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Friday, March 23, 2018 Presentations

Friday, March 23, 2018 Presentations

SCIENCE AT SUNRISE: Transforming Clinical Practice with Translational Informatics and Multi-Omics Data Science
Algorithms, Rapid Analyses, and Data Integrity in Clinical Practice
Sam Volchenboum, MD, PhD,  University of Chicago, Chicago, IL

Knowledge Representation Standards as a Translational Pivot
Robert Freimuth, PhD, Mayo Clinic, Rochester, MN

The Role of Informatics in Off-Label Recommendations and Biomarker-Guided Therapies
Subha Madhavan, PhD, Georgetown University, Washington, DC 

SCIENCE AT SUNRISE: Non-Traditional Pathway to Drug Approval
An Overview of the Regulations Commonly Known as the Animal Rule
Andrea Powell, PhD, US Food and Drug Administration, Silver Spring, MD

Approaches for Dose Translation under the Animal Rule Paradigm: Regulatory Perspective 
Islam Younis, PhD, US Food and Drug Administration, Silver Spring, MD

How Quantitative Pharmacology Can be Used to Facilitate Drug Approval Under the Animal Rule Paradigm: A Case Study in Acute Radiation Syndrome
Sandeep Dutta, PhD, Amgen, Thousand Oaks, CA

STATE OF THE ART LECTURE
Data is the New Black: How the Fourth Industrial Revolution is Changing Healthcare
Mara Aspinall, MBA, Health Catalysts, Tucson, AZ

AWARD LECTURE: Sheiner-Beal Pharmacometrics Award Lecture
"Standing on the Shoulders of Giants"
France Mentré, MD, PhD, University of Paris Diderot, Paris, France 

SYMPOSIUM: Healthy Volunteer Studies in Oncology Drug Development: Pivotal Considerations Toward Optimal Deployment
Chairs: Daria Stypinski, PhD, Pfizer, South San Francisco, CA and Mariam Ahmed, PhD, US Food and Drug Administration, Silver Spring, MD

Patient Care in Clinical Pharmacology Oncology Trials: Principal Investigator Perspective
Eric Roeland, MD, UC San Diego Moores Cancer Center, La Jolla, CA

Opportunities for Healthy Volunteer Clinical Pharmacology Studies in Oncology Drug Development: Targeted Agents, Immunomodulatory Agents, and Beyond 
Chirag Patel, PhD, Takeda, Cambridge, MA

Use of Healthy Volunteers in Clinical Oncology Drug Development
Weiwei Tan, PhD, Pfizer, San Diego, CA

Regulatory Challenges in the Use of Healthy Volunteers
Nicole Drezner, MD, US Food and Drug Administration, Silver Spring, MD

SYMPOSIUM: Biomarkers and Translational Tools to Inform Development of New Therapeutics for Neurodegeneration
Chairs: Sreeraj Macha, PhD, Merck & Co., Kenilworth, NJ and Daniela J. Conrado, PhD, Critical Path Institute, Cambridge, MA

Can Application of Quantitative Clinical Pharmacology Improve Early Clinical Development Success in Neurodegenerative Diseases?
Gianluca Nucci, PhD, Pfizer, Cambridge, MA

Translation from Bench to Bedside: PET Tracers for Use in Neuroscience Drug Development 
Eric Hostetler, PhD, Merck & Co., West Point, PA

Model-Informed Biomarker Qualification: Alzheimer and Parkinson Disease Neuroimaging Biomarkers
Daniela J. Conrado, PhD, Critical Path Institute, Tucson, AZ

Item Response Models for Translation  in CNS Disorders
Mats Karlsson, PhD, Uppsala University, Uppsala, Sweden

ORAL ABSTRACT SESSION: I Pharmacometrics and Pharmacokinetics
OI-001 ASSESSING THE ROLE OF HEART TISSUE CONCENTRATION IN BOTTOM UP MECHANISTIC PREDICTION OF QT PROLONGATION BY MOXIFLOXACIN USING PBPK-QST MODELING.
Presenter: Nikunjkumar Patel, MS,  Simcyp (a Certara Company)

OI-002 WHEN POPULATION PK MODELING HELPS DRIVE ONCOLOGY PHASE I TRIAL: FIRST IMPLEMENTATION OF EXPOSURE DRIVEN DOSE ESCALATION WITH OVERDOSE CONTROL DESIGN. 
Presenter: Sandrine Micallef, PhD, Roche

OI-003 PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING OF THE EFFECT OF CHRONIC KIDNEY DISEASE ON THE PHARMACOKINETICS OF NONRENALLY ELIMINATED DRUGS. 
Presenter: Ming-Liang Tan, PhD, US Food and Drug Administration

OI-004 IMPROVED PREDICTION OF INFLIXIMAB CLEARANCE USING ERYTHROCYTE SEDIMENTATION RATE AND ANTI-INFLIXIMAB ANTIBODY LEVELS 
IN PEDIATRIC PATIENTS WITH INFLAMMATORY BOWEL DISEASE.
 
