What can nonclinical findings tell us about what may happen in humans? Connecting nonclinical and clinical data can provide a more complete view of safety and help researchers understand how findings observed before clinical development may translate to patients. Drawing on TransCelerate’s Enabling Translational Safety initiative, this session will discuss practical considerations for data sharing, data quality, terminology alignment, and analytical approaches that help evaluate relationships between nonclinical observations and clinical outcomes. Speakers will also explore the opportunities and limitations of emerging AI-enabled and data-driven approaches to generate clinically meaningful insights and improve confidence in safety interpretation across the development continuum.

The objective of this session is to learn how proactive benchmarking of safety event rates using a cohort of patients in indicated populations can benefit pipeline and in-line products, enabling prompt decision-making, supporting pharmacovigilance, and responding to regulatory queries.

We developed a two-stage workflow to support safety and pharmacovigilance literature surveillance by combining automated retrieval with AI-based relevance ranking and triage. The approach is designed to improve consistency, reduce manual review burden, and preserve recall by surfacing high-value articles for expert review. We will share lessons learned on model benchmarking, evaluation, and operationalizing the workflow in a regulated review environment.

As clinical trial complexity continues to grow, safety teams must move beyond fragmented reviews and disconnected data sources. This session highlights AbbVie's journey to create a unified safety intelligence ecosystem spanning the core pillars of medical monitoring, safety review, and patient profiling. Attendees will learn how integrated analytics, standardized data foundations, and purpose-built workflows enable accelerated risk identification and a holistic understanding of patient safety.

Outsourcing is commonplace but is still a complex decision. Some PV activities are more amenable to outsourcing, while others should remain in-house under the sponsor's control. The final vendor selection will always be a very company-specific decision, but there are guardrails and processes to follow that will ease the path and ensure a successful long-term partnership.

Clinical trial safety management is often fragmented across reporting systems, SOPs, signal evaluation, and communication pathways, creating variability and delays in safety oversight. This session will present a practical framework for building a unified safety ecosystem that integrates standardized SOPs, internal and external reporting, signal evaluation and communication, and frontline nurse engagement. The approach clarifies roles, escalation pathways, and documentation while leveraging nurses as essential partners in early safety signal identification and escalation.

Gene therapies present distinct safety monitoring challenges across clinical development and post-marketing settings. Their complex mechanisms, individualized treatment pathways, and pre-treatment procedures can complicate causality assessment, risk characterization, and long-term follow-up. This presentation examines where traditional pharmacovigilance models may fall short and discusses practical approaches to strengthen signal detection, benefit-risk assessment, and patient protection for advanced therapeutics.

Centralized monitoring generates a significant volume of actions, but it can be difficult to know whether those actions truly reduced risk or simply closed a finding. This session shares a practical approach to measuring action effectiveness by connecting risks, signals, actions, and outcomes. I will discuss challenges, our work evaluating effectiveness, and how these insights can support more meaningful risk-based quality management.