Kishore hotha
president Dr.Hotha's life sciences LLC
Seminars
Thursday 30th April 2026
Establishing a Phase Appropriate CMC Strategy, from IND to NDA
11:30 am
- Establishing an ADC-specific control strategy framework that addresses critical quality attributes to reduces clinical holds
- Implementing a dynamic, phase-appropriate method and specification roadmap to align analytical rigor with patient risk and accelerating progression through Phases 1 to 3
- Deploying a proactive post-submission readiness plan ensuring a streamlined review and securing timely market authorization for patient access
