renal Products, Ctr for Drug Evaluation and Research, US Food & Drug Administration 1:05 – 1:30 pm 3:55 – 4:20 pm Cardiovascular Drug Discovery and Development: Translational Challenges Immunity, Inflammation and Hypertension David G. Harrison, MD, Betty and Jack Bailey Professor of Medicine and Pharmacology, Director, Clinical Pharmacology, Vanderbilt Univ School of Medicine Gangadhar Sunkara, PhD, Executive Director, Novartis Inst of BioMedical Research 4:20 – 5:00 pm / Panel Discussion 23 Symposia MONDAY, SEPTEMBER 15, 2014 l Symposium 8 l 1:00 – 5:00 pm Room D–E Biotherapeutics With Novel Protein Scaffolds: How Translational Research Helps Turn Creative Concepts into a Reality 1:05 – 1:45 pm Translational Considerations in Developing Bi-specific Antibodies: What Can We Learn from Mechanism PK/PD Modeling? Bernd Meibohm, PhD, Professor of Pharmaceutical Sciences, Associate Dean for Research and Graduate Programs, Coll of Pharmacy, The Univ of Tennessee Health Science Ctr Offers CPE Credit UAN #: 0238-0000-14-015-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 1:45 – 2:25 pm Risk Assessments for Biospecific Biotherapeutic Developability CHAIR: Honghui Zhou, PhD, Senior Director and Janssen Fellow, Biologics Clinical Pharmacology, Janssen Research & Development LLC Mark Chiu, PhD, Associate Director, Biologics Research, Janssen Biotechnology Ctr of Excellence TARGET AUDIENCE: The target audience is pharmaceutical scientists, pharmacists and clinical pharmacologists in either the pharmaceutical/biotech industry or regulatory agencies. 2:25 – 3:05 pm Absorption, Distribution, Metabolism and Elimination (ADME) and Drug-Drug Interactions (DDIs) of Antibody-Drug Conjugates (ADCs) BACKGROUND REQUIREMENT: Basic knowledge of biotherapeutics, PK/PD and clinical pharmacology. Jing Yang, PhD, Pharmacokineticist, Clinical Pharmacology, Seattle Genetics Inc GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Understand the challenges in developing biotherapeutics with novel protein scaffolds; 2. Address the challenges in developing bi-specific antibodies and antibody-drug conjugates (ADCs); 3. Effectively move those biotherapeutics from the preclinical space into evidence-based clinical development. 3:05 – 3:30 pm / Break 3:30 – 4:10 pm Characterizing Antibody-Drug Conjugates (ADCs) Efficacy and Toxicity: The PK/PD and Bioanalytical Challenges Brooke Rock, PhD, Senior Scientist, Amgen Inc 1:00 – 1:05 pm Introduction to Biotherapeutics With Novel Scaffolds 4:10 – 5:00 pm / Q&A Session Honghui Zhou, PhD, Senior Director and Janssen Fellow, Biologics Clinical Pharmacology, Janssen Research & Development LLC 24 Symposia TUESDAY, SEPTEMBER 16, 2014 l Symposium 9 l 8:00 – 11:30 am Room F–G Key Considerations for Efficient Study Designs in Early Stage Clinical Development and Proof-of-Concept Studies 8:05 – 8:50 am Some Ruminations on the Design, Analysis and Interpretation of First-in-Man and Phase 1 Studies Michael J. Fossler, Jr., PharmD, PhD, Senior Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline Offers CPE Credit UAN #: 0238-0000-14-016-L01-P ACPE - 3 CONTACT HOURS / APPLICATION-BASED 8:50 – 9:35 am Preclinical Designs/Efficacy Models Supporting Proof-of-Concept Studies CHAIR: Lorraine M. Rusch, PhD, Vice President, Business Development, Vince & Associates Clinical Research Inc TARGET AUDIENCE: The target audience is clinical pharmacologists, pharmacists, clinical operations personnel, clinical research associates, project managers, clinical study managers and coordinators and recruiting staff interested in the design and execution of early phase clinical trials utilizing a Proofof-Concept model. BACKGROUND REQUIREMENT: None Luana Pesco Koplowitz, MD, PhD, President, Chief Medical & Scientific Officer, DUCK FLATS Pharma LLC 9:35 – 10:10 am Recruitment and Medical Management of Special Patient Populations for Proof-ofConcept Studies Lorraine M. Rusch, PhD, Vice President, Business Development, Vince & Associates Clinical Research Inc 10:10 – 10:30 am / Break GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Implement best practices for designing a clinical development program encompassing preclinical studies through the First-in-Man and Patient Proof-of-Concept studies, including design, safety and recruiting options. 10:30 – 11:05 am IRB Considerations: Approving Protocols with Healthy Normal Volunteers/Special Populations and Overall Subject Safety Kathy A. Chase, PharmD, Chairperson, MidLands IRB 8:00 – 8:05 am 11:05 – 11:30 am / Panel Discussion Introduction Lorraine M. Rusch, PhD, Vice President, Business Development, Vince & Associates Clinical Research Inc 25 Symposia TUESDAY, SEPTEMBER 16, 2014 l Symposium 10 l 8:00 am – 12:00 pm Room D–E Is Rational Use of Medicines Guided by Laboratory Tests, Cost, Quality or Ethics? 8:05 – 8:35 am Perspectives of a Pediatrician John N. van den Anker, MD, PhD, Chief, Div of Pediatric Clinical Pharmacology, Children’s National Health System, Chair, Dept of Pediatric Pharmacology, Univ Children’s Hosp, Basel Offers both CPE and CME Credit UAN #: 0238-0000-14-017-L04-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED 8:35 – 9:05 am This Symposium is supported by an Educational Grant from GVK Biosciences Pvt Ltd The Use of Next Generation Diagnostics for the Rational Use of Drugs: A Comparison of Practices in the Developed World vs Developing Nations CO-CHAIRS: Nilima Kshirsagar, MD, PhD, National Chair, Clinical Pharmacology, Indian Council of Medical Research, Dean, ESI Post Graduate Inst of Medical Science and Research, Govt of India Hartmut Derendorf, PhD, Distinguished Professor and Chairman, Dept of Pharmaceutics, Univ of Florida Nikhil Phadke, PhD, Chief Scientific Officer, GenePath Dx 9:05 – 9:35 am Measuring the Cost Effectiveness of Pharmacogenomic Testing TARGET AUDIENCE: The target audience is clinical and administrative healthcare system decision makers, including physicans and pharmacists, pharma and diagnostic test researchers and manufacturers. Kenneth Levy, PhD, MBA, Adjunct Associate Professor of Medicine, Indiana Univ School of Medicine BACKGROUND REQUIREMENT: 9:35 – 10:05 am / Q&A Session None 10:05 – 10:30 am / Break GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Describe the current ethical, cost and outcomes dilemmas from the perspectives of healthcare providers, administrators and industry in developed and developing economies; 2. Implement methods to overcome these dilemmas; 3. Evaluate tests and techniques appropriately for their benefit, cost and importance of clinical history and examination; 4. Identify key tools to establish or expand a pharmacogenomic testing program. 10:30 – 11:00 am Pharmacogenetics and Ethics in Personalized Medicine David A. Flockhart, MD, PhD, Director, Indiana Inst for Personalized Medicine 11:00 – 11:30 am Rational Use of Medicines: Cost Considerations and the Way Forward 8:00 – 8:05 am Nilima Kshirsagar, MD, PhD, National Chair, Clinical Pharmacology, Indian Council of Medical Research, Dean, ESI Post Graduate Inst of Medical Science and Research, Govt of India Introduction Hartmut Derendorf, PhD, Distinguished Professor and Chairman, Dept of Pharmaceutics, Univ of Florida 11:30 am – 12:00 pm / Panel Discussion 26 Symposia TUESDAY, SEPTEMBER 16, 2014 l Symposium 11 l 1:30 – 5:30 pm Room F–G Many Features of an Integrated Development for Pediatric Drug Use Jian Wang, PhD, Senior Clinical Pharmacologist, Ctr for Drug Evaluation and Research, US Food & Drug Administration 2:10 – 2:40 pm Offers both CPE and CME Credit UAN #: 0238-0000-14-018-L01-P ACPE - 3.5 CONTACT HOURS / APPLICATION-BASED Clinical Perspectives: What We’ve Learned Illustrated by Case Studies Jeffrey Blumer, PhD, MD, Professor and Chair, Dept of Pediatrics, The Univ of Toledo Coll of Medicine CO-CHAIRS: Jing-He Yan, PhD, Senior Investigator, Clinical PK/PD, Novartis Inst of BioMedical Research Jun Yang, PhD, Senior Reviewer, Ctr for Drug Evaluation and Research, US Food & Drug Administration 2:40 – 3:10 pm The Role of Translational Medicine in Pediatric Research J. Steven Leeder, PharmD, PhD, Director, Div of Clinical Pharmacology and Therapeutic Innovation, Children’s Mercy Hosp and Clinics TARGET AUDIENCE: The target audience is specialty physicians, clinical pharmacologists, pharmacists, clinical research associates and basic scientists with an interest in an integrated development for pediatric drug use. 3:10 – 3:30 pm / Break BACKGROUND REQUIREMENT: Basic clinical pharmacology concepts such as pharmacokinetics and pharmacodynamics, basic regulatory knowledge, related research and development experience. 