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THE US GRANT, a Luxury Collection Hotel, San Diego

Nov 10, 2022 7:00 AM - Nov 11, 2022 12:30 PM

326 Broadway, San Diego, CA 92101

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 8: Leaping Forward: The Future of Real-World Evidence

Session Chair(s)

Nirosha M. Lederer, PhD, MS

Nirosha M. Lederer, PhD, MS

Head, US Government Partnerships; Senior Director, RWE Strategy

Aetion, United States

Jingyu (Julia)  Luan, PhD

Jingyu (Julia) Luan, PhD

Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D

AstraZeneca, United States

In the past two days, this conference has reviewed the proliferation of real-world data sources and technological advances that have spurred innovative uses of real-world data and real-world evidence by sponsors in product development and regulators in product evaluations. In this capstone session, we discuss the future trends for RWE. Potential topics may include:

  • How can RWE continue to improve the efficiency of drug development?
  • What should we do to expand the use of RWE in common disease areas?
  • How can we use RWE to enhance patient focused drug development and clinical trial diversity?
  • What novel technologies can address challenges in the use and evaluation of real-world data and evidence for regulatory decision-making?
Speakers and panelists from regulatory agencies, industry, and academia will discuss these questions through innovative health technologies, digital endpoints, AI/ML, tokenization, new real world data source, synthetic data, future diagnostics, PDUFA VII RWE pilot programs, etc.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe key anticipated trends in RWD and RWE
  • Recognize future opportunities to leverage RWD and RWE in generating RWE for regulatory decision-making
  • Be aware of the challenges that may be encountered when novel technologies are used to generate RWD/RWE


Lucy  Vereshchagina, PhD


Lucy Vereshchagina, PhD

PhRMA, United States

Vice President, Science and Regulatory Advocacy

Wendy  Turenne, MS

Synthetic Data and Data Operationalization Advancements

Wendy Turenne, MS

Aetion, United States

Senior Vice President, Real World Data & Delivery Operations

Sarah  Sheehan, MPA

Digital Medicine and RWE

Sarah Sheehan, MPA

Digital Medicine Society (DiMe), United States

Program Lead

Charles  Lee, MBA, MS


Charles Lee, MBA, MS

AstraZeneca, United States

Executive Regulatory Science Director

John  Concato, MD, MPH, MS


John Concato, MD, MPH, MS

FDA, United States

Associate Director for Real-World Evidence Analytics, OMP, CDER

Peter  Mol, PharmD, PhD

Virtual Panelist

Peter Mol, PharmD, PhD

MEB, Netherlands

CHMP member, NL

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