Dr. Frank Li, Founder & Principal Consultant of BLA Regulatory, will speak at the 2026 KoNECT International Conference (KIC) in Seoul, Korea, sharing insights into the evolving U.S. FDA regulatory landscape for rare disease drug development.
The 2026 KIC will take place October 13–15, 2026, at Lotte Hotel Seoul, bringing together professionals from government, academia, pharmaceutical and biotechnology companies, CROs, hospitals, and research organizations to explore the latest trends and challenges in global drug development and clinical trials.
Event Information:
📅 Conference: October 13–15, 2026
📍 Location: Lotte Hotel Seoul, Seoul, Korea
🎤 Frank Li’s Presentation: Thursday, October 15, 1:30–1:50 PM
📌 Session: S18 – Overcoming Scientific Challenges in Rare Diseases
🏢 Room: 2F Crystal B
Recent Updates and Shifting Trends in FDA Guidelines for Rare Diseases
Rare disease drug development presents unique scientific and regulatory challenges, from small and heterogeneous patient populations to limited natural history data, endpoint uncertainty, and difficulties applying conventional clinical development models.
During Session S18, Dr. Frank Li, PhD, RAC, will present “Recent Updates and Shifting Trends in FDA Guidelines for Rare Diseases,” examining how FDA’s approach to rare disease development continues to evolve.
His presentation will highlight recent FDA initiatives and regulatory developments, including the Rare Disease Innovation Hub, Rare Disease Evidence Principles (RDEP), START Pilot Program, and RDEA Pilot Program, as well as established rare disease incentives and emerging approaches to evidence generation.
Key Topics
Attendees will gain insights into:
-
- Recent developments in FDA’s rare disease regulatory framework
- FDA programs and initiatives supporting rare and ultra-rare disease development
- Clinical trial design, endpoint development, dose selection, and natural history data
- Evolving approaches to evidence generation for small patient populations
- Regulatory considerations and practical lessons from rare disease approval case studies
These areas reflect the presentation’s coverage of scientific development considerations and real-world FDA case studies.