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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.

Chair

Gregory Daniel, PhD, MPH, RPh

Speaker

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



Moderators
avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clincial Professor, Duke-Margolis Center For Health Policy
Dr. Gregory Daniel is Deputy Director and Clinical Professor in the Duke-Robert J. Margolis Center for Health Policy. Dr. Daniel directs the DC-based office and leads its pharmaceutical and medical device policy portfolio aimed at developing strategies for improving development a... Read More →

Speakers
avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clincial Professor, Duke-Margolis Center For Health Policy
Dr. Gregory Daniel is Deputy Director and Clinical Professor in the Duke-Robert J. Margolis Center for Health Policy. Dr. Daniel directs the DC-based office and leads its pharmaceutical and medical device policy portfolio aimed at developing strategies for improving development a... Read More →
GL

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 gai... Read More →
avatar for David Martin

David Martin

Liaison to the Reagan-Udall Foundation IMEDS Program, OMP, CDER, FDA
David Martin is involved in opening Sentinel resources to the public, developing real world evidence policy, and engaging patients in evidence generation. He is the principal investigator for the first effort to capture patient-provided data through a mobile device application, s... 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 administe... Read More →


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