Alexander Lee

• 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

• Structure the analytical sections to tell a compelling story of product understanding and control, going beyond simply presenting data to demonstrating a state of control, increasing reviewer confidence and facilitating a smoother BLA approval process
• Choosing characterization and comparability studies essential for submission to avoid unnecessary data while providing critical evidence, enabling a focused and efficient BLA preparation
• Integrate complex data sets for attributes like DAR distribution and impurity fate into a coherent narrative to facilitate regulator assessment of product consistency and control, reducing the risk of major objections and expedite the path to market