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Saturday, March 18, 2017

Special  Education Session
Publish or Perish: Getting in the Game, and Getting the Most Out of Your Published Works

Chair:

Catherine Sherwin, PhD
University of Utah School of Medicine, Salt Lake City, UT

Navigating to Find the Right Journal
John A. Wagner, MD, PhD
Takeda Pharmaceuticals, Cambridge, MA

Optimizing and Tracking the Impact of Your Published Article
Morna Conway, PhD
Morna Conway, Inc., Shelbyville, TN

Why Do I Need to Publish My Work?
Susan Abdel-Rahman, PharmD
Children’s Mercy Hospitals & Clinics, Kansas City, MO

Special Session
Subject Safety in First-in-Human (FIH) Studies: Perspectives, Pragmatism, and Practice

Chairs:

Sarah Robertson, PharmD
Vertex Pharmaceuticals, Boston, MA

Aubrey Stoch, MD
Merck & Co., Kenilworth, NJ

First-in-Human Studies: Practical Aspects of Design and Control
Jim Bush, MB ChB, PhD
Covance Clinical Research Unit, Leeds, United Kingdom

BIA 10-2474 Accident: Biotrial Crisis Management – Facts, Impact & Lessons
Jean-Marc Gandon, PharmD
Biotrial, Rennes, France

Death (or SAE) in First-in-Human Studies: What Next? A Regulatory Perspective
Jonathan P. Jarow, MD
US Food and Drug Administration, Silver Spring, MD

When First-in-Human Studies Results in Death: Legal and Regulatory Lessons
Robin Fretwell Wilson, BA, JD
University of Illinois College of Law, Champaign, IL

Oral Abstract Session
Regulators of Drug Transporters


OII-001
IN VITRO AND IN VIVO FUNCTIONAL TESTING OF SNPS IN THE 3’UTR OF CYP2B6.
Presenter: Kimberly Burgess, Indiana University School of Medicine

OII-002
CLINICALLY RELEVANT MULTIDRUG TRANSPORTERS ARE REGULATED BY DIFFERENT MICRORNAS ALONG THE HUMAN INTESTINE.
Presenter: Henrike Bruckmüller, PhD, University Hospital Schleswig-Holstein

OII-004
SUBSTANTIAL ENHANCER ACTIVITY OF NON-CODING REGIONS IN ABCG2 (BREAST CANCER RESISTANCE PROTEIN, BCRP).
Presenter: Kit Wun Kathy Cheung, PharmD, University of California, San Francisco

Oral Abstract Session
Drug Metabolizing Enzymes, Neonatal and Pediatric Pharmacology


OIII-001
FEASIBILITY OF A PEDIATRIC MICRODOSE STUDY OF [14C] MIDAZOLAM TO STUDY THE ONTOGENY OF CYP3A-MEDIATED DRUG METABOLISM.
Presenter: Bianca van Groen, Erasmus MC - Sophia Children’s Hospital

OIII-002
MATERNAL AND FETAL METHADONE EXPOSURE: ASSOCIATIONS WITH NEONATAL ABSTINENCE SYNDROME.
Presenter: Ingrid Metzger, PhD, Indiana University School of Medicine

OIII-003
CAFFEINE CITRATE DOSING ADJUSTMENT TO MAINTAIN TARGET CAFFEINE CONCENTRATION IN PRETERM NEONATES.
Presenter: Gilbert Koch, PhD, University Children’s Hospital Basel

Symposium
Innovation at the Intersection of Clinical Trials and Real-World Data to Advance Patient Care

Chair:

Lokesh Jain, PhD
Merck & Co., Inc., Rahway, NJ

Real World Data in the Real World of Healthcare. Why Now?
Craig White
QuintilesIMS, Cambridge, MA

Symposium
Reverse Translation Fueled by Quantitative Pharmacology: Informing Biology, Drug Development Decision-Making, and Therapeutic Optimization

Chair:

Sreeneeranj Kasichayanula, PhD
Amgen, Thousand Oaks, CA

Reflections on the Practice of R&D: Balancing Academic Curiosity Analyzing Observations for a Lifetime, with Patient-Centricity and Market-Driven Necessities to Move Fast
Amin Rostami-Hodjegan, PharmD, PhD
University of Manchester, Manchester, United Kingdom

Data-Driven Detection, Corroboration, and Validation of Novel Drug Effects and Drug-Drug Interactions
Nicholas Tatonetti, PhD
Columbia University Medical Center, New York, NY

Symposium
Gut Microbiome and Drug Response Phenotype


Genomics and Metabonomics in Disease and Drug Metabolism
Yulan Wang, PhD
Chinese Academy of Sciences, Wuhan, China

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