SCOPE Europe 2026

Break

Registration Open

Workshop

OPEN WORKSHOP 4: The End of Fragmented Clinical Data: A New Model for Trial Decision-Making

Workshop

WORKSHOP 1: Capital & Innovation at SCOPE Europe*

Workshop

OPEN WORKSHOP 2: AI, Digital Twins, and Connected Insights: The Future of Clinical Trials Is Here

Workshop

OPEN WORKSHOP 3: ICH E6(R3) in Practice: Redesigning Clinical Trial Execution, Quality, and Oversight

Networking

Join friends and colleagues for dinner at a spot near the conference hotel, which is in a great location:

Networking

SCOPE Europe Fun Run

Break

Registration and Morning Coffee

Other

Organiser's Welcome Remarks

Talk · Feasibility and Site Selection

From Fragmentation to a National Operating Model: How the UK Achieved Reliable 150-Day Commercial-Trial Set-Up

Kristina Duggleby, NIHR Industry Hub

Talk · Patient Engagement and Recruitment

Patient Information Sheet: Keep It Simple! Experience from the Dutch Authority (CCMO) with a Simplified Patient Information Sheet Template

Thera Max-Mos, Central Committee on Research Involving Human Subjects (CCMO)

Talk · Risk-Based Quality Management

Beyond Compliance: Embedding RBQM into the Clinical DNA—Lessons from the Roche CoE

Madeleine Whitehead, Roche Products Ltd.

Talk · Clinical Data Strategy and AI Innovation

Building a Data-Driven Culture in Clinical Development: Foundations First, Innovation, and AI Next

Carina Reinicke, Boehringer Ingelheim · Tracey Robertson, Inc.

Talk · Trial Design and Protocol Development

Embedding the Patient Voice to Improve Study Design, Feasibility, and Outcomes

Marta Garcia, Servier

Talk · AI Governance and Operational Readiness

From Possibility to Impact: Data Readiness as the Driver of AI Prioritisation

Julia Brodsky, Johnson & Johnson

Talk · Site Partnering, Engagement & Operations

Scaling Start-Up Speed in a Global Pharma Organisation: Dynamic Shared Ownership in Clinical Operations

Bernhard Glombitza, Bayer

Talk · Clinical Data Strategy and AI Innovation

How AI Reimagines Omics and Digital Insights in Clinical Trials

Disa Lee Choun, Johnson & Johnson

Talk · Feasibility and Site Selection

Designing Site Networks for Registrational Potential: Lessons from the Academic CRO Model

Charles Craddock, University of Warwick

Panel · Patient Engagement and Recruitment

PANEL DISCUSSION: Participant to Partner: Patients Leading the Clinical-Trial Conversation

Alexandra Charge, reCharge reSearch · Steve Clark, Strive for Five CIC · Maureen Martin, Patient Advocate · Sharon Rivera Sanchez, Trials of Color

Talk · Risk-Based Quality Management

Integrating Monitoring and Risk Management for Better Decision‑Making

Arunkumar Krishnamurthy, Novo Nordisk

Panel · Trial Design and Protocol Development

PANEL DISCUSSION: Site-Centric Trial Design: Embedding Engagement into the Protocol Design

Carrie BenSaid, Novartis Pharma AG · Daniel Bamford, Moderna · Abhishek Chatterjee, H1 · Awara Gbeblewo, CSL · Andrew Ustianowski, UK

Talk · AI Governance and Operational Readiness

Making AI Everyday in Study Leadership: Adoption, Governance, and the Human in the Loop

Aleksandra Wlasenko, Novartis

Talk · Site Partnering, Engagement & Operations

Partnering Earlier & Delivering Faster: How Aligning Clinical Operations & Science through Strategic Site Partnerships Will Truly Benefit All Patients

Edward Walsh, Pfizer Inc.

