Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 5: Real World Evidence and Real World Data (2019)


  1. Part I: Definitions
    1. Real World Data (RWD)
    2. Real World Evidence (RWE)
    3. Applications of RWE based on RWD
  2. Part II: Case Studies (drug development tools)
    1. Why do Drug Development Programs Fail?
    2. Clinical Trial Simulations
    3. Clinical Trial Simulator for Alzheimer’s disease
    4. Comprehensive Data Integration
    5. Model Endpoints/Covariates
    6. Implications for Application
    7. Extend Validation
    8. A Successful Pathway for Regulatory Endorsement of Quantitative Drug Development Tools
    9. Case Study 1
    10. Case Study 2
  3. Part III: Case Studies (medical devices)
    1. Medical Devices
    2. Aortic Valve Replacement
    3. What RWD/RWE was used?
  4. Part IV: Case Studies (drugs)
    1. Physiologically Based Pharmacokinetic/dynamic Modelling (PBPK)
    2. Conclusions


Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy |  


Klaus Cepeda, MD, MS, FCP
Director, Clinical Pharmacology and Quantitative Medicine at Critical Path Institute; Adjunct Professor of Clinical Pharmacy, USC School of Pharmacy

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