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Monday, June 19 • 8:30am - 10:00am
#102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making

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Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-565-L04-P; CME 1.50; IACET 1.50; RN 1.50

Though the Randomized Controlled Trial (RCT) has been the trusted standard for generating high-quality evidence of medical product safety and efficacy, the need for more rapid and cost effective understanding of product effectiveness and safety in the real-world has given rise to the vision that draws on real-world evidence as well as that derived from more traditional clinical research applications.

In this DIAmond session, prominent thinkers on scientific evidence for support of biomedical decision-making will discuss our readiness to tap Real World Evidence (RWE) for safety and efficacy questions and then consider its uses for regulatory purposes. The benefits and challenges of using RWE to generate evidence of sufficient quality for decision making, following the concept of using fit-for-purpose research tools, will be examined.

This DIAmond session will stimulate new insights on our readiness for the next steps in the evolution of evidence generation using RWE.

Learning Objectives

Discuss current uses of RWE in the medical product life cycle; Describe potential uses of RWE to improve the speed and cost effectiveness determining safety and effectiveness of medical products in real world use; Compare and contrast the strengths of RCT and RWE data as evidence for medical and regulatory decision making.


Iris Loew-Friedrich, DrMed


Nancy A. Dreyer, PhD, MPH

Robert J. Temple, MD

Alison Cave, PhD

Brian D. Bradbury, PhD, MA

Stephanie Devaney, PhD

avatar for Brian Bradbury

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States
Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →
avatar for Alison Cave

Alison Cave

Principal Scientific Administrator, European Medicines Agency (EMA)
Alison Cave is a Principal Scientific Administrator at the European Medicines Agency within the Pharmacovigilance and Epidemiology Department. She has over 20 years of academic research experience in the cardiovascular field gained in the US and UK. Prior to joining the EMA she was... Read More →

Stephanie Devaney

Deputy Director of the All of Us Research Program, National Institutes of Health (NIH)
Stephanie Devaney is the Deputy Director of the All of Us Research Program at NIH. Prior to this she led the coordination of the Precision Medicine Initiative from the Office of the Chief of Staff at the White House. In this role she coordinated the many components of the Initiative... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation, QuintilesIMS
Nancy Dreyer is the Global Chief of Scientific Affairs for QuintilesIMS Real-World Insights, and heads the Center for Advanced Evidence Generation. She leads an international team conducting research on the safety, effectiveness, and value of medical treatments using secondary and/or... Read More →
avatar for Iris Loew-Friedrich

Iris Loew-Friedrich

Chief Medical Officer, Executive VP and Head, Development and Medical Practices, UCB, Inc.
Iris is Chief Medical Officer at UCB, member of the Exec Committee and Head of the Development & Medical Practices. She provides strategic leadership for global Clin Dev, Medical & Regulatory Affairs, External Engagement and Patient Affairs. She is a physician, board-certified in... Read More →
avatar for Robert Temple

Robert Temple

Deputy Center Director for Clinical Science, Office of the Center Director, CDER, FDA, United States
Dr. Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND). Bob is a consultant to the OND director on matters related to clinical program objectives. Dr. Temple received his MD from... Read More →

Monday June 19, 2017 8:30am - 10:00am CDT
S100a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  12: DIAmond, Session
  • format json
  • Featured Topics Real World Evidence,Patient Centric ,Public Policy,StudentProgramming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session