Talk · Clinical Data Strategy and AI Innovation

Transforming Real-World Evidence: Integrating AI, Digital Health, and Patient-Centric RWE

Barbara Argibay, The Synergist · Nicholas Brooke, The Synergist

Talk · Feasibility and Site Selection

Eliminating Blind Spots in Site Selection with an AI Knowledge Platform

Andrei Seryi, PSI CRO AG · Emily McInturf, PSI CRO AG

Talk · Patient Engagement and Recruitment

Solving the Patient Recruitment Paradox: A Data-Driven Approach from Clariness and Bayer to Counter the Industry’s Declining Recruitment Rates

Tobias Kruse, Clariness · Silke Strommenger, Bayer AG

Talk · Risk-Based Quality Management

Trial Quality Under Pressure: Managing the Silent “Quality Killers” of Running a Successful Clinical Trial

Anne Rosenberg, Medidata

Talk · Trial Design and Protocol Development

Trial De-Risking: Three Sources of Noise That Quietly Sink Clinical Trials

Christer Nilsson, Replior AB

Talk · AI Governance and Operational Readiness

Governing AI in Clinical Development: Building Trust, Driving Impact, and Enabling Scalable Execution

Charlotte Byng, Fortrea

Talk · Site Partnering, Engagement & Operations

One Visit, Three Breakdowns: A Candid Conversation on Building Biospecimen Tech from the Site Outward

Ben Carmel, Slope · Ethan Seville, Slope

Talk · Clinical Data Strategy and AI Innovation

Feasibility without Guesswork: How Deeper Data (and Genomics) Improve Feasibility and Site Identification with Confidence

Samantha Eells, TriNetX

Panel · Feasibility and Site Selection

PANEL DISCUSSION: Measuring What Matters: Connecting Feasibility, Site Selection, and Operational Insights

Lydia Matombo, AbbVie · Naveen KK, Fortrea · Emilio Neto, Biogen · Viviënne van de Walle, PT&R | Partner in Trials & Research · Tomasz Zawadzki, AstraZeneca

Talk · Patient Engagement and Recruitment

Reimagining the Consent Process from the Patient Perspective

Shalome Sine, CISCRP

Panel · Risk-Based Quality Management

PANEL DISCUSSION: RBQM by Design: Are we Really Embedding Risk Thinking across the Protocol Lifecycle?

Rosa Monesma, Inc. · Joanna Florek-Marwitz, UCB Biosciences · Jesus Jadraque, Johnson & Johnson · Madeleine Whitehead, Roche Products Ltd. · Bettina Wieneke, MSD Sharp & Dohme GmbH

Talk · Trial Design and Protocol Development

From Fragmented Voices to Actionable Insight: J&J’s One-Stop Patient Insight Hub

Virginie Normand, Johnson & Johnson

Talk · AI Governance and Operational Readiness

From Pilots to Production: Scaling Agentic AI in Clinical Operations

Jonathan Crowther, Germany

Talk · Site Partnering, Engagement & Operations

From Sites to Strategic Allies: Elevating Engagement to Drive Portfolio Delivery

Awara Gbeblewo, CSL

Talk · Clinical Data Strategy and AI Innovation

Turning Yesterday’s Trial Data into Tomorrow’s Clinical Insight

Veronique Poinsot, Sanofi

Talk · Patient Engagement and Recruitment

Qualified & Engaged Patients by Design: How AI and Human Expertise Can Improve Trial Readiness

Jytte van Huijstee, myTomorrows · Anna Bartels, myTomorrows

Talk · Risk-Based Quality Management

The RBQM Trap: Can You Prove Your Risk Assessment Changed Study Conduct?

Artem Andrianov, Cyntegrity Germany GmbH

Talk · Clinical Data Strategy and AI Innovation

From Silos to Signals: Translation, eCOA, and AI as Connected Strategic Enablers

Elinor Rees, IQVIA · Dave Ledley, IQVIA

Talk · Trial Design and Protocol Development

Less Burden, Better Retention: A High-Impact Strategy Hiding in Plain Sight

Jeff Huntsman, EmVenio

Talk · AI Governance and Operational Readiness

Beyond the AI Agent: Designing Trusted Agentic Workflows for Clinical Development

Yatesh Midha, Saama

Break

Grand Opening Coffee Break in the Exhibit Hall

Talk

Organiser's Welcome to SCOPE Europe

Micah Lieberman, Cambridge Healthtech Institute

Keynote

KEYNOTE PRESENTATION: Past Pressures, Present Progress and a Promising Future: The UK Clinical Trials Story

Lawrence Tallon, Medicines and Healthcare Products Regulatory Agency (MHRA)

Panel

KEYNOTE PANEL: Can Europe Compete for the Future of Clinical Trials? Competitiveness, Regulation, and Investment

James O'Shaughnessy, UK Government · Elena Bolaños Cascales, Johnson & Johnson · Pilar De la Rocha Mur, BeOne Medicines · Thera Max-Mos, Central Committee on Research Involving Human Subjects (CCMO) · Lawrence Tallon, Medicines and Healthcare Products Regulatory Agency (MHRA)

Keynote

KEYNOTE PRESENTATION: FAST EU & ACT EU in Practice: What’s Actually Accelerating Clinical Trials in Europe and What Isn’t

Thera Max-Mos, Central Committee on Research Involving Human Subjects (CCMO)

Panel

KEYNOTE PANEL: Reinventing the Clinical Development Operating Model: New Models for Clinical Execution

Caroline Feys, J&J Innovative Medicine · Tim Horlacher, Bayer · Maria Koutsopoulou, Merck KGaA · Matthieu Ruffin, Novartis

Networking

Join Your Peers for a Networking Luncheon in the Exhibit Hall

Talk · Clinical Data Strategy and AI Innovation

Next-Gen Digital Endpoints in Clinical Trials: Using AI-Processed Longitudinal Sensor Data to Drive More Precise and Faster Parkinson’s Trials

Ventsislav Dobrev, F. Hoffmann La Roche AG

Talk · Feasibility and Site Selection

AI- and ML-Driven Analysis of Site Performance in Clinical Trials

Clara Cali Mella, Bayer AG

Talk · Patient Engagement and Recruitment

The Four Elements—Toward a Harmonised Recruitment Tracking

Frank M Berger, Boehringer Ingelheim Pharma GmbH & Co KG

Talk · Risk-Based Quality Management

Engineering RBQM at Scale: From Fragmented Integration to Intelligent Oversight

Julia Movshovich, Pfizer Inc. · Malgorzata Skrzypczak, Pfizer Inc.

Talk · Trial Design and Protocol Development

Protocol Design That Holds Up at Start-Up

Maria Bowen, Daiichi Sankyo

Talk · AI Governance and Operational Readiness

Designed In, Not Bolted On

Sara M. Huehls, Eli Lilly & Co.

Talk · Site Partnering, Engagement & Operations

Concierge Site Engagement: Understanding Site Personas & Integrating Voice of the Customer

Justin Bandura, Inc.

Talk · Clinical Data Strategy and AI Innovation

From Pre-competitive Collaboration to Regulatory-Ready Endpoints: A Bayer–DEEP Measures Case Study in Late-Onset Pompe Disease

John Batchelor · Julien Kroll, Bayer HealthCare

Talk · Feasibility and Site Selection

AI across the Clinical Workflow: From Study Design to Execution

Abhishek Chatterjee, H1 · Joshua Jacob, Novo Nordisk A/S · Akanksha Gupta, Novo Nordisk AS

Talk · Patient Engagement and Recruitment

From Feasibility to Enrollment in Europe: A Sponsor-Led Case Study in Site Enrollment and Engagement

Zoltan Varga, IQVIA · Sarah Thinnesen, IQVIA

Talk · Risk-Based Quality Management

Beyond RBQM: How Intelligent RBQM Gives Sponsors and CROs a Measurable Edge

Duncan Hall, TRI

Talk · Clinical Data Strategy and AI Innovation

eCOA Innovations to Increase Patient Engagement

Ben James, uMotif

Talk · Trial Design and Protocol Development

Leveraging Real-World Data and Laboratory Operational Innovation to Enable Trial Optimisation

Viviane Manghi, Labcorp

Talk · AI Governance and Operational Readiness

Responsible AI in Clinical Trials: A Guardrails-Based Approach

Daniela Duffett, Suvoda

Talk · Site Partnering, Engagement & Operations

Local Everywhere: A Global Framework for Participant Engagement, Retention & Trial Success

Andy Thurstan, Mural Health

Talk · Site Partnering, Engagement & Operations

Reducing Site Burden through Risk-Based Equipment Strategies

Alejandra Medina, Quipment

Panel · Feasibility and Site Selection

PANEL DISCUSSION: Increasing Transparency & Trust in Site Selection

Viviënne van de Walle, PT&R | Partner in Trials & Research · Amy Froment, Jazz Pharmaceuticals · Kayleigh Rogers, Siteworks Clinical Research · Edward Walsh, Pfizer Inc.

