Notes from presentations delivered at Leveraging Big Data II: What Does It Mean for Improving Product Development and Health Care? are provided below for the convenience of conference participants.
Welcome and Objectives
Polli Notes
James Polli, PhD
Shangraw/Noxell Endowed Chair in Industrial Pharmaceutics
Co-Principal Investigator, Center for Excellence in Regulatory Science and Innovation
University of Maryland School of Pharmacy
Leveraging Real-World Data and Analytics in the Device Industry
Abbott Notes
Thomas Abbott, PhD
Head, Health Care Informatics
Johnson & Johnson, Medical Devices and Diagnostics
FDA Use of Big Data in Modeling and Simulations
Florian Notes
Jeffry Florian, PhD
Review, Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research, FDA
Use of Big and Real-World Data by phrma: More than Data Warehousing
Galaznik Notes
Aaron Galaznik, MD
Senior Director, Real-World Data and Analytics
Pfizer, Inc.
IMEDS: Sentinel and OMOP Programs
Reese-Coulbourne Notes
Jane Reese-Coulbourne, MS, ChE
Executive Director
Reagan-Udall Foundation, FDA
Janus Clinical Trials Repository: An Update and Insights into Future Directions
Rosario Notes
Lilliam Rosario, PhD
Director, Office of Computational Science
Food and Drug Administration (FDA)
Big Data and the "Research Harbor" Concept
Tracy Notes
Kate Tracy, PhD
Associate Professor of Epidemiology and Public Health
University of Maryland School of Medicine