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