Talk · Patient Engagement and Recruitment

Leveraging Multimodal Data & Predictive Modelling to Improve Patient Retention

Lars Hulstaert, Johnson & Johnson Innovative Medicine · Yu Mao, Johnson & Johnson Innovative Medicine

Talk · Risk-Based Quality Management

Bridging Protocol Complexity and Compliance: Leveraging AI for Precision Risk Identification in Risk-Based Quality Management

Alessia Cantamessa, F. Hoffmann La Roche AG

Talk · Clinical Data Strategy and AI Innovation

From Process Intelligence to AI-Accelerated Clinical Trials

Wahib Joseph Abboud, Novo Nordisk AS · Ibrahim Kamstrup-Akkaoui, Novo Nordisk AS

Talk · Trial Design and Protocol Development

Prioritising Biospecimen Management before the Protocol Locks: A Cross-Stakeholder Framework for Better Planning

Karina Bienfait, Bristol Myers Squibb Co. · Amy Ripston, Biospecimen Management Consortium · Grigori Singovski, Hoffmann-La Roche · Diana Steinbuesch, Roche

Talk · AI Governance and Operational Readiness

The Algorithm Will See You Now: High-Impact AI in Clinical Studies

Carina Bjørnskov Steenholt, Novo · Ravinder Kaur, Novo Nordisk AS · Lars Pilegaard Thomsen, Novo Nordisk

Panel · Site Partnering, Engagement & Operations

PANEL DISCUSSION: Reducing the Burden of Clinical Trial Execution via Site-Focused Support

Nadir Ammour, Sanofi Group · Anthony Avornyo, Ameli Biogroup Ltd. · Daniela Karl, Neuropraxis München · Javier Malpesa Barcones, Novartis

Talk · Patient Engagement and Recruitment

Building and Measuring Participant Support beyond Recruitment

Anya Zeitlin, Trial Flow

Talk · Risk-Based Quality Management

RBQM & Change Management: The Marriage We Keep Avoiding

Frederic Blais, CluePoints

Talk · Clinical Data Strategy and AI Innovation

eCOA Isn’t a Commodity: Protecting Endpoint Integrity with Behavior-Informed Design, UAT, and Monitoring

Melissa Mooney, IQVIA

Talk · Trial Design and Protocol Development

The Care Pathway as a Decision Engine: Beyond Mapping, toward Smarter Trial Design

Mihail Tanev, TrialHub · Bert Hartog, Hartog Digital Health Consulting (HDHC)

Talk · AI Governance and Operational Readiness

Breaking Silos to Enable AI-Driven Enhancement: Shared Governance Between Sponsor and CRO

Andrew Barron, Syneos Health · Shyard Wong, Sanofi

Talk · Feasibility and Site Selection

Partnering with Sites Using AI to Identify and Enroll More Patients, Faster

Kourosh Davarpanah · Liz Beatty, inato · Nadir Ammour, Sanofi Group

Talk · Site Partnering, Engagement & Operations

Rethinking Site Training: Value over Volume

Mette Flindt Heisterberg, Novo Nordisk · Ann Katrine Miranda, Novo Nordisk

Talk · Patient Engagement and Recruitment

Best Practices in Patient Recruitment Technology

Eric Sandor, TrialX

Talk · Risk-Based Quality Management

The Deviations Your Monitors Never See and Performance Gaps You Didn't Know About

Jagoda Jablonska, Espresso Clinical

Talk · Clinical Data Strategy and AI Innovation

Data Was Never the Problem: Closing Europe's Feasibility Gap with the US

Pedro Ramos, Promptly Health

Talk · Trial Design and Protocol Development

The Gap Between Eligible and Enrollable

Ashley Brenton, Syneos Health

Talk · Feasibility and Site Selection

Beyond Site Selection: From Predicting Delays to Preventing Them

Dhvanil Karia, Credible Planning · Gaurang Ganatra, Jalson Business Solutions LLP

Talk · Patient Engagement and Recruitment

Aligning Patient Engagement in Clinical Trials with Corporate Branding: Proven Value through Successful Pilots and Key Metrics

Christophe Aubertin · Olivier Flexas, Sanofi

Panel · Clinical Data Strategy and AI Innovation

PANEL DISCUSSION: Efficiency+ SWG: Improve Clinical Trial Operations through Advanced Statistics

Clara Cali Mella, Bayer AG · Ken Getz, Tufts University School of Medicine · Bhargava Reddy, Janssen · Chenguang Wang, Inc. · Marion Wolfs, Bristol Myers Squibb

