Saturday, March 16, 2019 Presentations

ORAL ABSTRACT SESSION I: Model-Informed Applications in Malaria, HIV Prevention, and Drug-Resistant Infection
Daniele Ouellet, PhD, Pfizer
Matthew Rizk, PhD, Merck & Co., Inc. 
OI-001: Mechanism-Based Modeling (MBM) of Polymyxin B (PMB)-Chloramphenicol (CHL) Combination against Klebsiella pneumoniae (KP) based on Multi-Omics Analysis
Presenter: Patrick Hanafin, B.S., UNC Eshelman School of Pharmacy, University of North Carolina
OI-002: Leveraging Data from Volunteer Infection Studies in Malaria: Utility of an Adaptive Dose Selection
Presenter: Kayla Andrews, PharmD, Ph.D., Department of Pharmaceutical Sciences, State University of New York, Buffalo
OI-003: A Semi-mechanistic Population Pharmacokinetic-pharmacodynamic Model For Tenofovir In Rectal Mucosal Mononuclear Cells Of Healthy Volunteers
Presenter: Priya Jayachandran, PharmD, MSE, UCSF

SCIENCE AT SUNRISE: Catching a Glimpse of Gut Microbiome-Drug Interactions: What Clinical Pharmacologists Need to Know
Sook Wah Yee, PhD, University of California, San Francisco, San Francisco, CA
Eugene Chen, PhD, Genentech, South San Francisco, CA
Gut Microbiome 101: You Are What You Eat
Libusha Kelly, PhD, Albert Einstein College of Medicine, New York, NY
Regulatory Science Issues in the Effect of Microbiomes on Bioequivalence Determination for Generic Drug Products
Lei Zhang, PhD, N/A, Silver Spring, MD
ORAL ABSTRACT SESSION II: Data Analysis Approaches to Generate Novel Clinical Insights in Oncology
Neeraj Gupta, PhD, Takeda
Mark Stroh, PhD, CytomX 
OII-001: Developing a Physiologically Based Pharmacokinetic Model for Quantitative Characterization of Exogenously Administered T Cells.
Presenter: Antari Khot, BPharm, State University of New York at Buffalo
OII-002: Identifying Biological Signals Differentiating Responders and Non-Responders to MPDL3280A (Anti-PDL1) In NSCLC Using QSP Modeling of Immune Checkpoints.
Presenter: Vincent Lemaire, PhD, Genentech
OII-003: The NOTICE Breast Cancer Study First Quarter Results: Social Media Mining for Probable Endocrine Therapy-Induced Adverse Drug Reactions
Presenter: Matthew Breitenstein, PhD, Perelman School of Medicine, University of Pennsylvania

SYMPOSIUM: Immunogenicity in Clinical Practice and Drug Development: When is it Significant?
Yow-Ming Wang, PhD, US Food and Drug Administration, Silver Spring, MD
Lora Hamuro, PhD, Bristol-Myers Squibb, Princeton, NJ 
Immunogenicity Monitoring in Clinical Practice: From the Perspective of a Practicing Pediatric Gastroenterologist
Valentina Shakhnovich, MD, Children’s Mercy Kansas City, Kansas City, MO
Technical and Logistic Challenges in the Detection of Immunogenicity
Bernd Meibohm, PhD, University of Tennessee Health Science Center, Memphis, TN
Risk Assessment and Mitigation Strategies of Immunogenicity in Clinical Development: A Regulatory Perspective
Amy Rosenberg, MD, US Food and Drug Administration, Silver Srping, MD
The Development of a Consortium QSP Model of Immunogenicity with Case Examples
Andrzej Kierzek, PhD, Certara, Sheffield, United Kingdom

Open Data Revolution in Clinical Research: Current Challenges and Future Promises
Daniela J. Conrado, PhD, Critical Path Institute, Cambridge, MA
Mohamed H. Shahin, PhD, University of Florida, Gainesville, FL
Data Sharing in Clinical Trials, Video Featuring Jeffrey M. Drazen, MD, New England Journal of Medicine
Daniela J. Conrado, Critical Path Institute, Cambridge, MA
Imposing Risk: Ethical Challenges in Data Sharing
Diego Silva, PhD, Simon Fraser University, Burnaby, BC, Canada
Toward Leveraging Publicly Accessible Clinical Trials Data-Sharing, Dissemination and Repurposing
Sanchita Bhattacharya, MS, University of California, San Francisco, San Francisco, CA

