Event
Shaping the Future of Oncology: From Novel Designs to Latest Regulatory Insights
May 20, 2025 2:00 PM - 4:00 PM Korea Standard Time
KoNECT Lecture Hall, Data Practice Room 6F, KPX Building, 137, Mapo-daero, Mapo-gu, Seoul, Republic of Korea
In this rapidly evolving field, staying ahead of the curve is crucial. This seminar brings together leading experts to provide you with invaluable insights into:
- The latest advancements in oncology research, including radiopharmaceuticals and novel study designs
- The impact of the EU's Joint Clinical Assessment (JCA) on drug development and market access
- FDA perspectives on optimizing clinical trials and navigating regulatory uncertainties in oncology
Agenda
Speaker: Gwyn Bebb, Senior Vice President, Global Therapeutic Area Head – Oncology
- Radiopharmaceuticals: Emerging Opportunities and Challenges
- Novel Study Designs in Oncology: From Basket, Adaptive, and Umbrella trials to “Project Pragmatica”
- Biomarker Utilization in Oncology Research
Speaker: Sinan Sarac, Senior Vice President, Head, Regulatory Strategy
- Introduction to JCA
- HTA-Proofing Development: How JCA Impacts Early Trial Design for Smoother HTA
- Beyond Efficacy: Integrating Value into EMA Assessment
- JCA: Bridging the Gap to HTA Acceptance
Speaker: Pengfei Song, Vice President, Technical PC, Regulatory, Parexel International
- Leveraging Data to Optimize Clinical Trials: FDA’s Perspective
- FDA's Project Optimus: Impact on Therapeutic Radiopharmaceuticals in Oncology
- Navigating FDA Uncertainty: An Insider Perspective
Register
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