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

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

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