Event Schedule
Bright Start: Welcome Coffee, Registration & Itinerary Collection
Welcome Address From World BI
Co-Chair Welcome Address
Eric Hajjar
Project Lead â Serious Bacterial Infections
Global Antibiotic R&D Partnership (GARDP)
Andreas Panteli
Director, Clinical Trial Recruitment & Operations
Novartis
Dr. Rafik FELLAGUE-CHEBRA
Executive Global Group Medical Director, Solid Tumors Franchise, GI Cancers
Novartis Oncology
Opening Keynote Presentation: Precision Oncology in Clinical Trials Dimension
Moderator:
Diane Chisholm
Head of Global Clinical Operations
Owkin
Problem Solution Matrix: How Patient and Site-Friendly Design Improves Trial Results
Panellists:-
Andreas Panteli
Director, Clinical Trial Recruitment & Operations
Novartis
Dana Le DizĂšs, PhD, EMBA
Digital Transformation Project Manager - Clinical Trials
Ipsen
Matteo Talotta
Director of Clinical Solutions - Europe
Biorce
Partner Slot 1: AI-First Trial Design with Aika: Shortening Design Processes to Less Than 3 Months
Coffee Break Networking: Sip, Chat, Connect
Transforming Clinical Trials From the Patientâs Perspective
Moderator:-
Isabela Niculae, MPH
End to End Digital Business Transformation Leader
UCB
Next-Gen Panel: Smarter Trial Planning: Mining EHRs for Smarter, Faster Recruitment in Clinical Trials
Panellists:-
Nadir AMMOUR
Global Lead Engagement & Strategic Collaborations
Sanofi R&D
Dr Solange Corriol-Rohou, MD
Sr Regulatory Affairs & Global Policy Director
Former AstraZeneca
Rasmus Hjorth
Patient Engagement Director
James Lind Care
Moderator:-
Mounia Chabane de Saint Aubin
Co-Founder and Global Head Research & Development
IAROD International Association for Rare Ophthalmic Diseases
Patient Voice Panel: Voices of Impact: What Do Real Patients Actually Talk About?
Panellists:-
Yvette Venable
Global Senior Director, Payer Partnerships and Policy
AstraZeneca
Professor Lara Bloom
President and CEO
The Ehlers-Danlos Society
Sascha Sonnenberg
VP Global Business Development
SanaClis
Partner Slot 2: The (Not So) Hidden Cost of Clinical Delays
Clinical delays are rarely caused by a single failure. They usually originate early, when trial complexity is underestimated and information flows across too many disconnected stakeholder: often including clinical supply activities managed through additional outsourcing layers rather than an integrated clinical supply chain with clear in-house accountability. This session looks at how setup quality, reliability and cross-functional coordination influence timelines long before the first patient is enrolled.
Key Takeaways
- Why Early Planning and Correct Setup Matter More Than Late Firefighting
- What Improves Execution: Clear Ownership, Aligned Stakeholders & Reliable Information
Speed Networking Session
Gabrielle MADJLESSI
International Clinical Operations Lead
Servier
Deep Dive Session: Translating into Practice the Changing Patient Challenge Ecosystem: Servier R&D Patient-Centric Model
Nadir AMMOUR
Global Lead Engagement & Strategic Collaborations
Sanofi R&D
Featured Presentation: Modernizing Clinical Trial Sites in Europe: Upgrading Infrastructure to Enhance Attractivity
Lunch Break Dine & Discuss: Ideas on the Menu
Clinical Development â Rethinking Trial Design
Gabriel Westman
Head of Artificial Intelligence
Swedish Medical Products Agency (LĂ€kemedelsverket)
Deep Dive Presentation: AI in Clinical Development
- Study Design Optimization
- Intelligent Site Selection and Feasibility Assessment
- Patient Enrollment and Recruitment Strategies
- Safety Monitoring Using Real-Time AI Analytics
- Clinical Study Data Interpretation and Insights Generation
Bernhard Glombitza
Head Clinical Customer Engagement and Clinical Operations EMEA/LATAM
Bayer
Featured Presentation: Reimagining Clinical Operations: Navigating the Future of Efficiency and Innovation... an Outlook into the Year 2050
Shakthi Kumar
Chief Strategy and Business Officer
Edetek
Partner Slot 3: AI Enabled Protocol Intelligence for Smarter, Faster Clinical Operations
Where Protocol Logic Meets AI Powered Excellence
Richardus Vonk