3:30 – 4:00 pm Pre-clinical Safety: An Important Part of an Integrated Package GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Understand the regulatory landscape of pediatric clinical research for potential therapeutics; 2. Understand the scope of an integrated drug development for pediatric use; 3. Understand the importance of integration and interaction among different areas of expertise in pediatric drug research. 1:30 – 1:35 pm Introduction Lakshmi Sivaraman, PhD, Principal Scientist, Drug Safety Evaluation, Bristol-Myers Squibb 4:00 – 4:30 pm Modeling and Simulation in Pediatric Drug Development: Are We on Track? Kevin Krudys, PhD, Acting Team Leader, Div of Pharmacometrics, Ctr for Drug Evaluation and Research, US Food & Drug Administration 4:30 – 5:00 pm Jing-He Yan, PhD, Senior Investigator, Clinical PK/PD, Novartis Inst of BioMedical Research Jun Yang, PhD, Senior Reviewer, Ctr for Drug Evaluation and Research, US Food & Drug Administration Challenges in Formulation Development for Infants and Children Venkateswar Jarugula, PhD, Executive Director, Novartis Inst of BioMedical Research 1:35 – 2:10 pm 5:00 – 5:30 pm / Panel Discussion Pediatric Global Regulatory Overview: Status, Challenges and Opportunities with Focus on the US and European Union 27 Symposia TUESDAY, SEPTEMBER 16, 2014 l Symposium 12 l 1:30 – 5:00 pm Room D–E Bench to Market: REMS at the Crossroads 1:35 – 2:00 pm Offers both CPE and CME Credit UAN #: 0238-0000-14-019-L05-P ACPE - 3 CONTACT HOURS / APPLICATION-BASED Elizabeth E. Garrard, PharmD, Senior Director, Safety Risk Management, United Therapeutics Corp Effectiveness of REMS: Have We Progressed? 2:00 – 2:35 pm CHAIR: REMS: A US Food & Drug Administration Update Deven V. Parmar, MBBS, MD, Director, Clinical Development, Prolong Pharmaceuticals LLC Theresa Toigo, MBA, RPh, Associate Director, Drug Safety Operations, Ctr for Drug Evaluation and Research, US Food & Drug Administration TARGET AUDIENCE: The target audience is clinical practitioners, pharmacists, clinical pharmacologists and regulatory experts who need to understand and manage the risk profile of new and existing medications. 2:35 – 3:00 pm BACKGROUND REQUIREMENT: Global Risk Management Plans: Need of the Hour? None GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Outline the current thinking on REMS and the implications for clinical pharmacology; 2. Discuss differences between important identified risks and important potential risks; 3. Identify primary tools for managing product risks, how the effectiveness of a selected tool is assessed and triggers for modification or removal of a given intervention; 4. Describe the future drivers for REMS. Sheila Weiss, PhD, Chief Science Officer, Vice President, Research, DrugLogic 3:00 – 3:30 pm / Break 3:30 – 3:55 pm Communication in Drug Safety Dharani Gokul Munirathinam, MBBS, Senior Manager PV & Risk Management, Synowledge LLC 3:55 – 4:30 pm 1:30 – 1:35 pm Strategies to Address Prescribing Behavior and Physicians’ Knowledge Introduction Deven V. Parmar, MBBS, MD, Director, Clinical Development, Prolong Pharmaceuticals LLC Judith K. Jones, MD, PhD, President, Chief Executive Officer, The Degge Group Ltd 4:30 – 5:00 pm / Panel Discussion 28 Faculty Last Name First Name Activity Affiliation Agoram Balaji Bhansali Suraj G. Symposium 6 Manager, Clinical Pharmacology, Novartis Pharmaceuticals Corp Blumer Jeffrey Symposium 11 Professor and Chair, Dept of Pediatrics, The Univ of Toledo Coll of Medicine Burkhart Keith Pre-meeting Workshop 4 Burns Rebecca N. Chain Anne Symposium 5 Associate Principal Scientist, Merck Chase Kathy A. Symposium 9 Chairperson, MidLands IRB Chiu Mark Symposium 8 Associate Director, Biologics Research, Janssen Biotechnology Ctr of Excellence Curro Frederick A. Damiano Bruce Symposium 5 Derendorf Hartmut Symposia 3 & 10 Devineni Damayanthi Symposium 5 Director, Clinical Pharmacology, Janssen Research & Development LLC Farkas Ronald Symposium 4 Clinical Team Leader, Div of Neurology Products, Ctr for Drug Evaluation and Research, US Food & Drug Administration Flockhart David A. Symposium 10 Director, Indiana Inst for Personalized Medicine Florian Jeffry Pre-meeting Workshop 4 Fossler, Jr. Michael J. Symposium 9 Senior Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline Garnett Christine Symposium 5 Vice President, Lead Scientist, Certara, Pharsight Consulting Svcs Garrard Elizabeth E. Symposium 12 Senior Director, Safety Risk Management, United Therapeutics Corp Gobburu Joga Pre-meeting Workshops 1&4 Gokul Munirathinam Dharani Symposium 12 Gopalakrishnan Mathangi Greenblatt David J. Symposium 4 Professor of Pharmacology and Experimental Therapeutics, Tufts Univ School of Medicine Harrison David G. Symposium 7 Betty and Jack Bailey Professor of Medicine and Pharmacology, Director, Clinical Pharmacology, Vanderbilt Univ School of Medicine Huang Vanthida Symposium 1 Associate Professor, Midwestern Univ Coll of Pharmacy-Glendale Jacob Jesse T. Symposia 1 & 3 Jadhav Manoj Symposium 7 Post-doctoral Research Associate, Div of Cardiology, Coll of Medicine, Univ of Florida Jarugula Venkateswar Symposium 11 Executive Director, Novartis Inst of BioMedical Research Pre-meeting Workshop 4 Director, MedImmune Senior Advisor for Medical Toxicology, Ctr for Drug Evaluation and Research, US Food & Drug Administration Pre-meeting Workshop 4 Assistant Professor, Mercer Univ Pre-meeting Workshop 2 Director, PEARL Practice-Based Translational Network, New York Univ Scientific Director and Fellow, Preclinical Development and Safety, Discovery Sciences, Janssen Research & Development LLC Distinguished Professor and Chairman, Dept of Pharmaceutics, Univ of Florida Pharmacometrics Reviewer, Ctr for Drug Evaluation and Research, US Food & Drug Administration Professor, School of Pharmacy, Univ of Maryland Senior Manager PV & Risk Management, Synowledge LLC Pre-meeting Workshop 1 Research Assistant Professor, Univ of Maryland Assistant Professor of Medicine, Div of Infectious Diseases, Emory Univ School of Medicine 29 Faculty Last Name First Name Activity Affiliation Jones Judith K. Symposium 12 President, Chief Executive Officer, The Degge Group Ltd Kakar Shefali Symposium 6 Senior Director, Clinical Pharmacology, Novartis Pharmaceuticals Corp Kraft Walter K. Krudys Kevin Symposium 11 Acting Team Leader, Div of Pharmacometrics, Ctr for Drug Evaluation and Research, US Food & Drug Administration Kshirsagar Nilima Symposium 10 National Chair, Clinical Pharmacology, Indian Council of Medical Research, Dean, ESI Post Graduate Inst of Medical Science and Research, Govt of India Leeder J. Steven Symposium 11 Director, Div of Clinical Pharmacology and Therapeutic Innovation, Children’s Mercy Hosp and Clinics Levy Kenneth Symposium 10 Adjunct Associate Professor of Medicine, Indiana Univ School of Medicine Meibohm Bernd Symposium 8 Professor of Pharmaceutical Sciences, Associate Dean for Research and Graduate Programs, Coll of Pharmacy, The Univ of Tennessee Health Science Ctr Men Angela Yuxin Symposium 4 Neurology Team Leader, Ctr for Drug Evaluation and Research, US Food & Drug Administration Mok Steve Symposium 1 Antimicrobial Stewardship Pharmacist, Emory Healthcare Momary Kathryn M. Symposium 7 Associate Professor, Mercer Univ Coll of Pharmacy Neely Michael Symposium 1 Associate Professor of Pediatrics, Univ of Southern California Pacanowski Michael A. Symposium 2 Associate Director for Genomics and Targeted Therapy, Ctr for Drug Evaluation and Research, US Food & Drug Administration Parepally Jagan Mohan Symposium 4 Senior Clinical Pharmacologist, Ctr for Drug Evaluation and Research, US Food & Drug Administration Parmar Deven V. Symposia 7 & 12 Pesco Koplowitz Luana Symposium 9 President, Chief Medical & Scientific Officer, DUCK FLATS Pharma LLC Phadke Nikhil Symposium 10 Chief Scientific Officer, GenePath Dx Poirier Michael Powers John H. Rhudy Hayden A. Rizzo Matthew Symposium 4 Frances and Edgar Reynolds Professor & Chair, Dept Neurological Sciences, Univ of Nebraska Coll of Medicine Rock Brooke Symposium 8 Senior Scientist, Amgen Inc Roden Dan M. Symposium 2 Assistant Vice Chancellor for Personalized Medicine, Vanderbilt Univ School of Medicine Ross David Symposium 3 Director, HIV, Hepatitis and Public Health Pathogens Programs, Dept of Veterans Affairs, Associate Clinical Professor, George Washington Univ School of Medicine Rusch Lorraine