Presenter: Ye Xiong, PhD, Cincinnati Children’s Hospital Medical Center

WORKSHOP: Translational Medicine & Clinical Pharmacology Strategies Supporting Acceleration of Development of Anti-Infective Drugs
Human Malaria Challenge Model  in Early Development
James S. McCarthy, MD, QIMR Berghofer Medical Research Institute and Royal Brisbane and Women’s Hospital, Queensland, Australia

Model-Informed Malaria Drug Development from Animal Models to Phase II
Nathalie Gobeau, PhD, Medicines for Malaria Venture, Geneva, Switzerland

Clinical Pharmacology Aspects of Anti-Infective Drugs – Regulatory Experiences 
Dakshina Chilukuri, PhD, US Food and Drug Administration, Silver Spring, MD

FEATURED SPEAKER
Reverse Translational Studies to Understand Drug-Induced Toxicity 
Deanna L. Kroetz, PhD, University of California, San Francisco, San Francisco, CA

ORAL ABSTRACT SESSION II: Pharmacology Topics in the Popular Press—Opioids, Ketamine, Immune Checkpoint Inhibitors, and Digital Health
OII-001 EVALUATION OF RBP-6000 EFFECTS ON QT INTERVAL DURING TREATMENT FOR OPIOID USE DISORDER.
Presenter: Virginia (Ginny) Schmith, PhD, Nuventra Pharma Sciences

OII-002 KETAMINE AND KETAMINE METABOLITES AS NOVEL ESTROGEN RECEPTOR LIGANDS: INDUCTION OF CYP2A6, CYP2B6 AND AMPA RECEPTOR —GENOMIC LINKS TO SEX-DIFFERENCES IN KETAMINE RESPONSE.
Presenter: Ming-Fen Ho, PhD, Mayo Clinic

OII-003 APPLICATION OF A SYSTEMS PHARMACOLOGY APPROACH FOR A DETAILED INVESTIGATION OF AN ADVERSE DRUG REACTION DUE TO DISTINCT MECHANISMS OF IMMUNE CHECKPOINT INHIBITORS. 
Presenter: Sarah Kim, PhD, University of Florida

OII-004 SMART TRIALS: ASSESSMENT OF AT-HOME SAMPLING AND DIGITAL HEALTH TECHNOLOGIES IN A CLINICAL PILOT TRIAL.
Presenter: Marissa Dockendorf, PhD, Merck

AWARD LECTURE: Oscar B. Hunter Career Award in Therapeutics Lecture

PK/PD/Systems Modeling: Lessons from Corticosteroids
William J. Jusko, PhD, University at Buffalo, SUNY, Buffalo, NY

SPECIAL SESSION: #Science
Opportunities for Using Internet  Search to Learn About Drug Response 
Russ B. Altman, MD, PhD, Stanford University, Stanford, CA

Will You Follow Me? The Future of Social Media in Healthcare 
Michele Maddux, PhD, Children’s Mercy, Kansas City, MO

Social Media Mining for Pharmacovigilance: Challenges and Opportunities for Case-Control Studies 
Graciela Gonzalez-Hernandez, PhD, University of Pennsylvania, Philadelphia, PA

WORKSHOP: Mechanistic Joint Modeling for Longitudinal and Time-to-Event Data in Oncology Drug Development, Recent Advances, and Toward Personalized Medicine
Chairs: Diansong Zhou, PhD, AstraZeneca,  Waltham, MA, and Jennifer Sheng, PhD, Bristol-Myers Squibb, Lawrenceville, NJ

Mechanistic Joint Models Characterizing the Relationship Between Nonlinear Prostate Specific Antigen Kinetics and Survival in Prostate Cancer Patients 
France Mentré, MD, PhD, University of Paris Diderot, Paris, France

Joint Modeling Tumor Burden and Time to Event Data in Oncology Trials, Theoretical Consideration and Application in Non-Small Cell Lung Cancer Study
Ye Shen, PhD, University of Georgia, Athens, GA

Dynamic Predictions of Progression Free Survival and Overall Survival in Non-Small Cell Lung Cancer Using Tumor Sizes: A Longitudinal Joint Modeling Approach for Gefitinib
Nidal Al-Huniti, PhD, AstraZeneca,  Waltham, MA

SPECIAL SESSION: Career Development for Everyone
Chairs: Anuradha Ramamoorthy, PhD, US Food and Drug Administration, Silver Spring, MD and Virginia (Ginny) Schmith, PhD, Nuventra Pharma Sciences, Durham, NC

Evidence-Based Mentorship
Sharon Straus, MD, University of Toronto, Toronto, ON, Canada

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