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

Topics

  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

Acknowledgement

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu  

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

Instructors

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

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

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.