M. Symposium 9 Vice President, Business Development, Vince & Associates Clinical Research Inc Sadhasivam Senthilkumar Pre-meeting Workshop 2 Pre-meeting Workshop 2 Associate Professor of Pharmacology and Therapeutics, Thomas Jefferson Univ & Symposium 2 Director, Clinical Development, Prolong Pharmaceuticals LLC Pre-meeting Workshop 3 Vice President, Biogen Idec Symposium 3 Associate Clinical Professor of Medicine, George Washington Univ School of Medicine Pre-meeting Workshop 3 Director, Therapeutic Area Strategies, Government Affairs, AbbVie Inc Professor of Anesthesia and Pediatrics, Director of Perioperative Pain Svc, Cincinnati Children’s Hosp Medical Ctr 30 Faculty Last Name First Name Activity Affiliation Sager Philip Symposium 5 Chair, Scientific Programs Committee, Cardiac Safety Consortium, Consulting Professor, Stanford Medical School Shankar Gopi Symposium 6 Senior Director, Janssen Research & Development LLC Shenoy Vinayak Symposium 7 Assistant Research Scientist, Univ of Florida Sinha Vikram Pre-meeting Workshops 1&3 Sivaraman Lakshmi Symposium 11 Principal Scientist, Drug Safety Evaluation, Bristol-Myers Squibb Srinivasan Arjun Symposium 3 Associate Director for Healthcare Associated Infection Prevention Programs, Div of Healthcare Quality Promotion, Ctrs for Disease Control and Prevention Stockbridge Norman Symposia 5 & 7 Sugerman David E. Pre-meeting Workshop 2 Sunkara Gangadhar Symposium 7 Executive Director, Novartis Inst of BioMedical Research Tenero David M. Symposium 3 Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline Toigo Theresa Symposium 12 Associate Director, Drug Safety Operations, Ctr for Drug Evaluation and Research, US Food & Drug Administration van den Anker John N. Symposium 10 Chief, Div of Pediatric Clinical Pharmacology, Children’s National Health System, Chair, Dept of Pediatric Pharmacology, Univ Children’s Hosp, Basel Vinks Alexander A. Symposium 2 Professor, Pediatrics & Pharmacology, Director, Div of Clinical Pharmacology, Cincinnati Children’s Hosp Medical Ctr Voit Eberhard O. Wang Jian Symposium 11 Senior Clinical Pharmacologist, Ctr for Drug Evaluation and Research, US Food & Drug Administration Wang Yow-Ming C. Symposium 6 Clinical Pharmacology Biologics Team Leader, Ctr for Drug Evaluation and Research, US Food & Drug Administration Webster Lynn Weiss Sheila Symposium 12 Chief Science Officer, Vice President, Research, DrugLogic Weitzel Kristin Symposium 2 Associate Director, Clinical Associate Professor, Univ of Florida Health Personalized Medicine Woollett Gillian Symposium 6 Senior Vice President, Avalere Health Yan Jing-He Symposium 11 Senior Investigator, Clinical PK/PD, Novartis Inst of BioMedical Research Yang Jing Symposium 8 Pharmacokineticist, Clinical Pharmacology, Seattle Genetics Inc Yang Jun Symposium 11 Senior Reviewer, Ctr for Drug Evaluation and Research, US Food & Drug Administration Younis Islam R. Pre-meeting Workshop 3 Team Leader, Office of Clinical Pharmacology, Ctr for Drug Evaluation and Research, US Food & Drug Administration Zhou Honghui Symposium 8 Senior Director and Janssen Fellow, Biologics Clinical Pharmacology, Janssen Research & Development LLC Zubcevic Jasenka Symposium 7 Research Assistant Professor, Univ of Florida Director, Div of Pharmacometrics, Ctr for Drug Evaluation and Research, US Food & Drug Administration Director, Div of Cardiovascular and Renal Products, Ctr for Drug Evaluation and Research, US Food & Drug Administration Team Lead, Prescription Drug Overdose (PDO) Health System and State Intervention Team, Div of Unintentional Injury Prevention, Ctrs for Disease Control and Prevention Pre-meeting Workshop 4 Professor and David D. Flanagan Chair in Biological Systems, Georgia Inst of Technology Pre-meeting Workshop 2 Vice President of Scientific Affairs, PRA Health Sciences 31 Why Join ACCP? Why Should You Join the American College of Clinical Pharmacology? ACCP membership runs on a calendar year, January to December. Dues renewal notifications are sent in September for the coming year. Persons joining mid-year should utilize the “Half-year” dues option. Please note that the “Half-year” option is only available the first year of ACCP membership. All future payments must be full-year payments. • Free access to the latest scientific research. Members have free online access to ACCP’s high quality publications, The Journal of Clinical Pharmacology, published for over 50 years, and Clinical Pharmacology in Drug Development, introduced in 2012. eTOC notifications are sent for both journals, and the JCP eTOC highlights journal articles for Continuing Education credit and Editor’s Choice articles. Archives of The Journal of Clinical Pharmacology dating back to 1961 and Clinical Pharmacology in Drug Development since 2012 are available to Members. BEFORE YOU APPLY FOR MEMBERSHIP, PLEASE NOTE IF ANY OF THE FOLLOWING APPLY TO YOU: • CME and CPE credits on selected articles in The Journal of Clinical Pharmacology. • Been a Member of ACCP in the past; • Have attended an Annual Meeting or Frontiers Meeting; • Presented a poster at an ACCP Meeting; • Participated as Faculty at an ACCP Meeting. Please contact [email protected] for existing profile and login information. • Networking opportunities at the ACCP Annual Meeting and, for Students & Trainees, access to Mentors. ACCP MEMBERSHIP REQUIREMENTS • Access to the ACCP Job Center to view jobs and post your resume. • Discounted registration for the ACCP Annual Meeting, your source for current, interdisciplinary ACCME & ACPE accredited Continuing Education programs in a live format. • Opportunity to develop educational activities that make a difference by submitting proposals for ACCP educational events and getting involved in the clinical pharmacology community. All new applicants are required to Complete/Update a Profile; Submit a CV to [email protected]; Note which of the Activities & Specialties best describe your current position and send to [email protected]; • • Student Member applicants must also submit some form of verification of student status to [email protected]; Fellow applicants must submit two letters of support from current ACCP Fellows to [email protected]. ACCP offers discounted fees for Members in Developing Countries. • Opportunity to enhance your leadership skills by volunteering for one of ACCP’s many committees or by Mentoring Students & Trainees. • • • • Receive daily information on FDA notifications for Members who opt in to receive the FDANews Drug Daily Bulletin and routine recall/drug safety notices from FDA Medwatch. • Receive routine updates from ACCP about developments in the field of clinical pharmacology and future ACCP events. 32 Students & Trainees Send Us Your CV for a Review! Annual Meeting Events for Students & Trainees All Student & Trainee attendees were encouraged to provide their CV for review and suggestions by ACCP Mentors. If you submitted a resume and wish to meet with a Mentor in person at the meeting, please stop by the Registration Desk by the end of the day on Sunday, September 14th, to set up an appointment with a Mentor. Student & Trainee membership and participation in ACCP’s Annual Meeting are strongly encouraged and are beneficial on several levels: • Mentoring and expert guidance • Student & Trainee-specific events at the Annual Meeting • Substantially discounted registration fees for educational events • ACCP Student Abstract Awards Program Join, Get Involved and Enjoy the Benefits of ACCP Membership! Visit us at Join Us for the Student Tutorials on Poster Presentation Skills & Targeting Journals for Manuscript Submission – Sunday, September 14th, 5:30 – 6:30 pm, Room D – E 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 [email protected]. Students & Trainees and their advisors are encouraged to join us for this exceptional opportunity to acquire essential skills that can enhance their research efforts. Two tutorials will be presented: • Poster Presentation Skills: Increase your confidence and effectiveness at presenting your research poster at academic sessions and professional conferences, presented by Catherine M. Sherwin, PhD. • Finding the Right Journal for Your Work: Gain insight into approaches used by experienced professionals in targeting journals for manuscript submissions, presented by Barbara Ameer, PharmD, MBA. These tutorials are provided at no cost to Annual Meeting attendees. Let Your Poster Shine in a Podium Presentation! From the outstanding Student & Trainee abstracts submitted for the 2014 Annual Meeting, several have been selected for Podium Presentations on Monday, September 15th, 5:00 – 6:00 pm, Room D – E. Don’t miss the opportunity to hear the presentations of these young professionals! Amelia N. Deitchman, PharmD Poster Tours with Mentors Fellows or senior Members of ACCP will tour Students & Trainees through the poster area on Monday, September 15th to discuss preselected posters that provide exceptional educational material. Interested in participating? Please meet at the ACCP Registration Desk at 5:45 pm to join the tour group. 