CNS and mental health trials remain some of the most complex and challenging studies to execute. Unique patient populations, evolving diagnostic criteria, high placebo response rates, and burdensome assessments create hurdles that impact trial design, recruitment, and execution. This TA Spotlight session explores practical strategies for optimizing trial execution, from protocol design through site selection, recruitment and operations. Explore common challenges—including site selection and readiness, recruitment and retention of diverse patient populations, and the operationalization of innovative digital endpoints.

With a record number of obesity and metabolic trials currently underway, the demand for innovative strategies to advance clinical development has never been greater. This spotlight session explores approaches to strengthen collaborations, improve trial efficiency, and address the complexities of recruitment and retention in obesity and metabolic disease studies. Presentations will highlight emerging partnership models, novel tools such as point-of-care pre-screening to reduce costly screen failures, and best practices for aligning operational execution with scientific goals. The session will feature experts from sites, sponsors, and research organizations, who will share practical insights on overcoming barriers and driving progress in obesity and metabolic trials.

With oncology remaining the most active area of clinical research worldwide, the complexity and volume of trials demand new operational, technological, partnering, and regulatory approaches. This spotlight session examines how oncology trials are evolving across diverse settings, from the growth of community-based and decentralized research models to innovations in regulatory workflows and data management. Expert presentations will showcase applications of AI and advanced digital tools in driving efficiency, improving data quality, and advancing precision medicine. The program culminates with a forward-looking panel discussion on the future of oncology trial design, collaboration, and patient care.

I&I trials come with operational challenges that don't show up in other therapeutic areas. This session will convene leaders from various functional areas to weigh in on what makes them different: segmenting patients by disease severity when severity assessment is subjective across PIs, selecting sites that can deliver high-quality patients at volume, and managing specialized equipment requirements that many sites don't have on hand. Discussion will also cover eCOA/ePRO data integrity and the recruitment challenge of competing against established standard-of-care drugs in a crowded, head-to-head-driven market.