Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 3: Patient-Centered Drug Development (2019)

Data Management & Informatics
Regulatory & Quality Sciences
Mladen Bozic, MS

VP & Head, Global Regulatory Policy and Intelligence, Takeda

Topics

  1. Introduction and Background
  2. Patient Role in Drug Approval - Food for Thought
  3. Policy Analysis: Pre-existing Policies in Patient-Focused Drug Development
  4. Patient Advocacy Organizations’ Role in Drug Development: Sarepta Case
  5. Impact Analysis
    1. Current Paradigm
    2. Positive Aspects
    3. Negative Aspects
  6. Conclusion References

Acknowledgement

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

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.