33 Daniel Gonzalez, PharmD, PhD Sponsors ACCP gratefully acknowledges Sponsors of the 2014 Annual Meeting: GOLD S I LV E R BRONZE LEVEL SPONSOR LEVEL SPONSOR LEVEL SPONSORS 34 Exhibitors ACCP gratefully acknowledges 2014 Exhibitors BioPharma Services is a Physician-owned Early Phase CRO. We provide BioAnaltyical Services, Phase 1 Trials to Proof-of-Concept Studies. With over 220 clinical beds in the United States and Canada, BioPharma Services is able to provide a broad range of clinical trial services, and is proficient at recruiting Normal Healthy Volunteers, Special Populations, and Patient Populations. Backed by a strong, knowledgeable and experienced Scientific and Regulatory team, BioPharma Services currently serves Pharmaceutical, Biotechnology and Medical Device companies globally. www.biopharmaservices.ca Compass Research is a multi-therapeutic, Phase 0–4 clinical research company headquartered in Orlando, FL, with additional research centers located in Oviedo and Leesburg, FL. With proven experience since 1992, Compass has grown in size and industry presence to become one of the premier research sites in the world. Compass serves over 200 sponsors, from small biotech companies to the world’s largest pharmaceutical companies, and has completed over 1,300 trials. The company has 78 inpatient beds between its two inpatient research clinics. With more than 300 years of combined clinical research experience, the Compass team is renowned for enrolling specialty patient populations and completing advanced diagnostic procedures. www.compassresearch.com GVK Biosciences (GVK BIO) is Asia’s leading Contract Research Organization from India, which offers comprehensive services from Informatics and chemistry synthesis to clinical trials. Currently, we provide holistic services to nearly 200 companies, offering specialized services to our clients from various verticals from Chemistry and Biology to Informatics and Predictive Analytics to cater requirements of clients in different domains with flexible business models customized to suit client needs. The Informatics division of GVK BIO is one of the oldest and largest informatics service providers in India. We have over 500 scientists working to provide Informatics services and proprietary Bio/Chemical databases to our customers. GVK BIO’s Informatics group has more than 12 years of experience in data mining, curation and analysis aspects from data published in literature references, patents, company websites, and regulatory documents as well as confidential documents from the client’s side. Our scientists have expertise in multiple areas such as Chemistry, Pharmacology, Biology, Biomarker and Clinical data. Significant numbers of scientists work on client-specific projects where the objective and scope of data mining, curation and overall outcome of the project has been defined by the client with stringent quality control processes. www.gvkbio.com KCAS is a bioanalytical and immunoanalytical contract research organization supporting pharmaceutical and biotechnology companies with their discovery, preclinical and clinical development programs. Over the past 35 years our team has developed 4,600+ proprietary and 900+ generic assays. Our reputation is built on robust small molecule, large molecule and biomarker analysis. www.kcasbio.com 35 Exhibitors NIH/Loan Repayment Programs: To assist in the recruitment and retention of biomedical or behavioral researchers, the National Institutes of Health (NIH) Division of Loan Repayment (DLR) offers qualified participants substantial assistance to repay educational loans. DLR administers all aspects of the NIH Extramural Loan Repayment Programs (LRPs) for scientists conducting nonprofit research outside of NIH, and supports application and payment activities for the Intramural LRPs for NIH employee researchers. New awards are made for two-year periods. Participants may also apply for competitive renewals. The extramural research areas include Clinical, Pediatric, Health Disparities, Contraception and Infertility, and Clinical Research for Individuals from Disadvantaged Backgrounds. www.lrp.nih.gov NOCCR and VRG are privately owned, multispecialty clinical research groups conducting over 2000 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 University of Tennessee Medical Center, with code team and 24 hour critical care coverage. This Unit is well 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 At PRA Health Sciences, providing innovative solutions for our clients is what we do. Side-byside with our clients, we strive to move drug discovery forward, helping them to develop life-saving and life-improving drugs. PRA has more than 10,000 employees working in 80+ countries providing comprehensive clinical development services across all phases. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs. www.PRAHS.com Proove Biosciences is the Personalized Pain Medicine Company. Our mission is to Change the Future of Medicine. Based in Southern California, Proove provides physicians with information to improve the selection, dosing, and evaluation of medications. www.ProoveBio.com Simulations Plus gold-standard simulation & modeling software is used worldwide in drug discovery and development – GastroPlus™, DDDPlus™, MembranePlus™, ADMET Predictor™, MedChem Studio™ & MedChem Designer™ – for simulation of oral absorption/PK/PD/PBPK, in vitro dissolution & permeability experiments, and accurate ADMET property prediction, fast ADMET/QSAR model-building and classification of molecules. www.simulations-plus.com 36 Exhibitors Verified Clinical Trials (VCT) is the global, web-based research subject database registry adopted by major pharmaceutical companies, CROs and sites to stop dual enrollment in all phases of clinical research. Early phase clinical trials are especially prone to professional research subjects that attempt to gain access to more than one trial simultaneously or too soon before the mandated and safe lockout period has ended. VCT improves research volunteer safety and data quality and reduces liabilities. VCT will reduce placebo effects as well as potential adverse events which is critical to the success of an investigational product. VCT provides numerous safety alerts and helps select better quality subjects for your clinical trial. www.verifiedclinicaltrials.com Vince & Associates Clinical Research has provided early phase clinical research services to the global biopharmaceutical industry for nearly 15 years. Our extensive experience in Phase 1 through POC clinical trials coupled with our unparalleled access to special populations has made us one of the premier sites in the US. www.vinceandassociates.com Wiley is the leading society publisher. We publish on behalf of more societies and membership associations than anybody else, and offer libraries and individuals 1250 online journals, thousands of books and e-books, reviews, reference works, databases, and more. For more information, visit www.wiley.com, or our online resource: onlinelibrary.wiley.com. www.wiley.com NEW SUBSCRIBERS: Take 20% off Drug Research Editor-in-Chief: M. Wehling 2014/Volume 64/12 issues p.a./ISSN 2194-9379 USA and Canada Individuals: $769 $615 Please contact [email protected] For institutional licenses, please contact [email protected] Mexico, Central and South America Individuals: $823 $658 Please contact [email protected] For institutional licenses, please contact [email protected] Europe, Africa, Asia, Australia, New Zealand Individuals: €498 €398 (Please add handling charges: Germany €31.40, Europe €55.80, Africa, Asia, Australia, New Zealand €79.90) Please contact [email protected] For institutional licenses, please contact [email protected] Bangladesh, Bhutan, India, Nepal, Pakistan and Sri Lanka For subscription rates in INR, please contact [email protected] ORDER TODAY http://www.thieme.com Special introductory rates are only valid for new subscribers and are limited to the first year of subscription. Only qualified professionals and students are eligible for individual subscriptions. Orders from individuals must include the recipient's name and private address, and be paid by private funds. Become a fan at www.facebook.com/thiemepublishers. 