Chair: Susan M. Abdel-Rahman, PharmD, Children's Mercy Hospitals & Clinics, Kansas City, MO
Personalized, Personalized Medicine
David Fajgenbaum, MD, MBA, University of Pennsylvania, Philadelphia, PA
Patient-Focused Drug Development
Pujita Vaidya, MPH, US Food and Drug Administration, Silver Spring, MD
Engaging Patients Throughout the Life Cycle of Drug Development
Mark Skinner, JD, Institute for Policy Advancement, Ltd, Washington, DC
The Algorithm for Precision Medicine
Matthew Might, PhD, University of Alabama at Birmingham, Birmingham, AL

ORAL ABSTRACT SESSION III: Pharmacogenomics and Genetics
Sony Tuteja, PharmD, University of Pennsylvania
Laura Ramsey, PhD, Cincinnati Children's Hospital Medical Center
OIII-002: Multi-site Investigation Of Pharmacogenetic Determinants Of Warfarin Dose Variability In Latinos.
Presenter: Nihal El Rouby, PharmD, PhD, University of Florida
OIII-003: Pharmacogenomic Genotypes Define Genetic Ancestry In Patients And Enable Population-specific Genomic Implementation
Presenter: Wenndy Hernandez, Ph.D., The University of Chicago
OIII-004: CYP2C19 Genotype-Guided Escalation and De-Escalation Switching of Antiplatelet Therapy After Percutaneous Coronary Intervention in a Real-World Setting
Presenter: Jesse Martin, BS, Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy

NOVEL FORMAT: Will Antibody-Based Anti-Infective Therapies Save Conventional Treatment Failures? Opportunities and Challenges of Development of Antibody-Based Anti-Infective Therapies
Rong Deng, PhD, Genentech, South San Francisco, CA
Yang He, PhD, Jacobio Pharma, Boston, MA
A Clinician’s Perspective: The Opportunity and Challenges of Development of Antibody-Based Anti-Infective Treatment
Joshua Galanter, MD, Genentech, South San Francisco, CA
Experiences with Development of Antibody-Based Anti-Viral Drugs
Qin Sun, PhD, US Food and Drug Administration, Silver Spring, MD

SYMPOSIUM: Drug Repurposing
Katarina Ilic, MD, PhD, MPH, Shire, Lexington, MA
Valerie Kitchen, MD, GlaxoSmithKline, Collegeville, PA
Drug Repositioning
Zhichao Liu, PhD, US Food and Drug Administration, The National Center for Toxicological Research, Little Rock, AR
Using Human Genetic Variation to Repurpose Existing Medications for New Diseases
Jill Pulley, MBA, Vanderbilt University Medical Center, Nashville, TN

NOVEL FORMAT: MID3: Mission Impossible or Model-Informed, Drug Discovery and Development? Point / Counterpoint Discussions on Key Challenges
Sriram Krishnaswami, PhD, Pfizer, Groton, CT
Sandra A. G. Visser, PhD, GlaxoSmithKline, Collegeville, PA
Daniele Ouellet, PhD, Pfizer, Collegeville, PA
Marc Gastonguay, PhD, Metrum Research Group, Boston, MA
Stacey Tannenbaum, PhD, Astellas Pharma, Northbrook, IL
Oscar Della Pasqua, PhD, University College London, London, United Kingdom
Jogarao Gobburu, PhD, University of Maryland, Baltimore, MD
Daren Austin, PhD, GlaxoSmithKline, London, United Kingdom
Piet H. van der Graaf, PhD, PharmD, Certara, Canterbury, United Kingdom
ORAL ABSTRACT SESSION IV: Special Populations: Tailoring Current and New Interventions to Children and Elderly
Ping Zhao, PhD, Bill & Melinda Gates Foundation
Paulien Ravenstijn, PhD, Janssen Research & Development
OIV-001 Prediction Fetal Exposure To Acetaminophen And Its Metabolites Using Physiologically Based Pharmacokinetic Modeling
Presenter: Paola Mian, MSc, Intensive Care and Department of Paediatric Surgery, Erasmus MC Sophia Children's Hospital
OIV-002 Eculizumab Dosing Strategies in Pediatric Patients with Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA): PK-PD model-based assessment
Presenter: Kana Mizuno, PhD, Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center
OIV-003: Transdermal Testosterone Administration Attenuates Drug-Induced Lengthening of Both Early and Late Ventricular Repolarization in Older Men.
Presenter: Elena Muensterman, PharmD, Purdue University

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