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Monday, June 19 • 11:00am - 12:15pm
#126: Breaking Down the Wall for FDA to Leverage Real World Data

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will explore the use of real world evidence/big data in drug and device development, regulatory decision making under PDUFA VI and MDUFA IV, and transactional data sources.

Learning Objectives

Discuss FDA's plans for implementing the RWE provisions once PDUFA VI begins in October 2017; Describe potential methodologies for gathering and analyzing RWE; Explain perspectives from those who have conducted RWE/pragmatic clinical trial pilots or demonstrations; Discuss prospects for use of RWE to help inform efficacy not only in the postmarket space but also premarket for original NDAs.


Sophie Janssens


A Study on the Use of Real World Evidence in Clinical Research and Postmarketing Safety Monitoring
Mary Jo Lamberti, PhD, MA

FDA Perspective
Jonathan P. Jarow, MD, PhD

How Are Innovators Bringing Real World Data to the Table?
John Reites

avatar for Sophie Janssens

Sophie Janssens

Global Director Pricing and Market Access, UCB Pharma, Inc
Sophie has 20+ years of working experience; in the Pharmaceutical Industry, as Management Consultant for the pharma & public sector and as political advisor for the public sector. As Global Head of RWE at UCB Pharma, she has the responsibility to drive life cycle RWE strategy & tactics... Read More →

avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology... Read More →
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She is a global expert on benchmarking drug development operating practices. Her research focuses on a variety of areas including... Read More →
avatar for John Reites

John Reites

Chief Product Officer, Partner, THREAD
Executive intrapreneur turned digital health entrepreneur, John’s career includes over 14 years leading global drug development and healthcare innovation. Named one of the Top 100 Influencers in Digital Health, John provides expertise and execution experience in digital health strategy... Read More →

Monday June 19, 2017 11:00am - 12:15pm CDT
N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  10: Value-Access, Forum