Debojit Bose
Principal Scientist Regeneron Pharmaceuticals
Seminars
Early-phase gene therapy development demands speed, but analytical rigor cannot fall behind. Regulators now expect more robust justification for assay readiness, even at Phase I, while companies struggle with limited material, evolving processes, and unclear expectations around qualification versus validation.
This session breaks down how analytical teams can design phase-appropriate, strategic, and holistic analytical studies that:
- Support IND and clinical entry
- Avoid rework and delays later
- Build toward potency assurance and PPQ readiness
- Balance robustness with real-world resource constraints
Grounded in industry examples, this workshop will enable you to collaborate on determining the appropriate depth of early-phase analytical development, and where over-engineering wastes time while under-engineering creates risk of downstream rework and regulatory scrutiny
- Exploring why some teams still run ddPCR, ELISA, AUC, HPLC and TEM and how to reduce redundancy
- Discussing opportunities for how early teams can converge on a smaller assay panel
- Is there a one-size-fits-all, and how close are we to establishing one?
