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September 01 - 03, 2025 | Palace Hotel Berlin, Germany
1. Conference Day, 02. September 2025
8:30 - 9:10
Registration for the main conference with coffee
9:15 - 9:20
Opening of the first day of the conference by the Chair
Jessica Cordes -
INTERIM HEAD OF CLINICAL OPERATIONS,
Clinical Excellence GmbH
9:20 - 9:50
Opening-Keynote: Digital twins: Enabling precision oncology 2.0
Rafik Fellague-Chebra -
Executive Global Group medical Director, Solid tumors franchise, GI cancers,
Novartis
-From precision oncology to precision oncology 2.0: How AI and multi-omics integration are redefining individualized care strategies.
-The role of digital twins: Using virtual patient models to simulate disease progression, treatment responses, and predict outcomes.
-Use case in clinical development: Accelerating trial design, patient recruitment, and adaptive protocol optimization through predictive analytics.
-Regulatory and ethical considerations: What needs to be addressed for digital twin models and AI to be clinically validated and adopted.
Rafik Fellague-Chebra
Executive Global Group medical Director, Solid tumors franchise, GI cancersNovartis
9:50 - 10:20
Panel: Digitalization and AI in Clinical Trials
Roberta Pandolfi -
Analytics Innovation Strategist,
Boehringer Ingelheim
Dr. Frank Richard - Vice President Medical, AI and Machine Learning, Oncology Drug Development, Heidelberg Pharma AG
Rafik Fellague-Chebra - Executive Global Group medical Director, Solid tumors franchise, GI cancers, Novartis
Jessica Cordes - INTERIM HEAD OF CLINICAL OPERATIONS, Clinical Excellence GmbH
-Opportunities and Challenges – How are digital technologies and AI changing the efficiency, quality, and ethics of clinical trials?
-Automation and Data Analytics – What role does AI play in patient recruitment, data analysis, and decision-making?
-Future Perspectives – How can regulatory frameworks and technological innovations further advance the development of clinical trials?
-Human vs. Machine – How does the human factor remain relevant and crucial in an increasingly AI-driven research environment?
Dr. Frank Richard
Vice President Medical, AI and Machine Learning, Oncology Drug DevelopmentHeidelberg Pharma AG
Rafik Fellague-Chebra
Executive Global Group medical Director, Solid tumors franchise, GI cancersNovartis
10:20 - 10:50
Coffee break with networking opportunity
10:50 - 11:20
AI Imaging in Respiratory Clinical Trials
Federico Mollica -
Postdoctoral Researcher- Imaging Scientist,
Charite Universittsmedizin Berlin
- Application of AI-based airway segmentation and mucous plug detection in clinical trial settings
- Advantages and limitations of radiology-based outcomes in comparison to traditional functional measures
Federico Mollica
Postdoctoral Researcher- Imaging ScientistCharite Universittsmedizin Berlin
11:20 - 11:50
Creating AI- Augmented Patient Education Materials
Dimitri Metzger -
Digital, Data & IT Business Partner for Development & Medical Units & AI,
Merck
- How Gen AI can help simplify medical jargon and improve patient understanding
- Empowering healthcare teams to leverage AI tools for creating patient education materials that use confirmed patient-friendly language
- Measuring the impact of AI-augmented patient education Dimitri Metzger Technology Lead in Healthcare R&D, Merck Group
Dimitri Metzger
Digital, Data & IT Business Partner for Development & Medical Units & AIMerck
11:50 - 12:20
Innovation and Digital Trials: A Practical Perspective from R&D
Roberta Pandolfi -
Analytics Innovation Strategist,
Boehringer Ingelheim
- Reflections on the current state of digital trial innovation and why R&D still lags behind commercial and marketing domains
- Internal experiments and learnings from Boehringer Ingelheim and previous roles — including in silico research and early exploration of agent-based systems
- Outlook on what’s next: digital protocols, collaboration models with the SMI industry, and the potential of GenAI/agentic AI in clinical operations
12:20 - 13:50
Lunch Break
Table A - in front of Room Zoo 2
13:50 - 14:20 RWE, REGULATORY FRAMEWORK AND APPLICATION IN CLINICAL TRIALS Ana Serrato - Head of Clinical Development, Avextra-How can real-world evidence improve Phase 4 clinical trials?
