- Introduction and Background
- Patient Role in Drug Approval - Food for Thought
- Policy Analysis: Pre-existing Policies in Patient-Focused Drug Development
- Patient Advocacy Organizations’ Role in Drug Development: Sarepta Case
- Impact Analysis
- Current Paradigm
- Positive Aspects
- Negative Aspects
- Conclusion References
Mladen Bozic, MS
VP & Head, Global Regulatory Policy and Intelligence, Takeda