Talk · Trial Design and Protocol Development

Designing Trials with Biospecimens in Mind: Creating Best Practice for a Data-Driven Future

Catherine Mela, GSK · Brenda Yanak, Clinical Transformation Partners LLC

Talk · AI Governance and Operational Readiness

Insights into Effective AI Management and Implementation Strategies: Lessons from the Bayer Pharma Journey

Joerg Dobers, Bayer AG · Celia Miguel Blanco, Bayer

Networking

Reception in the Exhibit Hall with Beer, Wine, and Tapas

Break

Registration and Morning Coffee

Talk · Feasibility and Site Selection

From Decision to Activation: How a Biotech Built a High-Velocity Site Selection Engine

Pilar De la Rocha Mur, BeOne Medicines

Talk · Patient Engagement and Recruitment

Framework for Connected Operations from a Global Strategy to Local Execution

Nidhi Saxena, Johnson & Johnson

Talk · Risk-Based Quality Management

What Are These Critical to Quality Factors Anyway?

Keith Dorricott, Dorricott Metrics & Process Improvement Ltd.

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

Data Products in Practice: The Blueprint for Scalable Decisions in Clinical Development

Gernot Weber, Johnson & Johnson Innovative Medicine

Talk · Trial Design and Protocol Development

Closing the Gap between Design and Delivery: A Sponsor-Investigator Network Model in Action

Astrid Schut, WCN (Dutch Cardiovascular Investigator Network) · Jozien Sterck, Novo Nordisk

Talk · Site Partnering, Engagement & Operations

Designing with Sites, Not for Them: Rethinking Technology in Clinical Trials

Guillermo Carbonell, Boehringer Ingelheim

Talk · Feasibility and Site Selection

Centaur—The Site-First Platform: Where Operational Efficiency Meets Human Expertise

Erbin Lim, Pfizer · Nadia Lim, Pfizer · Ana Maria Sanchez De La Nava, Pfizer

Talk · Patient Engagement and Recruitment

Novo's Approach to Recruitment & Retention in CVOTs

Adam Dubayev, Novo Nordisk · Elin Hilstrøm Hoffmann, Novo

Talk · Risk-Based Quality Management

From Signals to Decisions: Making RBQM Actionable at the Study-Level

Lydia Matombo, AbbVie

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

Talk to Your Data: The Next Interface Shift in Clinical Trials

Royden James, Viedoc

Talk · Trial Design and Protocol Development

Yes, You Can (Digitalise That)—Streamlining Study Design through Protocol Digitalisation

Camilla Kehler, Novo Nordisk

Talk · Site Partnering, Engagement & Operations

Streamlining Execution across Complex Trial Ecosystems

Uday Prakash, Whatfix · Chris John, Whatfix

Talk · Feasibility and Site Selection

Bedrock to Frontier: How a Feasibility Foundation Unlocked an AI Ecosystem

Stathis Stathelos, AstraZeneca

Talk · Patient Engagement and Recruitment

Optimizing Patient Centricity to Help Address the Global Enrollment Crisis

Ken Getz, Tufts University School of Medicine

Talk · Risk-Based Quality Management

Less Noise, More Value: From Identifying Critical to Quality Data to Prioritising It

Tomasz Zawadzki, AstraZeneca

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

ClinicalAIDEN: An Agentic AI-Powered Decision Support System Transforming Clinical Trial Feasibility and Study Design

Eusebio Garcia Reina, Bayer AG

Talk · Trial Design and Protocol Development

From Tabletop to Trial: Enabling Embedded Pragmatic Trials and Selective Safety Data Collection

Zhanna Jumadilova, Pfizer Inc.

Talk · Site Partnering, Engagement & Operations

Building the Future of Clinical Trials through Site‑Centric Collaboration

Nadir Ammour, Sanofi Group

Talk · Feasibility and Site Selection

Beyond Site Selection: Building a Connected Workflow for Faster Study Start-Up

Andrea Bastek, Florence Healthcare

Talk · Patient Engagement and Recruitment

Beyond AI Features: Disruptions That Transform Patient Recruitment Scale and Costs

Brian Weiss, Inc.

