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