Round Table Discussion: Understanding the ADC Regulatory Compass & Navigating the “Case-by-Case” Environment to Accelerate Development Timelines by Anticipating & Addressing Key Regulatory Pain Points
- Analyze common “non-hold” comments from recent BLA reviews, to clarify the level of evidence expected by agencies like the FDA at each development stage, enabling sponsors to prepare more targeted and successful submissions from IND to BLA
- Apply a “fit-for-purpose” justification strategy for complex attributes like DAR and impurities, to provide a rationale in the absence of formal ADC-specific guidance, and streamline the approval pathway for novel ADC formats
- Leverage insights from direct regulatory feedback on stage-appropriate characterization to allocate resources more effectively and avoid both under- and over-characterization, therefore accelerating timelines and reducing CMC development costs