Session Details

Quality & Operations Track Session 8 - Real World Evidence and Applications in Product Development
Sunday, September 15, 2019 10:45 AM - 12:15 PM 
Ballroom B
The session will have speakers from the FDA/CBER/OTAT, industry and other stake holder groups to address:
•      What is the value of real world evidence (RWE) and how is used by each stake holder: regulator, product developer (industry), etc.
•      What are the current challenges to apply RWE in views of regulators, payers, developers;
•      To address the challenges, what can be done, where to start, and can use stake holder collaborations.


Chair:

Jiwen Zhang, PhD, PassageBio, USA

Speakers:
Real World Evidence: A Regulatory Perspective
Adnan Jaigirdar, MD, FACS, U.S. FDA, USA
Learning objectives:
•      Assess the role/value of real world evidence (RWE) in regulatory evaluation.
•      What are the current challenges to evaluate RWE in regulatory assessments.
•      What strategies are being undertaken to address these challenges, how to proceed forward

Trends and Challenges in Real-world Evidence Generation
Leanne Larson, MHA, PARAXEL, USA
Learning objectives:
•      Explore trends in applying real-world evidence in stakeholder decision-making
•      Understand current real-world study approaches
•      Understand challenges in implementing RWE studies today

Real World Evidence Generation: Motivations, Challenges and Solutions for Industry and Academia
John Booth, PhD, CTI Clinical Trial & Consulting Services, USA
Learning objectives:
- Discuss the utility of real-world evidence.
- Discuss and compare the motivations and challenges of real-world evidence in Industry and Academia.
- Discuss solutions that can result in synergy between Industry and Academia.

Jiwen Zhang PhD
U.S. FDA
Chair


Adnan Jaigirdar MD, FACS
U.S. FDA
Speaker


Leanne Larson
CVP, WW Head of Real-world Evidence
Parexel International
Speaker