Kashina Bugayong
Program Led Ultragenyx Pharmaceutical Inc.
Seminars
Wednesday 15th July 2026
Panel Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in EAPs
2:00 pm
- Comparing how FDA, EMA, and national health authorities interpret the use of RWD in expanded and post-trial access programs
- Examining differing company approaches, from limiting programs to treatment-only access to actively incorporating structured evidence generation
- Exploring real-world examples of where regulators accepted or rejected RWD submissions in filings and approvals
- Defining the boundaries of ethical and compliant RWD collection when patient care is the primary purpose
Wednesday 15th July 2026
Expanded Access in Latin America: Real‑World Lessons from Rare Disease Programs
9:30 am
- Navigating regulatory and importation bottlenecks in Latin America, including the impact of government changes and evolving approval pathways (with a focus on Mexico, Argentina, and Brazil)
- Managing operational and supply‑chain challenges in rare disease Expanded Access Programs while balancing global standards with country‑specific realities
- Strengthening physician engagement to sustain program momentum and patient access in high‑complexity regions
