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Wednesday, June 26 • 10:30am - 11:30am
#342: When is Real World Evidence Ready for Prime Time?

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-681-L04-P; CME 1.00; IACET 1.00; RN 1.00

We see growing interest in the value of using real world data (RWD) to support label expansions and approvals of drugs for rare conditions and oncology products. The FDA released its Framework for Real World Evidence Program in December 2018, following release of the its MyStudies App designed to incorporate patient-originated data with other RWD for research purposes. In Europe, the Heads of Medicines Agencies and the European Medicines Agency released a joint report in February, 2019 on their big data taskforce summarizing many areas of interest to better understand RWD and its possible uses. We will distill key lessons from demonstration projects and other experience to understand what is being done to evaluate data sets to give confidence in a RW study design, and its findings, including the challenges encountered when comparing data from clinical trials with a medicine’s performance in routine clinical practice, as actually prescribed by physicians and taken by patients.

Learning Objectives

Describe at least one innovative study design that used real world data for label expansion; Characterize the types of diseases and treatments for which real world evidence has been used to expand the labeled use.

Chair

Nancy Dreyer

Speaker

FDA Update
Peter P. Stein, MD

EMA Update
Anthony Humphreys, MPharm

Panelist
Gregory Daniel, PhD, MPH

Panelist
Solomon Iyasu, DrMed, MPH



Speakers
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 →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer & Senior Vice President, IQVIA
Nancy Dreyer is chief scientific officer and SVP at IQVIA. She focuses on generating real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional approaches. She is a Fellow of both DIA and the Int’l Society of Pharmacoepidemiology... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →
avatar for Solomon Iyasu

Solomon Iyasu

Vice President and Head of Pharmacoepidemiology, Merck & Co., Inc.
Dr. Iyasu joined Merck and Co. in August of 2015 as head of Pharmacoepidemiology in the Center for Observational and Real-World Evidence (CORE). In his current role, he leads a department that is responsible for designing and conducting postapproval observational safety and effectiveness... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related... Read More →
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 →


Wednesday June 26, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum