Archives: Agenda

• Decentralized research models in neuroscience: Explore how virtual site models and structural innovations are expanding the breadth and diversity of physician participation in real world studies.
• Generating robust Alzheimer’s Disease RWE: A look at ecosystem-wide challenges in AD real world evidence generation, including study design considerations from the INITIATE-SC program.
• Addressing Phase IV research barriers through innovative tactics: Eisai and SiteRx share a joint perspective on how decentralized approaches can overcome structural challenges unique to neuroscience post-marketing research.

There are many aspects to moving from early research to clinical delivery under one roof. This session explores the practical realities of building clinical operations and establishing an in-house Phase II unit.

• Building and scaling a clinical operations function
• Talent, structure, and service provider strategy
• In-house vs. outsourced clinical deliver: Key considerations for clinical trial delivery, from build decisions to patient recruitment

• A real-world case study demonstrating where AI has tangibly reduced costs or accelerated timelines
• How AI was implemented in practice (e.g. patient recruitment, data cleaning, site selection) and what made it successful
• Breaking down the ROI: cost savings, efficiency gains, and operational impact
• Lessons learned: where AI delivered value vs where it fell short—and how to replicate success in smaller biotech settings

• Meet the #1 AI CRO: Deep Intelligent Pharma Overview
• Industry Pain Points: High Clinical Development Failure
• DIP’s AI-Human Hybrid Approach to Clinical Development
• Real-World Success Stories & Proven Results

• Why finding the right site is only the beginning of clinical trial success
• How AI and human expertise work together to accelerate study start-up
• Proven approaches to reducing site burden and improving engagement
• Practical lessons for building more predictable, high-performing site networks

• The surge of high-quality assets from China: what’s driving the acceleration?
• Licensing trends: why Western pharma is increasingly looking East
• Regulatory implications: how the FDA and global bodies are adapting
• Geopolitics vs innovation: balancing risk, access, and opportunity in trial strategy

China’s life sciences sector is rapidly reshaping the global biotech landscape, with a growing pipeline of high-quality assets attracting significant international investment and licensing activity. This session will explore how this shift is impacting clinical development strategies, regulatory frameworks, and competitive dynamics. From navigating cross-border partnerships to understanding evolving FDA perspectives, join industry leaders as they unpack what this means for outsourcing, trial design, and the future of global collaboration.