08:30
Welcome Introduction
Paul Cooper, Therapeutic Area Lead, CVRM, DEPCS, Roche
Ernst Jan Bos, Global Medical Director, Roche
CONTENT BLOCK 1
INDUSTRY TRENDS
Unified Evidence: Bridging Clinical Research and Real-World Data
08:45
KEYNOTE PANEL DISCUSSION
Unified Evidence: Bridging Clinical Research and Real-World Data
This panel will look at the keys to integrating EHRs, Pragmatic Trials, and RWE to create a continuous feedback loop.
• Innovations in Design (AI/ML, Knowledge Management)
• Innovations in Execution (DHTs, Decentralized Trials, and Site Experience)
Panelists TBA
09:15
CASE STUDY
Protocol Simulations: An Innovative Way to Model Clinical Trials in the Real World
Clinical trials are inherently complex, with nearly 80% experiencing delays during execution. While most industries test products before launch, clinical trials are often initiated, sometimes globally, without prior real‑world validation. Protocol simulations address this gap by serving as a structured rehearsal of a clinical trial protocol in a real‑life setting providing actionable feedback.
Cristina De Juan, Clinical Innovation & Digital Solutions (CIDS) Lead, UCB
09:35
CASE STUDY
AIMS-2-TRIALS: Autism Research for Europe
Julian Tillmann, Clinical Scientist, Roche (pRED)
CONTENT BLOCK 2
TRIAL OPTIMIZATION
Innovations in Multi-Modal Intelligence, Digital Twins, Agentic AI, and Imaging
10:40
CASE STUDY
Scaling AI for Patient Impact in Clinical Trials
As clinical trials become more patient-centric, AI is shifting from pilots to production. This session examines scaling AI to improve patient experiences - reducing burden, enhancing safety monitoring, and enabling participation across decentralized and hybrid models. Focus on deployment realities: data integration, governance, regulatory compliance, and measuring impact beyond operational efficiency.
Piotr Maślak, Senior Director, Head of Emerging Technologies, AstraZeneca
11:00
CASE STUDY
Faster to First Insight: Leveraging Agentic AI to Unlock Strategic Options in Clinical Trial Design
This session will explore an agentic AI–powered decision support system that transforms how clinical trial feasibility and study design insights are generated, evaluated, and translated into strategic options. By orchestrating AI agents across data aggregation, analysis, and scenario evaluation, the system reduces manual effort, shortens insight cycles, and enables teams to explore multiple, evidence-backed development options earlier. This leads to faster, more robust, and better-aligned decision making.
Clara Cali Mella, Data Strategy Lead, Bayer
11:20
CASE STUDY
Delivering DCT Trials for Scale and Sustainability - A Case Study of Evidence in Practice
Dr. Michelle Longmire, Chief Executive Officer, Medable
11:40
CASE STUDY
The ROSA Experience:
Moving from Manual to AI-Assisted Image Grading in Ophthalmology to Unlock Novel Insights
Vivide Chang, Imaging Lead, Roche
12:00
PANEL
AI Imaging in Clinical Trials: Transforming Speed, Precision, and Decision-Making
Sandy Goss, Director, Digital Health Strategy, AbbVie
Additional Panelists TBA
CONTENT BLOCK 3
PATIENT-CENTRIC TRIAL INNOVATION
Accelerating Patient-Centric Trials and Technologies
13:20
PATIENT PERSPECTIVE
An (im)Patient Perspective
Mark Duman, Patient Engagement Pioneer, MD Healthcare
13:40
SITE PERSPECTIVE
Omnichannel (Personalised) Clinical Trials. Going Beyond DCTs vs. On-Site
Suki Balendra, Director of Strategic Partnerships, Imperial College, NHS Trust
14:00
CASE STUDY
IHI READI
This session will explore the collaboration behind the IHI-funded project - IHI READI - aimed at fostering a more cohesive and integrated clinical studies ecosystem for underserved (US) and underrepresented (UR) communities.
Speaker TBA
14:20
PANEL
Trial Design Considerations: UX and Digital Accessibility
Diversity is a key success factor in clinical trials: advancing science and medicine through a variety of lived experiences and living conditions – particularly, people with disabilities. Digital accessibility design standards for patients with disabilities can be critical to clinical trial access, engagement, adherence, and measurement. With the Web Content Accessibility Guidelines (WCAG) design standards for Information & Communication Technologies (ICT), explore the WHY, the HOW, and the WHAT for digital accessibility in clinical trial diversity.
Iulia Brehuescu, Global Accessibility Partner, Sanofi
Lauren Sunshine, Director of Digital Health, (Fmr) Bristol Myers Squibb
Moderator: Dr. Stephen Framil, Global Head of Accessibility, (Fmr) Merck
CONTENT BLOCK 4
BEYOND THE SITE
Omnichannel Engagement & Regulatory Strategy
15:20
CASE STUDY
Bridging the Cognitive Gap: How Novo Nordisk is Virtualizing Clinical Trial Decisions
Guillaume Carbonneau, Vice President of Operational Data Insights, Novo Nordisk
15:40
CASE STUDY
Delivering DCT Trials for Scale and Sustainability - A Case Study of Evidence in Practice
Alison Holland, Chief Customer Officer, Medable
16:00
CASE STUDY
Trust by Design: Building AI Governance That Earns Adoption
AI governance in regulated environments often looks solid on paper but falls apart in practice — creating a gap where shadow AI thrives and real risk becomes invisible. This talk explores what governance looks like when you design it from both sides of the wall, drawing on hands-on experience building AI governance frameworks inside pharma R&D at Merck.
Nuno Valerio, Head of Innovation, R&D Quality, Merck
16:20
CASE STUDY
Hype, Evidence, and Regulatory Reality: Digital Health in CNS Clinical Development
Abhi Pratap, Executive Director and Global Clinical Development Lead, Boehringer Ingelheim
16:35
CLOSING PANEL
Regulatory Strategy: DHTs in Clinical Trials - Reality Check and Key Takeaways
Address the evolving regulatory landscape, highlighting strategies for maintaining compliance while enabling innovation.
Panelists TBA
Suki Balendra, Director of Strategic Partnerships, Paddington Life Sciences, Imperial College Healthcare NHS Trust
Ernst Jan Bos, Global Medical Director, Roche
17:05 - 18:30
APÉRO & NETWORKING RECEPTION!