VP, Head of Biometrics
ITM Isotope Technologies Munich SE
Keynote Presentation: AI-Driven Evolution in Clinical Development
- How Artificial Intelligence is Reshaping Trial Design, Execution, and Data Analysis, with a Roadmap for Both Tactical Adoption and Long-Term Strategy
- Real-World Examples of AI-Driven Improvements in Predictive Modeling, Adaptive Execution, and Patient-Centered Research
- Actionable Approaches for Responsibly Integrating AI into Biometrics and Clinical Operations, Aligned with Regulatory Expectations and Advancing Patient-First Care
Coffee Break Networking: Sip, Chat, Connect
Co-Presentation: Navigating Clinical Trials: Integrating Operational Efficiency with Regulatory Strategy in Startups
Dagmara SĆaby
Regulatory Affairs Manager
JJP Biologics
Anna ĆosiĆska
Clinical Trial Specialist
JJP Biologics
Moderator:-
Eric Hajjar
Project Lead â Serious Bacterial Infections
Global Antibiotic R&D Partnership (GARDP)
Panel Discussion: Clinical Trial Flops and Lessons Learned: Post Trial Innovation and Life Cycle Integration (Post Market Survillance Innovation)
Panellists:-
Mounia Chabane de Saint Aubin
Co-Founder and Global Head Research & Development
IAROD International Association for Rare Ophthalmic Diseases
Abdulrizak Hudow
Medical Expert Clinical Research
BioNTech SE
Chairs Closing Remarks
Eric Hajjar
Project Lead â Serious Bacterial Infections
Global Antibiotic R&D Partnership (GARDP)
Andreas Panteli
Director, Clinical Trial Recruitment & Operations
Novartis
End of Day One With Drinks Reception
Bright Start: Welcome Coffee, Registration & Itinerary Collection
Welcome Address From World BI
Co-Chair Welcome Address
Eric Hajjar
Project Lead â Serious Bacterial Infections
Global Antibiotic R&D Partnership (GARDP)
Andreas Panteli
Director, Clinical Trial Recruitment & Operations
Novartis
Thierry Schulmann
Medical Affairs Strategy
Sumitomo Pharma Switzerland
Deep Dive Session: Optimizing Clinical Trial Design and Execution Through Structured KOL Collaboration: Why Engaging KOLs is Essential for Clinical Trial Success
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!
Marlene Vincent
Head of Patient Advocacy
Intercept Pharmaceuticals
Presentation 1: How DCTs are Reshaping Patient Advocacy?
Coffee Break Networking: Sip, Chat, Connect
Dorothy Bray, PhD
Director
CELTIC BIOTECH
Presentation 2: Challenges in Designing Phase I Studies in Oncology
Data Privacy Meets Data Potential â Harnessing Big Data & AI in Clinical Trials
Ruba Jaber
Clinical Research & Development Director
Hikma Pharmaceuticals
Featured Presentation: Clinical Studies: Bridging Science and Digital Innovation for Smarter Trials
Puja Myles
Director, Clinical Practice Research Datalink
Medicines and Healthcare Products Regulatory Agency
Presentation 3: Can Fake Data Save Real Lives? Exploring Synthetic Data and Security in Clinical Trials
Speed Networking Session
One Question, Many Insights! đ€
Katharina Schreeb
Former VP, Clinical Development, Sangamo
Presentation 4: Challenges and Opportunities of AI (Blockchain and ML) in Drug Development
Lunch Break Dine & Discuss: Ideas on the Menu
Improving Clinical Quality
Karen Dr. med. vet. Edelmann-Stergiou
Senior Principal Capability Manager
Boehringer Ingelheim
Presentation 5: Pioneering Sustainable Practices in Clinical Trials for a Healthier Future
Amer Alghabban
R&D Quality Regulatory Authority Inspection Management
Bristol Myers Squibb
Presentation 6: Inspection Readiness of AI-Enabled Trials Through the Inspector's Lens: Translating from FDA, MHRA, and EMA Into Compliance By Design (CbD)
- What Inspectors will Review Based on FDA, MHRA, and EMA Guidance
- Implementing Compliance By Design (CbD) to Build Inspection Readiness
- CbD Framework, AI Governance, and Inspection Readiness Checklist
Dr Violaine Desort-HĂ©nin
Medical Director and Regulatory Advisor
Roca Therapeutics
Presentation 7: TBC
Chairs Closing Remarks
Eric Hajjar
Project Lead â Serious Bacterial Infections
Global Antibiotic R&D Partnership (GARDP)
Andreas Panteli
Director, Clinical Trial Recruitment & Operations
