Anupam Talapatra
Global Regulatory Director, Precision Medicine & Companion Diagnostics Gilead Sciences
Seminars
Tuesday 23rd September 2025
Panel Discussion: Advancing Partnerships to Ensure Compliant, Scalable Solutions for Global Precision Medicine Applications
3:30 pm
- Determining a fit-for-purpose CDx strategy aligned with clinical trial endpoints
- When should biomarker advancement trigger formal CDx development efforts for harmonized drug-diagnostic codevelopment?
- How can collaborative, cross-functional teams streamline CDx integration into therapeutic development?
Tuesday 23rd September 2025
Navigating Through the Complex Compliance Landscape of Device Performance Study Under IVDR in the Context of an EU Clinical Trial
2:40 pm
- Dependence on the status of the associated drug study
- Patient-centric considerations
- Study sponsorship obligations and oversight responsibilities
- Alignment of all entities involved in the Performance Study ecosystem
