Event Schedule

Feb 9, Day 1
Feb 10, Day 2

8:00 – 8:50

Bright Start: Registration & Itinerary Collection

8:50 – 9:00

Welcome & Opening Remarks: Opening Words

Host / Conference Chairs
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 - 9:50

Moderator:

Andreas Panteli

Director, Clinical Trial Recruitment & Operations

Novartis

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?

Panellists:-

Rich Hutson

Digital Health Lead

Astellas Pharma

Agata Krasoń, PhD

Senior Clinical Imaging Data Scientist

Roche

9:50 - 10:15

Fireside Chat: Transforming Clinical Trials Through Digital Innovation and Organizational Change

Moderator:-

Ivanna Rosendal

Vice President of Business Digitalization

Ascendis Pharma

Panellist:-

Caroline Beaufour

Innovation Lead in Clinical Development

Servier

10:15 - 11:15

Coffee Break Networking: Sip, Chat, Connect

Session 2: Modern Clinical Trial Design & Operational Excellence

11:15 - 11:35

Dorothy Bray, PhD

Director

CELTIC BIOTECH

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 – 11:55

Partner Slot 1: TBC

11:55 – 12:20

Moderator:-

Judit Magos

Clinical Operations Manager

Viatris Innovation

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?

Panellists:-

Jens Wuerthner, MD PhD

Chief Medical Officer

FoRx Therapeutics

Tatyana Matveeva, PhD

Director of cGMP Operations- Clinical Cell Production

Harvard Medical School and Massachusetts General Hospital

12:20 - 12:35

Partner Slot 2: 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

Moderator:-

Victoria Hayes, MBA

Director Of Public Affairs, Northern Cluster (UK, Ireland, Nordics & Baltics)

Kyowa Kirin International plc.

Fireside Chat: Are We Truly Designing Clinical Trials Around Patients?

What Barriers Still Prevent Meaningful Patient Involvement?
How Can Patient Feedback Be Integrated From Protocol Design to Study Completion?
Which Patient-centric Strategies Deliver Measurable Improvements in Trial Outcomes?

Panellists:-

Letícia Bühler. MSc, MBA

Senior Clinical Research Coordinator

Santa Casa de Porto Alegre

Elvira Vacas Montero

Presidenta

FEDE Federación Española de Epilepsia

Monia Steenackers

Global Head, Patient Engagement Capability building, Impact Measurement & Digital Platforms

Novartis

14:25 - 14:45

Dr. Rania Al Shami

Chief Business and Strategy Officer

PDC CRO

Partner Slot 3: TBC

14:45 – 15:15

Nadir AMMOUR

Global Lead Engagement & Strategic Collaborations

Sanofi R&D

Featured Presentation: TBC

15:15 - 16:05

Coffee Break

16:05 – 16:30

Elvira Vacas Montero

Presidenta

FEDE Federación Española de Epilepsia

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?

16:30 – 16:40

Clinical Innovation Challenge Sprint ⭐

16:40 – 17:05

Moderator:-

Reserved

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?

Panellists:-

Nadia Peppa PhD

Global Clinical Trial Manager - Clinical Operations - Global Clinical Development

Lundbeck

Rasmus Hjorth

Patient Engagement Director

James Lind Care

17:05 - 17:10

Closing Remarks & Key Takeaways: Summary of Main Insights

17:10 - 18:10

End of Day 1 with Drink Reception

8:00 – 8:50

Bright Start: Registration & Itinerary Collection

8:50 – 9:00

Welcome & Opening Remarks: Opening Words

Host / Conference Chairs
Objectives of the Event

Session 4: Clinical Development Strategy & 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

Panellists:-

Cornelia Baumgartner

Clinical Operations Manager

T-CURX GmbH

Eugénie Suter

Project Team Lead (rotation)

Roche

Katia Stakhiv

Asc. Director, Clinical Operations

Amgen

9:55 - 10:15

Anatoly Rudnev

Director of Clinical Research

CORAT Therapeutics GmbH

Deep Dive Presentation: CORAT’s Experience in Conducting a Full-Scale Phase 2 Study During the War in Ukraine

10:15 - 11:15

Coffee Break

11:15 - 11:40

Andrea Federico Barbonetti

Country Clinical Operations Head

AbbVie

Featured Presentation: How Regulatory Changes Are Shaping Clinical Trial Operations in Europe and Switzerland

11:40 - 12:05

Laura Bonino

Head of Clinical Development

SIFI

Strategic Presentation: TBC

Session 5: Real-World Evidence & External Data Integration

12:05 – 12:30

Tim Williams

Head of Interventional Research - CPRD

Medicines and Healthcare products Regulatory Agency

Deep Dive Presentation: Beyond Traditional Trials: Leveraging Real-World Data to Transform Clinical Trials

Improving trial feasibility, patient recruitment, and follow-up
Integrating real-world data into pragmatic trial design
Using real-world data to strengthen external control arms

12:30 – 13:00

Strategic 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: Strategic Synergies Partnerships

14:00 - 14:40

Moderator:-

Anastasia Eremeeva

Associate Director, Clinical Operations Lead

CSL

Problem Solution Matrix: 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?

Panellists:-

Virginie Casarotto-Collins

Clinical Trial Leader

TOLREMO therapeutics

Dr. Sonja Schöpflin

Senior Clinical Trial Manager

Granite Bio

Neta Tobis

Director of Clinical Operations

Beech Biotech

Julie Mouton

Clinical Trial Leader

ANAVEON AG

14:40 - 15:15

Moderator:-

Joshua Webber

Founder and CEO

Clinical Research Learning Network (CRLN)

Vendor–Partner Strategic Panel: Beyond the Contract: Building High-Performing CRO Partnerships for Operational Excellence

15:15 - 16:05

Coffee Break

16:05 - 16:30

Featured Presentation: TBC

16:30 - 16:40

"Lessons Learned" Lightning Round: One Clinical Trial Lesson that Transformed the Way Your Organization Conducts Research

16:40 - 17:05

Executive Panel Discussion & Audience Q&A: AI Investment Strategy - Build vs Partner

Moderator:-

Nora Rösch, PhD, MBA

Global Medical Lead - Global Health Unit