A schedule of events for Leveraging Big Data II: What Does It Mean for Improving Product Development and Health Care is provided below for your convenience.

This one-day conference scheduled for Tuesday, February 11, 2014, will be held in the Southern Management Corporation Campus Center at the University of Maryland, Baltimore. It is open to the public. For a printable agenda, please Download the conference brochure.

TimeActivity
10:00-10:15 a.m. Welcome and Objectives
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

Eleanor Perfetto, PhD, MS
Professor of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
10:15-12:00 p.m. Use of Big and Real-World Data by phrma: More than Data Warehousing
Aaron Galaznik, MD
Senior Director, Real-World Data and Analytics
Pfizer, Inc.

Leveraging Real-World Data and Analytics in the Device Industry
Thomas Abbott, PhD
Head, Health Care Informatics
Johnson & Johnson, Medical Devices and Diagnostics

Janus Clinical Trials Repository: An Update and Insights into Future Directions
Lilliam Rosario, PhD
Director, Office of Computational Science
Food and Drug Administration (FDA)

Panel Q&A

Morning Session Moderator: Jennifer Graff, PharmD, Director of Comparative Effectiveness Research at the National Pharmaceutical Council
12:00-12:20 p.m. Break (Guests Receive Lunch and Return to Room for Lunch Speaker)
12:20-1:15 p.m. Introduction of Lunch Speaker
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

IMEDS: Sentinel and OMOP Programs
Jane Reese-Coulbourne, MS, ChE
Executive Director
Reagan-Udall Foundation, FDA
1:15-2:50 p.m. Big Data and the "Research Harbor" Concept
Kate Tracy, PhD
Associate Professor of Epidemiology and Public Health
University of Maryland School of Medicine

Big Data and Data Visualization: Extracting Insights from Electronic Health Records
Ben Shneiderman, PhD
Director, Human Computer Interaction Lab
University of Maryland, College Park

FDA Use of Big Data in Modeling and Simulations
Jeffry Florian, PhD
Review, Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research, FDA

Panel Q&A

Afternoon Session Moderator: TBD
2:50-3:50 p.m. Invited Reactor Panel with Representatives from the National Pharmaceutical Council (Jennifer Graff), Optum Labs (William Crown), Patient-Centered Outcomes Research Institute (Sarah Daugherty), and FDA (Taha Kass-Hout)

Reactor Panel Moderator: Eleanor Perfetto, PhD, MS, Professor of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy
3:50-4:00 p.m. Closing Remarks
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

Eleanor Perfetto, PhD, MS
Professor of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy