08:30
Welcome Introduction
Ernst Jan Bos, Global Medical Director, Roche
Luca Finelli, Head of Digital Endpoints & Patient Centred Solutions, Roche
CONTENT BLOCK 1
INDUSTRY TRENDS AND INNOVATIONS
08:45
FIRESIDE EXPERT KICK-OFF
Industry Trends: Innovations in Clinical Trial Design and Execution
• EU Policy: What does it take to make the EU clinical trial landscape more competitive?
• Innovations in Design (AI/ML, Knowledge Management)
• Innovations in Execution (DHTs, Decentralized Trials, and Site Experience)
Isabela Niculae, Head, Clinical Innovation and Digital Solutions, Global Clinical Operations, UCB
Joachim Lövin, Decentralised Clinical Trial (DCT) Specialist, Novo Nordisk
Andreas Wallnoefer, VC Biotech Advisor, Andreas Wallnoefer Life Sciences Consulting
Lorcan Walsh, Head, Digital Endpoint Capability Centre, Development, Novartis
Michelle Longmire, Co-Founder and CEO, Medable
Moderated by: Marco Rafael, Regulatory Science Policy Leader, Roche
09:15
CASE STUDY
Optimizing Drug Development with Actionable Data Insights:
Secondary Use of Data: Multimodal Data Assets
• Secondary use of data at Roche: leveraging multimodal data assets to give data a new life.
• Optimizing drug development: turning complex data into actionable insights to enhance our study and CDP designs.
Marta Carrasco, Biomedical Data Insights Leader, Roche
09:35
CASE STUDY
Patient Recruitment Enabled through EHRs
Nadir Ammour, Global Lead, Clinical Innovation & External Partnerships, Sanofi
09:55
AI-Driven Trial Simulation: The Art and the Value of the Possible
Adam Petrich, Chief Medical Officer, QuantHealth
10:15
The AI Policy Environment for Medicines Development and Clinical Trials
Thomas Brookland, Lead, European Data and AI Regulatory Policy, Roche
CONTENT BLOCK 2
Accelerating Patient-Centric Trials
11:00
CASE STUDY
Delivering Better Outcomes through Digital and AI-Enabled Clinical Development
Discover how Evinova's AI platform tackles critical challenges in clinical development, delivering measurable efficiency improvements that accelerate the path from trial to treatment. The session will demonstrate how Evinova's proven clinical technology solutions and deep therapeutic expertise combine to optimize outcomes and ultimately bring innovative medicines to patients faster.
Cristina Durán, President, Evinova
11:20
CASE STUDY
Scaling Clinical Innovation - The Novartis Operating Model for Sustainable Success
This session will explore how Novartis’s Clin Ops Innovation team is transforming clinical operations. Discover how their comprehensive operating model scales innovation through a structured framework, ensuring alignment with operational needs and challenges. Learn how they measure success with clear criteria, match specific innovations to operational requirements, and consistently assess the innovation landscape to identify new opportunities. This session will provide valuable insights into Novartis’s systematic approach to driving sustainable, value-driven innovation in clinical trials.
Scott Askin, Portfolio Innovation Director, Global Clinical Operations, Novartis
11:40
Pioneering a New Standard in Cognitive Care, Bridging Human Insight and AI Precision
Marc Jones, CEO, Altoida
12:00
PANEL
Identifying Innovations & Technologies Accelerating Patient-Centric Trials
Lauren Sunshine, Director, Product Management, Digital Health, Bristol Myers Squibb
Bola Grace, Senior Director, Digital Biomarkers, Real World Data & Analytics, GSK
Sam Hariry, Global Head, Clinical Innovation, Novartis Institutes for BioMedical Research (NIBR)
Thomas Boillat, Senior Digital Healht Product Lead, Roche
Moderated by: Judit Magos, Clinical Operations Manager, Idorsia
CONTENT BLOCK 3
Enhancing Diversity in Clinical Trials
13:20
PANEL
Patient Perspectives & Cultural Considerations in Clinical Trials
Vera Gomes, President, Associação Crohn Colite Portugal
Nicola Unterecker, Patient Advocate, Youth Cancer Europe
Amri B. Johnson, Founder, Inclusion Wins
Yovanna Castro, Principal Data Scientist, Patient Centered Outcome Research, Roche
Moderated by: Steve Bourke, Founder, PersonalPulse
13:45
CASE STUDY
End to End Inclusive Research
What can early stage development bring to late stage development?
Thierry Lave, R&D Academy and Faculty Lead, Roche
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.
Lea Proulx, Patient Voice Partner, Roche
Juliette Guillot, Development ESG Lead, IHI READI Project Lead, Novartis
14:20
CASE STUDY
Technology Fit for Purpose:
Understanding of Potential Issues to Decrease Patient Burden On Your Study
Stephan Cichos, Strategic Project Leader, Clinical Data Strategy & Operations, Bayer
14:35
CASE STUDY
The Frailty of Diversity: Including Older Adults in Oncology Trials
Sebastian Heinzmann, Global Medical Science Leader (GMSL), Thoracic Oncology, Roche
CONTENT BLOCK 4
IDEAS INTO ACTION
15:20
CASE STUDY
MSD’s In-House Site Selection Application:
Data-Driven Performance Ranking for Optimized Clinical Trials
Richard Bobek, Associate Director, Clinical Data Science, MSD
15:35
CASE STUDY
Delivering DCT Trials for Scale and Sustainability - A Case Study of Evidence in Practice
Alison Holland, Chief Customer Officer, Medable
15:55
CASE STUDY
Automated Assessment Auditing Across MindMed’s Pivotal Programs
Dan Karlin, Chief Medical Officer, MindMed
16:10
PATIENT PERSPECTIVE
An (im)Patient Perspective
Mark Duman, Patient Engagement Pioneer, MD Healthcare
16:30
CLOSING PANEL
DHTs in Clinical Trials: Reality Check and Key Takeaways from Patient and Site Interactions
Meri Kay Scott, Associate Vice President, Digital Health R&D, Eli Lilly & Company
Sachin Shah, Digital Biomarker Lead, GSK
Matteo Lai, Chief Executive Officer, Empatica
Mark Duman, Patient Engagement Pioneer, MD Healthcare
Moderated by: Suki Balendra, Director of Strategic Partnerships, Paddington Life Sciences, Imperial College Healthcare NHS Trust
Suki Balendra, Director of Strategic Partnerships, Paddington Life Sciences, Imperial College Healthcare NHS Trust
Ernst Jan Bos, Global Medical Director, Roche
17:00 - 18:30
APÉRO & NETWORKING RECEPTION!