Using Real World Evidence to Transform Drug Development and Evaluation:  Opportunities and Challenges

Duration: 60 minutes


**For more information, please see PharmaLex Privacy Policy.

If you do not wish to receive any communication from us, you may unsubscribe at any time.

Why watch


Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book or online source that systematically covers the latest development in the field.  In this webinar, Dr. Yang will illustrate the potential uses of RWE in biopharmaceutical development, and present a wide range of RWE applications throughout the lifecycle of drug product development.  The presentation will cover opportunities, challenges, and solutions in RWE.

Key Learnings

  •   Provide a broad overview of RWE in drug development
  •  Outline a broad array of topics on outcomes- and value-based RWE assessments  
  •   Demonstrate proper Bayesian application and causal inference for real-world data (RWD) 
  •   Present real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights
  •  Offer a balanced discussion of practical RWE issues at hand, and technical solutions suitable for practitioners with limited data science expertise 

A full hour of inspirational speaker(s)

Harry Yang, Ph.D.

Vice President and Head of Biometrics, Fate Therapeutics

Harry Yang, Ph.D. has 25 years of experience across all aspects of drug research and development, from early target discovery, through pre-clinical, clinical, and CMC programs to regulatory approval and post-approval lifecycle management. He has published 7 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP.