Keynote Presentation: Clinical is Not an Island: How Med Affairs and Access Can Transform Trial Success
Integrating Medical Affairs Early to Align Clinical Outcomes with Real-World Value
Leveraging Access Insights to Design Trials That Meet Payer and Patient Needs
Bridging Clinical Data with Market Access Strategies for Faster Adoption
9:25 - 9:50
Partner Slot 5: TBC
9:50 - 10:15
Presentation 4: The Role of CROs in Driving Clinical Innovation
Accelerating Adoption of Decentralized and Technology-Enabled Trial Models
Providing Global Expertise to Optimize Recruitment, Operations, and Compliance
Co-Creating Patient-Centric and Adaptive Trial Designs with Sponsors
10:15 - 11:05
Coffee Break Networking: Sip, Chat, Connect
11:05 - 11:30
Presentation 5: Building a Robust Data Foundation for AI Transformation
Ensuring Data Quality, Standardization, and Interoperability Across Systems
Integrating Real-World Evidence with Clinical Trial Data for Richer Insights
Establishing Governance Frameworks for Secure and Ethical AI Use
11:30 - 12:00
Panel Discussion: Citizen AI: Enabling Broader Adoption of AI/ML Using Low-Cost Solutions
Simplifying AI/ML Tools for Non-Technical Clinical and Research Teams
Leveraging Open-Source Platforms and Affordable Cloud-Based Solutions
Driving Scalability and Inclusion by Reducing Cost Barriers to AI Adoption
12:00 - 12:10
Speed Networking Session
One Question, Many Insights! 🎤
12:10 - 12:35
Presentation 6: Regulatory Intelligence in the Age of AI
FDA’s Current Stance on AI Use in Clinical Trials and Documentation
Real-World Data and Synthetic Control Arms: Guidance and Challenges
Validating AI Models for Regulatory Submissions
12:35 - 13:00
Fireside Chat: Change Management for AI Adoption in Pharma Clinical Development Teams
Building Trust and Readiness Through Training and Stakeholder Engagement
Aligning AI Initiatives with Existing Clinical Workflows and Culture
Managing Resistance by Demonstrating Clear Value and Quick Wins
13:00 - 14:00
Lunch Break Dine & Discuss: Ideas on the Menu
14:00 - 14:25
Presentation 7: Harnessing Wearables and Digital Biomarkers for Smarter Clinical Trials
Wearables Capture Continuous Patient Data (Smartwatches, Sensors, Apps)
Digital Biomarkers, Novel Endpoints (e.g., Heart Rate, Sleep, Activity) Support Traditional Endpoints
Trials Become Less Burdensome, Real-Time, and More Predictive than Site-Only Visits
14:25 - 14:50
Deep Dive Presentation: Quality in the Time of AI: Elevating Quality Culture Amid Technological Change
Embedding AI-Driven Quality Checks without Compromising Compliance
Fostering a Culture of Continuous Improvement Alongside Automation
Balancing Innovation with Regulatory and Ethical Standards for Trust
14:50 - 15:15
Give & Take: Clinical Trial Challanges/Barriers and Lessons Learned
Post Trial Innovation and Life Cycle Integration (Post Market Survillance Innovation)
15:15 - 15:25
Snap & Share Contest
Give Attendees a Few Minutes to Snap a Picture that Captures the Essence of the Conference or a Specific Theme. Share it on LinkedIn, Tagging World BI. The Photo with the Most Likes Wins a Surprise Gift! Ready, set, SNAP!