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

Using Artificial Intelligence-Driven Risk Prediction and CRA Intervention to Improve Enrollment Outcomes at Clinical Trial Sites

Tim Mudric, Thermo Fisher Scientific

Talk · Trial Design and Protocol Development

Pressure-Test Your Protocol: Leveraging AI-Powered Predictions to Optimise Enrollment & Retention

Robert Buka, Medidata a Dassault Systemes Co.

Talk · Site Partnering, Engagement & Operations

From Fragmentation to Flow: How Unified Financial Platforms Are Transforming Trial Execution

Zahiah Gueddar, IQVIA Technologies · Lorenzo Parma, IQVIA Technologies

Break

Coffee Break in the Exhibit Hall

Panel · Site Partnering, Engagement & Operations

PANEL DISCUSSION: We Mapped What Sites Actually Do to Prepare Source Docs—The Results Are Eye-Opening

Jonathan Andrus, Society for Clinical Data Management · Jack Evans, Civia Health · Agnieszka Gackowska, MediVera · Ken Getz, Tufts University School of Medicine · Claire Sears, EMS Healthcare

Panel · Feasibility and Site Selection

PANEL DISCUSSION: Improving Site Activation and Patient Enrollment Performance

Zachary Smith, Tufts Center for the Study of Drug Development · Mathias Fallstrom, AbbVie · Laura Meloni, Johnson & Johnson Innovative Medicine · Emilio Neto, Biogen

Talk · Patient Engagement and Recruitment

Diversity in Clinical Trials—What’s Working, What’s Next

Isabella Darbyshire, NIHR Research Delivery Network · Binita Patel, Bayer · Sharon Rivera Sanchez, Trials of Color · Adrienn Szabo, Novo Nordisk AS

Panel · Risk-Based Quality Management

PANEL DISCUSSION: Helping to Ensure Your Study-Specific KRIs Are up to the Job

Keith Dorricott, Dorricott Metrics & Process Improvement Ltd. · Louise Flint, Amgen Ltd. · Johann Proeve, Cyn­tegrity · Amandeep Sonik, Thermo Fisher Scientific

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

Transforming Clinical Trial Documents into an AI‑Driven Knowledge Layer

Bhargava Reddy, Janssen · Salvatore Saporito, Johnson & Johnson Innovative Medicine

Panel · Trial Design and Protocol Development

PANEL DISCUSSION: Pitch to the Patient: Fast-Track Feedback for Trial Innovation

Alexandra Charge, reCharge reSearch · Maria Bowen, Daiichi Sankyo · Steve Clark, Strive for Five CIC · Pilar Cocián, Patient Advocate · Alejandro Fernandez, Patient Advocate · Caroline Feys, J&J Innovative Medicine · Terttu Haring, Johnson & Johnson Innovative Medicine · Zhanna Jumadilova, Pfizer Inc.

Panel · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

PANEL DISCUSSION: From Policy to Practice: Implementing AI While Maintaining GCP Compliance and Data Integrity

Marc Wartenberger, CRIO · Charlotte Byng, Fortrea · Megan Olberding, MSD · Aurora Rojo Sanchís, Spanish Agency for Medicines and Medical Devices (AEMPS – Agencia Española de Medicamentos y Productos Sanitarios)

Networking

Join Your Peers for a Networking Luncheon in the Exhibit Hall

Talk · Feasibility and Site Selection

Listening beyond the Numbers: Using Qualitative Insights to Understand Patient and Site Burden

Marcus J. Duff, Biogen

Panel · Patient Engagement and Recruitment

PANEL DISCUSSION: Population Standards: The Missing Infrastructure Layer between Regulatory Intent and Protocol Execution

Craig Davenport, SGMA · Garo Kiledjian, SGMA · Binita Patel, Bayer · Andrew Ustianowski, UK

Talk · Risk-Based Quality Management

Integrating Centralised and Site Monitoring in a Risk-Based Approach for Study Oversight

Greg Cinciala, MSD · Helen Wong, MSD

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

Closing the Loop: A Validated Generative AI Framework for High-Quality Clinical Queries Drafting and Quality Oversight for Analytical Monitors

Qasim Bukhari, Johnson & Johnson Innovative Medicine · Jesús Medina Villaumbrales, Johnson & Johnson Innovative Medicine

Talk · Trial Design and Protocol Development

Practical Experience Integrating Sustainability as a Consideration in Clinical-Trial Design

Jason LaRoche, Johnson & Johnson Innovative Medicine

Talk · Site Partnering, Engagement & Operations

Advancing Portfolio-Level Site Collaboration in Neuroscience: Insights from J&J's Site and Patient Advisory Network Model

Narinder Chopra, J&J Innovative Medicine · Terttu Haring, Johnson & Johnson Innovative Medicine

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

From Virtual Teams to Convergent Evidence: Risk-Based Validation for AI-Driven Exploratory Clinical Analysis

Alejandro Gonzalez, Genmab AS

Talk · Site Partnering, Engagement & Operations

You Changed Your Sourcing Model, Did You Change How You Work?

