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Monday, June 25 • 3:00pm - 4:15pm
#155: Real World Evidence for Value and Access

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-552-L04-P; CME 1.25; IACET 1.25; RN 1.25

Increasing availability of real-world data (RWD) and real-world evidence (RWE) has created justifiable excitement for stakeholders. The applications of RWD and RWE seem limitless – from trial optimization, directing R&D spend, and defining risk-sharing arrangements and value. Also, the role of RWD and RWE is becoming increasingly important to drug development and patient safety and has been cited as a significant priority of the FDA. Yet, there is still a lot of work to be done before the use of RWD and RWE is widespread and truly impactful. The session will explore this potential as well as the areas for further exploration, alignment, methods, and infrastructure development. Also, the session will present a study conducted by Tufts Center for the Study of Drug Development that examines current RWE data uses, sources of data, how data is being integrated and operational approaches supporting RWD use.

Learning Objectives

Discuss the potential advantages and challenges, as well as return on investment, in using real-world data (RWD) and real world evidence (RWE); Assess the application of RWD and RWE for clinical research, value-based payment arrangements, and post-market safety surveillance; Describe emerging practices and definitions.


Marianne Hamilton Lopez, PhD, MPA


The Use of Real World Evidence and Data in Clinical Research and Post-Marketing Safety Applications
Mary Jo Lamberti, PhD, MA

How Real World Evidence is Rapidly Changing Drug Development and Value Demonstration
Charles Makin

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 Marianne Hamilton Lopez

Marianne Hamilton Lopez

Research Director, Value-Based Payment Reform, Duke-Margolis Center For Health Policy, United States
Marianne Hamilton Lopez, PhD, MPA is Research Director of Value-Based Payment Reform at the Duke-Robert J. Margolis, MD, Center for Health Policy. She focuses on value-based payment models for medical products; oversees a multi-stakeholder Consortium; and partners with faculty and... Read More →

Charles Makin

Vice President and Global Head, RWE and Late Phase Research, ICON plc
Charles Makin leads ICON’s late phase research unit, one of the industry’s largest teams dedicated to RWE generation and analysis. In over 15 years in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session