Anupam Talapatra
Director Gilead Sciences
Seminars
Wednesday 24th September 2025
Panel Discussion: Advancing Partnerships to Ensure Compliant, Scalable Solutions for Global Precision Medicine Applications
3:30 pm
- When should biomarker advancement trigger formal CDx development efforts for harmonized drug-diagnostic co-development?
- Determining a fit-for-purpose CDx strategy aligned with clinical trial endpoints
- How can collaborative, cross-functional teams streamline CDx integration into therapeutic development, adoption and launch planning and market access?
Wednesday 24th 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