Eric Vigas Saenz, AstraZeneca

Talk · Feasibility and Site Selection

Flipping the Script: From CRO Risk to Site Accountability in a Large UK Community Site Network

Daphne Hazell, Primary Care Research Alliance

Fireside chat · Patient Engagement and Recruitment

Fireside Chat: Beyond Incremental Improvement: Reimagining How We Recruit and Run Clinical Trials

Martin J. Landray, Protas · Craig Lipset, Decentralized Trials & Research Alliance (DTRA)

Talk · Risk-Based Quality Management

Beyond Traditional Sponsor Oversight: Innovation, Insight, Impact

Natalia Buchneva, UCB

Panel · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

PANEL DISCUSSION: AI Lifecycle and Governance in Clinical Research

Disa Lee Choun, Johnson & Johnson · Carrie BenSaid, Novartis Pharma AG · Jonathan Crowther, Germany · Robert McGregor, Novartis

Panel · Trial Design and Protocol Development

PANEL DISCUSSION: New Benchmarks on Clinical-Trial Sourcing Models and Their Association with Trial Performance

Zachary Smith, Tufts Center for the Study of Drug Development · Wendy Bilham, Syneos Health · James Chennells, Bayer · Barry Cymerman, Daiichi Sankyo · Carina Reinicke, Boehringer Ingelheim

Talk · Site Partnering, Engagement & Operations

From Fragmented Sites to Federated Networks: Building Scalable, Audit-Ready Clinical Trial Infrastructure across Emerging Markets

Tariro Makadzange, ACRN Africa Clinical Research Network

Talk · Feasibility and Site Selection

Country, Site, Investigator: What Agentic Feasibility Unlocks When the Data Is Ready

Claire Riches, Citeline · Brian Mundy, Citeline

Talk · Patient Engagement and Recruitment

How AI Feasibility and Pre-Screening at the Point of Care Increases Enrollment at Cancer Centers

Speaker to be Announced

Talk · Risk-Based Quality Management

Living with RBQM: Stories from the Frontlines

Marcin Makowski, GlaxoSmithKline

Talk · Clinical Data Strategy and AI Innovation · AI Governance and Operational Readiness

Closing the Trial Design: Execution Gap Leveraging AI Powered by Digitized Protocol Intelligence and Proprietary Operational Data

Mette Smedegaard Andersen, WCG Clinical

Talk · Trial Design and Protocol Development

The Protocol That Almost Wrote Itself—How AI Transforms Study Design, Protocol Digitisation, and Clinical Document Authoring

Pablo Chirosa Lara, Evinova · Francesco Multari, Evinova · Gernot Weber, Johnson & Johnson Innovative Medicine · Maria Bowen, Daiichi Sankyo · Carlos Erasun, AstraZeneca

Break

Transition to Plenary Keynote

Other

SCOPE 365 and TransCelerate Biopharma Challenge: Automating the Configuration of Data Acquisition

Keynote

KEYNOTE PRESENTATION: AI-Driven Computational Twins in Clinical Research: Simulating Feasibility, Site Performance, and Trial Operations

Robert McGregor, Novartis

Keynote

KEYNOTE PRESENTATION: When Investigator Sites Choose Sponsors: The Silent Shift Reshaping Clinical Operations

Nick Hodges, Ipsen

Panel

KEYNOTE PANEL: Sites and Sponsors: Reducing Site Burden and Operational Friction

Andrew Ustianowski, UK · Nadir Ammour, Sanofi Group · Terttu Haring, Johnson & Johnson Innovative Medicine · Nick Hodges, Ipsen · Viviënne van de Walle, PT&R | Partner in Trials & Research

Talk

Closing Remarks and Next Steps

Micah Lieberman, Cambridge Healthtech Institute