October 14, 2026

Emerging Therapies: Addressing Safety, Risk Management, and Regulatory Challenges Through the ADC Lens

Advances in precision medicine have accelerated the development of innovative therapeutic modalities, such as cell and gene therapies, RNA therapeutics, targeted protein degraders (such as Proteolysis Targeting Chimeras (PROTACs) and molecular glues), radiopharmaceuticals, and next-generation antibody-based therapies, including bispecific antibodies and antibody drug conjugates (ADCs). These emerging modalities are transforming the treatment landscape across multiple therapeutic areas by enabling more precise targeting of disease mechanisms and expanding therapeutic options for patients. However, they also introduce novel safety challenges, evolving benefit–risk considerations, and increasingly complex regulatory expectations. Antibody drug conjugates provide a particularly relevant example, demonstrating complexities such as off-target/off-tumor toxicities, payload-associated adverse events, long-term safety uncertainties, and the need for continuous benefit–risk evaluation throughout the product life cycle. Key challenges throughout clinical development may include selecting appropriate targets to maximize tumor specificity while minimizing toxicity, optimizing linker and payload design, managing dose-limiting toxicities, understanding exposure–response relationships, identifying predictive biomarkers, and characterizing class-specific toxicities, such as ocular, pulmonary, neurological, and hematological adverse events. The heterogeneous nature of ADCs often necessitates innovative clinical trial designs, enhanced safety monitoring strategies, and close integration of preclinical, clinical, and pharmacovigilance data to support informed decision-making.

This session will explore how pharmacovigilance and risk management are evolving to support emerging therapies, particularly ADCs, and the unique safety challenges they present throughout the product life cycle. Participants will learn about early risk identification, proactive signal detection and regulatory intelligence, and long-term safety monitoring across the product life cycle. The session will also highlight emerging regulatory expectations and practical considerations for maintaining patient safety while enabling therapeutic innovation.

Attendees will gain practical insights into anticipating and managing emerging safety concerns, maximizing patient benefit, and maintaining public trust throughout the life cycle of innovative therapies through real-world examples, such as risk evaluation and mitigation strategy (REMS) implementation to manage serious toxicities and industry perspectives.

• Understand the unique clinical safety and pharmacovigilance challenges associated with emerging therapeutic modalities, with a particular focus on ADCs.
• Review evolving global regulatory expectations for advanced therapies across the product life cycle.
• Discuss best practices for signal detection, risk management, and long-term safety monitoring.
• Gain practical insights into proactive approaches for managing emerging risks while supporting patient safety and innovation.
• Explore ADCs as a model for addressing complex benefit–risk, safety, and life cycle management considerations.