060 DRS Ad ACCP.indd 1 Follow us @ThiemeNY 37 11.06.2014 14:24:24 Poster Session 1 Sunday, September 14, 2014 / 6:00 – 8:00 pm, Room A – C Clinical Pharmacokinetics and Pharmacodynamics Board Control Title Type Authors Single-dose Pharmacokinetics of Deferiprone in Subjects With Various Degrees of Renal Impairment Josée Michaud, Jean-Michel Paquette, Rachida Essalihi, Mira Francis, Sylvie Boily, Julie Massicotte, Marc Lefebvre, Éric Sicard, Vincent Pichette, Caroline Fradette 1 1999932 2 2000019 Pharmacokinetics and PK-efficacy Analyses for Body Surface Area-adjusted Doses of Golimumab Following Repeated Subcutaneous Administrations in Pediatric Patients With Polyarticular Juvenile Idiopathic Arthritis Jocelyn H. Leu, Alan Mendelsohn, Joyce Ford, Hugh M. Davis, Honghui Zhou, Zhenhua Xu 3 2000193 Evaluation of the Possible Pharmacokinetic Interaction Between Meloxicam and Tizanidine Francisco J. Flores-Murrieta, Miriam D. Carrasco-Portugal, Jose C. Aguilar-Carrasco 4 2000198 Bioavailability of a Modified-release, Fixed-dose Combination of Meloxicam and Tizanidine in Healthy Volunteers Miriam D. Carrasco-Portugal, Francisco J. Flores-Murrieta, Jose C. Aguilar-Carrasco 5 2000214 Optimizing Antiplatelet Therapy and Drug Therapy in General Roger W. Jelliffe 6 2000293 Pharmacokinetics of Fixed-dose Combination (FDC) Tablets of Empagliflozin/ Christina Gondolfi, Jasmin Link, Metformin Compared With Monotherapies in Healthy Volunteers Thomas Meinicke, Sreeraj Macha 19 1994359 Pharmacokinetics and Pharmacodynamics of Twice-daily and Once-daily Regimens of Empagliflozin in Healthy Volunteers Sreeraj Macha, Tobias Brand, Thomas Meinicke, Jasmin Link, Uli C. Broedl 8 2000460 Effect of Food on the Bioavailability and Tolerability of the JAK2-selective Inhibitor Fedratinib (SAR302503): Results from Two Phase I Studies in Healthy Volunteers Meng Zhang, Christine R. Xu, Lei Ma, Elias Shamiyeh, Jian Y. Yin, Lisa L. von Moltke, William Smith 9 2000539 Kerry Culm-Merdek, Melissa Wasserstein, Pharmacokinetic and Pharmacodynamic Comparison of Single, AscendingSimon Jones, Brenda Pimlott, dose and Intra-patient Dose Escalation Data With Recombinant Human Acid Andrew Cunningham, Ana Cristina Puga, Sphingomyelinase for the Treatment of Adults With Niemann-Pick B Lisa L. von Moltke 10 2000545 Pharmacokinetics of LEE011, a CDK4/6 Inhibitor, in Adult and Pediatric Patients With Advanced Tumors Suraj G. Bhansali, Sudha Parasuraman, Alessandro Matano, Charles Davis, Abhijit Chakraborty 11 2000129 Immediate Release Formulations Containing Metformin: Bioequivalence Between Products Sourced from Various Countries Shripad Chitnis, Yi Han, Masayuki Yamaguchi, Sachiko Mita, Rong Zhao, Kenneth Kulmatycki, Gangadhar Sunkara Influence of Renal Impairment on the Pharmacokinetics of Pradigastat, a Potent and Selective DGAT1 Inhibitor Sachiko Mita, Charles D. Meyers, Pal Parasar, Andrew Joyson, TsuHan Lin, Tapan Majumdar, Sam Rebello, Gangadhar Sunkara, Jin Chen Pharmacokinetic Analyses of Bremelanotide Luana Pesco Koplowitz, Barry Koplowitz, Cheryl Van Walsh, Leonor Nazareno, Shailesh Vengurlekar, Robert Jordan, Jeffrey Edelson 12 13 1956516 1968552 NM Poster Sessions are supported by a Grant from Biogen Idec NM LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner Please visit www.ACCP1.org for updates on the Abstract Submission process and deadlines for the 2015 Annual Meeting 38 Poster Session 1 Sunday, September 14, 2014 / 6:00 – 8:00 pm, Room A – C Clinical Pharmacokinetics and Pharmacodynamics (cont) Board Control Title Type Poster Sessions are supported by a Grant from Biogen Idec Authors Jason D. Lickliter, Deborah Smith, Steve Russ, Bob Noble, Shannon R. Morris, Melisa Cooper 14 1971589 Pharmacokinetics and Food Effect of Formulations of Afuresertib 15 1981431 Effects of Ketoconazole on the Pharmacokinetics and Pharmacodynamics of Hamim Zahir, Jeanne Mendell, James Jin, Ling He, Dolly A. Parasrampuria Edoxaban in Healthy Adults 16 1982862 Effects of Erythromycin on the Pharmacokinetics and Pharmacodynamics of Edoxaban Jeanne Mendell, George Zhang, Ling He, Dolly A. Parasrampuria 17 1990627 Coadministration of Cyclosporine Increased Edoxaban Exposure in Healthy Adults Nobuko Matushima, Hamim Zahir, Jeanne Mendell, Shuquan Chen, Ling He, Dolly A. Parasrampuria 18 1993909 Influence of Hepatic Impairment on the Pharmacokinetics of Pradigastat, a Potent and Selective DGAT1 Inhibitor Masaru Hirano, Charles D. Meyers, GangaRaju Golla, Parasar Pal, Pascale Pinot, TsuHan Lin, Tapan Majumdar, Sam Rebello, Gangadhar Sunkara, Jin Chen 20 1997089 A Sensitive Assay for Analysis of Midazolam and its Metabolites in Pediatric Plasma and Urine Ganesh Moorthy, Praveen Srivastava, Athena F. Zuppa 21 1997277 Population Pharmacokinetic Modeling for Assessing Renal Impairment Effect Ophelia Yin, Domenico Merante, on the Pharmacokinetics of Mirogabalin Raymond Miller 22 1998447 Assessment of the Pharmacokinetics and Safety of Crushed Oxycodone DETERx Administered Intranasally in Recreational Opioid Users Ernest A. Kopecky, Melinda O’Connor, Ravi K. Varanasi, Alison B. Fleming 23 1984174 S Evaluation of S-warfarin Limited Sampling Models (LSMs) to Estimate Cytochrome P450 (CYP) 2C9 Activity Andrew Chang, Joseph S. Bertino, Anne Nafziger, Angela Kashua, Sandrine Turpault, Joseph Ma 24 1990718 S Effect of Clinical Trial Design on the Error Rates for Clearance Estimation in Pediatrics Using Adult Bayesian Priors Amir S. Youssef, Joel S. Owen, Juan Jose Pérez-Ruixo, Sameer Doshi 25 1999240 S, NM Population Pharmacokinetics of an Intra-nasally Administered Combination of Oxymetazoline and Tetracaine (Kovacaine MistTM) in Healthy Volunteers Tim Cacek, Jogarao V. Gobburu, Mathangi Gopalakrishnan Levofloxacin Dose Optimization for Multidrug-resistant Tuberculosis Based on Lung Microdialysis in Patients Aline Barth, Ravi Shankar P. Singh, Robert May, Judith Johnson, Ramiro Isaza, Henry Michael Blumberg, Sergo Vashakidze, Charles Peloquin, Hartmut Derendorf, Russell Kempker 26 2000532 E, NM S LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 39 Poster Session 1 Sunday, September 14, 2014 / 6:00 – 8:00 pm, Room A – C Poster Sessions are supported by a Grant from Biogen Idec New and Adaptive Clinical Trial Designs Board Control Title Type Authors 27 1996846 Application of SimCyp® and Real-time Pharmacokinetic Assessments in Defining Dose in Novel-Novel Combinations With Potential Drug-Drug Interactions in Cancer Patients 28 1999935 How an Adaptive Study Design Can Enrich an Early Phase 1 MAD Study Suraj G. Bhansali, Sudha Parasuraman, Becker Hewes, Heidi Einolf, Ken-Ichi Umehara, Alessandro Matano, Charles Davis Ulrike Lorch, Juleen Gayed, Jorg Taubel Pharmacoepidemiology / Pharmacogenomics Board Control Title Type Authors Association of Genetic Polymorphisms of ABCB1 (1236T>C), ABCC5 (3414+434A>C and 3933+313T>C) and Xanthine Oxidase (1936A>G and 2107A>G) With Adverse Events by Methotrexate, in Mexican Pediatric Patients With ALL Fausto Zaruma-Torres, Ismael Lares-Asseff, Aarón Reyes-Espinoza, Verónica LoeraCastañeda, Martha Sosa-Macías, Carlos Galaviz-Hernández, Miguel Reyes-López, María Cristina Arias-Pelaez, Agustín Vega Crespo 1987015 Regional Differences in Thiopurine Methyltransferase Activity Matthew W. Linakis, Sarah C. Campbell, Chris Stockmann, Kamisha L. JohnsonDavis, Gwendolyn A. McMillin, Catherine M. Sherwin, Michael G. Spigarelli 31 1999367 Sook Wah Yee, Joel A. Mefford, Jennifer E. Hibma, Richard Castro, Atsushi Takahashi, Transporterome-wide Analysis of Genetic Loci in SLC Transporters in African Michiaki Kubo, Shiro Maeda, John S. Witte, Americans With Type 2 Diabetics on Metformin Robert L. Davis, Monique M. Hedderson, Kathleen M. Giacomini 33 2000546 29 30 1983392 S, SA NM A National Study of Utilization of Gene Expression Profiling in Clinical Practice LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 40 Amalia M. Issa Poster Session 1 Sunday, September 14, 2014 / 6:00 – 8:00 pm, Room A – C Special Populations, Including Women, Children, the Elderly and Obese Patients Board Control 35 1990200 36 1996711 37 2000059 Title Type S Authors Han Han, Jonathan E. Constance, Evaluation of Disparities in Achieving