Wona Joo

• 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

The regulatory landscape for ADCs is at a tipping point, evolving from a “case-by-case” model towards a new paradigm for complex biotherapeutics. This panel will explore how industry leaders can proactively collaborate with global health authorities to shape future guidance, rather than just reacting to it. This discussion will address the most pressing gaps for novel modalities, the role of real-world evidence, and strategies for true global harmonization.

Join us to gain a forward-looking perspective on influencing the next generation of ADC regulation by:

• Defining the critical data needed from industry to justify novel control strategies for bispecific, dual-payload, and high DAR ADCs, moving beyond the small molecule vs. biologic dichotomy to establish a new regulatory framework
• Debating the feasibility of a unified global submission package and identifying the key compromises and scientific principles needed by both industry and regulators to make it a reality
• Exploring how artificial intelligence and advanced data visualization in eCTDs could transform regulatory reviews, enable a more dynamic assessment of complex CMC data and accelerating patient access

• Implement a holistic comparability strategy that integrates mass spectrometry-based characterization with forced degradation studies, to move beyond a checklist of attributes and identify critical quality shifts
• Develop a risk-based comparability protocol focused on novel ADC-specific attributes to prioritize patient safety and mechanism of action, for faster regulatory approval
• Structure the comparability report as a compelling scientific story linking analytical data to clinical impact, to transform complex datasets into a clear demonstration of product understanding and control, increasing reviewer confidence