Wednesday, June 21 • 4:00pm - 5:15pm
#384: The Increasing Role for Big Data for Late Phase Drug and Postapproval Purposes

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-561-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will clarify the growth of big data assets both in the private and public sector, the tools that can be used to evaluate drug real world safety and effectiveness, and the increasingly favorable view of big data by regulators as a more comprehensive and less expensive approach to postapproval monitoring for safety and effectiveness.

Learning Objectives

Explain use of data postapproval.


Gregory Daniel, PhD, MPH, RPh


Industry Perspective
Gracie Lieberman, MS

PCORI Perspective
Joe V. Selby

Fulfilling the Vision of Sentinel as a National Resource: Public Access Through the Reagan-Udall Foundation for the FDA
David Martin, MD, MPH

avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. He directs the DC-based office of the Center leading its pharmaceutical and medical device policy portfolio, and... Read More →


Gracie Lieberman

Director Regulatory Policy, Genentech, A Member of the Roche Group
Gracie Lieberman is a Biostatistician with 30+ years of experience in oncology clinical trials. Gracie is a Director of Regulatory Policy at Genentech and focuses on utilization of RWE in regulatory decision-making. While working at Genentech for the past 22 years, Gracie has gained... Read More →
avatar for David Martin

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →
avatar for Joe Selby

Joe Selby

Executive Director, Patient-Centered Outcomes Research Institute (PCORI)
A family physician, clinical epidemiologist, and health services researcher, Dr. Selby has more than 35 years of experience in patient care, research, and administration. He is responsible for identifying strategic issues and opportunities for PCORI and implementing and administering... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  10: Value-Access, Session