Therapeutic Recommendations Among Catherine M. Sherwin, Kent Korgenski, Pediatric Patients Receiving Gentamicin Michael G. Spigarelli S, SA Evaluation of Changes in Oral Drug Absorption in Preterm Neonates S Poster Sessions are supported by a Grant from Biogen Idec Amit A. Somani, Kirstin Thelen, Songmao Zheng, Mirjam N. Trame, Katrin Coboeken, Michaela Meyer, Katrin Schnizler, Ibrahim Ince, Stefan Willmann, Stephan Schmidt Patterns of Gentamicin Use Among Pediatric Cancer Patients Jonathan E. Constance, Alfred H. Balch, Catherine M. Sherwin, Kent Korgenski, Michael G. Spigarelli Kenneth Kulmatycki, Thomas Langenickel, Dik Ng, Parasar Pal, Wei Zhou, Iris Rajman, Sam Rebello, Gangadhar Sunkara, Priyamvada Chandra 38 1983814 Pharmacokinetics of Single-dose LCZ696 in Subjects With Mild and Moderate Hepatic Impairment 39 1990069 Physician Addicts and Buprenorphine or Methadone: Just Say No To Rx for Opiate-addicted Colleagues Mark S. Gold, Robert L. DuPont, William S. Jacobs 41 1996070 Age and Gender Effects on the Pharmacokinetics of LCZ696 Lu Gan, Thomas Langenickel, Kiran Kode, Jesika Petruck, Iris Rajman, Gangadhar Sunkara 42 2000353 Drug Interactions Between ASP015K (ASP) and Rosuvastatin (R) in Asian and Non-Asian Subjects Tong Zhu, Barbara Parker, Tomasz Wojtkowski, Tetsuya Nishimura, Jay Garg, David Han, Ogert Fisniku, James Keirns 43 2000364 Pharmacokinetics and Tolerability of Ponesimod in Subjects With Moderate and Severe Renal Function Impairment Christian Zwingelstein, Eva Peterfai, Matthias Hoch, Jasper Dingemanse NM LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 41 Poster Session 2 Monday, September 15, 2014 / 6:00 – 8:00 pm, Room A – C Clinical Pharmacokinetics and Pharmacodynamics Board Control 7 2000329 Title Type NM Poster Sessions are supported by a Grant from Biogen Idec Authors Assessment of Steadystate Pharmacokinetics of LCZ696 in Patients With Renal Impairment Thomas Langenickel, Surya P. Ayalasomayajula, Priyamvada Chandra, Pierre Jordaan, Diego Albrecht, Wei Pan, Pal Parasar, Gangadhar Sunkara Absorption, Distribution, Metabolism and Excretion Board Control 45 44 2000317 Title Type NM 1983398 Authors Effect of Food on the Oral Bioavailability of LCZ696 Surya P. Ayalasomayajula, Priyamvada Chandra, Eddie Wolfson, Sonika Mehra, Pal Parasar, Thomas Langenickel, Gangadhar Sunkara OCT1 and OCT2 Polymorphisms and Their Association With Metformin Population Pharmacokinetics in Mexican Patients With Type 2 Diabetes Ismael Lares-Asseff, Martha Sosa-Macías, Marcos Cobaleda-Velasco, Oscar ChávezArreola, Fausto Zaruma-Torres, Miriam D. Carrasco-Portugal, Francisco J. Flores-Murrieta Disease Management Board Control 47 Title Type Authors The Effect of Standard, Short-course Treatment on the Serum Concentrations of Interleukin-1 beta and Tumor Necrosis Factor Alpha in Nigerian Pulmonary Tuberculosis Patients 2001001 Chikere A. Anusiem, Paul O. Okonkwo Drug Interactions Board Control 48 52 Title Type Authors 1998218 Assessment of Transporter-mediated Pharmacokinetic Interaction Between Valsartan, an Angiotensin II Receptor Antagonist, and Alisporivir (ALV), a Cyclophilin Inhibitor in Healthy Subjects June Ke, Avantika Barve, Kristina Dabovic, Dineshram Mattapalli, Jie Zhang, Robert Maietta, Daniel S. Stein, Gangadhar Sunkara, Steven J. Kovacs 1999322 Assessment of the Pharmacokinetic Interactions Between the Nonimmunosuppressive Cyclophilin Inhibitor, Alisporivir (ALV), and AnxiolyticBuspirone and Antidepressant-Escitalopram in Healthy Subjects June Ke, Avantika Barve, Kristina Dabovic, Edward Wolfson, Dineshram Mattapalli, Jie Zhang, Daniel S. Stein, Gangadhar Sunkara, Steven J. Kovacs NM LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 42 Poster Session 2 Monday, September 15, 2014 / 6:00 – 8:00 pm, Room A – C Poster Sessions are supported by a Grant from Biogen Idec Drug Interactions (cont) Board Control Title Type Authors 60 2000340 The Effect of the Non-immunosuppressive Cyclophilin Inhibitor Alisporivir (ALV) on the Pharmacokinetics of Ethinyl Estradiol (EE) and Levonorgestrel (LG) in Adult Female Subjects Daniel S. Stein, Steven J. Kovacs, Avantika Barve, Kiran Dole, Jens Praestgaard, Jie Zhang, Gangadhar Sunkara, June Ke 70 1998211 Investigation of Pharmacokinetic Interactions Between the Cyclophilin Inhibitor, Alisporivir (ALV), and the HCV NS3/4A Protease Inhibitors, Telaprevir (TVR) and Boceprevir (BOC), in Healthy Subjects June Ke, Avantika Barve, Robert Maietta, Machineni Surendra, Jie Zhang, Daniel S. Stein, Gangadhar Sunkara, Steven J. Kovacs 49 1998489 NM Evaluation of the Effects of Repeat Oral Dosing of Diltiazem on the Pharmacokinetics of Repeat Oral Dosing of Darapladib Bonnie Shaddinger, Mindy Magee, David Collins, Dawn Gillmor, Joseph Soffer 50 1998498 NM Effects of Darapladib Coadministration on Midazolam Pharmacokinetics Bonnie Shaddinger, Mindy Magee, David Collins, Dawn Gillmor, Joseph Soffer 51 1998501 NM Pharmacokinetics of Rosuvastatin When Coadministered With Darapladib as Bonnie Shaddinger, Mindy Magee, Compared to When Administered Alone Shabana Siddiqi, David Collins, Joseph Soffer 53 1999978 Exploring the Relationship Between the Potency of CYP3A Induction and 4β-hydroxycholesterol by Population PK/PD Approach Xuemin Jiang, Catherine Dutreix, Venkateswar Jarugula, Sam Rebello, Haiying Sun 54 2000057 Tolerability, Pharmacokinetics and Pharmacodynamics of Apixaban, Aspirin and Clopidogrel Following Coadministration in Healthy Subjects Charles Frost, Zhigang Yu, Philip Wastall, Sunil Nepal, Kenneth Moore, Frank LaCreta 55 2000112 Lack of Pharmacokinetic Interaction Between Apixaban and Prasugrel in Healthy Subjects Malaz AbuTariff, Anh Bui, Janice Pursley, Joya He, Frank LaCreta, Charles Frost 2000181 Assessment of Disease-related Therapeutic Protein Drug-Drug Interaction (TP-DDI) for Etrolizumab in Patients With Moderate to Severely Active Ulcerative Colitis (UC) Xiaohui Wei, Jane Kenny, Leslie Dickmann, Romeo Maciuca, Carrie Looney, Cyrus Khojasteh-Bakht, John D. Davis, Meina T. Tang 57 2000233 Pharmacokinetics and Safety of Ibrutinib with Concomitant Use of CYP3A Inhibitors in Patients With B-Cell Malignancies Juthamas Sukbuntherng, Fong Clow, Jan de Jong, Donna Skee, Yvonne Pak, Maria Fardis, Susan O’Brien, John C. Byrd, Danelle F. James, Dana Lee 58 2000322 Prediction of P-Glycoprotein-mediated Fasiglifam-Digoxin Interaction Potential Using Physiologically-based Pharmacokinetic Modeling and Simulation Liming Zhang, Ronald D. Lee, Himanshu Naik, Yuu Moriya, Akifumi Kogame, Yoshihiko Tagawa 59 2000338 An Interaction Study of Repeated Doses of Fedratinib on Pharmacokinetics of a Single-dose Cocktail of Omeprazole, Metoprolol and Midazolam as Probe Substrates for CYP2C19, CYP2D6 and CYP3A4 in Adult Patients With Refractory Solid Tumors Jian Y. Yin, Christine R. Xu, Zuyu Guo, Liji Shen, Kimberly Bassi, Lisa L. von Moltke, Patricia LoRusso, Olivier Rixe, Anthony J. Olszanski 61 2000407 In Silico Evaluation of PK-mediated DDI Potential of Aprepitant With Targeted cART Agents: Clinical Rationale for Dosing HIV-infected Patients Ganesh Moorthy, Dimple Patel, Steven D. Douglas, Pablo Tebas, Jeffrey Barrett 62 2000530 The Effects of Repeated, 14-day, 200 mg BID Oral Doses of Ketoconazole on a Sequential, Ascending Single Oral Dose of Fedratinib in Healthy Subjects Christine R. Xu, Elias Shamiyeh, Vanaja Kanamaluru, Lisa L. von Moltke, James Kissling, Charles Xie 56 NM NM LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 43 Poster Session 2 Monday, September 15, 2014 / 6:00 – 8:00 pm, Room A – C Poster Sessions are supported by a Grant from Biogen Idec Drug Interactions (cont) Board Control Title Type Authors S, SA, Clinical Drug-Drug Interaction Study of Metformin With Famotidine, a NM MATE1-selective Inhibitor Jennifer E. Hibma, Arik A. Zur, Matthias B. Wittwer, Sook Wah Yee, Richard Castro, Sophie L. Stocker, Kari M. Morrissey, Srijib Goswami, Radojka M. Savic, Claire M. Brett, Kathleen M. Giacomini 63 1999997 64 1991069 65 1995793 Effect of Ciprofloxacin on Ivacaftor, a Sensitive CYP3A Substrate, in Healthy Sarah M. Robertson, Yulia Green, Julie Lekstrom-Himes, Lisa Mahnke Volunteers 66 1996061 Lu Gan, Thomas Langenickel, Assessment of Pharmacokinetic Drug-Drug Interaction Between LCZ696 and Srikanth Neelakantham, Joanne Nguyen, Levonorgestrel/Ethinyl Estradiol Iris Rajman, Gangadhar Sunkara 67 1998100 Evaluation of Disease-mediated Therapeutic Protein-Drug Interactions Between an Anti-interleukin-6 (Anti-IL-6) Monoclonal Antibody (Sirukumab) and Cytochrome P450 (CYP) Activities in Patients With Rheumatoid Arthritis (RA) Using a Cocktail Approach Yanli Zhuang, Dick de Vries, Zhenhua Xu, Stanley Marciniak, Dion Chen, Francisco Leon, Hugh M. Davis, Honghui Zhou 68 1998121 Development of a Physiologically-based Pharmacokinetic Model to Predict Therapeutic Protein-Disease-Drug Interactions: Modulation of Multiple Cytochrome P450 Enzymes by Interleukin-6 Xiling Jiang, Yanli Zhuang, Zhenhua Xu, Weirong Wang, Honghui Zhou 69 1998135 A Mechanism-based Characterization of Clobazam Drug-Drug Interactions Using a Model-based Approach Dwain Tolbert, Ihor Bekersky, Hui-May Chu, Ene Ette NM Effect of Verapamil (Ver), a P-gp Inhibitor on Pharmacokinetics (PK) of ASP015K (ASP) Tong Zhu, Tomasz Wojtkowski, Jay Garg, David Han, Ogert Fisniku, Mary Beth Holum, James Keirns Mechanism of Action Board Control 72 1989134 Title Authors Pharmacological Profile of Brexpiprazole Kenji Maeda, Tine Stensbøl Type E Safety and Efficacy Board Control 113 1999828 Title Type E Authors Efficacy and Safety of Aripiprazole Once-monthly in Obese and Non-obese Patients With Schizophrenia: A Post Hoc Analysis LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 44 Marc De Hert, Anna Eramo, Wally Landsberg, Lan-Feng Tsai, Ross Baker Poster Session 2 Monday, September 15, 2014 / 6:00 – 8:00 pm, Room A – C Poster Sessions are supported by a Grant from Biogen Idec Therapeutic Drug Monitoring Board Control 74 1961996 76 1991182 Title Type NM Authors Population Pharmacokinetics of Methotrexate in Pediatric Patients: A Simultaneous Analysis of the Serum and Urine Concentration Data Kazuro Ikawa, Kazuaki Matsumoto, Naoko Kanazawa, Yuta Yokoyama, Yasuo Takeda, Hartmut Derendorf, Norifumi Morikawa Evaluation of the Sparse Sampling Strategy for Long-lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Adolescent and Adult Hemophilia B Patients Lei Diao, Ivan Nestorov Translational Medicine, Including Biomarkers and/or Imaging Board Control 77 1998672 Title Type S Authors Study of SAE Reports Received by the Institutional Ethics Committee for Regulatory Compliance Raakhi Tripathi, Sandip Kapse, Yashahree Shetty, Padmaja Marathe, Sandhya Kamat, Urmila Thatte Applications of Modeling and Simulation Board Control Title Type 78 1997259 S 79 1997622 S, SA Authors Development of a Bedside-ready Dosing Algorithm for Clopidogrel Snehal Samant, Xiling Jiang, Richard B. Horenstein, Alan R. Shuldiner, Laura M. Yerges-Armstrong, Lambertus A. Peletier, Mirjam N. Trame, Lawrence J. Lesko, Stephan Schmidt Pharmacokinetic Modeling of Intranasal Scopolamine in Plasma, Saliva and Urine Lei Wu, Vincent Tam, Diana S. Chow, Lakshmi Putcha 80 1998080 S Meta-analysis of Sex Impact on Rheumatoid Arthritis Treatment Response With Biologics Xuyang Song, Haiyan Lu, Ping Ji, Yow-Ming Wang, Yaning Wang, Chandrahas Sahajwalla, Jessica Lee, Janet Maynard, Sarah Yim, Hartmut Derendorf, E. Dennis Bashaw, Lanyan Fang 81 2000134 S, NM Pharmacokinetic Modeling of Free and Total Dexmedetomidine in Pregnant Ewe and Fetus Zhiyi Cui, Olutoyin A. Olutoye, David A. Lazar, Rodrigo Ruano, Oluyinka O. Olutoye, Diana S. Chow 82 2000395 S, SA Development of a Drug-Disease Model for Type 2 Diabetes Mellitus Puneet Gaitonde, Mirjam N. Trame, Parag Garhyan, Jenny Y. Chien, Stephan Schmidt 83 2000544 S, SA, A Need to Revisit the Clinical Breakpoint of Tigecycline: Effect of Atypical NM Nonlinear Plasma Protein Binding Ravi Shankar P. Singh, Jatinder K. Mukker, Stephanie Drescher, Hartmut Derendorf LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 45 Poster Session 2 Monday, September 15, 2014 / 6:00 – 8:00 pm, Room A – C Poster Sessions are supported by a Grant from Biogen Idec Applications of Modeling and Simulation (cont) Board Control 84 2000366 85 1988229 86 1997983 87 1998022 89 2000194 90 2000425 Title Type S, SA NM E, NM Authors Linking the Population Pharmacokinetics of Tenofovir and Its Metabolites With Its Cellular Uptake and Metabolism Kumpal Madrasi, Rebecca N. Burns, Craig W. Hendrix, Michael J. Fossler, Jr., Ayyappa Chaturvedula Optimal Sampling to Estimate Busulfan AUC in Pediatric Patients Michael Neely, David Bayard, Teresa Rushing, Xiaowei Fu, Sylvain Goutelle, Nathalie Bleyzac Population Pharmacokinetic Modeling to Estimate the Bioavailability of a Novel, Delayed-release Formulation of Metformin Adekemi Taylor, Colleen Burns, Terri Kim, Mark Fineman Population Pharmacokinetics of Tenofovir and Tenofovir-diphosphate in Healthy Women Rebecca N. Burns, Craig W. Hendrix, Michael J. Fossler, Jr., Ayyappa Chaturvedula Population Pharmacokinetic Evaluation of Eslicarbazepine Acetate for Adjunctive Therapy in Refractory Partial Onset Seizures Elizabeth Ludwig, Soujanya Sunkaraneni, Jill Fiedler-Kelly, Qiang Lu, Gary Maier, David Blum, Jahnavi Kharidia Tacrolimus Dose Adjustment Assessment in Liver Transplantation Patients Using Modeling and Simulation Approach Xiaoying Xu, Heidi Einolf, Avantika Barve, Venkateswar Jarugula, Haiying Sun Poster Session 3 Tuesday, September 16, 2014 / 7:00 – 8:00 am, Room A – C Clinical Trials and Human Pharmacology Board Control Title Type Authors 92 1982798 Bioequivalence of Selexipag, a Non-prostanoid Prostacyclin Receptor Agonist, in a Multiple-dose, Up-titration Study Daniela Baldoni, Shirin Bruderer, Naguib Muhsen, Jasper Dingemanse 93 1985980 A Thorough QT/QTc Study to Assess the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers Brendt Stier, Michael J. Fossler, Jr., Feng Liu, Stephen Caltabiano LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 46 Poster Session 3 Tuesday, September 16, 2014 / 7:00 – 8:00 am, Room A – C Clinical Trials and Human Pharmacology (cont) Board Control Title Type Poster Sessions are supported by a Grant from Biogen Idec Authors Song Mu, Sunil Sharma, Petronella O. Witteveen, Martjin J. Lolkema, Effect of Renal Dysfunction on Pharmacokinetics of Panobinostat and Its Hans Gelderblom, Dagmar Hess, Metabolite BJB432 in Patients With Advanced Cancers Syed A. Hussain, Sue-zette Valera, Maria G. Porro, Edward Waldron Song Mu, Marije Slingerland, Dagmar Hess, Influence of Hepatic Impairment on Plasma Exposure of Panobinostat and Its Sally Clive, Sunil Sharma, Per Sandstrom, Metabolite BJB432 Niklas Loman, Maria G. Porro, Edward Waldron, Sue-zette Valera, Hans Gelderblom Sun Jing, Yaozong Yuan, Jie Li, Su Zhang, Single and Repeat-dose Pharmacokinetic Study of Vercirnon, a Potent Ayla Cui, Kelly Dong, Tingting Fu, Chemokine Receptor Antagonist in Healthy Chinese Subjects Sashi Gopaul, Lynda Haberer, Kai Wu 94 1988170 E 95 1995930 E 96 1998248 97 1998512 Pharmacokinetics of Nalbuphine Hydrochloride Extended-release Tablets in Hemodialysis and Healthy Subjects Following Multiple, Escalating Oral Doses Amale Hawi, Carey Hines, Prapoch Watanalumlerd, Harry Alcorn, Weslyn Ward, Thomas Sciascia 99 2000428 Endothelin-1 Levels and Renal Function in Newborns Anil Gulati, Gwendolyn Pais, Gospodin Stefanov, Lorene Schweig, Bhagya Puppala Experimental Pharmacology in In Vitro and In Vivo Studies Board Control Title Type Authors 100 2000369 Stimulation of ETB Receptors by IRL-1620 Modulates the Progression of Alzheimer’s Disease 101 2000374 GLP-1 Analogue, Liraglutide, Attenuates Apoptosis in the Rat Brain Following Seema Briyal, Anil Gulati Focal Cerebral Ischemia 102 2000385 Selective Endothelin-B Receptor Stimulation Enhances Vascular Endothelial Anil Gulati, Mary Leonard, Preetha Prazad, Growth Factor During Postnatal Development of the Rat Brain Bhagya Puppala 103 2000421 Centhaquin Produces Dose-dependent Antinociception in a Rat Model of Post-operative Pain Mary Leonard, Seok-hun Jung, Shridhar Andurkar, Anil Gulati 104 1957990 S, SA Assessment of Antileishmanial Activity of Pyrazinamide by In Vitro Time-Kill Curve Experiments Against Leishmania (Leishmania) Amazonensis Nivea Maria S. Falcao, Peter Kima, Cordula Heinrichs, Sebastian Morales, Kenneth Hernandez, Hartmut Derendorf 105 2000542 Evaluation of Hepatic Oxidative Stress in Rats Following Celecoxib and S, NM Misoprostol Concomitant Administration 106 1997986 Anil Gulati, Seema Briyal, Christopher Nguyen, Mary Leonard Derek E. Murrell, John D. Harrell, Yuyun Rahmasari, Dustin L. Cooper, Angela V. Hanley, Kenneth W. Bullins, Sam Harirforoosh Endothelin ETA Receptor Antagonist Reverses Naloxone-precipitated Opioid Shaifali Bhalla, Melissa Tapia, Withdrawal in Mice Gwendolyn Pais, Anil Gulati LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 47 Poster Session 3 Tuesday, September 16, 2014 / 7:00 – 8:00 am, Room A – C Poster Sessions are supported by a Grant from Biogen Idec Clinical Pharmacology Education Board Control 107 Title Type Authors An Introduction of the Fourth Year Pharmacy Student to the Drug Development Process and Applied Translational Medicine, a Phase I Clinical Kate Reese, Joy Olbertz Research Rotation 2000355 Effectiveness and Impact on Quality of Life Board Control Title Type Authors 108 1990141 Systematic Evaluation of Compliance to Prescribed Treatment Medications and Abstinence from Psychoactive Drug Abuse in Chemical Dependence Programs: Data from the Comprehensive Analysis of Reported Drugs William S. Jacobs, Kenneth Blum, David E. Smith, Mark S. Gold 109 1997195 Responder Rate in Overactive Bladder Women Treated With Oxytrol Shuchean Chien, Krishna Jhaveri, Rajesh Mishra 110 1999800 Improved Treatment Satisfaction in Patients With Type 1 Diabetes Mellitus (T1DM) Treated With Insulin Glargine vs NPH Insulin William Polonsky, Louise Traylor, Ling Gao, Wenhui Wei, Barbara Ameer, Andreas Stuhr, Aleksandra Vlajnic E Safety and Efficacy Board Control 111 2000543 Title Type Authors S, NM Increase in the Efficacy of Tigecycline: Effect of Metal-ion Chelation Ravi Shankar P. Singh, Amelia Deitchman, Jatinder K. Mukker, Tim Schumacher, Nadia D. Bharose, Sherwin Sy, Dorothee Ressing, Nivea Maria S. Falcao, Hartmut Derendorf 112 1995947 Effect of Uremic Toxins on Statin-induced Cytotoxicity in Patients With End-stage Renal Failure Masayuki Tsujimoto, Hitoshi Uchiyama, Tadakazu Shinmoto, Hitomi Ogino, Tomoko Oda, Takuya Yoshida, Taku Furukubo, Satoshi Izumi, Tomoyuki Yamakawa, Hidehisa Tachiki, Tetsuya Minegaki, Kohshi Nishiguchi 114 2000446 The DGAT1 Inhibitor Pradigastat Does Not Prolong the QTcF Interval in Humans Charles D. Meyers, Aishwarya Movva, Kate Danis, Randolph Sleet, Adele Noe, Atish Salunke, Jin Chen 115 2000464 The DGAT1 Inhibitor Pradigastat Does Not Induce Photosensitivity in Humans Charles D. Meyers, Adele Noe, Rachel Soon, Randolph Sleet, Kenneth Kulmatycki, Yuming Chen, Daniel Bauer, Jin Chen 116 2000513 Systems Approach: A Proof-of-Concept Study to Improve Drug Safety Xiaoyan Zhang, Lawrence J. Lesko 117 2003759 Safety, Tolerability and Pharmacokinetics of Intravenous Regadenoson in Healthy Subjects: a Randomized, Repeat-dose, Placebo-controlled Study Robert Townsend, Amit Desai, Diane Rammelsberg, Donna Kowalski, Therese Kitt NM LEGEND: NM = New Member (Dues paid by August 1, 2014) S = Student Abstract E = Encore Presentation SA = Student Award Winner 48 ACCP Officers, Regents, Vision & Mission 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 Lisa L. von Moltke, MD, FCP Genzyme, a Sanofi company Vikram Arya, PhD, FCP Silver Spring, MD Megan A. Gibbs, PhD, FCP Thousand Oaks, CA PRESIDENT-ELECT Bernd Meibohm, PhD, FCP Univ of Tennessee Guenther Hochhaus, PhD, FCP Gainesville, FL SECRETARY John N. van den Anker, MD, PhD, FCP Children’s National Health System & Univ Children’s Hosp, Basel Joan Korth-Bradley, PharmD, PhD, FCP Collegeville, PA TREASURER Michael W. Jann, PharmD, FCP Univ of North Texas System Coll of Pharmacy Donald E. Mager, PharmD, PhD, FCP Buffalo, NY Nancy A. Lass, MD, FAAP, FCP, LLD Westchester, IL Diane R. Mould, PhD, FCP Phoenixville, PA IMMEDIATE PAST PRESIDENT Michael J. Fossler, Jr., PharmD, PhD, FCP GlaxoSmithKline Michael N. Neely, MD, MSc, FCP Los Angeles, CA Peter H. Wiernik, MD, FCP Chappaqua, NY Honghui Zhou, PhD, FCP Malvern, PA 49 New Members: Sept 1, 2013 – Aug 1, 2014 Members (cont) Fellows Nastya Kassir Kathleen Neville Natella Rakhmanina Mark Rogge Nusrat Shafiq Catherine M. Sherwin David M. Tenero Mahnoosh Rajabnejad Amithvikram Rangarajan Ammar Raza Sibghatullah Sangi Bonnie Shaddinger Naman Shah Pramod Sharma Juthamas Sukbuntherng Krishna Mohan Surapaneni Adekemi Taylor Jing (Lisa) Tu Ka Wang William Wolowich Xiaoyu Yan Sook Wah Yee Xiaoyan Zhang Ping Zhao Bo Zheng Mingyan Zhou Tong Zhu PharmD, PhD MD MD, PhD PhD MD, MBBS PhD, MS PharmD Members Surya Ayalasomayajula PhD William Bailey PharmD Avantika Barve PhD Vallish Bn MD Dick Brashier MBBS, MD Ajit Chavan PhD Shripad Chitnis PhD John Davis PhD Brian Decker MD, PharmD, MS Caroline DenotPharmD Lei Diao PhD Matthew Dufek PhD Gerald Galluppi PhD Kathleen Giacomini PhD David Harrison MD Rupi Hashmi MD Syed Arif Hashmi MD Carey Hines PhD Paiboon Jungsuwadee PhD Noor Kamil PhD Sreeneeranj Kasichayanula PhD Jigar Katwala MBBS, MD Michael King MD, PhD Sanjeev Kumar PhD Donghwan Lee MD Sung-hack Lee PhD, RPh Shisheng Li PhD Elizabeth Ludwig PharmD Pavan Malhotra MBBS, MD Santhosh Manachery MBBS, MD Christina Mayer PharmD David Mayleben PhD Josee Michaud PhD Mohammad Misbahuddin MBBS, MD Ganesh Moorthy PhD Ruth Penn MD PharmD MBBS, MD MBBS, MBA MBBS, M Phil, PhD PharmD MBBS, MD MBBS, MD, DM PhD PhD PhD MD, MS PhD PharmD PhD PhD PhD, MD PhD PhD PhD PhD Student Members Waheed Adedeji Barnett Alfant Sharvari Bhagwat Anthony (Tim) Cacek Zhiyi Cui Jiexin Deng Nicholas Eschbacher Jennifer Hibma Yanhui Lu Kumpal Madrasi Ryan Mallo Jatinder Mukker Derek Murrell Rachana Rajagopal Matthew Romo Uta Schilling Keith Sharrow Ravi Shankar P. Singh Soujanya Sunkaraneni Syed Saoud Zaidi Daping Zhang Di Zhou 50 MBBS MS PharmD PhD PharmD PharmD PhD DNP, NP PhD BA MBBS, MD PharmD PhD PhD BS Pharm, MS PharmD, M Phil, PhD PhD Intensive interactive courses Individual 1.5 - 2 day “focused” workshops, each covering specific topics Model-based drug development: Incorporating population variability into mechanistic prediction of PK and modelling PK-PD Focused workshops offer an in-depth insight into specialist areas such as Transporters; Absorption; Paediatrics; Parameter estimation (PE) & pharmacodynamics (PD) Complex Drug Drug Interactions, Cardiac Safety and Biologics. Offered via lectures and hands on sessions using the Simcyp Population Based Simulator. Washington, USA DoubleTree by Hilton Hotel Washington DC - Silver Spring 17th -18th March 2015 19th - 20th March 2015 Transporters Discovery Biologics PE/PD The ABC of modelling drug transporter data: Mechanistic approaches to predict the impact of drug transport proteins on ADME/pharmacokinetics & toxicity Predicting pharmacokinetics and pharmacodynamics of therapeutic proteins. Drug Drug Interactions (DDI’s) Predicting and evaluating complex DDIs: Application of the Simcyp Population-based Simulator to real-life cases. Use of Simcyp in Drug Discovery: Case study based workshop focusing on using the dynamic models in the Simcyp Simulator to prioritise compounds based on data available in early drug discovery A systems pharmacology approach to modelling and simulation: Accelerating model building and covariate recognition in drug development by combining top-down and bottom-up modelling of pharmacokinetics linked to drug response. Paediatrics Predicting age related changes to pharmacokinetics and drug-drug interactions including associated variability: Linking this information to drug response in the paediatric population Simcyp workshops are an ideal way to enhance the continuous education of scientists working in clinical pharmacology and drug development. These events provide an excellent opportunity to develop skills, stay up-to-date with the latest scientific advances and network with delegates from industry, academia and regulatory agencies. The model-based approach to various aspects of drug development is rapidly being adopted by many of the leading pharmaceutical companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behaviour in various target populations. This integrated approach informs decisions related to Investigational New Drug (IND) and New Drug Applications (NDA) and assists with the conduct and optimal design of clinical studies. The ultimate aim is to improve the quality of submissions for regulatory approval. Please note that the focused ‘Absorption’ and ‘Cardiac Safety’ workshops are closed events in the USA at this time and seats are not on general sale. Further dates will hopefully be avaliable later in 2015 “The course, as well as the simulator, compiles up-todate ADME knowledge. It is tremendously useful for PK scientists in both discovery and clinical fields.” Senior Research Investigator, Bristol-Myers Squibb Visit simcyp.com for full workshop information, including registration details. 51 American College of Clinical Pharmacology 21750 Red Rum Dr, Suite 137, Ashburn, VA 20147 mailing address: PO Box 1758, Ashburn, VA 20146 phone: 571.291.3493 fax: 571.918.4167 website: www.ACCP1.org
