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Hyatt Regency Cambridge

Nov 14, 2019 7:30 AM - Nov 15, 2019 12:30 PM

575 Memorial Drive, Cambridge, MA 02139

Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes

Session 6: New Platforms for Clinical Research Purposes

Session Chair(s)

Debra  Schaumberg, DrSc, MPH

Debra Schaumberg, DrSc, MPH

Vice President and Global Head, Startegic Development Consulting Chair

Evidera | PPD, United States

Data from traditional RCT are often insufficient at the time of product approval for considerations concerning patient access, real-world effectiveness, and safety of drugs and devices. The rapid and continuous development of information infrastructures and capabilities has resulted in an explosion in the amount and quality of RWD and linkages that have expanded the possibilities for how RWD can be built into RWE to inform decisions. This session will introduce the rapid emergence of RWD platforms to enable RWE generation from both retrospective and prospective study designs. Speakers will cover how to leverage such resources to build fit-for-purpose evidence to inform decisions by regulators, payers, providers, and patients.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe relevant use cases for RWD platforms and the types of research questions they can best address
  • Discuss relevant examples of data platforms to support RWE generation
  • Identify challenges with data platforms associated with limitations of evidence generation and opportunities to address them


Tengbin  Xiong

Embrace the RWE Era in China: Trends, Challenges, and Solutions

Tengbin Xiong

Happy Life Technology, United States

Head of RWE Solutions and HEOR

Michelle  Longmire, MD

New Platforms for Clinical Research Purposes

Michelle Longmire, MD

Medable, United States

CEO & Co-Founder

Gigi  Hirsch, MD

Introduction to the MIT NEWDIGS “LEAPS Project”

Gigi Hirsch, MD

Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation, United States

Executive Director

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