Event Schedule
8:00 â 8:50
Bright Start: Registration & Itinerary Collection
8:50 â 9:00
Welcome & Opening Remarks: Opening Words
- Host / Conference Chair
- Objectives of the Event
Session 1: AI & Digital Transformation in Clinical Trials
9:00 - 9:25
Ventsislav Dobrev
Global Clinical Integration Lead Digital Biomarkers
Roche
Keynote Presentation: Beyond AI: How Digital Biomarkers Are Redefining Clinical Trial Design and Execution
9:25 - 9:55
Problem Solution Matrix: Barriers to Implementing AI and Digital Tools in Trials
- How do Sponsors Ensure Data Privacy and Security?
- What Operational Challenges Arise in Global Implementations?
- How do We Validate AI Models to Satisfy Regulators and Investigators?
9:55 - 10:15
Partner Slot 1: TBC
10:15 - 11:15
Coffee Break Networking: Sip, Chat, Connect
Session 2: Modern Clinical Trial Designs
11:15 - 11:35
Featured Presentation: Can Adaptive Trials Speed Up Development Without Compromising Data Quality
- How can Interim Analyses Inform Protocol Adjustments in Real Time?
- What Operational Challenges Arise with Adaptive Designs?
- How do Regulators View Adaptive Methodologies Today?
11:35 â 11:55
Partner Slot 2: TBC
11:55 â 12:25
Jens Wuerthner, MD PhD
Chief Medical Officer
FoRx Therapeutics
Interactive Panel Discussion & Audience Q&A: How We Operationalize Complex Protocols Seamlessly
- What Tools Support Risk-based Monitoring in Adaptive Trials?
- How Do Sites Manage Protocol Amendments Effectively?
- How Can Sponsors Ensure Alignment Across Global Regions?
12:25 â 12:35
Partner Slot 3: TBC
12:35 - 13:00
Paula Walker
Global Head Risk Based Quality Management
Roche
Deep Dive Presentation: How Quality By Design & RBQM Drive Patient-Centricity & Probability of Technical Success
13:00 - 14:00
Lunch Break
Session 3: Patient Centricity & Diversity in Clinical Research
14:00 - 14:25
Fireside Chat: How Can We Make Clinical Trials Truly Patient-Centric
- What Strategies Reduce Patient Burden and Improve Adherence?
- How Can Feedback Loops Inform Protocol Design?
- Which Digital Tools Enhance Engagement Without Overwhelming Patients?
14:25 â 14:45
Partner Slot 4: TBC
14:45 â 15:15
Case Study: Are We Reaching the Right Patient Populations
- How Can We Ensure Diversity and Inclusion in Recruitment?
- What Barriers Prevent Underrepresented Populations from Participating?
- Which Community Engagement Strategies Work Best Globally?
15:15 - 16:15
Coffee Break
16:15 â 16:50
Interactive Panel Discussion & Audience Q&A: How Do We Measure Success Beyond Enrollment
- How Can Patient Experience and Satisfaction be Quantified?
- What Metrics Track Retention and Long-term Engagement?
- How Do Patient Outcomes Influence Future Trial Design?
16:50 - 17:00
Closing Remarks & Key Takeaways: Summary of Main Insights
8:00 â 8:50
Bright Start: Registration & Itinerary Collection
8:50 â 9:00
Welcome & Opening Remarks: Opening Words
- Host / Conference Chair
- Objectives of the Event
Session 4: Clinical Development Strategy & Operational Transformation
9:00 - 9:25
Alexander Krupp
Executive Clinical Product Excellence Lead, VP
Bayer
Keynote Presentation: Transforming Drug Development Operating Models to Accelerate Large-Scale Outcome Trials and Advanced Therapy Programs
- Delivering the OCEANIC STROKE Trial with Over 12.327 Patients One Year Ahead Through Operational Transformation
- Building Agile and Scalable Clinical Development Models to Support Growing Cell and Gene Therapy Portfolios
- Enhancing Speed, Collaboration, and Execution Excellence Across Complex Global Development Programs
9:25 - 9:55
Panel Discussion: Building Agile Clinical Development or the Next Era of Drug Development
- Creating Flexible Operating Models for Evolving Clinical Pipelines
- Supporting Innovation Across Cell Therapy, Gene Therapy, and Complex Studies
- Improving Organizational Responsiveness Through Strategic Transformation
9:55 - 10:15
Partner Slot 5: TBC
10:15 - 11:15
Coffee Break
11:15 - 11:40
Featured Presentation: Modernizing Clinical Development Operations for Large Outcome and Advanced Therapy Trials
- Addressing Operational Complexity in Large-Scale Global Studies
- Building Scalable Infrastructures for Advanced Therapy Programs
- Integrating Innovation to Improve Development Speed and Adaptability
Session 5: Real-World Evidence & External Data Integration
11:40 - 12:05
Deep Dive Presentation: How Can Real-World Evidence Accelerate Clinical Development
- Which Types of External Data are Most Valuable for Early Decision-making?
- How Can RWE Complement Traditional Clinical Trial Data?
- What Challenges Exist in Integrating Diverse Datasets Effectively?
12:05 - 12:30
Fireside Chat: Can External Data Improve Trial Design and Patient Outcomes
- How Do EHRs, Claims, and Registries Inform Eligibility and Endpoints?
- What Approaches Ensure Data Quality and Reliability?
- Can External Controls Reduce the Need for Large Control Arms?
12:30 - 13:00
Stretegic Outlook Panel: What are the Regulatory and Ethical Considerations for RWE Use
- How Do Regulators View RWE for Submissions and Label Expansion?
- What Patient Privacy and Consent Issues Must be Addressed?
- How Do We Standardize Data to Satisfy Multiple Authorities?
13:00 - 14:00
Lunch Break
Session 6: Operational Excellence & CRO Partnerships
14:00 - 14:25
Fireside Chat: How Can Sponsors and CROs Collaborate for Maximum Efficiency
- What Models Ensure Clear Accountability and Aligned KPIs?
- How Can Workflows be Streamlined Across Multiple Vendors?
- What Lessons Can be Learned From Successful Global Partnerships?
14:25 - 14:50
Featured Presentation: Can Operational Excellence Reduce Trial Timelines and Costs
- Which Process Improvements Have the Highest Impact on Efficiency?
- How Can Technology Enable Real-Time Operational Oversight?
- What Metrics Best Measure Operational Performance Across Studies?
14:50 - 15:15
Panel Discussion: How Do We Build Resilient, Future-Ready Clinical Teams
- How Can Cross-Functional Alignment Improve Execution?
- What Training or Tools Ensure Consistency in Complex Trials?
- How Can Flexibility be Maintained in Adaptive or Decentralized Trials?
15:15 - 16:15
Coffee Break
16:15 - 16:50
Moderator:-
Nora Rösch, PhD, MBA
Global Medical Lead - Global Health Unit
Sanofi
Executive Panel Discussion & Audience Q&A: AI Investment Strategy - Build vs Partner
16:50 - 17:00