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 | ashtekar@usc.edu