Archives: Agenda
Unlocking FDA Strategies for Speedy Approval and Smart Dosing in Oncology Trials
- Exploring recent US FDA updates on expedited approval pathways and dosing strategies in oncology
- Designing clinical trials that meet FDA expectations for surrogate endpoints and biomarker use
- Developing regulatory-aligned strategies for oncology drug development under new FDA guidance
Chairperson’s closing remarks
Lunch and networking
Prize Draw taking place in exhibition hall at 14:15
Join us for a chance to win one of our prizes, including Apple products
Chairperson’s closing remarks
Morning refreshments and networking
Chairperson’s opening remarks
KEY NOTE: Patient Engagement at Kyowa Kirin – Insights from Clinical Development
Kyowa Kirin integrates patient voices from research to the entire product lifecycle
The Development Division, led by the Development Patient Engagement Lead (Dev PEL), uses a structured process to gather and apply patient feedback
Example: Developed an on‑body injector to remove next‑day hospital visits after chemotherapy
Registration and refreshments
PANEL DISCUSSION: Overview of Clinical Trial Dynamics Affecting Small to Mid-Sized Biopharma in Korea
- Current landscape and growth trends of clinical trials in Korea, especially for small/mid-sized biopharma
- Navigating the evolving vendor and CRO ecosystem as a small to mid-sized sponsor
- Regulatory environment and recent updates impacting trial initiation and approvals