-New regulatory framework enabling effective use of RWE
-Laying the groundwork for the use of AI and other technologies to increase efficiency and save time and costs
Table B - in Room Zoo 2
13:50 - 14:20 APPLICATION OF SYNTHETIC DATA IN CLINICAL TRIALS AND PHARMACEUTICAL RESEARCH Elmar Diederichs - Mathematician, HealthCare Futurists GmbH-Learn about practical applications of synthetic data in clinical trial design, patient simulation, and rare disease research.
-Discuss key challenges, including regulatory acceptance, data quality validation, and ethical considerations.
-Share strategies for integrating synthetic datasets to improve model training, study diversity, and data protection.
14:20 - 14:50
AI in clinical trials - when innovation meets feasibility
Dr. Frank Richard -
Vice President Medical, AI and Machine Learning, Oncology Drug Development,
Heidelberg Pharma AG
- AI in Pharma & Biotech
- Use cases & solutions
- Challenges & Lessons Learned
Dr. Frank Richard
Vice President Medical, AI and Machine Learning, Oncology Drug DevelopmentHeidelberg Pharma AG
14:50 - 15:20
Closing Keynote: Microsoft’s AI Applications in Pharma
Sonika Kapil -
AI & App Chief Architect,
Microsoft
-Enhancing Drug Discovery: Explore how Microsoft’s AI technology accelerates the identification and validation of new drug targets through advanced data analytics and machine learning models.
-Optimizing Clinical Trials: Discover Microsoft’s role in improving the efficiency of clinical trial designs, participant selection, and outcome predictions using AIdriven
insights.
-Quantum AI: new frontiers of quantum computing and first applications in drug discovery
15:20 - 16:00
Coffee Break and Networking
Masterclass B - Room Europa 6
16:00 - 17:30 Microsoft’s AI Applications in Pharma and Practical Use Cases Sonika Kapil - AI & App Chief Architect, MicrosoftIn this masterclass, we focus on the solutions and applications presented in the previous presentation, while going into practical examples and case studies.
- Enhancing Drug Discovery: Explore how Microsoft’s AI technology accelerates the identification and validation of new drug targets through advanced data analytics and machine learning models.
-Optimizing Clinical Trials: Discover Microsoft’s role in improving the efficiency of clinical trial designs, participant selection, and outcome predictions using AI-driven insights.
-Quantum AI: new frontiers of quantum computing and first applications in drug discovery
Masterclass C - Room Europa 2
16:00 - 17:30 AI Ready: Ihre Organisation fit für die KI-Zukunft Dimitri Metzger - Digital, Data & IT Business Partner for Development & Medical Units & AI, MerckDiese interaktive Masterclass richtet sich an Führungskräfte und Teams, die bereit sind, die Leistungsfähigkeit der KI in ihrem täglichen Betrieb zu nutzen. Unser Ziel ist es, KI zu entmystifizieren und Sie mit umsetzbaren Strategien auszustatten, um die Kompetenz Ihres Unternehmens bei der Nutzung dieser transformativen Technologie zu verbessern. Während des Workshops werden wir uns mit drei Schlüsselbereichen befassen:
-Was ist Everyday AI und wie kann man Unternehmen weiterbilden?
-Wie können Unternehmen in die Lage versetzt werden, Champions bei der täglichen Nutzung von KI zu werden und ihre Anwendungsfälle voranzutreiben?
-Wie kann man den Fortschritt messen und an die Geschäftsleitung berichten?
Dimitri Metzger
Digital, Data & IT Business Partner for Development & Medical Units & AIMerck
