Dimple Modi
Senior Director - Oncology Precision Medicine Regeneron Pharmaceuticals
Seminars
Tuesday 21st July 2026
Panel Discussion: From Exploratory Signal to Regulatory Confidence: Building the Evidence Base for MRD as an Approved Endpoint
4:20 pm
- Outlining the evidence regulators expect for ctDNA endpoint consideration, including how multiple myeloma secured its first approval
- Identifying gaps between exploratory biomarker use and surrogate endpoint qualification
- Positioning ctDNA endpoints for inclusion in regulatory dialogue and submission packages
Monday 20th July 2026
Integrating ctDNA Monitoring in Drug Development – Roadmap & Benefits
3:40 pm
What We Will Discuss:
- Overview of Personalis and high-level recent clinical evidence
- Integration of MRD in clinical trial development
- Regulatory and quality hurdles for ultra-high sensitivity assays
This collaborative session brings together industry leaders to discuss the integration of ctDNA monitoring into clinical trial development. Panellists will share their organizational strategies, implementation experiences, key opportunities, and internal adoption efforts. The Engager will also cover key opportunities to accelerate adoption, strategies for securing leadership alignment, and how Personalis can support these initiatives. Attendees will gain real-world insights into regulatory frameworks, academic requirements, and biotech perspectives, while also exploring how Personalis can further support pharma’s ctDNA integration goals.
